Language and Literacy Acquisition through Parental Mediation in American Sign Language

Science.gov (United States)

Bailes, Cynthia Neese; Erting, Lynne C.; Thumann-Prezioso, Carlene; Erting, Carol J.

2009-01-01

This longitudinal case study examined the language and literacy acquisition of a Deaf child as mediated by her signing Deaf parents during her first three years of life. Results indicate that the parents' interactions with their child were guided by linguistic and cultural knowledge that produced an intuitive use of child-directed signing (CDSi)…

Parental Perception of a Baby Sign Workshop on Stress and Parent-Child Interaction

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Mueller, Vannesa; Sepulveda, Amanda

2014-01-01

Introduction: Baby sign language is gaining in popularity. However, research has indicated a lack of empirical research supporting its use. In addition, research suggests that baby sign training may increase stress levels in parents. Methods: Nine families with children ranging in age from six months to two years; five months participated in a…

What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey.

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Carrol Gamble

Full Text Available To investigate parents' views about deferred consent to inform management of trial disclosure after a child's death.A postal questionnaire survey was sent to members of the Meningitis Research Foundation UK charity, whose child had suffered from bacterial meningitis or meningococcal septicaemia within the previous 5 years. Main outcome measures were acceptability of deferred consent; timing of requesting consent; and the management of disclosure of the trial after a child's death.220 families were sent questionnaires of whom 63 (29% were bereaved. 68 families responded (31%, of whom 19 (28% were bereaved. The majority (67% was willing for their child to be involved in the trial without the trial being explained to them beforehand; 70% wanted to be informed about the trial as soon as their child's condition had stabilised. In the event of a child's death before the trial could be discussed the majority of bereaved parents (66% 12/18 anticipated wanting to be told about the trial at some time. This compared with 37% (18/49 of non-bereaved families (p = 0.06. Parents' free text responses indicated that the word 'trial' held strongly negative connotations. A few parents regarded gaps in the evidence base about emergency treatments as indicating staff lacked expertise to care for a critically ill child. Bereaved parents' free text responses indicated the importance of individualised management of disclosure about a trial following a child's death.Deferred consent is acceptable to the majority of respondents. Parents whose children had recovered differed in their views compared to bereaved parents. Most bereaved parents would want to be informed about the trial in the aftermath of a child's death, although a minority strongly opposed such disclosure. Distinction should be drawn between the views of bereaved and non-bereaved parents when considering the acceptability of different consent processes.

When Can the Child Speak for Herself? The Limits of Parental Consent in Data Protection Law for Health Research.

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Taylor, Mark J; Dove, Edward S; Laurie, Graeme; Townend, David

2017-11-13

Draft regulatory guidance suggests that if the processing of a child's personal data begins with the consent of a parent, then there is a need to find and defend an enduring consent through the child's growing capacity and on to their maturity. We consider the implications for health research of the UK Information Commissioner's Office's (ICO) suggestion that the relevant test for maturity is the Gillick test, originally developed in the context of medical treatment. Noting the significance of the welfare principle to this test, we examine the implications for the responsibilities of a parent to act as proxy for their child. We argue, contrary to draft ICO guidance, that a data controller might legitimately continue to rely upon parental consent as a legal basis for processing after a child is old enough to provide her own consent. Nevertheless, we conclude that data controllers should develop strategies to seek fresh consent from children as soon as practicable after the data controller has reason to believe they are mature enough to consent independently. Techniques for effective communication, recommended to address challenges associated with Big Data analytics, might have a role here in addressing the dynamic relationship between data subject and processing. Ultimately, we suggest that fair and lawful processing of a child's data will be dependent upon data controllers taking seriously the truism that consent is ongoing, rather than a one-time event: the core associated responsibility is to continue to communicate with a data subject regarding the processing of personal data. © The Author 2017. Published by Oxford University Press.

Informed consent in clinical research; Do patients understand what they have signed?

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Elena Villamañán

2016-05-01

Full Text Available Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial

Voluntary Informed Consent in Paediatric Oncology Research.

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Dekking, Sara A S; Van Der Graaf, Rieke; Van Delden, Johannes J M

2016-07-01

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. © 2015 John Wiley & Sons Ltd.

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

Directory of Open Access Journals (Sweden)

Duszynski Katherine M

2011-01-01

Full Text Available Abstract Background The Vaccine Assessment using Linked Data (VALiD trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods/Design Single-centre, single-blind, randomised controlled trial (RCT stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response. A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. Discussion The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12610000332022

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

Science.gov (United States)

Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

2011-01-04

The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

OpenAIRE

Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

2011-01-01

Abstract Background The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods...

Informed consent and stimulant medication: adolescents' and parents' ability to understand information about benefits and risks of stimulant medication for the treatment of attention-deficit/hyperactivity disorder.

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Schachter, Debbie; Tharmalingam, Sukirtha; Kleinman, Irwin

2011-04-01

This study of informed consent examines understanding of information needed to consent to stimulant treatment for attention-deficit/hyperactivity disorder (ADHD). The understanding of adolescents with ADHD, their parents, control adolescents, and their parents is compared. Fifty-eight ADHD and 64 control adolescents between the ages of 12 and 16 and their parents were studied. Baseline understanding of information was determined. Subjects received information relevant to informed consent for stimulation medication and afterward were evaluated on their recall understanding and their final understanding. Knowledge was increased after the information session for all subjects. There was no significant difference between unadjusted baseline, recall, and final knowledge of control adolescents and parents. Although unadjusted baseline, recall, and final knowledge of ADHD adolescents is significantly less than that of parents, 78% of ADHD adolescents had final understanding scores within 2 standard deviations of parents' scores. After controlling for baseline understanding and cognitive variables, there was no significant difference between understanding of ADHD adolescents and ADHD parents, whereas control adolescents understanding scores were higher than that of their parents. Understanding was highly associated with mathematics achievement in all groups. The majority of adolescents with ADHD, both with and without a history of stimulant medication treatment, have understanding that is similar to their parents and their inclusion in the informed consent process should be encouraged. Extra care should be afforded to those adolescents with low numeracy or literacy to ensure their understanding.

Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study

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Kiguba Ronald

2012-08-01

Full Text Available Abstract Background The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Results Of the 600 participants interviewed, two thirds (64.2%, 385/600 were female. Overall mean age of study participants was 37.6 (SD = 7.7 years. Amongst all participants, less than a tenth (5.9%, 35/598 reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597 reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596 of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

Science.gov (United States)

Kiguba, Ronald; Kutyabami, Paul; Kiwuwa, Stephen; Katabira, Elly; Sewankambo, Nelson K

2012-08-21

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

[Informed consent and parental refusal for medical treatment in childhood. The threshold of medical and social tolerance. Part II].

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Guadarrama-Orozco, Jessica H; Garduño Espinosa, Juan; Vargas López, Guillermo; Viesca Treviño, Carlos

Medical care in pediatric patients is conditional to parental consent. Parents decide the time and type of treatment they want their children to receive when they are ill. The physician should request parental consent before carrying out the most appropriate therapy. When parents refuse the treatment offered, the physician should seek alternative therapies that may be better accepted by parents and find the most beneficial treatment for children and their families. If physicians and parents are unable to agree on the best therapeutic methods, then the physician becomes involved in an ethical conflict related to the best interests of the child and parental choices. From the above posture, the following questions arise: What should the physician do when faced with this situation? Should the physician use legal measures to force parents to accept treatment? Under what conditions is it justified to force parents and when should the decision be tolerated? What is the role of the Hospital Bioethics Committee concerning this issue? This second part focuses on proposing four practical criteria to be used by the physician and Hospital Bioethics Committee when all alternative therapies and conciliatory options have been exhausted with parents and they continue to refuse treatment. The physician then has to make a decision because the child is placed at risk of harm. This decision focuses on whether there is danger to the minor arising from the decisions of parents and if such harm is avoidable. Copyright © 2015 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

Obtaining active parental consent for school-based research: a guide for researchers.

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Wolfenden, Luke; Kypri, Kypros; Freund, Megan; Hodder, Rebecca

2009-06-01

Schools increasingly require researchers to obtain active parental consent for students to participate in health research. We sought to identify effective strategies for the recruitment of child research participants through schools. A search of Medline, PsycINFO, Educational Resources Information Center, ProQuest 5000 and the Cochrane Library electronic databases was conducted for the period 1988 to 2008. The review found evidence that the following strategies may be effective in enhancing participation rates: 1) promotion of the research to school principals, teachers, parents and students; 2) dissemination of study information using methods allowing direct contact with parents (i.e. telephone or face-to-face); 3) provision of incentives to teachers, students and at a class level; 4) making reminder contacts; and 5) having a member of the research team co-ordinate and closely monitor the recruitment process. Application of these strategies should reduce the risk of non-response and other biases that result from selective non-participation. Further randomised controlled trials of these and other strategies are required to strengthen the evidence base.

1,2-Ethylene Dichloride; Final Enforceable Consent Agreement and Testing Consent Order

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This document announces that EPA has signed an enforceable testing Consent Order with the Dow Chemical Co, Vulcan Materials Co, Occidental Chemical Corp, Oxy Vinyls, LP, Georgia Gulf Corp, Westlake Chemical Corp, PPG Industries, Inc., and Formosa Plastics.

Interactive informed consent: randomized comparison with paper consents.

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Michael C Rowbotham

Full Text Available Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session. Among research professionals (n = 14, there was a trend (p = .07 in the direction of iPad subjects testing better on the online test (mean correct  =  77% compared with paper subjects (mean correct = 57%. Among patients (n = 55, iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001. For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz. Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.

Testing Consent Order on Refractory Ceramic Fibers

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This notice announces that EPA has signed signed an enforceable testing consent order under the Toxic Substances Control Act (TSCA), 15 U.S.C. section 2601 at seq., with three of the primary producers of refractory ceramic fibers (RCF).

Informed consent in paediatric critical care research--a South African perspective.

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Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

2015-09-09

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both

Legal protection of informed consent of minors.

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Osuna, Eduardo

2010-06-01

One of the pillars of healthcare provision is respect for the autonomy of the patient's wishes, which is given substance by the process of obtaining informed consent. Minors deserve special protection, entitled to basic rights and increasingly autonomous as they develop. In certain situations, minors are deemed matures and able to consent to treatment without the involvement of a parent or guardian. The assessment of competence would be based on the child's functional ability, not on age or outcome of the decision. This manuscript includes a brief analysis of legal perspectives on informed consent of minors, and minors' capacities to make medical decisions. Remaining questions of how to evaluate capacity and balance parental and minor autonomy are explored. Considerations on informed consent in different situations as refusing treatment and termination of pregnancy by female children are analyzed.

Adolescents and consent to treatment.

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Dickens, B M; Cook, R J

2005-05-01

Adolescents, defined by WHO as 10 to 19 years old, can give independent consent for reproductive health services if their capacities for understanding have sufficiently evolved. The international Convention on the Rights of the Child, almost universally ratified, limits parental powers, and duties, by adolescents' "evolving capacities" for self-determination. Legal systems may recognize "mature minors" as enjoying adult rights of medical consent, even when consent to sexual relations does not absolve partners of criminal liability; their consent does not make the adolescents offenders. There is usually no chronological "age of consent" for medical care, but a condition of consent, meaning capacity for understanding. Like adults, mature minors enjoy confidentiality and the right to treatment according to their wishes rather than their best interests. Minors incapable of self-determination may grant or deny assent to treatment for which guardians provide consent. Emancipated minors' self-determination may also be recognized, for instance on marriage or default of adults' guardianship.

What a signature adds to the consent process.

LENUS (Irish Health Repository)

Neary, Peter

2012-02-03

BACKGROUND: "Consent is a process by which a patient is informed and becomes a participant in decisions regarding their medical management." It is argued, however, that providing a signature to a form adds little to the quality of this process. METHODS: Views regarding the consent ritual of nonselected patients undergoing endoscopy (cystoscopy or sigmoidoscopy) were prospectively studied together with those of the attending staff. Patient volunteers were randomly assigned to one of two groups and given verbal explanation before the procedure, either alone (group A) or with a request to sign a form in addition (group B). A standardized questionnaire regarding preferences then was applied. RESULTS: A total of 37 patients (22 men) were studied along with seven staff members. Most surveyed felt that signing a consent form helped to empower the patient (group A, 84%; group B, 83%; staff, 100%). Although the patients mainly believed that it functioned primarily to protect the hospital and doctor (group A, 89%; group B, 67%), only one patient (3% of total) felt that such a formality undermined the patient-doctor relationship. Most staff members favored signing a form (86%). The majority of patients either favored it (group A, 47%; group B, 78%) or expressed no strong preference (group A, 32%; group B, 11%). Interestingly, more women than men preferred signing (73 vs. 55%; p = 0.25), perhaps because more women believed that it functioned to preserve autonomy (93 vs. 77% of men). Age was no particular determinant of perspective. CONCLUSION: Although it may be viewed as primarily serving to protect the doctor and hospital, the formal process of signing written consent forms appeals to patients and staff.

Informed consent - a survey of doctors' practices in South Africa ...

African Journals Online (AJOL)

Informed consent - a survey of doctors' practices in South Africa. ... whether informed consent as envisioned by the law exists in reality. Cross-cultural research is needed to clarify patients' and parents' expectations of informed consent ...

Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department.

Science.gov (United States)

Spencer, Sandra P; Stoner, Michael J; Kelleher, Kelly; Cohen, Daniel M

2015-08-01

Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings. The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice. This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation. One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections. Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.

The accompanying adult: authority to give consent in the UK.

Science.gov (United States)

Lal, Seema Madhur Lata; Parekh, Susan; Mason, Carol; Roberts, Graham

2007-05-01

Children may be accompanied by various people when attending for dental treatment. Before treatment is started, there is a legal requirement that the operator obtain informed consent for the proposed procedure. In the case of minors, the person authorized to give consent (parental responsibility) is usually a parent. To ascertain if accompanying persons of children attending the Department of Paediatric Dentistry at the Eastman Dental Hospital, London were empowered to give consent for the child's dental treatment. A total of 250 accompanying persons of children attending were selected, over a 6-month period. A questionnaire was used to establish whether the accompanying person(s) were authorized to give consent. The study showed that 12% of accompanying persons had no legal authority to give consent for the child's dental treatment. Clinicians need to be aware of the status of persons accompanying children to ensure valid consent is obtained.

Physician counseling, informed consent and parental decision making for infants with hypoplastic left-heart syndrome.

Science.gov (United States)

Paris, J J; Moore, M P; Schreiber, M D

2012-10-01

Until the development in 1980 by William Norwood of a staged palliative surgical procedure for hypoplastic left heart syndrome (HPLHS), there was no treatment for that condition. With medical developments in the 1980s, parents had the option of the Norwood procedure, transplantation or comfort care for a child born with HPLHS. With an improvement in the survival rate for the Norwood procedure from an initial 30% to now better than 80%, some physicians believe that comfort care should no longer be an option. If, however, medically sophisticated parents, who know the neurological and motor skills impairments that accompany HPLHS, object to the surgery, they are allowed to opt for comfort care. This two-pronged approach to medical treatment seems to violate the norms on equity and fairness in the care of the patient. Parents need to be informed about long-term neurological and motor skill development as well as survival rates to give informed consent.

Use of informed consent with therapeutic paradox.

Science.gov (United States)

Farkas, M M

1992-01-01

Debate persists in the literature and among clinicians about the ethical appropriateness of paradoxical interventions. It has been suggested that informed consent with therapeutic paradox would alleviate ethical concerns of deception, manipulation, harm to the client, and withholding of information from the client in therapy. The purpose of this study was to explore health care consumer reactions to the benefits and risks of therapeutic paradox as stated in a consent for treatment form. The study explored the responses of 32 medical patients to a hypothetical consent for treatment form for therapeutic paradox. Data were collected in a brief semistructured interview after subjects read the hypothetical consent form. Utilizing a case study, the investigator then offered an example of a successful paradoxical intervention and additional subject comments were solicited. Content analysis of the responses was made. Health care consumers had mixed responses to the consent form. While the consent form served as an obstacle for some consumers, many were willing to sign the consent form and accept treatment even though they had internal reservations and questions. Appropriateness of the consent form format is discussed.

Informed Consent in Pediatric Oncology: A Systematic Review of Qualitative Literature.

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Alahmad, Ghiath

2018-01-01

Obtaining informed consent in pediatric cancer research can be subject to important ethical challenges because of the difficulty in distinguishing between care and research, which are interrelated. Pediatric oncologists also often conduct research, such as clinical trials, on their own patients, which may influence voluntary informed consent. This review aims to determine the ethical issues encountered in obtaining informed consent in pediatric oncology by identifying and summarizing the findings of existing qualitative studies on this topic. A systematic review of qualitative studies was conducted. Medline, Embase, CINAHL, and PubMed were searched using the following terms: (oncolog* or cancer or hematol* or haematol* or leuk* or malign* or neoplasm*) and (child* or adolescent* or minor* or young people or pediatr* or paediatr*) and ethic* or moral*) and (qualitative or interview). Other sources were also mined to identify all relevant studies. The data analysis method used was thematic analysis. At the end of the search process, 2361 studies were identified. Duplicates were removed and irrelevant studies were excluded. After screening the full text of the remaining studies against our inclusion and exclusion criteria, 13 studies were included in the qualitative analysis. All studies were qualitative studies using semistructured and structured interviews, qualitative analysis of open-ended questions, and observation of informed consent conferences. Four themes were identified: parental comprehension of the trial and medical terms, influence of parental distress on decision-making, no offer of an alternative treatment, and influence of the doctor-parent relationship. Many ethical challenges affect the informed consent process. These challenges may include a lack of parental understanding, the potential influence of treating doctors, and vulnerability because of psychological status. All of these result in parents being unable to give well-informed and voluntary

Testing Consent Order for Sodium Cyanide

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This document announces that EPA has signed an enforceable testing Consent Order with E.I. du Pont de Nemours and Company (DuPont), FMC Corporation (FMC), Degussa Corporation (Degussa), ICI Americas Incorporated (ICI), and Cyanco Company (Cyanco).

An Alternative Consent Process for Minimal Risk Research in the ICU.

Science.gov (United States)

Terry, Melissa A; Freedberg, Daniel E; Morris, Marilyn C

2017-09-01

Seeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit. Prospective cohort study. Five ICUs within a tertiary care hospital. Newly admitted ICU patients 18 years old or older. We administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed. One hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question "Did we make the right choice in waiting until now to ask your consent?" three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%). Most patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.

Music and Sign Language to Promote Infant and Toddler Communication and Enhance Parent-Child Interaction

Science.gov (United States)

Colwell, Cynthia; Memmott, Jenny; Meeker-Miller, Anne

2014-01-01

The purpose of this study was to determine the efficacy of using music and/or sign language to promote early communication in infants and toddlers (6-20 months) and to enhance parent-child interactions. Three groups used for this study were pairs of participants (care-giver(s) and child) assigned to each group: 1) Music Alone 2) Sign Language…

[Evaluation and improvement of the management of informed consent in the emergency department].

Science.gov (United States)

del Pozo, P; García, J A; Escribano, M; Soria, V; Campillo-Soto, A; Aguayo-Albasini, J L

2009-01-01

To assess the preoperative management in our emergency surgical service and to improve the quality of the care provided to patients. In order to find the causes of non-compliance, the Ishikawa Fishbone diagram was used and eight assessment criteria were chosen. The first assessment includes 120 patients operated on from January to April 2007. Corrective measures were implemented, which consisted of meetings and conferences with doctors and nurses, insisting on the importance of the informed consent as a legal document which must be signed by patients, and the obligation of giving a copy to patients or relatives. The second assessment includes the period from July to October 2007 (n=120). We observed a high non-compliance of C1 signing of surgical consent (CRITERION 1: all patients or relatives have to sign the surgical informed consent for the operation to be performed [27.5%]) and C2 giving a copy of the surgical consent (CRITERION 2: all patients or relatives must have received a copy of the surgical informed consent for the Surgery to be performed [72.5%]) and C4 anaesthetic consent copy (CRITERION 4: all patients or relatives must have received a copy of the Anaesthesia informed consent corresponding to the operation performed [90%]). After implementing corrective measures a significant improvement was observed in the compliance of C2 and C4. In C1 there was an improvement without statistical significance. The carrying out of an improvement cycle enabled the main objective of this paper to be achieved: to improve the management of informed consent and the quality of the care and information provided to our patients.

A survey on surgeons' perceived quality of the informed consent process in a Swiss paediatric surgery unit.

Science.gov (United States)

Guinand, Julie; Gapany, Christophe; Simon, Jeanne-Pascale; Wasserfallen, Jean-Blaise; Joseph, Jean-Marc

2015-01-01

To evaluate the levels of satisfaction and opinions on the usefulness of the informed consent form currently in use in our Paediatric Surgery Department. Qualitative study carried out via interviews of senior paediatric surgeons, based on a questionnaire built up from reference criteria in the literature and public health law. Physicians with between 2 and 35 years experience of paediatric surgery, with a participation rate of 92 %, agreed on the definition of an informed consent form, were satisfied with the form in use and did not wish to modify its structure. The study revealed that signing the form was viewed as mandatory, but meant different things to different participants, who diverged over whom that signature protected. Finally, all respondents were in agreement over what information was necessary for parents of children requiring surgery. Paediatric surgeons seemed to be satisfied with the informed consent form in use. Most of them did not identify that the first aim of the informed consent form is to give the patient adequate information to allow him to base his consent, which is a legal obligation, the protection of physicians by the formalisation and proof of the informed consent being secondary. Few surgeons brought up the fact that the foremost stakeholder in paediatric surgery are the children themselves and that their opinions are not always sought. In the future, moving from informed consent process to shared decision-making, a more active bidirectional exchange may be strongly considered. Involving children in such vital decisions should become the norm while keeping in mind their level of maturity.

Neurological soft signs in children with attention deficit hyperactivity disorder: Their relationship to executive function and parental neurological soft signs.

Science.gov (United States)

Gong, Jingbo; Xie, Jingtao; Chen, Gui; Zhang, Yajie; Wang, Suhong

2015-07-30

The correlations between neurological soft signs (NSS) in children with attention deficit hyperactivity disorder (ADHD) and their executive function, symptoms of inattention, and hyperactivity-impulsivity and the NSS of their parents remain unclear. This study aimed to examine: (1) the prevalence of NSS in children with ADHD and their parents; (2) the correlation between the NSS of children with ADHD and the NSS of their parents; and (3) the correlation between the NSS of children with ADHD and their executive function and symptoms. NSS were assessed with the Cambridge Neurological Inventory (CNI) in 57 children with ADHD (and 80 parents) and 60 healthy children (and 75 parents). Executive function was measured with the Behavioral Rating Inventory of Executive Function (BRIEF). Children with ADHD and their parents had significantly higher NSS than normal children and their parents, respectively, and the NSS of children with ADHD were correlated more strongly with the NSS of their fathers than their mothers. No correlation was found between NSS and BRIEF executive function, but Disinhibition in children with ADHD was significantly correlated with hyperactivity-impulsivity symptoms. Paternal and maternal NSS provided different predictions for child NSS. It may be that NSS are more likely to be genetically transmitted by fathers. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia.

Science.gov (United States)

Mboizi, Robert B; Afolabi, Muhammed O; Okoye, Michael; Kampmann, Beate; Roca, Anna; Idoko, Olubukola T

2017-09-02

Communicating essential research information to low literacy research participants in Africa is highly challenging, since this population is vulnerable to poor comprehension of consent information. Several supportive materials have been developed to aid participant comprehension in these settings. Within the framework of a pneumococcal vaccine trial in The Gambia, we evaluated the recall and decay of consent information during the trial which used an audio-visual tool called 'Speaking Book', to foster comprehension among parents of participating infants. The Speaking Book was developed in the 2 most widely spoken local languages. Four-hundred and 9 parents of trial infants gave consent to participate in this nested study and were included in the baseline assessment of their knowledge about trial participation. An additional assessment was conducted approximately 90 d later, following completion of the clinical trial protocol. All parents received a Speaking Book at the start of the trial. Trial knowledge was already high at the baseline assessment with no differences related to socio-economic status or education. Knowledge of key trial information was retained at the completion of the study follow-up. The Speaking Book (SB) was well received by the study participants. We hypothesize that the SB may have contributed to the retention of information over the trial follow-up. Further studies evaluating the impact of this innovative tool are thus warranted.

Impact of verbal explanation and modified consent materials on orthodontic informed consent.

Science.gov (United States)

Carr, Kelly M; Fields, Henry W; Beck, F Michael; Kang, Edith Y; Kiyak, H Asuman; Pawlak, Caroline E; Firestone, Allen R

2012-02-01

Comprehension of informed consent information has been problematic. The purposes of this study were to evaluate the effectiveness of a shortened explanation of an established consent method and whether customized slide shows improve the understanding of the risks and limitations of orthodontic treatment. Slide shows for each of the 80 subject-parent pairs included the most common core elements, up to 4 patient-specific custom elements, and other general elements. Group A heard a presentation of the treatment plan and the informed consent. Group B did not hear the presentation of the informed consent. All subjects read the consent form, viewed the customized slide show, and completed an interview with structured questions, 2 literacy tests, and a questionnaire. The interviews were scored for the percentages of correct recall and comprehension responses. Three informed consent domains were examined: treatment, risk, and responsibility. These groups were compared with a previous study group, group C, which received the modified consent and the standard slide show. No significant differences existed between groups A, B, and C for any sociodemographic variables. Children in group A scored significantly higher than did those in group B on risk recall and in group C on overall comprehension, risk recall and comprehension, and general risks and limitations questions. Children in group B scored significantly higher than did those in group C on overall comprehension, treatment recall, and risk recall. Elements presented first in the slide show scored better than those presented later. This study suggested little advantage of a verbal review of the consent (except for patients for risk) when other means of review such as the customized slide show were included. Regression analysis suggested that patients understood best the elements presented first in the informed consent slide show. Consequently, the most important information should be presented first to patients, and any

[Informed consent consultation as a part of patient safety in pediatric traumatology].

Science.gov (United States)

Kraus, R; Heberer, J

2013-10-01

In pediatric traumatology as in any other surgical specialty, every treatment measure has to be protected by an adequate clarification. A legally effective clarification has to cover various aspects, such as diagnosis, treatment, risk and safety clarification and leads to an informed consent consultation. The contents of this informed consent discussion must be documented. The nature and extent of clarification, among other things depend on the urgency of the procedure and in an emergency it can be dispensed with in pediatric traumatology. In the case of minors the conversation must be conducted basically in the presence of both parents as they alone are legally entitled to give approval. General treatment proxies are not allowed. If it is not possible to talk to both parents the physician is allowed to trust that the parent present represents the will of the absent parent. Intervention cannot be carried out against the will of adolescents capable of self-determination even with the consent of the parents. The application of these rules is illustrated by means of practical examples.

Emergency Physicians, Beware of the Consent Standard of Care

OpenAIRE

Moore, Gregory P.; Matlock, Aaron G.; Kiley, John L.; Percy, Katherine D.

2018-01-01

Many emergency physicians view informed consent as a necessary component of treatments or procedures to be performed on their patients. When such procedures are necessary, often there is a discussion of risks, benefits and alternatives with forms signed to validate the discussion. Two Wisconsin emergency department medical-legal cases have expanded liability of the duty of informed consent. These cases have focused on withholding medication and diagnostic tests.

34 CFR 300.9 - Consent.

Science.gov (United States)

2010-07-01

... SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES... parent revokes consent in writing for their child's receipt of special education services after the child... amend the child's education records to remove any references to the child's receipt of special education...

Key factors in children's competence to consent to clinical research.

Science.gov (United States)

Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

2015-10-24

Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05). Age is the factor that

Informed consent for the administration of an intravenous contrast agent: importance and determinants of patient refusal

International Nuclear Information System (INIS)

Martel, J.; Garcia-Diaz, J. D.

1999-01-01

We proposed to determine the proportion of patients who refuse to undergo intravenous contrast administration and the factors that influence their refusal. Our series consisted of 442 patients who were supposed to undergo imaging studies involving the intravenous injection of an iodine contrast. In a personal interview, the patients were issued a questionnaire specifically designed for this study. The following parameters were recorded: sex, age, inpatient or outpatient status, medical history available, person who informed them about the procedure, person signing the informed consent (patient or other) , highest academic degree, attitude toward receiving the information and degree of concern after reading and signing the consent form. In our series 8.6% of the patients (95% confidence interval: 6-11.2) refused to sign the informed consent form. In addition, there were a number of patients who delayed the procedure or hindered the daily work schedule by some other means. When the relationship between each of the variables studied and refusal to sign the consent form was assessed, significant associations were observed between the latter and the academic level of the patient, his or her degree of concern and having received the information from a trained person. There was also a nearly significant trend toward the association between refusal and the patient's background. Relatively few patients refuse to sign the informed consent to receive intravenous contrast administration but this negative decision interferes with the health care practice. It is possible to identify certain correctable factors that influence the patient in this respect. (Author) 13 refs

Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods.

Science.gov (United States)

Kang, Edith Y; Fields, Henry W; Kiyak, Asuman; Beck, F Michael; Firestone, Allen R

2009-10-01

Low general and health literacy in the United States means informed consent documents are not well understood by most adults. Methods to improve recall and comprehension of informed consent have not been tested in orthodontics. The purposes of this study were to evaluate (1) recall and comprehension among patients and parents by using the American Association of Orthodontists' (AAO) informed consent form and new forms incorporating improved readability and processability; (2) the association between reading ability, anxiety, and sociodemographic variables and recall and comprehension; and (3) how various domains (treatment, risk, and responsibility) of information are affected by the forms. Three treatment groups (30 patient-parent pairs in each) received an orthodontic case presentation and either the AAO form, an improved readability form (MIC), or an improved readability and processability (pairing audio and visual cues) form (MIC + SS). Structured interviews were transcribed and coded to evaluate recall and comprehension. Significant relationships among patient-related variables and recall and comprehension explained little of the variance. The MIC + SS form significantly improved patient recall and parent recall and comprehension. Recall was better than comprehension, and parents performed better than patients. The MIC + SS form significantly improved patient treatment comprehension and risk recall and parent treatment recall and comprehension. Patients and parents both overestimated their understanding of the materials. Improving the readability of consent materials made little difference, but combining improved readability and processability benefited both patients' recall and parents' recall and comprehension compared with the AAO form.

Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release trial [ISRCTN13204258

Directory of Open Access Journals (Sweden)

Weeks Andrew

2006-05-01

Full Text Available Abstract Service users within the NHS are increasingly being asked to participate in clinical research. In Liverpool Women's NHS Foundation Trust, approximately 35% of women take part in research during their pregnancy. For many studies the consent process is simple; information is provided and signed consent is given. There is a difficulty, however, with obtaining informed consent from women in pregnancy who become eligible only when they develop unforeseen complications, especially when they occur acutely. The problem is compounded with women in labour who may be frightened, vulnerable, in pain, under the effect of opiate analgesia, or all of the above. If research to improve the care of these women is to continue, then special consent procedures are needed. These procedures must ensure that the woman's autonomy is protected whilst recognising that women under these circumstances vary enormously, both in their desire for information and their ability to comprehend it. This paper will discuss the obtaining of consent in this situation, and describe an information and consent pathway for intrapartum research which has been developed in collaboration with consumer groups as a way in which these issues can be tackled.

[Ethical dilemma in research: informed consent in clinical studies on persons with dementia].

Science.gov (United States)

Sinoff, Gary

2012-09-01

With the world's population aging, there is an increase in the number of demented elderly. It is vital to study this phenomenon in epidemiological and clinical studies, particularly the effects on the increasing numbers of demented elderly. Researchers need to understand the factors predicting the general decline in the demented elderly. However, before any research is undertaken, it is necessary to obtain approval from the Local Internal Review Board. This committee is responsible to maintain accepted national and international ethical standards. The basis for recruitment to a study is the signature on the informed consent form, where the patient is required to understand the study, internalize the study's aim, to consider all options and finally, to express an opinion. Potential elderly participants need to have their judgment evaluated before signing the form. In cases where the subject is incapable, some countries, including Israel, require that there be a legal guardianship. This is a long and complicated process that causes researchers not to recruit demented patients into a study which may actually be beneficial to all. Some countries allow a proxy to sign informed consent forms to permit the demented subject to participate in the study. Often the threshold may depend on the invasiveness of the intervention. The problem of proxies to sign informed consent form troubles researchers worldwide. This article addresses the history and development of ethics in research, and raises the issue to promote an official policy for proxy consent signing.

Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

Science.gov (United States)

Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

2016-01-01

Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face

A randomized controlled trial of an electronic informed consent process.

Science.gov (United States)

Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

2014-12-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.

Science.gov (United States)

Megone, Christopher; Wilman, Eleanor; Oliver, Sandy; Duley, Lelia; Gyte, Gill; Wright, Judy

2016-09-09

Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental 'consent' to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental 'consent' in a perinatal context, parents are authorising infant participation, not giving 'proxy consent'. Finally, there are reasons for giving weight to both parental 'consent' and the infant's best interests in

Arrays in postnatal and prenatal diagnosis: An exploration of the ethics of consent.

Science.gov (United States)

Dondorp, Wybo; Sikkema-Raddatz, Birgit; de Die-Smulders, Christine; de Wert, Guido

2012-06-01

The introduction of genome-wide arrays in postnatal and prenatal diagnosis raises challenging ethical issues. Here, we explore questions with regard to the ethics of consent. One important issue is whether informed consent for genome-wide array-based testing is in fact feasible, given the wide range of possible outcomes and related options. The proposed alternative of "generic consent" will have to be studied in practice. From an ethical point of view, the question is whether consent would still be sufficiently "informed" in a generic approach. Another issue that has not yet been given much attention is how far parents, or pregnant women and their partners, should be allowed to determine the range of possible outcomes that will or will not be reported back to them. The scope and limits of parents' and prospective parents' right to know or not to know are far from clear. The complex normative issues on the content and weight of these rights can only be answered by taking full account of the rights and interests of all the parties involved: prospective and actual parents, children, and relatives. This paper is the result of a working group meeting preceding the European Society of Human Genetics 2011 Conference, where these issues were addressed. © 2012 Wiley Periodicals, Inc.

[The informed consent in international clinical trials including developing countries].

Science.gov (United States)

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

Informed consent: not just for procedures anymore.

Science.gov (United States)

Feld, Andrew D

2004-06-01

The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.

Orthodontic informed consent considering information load and serial position effect.

Science.gov (United States)

Pawlak, Caroline E; Fields, Henry W; Beck, F Michael; Firestone, Allen R

2015-03-01

Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents. The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom "chunks" at the beginning of an informed consent presentation improved the recall and comprehension of the risks, benefits, and alternatives of orthodontic treatment. A second objective was to evaluate the current related data for recommendable practices. Seventy patient-parent pairs were randomly divided into 2 groups. The intervention group (group A) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment. Group B followed the same protocol without viewing the videotape. All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions. Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook. Lastly, the patients and parents were given 2 reading literacy tests, 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires. There were no significant differences between the groups for sociodemographic variables. There were no significant differences between the groups for overall recall and comprehension; recall and comprehension for the domains of treatment, risk, and responsibility; and recall and comprehension for core, general, and custom items. The positional effects were limited in impact. When compared with previous studies, these data further demonstrate the benefit of improved readability and audiovisual supplementation with the

16 CFR 312.5 - Parental consent.

Science.gov (United States)

2010-01-01

..., to the extent reasonably necessary: (i) To protect the security or integrity of its website or online... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... online contact information of a parent or child to be used for the sole purpose of obtaining parental...

Infant Signs as Intervention? Promoting Symbolic Gestures for Preverbal Children in Low-Income Families Supports Responsive Parent-Child Relationships

Science.gov (United States)

Vallotton, Claire D.

2012-01-01

Gestures are a natural form of communication between preverbal children and parents which support children's social and language development; however, low-income parents gesture less frequently, disadvantaging their children. In addition to pointing and waving, children are capable of learning many symbolic gestures, known as "infant signs," if…

Hope and persuasion by physicians during informed consent.

Science.gov (United States)

Miller, Victoria A; Cousino, Melissa; Leek, Angela C; Kodish, Eric D

2014-10-10

To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. © 2014 by American Society of Clinical Oncology.

Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study.

Science.gov (United States)

Furyk, Jeremy; McBain-Rigg, Kristin; Watt, Kerrianne; Emeto, Theophilus I; Franklin, Richard C; Franklin, Donna; Schibler, Andreas; Dalziel, Stuart R; Babl, Franz E; Wilson, Catherine; Phillips, Natalie; Ray, Robin

2017-11-15

A challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency research. To explore the attitudes of parents to the concept of DC and to expand the knowledge of the limitations to informed consent and DC in these situations. Children presenting with uncomplicated febrile seizures or bronchiolitis were identified from three separate hospital emergency department databases. Parents were invited to participate in a semistructured telephone interview exploring themes of limitations of prospective informed consent, acceptability of the DC process and the most appropriate time to seek DC. Transcripts underwent inductive thematic analysis with intercoder agreement, using Nvivo 11 software. A total of 39 interviews were conducted. Participants comprehended the limitations of informed consent under emergency circumstances and were generally supportive of DC. However, they frequently confused concepts of clinical care and research, and support for participation was commonly linked to their belief of personal benefit. Participants acknowledged the requirement for alternatives to prospective informed consent in emergency research, and were supportive of the concept of DC. Our results suggest that current research practice seems to align with community expectations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study

OpenAIRE

Furyk, Jeremy; McBain-Rigg, Kristin; Watt, Kerrianne; Emeto, Theophilus I; Franklin, Richard C; Franklin, Donna; Schibler, Andreas; Dalziel, Stuart R; Babl, Franz E; Wilson, Catherine; Phillips, Natalie; Ray, Robin

2017-01-01

Background A challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency...

Informing the Uninformed: Optimizing the Consent Message Using a Fractional Factorial Design

Science.gov (United States)

Tait, Alan R.; Voepel-Lewis, Terri; Nair, Vijayan N.; Narisetty, Naveen N.; Fagerlin, Angela

2013-01-01

Objective Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions. This study was designed to examine the effect of different communication strategies on parental understanding of research information. Participants 640 parents of children scheduled for elective surgery Design Observational study using a fractional factorial design Setting Large tertiary care children's hospital Interventions Parents were randomized to receive information about a hypothetical pain trial presented in one of 16 consent documents containing different combinations of 5 selected communication strategies (i.e., length, readability, processability [formatting], graphical display, and supplemental verbal disclosure). Main outcome measures Parents were interviewed to determine their understanding of the study elements (e.g., protocol, alternatives etc.) and their gist (main point) and verbatim (actual) understanding of the risks and benefits. Results Main effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, 8th grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 95% CI = 0.57, 0.26–0.88, correct responses out of 7 and 0.54, 0.20–0.88 correct responses out of 4 for gist and verbatim, respectively). Conclusions Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, IRBs, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding. PMID:23700028

Undergraduate Consent Form Reading in Relation to Conscientiousness, Procrastination, and the Point-of-Time Effect.

Science.gov (United States)

Theiss, Justin D; Hobbs, William B; Giordano, Peter J; Brunson, Olivia M

2014-07-01

Informed consent is central to conducting ethical research with human participants. The present study investigated differences in consent form reading in relation to conscientiousness, procrastination, and the point-of-time (PT) effect among undergraduate participants at a U.S. university. As hypothesized, conscientious participants and those who signed up to participate in a research study more days in advance and for earlier sessions (PT effect) read the consent form more thoroughly. However, procrastination was not related to consent form reading. Most importantly, consent form reading in general was poor, with 80% of participants demonstrating that they had not read the consent form. Conscientious participants were more likely to self-report reading the consent form, irrespective of their measured consent form reading. The article closes with suggestions to improve the process of obtaining informed consent with undergraduate participants. © The Author(s) 2014.

Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.

Science.gov (United States)

Hein, Irma M; De Vries, Martine C; Troost, Pieter W; Meynen, Gerben; Van Goudoever, Johannes B; Lindauer, Ramón J L

2015-11-09

For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents

An approach to radiotherapy under informed consent

International Nuclear Information System (INIS)

Okazaki, Atsushi; Maehara, Tadayuki; Baba, Sadaaki; Nakamura, Yuji; Kamitani, Hiroshi

1996-01-01

Over the past two years, we have attempted to practice radiotherapy in accordance with the principle of informed consent. The procedure used in our radiotherapy, which consists of informing the patient of the seriousness of his or her disease (malignant and benign) and receiving signed consent forms, is a new system in Japan. This is a report of our experience with this system and its advantages and disadvantages. We are satisfied with the clinical results of the attempt. Radiotherapy in accordance with informed consent has now become routine at our hospital. We feel that this practice will produce the mutual enhancement of our responsibility to patients and their trust in us, and improve cure rates. In promoting mutual understanding between our patients and ourselves, we must keep in mind that we, radiation oncologists, are not only radiotherapists but also health-care providers in our capacity as medical and surgical doctors. It is also necessary to achieve the best radiotherapeutic system in Japan. (author)

[Informed consent and parental refusal to medical treatment in childhood. The threshold of medical and social tolerance. Part I].

Science.gov (United States)

Guadarrama-Orozco, Jessica H; Garduño Espinosa, Juan; Vargas López, Guillermo; Viesca Treviño, Carlos

Informed consent is a right of all individuals and no one can force anyone to receive treatment against their wishes. The right to accept or refuse treatment persists in individuals who are incompetent from a legal point of view; this is exercised on their behalf by a third party. Children are considered incompetent to make medical decisions about their own health and their parents or legal guardians are empowered to make those decisions. However, parental authority is not absolute and there are situations where their decisions are not the best, sometimes leading to jeopardizing the well-being and even the lives of their children, forcing the state to intervene on behalf of the best interests of the child. This is the reason why it is necessary to ask the following questions: is it really the child's best interest that moves us to legally intervene when a parent refuses to accept the proposed medical treatment or is the damage done to make this decision? What kind of parental decisions are those that should not be tolerated? After a review of the theme, we conclude that if the decision of the parents regarding a medical decision is considered to be made with maleficence that is harmful to the child, it is justified that the State intervenes. Finally, we exposed four criteria that can be used in making decisions in complex cases where parents refuse treatment for their children. Copyright © 2015. Publicado por Masson Doyma México S.A.

Community perspectives on research consent involving vulnerable children in Western Kenya.

Science.gov (United States)

Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula

2012-10-01

Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent.

Parental decision making around perinatal autopsy: a qualitative investigation.

Science.gov (United States)

Meaney, Sarah; Gallagher, Stephen; Lutomski, Jennifer E; O'Donoghue, Keelin

2015-12-01

Decades of decline in uptake rates of perinatal autopsies has limited investigation into the causes and risk factors for stillbirth. This study aimed to qualitatively explore perinatal autopsy decision-making processes in parents who experienced antepartum and intrapartum stillbirths. A qualitative semi-structured interview format was utilized. The line of questioning centred on how parents came to decide on consenting or declining to have a perinatal autopsy undertaken. Interpretative phenomenological analysis was employed as the analytic strategy. Purposive sampling was used to recruit 10 parents who either consented or declined autopsy from a large tertiary maternity hospital in Cork Ireland, where there were 30 stillbirths in 2011. Findings revealed four superordinate themes influencing parents' decision-making which varied with type of stillbirth experienced. Those parents who experienced antepartum stillbirths were more likely to consent; thus, knowing that the child was stillborn prior to delivery rather than on the day of delivery was associated with consent. In fact, these parents had more time for meaning-making; those consenting wanted to rule out self-blame and were fearful about future pregnancies. Parents who declined autopsy wanted to protect their infant from further harm. Interestingly, parents' knowledge and understanding of the autopsy itself were acquired primarily from public discourse. Parents' decision-making regarding autopsy is profoundly affected by their emotional response to stillbirth; clinicians and other health professionals may play a key role, especially if they can address parental concerns regarding the invasiveness of the autopsy procedure. © 2014 John Wiley & Sons Ltd.

Parent Management

DEFF Research Database (Denmark)

Knudsen, Hanne

2007-01-01

and parents say given these assumptions? Which management responsibility is addressed through such training of the difficult conversation?  My conclusions are, briefly, that the difficult conversation is more correctly to be called an impossible conversation. It is an asking for the parent's consent...

Informed consent, parental awareness, and reasons for participating in a randomised controlled study

NARCIS (Netherlands)

M. van Stuijvenberg (Margriet); M.H. Suur (Marja); S. de Vos (Sandra); G.C.H. Tjiang (Gilbert); E.W. Steyerberg (Ewout); G. Derksen-Lubsen (Gerarda); H.A. Moll (Henriëtte)

1998-01-01

textabstractBACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A

Emerging issues in paediatric health research consent forms in Canada: working towards best practices.

Science.gov (United States)

Dove, Edward S; Avard, Denise; Black, Lee; Knoppers, Bartha M

2013-01-30

Obtaining a research participant's voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008-2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child's assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child's psychological and social perspective; (3) whether a child's ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child's perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. The analysis provides valuable insight and evidence into

Emerging issues in paediatric health research consent forms in Canada: working towards best practices

Directory of Open Access Journals (Sweden)

Dove Edward S

2013-01-01

Full Text Available Abstract Background Obtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Methods Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1 whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2 whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3 whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4 whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5 whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6 whether retention of and access to paediatric biological samples and associated medical data are addressed. Results The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad, and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the

A Qualitative Study into Dependent Relationships and Voluntary Informed Consent for Research in Pediatric Oncology.

Science.gov (United States)

Dekking, Sara A S; van der Graaf, Rieke; Schouten-van Meeteren, Antoinette Y N; Kars, Marijke C; van Delden, Johannes J M

2016-04-01

In pediatric oncology, many oncologists invite their own patients to participate in research. Inclusion within a dependent relationship is considered to potentially compromise voluntariness of consent. Currently, it is unknown to what extent those involved in pediatric oncology experience the dependent relationship as a threat to voluntary informed consent, and what they see as safeguards to protect voluntary informed consent within a dependent relationship. We performed a qualitative study among key actors in pediatric oncology to explore their experiences with the dependent relationship and voluntary informed consent. We conducted three focus groups and 25 semi-structured, in-depth interviews with pediatric oncologists, research coordinators, Research Ethics Committee members, parents of children with cancer, and adolescents with cancer. Professionals regarded the dependent relationship both as a potential threat to and as a positive influence on voluntary decision making. Parents and adolescents did not feel as though dependency upon the oncologist influenced their decisions. They valued the involvement of their own physician in the informed consent process. The professionals suggested three strategies to protect voluntariness: emphasizing voluntariness; empowering families; involvement of an independent person. Although the dependent relationship between pediatric oncologists, patients and parents may be problematic for voluntary informed consent, this is not necessarily the case. Moreover, the involvement of treating physicians may even have a positive impact on the informed consent process. Although we studied pediatric oncology, our results may also apply to many other fields of pediatric medicine where research and care are combined, for example, pediatric rheumatology, neurology and nephrology. Clinical trials in these fields are inevitably often designed, initiated and conducted by medical specialists closely involved in patient care.

Influence of Visual Information on Consent for Invasive Procedures ...

African Journals Online (AJOL)

2018-05-22

May 22, 2018 ... decision-making of the physician-patient-relative” as a period of transition. ..... recall of informed consent information by low-income parents: A comparison of ... Media and memory: The efficacy of video and print materials for ...

Universal donor education and consent: what we know and where we should go.

Science.gov (United States)

Wehrli, Gay; Sazama, Kathleen

2010-11-01

Each day thousands of blood donors across the country are given educational materials and sign a consent form, thus fulfilling two blood collection accreditation requirements. Very few donors will experience a documented adverse event, although a disproportionate number of these events occur in the youngest donor cohort. The literature reflects this disproportion and suggests mitigation strategies. Studies describe subjective, undocumented donor reactions and decreased donor return rates after a documented or subjective reaction. Additionally, studies have shown donor consent form variability among blood collection facilities and that donor comprehension of the educational materials and consent is limited. There are few standardized donor education materials or consent documents. Current accreditation standards for educational materials are limited to aspects of transfusion-transmitted diseases and for donor consent process and documentation are vague and nonspecific. Recent experiences with young donors and current research compel our community to engage in creating standardized, expanded donor educational materials and standardized donor consent processes and documents. © 2010 American Association of Blood Banks.

Applying a sociolinguistic model to the analysis of informed consent documents.

Science.gov (United States)

Granero-Molina, José; Fernández-Sola, Cayetano; Aguilera-Manrique, Gabriel

2009-11-01

Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient-professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients' consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions.

But is this really the 'parent' or 'guardian'? Practical strategies for ...

African Journals Online (AJOL)

Research ethics committees (RECs) in South Africa may require consent from a parent or legal guardian for child research. In instances where an REC determines that parental or guardianship consent is required, how far should researchers go to establish if the accompanying adult is in fact the parent or guardian? Should ...

Quality and extent of informed consent for invasive procedures: a pilot study at the institutional level in Turkey.

Science.gov (United States)

Dogan, H Hanzade; Işik, Elif; Vural, Ezgi; Vehid, Hayriye; Brezis, Mayer

2015-02-01

To assess the quality of informed consent for patients undergoing invasive procedures and to reveal patient preferences for being informed about the potential risks of treatment and alternatives to treatment. This study was planned as a pilot study. Hospitalized patients' perceptions and expectations about the informed-consent process were explored in a general surgery department. The prepared questionnaire was completed by patients via interview. Inpatient services of the general surgery department of a large academic hospital in Istanbul, Turkey. The study population consisted of hospitalized patients in a general surgery department who underwent invasive procedures in March 2013. Recognition of consent forms by the patients, rate of patients' recall of risks, rate of patients who were willing to be involved in decision making, and rate of patients who were satisfied with the whole decision-making process were measured. All patients signed consent forms. Most patients did not properly read the consent form since they trusted their physician. Potential exposure to risk seemed to be important for patient expectations. Paternalism seemed to dominate our clinical setting. The informed-consent process was definitely a separate issue from signing the consent forms. We conclude that the informed-consent process should be modified to be more functional and appropriate to human psychology. We suggest that education is necessary for informed consent to promote better quality and safety in health care. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Ethical considerations in investigating youth alcohol norms and behaviours: a case for mature minor consent.

Science.gov (United States)

Hildebrand, J; Maycock, B; Comfort, J; Burns, S; Adams, E; Howat, P

2015-12-01

Mature minor consent only became available in Australia in 2007. There is neither an explicitly defined protocol, nor a clear definition evident in the literature relating to use of the mature minor concept in health research. Due to difficulties in defining fixed age ranges to varying levels of maturity and vulnerability, there is a lack of clarity surrounding when it might be reasonable and ethical to apply for or grant a waiver for parental consent. This paper describes the challenges faced and solutions created when gaining approval for use of mature minor consent in a respondent-driven sampling (RDS) study to explore the social norms and alcohol consumption among 14-17-year-old adolescents (n = 1012) in the community. The University's Human Research Ethics Committee granted mature minor consent for this study, and the techniques applied enabled recruitment of adolescents from community-based settings through use of RDS to achieve the required sample. This paper has relevance for research that requires a waiver for parental consent; it presents a case study for assessing mature minors and makes recommendations on how ethical guidelines can be improved to assist human research ethics application processes.

Risk management in clinical practice. Part 2. Getting to 'yes'--the matter of consent.

Science.gov (United States)

D'Cruz, L

2010-07-24

Consent is an integral part of delivering the care patients want. In order to consent to treatment, patients must have the legal capacity to give valid consent. If this three stage test is satisfied, the patient can elect to have any treatment they wish even if it is not in their best interest. Before a patient is able to consent to treatment they must have adequate knowledge about the risks, benefits and alternatives to the treatment. The amount of information provided to the patient by the dentist is determined to some degree by the legal system prevailing. The patient must voluntarily agree to treatment without being coerced by the dentist or other parties and if things change during treatment the patient needs to be advised. Written consent is very useful in the defence of cases but simply signing the consent form does not mean that the patient knows or understands the treatment to which they have agreed.

The Use of Sign Language Pronouns by Native-Signing Children with Autism

Science.gov (United States)

Shield, Aaron; Meier, Richard P.; Tager-Flusberg, Helen

2015-01-01

We report the first study on pronoun use by an under-studied research population, children with autism spectrum disorder (ASD) exposed to American Sign Language from birth by their deaf parents. Personal pronouns cause difficulties for hearing children with ASD, who sometimes reverse or avoid them. Unlike speech pronouns, sign pronouns are…

Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study

Science.gov (United States)

Desch, Karl; Li, Jun; Kim, Scott; Laventhal, Naomi; Metzger, Kristen; Siemieniak, David; Ginsburg, David

2012-01-01

Background The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research. Objective To examine the use of online consent documents in a minimal-risk genetic study. Design Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits. Setting University of Michigan Campus, Ann Arbor, Michigan. Participants Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. Measurements Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document. Results The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. Limitation The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once. Conclusion Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. Primary Funding Source National Institutes of Health. PMID:21893624

The Minor's Right to Consent to Medical Treatment: A Corollary of the Constitutional Right of Privacy

Science.gov (United States)

Raitt, G. Emmett, Jr.

1975-01-01

Argues that the existing rules governing a physician's liability for treating a child without parental consent merit reconsideration because the minor possesses a fundamental constitutional right, stemming from the right of privacy, to consent to medical care. Proposes guidelines for the development of a legislative program implementing these…

Minors' rights to consent to treatment: navigating the complexity of State laws.

Science.gov (United States)

Vukadinovich, David M

2004-01-01

State laws recognize that a competent adult patient has the right to consent to or refuse medical treatment. While the law is clear with regard to the right of competent adults, state statutes are more complicated when the patient is a minor. While the law should, and does, attempt to balance the rights and obligations of parents and guardians against the access and privacy rights of minors, complicated state statutory schemes often fail to simultaneously address those contrasting goals in a consistent and uniform manner. The result is a confusing set of seemingly arbitrary and sometimes conflicting provisions that require the detailed attention of healthcare providers to ensure legal compliance. With the aim of helping healthcare practitioners meet their legal obligations, this Article examines state laws governing minor's consent rights byfocusing on the instances in which a minor's parent, guardian, or other authorized adult is permitted to consent to treatment on behalf of a minor and the instances in which a minor is authorized to act independent of adult intervention.

Optimization of informed consent for umbilical cord blood banking.

Science.gov (United States)

Sugarman, Jeremy; Kurtzberg, Joanne; Box, Tamara L; Horner, Ronnie D

2002-12-01

The purpose of this project was to evaluate the informed consent process for donation to a public umbilical cord blood bank. Telephone interviews were conducted with 170 women who had given consent to donate their newborn infants' umbilical cord blood. Of the 170 women who were contacted, 96.8% of the women reported that all their questions had been answered. Nevertheless, approximately one third of the respondents did not consider themselves to be in research, and almost one quarter of the respondents did not know how to contact the umbilical cord blood bank if they or their infant became seriously ill. Further, a substantial proportion of the respondents did not understand the full range of alternatives to donation and incorrectly endorsed potential benefits. Informed consent could be optimized by (1) having those personnel who obtain consent emphasize that banking involves research and to explain the true benefits of donation, (2) ensuring that parents know how and when to contact the umbilical cord blood bank after donation, and (3) using phone surveys to continue assessments and to monitor changes in the process.

Click here to consent forever: Expiry dates for informed consent

Directory of Open Access Journals (Sweden)

Bart Custers

2016-01-01

Full Text Available The legal basis for processing personal data and some other types of Big Data is often the informed consent of the data subject involved. Many data controllers, such as social network sites, offer terms and conditions, privacy policies or similar documents to which a user can consent when registering as a user. There are many issues with such informed consent: people get too many consent requests to read everything, policy documents are often very long and difficult to understand and users feel they do not have a real choice anyway. Furthermore, in the context of Big Data refusing consent may not prevent predicting missing data. Finally, consent is usually asked for when registering, but rarely is consent renewed. As a result, consenting once often implies consent forever. At the same time, given the rapid changes in Big Data and data analysis, consent may easily get outdated (when earlier consent no longer reflects a user’s preferences. This paper suggests expiry dates for consent, not to settle questions, but to put them on the table as a start for further discussion on this topic. Although such expiry dates may not solve all the issues of informed consent, they may be a useful tool in some situations.

Is my child sick? Parents' management of signs of illness and experiences of the medical encounter: parents of recurrently sick children urge for more cooperation.

Science.gov (United States)

Ertmann, Ruth K; Reventlow, Susanne; Söderström, Margareta

2011-03-01

Parents of sick children frequently visit their general practitioners (GPs). The aim was to explore parents' interpretation of their child's incipient signs and symptoms when falling ill and their subsequent unsatisfactory experience with the GP in order to make suggestions for improvements in the medical encounter. Semi-structured interviews. Twenty strategically selected families with a child from a birth cohort in Frederiksborg County, Denmark were interviewed. Parents wanted to consult their GP at the right time, i.e. neither too early nor too late. Well-educated parents experienced a discrepancy between their knowledge about their child, the information they had sought about the illness and the consultation with the GP, when they were dismissed with phrases such as "it will disappear" or "it is just a virus". The parents went along with the GP's advice if the child only occasionally became sick. However, parents of children with recurrent illnesses seemed very frustrated. During the course of several consultations with their GP, they started to question the GP's competence as the child did not regain health. Parents want to be acknowledged as competent collaborators. The GP's failure to acknowledge the parents' knowledge of their child's current illness, and the parents' attempt to identify what is wrong with the child and make the child feel better before the encounter may have consequences for the GP's credibility. It is therefore recommended that parents of children with recurrent illnesses receive extra attention and information.

Using the "Common European Framework of Reference for Languages" to Teach Sign Language to Parents of Deaf Children

Science.gov (United States)

Snoddon, Kristin

2015-01-01

No formal Canadian curriculum presently exists for teaching American Sign Language (ASL) as a second language to parents of deaf and hard of hearing children. However, this group of ASL learners is in need of more comprehensive, research-based support, given the rapid expansion in Canada of universal neonatal hearing screening and the…

[Quality of information in the process of informed consent for anesthesia].

Science.gov (United States)

Guillén-Perales, José; Luna-Maldonado, Aurelio; Fernández-Prada, María; Guillén-Solvas, José Francisco; Bueno-Cavanillas, Aurora

2013-11-01

To assess the quality of the information that patients receive in the informed consent document signed prior to surgery. Cross-sectional study of a sample of cancer patients admitted for surgery at the University Hospital San Cecilio of Granada in 2011. After checking the inclusion criteria and obtaining their consent, demographic data were collected and procedure data, and a questionnaire «ad hoc» to assess the quality and comprehensiveness of the information provided in the informed consent. 150 patients were studied. The majority (109 over 150) said they had received sufficient information, in appropriate language, and had the opportunity to ask questions, but only 44.7% correctly answered three or more issues related to anesthesia. University education level, knowledge of the intervention, information about the anesthesia problems and appropriate language were associated. Although systematic informed consent was performed, half of the patients did not comprehend the anesthesia risks. Variables primarily related to the information received were associated with the quality of the response, but not with patient characteristics. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials.

Science.gov (United States)

Ott, Mary A; Crawley, Francis P; Sáez-Llorens, Xavier; Owusu-Agyei, Seth; Neubauer, David; Dubin, Gary; Poplazarova, Tatjana; Begg, Norman; Rosenthal, Susan L

2018-06-01

Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12-14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.

From Informed Consent to Negotiated Consent.

Science.gov (United States)

Moody, Harry R.

1988-01-01

Considers informed consent standard inadequate for insuring autonomy in long term care. Argues for complex standard of "negotiated consent." Illuminates philosophical argument by qualitative data from interviews with physicians, nurses, and social workers in nursing homes, which demonstrated continuum of interventions ranging from…

Obtaining subjects' consent to publish identifying personal information: current practices and identifying potential issues.

Science.gov (United States)

Yoshida, Akiko; Dowa, Yuri; Murakami, Hiromi; Kosugi, Shinji

2013-11-25

objective, subjects' right to refuse consent and the withdrawal of consent. Whether responsibility for ensuring that the consent form has been signed lies with publishers also needs to be discussed.

Obtaining subjects’ consent to publish identifying personal information: current practices and identifying potential issues

Science.gov (United States)

2013-01-01

to address issues around the study objective, subjects’ right to refuse consent and the withdrawal of consent. Whether responsibility for ensuring that the consent form has been signed lies with publishers also needs to be discussed. PMID:24267590

Cultural transmission through infant signs: Objects and actions in U.S. and Taiwan.

Science.gov (United States)

Wang, Wen; Vallotton, Claire

2016-08-01

Infant signs are intentionally taught/learned symbolic gestures which can be used to represent objects, actions, requests, and mental state. Through infant signs, parents and infants begin to communicate specific concepts earlier than children's first spoken language. This study examines whether cultural differences in language are reflected in children's and parents' use of infant signs. Parents speaking East Asian languages with their children utilize verbs more often than do English-speaking mothers; and compared to their English-learning peers, Chinese children are more likely to learn verbs as they first acquire spoken words. By comparing parents' and infants' use of infant signs in the U.S. and Taiwan, we investigate cultural differences of noun/object versus verb/action bias before children's first language. Parents reported their own and their children's use of first infant signs retrospectively. Results show that cultural differences in parents' and children's infant sign use were consistent with research on early words, reflecting cultural differences in communication functions (referential versus regulatory) and child-rearing goals (independent versus interdependent). The current study provides evidence that intergenerational transmission of culture through symbols begins prior to oral language. Copyright © 2016 Elsevier Inc. All rights reserved.

About using serious games to teach (Portuguese) sign language

OpenAIRE

Gameiro, João Manuel Ferreira

2014-01-01

Sign language is the form of communication used by Deaf people, which, in most cases have been learned since childhood. The problem arises when a non-Deaf tries to contact with a Deaf. For example, when non-Deaf parents try to communicate with their Deaf child. In most cases, this situation tends to happen when the parents did not have time to properly learn sign language. This dissertation proposes the teaching of sign language through the usage of serious games. Currently, similar soluti...

Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting.

Science.gov (United States)

Lawton, J; Hallowell, N; Snowdon, C; Norman, J E; Carruthers, K; Denison, F C

2017-05-24

Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women's and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment. Interviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants' views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for

Early Sign Language Exposure and Cochlear Implantation Benefits.

Science.gov (United States)

Geers, Ann E; Mitchell, Christine M; Warner-Czyz, Andrea; Wang, Nae-Yuh; Eisenberg, Laurie S

2017-07-01

Most children with hearing loss who receive cochlear implants (CI) learn spoken language, and parents must choose early on whether to use sign language to accompany speech at home. We address whether parents' use of sign language before and after CI positively influences auditory-only speech recognition, speech intelligibility, spoken language, and reading outcomes. Three groups of children with CIs from a nationwide database who differed in the duration of early sign language exposure provided in their homes were compared in their progress through elementary grades. The groups did not differ in demographic, auditory, or linguistic characteristics before implantation. Children without early sign language exposure achieved better speech recognition skills over the first 3 years postimplant and exhibited a statistically significant advantage in spoken language and reading near the end of elementary grades over children exposed to sign language. Over 70% of children without sign language exposure achieved age-appropriate spoken language compared with only 39% of those exposed for 3 or more years. Early speech perception predicted speech intelligibility in middle elementary grades. Children without sign language exposure produced speech that was more intelligible (mean = 70%) than those exposed to sign language (mean = 51%). This study provides the most compelling support yet available in CI literature for the benefits of spoken language input for promoting verbal development in children implanted by 3 years of age. Contrary to earlier published assertions, there was no advantage to parents' use of sign language either before or after CI. Copyright © 2017 by the American Academy of Pediatrics.

Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent.

Science.gov (United States)

Nacci, A; Ursino, F; La Vela, R; Matteucci, F; Mallardi, V; Fattori, B

2008-08-01

Fiberoptic endoscopic evaluation of swallowing (FEES) is now a first choice method for studying swallowing disorders on account of the various advantages it offers: easy to use, very well tolerated, allows bedside examination and is economic. Nevertheless, this diagnostic procedure is not without risks, the most probable consequences of which include discomfort, gagging and/or vomiting, vasovagal syncope, epistaxis, mucosal perforation, adverse reactions to topical anaesthetics and laryngospasm. The risks involved with FEES stress the importance of informing the patient of these; this is an important aspect in medicine that necessarily and immediately implies receiving the patient's so-called "informed consent". Informed consent should be obtained not only by means of specific printed forms but also after the patient has had an interview with the physician who will be performing the procedure and who will offer information according to the personal clinical, psychological, cultural and linguistic situation of the patient and in keeping with the type of procedure proposed. In the case of FEES, as with other invasive or non-invasive diagnostic procedures, therefore, routine written and signed consent, together with a patient/physician interview should fulfil what is known as "complete information". In this report, a specific form for informed consent to FEES procedures, is proposed.

Under-age girls and contraception: the parent's right to be informed.

Science.gov (United States)

Brahams, Diana

1983-08-06

A British barrister considers the issue of whether the giving of advice or the prescribing of contraceptives to girls younger than 16 without parental consent constitutes criminal conduct by the physician. Brahams examines relevant criminal and family law, common law, recent court decisions, and Department of Health and Human Services policy concerning the minor's right to consent, parental interests, and physician responsibilities.

A cognitive approach for design of a multimedia informed consent video and website in pediatric research.

Science.gov (United States)

Antal, Holly; Bunnell, H Timothy; McCahan, Suzanne M; Pennington, Chris; Wysocki, Tim; Blake, Kathryn V

2017-02-01

Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial. A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. New consent strategies that have an integrated cognitive approach need to be developed and

Informed consent and the readability of the written consent form.

Science.gov (United States)

Sivanadarajah, N; El-Daly, I; Mamarelis, G; Sohail, M Z; Bates, P

2017-11-01

Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

Informed Consent and Capacity to Give Consent in Mental Disorders

Directory of Open Access Journals (Sweden)

Zeynep Mackali

2014-09-01

Full Text Available Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interaction between the clinician and the client. This concept sheds light on criteria regarding the limits of confidentiality, competency, appropriate and sufficient information sharing and voluntariness. In this theoretical review, the definitions and the content of informed consent were shared, and then a section regarding the required content of informed consent for psychotherapy process was provided. Then, the components of informed consent were discussed and the relationship between capacity to consent and mental disorders in terms of aforementioned diagnostic groups was examined. [Psikiyatride Guncel Yaklasimlar - Current Approaches in Psychiatry 2014; 6(3.000: 227-242

Readability and Understanding of Informed Consent Among Participants With Low Incomes: A Preliminary Report.

Science.gov (United States)

Ittenbach, Richard F; Senft, Elizabeth C; Huang, Guixia; Corsmo, Jeremy J; Sieber, Joan E

2015-12-01

With passage and implementation of the Affordable Health Care Act, more vulnerable segments of the U.S. population will now have access to regular health care and increased opportunities to participate in biomedical research. Yet, access to new groups brings with it new responsibilities for investigators, most importantly, reducing burdens for participants. Data collected through this small pilot study suggest several preliminary but potentially important findings when working with adults from low-income populations: First, while all participants read some parts of the consent forms (55%), only a minority reported reading the entire form (45%); second, 73% of participants reported understanding the study very well whereas only 27% reported understanding the study "a little"; third, there was a slight reported advantage of the simplified form over the regular form; however, this difference varied by section. Relatedly, other research has shown a high incidence of persons reading none of the consent form, but signing a statement that they have read and understood the study. Why does this occur? What are we teaching people when we request that they sign a consent form they have chosen not to read? What are the ethical and regulatory implications? Embedded ethics studies such as this one, although pilot and preliminary in nature, offer a number of advantages, such as stimulating additional scientific inquiry as well as challenging established institutional practices. © The Author(s) 2015.

Organ donation in Switzerland--an analysis of factors associated with consent rate.

Directory of Open Access Journals (Sweden)

Julius Weiss

Full Text Available BACKGROUND AND AIM: Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased's next of kin (NOK for organ donation, which is a prerequisite for donation in Switzerland. METHODS AND ANALYSIS: During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values <0.2 were selected for a multivariable logistic regression. RESULTS: Of 266 NOK approached for consent, consent was given in 137 (51.5% cases. In multivariable analysis, we found associations of consent rates with Swiss nationality (OR 3.09, 95% CI: 1.46-6.54 and German language area (OR 0.31, 95% CI: 0.14-0.73. Consent rates tended to be higher if a parent was present during the request (OR 1.76, 95% CI: 0.93-3.33 and if the request was done before brain death was formally declared (OR 1.87, 95% CI: 0.90-3.87. CONCLUSION: Establishing an atmosphere of trust between the medical staff putting forward a request and the NOK, allowing sufficient time for the NOK to consider donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions.

Informed consent for the administration of an intravenous contrast agent: importance and determinants of patient refusal; Consentimiento informado para la administracion de contraste intravenoso. Importancia y factores determinantes del rechazo por los pacientes

Energy Technology Data Exchange (ETDEWEB)

Martel, J. [Fundacion Hospital Alcorcon. Madrid (Spain); Garcia-Diaz, J. D. [Hospital Universitario Principe de Asturias. Alcala de Henares. Madrid (Spain)

1999-07-01

We proposed to determine the proportion of patients who refuse to undergo intravenous contrast administration and the factors that influence their refusal. Our series consisted of 442 patients who were supposed to undergo imaging studies involving the intravenous injection of an iodine contrast. In a personal interview, the patients were issued a questionnaire specifically designed for this study. The following parameters were recorded: sex, age, inpatient or outpatient status, medical history available, person who informed them about the procedure, person signing the informed consent (patient or other) , highest academic degree, attitude toward receiving the information and degree of concern after reading and signing the consent form. In our series 8.6% of the patients (95% confidence interval: 6-11.2) refused to sign the informed consent form. In addition, there were a number of patients who delayed the procedure or hindered the daily work schedule by some other means. When the relationship between each of the variables studied and refusal to sign the consent form was assessed, significant associations were observed between the latter and the academic level of the patient, his or her degree of concern and having received the information from a trained person. There was also a nearly significant trend toward the association between refusal and the patient's background. Relatively few patients refuse to sign the informed consent to receive intravenous contrast administration but this negative decision interferes with the health care practice. It is possible to identify certain correctable factors that influence the patient in this respect. (Author) 13 refs.

The Comparison of the Effectiveness of Parents Behavioral Training and Medication with Ritalin on the Rate of the Signs of Attention-Deficit Hyperactivity Disorder (ADHD

Directory of Open Access Journals (Sweden)

Mina Shahrbanian

2013-04-01

Full Text Available Introduction: The aim of the present research is to determine the effectiveness of parents’ behavioral training in compare to medication on the rate of the signs of attention deficit hyperactivity disorder (ADHD. Materials & Methods: Our population in this research was all boys in the elementary school (third, fourth and fifth grades and finally a sample of 630 subjects were included. We used a questionnaire of children’s morbid signs (CSI-4 which was completed by parents. For determination of acceptable scores in this scale, all subjects who obtained score 6 and more were selected and out of these subjects by use of random method as many as 45 subjects were chosen and 15 subjects were considered as the behavioral experimental group (under special care of a psychiatrist and the other 15 subjects were randomly put as the control group. The parents participated in seven sessions of behavioral training program, while for control group no kinds of training and medication intervention were carried out. Results: The results showed that both parent’s behavioral training program and medication have been effective meaningfully on ADHD (P=0.0005, also considering the averages differences, medication with Ritalin has caused more reduction of the signs of ADHD than parent’s behavioral training. Conclusion: At present, for children afflicted with ADHD, multi interventions are recommended that contains medication and parents training.

Consent ain't anything

DEFF Research Database (Denmark)

Di Nucci, Ezio

2016-01-01

I argue against various versions of the 'attitude' view of consent and of the 'action' view of consent: I show that neither an attitude nor an action is either necessary or sufficient for consent. I then put forward a different view of consent based on the idea that, given a legitimate epistemic ...

Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing.

Science.gov (United States)

Roberts, Laura Weiss; Warner, Teddy D; Anderson, Charles T; Smithpeter, Megan V; Rogers, Melinda K

2004-04-01

To examine the perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing of people with schizophrenia who volunteered for research protocols. A structured interview to assess research-related views of people with schizophrenia was developed and piloted. Data collection occurred at three sites. For this analysis, we examined the subset of responses from schizophrenia patients currently enrolled in a protocol. Data from 28 schizophrenia research volunteers were analyzed. Of these, 22 were men and 11 were voluntary inpatients. Most (n=23) recalled speaking with someone before enrolling in the protocol, and most (n=26) reported trusting the person who told them about it. Participants reported a moderate understanding of their protocols. All but one person (n=27) remembered signing a consent form. Twenty-one volunteers indicated that consent forms are meant to help both the patient and the researcher. Most (n=23) reported making the enrollment decision alone, with 22 making this decision prior to reviewing the consent form. The decision was described as relatively easy. Respondents felt some pressure to enroll, with women experiencing more pressure. Debriefing practices were strongly endorsed by participants. All 28 of the volunteers wished to be informed if a health problem (i.e., "something wrong") was discovered during the protocol. The persons living with schizophrenia who were interviewed for this project expressed interesting perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing in clinical research that may help guide efforts to make research processes more attuned to participants and merit further inquiry.

75 FR 28820 - Notice of Public Meeting by Teleconference Concerning Heavy Duty Diesel Engine Consent Decrees

Science.gov (United States)

2010-05-24

... implementation of the provisions of the seven consent decrees signed by the United States and diesel engine..., or anticipates receiving, requests from the diesel engine manufacturers for termination of their respective decrees. This meeting notice is also available on EPA's Diesel Engine Settlement Web site at http...

Parent education: an evaluation of STEP on abusive parents' perceptions and abuse potential.

Science.gov (United States)

Fennell, D C; Fishel, A H

1998-01-01

To examine the effects of a structured, time-limited parent training group on abusive or potentially abusive parents. A pretest-posttest control group design was used with consenting parents (N = 18) to examine the effects of Systematic Training for Effective Parenting (STEP) on abusive parents' perceptions of their children's behaviors and on the parents' potential to physically abuse. The Adlerian Parental Assessment of Child Behavior Scale and the Child Abuse Potential Inventory were used to measure treatment effects. After participating in STEP, abusive parents had significantly more positive perceptions of their children and were significantly less potentially abusive. Using volunteers, the project cost an average of $100 for each parent. The research lends empirical support to individual psychology and family systems theory. Future research is indicated using larger samples to examine lay vs. professional leadership of the groups, as well as comparisons of different parenting programs with abusive parents.

The ethics of neonatal research: An ethicist's and a parents' perspective.

Science.gov (United States)

Janvier, Annie; Farlow, Barbara

2015-12-01

The ethics of neonatal research are complex because vulnerable new parents are asked to provide consent on behalf of their fragile baby. Whereas clinical neonatal care has evolved to value personalized and shared decision-making, the goal of research ethics is still to standardize the informed consent process and make it as complete and thorough as possible. Ethicists, lawyers and physicians have shaped the field of research ethics and consent for research. The goal of detailed informed consent is to protect participants from harm, but procedures were developed without input from the principal stakeholders: ex-neonatal intensive care unit parents/patients. Empirical investigations examining patient and parental perspectives on research and research ethics are lacking. Rigorous investigations are needed to determine how parents of sick neonates want their families to be protected, knowing that a lack of research is also harmful. Large randomized controlled multicenter trials will always be needed to improve neonatal outcomes. These trials are costly and time-consuming. Currently, the way in which research is funded and regulated and the way in which academic merit is recognized lead to inefficiency and a waste of precious resources. Following a review of the history of research ethics, this article examines and discusses the ethics of research in neonatology. In addition, challenges and opportunities are identified and ideas for future investigations are proposed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Informed Consent in Dentistry.

Science.gov (United States)

Reid, Kevin I

2017-03-01

A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

Consenting options for posthumous organ donation: presumed consent and incentives are not favored

Directory of Open Access Journals (Sweden)

Hammami Muhammad M

2012-11-01

Full Text Available Abstract Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD age was 32(9 year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p vs. 11[6,11], respectively, p = 0.002. Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p vs. 8[4,9], p vs. 5[2,7], p  Conclusions We conclude that: 1 most respondents were in favor of posthumous organ donation, 2 mandated choice system was the most preferred and presumed consent system was the least preferred, 3 there was no difference between preference and perception of norm in consenting systems ranking, and 4 financial (especially in females and medical (especially in males incentives reduced preference.

The quality of informed consent in Croatia-a cross-sectional study and instrument development.

Science.gov (United States)

Vučemilo, Luka; Milošević, Milan; Dodig, Doris; Grabušić, Bruno; Đapić, Biljana; Borovečki, Ana

2016-03-01

To examine the informed consent process implementation and quality in Croatia using a specially developed instrument. A cross-sectional questionnaire study was conducted in 300 patients (response rate 73%) from six hospitals in Croatia, along with psychometric evaluation of the questionnaire. Signing the informed consent form was a formality for 64% of patients, 54% of patients did not give their written consent, and in 39% of cases physicians made treatment decisions by themselves. The overall informed consent process score was 4.06±0.60 (of 5.00). Physician-patient relationship score was 4.61±0.57, Verbal information 3.99±0.98, Decision making 3.94±0.75, and Written information 3.60±1.42. The overall Cronbach's alpha coefficient was 0.890. Significant correlations were found in relation to Physician-patient relationship and education levels (OR=0.43, 95% CI=0.18-0.99, p=0.048), and Verbal information and duration of health problems (OR=1.83, 95% CI=1.02-3.25, p=0.041). The developed questionnaire is reliable and valid. The informed consent process quality in Croatia was reasonably high, although insufficient and inadequate written materials represent a weak spot that require enhancement. The study contributes to the development of suitable measuring instrument for assessment of the informed consent process quality in clinical practice. The questionnaire could be of use in the hospital accreditation process. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Development of a baby friendly non-contact method for measuring vital signs: First results of clinical measurements in an open incubator at a neonatal intensive care unit

Science.gov (United States)

Klaessens, John H.; van den Born, Marlies; van der Veen, Albert; Sikkens-van de Kraats, Janine; van den Dungen, Frank A.; Verdaasdonk, Rudolf M.

2014-02-01

For infants and neonates in an incubator vital signs, such as heart rate, breathing, skin temperature and blood oxygen saturation are measured by sensors and electrodes sticking to the skin. This can damage the vulnerable skin of neonates and cause infections. In addition, the wires interfere with the care and hinder the parents in holding and touching the baby. These problems initiated the search for baby friendly 'non-contact' measurement of vital signs. Using a sensitive color video camera and specially developed software, the heart rate was derived from subtle repetitive color changes. Potentially also respiration and oxygen saturation could be obtained. A thermal camera was used to monitor the temperature distribution of the whole body and detect small temperature variations around the nose revealing the respiration rate. After testing in the laboratory, seven babies were monitored (with parental consent) in the neonatal intensive care unit (NICU) simultaneously with the regular monitoring equipment. From the color video recordings accurate heart rates could be derived and the thermal images provided accurate respiration rates. To correct for the movements of the baby, tracking software could be applied. At present, the image processing was performed off-line. Using narrow band light sources also non-contact blood oxygen saturation could be measured. Non-contact monitoring of vital signs has proven to be feasible and can be developed into a real time system. Besides the application on the NICU non-contact vital function monitoring has large potential for other patient groups.

Consenting options for posthumous organ donation: presumed consent and incentives are not favored

Science.gov (United States)

2012-01-01

Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and

Remote preenrollment checking of consent forms to reduce nonconformity.

Science.gov (United States)

Journot, Valérie; Pérusat-Villetorte, Sophie; Bouyssou, Caroline; Couffin-Cadiergues, Sandrine; Tall, Aminata; Chêne, Geneviève

2013-01-01

In biomedical research, the signed consent form must be checked for compliance with regulatory requirements. Checking usually is performed on site, most frequently after a participant's final enrollment. We piloted a procedure for remote preenrollment consent forms checking. We applied it in five trials and assessed its efficiency to reduce form nonconformity before participant enrollment. Our clinical trials unit (CTU) routinely uses a consent form with an additional copy that contains a pattern that partially masks the participant's name and signature. After completion and signatures by the participant and investigator, this masked copy is faxed to the CTU for checking. In case of detected nonconformity, the CTU suspends the participant's enrollment until the form is brought into compliance. We checked nonconformities of consent forms both remotely before enrollment and on site in five trials conducted in our CTU. We tabulated the number and nature of nonconformities by location of detection: at the CTU or on site. We used these data for a pseudo before-and-after analysis and estimated the efficiency of this remote checking procedure in terms of reduction of nonconformities before enrollment as compared to the standard on-site checking procedure. We searched for nonconformity determinants among characteristics of trials, consent forms, investigator sites, and participants through multivariate logistic regression so as to identify opportunities for improvement in our procedure. Five trials, starting sequentially but running concurrently, with remote preenrollment and on-site checking of consent forms from 415 participants screened in 2006-2009 led to 518 consent forms checked; 94 nonconformities were detected in 75 forms, 75 (80%) remotely and 19 more (20%) on site. Nonconformities infrequently concerned dates of signatures (7%) and information about participants (12%). Most nonconformities dealt with investigator information (76%), primarily contact information

Informed Consent and Routinisation

DEFF Research Database (Denmark)

Ploug, Thomas; Holm, Søren

2013-01-01

provide evidence of the routinisation of informed consent in various types of interaction on the internet; among these, the routinisation of consent to the exchange of health related information. We also provide evidence that the extent of the routinisation of informed consent is dependent...

Investigating aggressive styles and defense mechanisms in bipolar patients and in their parents

Directory of Open Access Journals (Sweden)

Nicola Luigi Bragazzi

2014-10-01

Full Text Available Bipolar disorder (BD is a very common mental health disorder, whose etiology concerning aggressive styles and defense mechanisms is still poorly known despite the efforts dedicated to develop psychological and biological theories. After obtaining written signed informed consent, this study will recruit inpatients with a clinical diagnosis of BD, based on Structured Clinical Interview and the Diagnostic and Statistical Manual of Mental Disorders criteria, and their parents. The Bus-Perry Aggression Questionnaire, the Defense Style Questionnaire 40, the Symptom check list SCL-90-R, developed by DeRogatis will be administered to the participants, together with a semi-structured questionnaire concerning demographic data (age, gender, employment, education and only for the patients clinical information (onset year of the disorder, presence of co-morbidities, alcohol and drug use, suicide tendencies, kind of treatment. All the questionnaires are in the Italian validated version. The successful completion of this study will shed light on the relationship between aggressive styles and defensive mechanisms in bipolar inpatients and in their parents, helping the clinicians to develop ad hoc psychological interventions.

Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices.

Science.gov (United States)

Gibson, Barbara E; Stasiulis, Elaine; Gutfreund, Shawna; McDonald, Maria; Dade, Lauren

2011-08-01

In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a 'family decision-making' model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family.

Radiographers' and radiology practitioners' opinion, experience and practice of benefit-risk communication and consent in paediatric imaging

International Nuclear Information System (INIS)

Portelli, J.L.; McNulty, J.P.; Bezzina, P.; Rainford, L.

2016-01-01

Objectives: To investigate radiographers' and radiology practitioners' opinion, experience and practice of radiation benefit-risk communication and consent for paediatric imaging examinations. Methods: A cross-sectional survey was conducted amongst radiographers and radiology practitioners working at a primary paediatric referral centre in Malta, so as to acquire information about their interactions with paediatric patients and/or their parents, particularly their opinion and practice of communicating benefit-risk information and seeking consent for imaging examinations. Results: The return of 112 questionnaires provided a response rate of 66.7%. Findings revealed varied practice relating to the provision of benefit-risk information, whereby details concerning examination benefits and potential risks are not always conveyed. For 89% of participants, parental consent was sought for paediatric imaging examinations in their current practice. Only 36.7% of participants indicated that they were highly confident in their ability to communicate benefit-risk information. The study findings also revealed that parents can truly be worried about the associated radiation exposure, with some even refusing an imaging examination as a result of such concerns. Conclusions: The practice of communicating benefit-risk information to paediatric patients and/or their parents is varied. A possible gap in benefit-risk communication education and/or training was identified, which may impact radiographers' and radiology practitioners' confidence in conveying such information. Education/training activities for radiographers and radiology practitioners are therefore necessary to foster improved benefit-risk dialogues and help provide reassurance to parents/guardians about the benefits of appropriately indicated paediatric imaging examinations. - Highlights: • The practice of communicating radiation benefit-risk information to parents of paediatric patients is varied. �

An Observational Study of Children's Involvement in Informed Consent for Exome Sequencing Research.

Science.gov (United States)

Miller, Victoria A; Werner-Lin, Allison; Walser, Sarah A; Biswas, Sawona; Bernhardt, Barbara A

2017-02-01

The goal of this study was to examine children's involvement in consent sessions for exome sequencing research and associations of involvement with provider and parent communication. Participants included 44 children (8-17 years) from five cohorts who were offered participation in an exome sequencing study. The consent sessions were audiotaped, transcribed, and coded. Providers attempted to facilitate the child's involvement in the majority (73%) of sessions, and most (75%) children also verbally participated. Provider facilitation was strongly associated with likelihood of child participation. These findings underscore that strategies such as asking for children's opinions and soliciting their questions show respect for children and may increase the likelihood that they are engaged and involved in decisions about research participation.

Assessing Consent through External Signs. Three Cases of Madness, Repulsion and Love before the Tribunal of the Roman Rota (1579-1619

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Isabelle Poutrin

2017-11-01

Full Text Available How can it be assumed that an individual is incapable of giving consent or does not give it freely? This article analyses three cases handled by the Tribunal of the Roman Rota between 1579 and 1619: the case of a nun from the monastery of Odivelas (Portugal suffering from mental disorders, and two demands for nullification of marriage based on the grounds of duress exerted by immediate family; the case of Doña Antonia Portocarrero y Cárdenas, of the diocese of Seville, married to Don Felipe de Guzman y Aragón; and the case of Manuel de Meneses and Branca de Baredo of the diocese of Coimbra. The testimonies on file relate the words and actions of the main parties involved, revealing affects and intentions. Auditors embarked on a complex operation to translate this information into the language of the law, in the light of legal experts’ theories on individual responsibility and the nature of violence or constraints that may alter freedom of consent. Yet this also encompassed social practices and representations in which individual behaviours exist. This study illustrates the contrast between judges’ know-how in assessing the absence of consent regarding marriage or religious profession and the fact that these notions were not taken into account regarding consent to baptism.

Childhood immunization: when physicians and parents disagree.

Science.gov (United States)

Gilmour, Joan; Harrison, Christine; Asadi, Leyla; Cohen, Michael H; Vohra, Sunita

2011-11-01

Persistent fears about the safety and efficacy of vaccines, and whether immunization programs are still needed, have led a significant minority of parents to refuse vaccination. Are parents within their rights when refusing to consent to vaccination? How ought physicians respond? Focusing on routine childhood immunization, we consider the ethical, legal, and clinical issues raised by 3 aspects of parental vaccine refusal: (1) physician counseling; (2) parental decision-making; and (3) continuing the physician-patient relationship despite disagreement. We also suggest initiatives that could increase confidence in immunization programs.

Young people's views about consenting to data linkage: findings from the PEARL qualitative study.

Science.gov (United States)

Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

2016-03-21

Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants' views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Digitally recorded interviews were conducted with 55 participants aged 17-19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with 'opt-in' consent through which participants are 'asked' if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent. Findings

78 FR 77106 - U.S. Air Force Reminder Re: United Launch Alliance (ULA) Consent Order and Recent Change in...

Science.gov (United States)

2013-12-20

... Consent Order also requires firewalls to prevent information from a space vehicle provider being shared by ULA with its Boeing or LMC parent company. Similarly, Boeing and LMC must have firewalls to ensure...

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

Science.gov (United States)

Borello, Alessandro; Ferrarese, Alessia; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

2016-01-01

Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

Preoperative parental information and parents' presence at induction of anaesthesia.

Science.gov (United States)

Astuto, M; Rosano, G; Rizzo, G; Disma, N; Raciti, L; Sciuto, O

2006-06-01

Preoperative preparation of paediatric patients and their environment in order to prevent anxiety is an important issue in paediatric anaesthesia. Anxiety in paediatric patients may lead to immediate negative postoperative responses. When a child undergoes surgery, information about the child's anaesthesia must be provided to parents who are responsible for making informed choices about healthcare on their child's behalf. A combination of written, pictorial, and verbal information would improve the process of informed consent. The issue of parental presence during induction of anaesthesia has been a controversial topic for many years. Potential benefits from parental presence at induction include reducing or avoiding the fear and anxiety that might occur in both the child and its parents, reducing the need for preoperative sedatives, and improving the child's compliance even if other studies showed no effects on the anxiety and satisfaction level. The presence of other figures such as clowns in the operating room, together with one of the child's parents, is an effective intervention for managing child and parent anxiety during the preoperative period.

The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

Science.gov (United States)

Perrenoud, Beatrice; Velonaki, Venetia-Sofia; Bodenmann, Patrick; Ramelet, Anne-Sylvie

2015-10-01

The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is:What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? Informed consent is a fundamental principal in the health care context which nowadays includes the patient's capacity to judge and to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. The importance of obtaining a valid consent before any medical procedure is well-established. In a US court case in 1914, it was stated that it is the right of any adult with the capability of making decisions concerning his own body, and that any surgical operation without the patient's consent could be considered as an assault. In another US court case, the court stated that it is a doctor's duty to make a reasonable disclosure to his patient of the nature, probable consequences and dangers of the proposed treatment to the patient. The application of the doctrine of informed consent as a legal procedure may slightly differ from country to country or from state to state, and may have different forms even within the same country. For example in the UK, consent can be written, verbal or non-verbal/implied, and a written consent form is not the actual consent itself but merely serves as evidence that consent has been given. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Nowadays it is widely accepted that prior to the application of any medical procedure, its benefits, risks and alternatives must have been explained to the patient, and the competent patient should have voluntarily and understandingly consented. Hence, the informed consent refers

Signs and symptoms in children with a serious infection: a qualitative study

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Aerssens Peter

2005-08-01

Full Text Available Abstract Background Early diagnosis of serious infections in children is difficult in general practice, as incidence is low, patients present themselves at an early stage of the disease and diagnostic tools are limited to signs and symptoms from observation, clinical history and physical examination. Little is known which signs and symptoms are important in general practice. With this qualitative study, we aimed to identify possible new important diagnostic variables. Methods Semi-structured interviews with parents and physicians of children with a serious infection. We investigated all signs and symptoms that were related to or preceded the diagnosis. The analysis was done according to the grounded theory approach. Participants were recruited in general practice and at the hospital. Results 18 children who were hospitalised because of a serious infection were included. On average, parents and paediatricians were interviewed 3 days after admittance of the child to hospital, general practitioners between 5 and 8 days after the initial contact. The most prominent diagnostic signs in seriously ill children were changed behaviour, crying characteristics and the parents' opinion. Children either behaved drowsy or irritable and cried differently, either moaning or an inconsolable, loud crying. The parents found this illness different from previous illnesses, because of the seriousness or duration of the symptoms, or the occurrence of a critical incident. Classical signs, like high fever, petechiae or abnormalities at auscultation were helpful for the diagnosis when they were present, but not helpful when they were absent. Conclusion behavioural signs and symptoms were very prominent in children with a serious infection. They will be further assessed for diagnostic accuracy in a subsequent, quantitative diagnostic study.

iConsent an Electronic Consent Platform with the MS Register

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Rod Middleton

2017-04-01

Patients who have been e-consented have expressed satisfaction in the ease of use and security of the software. Patients being unable to rest their hands on the screen is being examined. Newer tablets can ignore inputs other than the stylus. The MS Register intends to use the software in additional centres to capture patient consent.

Autism spectrum disorder and autistic traits in the Avon Longitudinal Study of Parents and Children: precursors and early signs.

Science.gov (United States)

Bolton, Patrick F; Golding, Jean; Emond, Alan; Steer, Colin D

2012-03-01

To chart the emergence of precursors and early signs of autism spectrum disorder (ASD) and autistic traits in the Avon Longitudinal Study of Parents and Children, a prospective longitudinal cohort study of the surviving offspring of 14,541 pregnant women from southwestern England with an expected delivery date between April 1991 and December 1992. Parents' contemporaneous reports of their infant's development (241 questionnaire responses collected up to 30 months of age) were examined in relation to the diagnosis of autism spectrum disorder by age 11 years (n = 86) and a measure of autistic traits, derived by factor analysis. Among the children later diagnosed with ASD, concerns about vision and hearing were more often reported in the first year, and differences in social, communication, and fine motor skills were evident from 6 months of age. Repetitive behaviors and differences in play, imitation, and feeding habits were reported in the second year. Differences in temperament emerged at 24 months of age and bowel habit by 30 months. All of these early signs were strongly associated with the presence of autistic traits in the rest of the population and these differences were often evident in the first year of development. Over the first 30 months of development, the best predictors of both later ASD and autistic traits included the Social Achievement and Communication scores from the Denver Developmental Screening Test, measures of communicative skills (Vocabulary and Combines Words) from the MacArthur Infant Communicative Development Inventories, and a repetitive behavior score. Precursors, early signs, and other developmental differences were reported in the first year of development among children from the general population who later developed autism spectrum disorder and subtler autistic traits. Other differences emerged and unfolded as development progressed. The findings confirm the long-held suspicion that early differences underscore the multifaceted

Mental Illness in Children: Know the Signs

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... how you can help. By Mayo Clinic Staff Mental illness in children can be hard for parents to ... help they need. Understand the warning signs of mental illness in children and how you can help your ...

Assessing physician-parent communication during emergency medical procedures in children: an observational study in a low-literacy Latino patient population.

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Dahl, Aaron; Sinha, Madhumita; Rosenberg, David I; Tran, Melissa; Valdez, André

2015-05-01

Effective physician-patient communication is critical to the clinical decision-making process. We studied parental recall of information provided during an informed consent discussion process before performance of emergency medical procedures in a pediatric emergency department of an inner-city hospital with a large bilingual population. Fifty-five parent/child dyads undergoing emergency medical procedures were surveyed prospectively in English/Spanish postprocedure for recall of informed consent information. Exact logistic regression was used to predict the ability to name a risk, benefit, and alternative to the procedure based on a parent's language, education, and acculturation. Among English-speaking parents, there tended to be higher proportions that could name a risk, benefit, or alternative. Our regression models showed overall that the parents with more than a high school education tended to have nearly 5 times higher odds of being able to name a risk. A gap in communication may exist between physicians and patients (or parents of patients) during the consent-taking process, and this gap may be impacted by socio-demographic factors such as language and education level.

Level of knowledge and understanding of informed consent amongst the training grade group orthodontists in England, Wales and Northern Ireland.

Science.gov (United States)

Sharma, Pratik K; Chate, Robert A

2011-06-01

To assess the level of knowledge and understanding of informed consent in UK orthodontic trainees. A cross-sectional, written questionnaire-based study. Hospital orthodontic departments in England, Wales and Northern Ireland. A one page questionnaire which covered a range of legal issues pertinent to informed consent was circulated to 207 members of the Training Grades Group (TGG) of the British Orthodontic Society (BOS). The questionnaire consisted of four open questions with 11 responses, which the investigators considered to be ideal, seven closed questions requiring yes/no responses and one question requiring a yes/no response followed by two open responses. Following the initial circulation, a second posting to non-responders was conducted. The response rate was 61% (N=126). The mean number of complete answers to the 21 questions was 13 (62%; median 13; mode 14). There were a low number of complete responses to specific questions in the following areas - explanations patients need from clinicians prior to obtaining consent; how to fully judge if a patient is capable of consenting; how to manage a patient incapable of giving consent; the legal status of fathers consenting on behalf of their children; whether consent forms have to be re-signed if the start of treatment is delayed by six months or more and responsibility for obtaining consent for dental treatment under general anaesthesia. There was a disappointingly high proportion of incomplete answers to questions testing the knowledge and understanding of the law as it pertains to informed consent exists amongst members of the TGG of BOS.

Informed consent in colonoscopy: A comparative analysis of 2 methods.

Science.gov (United States)

Sanguinetti, J M; Lotero Polesel, J C; Iriarte, S M; Ledesma, C; Canseco Fuentes, S E; Caro, L E

2015-01-01

The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent. A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later. The study included a total of 176 subjects (group A [n=55] and group B [n=121]). As regards education level, 69.88% (n=123) of the patients had completed university education, 23.29% (n= 41) secondary level, 5.68% (n=10) primary level, and the remaining subjects (n=2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n=44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P=.0027) and group A had a better recollection of the major complications (P<.0001). Group A had a higher number of affirmative answers (P<.0001). The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure. Copyright © 2014 Asociación Mexicana de Gastroenterología. Published by Masson Doyma México S.A. All rights reserved.

32 CFR Appendix F to Part 57 - Parent and Student Rights

Science.gov (United States)

2010-07-01

... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial... child, age 3 through 21 years, inclusive. (2) The right to confidentiality of personally identifiable... the native language of the parent or other mode of communication used by the parent, unless it is...

Challenges to obtaining parental permission for child participation in a school-based waterpipe tobacco smoking prevention intervention in Qatar.

Science.gov (United States)

Nakkash, Rima T; Al Mulla, Ahmad; Torossian, Lena; Karhily, Roubina; Shuayb, Lama; Mahfoud, Ziyad R; Janahi, Ibrahim; Al Ansari, Al Anoud; Afifi, Rema A

2014-09-30

Involving children in research studies requires obtaining parental permission. A school-based intervention to delay/prevent waterpipe use for 7th and 8th graders in Qatar was developed, and parental permission requested. Fifty three percent (2308/4314) of the parents returned permission forms; of those 19.5% of the total (840/4314) granted permission. This paper describes the challenges to obtaining parental permission. No research to date has described such challenges in the Arab world. A random sample of 40 schools in Doha, Qatar was selected for inclusion in the original intervention. Permission forms were distributed to parents for approval of their child's participation. The permission forms requested that parents indicate their reasons for non-permission if they declined. These were categorized into themes. In order to understand reasons for non-permission, interviews with parents were conducted. Phone numbers of parents were requested from the school administration; 12 of the 40 schools (30%) agreed to provide the contact information. A random sample of 28 parents from 12 schools was interviewed to reach data saturation. Thematic analysis was used to analyze their responses. Reasons for non-permission documented in both the forms and interviews included: poor timing; lack of interest; the child not wanting to participate; and the child living in a smoke-free environment. Interviews provided information on important topics to include in the consent forms, parents' decision-making processes regarding their child's participation, and considerations for communicating with parents. Many parents also indicated that this was the first time they had been asked to give an informed consent for their child's participation in a study. Results indicate that more attention needs to be given to the informed parental consent process. Researchers should consider enhancing both the methods of communicating information as well the specific information provided. Before

The limits of informed consent.

Science.gov (United States)

1975-09-01

The patient, a 59-year-old man, was referred to a psychiatric hospital with what appeared initially to be the signs and symptoms of mental disorder. In hospital a lesion of the brain was diagnosed and surgery was proposed to relieve the condition. The patient, however, during this and subsequent admissions to hospital, refused operation. His refusal to consent was regarded as valid as he seemed to have good insight into his condition. Finally, under section 26 of the Mental Health Act, he was treated surgically. Unfortunately the patient died six weeks later of intracranial haemorrhage. Three comments are made on this case - two by psychiatrists, Dr K Davison and Dr Ashley Robin, the other by a professor of Christian ethics, Professor F C Blackie. Both psychiatrists argue that when a patient's mind is affected by mental or organic illness to the degree that 'he cannot bring a rational and conscious mind' to the question of his treatment then the doctor, in consultation with the relatives, making clear to them the likely course of events if an operation is not performed, must take whatever is the proper course of action, in this case surgery. In this view, such an operation performed immediately the diagnosis was confirmed might not have been so complicated. Professor Blackie, commending 'the attempt to regard the patient as a responsible human being' with a 'moral right to be consulted on all aspects of treatment', questions in this patient the limits to which the appeal to reason was carried. He concludes that 'in this situation the advice and consent of the family must weigh more heavily than the statements of the patient'.

Young people’s views about consenting to data linkage: findings from the PEARL qualitative study

Directory of Open Access Journals (Sweden)

Suzanne Audrey

2016-03-01

Full Text Available Abstract Background Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants’ views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Methods Digitally recorded interviews were conducted with 55 participants aged 17–19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Results Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with ‘opt-in’ consent through which participants are ‘asked’ if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

OpenAIRE

Borello Alessandro; Ferrarese Alessia; Passera Roberto; Surace Alessandra; Marola Silvia; Buccelli Claudio; Niola Massimo; Di Lorenzo Pierpaolo; Amato Maurizio; Di Domenico Lorenza; Solej Mario; Martino Valter

2016-01-01

Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a grap...

Consented Autopsy and the Middle-East.

Science.gov (United States)

Kharoshah, Magdy A; Hussain, Syed Ather; Madadin, Mohammed; Menezes, Ritesh G

2017-02-01

Consented autopsy is almost non-existent in the Middle-East where established social and cultural beliefs regarding the procedure might discourage family members from requesting a consented autopsy. Evidence suggests that new information is obtained from consented autopsies. It would not be in the best interest of medicine if social and cultural misconceptions succeed in erasing the existence of consented autopsies entirely.

Informed Consent and Capacity to Give Consent in Mental Disorders

OpenAIRE

Zeynep Mackali

2014-01-01

Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice) which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interacti...

Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.

Directory of Open Access Journals (Sweden)

Serebe Abay

Full Text Available Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study.A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI and Focus Group Discussions (FGDs with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes.The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study.This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to

Nudging, informed consent and bullshit.

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Simkulet, William

2017-11-18

Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person's behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt's account of bullshit. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effective Group Work for Elementary School-Age Children Whose Parents Are Divorcing.

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DeLucia-Waack, Janice; Gerrity, Deborah

2001-01-01

Parental divorce is the issue of most concern for elementary school children. This article describes interventions for children-of-divorce groups for elementary school children. Suggests guidelines related to goal setting; securing agency and parental consent; leadership planning; recruitment, screening, and selection of members; group member…

Engaging Urban Parents of Early Adolescents in Parenting Interventions: Home Visits vs. Group Sessions.

Science.gov (United States)

Finigan-Carr, Nadine M; Copeland-Linder, Nikeea; Haynie, Denise L; Cheng, Tina L

2014-01-01

Interventions targeting parents of young children have shown effectiveness, but research is lacking about best practices for engaging parents of early adolescents. Low levels of enrollment and attendance in parenting interventions present major problems for researchers and clinicians. Effective and efficient ways to engage and collaborate with parents to strengthen parenting practices and to promote healthy development of early adolescents are needed. This exploratory mixed methods study examined the feasibility of three methods of engaging parents in positive parenting activities. Participants were parents of youth ages 11-13 enrolled in three urban, public middle schools in neighborhoods characterized by high rates of community violence. Families ( N = 144) were randomized into one of three interventions: six home sessions, two home sessions followed by four group sessions, or six group sessions. The majority of parents were single, non-Hispanic, African American mothers. Urban parents of middle school students were more likely to participate in home visits than in group sessions; offering a combination did not increase participation in the group sessions. As only 34% of those who consented participated in the intervention, qualitative data were examined to explain the reasons for non-participation.

Informed consent for exome sequencing research in families with genetic disease: the emerging issue of incidental findings.

Science.gov (United States)

Bergner, Amanda L; Bollinger, Juli; Raraigh, Karen S; Tichnell, Crystal; Murray, Brittney; Blout, Carrie Lynn; Telegrafi, Aida Bytyci; James, Cynthia A

2014-11-01

Genomic sequencing technology is increasingly used in genetic research. Studies of informed consent for exome and genome sequencing (ES/GS) research have largely involved hypothetical scenarios or healthy individuals enrolling in population-based studies. Studies have yet to explore the consent experiences of adults with inherited disease. We conducted a qualitative interview study of 15 adults recently enrolled in a large-scale ES/GS study (11 affected adults, four parents of affected children). Our study had two goals: (1) to explore three theoretical barriers to consent for ES/GS research (interpretive/technical complexity, possibility of incidental findings, and risks of loss of privacy); and (2) to explore how interviewees experienced the consent process. Interviewees could articulate study goals and processes, describe incidental findings, discuss risks of privacy loss, and reflect on their consent experience. Few expected the study would identify the genetic cause of their condition. All elected to receive incidental findings. Interviewees acknowledged paying little attention to potential implications of incidental findings in light of more pressing goals of supporting research regarding their own medical conditions. Interviewees suggested that experience living with a genetic condition prepared them to adjust to incidental findings. Interviewees also expressed little concern about loss of confidentiality of study data. Some experienced the consent process as very long. None desired reconsent prior to return of study results. Families with inherited disease likely would benefit from a consent process in which study risks and benefits were discussed in the context of prior experiences with genetic research and genetic disease. © 2014 Wiley Periodicals, Inc.

Informed consent in surgical trials.

Science.gov (United States)

Etchells, E

1999-12-01

All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

Directory of Open Access Journals (Sweden)

Borello Alessandro

2016-01-01

Full Text Available Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.

Communicating with parents about vaccination: a framework for health professionals.

Science.gov (United States)

Leask, Julie; Kinnersley, Paul; Jackson, Cath; Cheater, Francine; Bedford, Helen; Rowles, Greg

2012-09-21

A critical factor shaping parental attitudes to vaccination is the parent's interactions with health professionals. An effective interaction can address the concerns of vaccine supportive parents and motivate a hesitant parent towards vaccine acceptance. Poor communication can contribute to rejection of vaccinations or dissatisfaction with care. We sought to provide a framework for health professionals when communicating with parents about vaccination. Literature review to identify a spectrum of parent attitudes or 'positions' on childhood vaccination with estimates of the proportion of each group based on population studies. Development of a framework related to each parental position with determination of key indicators, goals and strategies based on communication science, motivational interviewing and valid consent principles. Five distinct parental groups were identified: the 'unquestioning acceptor' (30-40%), the 'cautious acceptor' (25-35%); the 'hesitant' (20-30%); the 'late or selective vaccinator' (2-27%); and the 'refuser' of all vaccines (parents' readiness to vaccinate. In all encounters, health professionals should build rapport, accept questions and concerns, and facilitate valid consent. For the hesitant, late or selective vaccinators, or refusers, strategies should include use of a guiding style and eliciting the parent's own motivations to vaccinate while, avoiding excessive persuasion and adversarial debates. It may be necessary to book another appointment or offer attendance at a specialised adverse events clinic. Good information resources should also be used. Health professionals have a central role in maintaining public trust in vaccination, including addressing parents' concerns. These recommendations are tailored to specific parental positions on vaccination and provide a structured approach to assist professionals. They advocate respectful interactions that aim to guide parents towards quality decisions.

Influence of parental alcohol-related attitudes, behavior and parenting styles on alcohol use in late and very late adolescence.

Science.gov (United States)

Stafström, Martin

2014-01-01

Parents influence adolescent drinking behavior, but to what extent does this association diminish with age, however? The cross-sectional data was drawn from the Scania drug use survey 2007, consisting of 4,828 secondary education students in the 9th and 11th grade. The age- and gender-adjusted findings indicate that having parents who are consenting to alcohol use (OR 1.4), having been provided with alcohol by one's parents (OR 1.8), having parents with an authoritarian (OR 1.5) or neglectful (OR 2.1) parenting style, and having parents who both have a university degree (OR 1.3) were factors significantly associated with monthly heavy episodic drinking. These findings lead to the conclusion that parenting styles as well as parental attitudes and behaviors are important throughout the high school years. Thus, prevention targeting parents should emphasize both these domains. © 2014 S. Karger AG, Basel.

Assessing children’s competence to consent in research by a standardized tool: a validity study

Science.gov (United States)

2012-01-01

Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish

Assessing children’s competence to consent in research by a standardized tool: a validity study

Directory of Open Access Journals (Sweden)

Hein Irma M

2012-09-01

Full Text Available Abstract Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s. It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In

Aging Parents: 7 Warning Signs of Health Problems

Science.gov (United States)

... a car or van service or hiring a driver. Consider home care services. You could hire someone ... 2017 Original article: http://www.mayoclinic.org/healthy-lifestyle/caregivers/in-depth/aging-parents/art-20044126 . Mayo ...

Informed Consent in Adult Psychiatry

Directory of Open Access Journals (Sweden)

Ahmed Bait Amer

2013-07-01

Full Text Available This article addresses some of the groundwork of informed consent in people with mental illness whose decision-making capacity has obviously been compromised. This article examines four crucial aspects in particular, namely: i the main elements of informed consent; ii difficulties pertaining to psychiatric illnesses; iii the effect of psychiatric disorders on the patient’s capability; iv how to assess situations in which consents may not be required.

Implementation of a national school-based Human Papillomavirus (HPV) vaccine campaign in Fiji: knowledge, vaccine acceptability and information needs of parents.

Science.gov (United States)

La Vincente, S F; Mielnik, D; Jenkins, K; Bingwor, F; Volavola, L; Marshall, H; Druavesi, P; Russell, F M; Lokuge, K; Mulholland, E K

2015-12-18

In 2008 Fiji implemented a nationwide Human Papillomavirus (HPV) vaccine campaign targeting all girls aged 9-12 years through the existing school-based immunisation program. Parents of vaccine-eligible girls were asked to provide written consent for vaccination. The purpose of this study was to describe parents' knowledge, experiences and satisfaction with the campaign, the extent to which information needs for vaccine decision-making were met, and what factors were associated with vaccine consent. Following vaccine introduction, a cross-sectional telephone survey was conducted with parents of vaccine-eligible girls from randomly selected schools, stratified by educational district. Factors related to vaccine consent were explored using Generalised Estimating Equations. There were 560 vaccine-eligible girls attending the participating 19 schools at the time of the campaign. Among these, 313 parents could be contacted, with 293 agreeing to participate (93.6%). Almost 80% of participants reported having consented to HPV vaccination (230/293, 78.5%). Reported knowledge of cervical cancer and HPV prior to the campaign was very low. Most respondents reported that they were satisfied with their access to information to make an informed decision about HPV vaccination (196/293, 66.9%). and this was very strongly associated with provision of consent. Despite their young age, the vaccine-eligible girls were often involved in the discussion and decision-making. Most consenting parents were satisfied with the campaign and their decision to vaccinate, with almost 90% indicating they would consent to future HPV vaccination. However, negative media reports about the vaccine campaign created confusion and concern. Local health staff were cited as a trusted source of information to guide decision-making. Just over half of the participants who withheld consent cited vaccine safety fears as the primary reason (23/44, 52.3%). This is the first reported experience of HPV introduction

Informed consent for radiotherapy: Our responsibility

International Nuclear Information System (INIS)

Colyer, Hazel

2007-01-01

This article describes and contextualises the findings from an email survey of cancer centres in the United Kingdom (UK) conducted early in 2005. It sought to discover how widely the model consent policy and process, published in 2001 [Department of Health. Good practice in consent. Achieving the NHS Plan commitment to patient-centred consent practice. HSC 2001/023. NHS Executive; November 2001], had been implemented and, more controversially, which professional groups gained the consent of patients to radiotherapy. The survey was sent on the author's behalf by the Society and College of Radiographers (SCoR) to all cancer centres in the UK, including five private sector facilities (n = 63). Forty-eight responses were received (76%). A majority of cancer centres have implemented the new procedures and these are undertaken most commonly by consultant oncologists and trained specialist registrars. In 10 centres, therapeutic radiographers (radiographers) are among the team gaining consent to radiotherapy and other centres have radiographers in training. There is widespread adherence to government guidance for obtaining consent and a growing number of centres are implementing radiographer-led consent. However, this is controversial from both medical and radiographic professional perspectives despite guidance indicating that the person who is actually treating the patients should seek their consent [Department of Health. 12 Key points on consent: the law in England. March 2001]. In the context of creating person-centred services, the significance for the development of the profession of therapeutic radiography is evaluated. In particular, the implications of radiographers both capitalising on and failing to assume this professional responsibility were explored

[Schizophrenia and informed consent to research].

Science.gov (United States)

Fovet, T; Amad, A; Thomas, P; Jardri, R

2015-10-01

Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

Associations between general parenting styles and specific food-related parenting practices and children's food consumption.

Science.gov (United States)

Vereecken, Carine; Legiest, Erwin; De Bourdeaudhuij, Ilse; Maes, Lea

2009-01-01

Explore the impact of general parenting style and specific food-related parenting practices on children's dietary habits. Cross-sectional study of sixth graders and their parents. Data were gathered (in 2003) in 69 of 100 randomly selected elementary schools in Belgium. All sixth graders (N = 1957) were invited to participate; 82.4% of their parents gave consent and completed questionnaires, resulting in 1614 parent-child pairs. Children's consumption of breakfast, fruit, vegetables, soft drinks, and sweets was assessed by self-administered food frequency questionnaires. Parents completed questionnaires on sociodemographic characteristics, general parenting styles (authoritarian, authoritative, indulgent, or neglecting) and specific food-related parenting practices (pressure, reward, encouragement through negotiation, catering on children's demands, permissiveness, avoiding negative modeling, and praise). Logistic regression analyses were performed, with general parenting style and specific food-related parenting practices as predictors and dietary habits as dependent variables, controlling for sociodemographic characteristics and children's weight status. General parenting style did not show any significant impact on dietary habits. In contrast, the food-related parenting practice "encouragement through negotiation" showed a significant positive impact, whereas "pressure," "catering on demand," and "permissiveness" were practices with an unhealthy impact. Nutrition education programs that guide parents in firm but not coercive food parenting skills are likely to have a positive impact upon children's dietary habits.

Informed consent in psychotherapy.

Science.gov (United States)

Beahrs, J O; Gutheil, T G

2001-01-01

The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

Science.gov (United States)

Williams, Barbara F; French, John K; White, Harvey D

2003-03-15

Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

Vital Signs-Preventing Pregnancy in Younger Teens

Centers for Disease Control (CDC) Podcasts

This podcast is based on the April 2014 CDC Vital Signs report. Births to teens are declining, still, in 2012, more than 86,000 teens ages 15 to 17 gave birth. This program discusses what health care providers, parents, and teens can do to help prevent teen pregnancy.

Satisfying the needs of Japanese cancer patients: a comparative study of detailed and standard informed consent documents.

Science.gov (United States)

Sato, Keiko; Watanabe, Toru; Katsumata, Noriyuki; Sato, Tosiya; Ohashi, Yasuo

2014-02-01

Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. s To investigate whether a detailed consent form explaining the key elements of informed consent, in comparison to a standard consent form, would increase the comprehension and satisfaction of adult cancer patients. Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer (protocol 01(N-SAS/BC-01)) were randomly selected to receive one of the following four versions: detailed document with graphics, detailed document without graphics, standard document with graphics, and standard document without graphics. The forms were written in plain language from the patients' point of view. A total of 85 patients were administered questionnaires via interview to assess levels of comprehension, satisfaction, and anxiety. Patients demonstrated a strong understanding of information regarding treatment and research. Patient comprehension did not differ significantly between the detailed document arms and the standard document arms. Patient satisfaction level increased according to the amount of information presented in the consent form; most patients preferred the detailed document with graphics. Anxiety and accrual rates in the parent study were not affected by informed consent procedures. Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy. Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences.

Discourses of prejudice in the professions: the case of sign languages.

Science.gov (United States)

Humphries, Tom; Kushalnagar, Poorna; Mathur, Gaurav; Napoli, Donna Jo; Padden, Carol; Rathmann, Christian; Smith, Scott

2017-09-01

There is no evidence that learning a natural human language is cognitively harmful to children. To the contrary, multilingualism has been argued to be beneficial to all. Nevertheless, many professionals advise the parents of deaf children that their children should not learn a sign language during their early years, despite strong evidence across many research disciplines that sign languages are natural human languages. Their recommendations are based on a combination of misperceptions about (1) the difficulty of learning a sign language, (2) the effects of bilingualism, and particularly bimodalism, (3) the bona fide status of languages that lack a written form, (4) the effects of a sign language on acquiring literacy, (5) the ability of technologies to address the needs of deaf children and (6) the effects that use of a sign language will have on family cohesion. We expose these misperceptions as based in prejudice and urge institutions involved in educating professionals concerned with the healthcare, raising and educating of deaf children to include appropriate information about first language acquisition and the importance of a sign language for deaf children. We further urge such professionals to advise the parents of deaf children properly, which means to strongly advise the introduction of a sign language as soon as hearing loss is detected. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Parental Intentions to Enroll Children in a Voluntary Expanded Newborn Screening Program

Science.gov (United States)

Paquin, Ryan S.; Peay, Holly L.; Gehtland, Lisa M.; Lewis, Megan A.; Bailey, Donald B.

2016-01-01

Background and Objectives Nearly all babies in the United States are tested at birth for rare, serious, and treatable disorders through mandatory state newborn screening (NBS). Recently, there have been calls for an expanded, voluntary model to facilitate early diagnosis and treatment of a wider range of disorders. We applied the reasoned action framework to examine parental intentions to participate in voluntary expanded screening. Methods We recruited a national cohort of recent and expectant parents living in the U.S. who completed a self-administered online survey (N = 1,001). Using a mixed-level fractional factorial experiment, we studied parental participation intentions and preferences for timing of consent, cost, consent format, and testing options. Results We conducted a hierarchical regression analysis assessing parental intentions to participate in voluntary expanded NBS. Attitudes, perceived normative influence, and perceived behavioral control explained substantial variance in intention, with perceived normative influence emerging as the strongest predictor. We found no evidence that the manipulated program features altered mean levels of intention, but timing of parental permission, cost, and permission format moderated the relative importance of reasoned action constructs on intention. Conclusion Program design features may impact the psychological mechanisms underlying parental decision making for voluntary expanded screening. These results have important implications for parent education, outreach, and informed parental permission procedures. PMID:27526258

Parental intentions to enroll children in a voluntary expanded newborn screening program.

Science.gov (United States)

Paquin, Ryan S; Peay, Holly L; Gehtland, Lisa M; Lewis, Megan A; Bailey, Donald B

2016-10-01

Nearly all babies in the United States are tested at birth for rare, serious, and treatable disorders through mandatory state newborn screening (NBS). Recently, there have been calls for an expanded, voluntary model to facilitate early diagnosis and treatment of a wider range of disorders. We applied the reasoned action framework to examine parental intentions to participate in voluntary expanded screening. We recruited a national cohort of recent and expectant parents living in the U.S. who completed a self-administered online survey (N = 1001). Using a mixed-level fractional factorial experiment, we studied parental participation intentions and preferences for timing of consent, cost, consent format, and testing options. We conducted a hierarchical regression analysis assessing parental intentions to participate in voluntary expanded NBS. Attitudes, perceived normative influence, and perceived behavioral control explained substantial variance in intention, with perceived normative influence emerging as the strongest predictor. We found no evidence that the manipulated program features altered mean levels of intention, but timing of parental permission, cost, and permission format moderated the relative importance of reasoned action constructs on intention. Program design features may impact the psychological mechanisms underlying parental decision making for voluntary expanded screening. These results have important implications for parent education, outreach, and informed parental permission procedures. Copyright © 2016 Elsevier Ltd. All rights reserved.

Informing Parents about the Pharmacological and Invasive Behavior Management Techniques Used in Pediatric Dentistry

Directory of Open Access Journals (Sweden)

Mehrysa Paryab

2014-06-01

Full Text Available Background and aims. Parental acceptance and consent are important parameters in selecting the required behavior management technique during pediatric dental treatment. The present study sought to assess the effect of three different informing methods on the parental acceptance, consent and concern regarding the pharmacological and invasive behavior management techniques used in pediatric dentistry. Materials and methods. Ninety mothers of 3-6-year-old uncooperative children were selected and randomly assigned to three study groups. The parents in each group were initially asked to answer three questions related to their levels of ‘acceptance’, ‘consent’, and ‘concern’ toward the five behavior management techniques. Then, the information about the techniques was presented through a piece of writing in group I, verbal presentation in group II and showing a film in group III. At last, the parents answered the same three questions again. Score changes were analyzed by using ANOVA, correlations, Mann-Whitney U and Kruskal-Wallis methods. Results. There were no statistically significant differences in score changes of parental acceptance, consent and concern between the three groups, overall and in relation to each behaviour management technique (P > 0.05. Mothers with academic education revealed more statistically significant concern following presentation of information by film (P < 0.05. Conclusion. None of the presentation methods had a significant preference over the others; in selecting the behavioral management techniques, it is advisable to observe individual factors, such as the level of education of the mothers.

Signs of Bullying: Important Questions for Parents to Ask

Science.gov (United States)

... It reaches victims in school and online via social media apps and programs like Instagram, SnapChat, WhatsApp, Burn Note, Whisper, Yik Yak and YouTube. Some apps are anonymous or enable messages to disappear after a period of time. Bullying Signs Kids ...

32 CFR 634.8 - Implied consent.

Science.gov (United States)

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Implied consent. 634.8 Section 634.8 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) LAW ENFORCEMENT AND CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Driving Privileges § 634.8 Implied consent. (a) Implied consent to blood, breath, or urine tests....

Semantic Representation of Mutual-Consent Divorce

Directory of Open Access Journals (Sweden)

مهری سادات موسوی

2016-09-01

Full Text Available This article discussed mutual-consent divorce in the context of thoughts and attitude of female applicants of this type of divorce with an inductive qualitative and ethnographic method. Based on the qualitative purposive sampling, 30 women of those who had referred for divorce to family court of Karaj, were selected and deeply interviewed. The results obtained in six major categories as follows: Rethinking the role of men as families’ breadwinners, inappropriate sexual relationships, emotional conflicts, cultural- social dissensions, normative pressures of family and relatives, and personality and behavioral disorders. The core-oriented category of this study is "Women's attitude towards mutual-consent divorce" that includes other major categories and can semantically alter and redirect women’s opinion about mutual-consent divorce. According to the results, the term of mutual-consent is thought-provoking in this type of divorce; because considering the situations which were leaded to mutual-consent divorce and quantifying them revealed that nearly 32% of mutual-consent divorces were not mutual in fact; since, these women accepted divorce with desperation, coercion and threat.

A descriptive study of consent documentation.

LENUS (Irish Health Repository)

Murphy, K

2011-09-01

The aim of this study was to observe the error rate in the consent process of a university hospital and to illicit the opinions of the consenting doctors on the process. A prospective observational review of theatre consent forms was performed along with an anonymous survey of non-consultant hospital doctors (NCHD\\'s). No potential risks were documented in 95.3% of the 64 scrutinized consents and late alterations were required in 9%. Respondents to the NCHD survey estimated that they were unsure of the procedure or risks involved in an average of 29% of occasions. Interns admitted to being unsure of the details of the procedure in almost a third (32%) of cases, making them less well informed than their senior colleagues (p=0.024). This study highlights the difficulties encountered by consenting doctors, an issue which may lead to patient dissatisfaction, threaten the efficient running of a surgical unit and potentially expose its staff to avoidable litigation. It also recommends the use of multimedia adjuncts to facilitate both patient and doctor education in the consent process.

Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement With Standardized Versus Procedure-Specific Consent Forms.

Science.gov (United States)

Pomeroy, Eoghan; Shaarani, Shahril; Kenyon, Robert; Cashman, James

2017-08-25

Informed consent plays a pivotal role in the operative process, and surgeons have an ethical and legal obligation to provide patients with information to allow for shared decision-making. Unfortunately, patient recall after the consent process is frequently poor. This study aims to evaluate the effect of procedure-specific consent forms on patient's recall four weeks after total hip replacement (THR). This is a prospective study using a posttest-only control group design. Sixty adult patients undergoing total hip replacement were allocated to be consented using either the generic or the surgery-specific consent form. Four weeks after surgery, a phone interview was conducted to assess patient's recall of risk of surgical complications. Patient demographic characteristics and educational attainment were similar in both groups. There was a statistically significant increase in the mean number of risks recalled in the study group at 1.43 compared with 0.67 in the control group (P = 0.0131). Consent is a complex process, and obtaining informed consent is far from straightforward. A statistically significant improvement in patient's recall with the use of procedure-specific consent forms was identified, and based on this, we would advocate their use. However, overall patient recall in both groups was poor. We believe that improving the quality of informed consent may require the sum of small gains, and the use of procedure-specific consent forms may aid in this regard.

Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

Science.gov (United States)

King, Cheryl A.; Kramer, Anne C.

2008-01-01

Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

USign--a security enhanced electronic consent model.

Science.gov (United States)

Li, Yanyan; Xie, Mengjun; Bian, Jiang

2014-01-01

Electronic consent becomes increasingly popular in the healthcare sector given the many benefits it provides. However, security concerns, e.g., how to verify the identity of a person who is remotely accessing the electronic consent system in a secure and user-friendly manner, also arise along with the popularity of electronic consent. Unfortunately, existing electronic consent systems do not pay sufficient attention to those issues. They mainly rely on conventional password based authentication to verify the identity of an electronic consent user, which is far from being sufficient given that identity theft threat is real and significant in reality. In this paper, we present a security enhanced electronic consent model called USign. USign enhances the identity protection and authentication for electronic consent systems by leveraging handwritten signatures everyone is familiar with and mobile computing technologies that are becoming ubiquitous. We developed a prototype of USign and conducted preliminary evaluation on accuracy and usability of signature verification. Our experimental results show the feasibility of the proposed model.

Enhancing informed consent for research and treatment.

Science.gov (United States)

Dunn, L B; Jeste, D V

2001-06-01

Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

Cross-cultural perspectives on research participation and informed consent.

Science.gov (United States)

Barata, Paula C; Gucciardi, Enza; Ahmad, Farah; Stewart, Donna E

2006-01-01

This study examined Portuguese Canadian and Caribbean Canadian immigrants' perceptions of health research and informed consent procedures. Six focus groups (three in each cultural group) involving 42 participants and two individual interviews were conducted. The focus groups began with a general question about health research. This was followed by three short role-plays between the moderator and the assistant. The role-plays involved a fictional health research study in which a patient is approached for recruitment, is read a consent form, and is asked to sign. The role-plays stopped at key moments at which time focus group participants were asked questions about their understanding and their perceptions. Focus group transcripts were coded in QSR NUDIST software using open coding and then compared across cultural groups. Six overriding themes emerged: two were common in both the Portuguese and Caribbean transcripts, one emphasized the importance of trust and mistrust, and the other highlighted the need and desire for more information about health research. However, these themes were expressed somewhat differently in the two groups. In addition, there were four overriding themes that were specific to only one cultural group. In the Portuguese groups, there was an overwhelming positive regard for the research process and an emphasis on verbal as opposed to written information. The Caribbean participants qualified their participation in research studies and repeatedly raised images of invasive research.

Informed consent

International Nuclear Information System (INIS)

Bundy, A.L.

1988-01-01

Numerous articles on informed consent have appeared in medical and legal journals over the past few years. Many of these have been in the radiological literature. This chapter presents an overview of the legal principles behind this controversial topic. Recent articles are reviewed and specific suggestions are made where applicable. The doctrine of informed consent is both a product of and the basis for the physician-patient relationship. Their communications to each other establish the relationship, but once established, heightened degrees of expectations on the patient's part have dictated the need for a more sophisticated level of communication. Since patients and physicians often expect different things of each other, it is imperative that the relationship leads to effective and respectful conversation

Children, Deaf, of Deaf Parents

NARCIS (Netherlands)

Baker, A.E.; van den Bogaerde, B.; Gertz, G.; Boudreault, P.

2016-01-01

Deaf children with Deaf parents usually grow up in the Deaf community, that is if their parents offer them a sign language and are active members of the community. These Deaf children are similar to other children of linguistic and cultural minorities in many ways. They are also different in that

Involving Medical Students in Informed Consent: A Pilot Study.

Science.gov (United States)

Chiapponi, Costanza; Meyer, Frank; Jannasch, Olof; Arndt, Stephan; Stübs, Patrick; Bruns, Christiane J

2015-09-01

Studies have reported that patients often sign consent documents without understanding the content. Written paperwork, audio-visual materials, and decision aids have shown to consistently improve patients' knowledge. How informed consent should be taken is not properly taught at most universities in Germany. In this cross-sectional study, we investigated how much information about their procedure our patients retain. In particular, it should be elucidated whether an additional conversation between patients and properly prepared medical students shortly before surgery as an adjunct to informed consent can be introduced as a new teaching unit aimed to increase the understanding of surgery by patients and students. Informed consent of all patients had been previously obtained by three surgical residents 1-3 days in advance. All patients had received a copy of their consent form. The same residents developed assessment forms for thyroidectomy, laparoscopic cholecystectomy, umbilical hernia repair, and Lichtenstein procedure for inguinal hernia, respectively, containing 3-4 major common complications (e.g., bile duct injury, hepatic artery injury, stone spillage, and retained stones for laparoscopic cholecystectomy) and briefed the medical students before seeing the patients. Structured one-to-one interviews between students (n = 9) and patients (n = 55) based on four different assessment forms were performed and recorded by students. Both patients and students were asked to assess the new teaching unit using a short structured questionnaire. Although 100% of patients said at the beginning of their interview to have understood and memorized the risks of their imminent procedure, 5.8% (3/55) were not even able to indicate the correct part of the body where the incision would take place. Only 18.2% (10/55) of the patients were able to mention 2 or more complications, and 45.3% (25/55) could not even recall a single one. 96.4% (53/55) of the patients and 100% (9/9) of the

Pediatric data sharing in genomic research: attitudes and preferences of parents.

Science.gov (United States)

Burstein, Matthew D; Robinson, Jill Oliver; Hilsenbeck, Susan G; McGuire, Amy L; Lau, Ching C

2014-04-01

In the United States, data from federally funded genomics studies are stored in national databases, which may be accessible to anyone online (public release) or only to qualified researchers (restricted release). The availability of such data exposes participants to privacy risk and limits the ability to withdraw from research. This exposure is especially challenging for pediatric participants, who are enrolled in studies with parental permission. The current study examines genomic research participants' attitudes to explore differences in data sharing (DS) preferences between parents of pediatric patients and adult patients. A total of 113 parents of pediatric patients and 196 adult participants from 6 genomics studies were randomly assigned to 3 experimental consent forms. Participants were invited to a follow-up structured interview exploring DS preferences, study understanding, and attitudes. Descriptive analyses and regression models were built on responses. Most parents (73.5%) and adult participants (90.3%) ultimately consented to broad public release. However, parents were significantly more restrictive in their data release decisions, not because of understanding or perceived benefits of participation but rather autonomy and control. Parents want to be more involved in the decision about DS and are significantly more concerned than adult participants about unknown future risks. Parents have the same altruistic motivations and grasp of genomics studies as adult participants. However, they are more concerned about future risks to their child, which probably motivates them to choose more restrictive DS options, but only when such options are made available.

What is presumed when we presume consent?

Directory of Open Access Journals (Sweden)

Pierscionek Barbara K

2008-04-01

Full Text Available Abstract Background The organ donor shortfall in the UK has prompted calls to introduce legislation to allow for presumed consent: if there is no explicit objection to donation of an organ, consent should be presumed. The current debate has not taken in account accepted meanings of presumption in law and science and the consequences for rights of ownership that would arise should presumed consent become law. In addition, arguments revolve around the rights of the competent autonomous adult but do not always consider the more serious implications for children or the disabled. Discussion Any action or decision made on a presumption is accepted in law and science as one based on judgement of a provisional situation. It should therefore allow the possibility of reversing the action or decision. Presumed consent to organ donation will not permit such reversal. Placing prime importance on the functionality of body organs and their capacity to sustain life rather than on explicit consent of the individual will lead to further debate about rights of ownership and potentially to questions about financial incentives and to whom benefits should accrue. Factors that influence donor rates are not fully understood and attitudes of the public to presumed consent require further investigation. Presuming consent will also necessitate considering how such a measure would be applied in situations involving children and mentally incompetent adults. Summary The presumption of consent to organ donation cannot be understood in the same way as is presumption when applied to science or law. Consideration should be given to the consequences of presuming consent and to the questions of ownership and organ monetary value as these questions are likely to arise should presumed consent be permitted. In addition, the implications of presumed consent on children and adults who are unable to object to organ donation, requires serious contemplation if these most vulnerable

Informed consent comprehension in African research settings.

Science.gov (United States)

Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

2014-06-01

Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for

Consent in escrow.

Science.gov (United States)

Van der Loos, Kiah I; Longstaff, Holly; Virani, Alice; Illes, Judy

2015-02-01

Disasters such as flash flooding, mass shootings, and train and airplane accidents involving large numbers of victims produce significant opportunity for research in the biosciences. This opportunity exists in the extreme tails of life events, however, during which decisions about life and death, valuing and foregoing, speed and patience, trust and distrust, are tested simultaneously and abundantly. The press and urgency of these scenarios may also challenge the ability of researchers to comprehensively deliver information about the purposes of a study, risks, benefits, and alternatives. Under these circumstances, we argue that acquiring consent for the immediate use of data that are not time sensitive represents a gap in the protection of human study participants. In response, we offer a two-tiered model of consent that allows for data collected in real-time to be held in escrow until the acute post-disaster window has closed. Such a model not only respects the fundamental tenet of consent in research, but also enables such research to take place in an ethically defensible manner.

Parental refusal of life-saving treatments for adolescents: Chinese familism in medical decision-making re-visited.

Science.gov (United States)

Hui, Edwin

2008-06-01

This paper reports two cases in Hong Kong involving two native Chinese adolescent cancer patients (APs) who were denied their rights to consent to necessary treatments refused by their parents, resulting in serious harm. We argue that the dynamics of the 'AP-physician-family-relationship' and the dominant role Chinese families play in medical decision-making (MDM) are best understood in terms of the tendency to hierarchy and parental authoritarianism in traditional Confucianism. This ethic has been confirmed and endorsed by various Chinese writers from Mainland China and Hong Kong. Rather than giving an unqualified endorsement to this ethic, based more on cultural sentimentalism than rational moral reasoning, we warn that a strong familism in MDM, which deprives 'weak' family members of rights, represents the less desirable elements of this tradition, against which healthcare professionals working in this cultural milieu need to safeguard. Specifically for APs, we suggest that parental authority and family integrity should be re-interpreted in terms of parental responsibility and the enhancement of children's interests respectively, as done in the West. This implies that when parents refuse to consent to necessary treatment and deny their adolescent children's right to consent, doctors, as the only remaining advocates of the APs' interest, have the duty to inform the state, which can override parental refusal to enable the doctors to fulfill their professional and moral obligations. In so doing the state exercises its 'parens patriae' power to defend the defenseless in society and the integrity of the medical profession.

Dynamic axes of informed consent in Japan.

Science.gov (United States)

Specker Sullivan, Laura

2017-02-01

Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.

The limits of parental responsibility regarding medical treatment decisions.

Science.gov (United States)

Woolley, Sarah L

2011-11-01

Parental responsibility (PR) was a concept introduced by the Children Act (CA) 1989 which aimed to replace the outdated notion of parental rights and duties which regarded children as parental possessions. Section 3(1) CA 1989 defines PR as 'all the rights, duties, powers, responsibilities and authority which by law a parent of a child has in relation to the child'. In exercising PR, individuals may make medical treatment decisions on children's behalf. Medical decision-making is one area of law where both children and the state can intercede and limit parental decision-making. Competent children can consent to treatment and the state can interfere if parental decisions are not seemingly in the child's 'best interests'. This article examines the concept, and limitations, of PR in relation to medical treatment decision-making.

Autism beyond pediatrics: why bioethicists ought to rethink consent in light of chronicity and genetic identity.

Science.gov (United States)

Perry, Alexandra

2012-06-01

Autism is a chronic neurodevelopmental disorder that presents unique challenges to bioethicists. In particular, bioethicists ought to reconsider pediatric consent in light of disparity between beliefs that are held about the disorder by parents and adults with autism. The neurodiverse community ought to be given some consideration in this debate, and, as such, there may be a role for autistic narratives in clarifying this problem. © 2011 Blackwell Publishing Ltd.

Clinical signs suggestive of pharyngeal dysphagia in preschool children with cerebral palsy.

Science.gov (United States)

Benfer, Katherine A; Weir, Kelly A; Bell, Kristie L; Ware, Robert S; Davies, Peter S W; Boyd, Roslyn N

2015-03-01

This study aimed to determine the discriminative validity, reproducibility, and prevalence of clinical signs suggestive of pharyngeal dysphagia according to gross motor function in children with cerebral palsy (CP). It was a cross-sectional population-based study of 130 children diagnosed with CP at 18-36 months (mean=27.4, 81 males) and 40 children with typical development (TD, mean=26.2, 18 males). Sixteen signs suggestive of pharyngeal phase impairment were directly observed in a videoed mealtime by a speech pathologist, and reported by parents on a questionnaire. Gross motor function was classified using the Gross Motor Function Classification System. The study found that 67.7% of children had clinical signs, and this increased with poorer gross motor function (OR=1.7, pDysphagia cut-points were modified to exclude a single cough on fluids, with a modified prevalence estimate proposed as 50.8%. Clinical signs suggestive of pharyngeal dysphagia are common in children with CP, even those with ambulatory CP. Parent-report on 16 specific signs remains a feasible screening method. While coughing was consistently identified by clinicians, it may not reflect children's regular performance, and was not sufficiently discriminative in children aged 18-36 months. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

Toxoplasmosis (For Parents)

Science.gov (United States)

... Staying Safe Videos for Educators Search English Español Toxoplasmosis KidsHealth / For Parents / Toxoplasmosis What's in this article? ... t show any signs of a toxoplasmosis infection.) Toxoplasmosis in Kids In kids, toxoplasmosis infections can be: ...

Where no consent = death.

Science.gov (United States)

1977-01-01

Men must be made to understand the value of family planning - particularly in societies where men hold the power of decision in the family. Dr. Kotha Pannikar, chairman of the Kedah Family Planning Association (FPA) in Malaysia, illustrated this point in discussion which followed the Consultation of Medical and Communication Fieldworkers conference in Kuala Lumpur in August, with a story about 1 of her own patients. When the girl, who had a rheumatic heart, was 16, Dr. Pannikar advised the parents that she needed cardiac surgery if she were to be a healthy wife and mother. But the parents lived some distance from Dr. Pannikar's surgery and did not heed the advice. The girl was married to a carpenter from a traditional Chinese family, in which "the man is lord and master." Her new home had no piped water, and in additional to normal domestic tasks she had to carry water from a source 1 1/2 miles agay. In the 7th month of her 1st pregnancy, she went into cardiac failure. After the 3rd pregnancy and a 3rd cardiac failure, Dr. Pannikar tried to arrange a sterilization "but we could not get consent - her husband refused to turn up at the hospital." When the girl was admitted to hospital 6 months into her 4th pregnancy, Dr. Pannikar got hold of her patient's mother-in-law. "I told her if she wanted a servant in the house, it was easy to get one. But no servant would look after her grandchildren the way their mother would. I told her if she wanted to save the girl's life she had better speak to her son." During the 4th delivery, the girl went into cardiac arrest and spent 2 weeks in intensive care. The mother-in-law prevailed upon her son to at least consent, and the girl was sterilized before she left hospital. But "it was a very near thing," Dr. Pannikar recalls "and it wouldn't have happened if the husband had felt he was responsible in parenthood." The Kedah FPA makes special efforts to reach men. Dr. Pannikar herself talks to men's organizations like the Lions and

Physical punishment and signs of mental distress in normal adolescents.

Science.gov (United States)

Bachar, E; Canetti, L; Bonne, O; DeNour, A K; Shalev, A Y

1997-01-01

Adolescents (375 males and 496 females) were administered the Brief Symptom Inventory (BSI), the General Well-Being Scale (GWB), the Parental Bonding Instrument (PBI), and two questions about each parent, supplementing the PBI, tapping violent punitive behavior. Signs of mental distress in adolescents and reported physical punishment from parents were analyzed. Results indicated that greater physical punishment was associated with higher levels of psychiatric symptoms and lower general well-being. These results persisted after controlling for parental attitudes, as quantified by the PBI, and socioeconomic status. The findings of this study can contribute to efforts to raise public awareness of the negative consequences of physical punishment on the mental health of children.

Semantic Fluency in Deaf Children Who Use Spoken and Signed Language in Comparison with Hearing Peers

Science.gov (United States)

Marshall, C. R.; Jones, A.; Fastelli, A.; Atkinson, J.; Botting, N.; Morgan, G.

2018-01-01

Background: Deafness has an adverse impact on children's ability to acquire spoken languages. Signed languages offer a more accessible input for deaf children, but because the vast majority are born to hearing parents who do not sign, their early exposure to sign language is limited. Deaf children as a whole are therefore at high risk of language…

Role of informed consent for intravascular contrast media

International Nuclear Information System (INIS)

Hopper, K.D.; Tyler, H.N. Jr.

1988-01-01

To evaluate the usefulness of different degrees of informed consent for intravascular contrast media, the authors divided 100 patients into four groups: (1) informed consent with no information on intravascular contrast media, (2) simple written informed consent that detailed common risks, (3) detailed written informed consent that detailed all known risks, and (4) MD informed consent, during which a radiologist discussed all known risks of intravascular contrast media. Physician counseling time for group 4 averaged 11.4 minutes. On a postprocedure test about the common complications and risk factors of intravascular contrast media, the average scores were: group 1, 38.4%; group 2, 68.2%; group 3, 63.2%; and group 4, 69.8%. There was no statistical difference between groups 2-4 on the postprocedure test. If informed consent is to be used prior to intravascular contrast media administration, a simple written consent detailing the common risks and risk factors appears to be the best method

Parental consent requirements and privacy rights of minors: the contraceptive controversy.

Science.gov (United States)

1975-03-01

That the adult zone of privacy recognized by the Supreme Court during the past decade embraces access to contraceptives is suggested. 2 further questions are examined: 1) whether the right of children to have access to contraceptives is fundamental and 2) whether countervailing interests of parents and state should outweigh whatever interest the child has in obtaining contraceptives. More fundamentally, 3 complex issues relative to an analysis of minors' rights to obtain contraceptives are discussed: 1) the scope of the constitutional right of adults to obtain contraceptives remains uncertain; 2) courts have not yet articulated the special factors that determine how existing frameworks for analyzing the rights of adults are to be applied to minors; and 3) the question of minors' access to contraceptive involves a particularly complex mixture of the interests of minors, parents, and the state.

[Issues related to consent to healthcare decisions in children and adolescents].

Science.gov (United States)

Bailly, D

2010-02-01

The process of consent to healthcare decisions in children and adolescents often set physicians difficult problems. From what age is a child able to understand the information given to him or her about illness and treatment? Is an ill child indeed in the capacity to give his or her voluntary consent to treatment? How to define and to assess the capacity of an ill child to take part in treatment decisions? More than the age of the child, it is his or her level of cognitive, emotional and social development and its interactions with illness that will determine his or her degree of involvement in the decision-making process. There is a moral and ethical need to respect the rights and autonomy of every individual, regardless of age. This does not mean viewing children and adolescents as rational and autonomous decision-makers. This implies that we must promote their developmentally appropriate participation in shared decision-making with parents and physicians. Therefore, instead of asking, "should children and adolescents be granted absolute autonomy in decision making?" we ought to ask, "should we treat children and adolescents like people?" Copyright (c) 2010 Elsevier Masson SAS. All rights reserved.

Improving the Proficiency of Research Consent Administrators

Science.gov (United States)

Larson, Elaine L.; Lally, Rachel; Foe, Gabriella; Joaquin, Gabriela; Meyer, Dodi D.; Cohn, Elizabeth G.

2015-01-01

Abstract Objective: To describe the development and testing of a module to improve consent administrators’ skills when obtaining research consent from culturally and linguistically diverse and low literacy populations. Design: Development and psychometric testing of video module including community vignettes. Methods: Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre‐ and postknowledge tests and satisfaction surveys completed by 112 consent administrators. Results: Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t‐test 95% confidence interval of difference: –0.18 to –0.88; two‐tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0–35), but years of experience was not significantly associated with either pre‐ or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made. Conclusion: Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training. PMID:25676061

Communicating with parents of premature infants: who is the informant?

Science.gov (United States)

Kowalski, W J; Leef, K H; Mackley, A; Spear, M L; Paul, D A

2006-01-01

To determine what sources of information are most helpful for neonatal intensive care unit (NICU) parents, who provides NICU parents with the information, and also what expectations parents have regarding obtaining information. A 19-item questionnaire was given to the parents of infants 32 weeks or younger prior to discharge from the NICU. Out of the 101 parents who consented, almost all of the parents (96%) felt that 'the medical team gave them the information they needed about their baby' and that the 'neonatologist did a good job of communicating' with them (91%). However, the nurse was chosen as 'the person who spent the most time explaining the baby's condition, 'the best source of information,' and the person who told them 'about important changes in their baby's condition' (Pparent education is satisfactory, the parents identified the nurses as the primary source of information.

Requesting a unique personal identifier or providing a souvenir incentive did not affect overall consent to health record linkage: evidence from an RCT nested within a cohort.

Science.gov (United States)

Ni, Michael Y; Li, Tom K; Hui, Rex W H; McDowell, Ian; Leung, Gabriel M

2017-04-01

It is unclear if unique personal identifiers should be requested from participants for health record linkage: this permits high-quality data linkage but at the potential cost of lower consent rates due to privacy concerns. Drawing from a sampling frame based on the FAMILY Cohort, using a 2 × 2 factorial design, we randomly assigned 1,200 participants to (1) request for Hong Kong Identity Card number (HKID) or no request and (2) receiving a souvenir incentive (valued at USD4) or no incentive. The primary outcome was consent to health record linkage. We also investigated associations between demographics, health status, and postal reminders with consent. Overall, we received signed consent forms from 33.3% (95% confidence interval [CI] 30.6-36.0%) of respondents. We did not find an overall effect of requesting HKID (-4.3%, 95% CI -9.8% to 1.2%) or offering souvenir incentives (2.4%, 95% CI -3.1% to 7.9%) on consent to linkage. In subgroup analyses, requesting HKID significantly reduced consent among adults aged 18-44 years (odds ratio [OR] 0.53, 95% CI 0.30-0.94, compared to no request). Souvenir incentives increased consent among women (OR 1.55, 95% CI 1.13-2.11, compared to no souvenirs). Requesting a unique personal identifier or providing a souvenir incentive did not affect overall consent to health record linkage. Copyright © 2017 Elsevier Inc. All rights reserved.

Parents as passengers during pediatric transport.

Science.gov (United States)

Lewis, M M; Holditch-Davis, D; Brunssen, S

1997-01-01

The transport environment presents a unique setting in which the feasibility, advantages, and disadvantages of passengers accompanying a patient must be assessed carefully. The purpose of this study was to describe the current practice of including parents as passengers during pediatric interfacility transport. One-hundred-eighty-eight critical care transport programs in the United States responded to a voluntary mail survey, providing information about current policies, practices, and crew perceptions of the advantages and disadvantages of carrying parents as passengers. Extra seating for passengers was available in 96% of ambulances, 86% of fixed-wing aircraft, and 54% of helicopters used for pediatric transport. Parents traveled as passengers in all types of vehicles; most frequently in ambulances and fixed-wing aircraft. Twenty percent of helicopter programs allowed parent passengers on more than half of their pediatric transports in this vehicle. Advantages of parent passengers included emotional benefit for the parent and child, availability of parents for history and consent, good public relations, and having the parent present if the child dies. Disadvantages included potential parent anxiety, crew distraction, and space limitations. This study reflects the widely diverse policies, practices, and opinions relevant to this topic and confirms a need for further study.

12 CFR 980.6 - Finance Board consent.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank to undertake a particular new business activity and...

Interactive multimedia consent for biobanking: a randomized trial.

Science.gov (United States)

Simon, Christian M; Klein, David W; Schartz, Helen A

2016-01-01

The potential of interactive multimedia to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence in understanding of informed consent compared with a standard, face-to-face (F2F) biobank consent process. A 2 (face-to-face versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the biobank's nine-page consent document. Interactivity (F(1,196) = 7.56, P = 0.007, partial η(2) = 0.037) and media (F(1,196) = 4.27, P = 0.04, partial η(2) = 0.021) independently improved participants' understanding of the biobank consent. Interactivity (F(1,196) = 6.793, P = 0.01, partial η(2) = 0.033), but not media (F(1,196) = 0.455, not significant), resulted in increased participant confidence in their understanding of the biobank's consent materials. Patients took more time to complete the multimedia condition (mean = 18.2 min) than the face-to-face condition (mean = 12.6 min). This study demonstrated that interactivity and multimedia each can be effective at promoting an individual's understanding and confidence in their understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather should separate the two constructs when studying electronic consent.

But is this really the 'parent' or 'guardian'? Practical strategies for ...

African Journals Online (AJOL)

consent for other child studies that are more than minimal risk, according ... a parent or legal guardian is required for child enrolment into a ... Should researchers accept disclosures at face value, probe assertions that are made, or even call for ...

Readability of Invasive Procedure Consent Forms.

Science.gov (United States)

Eltorai, Adam E M; Naqvi, Syed S; Ghanian, Soha; Eberson, Craig P; Weiss, Arnold-Peter C; Born, Christopher T; Daniels, Alan H

2015-12-01

Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch-Kincaid Grade Level, Fog Scale, SMOG Index, Coleman-Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level. Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p readability guidelines for patient materials of 6th grade (p readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions. © 2015 Wiley Periodicals, Inc.

Taiwanese parents' experience of making a "do not resuscitate" decision for their child in pediatric intensive care unit.

Science.gov (United States)

Liu, Shu-Mei; Lin, Hung-Ru; Lu, Frank L; Lee, Tzu-Ying

2014-03-01

The purpose of this project was to explore the parental experience of making a "do not resuscitate" (DNR) decision for their child who is or was cared for in a pediatric intensive care unit in Taiwan. A descriptive qualitative study was conducted following parental signing of a standard hospital DNR form on behalf of their critically ill child. Sixteen Taiwanese parents of 11 children aged 1 month to 18 years were interviewed. Interviews were recorded, transcribed, analyzed and sorted into themes by the sole interviewer plus other researchers. Three major themes were identified: (a) "convincing points to sign", (b) "feelings immediately after signing", and (c) "post-signing relief or regret". Feelings following signing the DNR form were mixed and included "frustration", "guilt", and "conflicting hope". Parents adjusted their attitudes to thoughts such as "I have done my best," and "the child's life is beyond my control." Some parents whose child had died before the time of the interview expressed among other things "regret not having enough time to be with and talk to my child". Open family visiting hours plus staff sensitivity and communication skills training are needed. To help parents with this difficult signing process, nurses and other professionals in the pediatric intensive care unit need education on initiating the conversation, guiding the parents in expressing their fears, and providing continuing support to parents and children throughout the child's end of life process. Copyright © 2013. Published by Elsevier B.V.

7 CFR 718.206 - Determining farms, tracts, allotments, quotas, and bases when reconstitution is made by division.

Science.gov (United States)

2010-01-01

... transferring owner and transferee shall file a signed written memorandum of understanding of the designation... allotments, quotas, and bases shall be apportioned in the manner agreed to in writing by all interested heirs... totals of the parent farm than the cropland method would; and (ii) Obtains written consent of all owners...

Obtaining consent to oral and maxillofacial surgery.

Science.gov (United States)

Poswillo, D

1989-09-01

The question of whether or not a patient has consented to treatment has recently become significant to all who practise oral and maxillofacial surgery. It is often linked to professional negligence when the outcome differs from the patient's perception or expectation of the operation. Consent may be oral or written, applies to referred patients and all those with physical and mental handicap and religious restrictions. Examples of procedure in discussing consent assist the surgeon to inform without creating fear. Knowledge of the benefits of informed consent and current legal opinion assist the oral and maxillofacial surgeon to avoid the pitfalls of failure to inform.

Oncologists’ view of informed consent and shared decision making in paediatric radiation oncology

International Nuclear Information System (INIS)

Olson, Robert A.; Bobinski, Mary Ann; Ho, Anita; Goddard, Karen J.

2012-01-01

Background and purpose: Cure rates of paediatric malignancies have dramatically improved with therapy intensification, at the cost of late treatment side effects. A survey was developed, centred around medulloblastoma scenarios, in order to explore paediatric oncology physicians’ views on discussing late effects and involving parents in treatment decisions. Materials and methods: Participants were 59 paediatric radiation and medical oncologists or fellows from USA (22), Canada (18), Europe (16), Australia (2), and Asia (1). Results: Ninety-five percent of respondents indicated late effects discussion prior to multimodality treatment was important. Of those who supported it, 100%, 83%, 64%, and 48% thought discussing cognitive impairment, infertility, stroke, and seizures as potential late effects was important, respectively. Only 71% of respondents believed parents should be involved in treatment decisions, which did not significantly vary by respondent age, country, specialty, gender, or years in practice. Conclusions: The majority of oncologists who treat children believe discussing late effects with parents is important. However, there is mixed opinion on which late effects should be discussed and whether parents should be involved in deciding which treatments should be pursued. Research into perceived barriers to shared decision making and effective methods of improving the informed consent process in paediatric malignancies is needed.

Risk perception and decision processes underlying informed consent to research participation.

Science.gov (United States)

Reynolds, William W; Nelson, Robert M

2007-11-01

According to the rational choice model, informed consent should consist of a systematic, step-by-step evaluation of all information pertinent to the treatment or research participation decision. Research shows that people frequently deviate from this normative model, however, employing decision-making shortcuts, or heuristics. In this paper we report findings from a qualitative study of 32 adolescents and (their) 31 parents who were recruited from two Northeastern US hospitals and asked to consider the risks of and make hypothetical decisions about research participation. The purpose of this study was to increase our understanding of how diabetic and at-risk adolescents (i.e., those who are obese and/or have a family history of diabetes) and their parents perceive risks and make decisions about research participation. Using data collected from adolescents and parents, we identify heuristic decision processes in which participant perceptions of risk magnitude, which are formed quickly and intuitively and appear to be based on affective responses to information, are far more prominent and central to the participation decision than are perceptions of probability. We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers.

Parental consent for bone marrow transplantation in the case of genetic disorders.

Science.gov (United States)

Prows, C A; McCain, G C

1997-01-01

To describe the responses of mothers and fathers who were offered bone marrow transplantation (BMT) for their children with genetic disorders. Qualitative. Private hospital rooms/offices. Six mothers and 4 fathers of children with genetic disorders. The basic social-psychological problem confronting the parents was the conflicting alternatives of life versus death for their children. It was certain that these children would die from their genetic disorders but without having to endure the pain and suffering of a BMT. The BMT would be difficult, possibly resulting in death, but with a chance of survival. Parents believed that BMT was the only chance of survival for their children, leaving them no choice except to pursue the BMT treatment.

ERP correlates of German Sign Language processing in deaf native signers.

Science.gov (United States)

Hänel-Faulhaber, Barbara; Skotara, Nils; Kügow, Monique; Salden, Uta; Bottari, Davide; Röder, Brigitte

2014-05-10

The present study investigated the neural correlates of sign language processing of Deaf people who had learned German Sign Language (Deutsche Gebärdensprache, DGS) from their Deaf parents as their first language. Correct and incorrect signed sentences were presented sign by sign on a computer screen. At the end of each sentence the participants had to judge whether or not the sentence was an appropriate DGS sentence. Two types of violations were introduced: (1) semantically incorrect sentences containing a selectional restriction violation (implausible object); (2) morphosyntactically incorrect sentences containing a verb that was incorrectly inflected (i.e., incorrect direction of movement). Event-related brain potentials (ERPs) were recorded from 74 scalp electrodes. Semantic violations (implausible signs) elicited an N400 effect followed by a positivity. Sentences with a morphosyntactic violation (verb agreement violation) elicited a negativity followed by a broad centro-parietal positivity. ERP correlates of semantic and morphosyntactic aspects of DGS clearly differed from each other and showed a number of similarities with those observed in other signed and oral languages. These data suggest a similar functional organization of signed and oral languages despite the visual-spacial modality of sign language.

Understanding Puberty (For Parents)

Science.gov (United States)

... Safe Videos for Educators Search English Español Understanding Puberty KidsHealth / For Parents / Understanding Puberty What's in this ... your child through all the changes? Stages of Puberty Sure, most of us know the telltale signs ...

Spider Bites (For Parents)

Science.gov (United States)

... Videos for Educators Search English Español First Aid: Spider Bites KidsHealth / For Parents / First Aid: Spider Bites ... rare. Signs and Symptoms Of a brown recluse spider bite: red blister in the center with surrounding ...

Unanimous Constitutional Consent and the Immigration Problem

OpenAIRE

Josten, Stefan D.; Zimmermann, Klaus W.

2004-01-01

This paper utilizes the cross-cutting cleavages approach to evaluate the probability of a unanimous constitutional consent and, based on these results, discusses the implications of immigration on an existing constitutional consent. It is shown that previous conclusions of beneficial effects stemming from a multitude of political dimensions for a unanimous constitutional consent crucially depend on the assumption of an extreme mode of intrapersonal compensation of constitutional majority and ...

Description of a Mobile-based Electronic Informed Consent System Development.

Science.gov (United States)

Hwang, Min-A; Kwak, In Ja

2015-01-01

Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

Consent for pediatric anesthesia: an observational study.

Science.gov (United States)

Lagana, Zoe; Foster, Andrew; Bibbo, Adriana; Dowling, Kate; Cyna, Allan M

2012-08-01

Informed consent prior to anesthesia is an important part of the pediatric pre-anesthetic consultation. This study aimed to observe and identify the number and nature of the anesthesia risks considered and communicated to parents/guardians and children during the pediatric informed consent process on the day of elective surgery. A convenience sample of anesthetists had their pre-anesthesia consultations voice recorded, prior to elective surgery, during a 4-month period at the largest tertiary referral centre for pediatric care in South Australia. A data collection form was used to note baseline demographic data, and voice recording transcripts were independently documented by two researchers and subsequently compared for accuracy regarding the number and nature of risks discussed. Of the 96 voice recordings, 91 (92%) were suitable for the analysis. The five most commonly discussed risks were as follows: nausea and vomiting (36%); sore throat (35%); allergy (29%); hypoxia (25%); and emergence delirium (19%). Twenty-seven pre-anesthetic consultations (30%) were found to have had no discussion of anesthetic risk at all while a further 23 consultations (26%) incorporated general statements inferring that anesthesia carried risks, but with no elaboration about their nature, ramifications or incidence. The median number of risks (IQR) specifically mentioned per consultation was higher, 3 (1) vs 1 (1), P anesthesia experience odds ratio 0.34, 95% CI [0.13, 0.87], P = 0.025. The pediatric anesthesia risk discussion is very variable. Trainees tend to discuss more specific risks than consultants and a patient's previous experience of anesthesia was associated with a more limited discussion of anesthesia risk. © 2011 Blackwell Publishing Ltd.

Name signs in Danish Sign Language

DEFF Research Database (Denmark)

Bakken Jepsen, Julie

2018-01-01

in spoken languages, where a person working as a blacksmith by his friends might be referred to as ‘The Blacksmith’ (‘Here comes the Blacksmith!’) instead of using the person’s first name. Name signs are found not only in Danish Sign Language (DSL) but in most, if not all, sign languages studied to date....... This article provides examples of the creativity of the users of Danish Sign Language, including some of the processes in the use of metaphors, visual motivation and influence from Danish when name signs are created.......A name sign is a personal sign assigned to deaf, hearing impaired and hearing persons who enter the deaf community. The mouth action accompanying the sign reproduces all or part of the formal first name that the person has received by baptism or naming. Name signs can be compared to nicknames...

Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

Science.gov (United States)

Mellado, J M

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Vital Signs – Preventing Repeat Teen Births

Centers for Disease Control (CDC) Podcasts

2013-04-02

This podcast is based on the April 2013 CDC Vital Signs report, which discusses repeat teen births and ways teens, parents and guardians, health care providers, and communities can help prevent them.  Created: 4/2/2013 by Centers for Disease Control and Prevention (CDC).   Date Released: 4/2/2013.

Tips for Divorcing Parents

Science.gov (United States)

... parents and kids, and watching for signs of stress can help prevent problems developing. Getting Help Figure out how ... Move Helping Your Child Through a Divorce Childhood Stress How Can I Help My Child Cope With Divorce? How Can I ...

Competence for Contract and Competence to Consent to Treatment

OpenAIRE

前田, 泰

2008-01-01

This paper analyzes assessing competence to consent to treatment. It focuses on problems of competence for contract and competence to consent to treatment. Finally, it discusses the degree of assessing competence to consent to treatment.

Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders' views in South Wales.

Science.gov (United States)

Wood, Fiona; Prout, Hayley; Bayer, Antony; Duncan, Donna; Nuttall, Jacqueline; Hood, Kerenza; Butler, Christopher C

2013-08-09

Care home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders' views about the ethical and practical challenges associated with recruiting care home residents into research studies. Qualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes. Respondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study. Research staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a

On the System of Person-Denoting Signs in Estonian Sign Language: Estonian Name Signs

Science.gov (United States)

Paales, Liina

2010-01-01

This article discusses Estonian personal name signs. According to study there are four personal name sign categories in Estonian Sign Language: (1) arbitrary name signs; (2) descriptive name signs; (3) initialized-descriptive name signs; (4) loan/borrowed name signs. Mostly there are represented descriptive and borrowed personal name signs among…

Changes in Children's Behavior and Costs for Service Use Associated with Parents' Response to Treatment for Dysthymia

Science.gov (United States)

Byrne, Carolyn; Browne, Gina; Roberts, Jacqueline; Mills, Michael; Bell, Barbara; Gafni, Amiram; Jamieson, Ellen; Webb, Michelle

2006-01-01

Objective: This study examined differences in children's behavior and expenditures for health and social services used when their parents with dysthymia did or did not respond to antidepressant therapy. Method: Children ages 4 to 16 years of consenting parents enrolled in a treatment trial for dysthymia who did and did not respond to treatment…

How modifiable factors influence parental decision-making about organ donation.

Science.gov (United States)

Luberda, Kamila; Cleaver, Karen

2017-11-07

A global shortage of organs from children and adults available for transplantation is compounded by the failure of next of kin to consent for organs to be donated after death. Non-modifiable and modifiable factors influence decision-making in this area. Modifiable factors are of interest when examining families' decision-making about the donation of organs from their deceased child. A scoping review was undertaken to determine how modifiable factors influence parental decision-making about organ donation. Thematic analysis identified two themes: interactions with healthcare professionals and pre-disposition to organ donation. Satisfaction with experiences of hospital care, the information provided and the way it was communicated, as well as interactions pertaining to emotional support were all found to be modifiable factors that influenced decision making. Likewise, a predisposition to organ donation and knowing the deceased's wishes were associated with the consent decision. Nurses working in critical care environments need to be able to support parents during this difficult time. This article aims to raise awareness of modifiable factors that influence parental decision-making, highlighting their relevance for children's nursing practice. ©2017 RCN Publishing Company Ltd. All rights reserved. Not to be copied, transmitted or recorded in any way, in whole or part, without prior permission of the publishers.

Testing an alternate informed consent process.

Science.gov (United States)

Yates, Bernice C; Dodendorf, Diane; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

2009-01-01

One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions. The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial. An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process. Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study. Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

The Challenges of Research Informed Consent in Socio-Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo.

Science.gov (United States)

Kalabuanga, Marion; Ravinetto, Raffaella; Maketa, Vivi; Muhindo Mavoko, Hypolite; Fungula, Blaise; Inocêncio da Luz, Raquel; Van Geertruyden, Jean-Pierre; Lutumba, Pascal

2016-08-01

In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio-economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of 'culturally acceptable representative' under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low-literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power-unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to 'competition' to access the research-related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees. © 2015 John Wiley & Sons Ltd.

What Parents Need To Know about Marijuana.

Science.gov (United States)

Office of National Drug Control Policy, Washington, DC.

This publication, part of the Office of National Drug Control Policys Asian Language Initiative, offers facts and answers about marijuana. It educates parents about what it is, its physical and physiological effects, slang terms, and how its used. It also identifies signs that indicate marijuana use, and provides tips for parents who want to…

The Retention Challenge--Should We Include Parents?

Science.gov (United States)

Cartmell, Brandy Mallory

2015-01-01

University campuses continue to see an increase in the number of helicopter parents, those parents who are hovering about the campus, ready to swoop down and rescue their children at the first sign of distress (Cartmell and McCullough 2014). Retention personnel on campus questioned whether it would be possible to develop initiatives that would…

Vital Signs-Preventing Pregnancy in Younger Teens

Centers for Disease Control (CDC) Podcasts

2014-04-08

This podcast is based on the April 2014 CDC Vital Signs report. Births to teens are declining, still, in 2012, more than 86,000 teens ages 15 to 17 gave birth. This program discusses what health care providers, parents, and teens can do to help prevent teen pregnancy.  Created: 4/8/2014 by National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP).   Date Released: 4/8/2014.

Understanding how different recruitment strategies impact parent engagement with an iPad-based intervention to provide personalized information about adolescent vaccines.

Science.gov (United States)

Dempsey, Amanda F; Maertens, Julie; Beaty, Brenda L; O'Leary, Sean T

2015-05-01

Inadequate provider time for addressing parents' questions and concerns about adolescent vaccines is a barrier to vaccine utilization. We sought to determine how different recruitment strategies impact the degree of engagement with an intervention that provided this information via an iPad placed in a clinical setting. We provided to three pediatric practices in the Denver area the "Teen VaxScene" web site that generates individually customized information for parents about adolescent vaccines. Three recruitment strategies were assessed for their impact on parental use of the intervention as follows: passive recruitment using posters to advertise a "kiosk" version of the intervention; posters plus a $10 incentive for using the kiosk; and posters plus a $10 incentive plus decoupling the iPad from the kiosks to enable "roving." We assessed the engagement with the intervention at multiple levels including log in, consent, and completion of a baseline survey and viewing individually tailored web pages. Surveys were used to assess barriers to using the intervention. During the 14-month study period, 693 people had contact with the iPad, 199 consented, and 48 completed the survey to enable creation of tailored content; and 42 used the tailored site. Five times as many parents (n = 40) consented to participation during the 2 months when the intervention was "roving" than during the 10-month "passive" recruitment period. Engagement with the tailored material was low, with most users viewing only the "table of contents" pages. Utilizers and nonutilizers of the intervention had similar demographic characteristics. Enabling the iPad to "rove" in the clinic greatly increased the proportion of parents consenting to use the intervention. However, meaningful engagement with the material was low. Further research is needed to understand the most effective and time efficient ways to provide vaccine-related educational information to parents of adolescents. Copyright © 2015 Society

Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent.

Science.gov (United States)

Osuji, Peter I

2018-03-01

The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism.

[Dentistry and healthcare legislation 3: informed consent].

Science.gov (United States)

Brands, W G; van der Ven, J M; Eijkman, M A J

2013-06-01

The relationship between a dentist and his patient is based on trust. The principle of informed consent contributes to the quality of that relationship of trust. According to the professional standards for such a relationship, it is up to the dentist to make sure that the patient is well informed. Reliable information is necessary if the patient is to be in a position to give his or her consent for treatment. The Dutch Law of Agreement to Medical Treatment (WGBO) provides aframework for informed consent. Disciplinary judges establish the scope and if necessary the limits. It is clear that, among other things, not defining the risks beforehand can be the basis for a (disciplinary) complaint. Determining the requirements of informed consent calls for familiarity with the law and communication skills. Programmes in dental education ought to devote more attention to this issue.

Informed consent for braces.

Science.gov (United States)

Jharwal, Vikas; Trehan, Mridula; Rathore, Nidhi; Rathee, Pooja; Agarwal, Deepesh; Mathur, Nikunj

2014-05-01

The influence of law on the orthodontic profession has greatly increased in the last few decades. Dental law has emerged today as a full-fedged specialty dealing with a variety of areas, like professional negligence, doctor-patient contracts, consumer protection laws, ethics, general and special health legislations and practice regulatory mechanisms. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment. How to cite this article: Jharwal V, Trehan M, Rathore N, Rathee P, Agarwal D, Mathur N. Informed Consent for Braces. Int J Clin Pediatr Dent 2014;7(2):105-108.

Consent, competence, and confidentiality related to psychiatric conditions in adolescent medicine practice.

Science.gov (United States)

Campbell, Amy T

2006-02-01

Health care for adolescents with psychiatric conditions plays out on a complex stage with considerable state variation, based on a mix of statutory and case law. Added to this are less defined factors such as level of trust in community providers, level of cooperation between generalists and specialists, and local regulatory stances toward adolescent health care and mental health care. And, of course, there is the great diversity in diagnosis and maturity level, as well as family cohesion, from patient to patient (and even within a given patient across time). Finally, this situation resides within a larger environment of stigma vis-a-vis mental health care, most notably evident in the United States in disparate insurance coverage of mental versus physical health treatment. With so complex and varied a picture, clinicians should consult with legal counsel to understand applicable state law and local regulatory guidance (if any)and should also seek out ethical consultation when law does not apply or is not decisive, leaving ongoing concerns. And, as with clinical decision-making, in law and ethics "facts matter" [4]. A growing body of law carves out exceptions to general requirements for parental consent, including in mental health care. Ethically informed discussion around capacity determinations, the consent process, and confidentiality can help engage adolescents as "emerging adults"while remaining mindful of risky behavior and "immediate future" orientation that can be hallmarks of adolescence [30]. Respect for the adolescent, parental responsibility toward their child's best interests, and the family unit generally are paramount. Respect--coupled with caution, greater disclosure and cultural sensitivity, and a participatory approach to decision-making that seeks out the least restrictive and coercive options-can help avoid potential legal traps. How best to proceed? It truly depends-with law and ethics the start (not end) of the discussion and analysis.

HIV testing and informed consent - ethical considerations

African Journals Online (AJOL)

donation; and the protection of third parties, including the health care worker. .... closest available relative or, in the case of a minor, the consent of the medical ... case informed consent to the taking of blood is obviously mandatory. . Blood ...

Consent to tissue banking for research: qualitative study and recommendations.

Science.gov (United States)

Soto, Carmen; Tarrant, Carolyn; Pritchard-Jones, Kathy; Dixon-Woods, Mary

2012-07-01

To explore how families of children with cancer experience giving consent for tissue banking and to produce recommendations on good practice. 79 participants from 42 families (41 mothers, 18 fathers, 20 children and young people with cancer) took part in semistructured interviews to explore their experiences of being approached for consent to tissue banking. Tertiary care facilities for childhood cancer. Families are generally supportive of tissue banking, although they report that it may be difficult for them to consider all the implications when asked for consent. They typically do not want detailed information when consent is sought close to diagnosis, preferring to see tissue banking as part of routine practice. Families often recognise that their consent may not be fully informed, but are content to give consent based on their understanding at the time. Some may want a chance to go over the information and revisit their decision when things have settled. Families' views can inform practical recommendations for optimising the experience of consent for tissue banking. Current guidelines for obtaining consent should be revisited to take account of families' preferences.

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

Science.gov (United States)

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

Science.gov (United States)

Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Non-completion and informed consent.

Science.gov (United States)

Wertheimer, Alan

2014-02-01

There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the 'therapeutic misconception', but has ignored the 'completion misconception'. This article argues that, other things being equal, prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if (1) it is or should be anticipatable that there is a non-trivial possibility of non-completion and (2) that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult.

Does "Wanting the Best" Create More Stress? The Link between Baby Sign Classes and Maternal Anxiety

Science.gov (United States)

Howlett, Neil; Kirk, Elizabeth; Pine, Karen J.

2011-01-01

This study investigated whether gesturing classes (baby sign) affected parental frustration and stress, as advertised by many commercial products. The participants were 178 mother-infant dyads, divided into a gesture group (n = 89) and a non-gesture group (n = 89), based on whether they had attended baby sign classes or not. Mothers completed a…

Understanding the Public's Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey.

Science.gov (United States)

De Vries, Raymond Gene; Tomlinson, Tom; Kim, Hyungjin Myra; Krenz, Chris; Haggerty, Diana; Ryan, Kerry A; Kim, Scott Y H

2016-01-01

Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket-or broad-consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using "real-time"-or study-by-study-consent, but this policy places a significant burden on biobanks. In order to better understand the public's preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

IMPLEMENTASI PERSETUJUAN TINDAKAN KEDOKTERAN (INFORMED CONSENT DALAM PERJANJIAN TERAPEUTIK OLEH TENAGA KESEHATAN TERHADAP PASIEN RUMAH SAKIT DI PROVINSI BALI

Directory of Open Access Journals (Sweden)

Ida Ayu Sri Kusuma Wardhani

2014-03-01

Full Text Available Health is the most important part of human life that can affect productivity and optimal human activity. When a person's health is compromised, then that person will seek treatment in health care facilities in the hospital one of them in order to get action. Measures of medicine containing the high risk should get written consent from patient/family called Informed Consent. The legal relationship between health professionals with patients occurs because of the agreement that causes the therapeutic relationship inspaningverbintenis law (treaty effort. Similarly in the Bali Provincial Hospital in any medical act especially those containing a high risk, which is done by some health professionals are also using the Informed Consent. But if there is negligence actions that cause harm, who will be responsible for the risks in the suffering patient / family? and how the efforts of patient / family to resolve medical disputes against the risk of Informed Consent? The method used in this research is an empirical law derived from primary data and secondary data. The nature of the study is descriptive, with qualitative data analysis. Overall the results of these analyzes are presented in the description which describes the complete problem under study, along with a critical discussion. Based on the Theory of Legal System of L. M. Friedman, legal systems theory described by Soerjono Soekanto be legal efficacy theory, the theory of Hans Kelsen responsibility, and legislation as well as the results of research in the field, it is known that the liability of health professionals based on Informed Consent Agreement Therapeutic Hospital in Bali province is on the doctor who signed the operator of the informed consent form. However, if the patient / family prosecute acts of negligence committed by health professionals, the hospital will be responsible jointly and severally against such negligence. From the result of  research in the hospital in the province of

The changing face of informed surgical consent.

LENUS (Irish Health Repository)

Oosthuizen, J C

2012-03-01

To determine whether procedure-specific brochures improve patients\\' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed \\'Request for Treatment\\' consenting process is viable on a large scale.

Consenting to Heteronormativity: Assumptions in Biomedical Research

NARCIS (Netherlands)

Cottingham, M.D.; Fisher, J.A.

2015-01-01

The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of

Organ procurement organizations Internet enrollment for organ donation: Abandoning informed consent

Directory of Open Access Journals (Sweden)

Verheijde Joseph L

2006-12-01

Full Text Available Abstract Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47, 79% (57–86, and 75% (50–100, respectively. The informed consent score was 0% (0–33. The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent.

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

Directory of Open Access Journals (Sweden)

Rachel G. Greenberg

2018-03-01

In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Changing trends in informed consent

OpenAIRE

Victor Lim

2014-01-01

Abstract: Consent is defined as the “voluntary agreement to or acquiescence in what another person proposes or desires”. In the context of medical practice it is now universally accepted that every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body. Informed consent is now a central part of medical ethics and medical law. There has been a change in the public’s expectations of their role in medical decisi...

Value of informed consent in surgical orthodontics

NARCIS (Netherlands)

Brons, S.; Becking, A.G.; Tuinzing, D.B.

2009-01-01

PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

Value of informed consent in surgical orthodontics

NARCIS (Netherlands)

Brons, S.; Becking, A.G.; Tuinzing, D.B.

2009-01-01

Purpose: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

Value of informed consent in surgical orthodontics.

NARCIS (Netherlands)

Brons, S.; Becking, A.G.; Tuinzing, D.B.

2009-01-01

PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

Value of informed consent in surgical orthodontics

NARCIS (Netherlands)

Brons, Sander; Becking, Alfred G.; Tuinzing, D. Bram

2009-01-01

Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, attention was

Alarming signs and symptoms in febrile children in primary care: an observational cohort study in The Netherlands.

Directory of Open Access Journals (Sweden)

Gijs Elshout

Full Text Available CONTEXT: Febrile children in primary care have a low risk for serious infection. Although several alarming signs and symptoms are proposed to have predictive value for serious infections, most are based on research in secondary care. The frequency of alarming signs/symptoms has not been established in primary care; however, in this setting differences in occurrence may influence their predictive value for serious infections. OBJECTIVE: To determine the frequency of alarming signs/symptoms in febrile children in primary care. DESIGN: Observational cohort study. Clinical information was registered in a semi-structured way and manually recoded. SETTING: General practitioners' out-of-hours service. SUBJECTS: Face-to-face patient contacts concerning children (aged ≤16 years with fever were eligible for inclusion. MAIN OUTCOME MEASURES: Frequency of 18 alarming signs and symptoms as reported in the literature. RESULTS: A total of 10,476 patient contacts were included. The frequency of alarming signs/symptoms ranged from n = 1 (ABC instability; 40°C as reported by the parents; 12.9% to 8,647 contacts (parental concern; 82.5%. CONCLUSION: Although the prevalence of specific alarming signs/symptoms is low in primary care, ≥50% of children have one or more alarming signs/symptoms. There is a need to determine the predictive value of alarming signs/symptoms not only for serious infections in primary care, but as well for increased risk of a complicated course of the illness.

Disappointment and adherence among parents of newborns allocated to the control group

DEFF Research Database (Denmark)

Meinich Petersen, Sandra; Zoffmann, Vibeke; Kjærgaard, Jesper

2014-01-01

among parents of newborns who were randomized to the control group, but also a broad expression of understanding and accepting the idea of randomization. The trial staff might use the model of reactions in understanding the parents' disappointment and in this way support their motives for participation......BACKGROUND: When a child participates in a clinical trial, informed consent has to be given by the parents. Parental motives for participation are complex, but the hope of getting a new and better treatment for the child is important. We wondered how parents react when their child is allocated...... to achieve saturation. Thematic analysis was used to identify themes across the data sets. RESULTS: The parents reported good understanding of the randomization process. Their most common reaction to allocation was disappointment, though relief was also seen. A model of reactions to being allocated...

Consent and assessment of capacity to decide or refuse treatment.

Science.gov (United States)

Simpson, Owena

Consent protects the right of patients to decide what happens to them. Before any medical intervention, adults must give valid consent, which must be voluntary, informed and given free of undue influence. When consent is being obtained, patients must be informed about the intervention, why it is being done and its risks; information they are given must be recorded. Every effort should be made to explain the issues in terms that the patient can understand and by providing support and aids to communicate. Consent can be expressed, where patients say they consent or put it in writing, or implied, where a healthcare professional infers from their behaviour that they consent. While different types of consent are valid, some are evidence of stronger proof in court that valid consent has been given. Competent adults have the right to refuse treatment, regardless of the reasons they give for refusal and even if the refusal will result in death; clinicians must respect their decision. In some circumstances-such as when an unconscious person is admitted as an emergency-healthcare professionals can make decisions on behalf of patients, and must do so in patients' best interests.

Optimizing Opt-Out Consent for Record Linkage

Directory of Open Access Journals (Sweden)

Das Marcel

2014-09-01

Full Text Available This article reports on a study testing the effects of different ways of administering an opt-out consent for record linkage in a probability-based Internet panel. First, we conducted cognitive interviews to explore reactions to a draft version of the opt-out consent text. Second, we conducted a two-factor experiment to test the effects of content manipulations and mode. The results indicate that the way in which respondents were informed did not have much effect on opting out. Results from a follow-up survey on attitudes regarding privacy, confidentiality, and trust, along with knowledge questions about the process of linking, showed no evidence that presenting the opt-out consent statement makes respondents more concerned about privacy. Knowledge about the aspects of record linkage is generally not high. When looking at long-term effects of sending an opt-out consent statement, we found no evidence that this leads to higher attrition or lower participation rates.

Informed Consent: An Ethical Obligation or Legal Compulsion?

OpenAIRE

Satyanarayana Rao, K H

2008-01-01

Informed consent is a vital document while performing all surgical and aesthetic procedures, particularly in the current day practice. Proper documentation and counseling of patients is important in any informed consent.

Signs of Change? At-Home and Breadwinner Parents' Housework and Child-Care Time.

Science.gov (United States)

Chesley, Noelle; Flood, Sarah

2017-04-01

We analyze American Time Use Survey (ATUS) data to examine patterns in domestic work among at-home and breadwinner parents to further gauge how time availability, relative earnings, and gender shape time use in couples with extreme differences in earnings and work hours. We find that involvement in female-typed housework is an important driver of overall housework time. It is counter-normative housework behavior by at-home fathers that shapes conclusions about how time availability, relative resources, and gender influence parents' housework. While time availability appears to shape child care in comparable ways across parents, mothers are more engaged in child care than similarly-situated fathers. Overall, our comparisons point to the importance of distinguishing among gender-normative housework tasks and accounting for differences in engagement on work and non-work days. Our results also provide a basis for assessing the social significance of growing numbers of parents in work-family roles that are not gender-normative.

How accurate are parental responses concerning their fourth-grade children's school-meal participation, and what is the relationship between children's body mass index and school-meal participation based on parental responses?

Directory of Open Access Journals (Sweden)

Paxton-Aiken Amy E

2012-03-01

Full Text Available Abstract Background This article investigated (1 parental response accuracy of fourth-grade children's school-meal participation and whether accuracy differed by children's body mass index (BMI, sex, and race, and (2 the relationship between BMI and school-meal participation (based on parental responses. Methods Data were from four cross-sectional studies conducted from fall 1999 to spring 2003 with fourth-grade children from 13 schools total. Consent forms asked parents to report children's usual school-meal participation. As two studies' consent forms did not ask about lunch participation, complete data were available for breakfast on 1,496 children (51% Black; 49% boys and for lunch on 785 children (46% Black; 48% boys. Researchers compiled nametag records (during meal observations of meal participation on randomly selected days during children's fourth-grade school year for breakfast (average nametag days across studies: 7-35 and for lunch (average nametag days across studies: 4-10 and categorized participation as "usually" (≥ 50% of days or "not usually" ( Results Concerning breakfast participation and lunch participation, 74% and 92% of parents provided accurate responses, respectively. Parental response accuracy was better for older children for breakfast and lunch participation, and for Black than White children for lunch participation. Usual school-meal participation was significantly related to children's BMI but in opposite directions -- positively for breakfast and inversely for lunch. Conclusions Parental response accuracy of children's school-meal participation was moderately high; however, disparate effects for children's age and race warrant caution when relying on parental responses. The BMI results, which showed a relationship between school-meal participation (based on parental responses and childhood obesity, conflict with results from a recent article that used data from the same four studies and found no significant

42 CFR 50.205 - Consent form requirements.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Consent form requirements. 50.205 Section 50.205 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.205 Consent form...

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study

Science.gov (United States)

de Laat, Sonya; Schwartz, Lisa

2016-01-01

Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. Methods and analysis The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Design: Qualitative research study involving individual interviews and grounded theory methodology. Participants: SDMs for children enrolled into the SQUEEZE pilot trial. Sample size: Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. Ethics and dissemination This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent

Parental Decision-Making Preferences in Neonatal Intensive Care.

Science.gov (United States)

Weiss, Elliott Mark; Barg, Frances K; Cook, Noah; Black, Emily; Joffe, Steven

2016-12-01

To explore how characteristics of medical decisions influence parents' preferences for control over decisions for their seriously ill infants. In qualitative interviews, parents of infants in the neonatal intensive care unit (NICU) were asked to consider all medical decisions they could recall, and were prompted with decisions commonly encountered in the NICU. For each decision, parents were asked detailed questions about who made each decision, whom they would have preferred to make the decision, and why. Using standard qualitative methods, responses were coded and organized such that decision-level characteristics could be analyzed according to preferred decision-making role. Parents identified 2 factors that were associated with a preference to delegate decisions to the medical team (high degree of urgency, high level of required medical expertise) and 4 factors associated with a preference to retain parental control (high perceived risk, high personal experience with the decision, involvement of foreign bodily fluids, and similarity to decisions that they perceived as part of the normal parental role). Characteristics of decisions influence preferences for control over medical decisions among parents of patients in the NICU. These insights may guide improvements in physician-parent communication and consent. Copyright © 2016 Elsevier Inc. All rights reserved.

The Impact of Input Quality on Early Sign Development in Native and Non-Native Language Learners

Science.gov (United States)

Lu, Jenny; Jones, Anna; Morgan, Gary

2016-01-01

There is debate about how input variation influences child language. Most deaf children are exposed to a sign language from their non-fluent hearing parents and experience a delay in exposure to accessible language. A small number of children receive language input from their deaf parents who are fluent signers. Thus it is possible to document the…

Early vocabulary development in deaf native signers: a British Sign Language adaptation of the communicative development inventories.

Science.gov (United States)

Woolfe, Tyron; Herman, Rosalind; Roy, Penny; Woll, Bencie

2010-03-01

There is a dearth of assessments of sign language development in young deaf children. This study gathered age-related scores from a sample of deaf native signing children using an adapted version of the MacArthur-Bates CDI (Fenson et al., 1994). Parental reports on children's receptive and expressive signing were collected longitudinally on 29 deaf native British Sign Language (BSL) users, aged 8-36 months, yielding 146 datasets. A smooth upward growth curve was obtained for early vocabulary development and percentile scores were derived. In the main, receptive scores were in advance of expressive scores. No gender bias was observed. Correlational analysis identified factors associated with vocabulary development, including parental education and mothers' training in BSL. Individual children's profiles showed a range of development and some evidence of a growth spurt. Clinical and research issues relating to the measure are discussed. The study has developed a valid, reliable measure of vocabulary development in BSL. Further research is needed to investigate the relationship between vocabulary acquisition in native and non-native signers.

Consent, ethics and genetic biobanks: the case of the Athlome project.

Science.gov (United States)

Thompson, Rachel; McNamee, Michael J

2017-11-14

This article provides a critical overview of the ethics and governance of genetic biobank research, using the Athlome Consortium as a large scale instance of collaborative sports genetic biobanking. We present a traditional model of written informed consent for the acquisition, storage, sharing and analysis of genetic data and articulate the challenges to it from new research practices such as genetic biobanking. We then articulate six possible alternative consent models: verbal consent, blanket consent, broad consent, meta consent, dynamic consent and waived consent. We argue that these models or conceptions of consent must be articulated in the context of the complexities of international legislation and non legislative national and international biobank governance frameworks and policies, those which govern research in the field of sports genetics. We discuss the tensions between individual rights and public benefits of genomic research as a critical ethical issue, particularly where benefits are less obvious, as in sports genomics. The inherent complexities of international regulation and biobanking governance are challenging in a relatively young field. We argue that there is much nuanced ethical work still to be done with regard to governance of sports genetic biobanking and the issues contained therein.

Value of informed consent in surgical orthodontics.

Science.gov (United States)

Brons, Sander; Becking, Alfred G; Tuinzing, D Bram

2009-05-01

Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, attention was given to all aspects of the treatment. However, because of "insurance-related factors," the need for treatment because of functional reasons was stressed over esthetics. The recall of information given during an informed consent interview before orthognathic surgery was measured using a questionnaire. Patients with a mandibular deficiency with a low mandibular plane angle were questioned after an informed consent interview regarding surgical orthodontic treatment. Esthetics were more frequently and functional problems were less frequently recalled as the reason for operation than was expected. The risk of a change in the sensation of the lower lip by surgery was frequently recalled as a reason to refrain from the operation. The overall recall rate of the possible risks and complications of orthodontic surgery was 40%. No reports were found of comparable research on the preoperative recall after consultation before surgical orthodontic surgery. The aspects of communication that can improve recall must be clarified. A recall rate of 100% seems a utopia, although an arbitrary line is needed to determine the quality of an informed consent interview.

Autonomy and informed consent: a mistaken association?

Science.gov (United States)

Kristinsson, Sigurdur

2007-09-01

For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill's conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill's conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy.

Informed consent in Malaysia: an overview.

Science.gov (United States)

Che Ngah, Anisah

2005-01-01

The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.

What Is Child Abuse and Neglect? Recognizing the Signs and Symptoms

Science.gov (United States)

... Signs of Sexual Abuse Consider the possibility of sexual abuse when the child: • Has difficulty walking or sitting • Suddenly refuses to ... adults in their environment Consider the possibility of sexual abuse when the parent ... unduly protective of the child or severely limits the child’s contact with other ...

Evidence for Website Claims about the Benefits of Teaching Sign Language to Infants and Toddlers with Normal Hearing

Science.gov (United States)

Nelson, Lauri H.; White, Karl R.; Grewe, Jennifer

2012-01-01

The development of proficient communication skills in infants and toddlers is an important component to child development. A popular trend gaining national media attention is teaching sign language to babies with normal hearing whose parents also have normal hearing. Thirty-three websites were identified that advocate sign language for hearing…

Cytogenetic survey results in children and teens who sit in the area of Chernobyl

International Nuclear Information System (INIS)

Montoro, A.; Sebastia, N.; Barquinero, J. F.; Soriano, J. M.; Almonacid, M.; Alonso, O.; Cervera, J.; Such, E.; Sila, M. A.; Ibanez, M.; Arnal, C.; Villaescusa, J. I.

2012-01-01

The biological effects are analyzed cytogenetic abnormalities (chromosomal) produced in peripheral blood lymphocytes. The study was conducted in 55 children from Ukraine and residing in areas affected by the Chernobyl nuclear accident. Blood samples were taken after the signing of informed consent by parents guardians and cultured following the technical protocol of the IAEA (2001) for studies of biological dosimetry.

Concerns regarding Direct-to-Consumer Hearing Aid Purchasing

Science.gov (United States)

Kimball, Suzanne H.

2010-01-01

An individual over age 18 can purchase a hearing aid online or through mail order if they sign a waiver declining a medical evaluation, while those under 18 are required to be seen by a physician to obtain medical consent. However, in many states there is nothing to prevent a parent or caregiver from purchasing hearing aids for their child from a…

Cytogenetic survey results in children and teens who sit in the area of Chernobyl; Resultados del estudio citogenetico en ninos y adolescentes que habitan en el area de Chernobil

Energy Technology Data Exchange (ETDEWEB)

Montoro, A.; Sebastia, N.; Barquinero, J. F.; Soriano, J. M.; Almonacid, M.; Alonso, O.; Cervera, J.; Such, E.; Sila, M. A.; Ibanez, M.; Arnal, C.; Villaescusa, J. I.

2012-07-01

The biological effects are analyzed cytogenetic abnormalities (chromosomal) produced in peripheral blood lymphocytes. The study was conducted in 55 children from Ukraine and residing in areas affected by the Chernobyl nuclear accident. Blood samples were taken after the signing of informed consent by parents guardians and cultured following the technical protocol of the IAEA (2001) for studies of biological dosimetry.

Blockchain protocols in clinical trials: Transparency and traceability of consent

Science.gov (United States)

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2018-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be

Blockchain protocols in clinical trials: Transparency and traceability of consent.

Science.gov (United States)

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2017-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a

Informed consent in neurosurgery--translating ethical theory into action.

Science.gov (United States)

Schmitz, Dagmar; Reinacher, Peter C

2006-09-01

Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician-patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent.

Informed consent in neurosurgery—translating ethical theory into action

Science.gov (United States)

Schmitz, Dagmar; Reinacher, Peter C

2006-01-01

Objective Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. Methods By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. Results The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician–patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. Conclusion To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent. PMID:16943326

Informed consent in Sri Lanka: a survey among ethics committee members.

Science.gov (United States)

Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

2008-05-20

Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed

Improving consent in patients undergoing surgery for fractured neck of femur.

Science.gov (United States)

Thiruchandran, Gajendiran; McKean, Andrew R; Rudran, Branavan; Imam, Mohamed A; Yeong, Keefai; Hassan, Abdel

2018-05-02

Background Neck of femur fractures and their subsequent operative fixation are associated with high rates of perioperative morbidity and mortality. Consenting in this setting is suboptimal with the Montgomery court ruling changing the perspective of consent. This quality improvement project assessed the adequacy of consenting against British Orthopaedic Association-endorsed guidance and implemented a series of changes to improve the documentation of risks associated with surgery for fractured neck of femur. Methods Seventy consecutive patients who underwent any operative fixation of a neck of femur fracture were included over a 6-month period at a single centre. Patients unable to consent or without electronic notes were excluded. Consent forms were analysed and the documented potential risks or complications associated with surgery were compared to British Orthopaedic Association-endorsed guidance. A series of changes (using the plan, do study, act (PDSA) approach) was implemented to improve the adequacy of consent. Results Documentation of four out of 12 potential risks or complications was recorded in <50% of cases for patients with intracapsular fractures (n=35), and documentation of seven out of 12 potential risks or complications was recorded in <50% of cases for patients with extracapsular fractures (n=35). Re-audit following raising awareness and attaching consent guidance showed 100% documentation of potential risks or complications in patients with intracapsular and extracapsular fractures (n=70). A neck of femur fracture-specific consent form has been implemented which will hopefully lead to sustained improvement. Conclusions Consenting patients with fractured neck of femur for surgery in the authors' unit was suboptimal when compared to British Orthopaedic Association-endorsed consent guidance. This project has shown that ensuring such guidance is readily available has improved the adequacy of consent. The authors hope that introduction of a neck of

Is The Consent Process Appropriate - The Interns’ Perspective?

LENUS (Irish Health Repository)

Rohan, P

2018-04-01

Consent is an integral component to any medical procedure involving a competent patient, a communicating doctor, and transfer of information about the procedure. The aim of this study was to assess interns’ experience of the consent process.

Scientists' perspectives on consent in the context of biobanking research.

Science.gov (United States)

Master, Zubin; Campo-Engelstein, Lisa; Caulfield, Timothy

2015-05-01

Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking.

A qualitative exploration of trial-related terminology in a study involving Deaf British Sign Language users.

Science.gov (United States)

Young, Alys; Oram, Rosemary; Dodds, Claire; Nassimi-Green, Catherine; Belk, Rachel; Rogers, Katherine; Davies, Linda; Lovell, Karina

2016-04-27

Internationally, few clinical trials have involved Deaf people who use a signed language and none have involved BSL (British Sign Language) users. Appropriate terminology in BSL for key concepts in clinical trials that are relevant to recruitment and participant information materials, to support informed consent, do not exist. Barriers to conceptual understanding of trial participation and sources of misunderstanding relevant to the Deaf community are undocumented. A qualitative, community participatory exploration of trial terminology including conceptual understanding of 'randomisation', 'trial', 'informed choice' and 'consent' was facilitated in BSL involving 19 participants in five focus groups. Data were video-recorded and analysed in source language (BSL) using a phenomenological approach. Six necessary conditions for developing trial information to support comprehension were identified. These included: developing appropriate expressions and terminology from a community basis, rather than testing out previously derived translations from a different language; paying attention to language-specific features which support best means of expression (in the case of BSL expectations of specificity, verb directionality, handshape); bilingual influences on comprehension; deliberate orientation of information to avoid misunderstanding not just to promote accessibility; sensitivity to barriers to discussion about intelligibility of information that are cultural and social in origin, rather than linguistic; the importance of using contemporary language-in-use, rather than jargon-free or plain language, to support meaningful understanding. The study reinforces the ethical imperative to ensure trial participants who are Deaf are provided with optimum resources to understand the implications of participation and to make an informed choice. Results are relevant to the development of trial information in other signed languages as well as in spoken/written languages when

Parental Virtue and Prenatal Genetic Alteration Research.

Science.gov (United States)

Tonkens, Ryan

2015-12-01

Although the philosophical literature on the ethics of human prenatal genetic alteration (PGA) purports to inform us about how to act, it rarely explicitly recognizes the perspective of those who will be making the PGA decision in practice. Here I approach the ethics of PGA from a distinctly virtue-based perspective, taking seriously what it means to be a good parent making this decision for one's child. From this perspective, I generate a sound verdict on the moral standing of human PGA (research): given the current state of the art, good parents have compelling reason not to consent to PGA (research) for their child, especially as part of the first wave(s) of PGA research participants and especially for non-medically oriented purposes. This is because doing otherwise is inconsistent with a plausible and defensible understanding of virtuous parenting and parental virtues, founded on a genuine concern for promoting the overall flourishing of the eventual child. In essence, given the current and foreseeable state of the art, parents who allow prenatal genetic alteration of their children are less-than-virtuous parents to those children, even in cases where they have a right to do so and even if PGA turns out to be beneficial to the eventual child.

Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content.

Science.gov (United States)

Lo, William B; McAuley, Ciaran P; Gillies, Martin J; Grover, Patrick J; Pereira, Erlick A C

2017-11-01

Prospective, multi-centre, multi-specialty medical notes review and patient interview. The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall. Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall. The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade. Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.

Effect of Training Programme on Developing Functional Sign Language among Parents of Students with Deafness

Science.gov (United States)

Bhuvaneswari, N. R.; Srivastava, Abhishek Kumar

2016-01-01

Parents' involvement is highly needed for ensuring holistic development of their words; however parents can only assist the child when they themselves have adequate knowledge, required skills, and proper awareness regarding various aspects of children's growth and development. To have adequate communication skill among parents, ensuring better…

Tailoring consent to context: designing an appropriate consent process for a biomedical study in a low income setting.

Directory of Open Access Journals (Sweden)

Fasil Tekola

2009-07-01

Full Text Available Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis in southern Ethiopia.We adapted a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent.Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis.

Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior.

Science.gov (United States)

Balestra, Martina; Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

2016-07-20

Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments' valence on prospective participants' beliefs and behavior. This study focuses specifically on the influence of annotations' valence on participants' perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants' perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. We find that comment valence has a marginally significant main effect on participants' perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the

Simplifying informed consent for biorepositories: stakeholder perspectives.

Science.gov (United States)

Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

2010-09-01

Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.

Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent.

Science.gov (United States)

Mellado, J M

2016-01-01

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Testicular tissue cryopreservation in prepubertal male children: an analysis of parental decision-making.

Science.gov (United States)

Ginsberg, Jill P; Li, Yimei; Carlson, Claire A; Gracia, Clarisa R; Hobbie, Wendy L; Miller, Victoria A; Mulhall, John; Shnorhavorian, Margarett; Brinster, Ralph L; Kolon, Thomas F

2014-09-01

Infertility is an unfortunate treatment-related consequence for some pediatric malignancies as well as some non-malignant conditions treated with stem cell transplant. Unlike pubertal males, prepubertal males cannot produce semen for cryopreservation. This manuscript reports on the acceptability and safety of a multi-institutional protocol for offering testicular tissue cryopreservation to families of prepubertal male children at highest risk for infertility. Data on decision influences, decision-making control, and emotional state when considering this option are described. Prepubertal males facing gonadotoxic therapy were offered testicular cryopreservation. Post-biopsy, patients were followed for acute side effects. In addition, parents and patients were asked to complete questionnaires, whether or not they chose to cryopreserve tissue. Seventy-four prepubertal male children were approached. Fifty-seven families (77%) consented to the testicular biopsy; 48 of 57 underwent the procedure. There was one post-operative side effect. Parents who agreed to testicular cryopreservation and those that did not felt in control of this decision. Parents who consented to the biopsy and refusers were not deterred by the experimental nature of the protocol. An important decision-making influence was the risk of the biopsy. Biopsy and cryopreservation of testicular tissue from prepubertal male children was performed successfully and safely at three institutions. Parents faced with this option at diagnosis can make an informed decision and weigh carefully the risks and benefits. Although asked to make a decision soon after they were given a difficult diagnosis, parents uniformly felt in control of this decision. © 2014 Wiley Periodicals, Inc.

Establishing and adhering to sexual consent: the association between reading magazines and college students' sexual consent negotiation.

Science.gov (United States)

Hust, Stacey J T; Marett, Emily Garrigues; Ren, Chunbo; Adams, Paula M; Willoughby, Jessica F; Lei, Ming; Ran, Weina; Norman, Cassie

2014-01-01

Content analyses have cataloged the sexual scripts present in magazines largely because of their perceived value to readers and their potential role as sex educators. Although it is generally agreed that magazines have the potential to influence sexual attitudes and behavioral intentions, the effects of this medium are not as frequently researched as are other forms of media. The current study tested whether exposure to magazines was associated with intentions related to sexual consent negotiation. A survey of 313 college students indicated that exposure to men's magazines was significantly associated with lower intentions to seek sexual consent and lower intentions to adhere to decisions about sexual consent. In contrast, exposure to women's magazines was significantly associated with greater intentions to refuse unwanted sexual activity. Overall, the findings of this study further reinforce the critical need for responsible and realistic portrayals of sex in entertainment media, specifically magazines.

Perinatal postmortems: what is important to parents and how do they decide?

Science.gov (United States)

Breeze, Andrew C G; Statham, Helen; Hackett, Gerald A; Jessop, Flora A; Lees, Christoph C

2012-03-01

Falling consent rates for postmortems, regardless of age of death, have been widely reported in recent years. The aim of this study was to explore parental attitudes to, and decision-making about, a perinatal postmortem after termination for fetal abnormality, late miscarriage, or stillbirth. A prospective self-completion questionnaire was given to 35 women and their partners. The participants had experienced second or third trimester pregnancy loss in a single fetal medicine and delivery unit in the United Kingdom and were making decisions about having a postmortem. They were asked to complete a questionnaire about their attitudes to, and expectations of, a perinatal postmortem. Thirty-one questionnaires were received from parents of 17 babies (49% of those asked; 16 from mothers, 15 from fathers). Parents of nine babies (53%) said they would agree to a full postmortem, of three babies to a limited postmortem, and of four babies to an external examination only; one couple were undecided. The most important issues for the parents in this study that related to their decisions about a postmortem centered on the need for information, both for future planning and about what had happened. Moderately important issues related to altruism, which is, improving medical knowledge and helping other parents experiencing similar bereavement. Among the lowest scoring issues were potential barriers, such as concerns about cultural or religious acceptability of a postmortem, funeral delays, and what would happen to the baby's body. Bereaved parents who participated in this study, where postmortem consent rates were relatively high, thought that their need for knowledge eclipsed assumed barriers when deciding whether or not to have a postmortem for their baby. © 2012, Copyright the Authors. Journal compilation © 2012, Wiley Periodicals, Inc.

CDC Vital Signs-ADHD in Young Children: What You Should Know

Centers for Disease Control (CDC) Podcasts

This podcast is based on the May 2016 CDC Vital Signs report. For children ages two to five who have ADHD, behavior therapy is recommended before prescribing medicine. This therapy teaches parents ways to improve their child’s behavior and can work as well as medicine, without the risk of side effects.

Informed consent and collaborative research: perspectives from the developing world.

Science.gov (United States)

Hyder, Adnan A; Wali, Salman A

2006-03-01

Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research.

Improving participant comprehension in the informed consent process.

Science.gov (United States)

Cohn, Elizabeth; Larson, Elaine

2007-01-01

To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies. Integrative review of literature. The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals. Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it. Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study.

Informed consent in Sri Lanka: A survey among ethics committee members

Directory of Open Access Journals (Sweden)

Siriwardhana Chesmal

2008-05-01

Full Text Available Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Results Twenty-nine members from ethics committees participated. Majority of participants (23, believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%, believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52% believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. Conclusion The number of themes generated for the consent form (N = 18 is as many as for the information leaflet (N = 19 and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and

1,1,2-Trichloroethane (TCE); Final Enforceable Consent Agreement and Testing Consent Order

Science.gov (United States)

EPA has issued an enforceable consent agreement (ECA) with The Dow Chemical Company; Vulcan Materials Company; Occidental Chemical Corp; Oxy Vinyls, LP; Georgia Gulf Corp; Westlake Chemical Corp; PPG, Borden Chemicals & Plastics, and Formosa Plastics.

The unbearable lightness of user consent

Directory of Open Access Journals (Sweden)

Rikke Frank Joergensen

2014-10-01

Full Text Available The article discusses challenges to privacy protection in social media platforms, focusing in particular on the principle of user consent. Based on a Danish study, the article argues that in relation to Facebook, user consent de facto served as the price for participating and for gaining access to a social infrastructure. The article opens with a brief introduction to privacy as a human right, followed by a discussion of some of the critique that has been raised towards social media platforms vis-à-vis the right to privacy. Second, it presents the findings from a study conducted amongst 68 Danish high school students in October 2013 concerning their privacy perceptions and practices when using social media platforms. Thirdly, it discusses the implications of these findings in relation to the principle of user consent as a means of providing individuals with control over their personal information in the context of social media platforms.

Can children withhold consent to treatment?

Science.gov (United States)

Devereux, J A; Jones, D P; Dickenson, D L

1993-05-29

A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose competence is in doubt will be found rational if he or she accepts the proposal to treat but may be found incompetent if he or she disagrees. Practitioners are alerted to the anomalies now exhibited by the law on the issue of children's consent and refusal. The impact of the decisions from the perspectives of medicine, ethics, and the law are examined. Practitioners should review each case of child care carefully and in cases of doubt seek legal advice.

Informed consent for medical photography in Nigerian surgical ...

African Journals Online (AJOL)

Background: The aim of this study is to assess the current practice of informed consent for medical photography in the Nigerian surgical practice and how it compares to international best practices. Methods: Self-administered questionnaires were distributed to consenting surgeons attending two major surgical conferences.

Practice variation across consent templates for biobank research. A survey of German biobanks

Directory of Open Access Journals (Sweden)

Irene eHirschberg

2013-11-01

Full Text Available Introduction: Informed, voluntary, and valid consent from biomaterial donors is a precondi-tion for biobank research. Valid consent protects donors’ rights and helps maintain public trust in biobank research. Harmonisation of consent procedures in biobank research is needed, because of the widely shared vision on national and international networking of biobanks in-cluding data and sample sharing. So far, no study has assessed and compared the content of current consent forms for biobank research. The objective of this study was to perform a con-tent analysis of consent forms in German biobanks. Methods: Based on 10 guidelines for biomedical research, we developed an assessment ma-trix with 41 content issues that are potentially relevant for consent forms in biobank research. This assessment matrix was applied in a thematic text analysis to 30 consent documents of German biobanks identified via the German Biobank Registry in July 2012. Results: Coverage of the 41 items in the assessed consent forms varied widely. For example, the items Right to withdraw consent (without disadvantage, Policy for genetic infor-mation / consent to genetic analyses and International cooperation / transborder use were addressed in 97%, 40% and 23% of all 30 consent forms respectively. The number of items covered by a single consent form ranged from 9 to 36 (22% to 88% out of 41 items.Discussion: Our findings serve as a starting point to reflect upon the spectrum of consent is-sues that must be addressed in biobank research. The findings show that the majority of con-sent forms for German biobanks, if not all, should be improved and harmonised to better sup-port an informed and balanced choice of potential donors and to facilitate networking of bi-obanks. Best practice models for consent forms in biobank research should be developed and biobank operators need to be more aware of relevant consent issues.

Can a subject consent to a 'Ulysses contract'?

Science.gov (United States)

1982-08-01

A case study is presented in which a schizophrenic consents to experimental drug treatment while competent and then refuses the treatment when in a psychotic state. Three commentaries consider the ethical and legal issues involved in permitting informed consent by the mentally ill by means of a "Ulysses contract," i.e., by agreeing at the time of consent that later refusal of treatment is to be ignored if the patient is no longer competent. The commentators see value in such agreements, provided that safeguards are included to ensure that the patient's legitimate wishes and interests are not ignored.

Epidural analgesia for labour: maternal knowledge, preferences and informed consent.

LENUS (Irish Health Repository)

2012-02-29

Epidural analgesia has become increasingly popular as a form of labour analgesia in Ireland. However obtaining true inform consent has always been difficult. Our study recruited 100 parturients who had undergone epidural analgesia for labour, aimed to determine the information they received prior to regional analgesia, and to ascertain their preferences regarding informed consent. Only 65 (65%) of patients planned to have an epidural. Knowledge of potential complications was variable and inaccurate, with less than 30 (30%) of women aware of the most common complications. Most women 79 (79%) believed that discomfort during labour affected their ability to provide informed consent, and believe consent should be taken prior to onset of labour (96, 96%). The results of this study helps define the standards of consent Irish patients expect for epidural analgesia during labour.

PARENTING AND ITS INFLUENCE ON CHILD BEHAVIOUR

Directory of Open Access Journals (Sweden)

Jiji Mary Antony

2017-12-01

Full Text Available BACKGROUND Parenting is the process of giving care to the young and preparing them to face the challenges of life. Diana Baumrind introduced the models of parenting, authoritative, authoritarian and permissive depending on the level of demandingness and responsiveness. Defective parenting is associated with problem behaviours in children. This study was undertaken to find out which parenting style is least associated with behavioural problems and what are the problems associated with the different parenting style. MATERIALS AND METHODS 46 children who were admitted with minor illness at the institute of Child Health, Kottayam from January 2017 to Oct 2017 were enrolled after getting informed consent and IRB clearance. Purposive sampling method were used for the study. Demographic data was entered into a proforma. The PSDQ and CBCL 1½ -5 questionnaire was given to mothers to assess the parenting style and behavioural problems in their children. Data was analysed with statistical tests. The t test, one way ANOVA, Pearson correlation coefficient and regression analyses were used for the analyses. RESULTS The parenting styles of the mothers and the behavioural problems seen in their children were studied in this research. There was no significant difference in behavioural problems between the different age group studied and there was no difference in problem behaviours between male children and female children. Authoritative parenting style was least associated with problem behaviour. Authoritarian parenting style is associated with internalizing problems and permissive parenting is associated with externalizing problems. CONCLUSION Since the behaviour problems tends to linger through adolescence and adulthood, parental education regarding the positive parenting style and interventions can be given from early childhood during routine child care and structured programs.

Evaluating nurse understanding and participation in the informed consent process.

Science.gov (United States)

Axson, Sydney A; Giordano, Nicholas A; Hermann, Robin M; Ulrich, Connie M

2017-01-01

Informed consent is fundamental to the autonomous decision-making of patients, yet much is still unknown about the process in the clinical setting. In an evolving healthcare landscape, nurses must be prepared to address patient understanding and participate in the informed consent process to better fulfill their well-established role as patient advocates. This study examines hospital-based nurses' experiences and understandings of the informed consent process. This qualitative descriptive study utilized a semi-structured interview approach identifying thematic concerns, experiences, and knowledge of informed consent across a selected population of clinically practicing nurses. Participants and research context: In all, 20 baccalaureate prepared registered nurses practicing in various clinical settings (i.e. critical care, oncology, medical/surgical) at a large northeastern academic medical center in the United States completed semi-structured interviews and a demographic survey. The mean age of participants was 36.6 years old, with a mean of 12.2 years of clinical experience. Ethical considerations: Participation in this study involved minimal risk and no invasive measures. This study received Institutional Review Board approval from the University of Pennsylvania. All participants voluntarily consented. The majority of participants (N = 19) believe patient safety is directly linked to patient comprehension of the informed consent process. However, when asked if nurses have a defined role in the informed consent process, nearly half did not agree (N = 9). Through this qualitative approach, three major nursing roles emerged: the nurse as a communicator, the nurse as an advocate, and the clerical role of the nurse. This investigation contributes to the foundation of ethical research that will better prepare nurses for patient engagement, advance current understanding of informed consent, and allow for future development of solutions. Nurses are at the forefront of

Improving readability of informed consents for research at an academic medical institution.

Science.gov (United States)

Hadden, Kristie B; Prince, Latrina Y; Moore, Tina D; James, Laura P; Holland, Jennifer R; Trudeau, Christopher R

2017-12-01

The final rule for the protection of human subjects requires that informed consent be "in language understandable to the subject" and mandates that "the informed consent must be organized in such a way that facilitates comprehension." This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention. Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year. The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade. Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Making a difference: incorporating theories of autonomy into models of informed consent.

Science.gov (United States)

Delany, C

2008-09-01

Obtaining patients' informed consent is an ethical and legal obligation in healthcare practice. Whilst the law provides prescriptive rules and guidelines, ethical theories of autonomy provide moral foundations. Models of practice of consent, have been developed in the bioethical literature to assist in understanding and integrating the ethical theory of autonomy and legal obligations into the clinical process of obtaining a patient's informed consent to treatment. To review four models of consent and analyse the way each model incorporates the ethical meaning of autonomy and how, as a consequence, they might change the actual communicative process of obtaining informed consent within clinical contexts. An iceberg framework of consent is used to conceptualise how ethical theories of autonomy are positioned and underpin the above surface, and visible clinical communication, including associated legal guidelines and ethical rules. Each model of consent is critically reviewed from the perspective of how it might shape the process of informed consent. All four models would alter the process of obtaining consent. Two models provide structure and guidelines for the content and timing of obtaining patients' consent. The two other models rely on an attitudinal shift in clinicians. They provide ideas for consent by focusing on underlying values, attitudes and meaning associated with the ethical meaning of autonomy. The paper concludes that models of practice that explicitly incorporate the underlying ethical meaning of autonomy as their basis, provide less prescriptive, but more theoretically rich guidance for healthcare communicative practices.

Can children withhold consent to treatment?

OpenAIRE

Devereux, J A; Jones, D P; Dickenson, D L

1993-01-01

A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose c...

42 CFR 35.15 - Consent to operative procedures.

Science.gov (United States)

2010-10-01

... emergencies when the patient is physically or mentally incapable of consenting and the delay required to... operative procedure shall be undertaken unless the patient or, in the case of a minor or incompetent, his... or refusal of consent shall be made a part of the clinical record. ...

40 CFR 26.1117 - Documentation of informed consent.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a...

Sign Lowering and Phonetic Reduction in American Sign Language.

Science.gov (United States)

Tyrone, Martha E; Mauk, Claude E

2010-04-01

This study examines sign lowering as a form of phonetic reduction in American Sign Language. Phonetic reduction occurs in the course of normal language production, when instead of producing a carefully articulated form of a word, the language user produces a less clearly articulated form. When signs are produced in context by native signers, they often differ from the citation forms of signs. In some cases, phonetic reduction is manifested as a sign being produced at a lower location than in the citation form. Sign lowering has been documented previously, but this is the first study to examine it in phonetic detail. The data presented here are tokens of the sign WONDER, as produced by six native signers, in two phonetic contexts and at three signing rates, which were captured by optoelectronic motion capture. The results indicate that sign lowering occurred for all signers, according to the factors we manipulated. Sign production was affected by several phonetic factors that also influence speech production, namely, production rate, phonetic context, and position within an utterance. In addition, we have discovered interesting variations in sign production, which could underlie distinctions in signing style, analogous to accent or voice quality in speech.

Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation.

Science.gov (United States)

Afolabi, Muhammed O; Bojang, Kalifa; D'Alessandro, Umberto; Ota, Martin O C; Imoukhuede, Egeruan B; Ravinetto, Raffaella; Larson, Heidi J; McGrath, Nuala; Chandramohan, Daniel

2014-06-24

To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants' comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. The primary outcome measure was reliability and validity of the questionnaire. Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73-0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to

Communicating with parents about vaccination: a framework for health professionals

Directory of Open Access Journals (Sweden)

Leask Julie

2012-09-01

Full Text Available Abstract Background A critical factor shaping parental attitudes to vaccination is the parent’s interactions with health professionals. An effective interaction can address the concerns of vaccine supportive parents and motivate a hesitant parent towards vaccine acceptance. Poor communication can contribute to rejection of vaccinations or dissatisfaction with care. We sought to provide a framework for health professionals when communicating with parents about vaccination. Methods Literature review to identify a spectrum of parent attitudes or ‘positions’ on childhood vaccination with estimates of the proportion of each group based on population studies. Development of a framework related to each parental position with determination of key indicators, goals and strategies based on communication science, motivational interviewing and valid consent principles. Results Five distinct parental groups were identified: the ‘unquestioning acceptor’ (30–40%, the ‘cautious acceptor’ (25–35%; the ‘hesitant’ (20–30%; the ‘late or selective vaccinator’ (2–27%; and the ‘refuser’ of all vaccines ( Conclusions Health professionals have a central role in maintaining public trust in vaccination, including addressing parents’ concerns. These recommendations are tailored to specific parental positions on vaccination and provide a structured approach to assist professionals. They advocate respectful interactions that aim to guide parents towards quality decisions.

29 CFR 1921.8 - Consent findings and order.

Science.gov (United States)

2010-07-01

... 29 Labor 7 2010-07-01 2010-07-01 false Consent findings and order. 1921.8 Section 1921.8 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... WORKERS' COMPENSATION ACT Prehearing Procedures § 1921.8 Consent findings and order. (a) General. At any...

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

Science.gov (United States)

Parker, Melissa J; de Laat, Sonya; Schwartz, Lisa

2016-09-13

Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Qualitative research study involving individual interviews and grounded theory methodology. SDMs for children enrolled into the SQUEEZE pilot trial. Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE

Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

Science.gov (United States)

Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

2014-09-01

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. © 2012 John Wiley & Sons Ltd.

Child-Parent Interactions in Families Raising Children with Hearing Impairment

Directory of Open Access Journals (Sweden)

Nikitina Yu.V.

2015-06-01

Full Text Available Article reveals communication (information exchange between parents and their deaf children. The effectiveness of information exchange in different communication means between parents and children having hearing loss was investigated. Effectiveness here is an opportunity of fast understanding of the information given by one participant to another. Special experimental situation was constructed to measure the effectiveness. This situation was divided in two parts: at first parent was giving instructions to the child, then – child was giving instructions to the parent. The time that was needed to follow the instructions was measured, and communication means were registered. 17 deaf children and their mothers participated in the study. 5 of those mothers also have hearing impairment and do know sign language. Control group was represented by 10 regular developing children and their parents. Experimental results allows us to make the conclusion that there are significant difficulties in information exchange between parent and child in families raising deaf children. These difficulties are more shown in situations when children have to understand parents’ instructions and are the result of not very efficient communication means that parents use in several cases. The most efficient communication means that allow receiving information faster, accurately and fully is Russian sign language. That is shown by the best results of information exchange in pairs of mother and child both having hearing loss.

21 CFR 50.25 - Elements of informed consent.

Science.gov (United States)

2010-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic... pertinent questions about the research and research subjects' rights, and whom to contact in the event of a...

Alcohol and Sexual Consent Scale: Development and Validation

Science.gov (United States)

Ward, Rose Marie; Matthews, Molly R.; Weiner, Judith; Hogan, Kathryn M.; Popson, Halle C.

2012-01-01

Objective: To establish a short measure of attitudes toward sexual consent in the context of alcohol consumption. Methods: Using a multistage and systematic measurement development process, the investigators developed the Alcohol and Sexual Consent Scale using a sample of college students. Results: The resulting 12-item scale, the Alcohol and…

Rights and duties in parenting practices

Directory of Open Access Journals (Sweden)

Ana Paula Solans

2015-10-01

Full Text Available The aim of this presentation is to present the results of three qualitative research on the exercise of rights and duties on Parenting Practices (PP, held in Buenos Aires, Argentina. They included interviews with mothers of children with Unsatisfied Basic Needs concretized between 2009 and 2013. Their analysis revealed that in this set of households were carried out three types of PP: imposition, guide and free will, the latter was the most used. As part of this practice, children managed their hours of sleep, wakefulness and leisure, without the intervention of their parents. It was noted, for example, that children over 10 years decided on matters concerning their schooling, absenting progressively to school, to abandonment. These practices were respected by their parents. By default, the postponement of pleasure (tolerance to frustration will not be exercised: they let children do at will. A trend of teenage pregnancy and the formation of pairs of children between 14-16 years with parental consent was also noted. In this sense, even when children lived in a house in contact with their parents, with a supply of food and available school, the indiscriminate exercise of free will put children's health at risk and full development, curtailing their rights. We recommend further studies such timely interventions to promote programs and projects designed to guide parents on issues related to the development of children as subjects of Rights and Duties.

[Informed consent right of the appraised individuals in forensic clinical examination].

Science.gov (United States)

Li, Ju-Ping; Han, Wei; Gu, Shan-Zhi; Chen, Teng

2015-02-01

Informed consent right is not just for basic ethical consideration, but is important for protecting patient's right by law, which is expressed through informed consent contract. The appraised individuals of forensic clinical examination have the similar legal status as the patients in medical system. However, the law does not require informed consent right for the appraised individuals. I recommend giving certain informed consent right to the appraised individuals in the forensic clinical examination. Under the contracted relationship with the institution, the appraised individuals could participate in the examination process, know the necessary information, and make a selected consent on the examination results, which can assure the justice and fairness of judicial examination procedure.

Customising informed consent procedures for people with schizophrenia in India.

Science.gov (United States)

Chatterjee, Sudipto; Kieselbach, Berit; Naik, Smita; Kumar, Shuba; John, Sujit; Balaji, Madhumitha; Koschorke, Mirja; Dabholkar, Hamid; Varghese, Mathew; Patel, Vikram; Thornicroft, Graham; Thara, Rangaswamy

2015-10-01

There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

How do parents experience being asked to enter a child in a randomised controlled trial?

Science.gov (United States)

Shilling, Valerie; Young, Bridget

2009-02-16

As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enroll their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfillment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help

[Informed consent and neuromodulation techniques for psychiatric purposes: an introduction].

Science.gov (United States)

Mandarelli, Gabriele; Moscati, Filippo Maria; Venturini, Paola; Ferracuti, Stefano

2013-01-01

The aim of this review was to investigate informed consent-related issues concerning vagus nerve stimulation and deep brain stimulation in the treatment of psychiatric disorders. We searched the principal medical databases for studies concerning informed consent, as well as ethical and deontological issues in psychosurgery. Data were critically analysed. We also provided guidelines for the evaluation of accuracy of the informed consent in such treatments. Despite major deontological and ethical implications, there is substantial lack of information pertaining informed consent decision-making in psychiatric patients with an indication for psychosurgery. In clinical research studies, deep brain stimulation and vagus nerve stimulation have been mainly used in drug-resistant major depressive disorder, Tourette syndrome and obsessive-compulsive disorder. Existing data on efficacy and tolerability, as well as those studies indicating the risk for incapacity in drug-resistant severe mental disorders, suggest the need to achieve a better understanding of the capacity to consent to psychosurgery in patients affected by mental disorders. Informed consent decision-making in clinical trials of deep brain stimulation and vagus nerve stimulation in psychiatric patients is largely unknown and deserves further investigation.

I had no other option: Women, electroconvulsive therapy, and informed consent.

Science.gov (United States)

Clarke, Karen-Ann; Barnes, Margaret; Ross, Dyann

2018-06-01

Electroconvulsive therapy (ECT) is a controversial procedure used in the management of depression. Whilst it may be administered under mental health legislation, it is usually given to people who voluntarily consent. At the practice level, the consent process for ECT requires a detailed explanation of the procedure. The person consenting must have capacity to make this decision, and consent must be given freely and without coercion. Research using a feminist narrative approach unexpectedly highlighted the issue of potential coercion in the context of explaining the procedure. In-depth interviews were used to understand seven women's accounts of deciding to receive ECT. A thematic analysis of their narratives uncovered a shared concern with how they consented to the treatment. Four subthemes were identified that related to the way in which they provided their consent: (i) 'Not enough information'; (ii) 'I had no other choice'; (iii) 'Just go along with it'; and (iv) 'Lacking capacity'. A consent process that includes elements of passive coercion and a lack of timely and appropriate information influences the way some women make decisions. These factors can disempower women at the point of decision-making. A practice shift is needed where women are enabled to have control over decisions. Further, there is a need to adhere more rigorously to noncoercive practice when obtaining consent. © 2017 Australian College of Mental Health Nurses Inc.

Ethical Issues Regarding Informed Consent for Minors for Space Tourism

Science.gov (United States)

Marsh, Melvin S.

2010-01-01

This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

The impact of visual communication on the intersubjective development of early parent-child interaction with 18- to 24-month-old deaf toddlers.

Science.gov (United States)

Loots, Gerrit; Devisé, Isabel; Jacquet, Wolfgang

2005-01-01

This article presents a study that examined the impact of visual communication on the quality of the early interaction between deaf and hearing mothers and fathers and their deaf children aged between 18 and 24 months. Three communication mode groups of parent-deaf child dyads that differed by the use of signing and visual-tactile communication strategies were involved: (a) hearing parents communicating with their deaf child in an auditory/oral way, (b) hearing parents using total communication, and (c) deaf parents using sign language. Based on Loots and colleagues' intersubjective developmental theory, parent-deaf child interaction was analyzed according to the occurrence of intersubjectivity during free play with a standard set of toys. The data analyses indicated that the use of sign language in a sequential visual way of communication enabled the deaf parents to involve their 18- to 24-month-old deaf infants in symbolic intersubjectivity, whereas hearing parents who hold on to oral-only communication were excluded from involvement in symbolic intersubjectivity with their deaf infants. Hearing parents using total communication were more similar to deaf parents, but they still differed from deaf parents in exchanging and sharing symbolic and linguistic meaning with their deaf child.

Language, cultural brokerage and informed consent – will ...

African Journals Online (AJOL)

2014-05-14

May 14, 2014 ... focus of recent debate around ethical issues relating to the standard of care and ... Forty-one key words relevant to computer terminology and concepts required to gain informed consent for a .... patients did not understand the meaning of the word 'consent' and .... [24] Lindegger and Richter[25] looked at.

Implications of the UK NHS consent policy for nuclear medicine practice.

Science.gov (United States)

Greaves, Claire D; Tindale, Wendy B

2005-02-01

To comply with government policy on consent, the Sheffield Teaching Hospitals (STH) National Health Service (NHS) Trust introduced a new consent policy in February 2002. Verbal or written consent (depending on the level of risk) must be obtained prior to each study. The patient must be fully informed and given time to reach a decision. Consideration needs to be given to the following: to whom, when and how to provide such information and obtain consent. Each study type and patient circumstance needs to be classified according to risk. Consideration of the risks resulted in a local policy in which written consent is required for the following: therapeutic procedures, studies on pregnant women, studies in which pregnancy needs to be avoided, research procedures, cardiac stress for myocardial perfusion scintigraphy and intrathecal administration. Patient information leaflets have been updated with new information about the study and any risks. Information is now available for both patients and hospital staff. Compliance with the consent policy in a service department provides logistic challenges, but it is possible to fully inform patients in advance about their treatment, allowing them to give informed consent.

Presuming consent in the ethics of posthumous sperm procurement and conception.

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Kroon, Frederick

2015-12-01

This paper compares standard conceptions of consent with the conception of consent defended by Kelton Tremellen and Julian Savulescu in their attempt to re-orient the ethical debate around posthumous sperm procurement and conception, as published in Reproductive BioMedicine Online in 2015. According to their radical proposal, the surviving partner's wishes are, in effect, the only condition that needs to be considered for there to be a legitimate moral case for these procedures: the default should be presumed consent to the procedures, whether or not the agent did consent or would have consented. The present paper argues that Tremellen and Savulescu's case for this position is flawed, but offers a reconstruction that articulates what may well be a hidden, and perhaps reasonable, assumption behind the argument. But while the new argument appears more promising, the reconstruction also suggests that the position of presumed consent is currently unlikely to be acceptable as policy.

Presuming consent in the ethics of posthumous sperm procurement and conception

Directory of Open Access Journals (Sweden)

Frederick Kroon

2015-12-01

Full Text Available This paper compares standard conceptions of consent with the conception of consent defended by Kelton Tremellen and Julian Savulescu in their attempt to re-orient the ethical debate around posthumous sperm procurement and conception, as published in Reproductive BioMedicine Online in 2015. According to their radical proposal, the surviving partner’s wishes are, in effect, the only condition that needs to be considered for there to be a legitimate moral case for these procedures: the default should be presumed consent to the procedures, whether or not the agent did consent or would have consented. The present paper argues that Tremellen and Savulescu’s case for this position is flawed, but offers a reconstruction that articulates what may well be a hidden, and perhaps reasonable, assumption behind the argument. But while the new argument appears more promising, the reconstruction also suggests that the position of presumed consent is currently unlikely to be acceptable as policy.

Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials.

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Haussen, Diogo C; Doppelheuer, Shannon; Schindler, Kiva; Grossberg, Jonathan A; Bouslama, Mehdi; Schultz, Meagan; Perez, Hilarie; Hall, Alex; Frankel, Michael; Nogueira, Raul G

2017-11-01

The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy. The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017. During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; P =0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; P =0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; P =0.002). e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes. © 2017 American Heart Association, Inc.

Paper trails, trailing behind: improving informed consent to IVF through multimedia applications

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Madeira, Jody Lyneé; Andraka-Christou, Barbara

2016-01-01

Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process. PMID:27774231

No Understanding, No Consent: The Case Against Alternative Medicine.

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Shahvisi, Arianne

2016-02-01

The demand for informed consent in clinical medicine is usually justified on the basis that it promotes patient autonomy. In this article I argue that the most effective way to promote autonomy is to improve patient understanding in order to reduce the epistemic disparity between patient and medical professional. Informed consent therefore derives its moral value from its capacity to reduce inequalities of power as they derive from epistemic inequalities. So in order for a patient to have given informed consent, she must understand the treatment. I take this to mean that she has sufficient knowledge of its causal mechanisms and has accepted the explanations in which the treatment is implicated. If this interpretation of informed consent is correct, it is unethical for medical professionals to offer or endorse 'alternative medicine' treatments, for which there is no known causal mechanism, for if they do, they may end up widening the epistemic disparity. In this way, informed consent may be understood as an effective way of ruling out particular treatments in order to improve patient autonomy and maintain trust in the medical profession. © 2016 John Wiley & Sons Ltd.

Informed Consent in Research on Second Language Acquisition

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Thomas, Margaret; Pettitt, Nicole

2017-01-01

The practice of securing informed consent from research participants has a relatively low profile in second language (L2) acquisition research, despite its prominence in the biomedical and social sciences. This review article analyses the role that informed consent now typically plays in L2 research; discusses an example of an L2 study where…

Non-Informed Consent Cultures: Privacy policies and app contracts on Facebook

DEFF Research Database (Denmark)

Bechmann, Anja

2014-01-01

of consent practices on Facebook, the article argues that with the growing importance and use of these services the consent culture of the internet has turned into a blind non-informed consent culture, heavily relying on social incentives and group dynamics in decision-making that are not adequately...

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

Science.gov (United States)

Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

Pan-Britain, mixed-methods study of multidisciplinary teams teaching parents to manage children's long-term kidney conditions at home: Study protocol

Science.gov (United States)

2012-01-01

-study. Participants will provide signed consent; data gathering will involve a combination of: minimally-obtrusive observations in the clinical setting and families' homes; de-briefing interviews with participants to obtain views on selected interactions; focussed 'verbatim' field-notes, and case-note reviews. Data gathering will focus on communication between parents and professionals as parents learn care-giving skills and knowledge. Interviews will be digitally recorded and transcribed anonymously. Discussion This study involves an iterative-inductive approach and will provide a unique, detailed insight into the social context in which professionals teach and parents learn; it will inform professionals' parent-educative roles, educational curricula, and health care policy PMID:22333296

Informed consent prior to coronary angiography in a real world scenario: what do patients remember?

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Aslihan Eran

Full Text Available BACKGROUND: Patients' informed consent is legally essential before elective invasive cardiac angiography (CA and successive intervention can be done. It is unknown to what extent patients can remember previous detailed information given by a specially trained doctor in an optimal scenario as compared to standard care. METHODOLOGY/PRINCIPAL FINDINGS: In this prospective cohort study 150 consecutive in-patients and 50 out-patients were included before elective CA was initiated. The informed consent was provided and documented in in-patients by trained and instructed physicians the day before CA. In contrast, out-patients received standard information by different not trained physicians, who did not know about this investigation. All patients had to sign a form stating that enough information had been given and all questions had been answered sufficiently. One hour before CA an assessment of the patients' knowledge about CA was performed using a standard point-by-point questionnaire by another independent physician. The supplied information was composed of 12 potential complications, 3 general, 4 periprocedural and 4 procedural aspects. 95% of the patients felt that they had been well and sufficiently informed. Less than half of the potential complications could be remembered by the patients and more patients could remember less serious than life-threatening complications (27.9±8.8% vs. 47.1±11.0%; p<0.001. Even obvious complications like local bleeding could not be remembered by 35% of in-patients and 36% of out-patients (p = 0.87. Surprisingly, there were only a few knowledge differences between in- and out-patients. CONCLUSIONS: The knowledge about CA of patients is vague when they give their informed consent. Even structured information given by a specially trained physician did not increase this knowledge.

American Sign Language Syntax and Analogical Reasoning Skills Are Influenced by Early Acquisition and Age of Entry to Signing Schools for the Deaf.

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Henner, Jon; Caldwell-Harris, Catherine L; Novogrodsky, Rama; Hoffmeister, Robert

2016-01-01

Failing to acquire language in early childhood because of language deprivation is a rare and exceptional event, except in one population. Deaf children who grow up without access to indirect language through listening, speech-reading, or sign language experience language deprivation. Studies of Deaf adults have revealed that late acquisition of sign language is associated with lasting deficits. However, much remains unknown about language deprivation in Deaf children, allowing myths and misunderstandings regarding sign language to flourish. To fill this gap, we examined signing ability in a large naturalistic sample of Deaf children attending schools for the Deaf where American Sign Language (ASL) is used by peers and teachers. Ability in ASL was measured using a syntactic judgment test and language-based analogical reasoning test, which are two sub-tests of the ASL Assessment Inventory. The influence of two age-related variables were examined: whether or not ASL was acquired from birth in the home from one or more Deaf parents, and the age of entry to the school for the Deaf. Note that for non-native signers, this latter variable is often the age of first systematic exposure to ASL. Both of these types of age-dependent language experiences influenced subsequent signing ability. Scores on the two tasks declined with increasing age of school entry. The influence of age of starting school was not linear. Test scores were generally lower for Deaf children who entered the school of assessment after the age of 12. The positive influence of signing from birth was found for students at all ages tested (7;6-18;5 years old) and for children of all age-of-entry groupings. Our results reflect a continuum of outcomes which show that experience with language is a continuous variable that is sensitive to maturational age.

Assessing the Magnitude of Non-Consent Biases in Linked Survey and Administrative Data

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Joseph W. Sakshaug

2012-07-01

Full Text Available Administrative records are increasingly being linked to survey records to highten the utility of the survey data. Respondent consent is usually needed to perform exact record linkage; however, not all respondents agree to this request and several studies have found significant differences between consenting and non-consenting respondents on the survey variables. To the extent that these survey variables are related to variables in the administrative data, the resulting administrative estimates can be biased due to non-consent. Estimating non-consent biases for linked administrative estimates is complicated by the fact that administrative records are typically not available for the non-consenting respondents. The present study can overcome this limitation by utilizing a unique data source, the German Panel Study "Labour Market and Social Security" (PASS, and linking the consent indicator to the administrative records (available for the entire sample. This situation permits the estimation of non-consent biases for administrative variables and avoids the need to link the survey responses. The impact of non-consent bias can be assessed relative to other sources of bias (nonresponse, measurement for several administrative estimates. The results show that non-consent biases are present for few estimates, but are generally small relative to other sources of bias.

Creating a Digital Jamaican Sign Language Dictionary: A R2D2 Approach

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MacKinnon, Gregory; Soutar, Iris

2015-01-01

The Jamaican Association for the Deaf, in their responsibilities to oversee education for individuals who are deaf in Jamaica, has demonstrated an urgent need for a dictionary that assists students, educators, and parents with the practical use of "Jamaican Sign Language." While paper versions of a preliminary resource have been explored…

Nudging and informed consent.

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Cohen, Shlomo

2013-01-01

Libertarian paternalism's notion of "nudging" refers to steering individual decision making so as to make choosers better off without breaching their free choice. If successful, this may offer an ideal synthesis between the duty to respect patient autonomy and that of beneficence, which at times favors paternalistic influence. A growing body of literature attempts to assess the merits of nudging in health care. However, this literature deals almost exclusively with health policy, while the question of the potential benefit of nudging for the practice of informed consent has escaped systematic analysis. This article focuses on this question. While it concedes that nudging could amount to improper exploitation of cognitive weaknesses, it defends the practice of nudging in a wide range of other conditions. The conclusion is that, when ethically legitimate, nudging offers an important new paradigm for informed consent, with a special potential to overcome the classical dilemma between paternalistic beneficence and respect for autonomy.

Children's views on research without prior consent in emergency situations: a UK qualitative study.

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Roper, Louise; Sherratt, Frances C; Young, Bridget; McNamara, Paul; Dawson, Angus; Appleton, Richard; Crawley, Esther; Frith, Lucy; Gamble, Carrol; Woolfall, Kerry

2018-06-09

We explored children's views on research without prior consent (RWPC) and sought to identify ways of involving children in research discussions. Qualitative interview study. Participants were recruited through a UK children's hospital and online advertising. 16 children aged 7-15 years with a diagnosis of asthma (n=14) or anaphylaxis (n=2) with recent (<12 months) experience of emergency care. Children were keen to be included in medical research and viewed RWPC as acceptable in emergency situations if trial interventions were judged safe. Children trusted that doctors would know about their trial participation and act in their best interests. All felt that children should be informed about the research following their recovery and involved in discussions with a clinician or their parent(s) about the use of data already collected as well as continued participation in the trial (if applicable). Participants suggested methods to inform children about their trial participation including an animation. Children supported, and were keen to be involved in, clinical trials in emergency situations. We present guidance and an animation that practitioners and parents might use to involve children in trial discussions following their recovery. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Longitudinal Receptive American Sign Language Skills across a Diverse Deaf Student Body

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Beal-Alvarez, Jennifer S.

2016-01-01

This article presents results of a longitudinal study of receptive American Sign Language (ASL) skills for a large portion of the student body at a residential school for the deaf across four consecutive years. Scores were analyzed by age, gender, parental hearing status, years attending the residential school, and presence of a disability (i.e.,…

Customizable pre-printed consent forms: a solution in light of the Montgomery ruling.

Science.gov (United States)

Owen, Deborah; Aresti, Nick; Mulligan, Alex; Kosuge, Dennis

2018-02-02

This article presents an audit cycle supported quality improvement project addressing best practice in the consent process for lower limb arthroplasty which takes into account the new standard in surgical consent and the importance of material risks. 50 consecutive total hip and total knee replacement consent forms over a 3-month period were reviewed for legibility and completeness. Following the introduction of a new, pre-printed but customizable consent form the review process was repeated. The introduction of a customizable, pre-printed consent form that can be adjusted to reflect the individualized material risks of each patient increased legibility, reduced inappropriate human error variation and abolished the use of abbreviations and medical jargon. When used as part of an extended consent process, the authors feel that the use of pre-printed but customizable consent forms improves legibility, completeness and consistency and also provides the ability to highlight those complications that are of particular importance for that patient to satisfy the new accepted standard in surgical consent.

Selections from Unequal Partners: Teaching about Power, Consent, and Healthy Relationships

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deFur, Kirsten

2016-01-01

The Center for Sex Education recently published the fourth edition of "Unequal Partners: Teaching about Power, Consent, and Healthy Relationships, Volumes 1 and 2." Included here are two lesson plans about sexual consent selected from each volume. "What does it take … to give sexual consent?" [Sue Montfort and Peggy Brick] is…

Informed consent to healthcare interventions in people with learning disabilities--an integrative review.

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Goldsmith, Lesley; Skirton, Heather; Webb, Christine

2008-12-01

This paper is a report of an integrative review of informed consent to healthcare interventions in people with learning disabilities. Consent to treatment lies at the heart of the relationship between patient and healthcare professional. In order for people with learning disabilities to have equity of access to health care, they need to be able to give informed consent to health interventions--or be assessed as incompetent to give consent. The British Nursing Index (BNI), CINAHL, MEDLINE, Social Care Online, ERIC and ASSIA and PsycINFO databases were searched using the search terms: Consent or informed choice or capacity or consent to treat* or consent to examin* AND Learning disab* or intellectual* disab* or mental* retard* or learning difficult* or mental* handicap*. The search was limited to papers published in English from January 1990 to March 2007. An integrative review was conducted and the data analysed thematically. Twenty-two studies were reviewed. The main themes identified were: life experience, interaction between healthcare professionals and participants, ability to consent, and psychometric variables. A consensus seemed to emerge that capacity to consent is greater in people with higher cognitive ability and verbal skills, but that the attitudes and behaviour of healthcare professionals was also a crucial factor. The findings support use of the functional approach to assessing mental capacity for the purpose of obtaining informed consent. Future research into informed consent in people with learning disabilities is needed using real life situations rather than hypothetical vignettes.

How do parents experience being asked to enter a child in a randomised controlled trial?

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Young Bridget

2009-02-01

Full Text Available Abstract Background As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Discussion Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Summary Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future

Futility, autonomy, and informed consent.

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Trau, J M

1994-03-01

If clinicians deem a treatment medically futile, is it appropriate to mention such a treatment to patients? Do healthcare professionals violate informed consent if they do not offer patients an opportunity to decline futile treatments? The notion of futility involves an assessment of patient best interest--both short-term and long-term therapeutic benefit for a patient and the community in which he or she intends to survive and flourish. Although survival interests may be construed as long term, a treatment that offers survival without any promise of flourishing is not the goal of medicine and is futile. Flourishing requires some cognitive and affective function. The goal of informed consent practices is to ensure that patients accept the benefits of treatment with cognizance of the burdens and risks. Given the impact of illness on the emotional and psychological states of patients and their families and their resultant vulnerability, the omission of futile options from treatment plans is logical and exemplifies the best of paternalistic behavior. The claim that requests for futile treatment must be honored is based on a perverse understanding of patient autonomy. Rational medicine demands that patients' requests be reasonable from a clinical perspective, as well as from a subjective one. The practice of informed consent can be implemented as a balance between these two interests.

Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale.

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Blake, Kathryn; Holbrook, Janet T; Antal, Holly; Shade, David; Bunnell, H Timothy; McCahan, Suzanne M; Wise, Robert A; Pennington, Chris; Garfinkel, Paul; Wysocki, Tim

2015-05-01

Phase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial. Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing. This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases. Copyright © 2015 Elsevier Inc. All rights reserved.

Vital Signs – HIV Among Youth in the US: Protecting a Generation

Centers for Disease Control (CDC) Podcasts

This podcast is based on the December 2012 CDC Vital Signs report, which presents information about the impact of HIV on youth, the factors that place youth at risk for HIV, and calls for prevention through parents, schools, and community-based HIV prevention programs for youth.

Shaping parents: impact of contrasting professional counseling on parents' decision making for children with disorders of sex development.

Science.gov (United States)

Streuli, Jürg C; Vayena, Effy; Cavicchia-Balmer, Yvonne; Huber, Johannes

2013-08-01

The management of disorders or differences of sex development (DSD) remains complex, especially with respect to parents' decision for or against early genitoplasty. Most parents still tend to disfavor postponing surgery until the child is old enough to provide consent. To identify the determinants of parental decisions for or against early sex assignment surgery in DSD children, and in particular to assess the influence of contrasting behavior of health-care professionals and the information they dispense. Preliminary data analysis from a focus group identified two broad approaches to counseling information. Two six-minute counseling videos were produced on this basis: one medicalized, by an endocrinologist, the other demedicalized, by a psychologist. Third-year medical students (N = 89) were randomized to watch either video as prospective parents and report its impact on their decision in a self-administered questionnaire. Statistical analysis of questionnaire responses regarding decisions for or against surgery, including self-assessed impact of potential determinants. Thirty-eight of eighty-nine "parents" (43%) chose early surgery for "their" child, including 27/41 "parents" (66%) shown the medicalized video vs. 11/48 (23%) shown the demedicalized video (P parents" perceived their personal attitudes on a four-point Likert scale as the main influence on their decision although their "attitude" was significantly shaped by the video. Parental decisions concerning early sex assignment surgery for DSD children depend on the health professional counseling received, to a degree of which neither parents nor professionals appear fully aware. In the absence of conclusive data for or against early surgery, there is a danger of medicalized or demedicalized parentalism resulting in irreversible and inadequately grounded decisions, regardless of the consensus statement of 2005 and the subsequent call for multidisciplinary management. © 2013 International Society for

Magnetic field control of 90 Degree-Sign , 180 Degree-Sign , and 360 Degree-Sign domain wall resistance

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Majidi, Roya, E-mail: royamajidi@gmail.com [Department of Physics, Shahid Rajaee Teacher Training University, Lavizan, 16788-15811 Tehran (Iran, Islamic Republic of)

2012-10-01

In the present work, we have compared the resistance of the 90 Degree-Sign , 180 Degree-Sign , and 360 Degree-Sign domain walls in the presence of external magnetic field. The calculations are based on the Boltzmann transport equation within the relaxation time approximation. One-dimensional Neel-type domain walls between two domains whose magnetization differs by angle of 90 Degree-Sign , 180 Degree-Sign , and 360 Degree-Sign are considered. The results indicate that the resistance of the 360 Degree-Sign DW is more considerable than that of the 90 Degree-Sign and 180 Degree-Sign DWs. It is also found that the domain wall resistance can be controlled by applying transverse magnetic field. Increasing the strength of the external magnetic field enhances the domain wall resistance. In providing spintronic devices based on magnetic nanomaterials, considering and controlling the effect of domain wall on resistivity are essential.

Consent in dentistry: ethical and deontological issues.

Science.gov (United States)

Conti, Adelaide; Delbon, Paola; Laffranchi, Laura; Paganelli, Corrado

2013-01-01

In Italy, consent for health treatment, aside from being an ethical and deontological obligation, constitutes an essential requirement for any medical treatment according to articles 13 and 32 of the National Constitution and also in accordance with the Council of Europe's 'Convention on Human Rights and Biomedicine'. An essential requirement for the validity of consent is that clear, exhaustive and adequate information be provided to the patient himself: the practice of informed consent is a communicative relationship in which the patient can express doubts, perplexities and clarification requests to the dentist. Furthermore, dental treatment has specific peculiarities: the relationship between dentistry and aesthetics, the concomitant presence of pathologies requiring different treatments, the elongated care process and the establishment of a trustworthy relationship and familiarity with the patient represent important aspects in the configuration of the dentist-patient relationship and in the process of acquiring informed consent. The dentist must offer correct information on diagnosis, prognosis, the therapeutic perspective and the likely consequences of therapy, alternative therapy and refusal of therapy, as well as eventual commitments for the period after treatment. Particular consideration must be given to minors and patients of unsound mind: the dentist's approach to these patients needs to be clear and appropriate to the person's age and understanding ability, even if the decisional power for sanitary treatment may be in the hands of a third person.

29 CFR 70.42 - Consent to Pay Fees.

Science.gov (United States)

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Consent to Pay Fees. 70.42 Section 70.42 Labor Office of the....42 Consent to Pay Fees. (a) The filing of a request under this subpart will be deemed to constitute an agreement by the requester to pay all applicable fees charged under this part up to and including...

Parental Interaction Patterns in Children with Adhd and Controls; a Comparative Study

Directory of Open Access Journals (Sweden)

M Afkhami -Aghda

2007-04-01

Full Text Available Introduction: Communicational patterns of the parents can either positively or negatively influence children's personality. Parenting manner has long-term effects on behavior, function, expectations and eventually people's future personality. This study investigates parental interaction patterns in children with attention deficit- hyperactive disorder. Methods :In this study, 50 male children aged 7-12 years were selected in two groups including 1 25 students with ADHD referring to psychiatry clinics in Isfahan according to the diagnostic scale of DSM- IV and 2 25 healthy boys selected by random cluster multistage sampling from primary schools in five districts of Isfahan from Septamber 2005 until March 2005. Schaffer and Edgerton parental interaction questionnaire was filled for them. Results: In "Communication" interaction pattern, the mean score of healthy children was 15.08, while the mean score of ADHD children was 13.42. In "admission" interactional pattern; the mean of the first group was 14.76, while the second group was 11.76. In "control" interactional pattern, mean of group one was 13.28 and the second group was 11.76. In "aggression control" interactional pattern, the mean of group one was 13 and the second group was 14.68. In "lack of aggressive attachment" interactional pattern, mean of the first group was 13.36 and the second group was 16.67. The mean scores of parental interactional pattern in healthy children were all higher than ADHD children except for "aggression control" and "lack of aggressive attachment" interactional patterns. Conclusion: The more the parental "admission" interactional pattern score, the lower the signs of ADHD in children. The signs of severity are lower in cases with more positive parental "control" interactional patterns. If the scores of "lack of aggressive/ attachment" and "aggressive/ control" interactional patterns are higher, ADHD signs are more severe.

The Road to Language Learning Is Not Entirely Iconic: Iconicity, Neighborhood Density, and Frequency Facilitate Acquisition of Sign Language.

Science.gov (United States)

Caselli, Naomi K; Pyers, Jennie E

2017-07-01

Iconic mappings between words and their meanings are far more prevalent than once estimated and seem to support children's acquisition of new words, spoken or signed. We asked whether iconicity's prevalence in sign language overshadows two other factors known to support the acquisition of spoken vocabulary: neighborhood density (the number of lexical items phonologically similar to the target) and lexical frequency. Using mixed-effects logistic regressions, we reanalyzed 58 parental reports of native-signing deaf children's productive acquisition of 332 signs in American Sign Language (ASL; Anderson & Reilly, 2002) and found that iconicity, neighborhood density, and lexical frequency independently facilitated vocabulary acquisition. Despite differences in iconicity and phonological structure between signed and spoken language, signing children, like children learning a spoken language, track statistical information about lexical items and their phonological properties and leverage this information to expand their vocabulary.

Trends and Determinants of Familial Consent for Corneal Donation in Chinese.

Science.gov (United States)

Lee, Allie; Ni, Michael Y; Luk, Amanda C K; Lau, Jessie K P; Lam, Karen S Y; Li, Tom K; Wong, Catherine S M; Wong, Victoria W Y

2017-03-01

Corneal transplantation is the treatment of choice for many corneal diseases. At present, there is a global shortage of corneal transplant tissues, and failure to obtain consent from families of potential donors is a major limiting factor in tissue procurement. All family members of potential donors after cardiac death approached by the local eye bank staff members from January 2008 to December 2014 in Hong Kong were included. Reasons for consent or refusal and sociodemographic details of the deceased and the family members approached were reviewed. Trends in consent rates from 2008 to 2014 were examined. Multivariable logistic regression was performed to examine determinants of donation among cases from 2013 to 2014. A total of 1740 cases were identified. The overall consent rate was 36.8%, and the consent rate did not change significantly over the 7-year study period (P = 0.24). The most common reason for consent by family members was "the wish to help others" (86.0%), and the most common reason for refusal was "traditional Chinese culture to keep the body intact after death" (42.7%). From the multivariable analysis in the subset of cases from 2013 to 2014 (n = 628), family members were more likely to consent when the deceased was female (adjusted odds ratio 1.45, P = 0.03), with a do-not-resuscitate order (adjusted odds ratio 2.27, P < 0.001). The consent rate for eye donation did not change significantly from 2008 to 2014. Our findings suggest that health education and promotion campaigns need to address cultural barriers to organ donation.

Study protocol: evaluation of an online, father-inclusive, universal parenting intervention to reduce child externalising behaviours and improve parenting practices.

Science.gov (United States)

Tully, Lucy A; Piotrowska, Patrycja J; Collins, Daniel A J; Mairet, Kathleen S; Hawes, David J; Kimonis, Eva R; Lenroot, Rhoshel K; Moul, Caroline; Anderson, Vicki; Frick, Paul J; Dadds, Mark R

2017-06-19

Parenting interventions that focus on enhancing the quality and consistency of parenting are effective for preventing and reducing externalising problems in children. There has been a recent shift towards online delivery of parenting interventions in order to increase their reach and impact on the population prevalence of child externalising problems. Parenting interventions have low rates of father participation yet research suggests that father involvement may be critical to the success of the intervention. Despite this, no online parenting interventions have been specifically developed to meet the needs and preferences of fathers, as well as mothers. This paper describes the protocol of a study examining the effectiveness of an online, father-inclusive parenting intervention called 'ParentWorks', which will be delivered as a universal intervention to Australian families. A single group clinical trial will be conducted to examine the effectiveness of ParentWorks for reducing child externalising problems and improving parenting, as well as to explore the impact of father engagement (in two-parent families) on child outcomes. Australian parents/caregivers with a child aged 2-16 years will be recruited. Participants will provide informed consent, complete pre-intervention measures and will then complete the intervention, which consists of five compulsory video modules and three optional modules. The primary outcomes for this study are changes in child externalising behaviour, positive and dysfunctional parenting practices and parental conflict, and the secondary outcome is changes in parental mental health. Demographic information, satisfaction with the intervention, and measures of parental engagement will also be collected. Questionnaire data will be collected at pre-intervention, post-intervention and three-month follow-up, as well as throughout the program. This paper describes the study protocol of a single group clinical trial of a national, online, father

Informed consent: Do not be afraid

Directory of Open Access Journals (Sweden)

Dominique Sprumont

2017-04-01

Full Text Available Informed consent is the cornerstone of the doctor–patient relationship. At least this is how it is presented in theory. In practice, doctors struggle with their obligation to inform their patient before obtaining their approval prior to a medical intervention. In Taiwan, the culture is often mentioned to justify the doctor's reluctance to speak openly with their patient. Invoking the importance of the family in the society, doctors tend to rely less on their patients and more on their relatives to make important decisions. Yet, the cultural argument for not seeking the patients' informed consent sounds more like a mere excuse than the real cause of the difficulties doctors face today in obtaining their patients' consent. This paper argues that today the doctors in Taiwan are mostly governed by the same fear that was the rule in the USA and Europe until the 1980s. It may be time for changing the paradigm, admitting that patients are able to handle even the most dramatic diagnosis. It seems also important to get away from the sterile opposition of doctor's paternalism versus patient's autonomy and to introduce a true partnership between doctors and patients.

75 FR 68620 - Notice of Lodging Proposed Consent Decree

Science.gov (United States)

2010-11-08

... Florida on November 1, 2010. The proposed Consent Decree concerns a First Amended Complaint filed by the...; Century Partners Group, Ltd.; Century Homebuilders of South Florida, LLC; and Cesar E. Llano to obtain...). The proposed Consent Decree resolves these allegations by requiring the defendants to enhance wetlands...

Informed consent and the law--an English legal perspective.

Science.gov (United States)

Hassan, Majid

2008-01-01

'Informed consent' is a widely used term, but its application in a legal perspective can be varied. American and Commonwealth jurisdictions have developed a 'patient-based' true informed consent approach, whereas in the English legal system a 'doctor-based' approach has traditionally been applied in relation to disclosure of risk. This article will seek to compare these approaches and give a brief overview of some of the key legal rulings which have shaped the requirement of consent. The decision in the English case of Chester vs. Afshar is considered as showing the significance the court attached to the principle of autonomy and using ethical and policy considerations to depart from established principles of English law relating to consent to treatment and disclosure of risk. This review is intended as general information and not as legal advice which should be sought from defence organisation and specialist health care lawyers. Copyright 2008 S. Karger AG, Basel.

The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial.

Science.gov (United States)

Winter, Matthew; Kam, Jonathan; Nalavenkata, Sunny; Hardy, Ellen; Handmer, Marcus; Ainsworth, Hannah; Lee, Wai Gin; Louie-Johnsun, Mark

2016-11-01

To determine if portable video media (PVM) improves patient's knowledge and satisfaction acquired during the consent process for cystoscopy and insertion of a ureteric stent compared to standard verbal communication (SVC), as informed consent is a crucial component of patient care and PVM is an emerging technology that may help improve the consent process. In this multi-centre randomised controlled crossover trial, patients requiring cystoscopy and stent insertion were recruited from two major teaching hospitals in Australia over a 15-month period (July 2014-December 2015). Patient information delivery was via PVM and SVC. The PVM consisted of an audio-visual presentation with cartoon animation presented on an iPad. Patient satisfaction was assessed using the validated Client Satisfaction Questionnaire 8 (CSQ-8; maximum score 32) and knowledge was tested using a true/false questionnaire (maximum score 28). Questionnaires were completed after first intervention and after crossover. Scores were analysed using the independent samples t-test and Wilcoxon signed-rank test for the crossover analysis. In all, 88 patients were recruited. A significant 3.1 point (15.5%) increase in understanding was demonstrable favouring the use of PVM (P < 0.001). There was no difference in patient satisfaction between the groups as judged by the CSQ-8. A significant 3.6 point (17.8%) increase in knowledge score was seen when the SVC group were crossed over to the PVM arm. A total of 80.7% of patients preferred PVM and 19.3% preferred SVC. Limitations include the lack of a validated questionnaire to test knowledge acquired from the interventions. This study demonstrates patients' preference towards PVM in the urological consent process of cystoscopy and ureteric stent insertion. PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process. © 2016 The

Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

Science.gov (United States)

Nusbaum, Lika; Douglas, Brenda; Damus, Karla; Paasche-Orlow, Michael; Estrella-Luna, Neenah

2017-01-01

Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research. PMID:28975139

Sexual Consent as a Scientific Subject: A Literature Review

Science.gov (United States)

Fenner, Lydia

2017-01-01

Despite the presumed centrality of sexual consent to definitions of sexual violence, it remains an ambiguous and often unexamined concept both in lay and professional/scientific discourses. The following literature review of peer-reviewed research studying sexual consent as a scientific object will thematically present major findings from said…

Readability of Informed Consent Documents at University Counseling Centers

Science.gov (United States)

Lustgarten, Samuel D.; Elchert, Daniel M.; Cederberg, Charles; Garrison, Yunkyoung L.; Ho, Y. C. S.

2017-01-01

The extent to which clients understand the nature and anticipated course of therapy is referred to as informed consent. Counseling psychologists often provide informed consent documents to enhance the education of services and for liability purposes. Professionals in numerous health care settings have evaluated the readability of their informed…

Awareness, knowledge and attitude toward informed consent among doctors in two different cultures in Asia: a cross-sectional comparative study in Malaysia and Kashmir, India.

Science.gov (United States)

Yousuf, R M; Fauzi, A R M; How, S H; Rasool, A G; Rehana, K

2007-06-01

Informed consent is now accepted as the cornerstone of medical practice, with reasonable patient standards typically considered to be appropriate in the developed countries; however it is still challenged in many developing countries. The objective of this descriptive study was to evaluate the perceptions and practices among attending medical professionals in matters relating to informed consent in selected hospitals. A questionnaire-based cross sectional survey among doctors in the two tertiary care hospitals, one in Malaysia and the other in Kashmir, was performed. Awareness on informed consent was universal with "reasonable physician standard" as the most popular choice. As compared to doctors in Malaysia, doctors from Kashmir showed a tendency to reservedly disclose medical information (p-value equals 0.051) and withhold it, if it was deemed potentially harmful (p-value is less than 0.001) or requested so by relatives (p-value is less than 0.023). They also withheld some information from female patients (p-value is less than 0.001). When consent was refused despite needing lifesaving intervention, the majority of both respondents (73 percent versus 80 percent) considered intervention without consent to be justified. Respondents from Malaysia felt that parents could refuse treatment on their children's behalf on the basis of their beliefs (p-value is less than 0.001). Despite a very high awareness of informed consent, the model chosen reflected age-old medical paternalism. Doctors' opinions are accorded a larger role in clinical decision-making in Kashmir. The results emphasise the need for doctors to change their attitude and acknowledge the patient's autonomy, which is the basis of modern medical ethics, and yet still be aware of the cultural and religious views of the local population.

Children's competency to consent: an ethical dilemma.

Science.gov (United States)

Spencer, G E

2000-01-01

The application of the best interests principle in current legislation creates an ethical dilemma in relation to children's consent to treatment. The guiding principle of the UN Convention on the Rights of the Child (1989) symbolises a formal expression of children's participation rights. Children's rights to consent to treatment are granted on socially determined ideals of competency. Children's participation in health care is increasingly advocated in legislation but many barriers remain. Nurses can facilitate children's participation through communicating information and creating partnerships with children.

A comparative study of expectant parents ' childbirth expectations.

Science.gov (United States)

Kao, Bi-Chin; Gau, Meei-Ling; Wu, Shian-Feng; Kuo, Bih-Jaw; Lee, Tsorng-Yeh

2004-09-01

The purpose of this study was to understand childbirth expectations and differences in childbirth expectations among expectant parents. For convenience sampling, 200 couples willing to participate in this study were chosen from two hospitals in central Taiwan. Inclusion criteria were at least 36 weeks of gestation, aged 18 and above, no prenatal complications, and willing to consent to participate in this study. Instruments used to collect data included basic demographic data and the Childbirth Expectations Questionnaire. Findings of the study revealed that (1) five factors were identified by expectant parents regarding childbirth expectations including the caregiving environment, expectation of labor pain, spousal support, control and participation, and medical and nursing support; (2) no general differences were identified in the childbirth expectations between expectant fathers and expectant mothers; and (3) expectant fathers with a higher socioeconomic status and who had received prenatal (childbirth) education had higher childbirth expectations, whereas mothers displayed no differences in demographic characteristics. The study results may help clinical healthcare providers better understand differences in expectations during labor and birth and childbirth expectations by expectant parents in order to improve the medical and nursing system and promote positive childbirth experiences and satisfaction for expectant parents.

Access to special care dentistry, part 3. Consent and capacity.

Science.gov (United States)

Dougall, A; Fiske, J

2008-07-26

This article considers what is meant by informed consent and the implications of the Mental Capacity Act in obtaining consent from vulnerable adults. It explores a number of conditions which impact on this task, namely dyslexia, literacy problems and learning disability. The focus on encouraging and facilitating autonomy and the use of the appropriate level of language in the consent giving process ensures that consent is valid. The use of appropriate methods to facilitate communication with individuals in order to be able to assess capacity and ensure that any treatment options that are chosen on their behalf are in their best interests are outlined. The use of physical intervention in special care dentistry in order to provide dental care safely for both the patient and the dental team is also considered.

"Consent is Good, Joyous, Sexy": A banner campaign to market consent to college students.

Science.gov (United States)

Thomas, Kristie A; Sorenson, Susan B; Joshi, Manisha

2016-01-01

This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. A stratified random sample of 1,200 undergraduates was recruited during fall of 2010; 628 (52.3%) participated. To account for history and maturation, an experimental research design was employed with an online survey. Direct and indirect campaign exposure was associated with increased action. Students expressed primarily positive reactions to and appeared to understand the consent message. The campaign appealed to and was associated with increased activity among a wide range of students with one exception: a negative effect was observed for business students. Colorful banners with pithy, upbeat messages hold promise for engaging undergraduates in conversations and proactive activities related to sexual assault prevention.

Reading books with young deaf children: strategies for mediating between American Sign Language and English.

Science.gov (United States)

Berke, Michele

2013-01-01

Research on shared reading has shown positive results on children's literacy development in general and for deaf children specifically; however, reading techniques might differ between these two populations. Families with deaf children, especially those with deaf parents, often capitalize on their children's visual attributes rather than primarily auditory cues. These techniques are believed to provide a foundation for their deaf children's literacy skills. This study examined 10 deaf mother/deaf child dyads with children between 3 and 5 years of age. Dyads were videotaped in their homes on at least two occasions reading books that were provided by the researcher. Descriptive analysis showed specifically how deaf mothers mediate between the two languages, American Sign Language (ASL) and English, while reading. These techniques can be replicated and taught to all parents of deaf children so that they can engage in more effective shared reading activities. Research has shown that shared reading, or the interaction of a parent and child with a book, is an effective way to promote language and literacy, vocabulary, grammatical knowledge, and metalinguistic awareness (Snow, 1983), making it critical for educators to promote shared reading activities at home between parent and child. Not all parents read to their children in the same way. For example, parents of deaf children may present the information in the book differently due to the fact that signed languages are visual rather than spoken. In this vein, we can learn more about what specific connections deaf parents make to the English print. Exploring strategies deaf mothers may use to link the English print through the use of ASL will provide educators with additional tools when working with all parents of deaf children. This article will include a review of the literature on the benefits of shared reading activities for all children, the relationship between ASL and English skill development, and the techniques

Sole risk and non-consent

International Nuclear Information System (INIS)

Winsor, Tom

1994-01-01

This article discusses the subjects of sole risk and non-consent in joint operation agreements as used by oil and gas joint ventures in the United Kingdom. The difference between these two concepts is examined in detail. (UK)

Informed consent for and regulation of critical care research.

Science.gov (United States)

Lemaire, François

2008-12-01

Critical care is a special area in which research needs to take place, because of the severity of the diseases which are treated there, but it is also a place where research faces a lot of hurdles and difficulties. The main cause of difficulties is the consent issue, as most patients cannot consent for themselves. Recently, all national legislations in the countries of the European Union have been modified to include the provisions of directive 2001/20. This review article provides a summary of the recent literature concerning the issue of consent for clinical care research such as how the surrogate consent reflects the view of the patient and how time consuming and inaccurate can be the consultation of a community before the start of a trial with a waiver of consent. Another hurdle to research is the rigidity of our legislations concerning clinical research, especially the absence of a simplified way for low or no-risk research. This article shows how this situation is potentially deleterious and how it could ultimately forbid low-risk research. Critical research remains a domain in which research on patients is difficult and controversial. Regulation can be difficult to implement, largely inadequate or uselessly complicated. Intensive care physicians need to keep pressure on politicians and lawmakers to constantly explain the necessity and specificities of critical care research.

Getting meaningful informed consent from older adults: a structured literature review of empirical research.

Science.gov (United States)

Sugarman, J; McCrory, D C; Hubal, R C

1998-04-01

To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve

Capacity to consent to research among patients with bipolar disorder.

Science.gov (United States)

Misra, Sahana; Ganzini, Linda

2004-06-01

Experts have debated the influence of mental illness on decision-making capacity. This paper reviews concepts of decision-making capacity and existing research on the influence of mental illness on capacity to consent to research. We propose how bipolar disorder, especially mania, may have an effect on consent capacity. The current conceptualization of capacity utilizes legal standards of 'choice', 'understanding', 'appreciation' and 'rational reasoning', as well as voluntarism, or the assurance that the patient is free to agree or to decline to participate in research. Studies of patients with schizophrenia suggest impaired cognition influences 'understanding' and is more important than severity of psychosis in affecting decision-making abilities. There are no studies of sources and extent of impairment to consent to research among manic patients. Mania may influence a patient's understanding of the research protocol, but also alter the patient's views, values and level of insight, thus impairing decision-making abilities at the 'appreciation' standard even when the patient understands the relevant information. Mania may impact freedom to decide, yet paradoxically, manic patients may be less influenced by others and less vulnerable to coercion, undue influence and undue incentives compared to patients without mental illness. We suggest that in patients with mood disorders, the legal standard of appreciation be thoroughly probed during the consent procedure. Studies of the effect of mania and depression on consent capacity and voluntarism are needed in order to develop processes that increase safeguards in the informed consent process.

Predicting Participant Consent in mHealth Trials – A Caregiver’s Perspective

Directory of Open Access Journals (Sweden)

Yvonne O'Connor

2017-11-01

Full Text Available Informed consent is sought prior to conducting a healthcare intervention on a person. When a healthcare intervention involves a young child, their caregiver is required to provide informed consent on their behalf. However, little is known on the behavioural intentions of participants to provide consent when a mobile health (mHealth intervention is involved in a clinical trial scenario. Understanding this phenomenon is important, without consent appropriate data may not be collected to empirically examine the implications of mHealth initiatives when delivering healthcare services to children in a ‘real world context’. The objective of this paper is to explore the behavioural intentions of caregivers to provide consent for children (under five years of age to participate in mHealth Randomised Control Trials (RCT in developing countries and subsequently develop a predictive model for consent giving. Data was captured vis-à-vis interviews with Malawian caregivers in Africa. The findings reveal that emotional response stimuli play a major role during the participant informed consent process resulting in the involvement (or not of a child within an RCT. The study contributes to, and opens up, avenues for critical research on the role of informed consent as part of RCT-related projects, especially concerning the involvement of children. This new knowledge may be leveraged to address participant uncertainties and subsequently improve the rate of paediatric recruitment in mHealth trial scenarios.

Metacarpal sign

Directory of Open Access Journals (Sweden)

Barbara Nieradko-Iwanicka

2018-02-01

Full Text Available Background Archibald's sign, or metacarpal sign is defined as shortening of the IV and V metacarpal bones, is a rare phenomenon found in the Turner syndrome, homocystinuria and in Albright's osteodystrophy. Objectives The aim of the article was to show a rare case of metacarpal sign with atypical shortening of the III and IV metacarpal bones not connected with gonadal dysgenesia, genetic disorders nor osteodystrophy. Material and methods Case report of a 60-year-old female patient. Results Artchibald's metacarpal sign in the described case was accompanied by erosive arthritis in the left lower extremity. No features of genetic disorders nor gonadal disgenesia were found in the patient. Undifferentiated seronegative asymmetric erosive arthritis developed in the patient. The level of parathormon was within the normal range. No signs of tumor were seen in bone scintigraphy. Conclusions Archibald's metacarpal sign may be present in patients without genetic disorders.

Negligence in securing informed consent and medical malpractice.

Science.gov (United States)

Perry, C

1988-01-01

The doctrine of informed consent requires that the patient must act voluntarily and in the light of adequate information in order to give legally valid consent to medical care. Different models have been developed by various courts to determine whether the informational requirement, what the physician must disclose to the patient about the potential risks of the proposed treatment, has been met under the tort theory of negligence. To prevail, the patient plaintiff must show that a particular jurisdiction's disclosure standard has been breached, that harm has resulted, and that the defendant physician's negligent failure to discuss certain risks was causally responsible for the patient's failure to withhold consent. Perry discusses possible problems of redundancy or inconsistency concerning the relationship between different models for disclosure and causality, and notes that these problems may have serious implications for patient autonomy.

Ergonomics and design: traffic sign and street name sign.

Science.gov (United States)

Moroni, Janaina Luisa da Silva; Aymone, José Luís Farinatti

2012-01-01

This work proposes a design methodology using ergonomics and anthropometry concepts applied to traffic sign and street name sign projects. Initially, a literature revision on cognitive ergonomics and anthropometry is performed. Several authors and their design methodologies are analyzed and the aspects to be considered in projects of traffic and street name signs are selected and other specific aspects are proposed for the design methodology. A case study of the signs of "Street of Antiques" in Porto Alegre city is presented. To do that, interviews with the population are made to evaluate the current situation of signs. After that, a new sign proposal with virtual prototyping is done using the developed methodology. The results obtained with new interviews about the proposal show the user satisfaction and the importance of cognitive ergonomics to development of this type of urban furniture.

Sign language comprehension: the case of Spanish sign language.

Science.gov (United States)

Rodríguez Ortiz, I R

2008-01-01

This study aims to answer the question, how much of Spanish Sign Language interpreting deaf individuals really understand. Study sampling included 36 deaf people (deafness ranging from severe to profound; variety depending on the age at which they learned sign language) and 36 hearing people who had good knowledge of sign language (most were interpreters). Sign language comprehension was assessed using passages of secondary level. After being exposed to the passages, the participants had to tell what they had understood about them, answer a set of related questions, and offer a title for the passage. Sign language comprehension by deaf participants was quite acceptable but not as good as that by hearing signers who, unlike deaf participants, were not only late learners of sign language as a second language but had also learned it through formal training.

"Consent Is Good, Joyous, Sexy": A Banner Campaign to Market Consent to College Students

Science.gov (United States)

Thomas, Kristie A.; Sorenson, Susan B.; Joshi, Manisha

2016-01-01

Objective: This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. Participants: A stratified random…

Language and cognitive development in deaf children: deaf children with deaf and deaf children with hearing parents

OpenAIRE

Ajda Pfifer

2011-01-01

The article reviews the current studies regarding language and cognitive development in children who are deaf. Deaf communicate orally and with sign language. 90 % of deaf children are born into hearing families and hearing parents in most cases do not know the sign language. Besides, hearing parents usually want for their child to become "normally" speaking. Most of the deaf children born into hearing families have very poor early communication. It is now well established that deaf children ...

[A child whose parents denied her psychiatric care].

Science.gov (United States)

de Vries, T W; Doddema, J W

2003-01-11

A 15-year-old girl was admitted because of an abdominal tumour and inability to eat. History revealed that after an accident at 9 years of age she increasingly developed medically unexplained signs and symptoms (e.g. tunnel vision with blindness, paralysis and loss of sensitivity below the umbilicus, periods of diminished consciousness). No somatic explanation could be found; the parents rejected psychiatric examination. Upon physical examination the patient's weight's was far below the third percentile (32 kg) and the tumour appeared to be the lumbar spine, palpable through the abdominal wall. Following tube feeding and behavioural therapy the girl gained weight and the tumour disappeared. No cause for the underweight was found. Conversion disorder was diagnosed. However, the parents strongly refused to accept this diagnosis; they lodged complaints with various bodies and made further treatment and counseling impossible. Children with psychological problems who were treated as having a somatic disorder by their mothers have been described before. The outcome can be lethal. Children showing unexplained signs and symptoms whose parents strongly refuse psychiatric care will be seriously jeopardised in terms of their somatic and psychological development. Physicians should identify this situation at an early stage.

Sign reversal of transformation entropy change in Co2Cr(Ga,Si) shape memory alloys

International Nuclear Information System (INIS)

Xu, Xiao; Omori, Toshihiro; Kainuma, Ryosuke; Nagasako, Makoto; Kanomata, Takeshi

2015-01-01

In situ X-ray diffraction (XRD) measurements and compression tests were performed on Co 2 Cr(Ga,Si) shape memory alloys. The reentrant martensitic transformation behavior was directly observed during the in situ XRD measurements. The high-temperature parent phase and low-temperature reentrant parent phase were found to have a continuous temperature dependence of lattice parameter, therefore suggesting that they are the same phase in nature. Moreover, compression tests were performed on a parent-phase single crystal sample; an evolution from normal to inverse temperature dependence of critical stress for martensitic transformation was directly observed. Based on the Clausius-Clapeyron analysis, a sign reversal of entropy change can be expected on the same alloy

Lowering the Age of Consent: Pushing Back against the Anti-Vaccine Movement.

Science.gov (United States)

Whelan, Allison M

2016-09-01

This article examines the rise of the anti-vaccination movement, the proliferation of laws allowing parental exemptions to mandatory school vaccines, and the impact of the movement on immunization rates for all vaccines. It uses the ongoing debate about the Human Papillomavirus (HPV) vaccine as an example to highlight the ripple effect and consequences of the anti-vaccine movement despite robust evidence of the vaccine's safety and efficacy. The article scrutinizes how state legislatures ironically promote vaccination while simultaneously deferring to the opposition by promulgating broad opt-outs from mandatory vaccine laws. This article concludes by offering an alternative legislative approach to specifically combat the anti-vaccine movement's impact on HPV vaccination rates. Lowering the age of consent has not been widely attempted or proposed and provides an alternative statutory mechanism to push back against vaccine resistance. © 2016 American Society of Law, Medicine & Ethics.

Headaches - danger signs

Science.gov (United States)

Migraine headache - danger signs; Tension headache - danger signs; Cluster headache - danger signs; Vascular headache - danger signs ... and other head pain. In: Goldman L, Schafer AI, eds. Goldman-Cecil Medicine . 25th ed. Philadelphia, PA: ...

Informed consent for caesarean section at a Nigerian university ...

African Journals Online (AJOL)

Results: The mean age of the respondents was 32±1.8 yearswith 118(79%) of the surgeries being emergency Cesarean sections. The consent for CS were mostly given by the patients (96, 64.0%) and husbands (43, 28.6%). Majority of the respondents 123(81.5%) had the consent obtained in the labour ward with profuse ...

Lifestyle intervention as a treatment for obesity in school-age-children in Celaya, Guanajuato: An experimental study

OpenAIRE

Nicolas Padilla-Raygoza; Rosalina Diaz-Guerrero; Ma. Laura Ruiz-Paloalto

2013-01-01

Introduction: Obesity is a risk factor in chronic diseases, and its frequency among children in Mexico is increasing. Objective: To determine the effect of lifestyle intervention as a treatment for obesity in school-age-children from Celaya, Mexico.Methodology: For this experimental study, four schools were randomly selected. Children and parents participated voluntarily and signed consent forms. Two schools were chosen as the experimental group and the other two formed the control group. Age...

Perception on Informed Consent Regarding Nursing Care Practices in a Tertiary Care Center.

Science.gov (United States)

Paudel, B; Shrestha, G K

Background Consent for care procedures is mandatory after receipt of adequate information. It maintains patient's rights and autonomy to make thoughtful decisions. Poor communication often leads to poor health quality. Objective To assess hospitalized patients' perception on informed consent regarding nursing care practices in a tertiary care center. Method This is a descriptive cross-sectional study among 113 admitted patients conducted in February 2012 at Dhulikhel Hospital, Nepal. Patients of various wards were selected using purposive non-probability sampling with at least 3 days of hospitalization. Close ended structured questionnaire was used to assess patients' perception on three different areas of informed consent (information giving, opportunity to make decision and taking prior consent). Result Among the participants 71.6% perceived positively regarding informed consent towards nursing care practices with a mean score of 3.32 ± 1.28. Patients' perception on various areas of informed consent viz. information giving, opportunities to make specific decision and taking prior consent were all positive with mean values of 3.43±1.12, 2.88±1.23, 3.65±1.49 respectively. Comparison of mean perception of informed consent with various variables revealed insignificant correlation (p-value >0.05) for age, educational level and previous hospitalization while it was significant (p-value perception on informed consent towards nursing care practices. Communication skills of nurses affect the perception of patients' regardless of age, education level and past experiences.

Sign language typology: The contribution of rural sign languages

NARCIS (Netherlands)

de Vos, C.; Pfau, R.

2015-01-01

Since the 1990s, the field of sign language typology has shown that sign languages exhibit typological variation at all relevant levels of linguistic description. These initial typological comparisons were heavily skewed toward the urban sign languages of developed countries, mostly in the Western

Parental health literacy and its impact on patient care.

Science.gov (United States)

Scotten, Mitzi

2015-03-01

The process of navigating through the modern American health care system is becoming progressively challenging. The range of tasks being asked of patients in the digital age is vast and complex and includes completing intricate insurance applications, signing complex consent forms, and translating medical data and prescription medication directions. Nearly 9 out of 10 adults have difficulty using the everyday health information that is routinely offered by medical providers. Mounting evidence now supports a growing awareness that general health literacy is the greatest individual factor affecting a person's health status. Copyright © 2015 Elsevier Inc. All rights reserved.

Should informed consent be based on rational beliefs?

OpenAIRE

Savulescu, J; Momeyer, R W

1997-01-01

Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide ...

Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial.

Science.gov (United States)

Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo; Mehta, Sangeeta; Ferguson, Niall D; Hall, Richard; Fowler, Robert; Burns, Karen; Qushmaq, Ismael; Ostermann, Marlies; Heels-Ansdell, Diane; Cook, Deborah

2013-02-01

Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. The trial was conducted in 67 centers in 6 countries. A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P 10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Characteristics of study centers, research infrastructure, and experience

Achieving new levels of recall in consent to research by combining remedial and motivational techniques.

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Festinger, David S; Dugosh, Karen L; Marlowe, Douglas B; Clements, Nicolle T

2014-04-01

Research supports the efficacy of both a remedial consent procedure (corrected feedback (CF)) and a motivational consent procedure (incentives) for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivised consent and CF procedure that simplifies the cognitive task and increases motivation to learn consent information. We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual (CAU) condition (n=52) or an incentivised CF (ICF) condition (n=52). All participants were told they would be quizzed on their consent recall following their baseline assessment and at 4 monthly follow-ups. ICF participants were also informed that they would earn $5 for each correct answer and receive CF as needed. Quiz scores in the two conditions did not differ at the first administration (p=0.39, d=0.2); however, ICF scores were significantly higher at each subsequent administration (second: p=0.003, Cohen's d=0.6; third: pmotivational consent procedure for enhancing recall of study information and human research protections.

Key factors in children's competence to consent to clinical research

NARCIS (Netherlands)

Hein, Irma M.; Troost, Pieter W.; Lindeboom, Robert; Benninga, Marc A.; Zwaan, C. Michel; van Goudoever, Johannes B.; Lindauer, Ramón J. L.

2015-01-01

Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors

Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

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Kim, Eun Jin; Kim, Su Hyun

2015-06-01

This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

The Consent Solution to Punishment and the Explicit Denial Objection

Directory of Open Access Journals (Sweden)

Miroslav Imbrisevic

2010-06-01

Full Text Available Recently, David Boonin has put forward several objections to Carlos S. Nino's 'Consensual Theory of Punishment'. In this paper I will defend Nino against the 'explicit denial objection'. I will discuss whether Boonin's interpretation of Nino as a tacit consent theorist is right. I will argue that the offender's consent is neither tacit nor express, but a special category of implicit consent. Further, for Nino the legal-normative consequences of an act (of crime are 'irrevocable', i.e. one cannot (expressly and successfully deny liability to them. I will suggest an explanation for Nino's irrevocability claim.

A qualitative study of participants' views on re-consent in a longitudinal biobank.

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Dixon-Woods, Mary; Kocman, David; Brewster, Liz; Willars, Janet; Laurie, Graeme; Tarrant, Carolyn

2017-03-23

Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or "biobanks" over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants' perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

Directory of Open Access Journals (Sweden)

Go Yoshizawa

2017-07-01

Full Text Available The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.

Science.gov (United States)

Yoshizawa, Go; Sasongko, Teguh H; Ho, Chih-Hsing; Kato, Kazuto

2017-01-01

The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More

Qualitative study of patient consent for health information exchange in an HIV clinic.

Science.gov (United States)

Ramos, S Raquel; Bakken, Suzanne

2014-01-01

Health information exchange (HIE) is the secure, electronic transfer and/or accessibility of clinical data among healthcare providers. In the United States (US), the consent process for participation varies state to state. New York State (NYS) mandates written patient consent. The purpose of this study was to examine workflow and perceptions related to obtaining HIE consent in an HIV clinic. We used contextual inquiry to observe the HIE consent-related workflow of four registration clerks for a total of 4 hours on two weekdays and subsequently created a flow chart and sequence model diagram. Clerks were also interviewed and the resulting narrative data were coded into themes. Observational and interview data suggested that patient privacy/confidentiality/trust, high volume workflow, and multiple competing demands affect the patient HIE consent process. Additional qualitative data needs to be gathered from the perspectives of patients and clinicians about the HIE consent process.

Perceived legitimacy of parental authority and tobacco and alcohol use during early adolescence.

Science.gov (United States)

Jackson, Christine

2002-11-01

To assess the likelihood that young adolescents perceive that parents have legitimate authority regarding cigarette smoking and alcohol consumption; to test whether perceived parental authority predicts adolescents' use of tobacco and alcohol, and to test the association between parenting style and the legitimacy of parental authority regarding tobacco and alcohol. Survey data were obtained in 1997 from 1220 sixth and eighth grade adolescents enrolled in a central North Carolina school district. The sample comprised 72.3% of 1687 eligible students and 92.3% of 1321 students with parental consent; 83.8% of the sample was European-American and 16.2% African-American. Students completed self-report questionnaires administered in classrooms. Logistic regression models were used to test the study hypotheses. Adolescents were significantly more likely to legitimize parental authority regarding tobacco and alcohol than parental authority regarding conventional or contemporary issues. Failure to legitimize parental authority was associated with significantly greater odds of current smoking (OR = 4.06; p parental authority regarding tobacco and alcohol varied significantly by parenting style. The results discredit the myth that adolescents uniformly disregard parental values and rules regarding tobacco and alcohol. The results also showed that general parenting style covaried strongly with adolescents' perceptions of parental authority regarding substance use. Additional research is warranted to test for causal relations between general parenting style, adolescents' perceptions of parental authority regarding substance use, and adolescents' risk of substance use.

17 CFR 230.263 - Consent to Service of Process.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Consent to Service of Process... Consent to Service of Process. (a) If the issuer is not organized under the laws of any of the states of... [§ 239.42 of this chapter]. (b) Any change to the name or address of the agent for service of the issuer...

Characteristics and attitudes of parents of children born with the use of assisted reproductive technology.

Science.gov (United States)

Braverman, A M; Boxer, A S; Corson, S L; Coutifaris, C; Hendrix, A

1998-11-01

To explore the medical issues, attitudes, concerns, and choices that parents have about their children born with the use of assisted reproductive technology (ART). Retrospective and prospective survey. An academic medical center and a private practice. Participants who conceived and were delivered of infants in two ART programs. A total of 373 patients were mailed an anonymous survey, a consent form, and the Parent Child Relationship Inventory. The rate of response was approximately 49% for clinic A and 33% for clinic B. Pregnancy outcomes and attitudes about parenting. Respondents' major concerns during pregnancy revolved around miscarriage and the infant's health; complications occurred in 38.9% of first pregnancies. Parents believed that their children were more appreciated, that their children were not emotionally different, that ART did not create ongoing medical or emotional problems, and they were not overprotective as parents. Gender differences were statistically significant on attitudinal variables. Parents had concerns about pregnancy. Overall, men and women felt positive about ART and their parenting. The ART experience is associated with complex choices, attitudes, and emotions.

Law on consent and confidentiality in India: a need for clarity.

Science.gov (United States)

Mathiharan, Karunakaran

2014-01-01

The concept of informed consent specific to medical research and treatment is still alien to many medical researchers and practitioners and to millions of Indians. The doctor-patient relationship in India is governed more by trust where the doctor is the authoritative person. Therefore, the benefit of informed consent does not reach all patients in day-to-day medical practice. To complicate the issue, the Indian law is not specific about the age at which a person can give valid consent. The Indian Penal Code is silent about the legal validity of consent given by persons between 12 and 18 years of age. Similarly, the age at which the 'Right to Confidentiality' begins is yet to be defined either by the statute or by the courts. Hence, there is a need for a clear statutory provision to remove the anomalies and ambiguities regarding the age of consent to undergo invasive therapeutic or investigative procedures, participate in clinical trials, as well as define the age at which a person's right to medical confidentiality begins.

Influenza vaccination in Dutch nursing homes: is tacit consent morally justified?

Science.gov (United States)

Verweij, M F; van den Hoven, M A

2005-01-01

Efficient procedures for obtaining informed (proxy) consent may contribute to high influenza vaccination rates in nursing homes. Yet are such procedures justified? This study's objective was to gain insight in informed consent policies in Dutch nursing homes; to assess how these may affect influenza vaccination rates and to answer the question whether deviating from standard informed consent procedures could be morally justified. A survey among nursing home physicians. We sent a questionnaire to all (356) nursing homes in the Netherlands, to be completed by one of the physicians. We received 245 completed questionnaires. As 21 institutions appeared to be closed or merged into other institutions, the response was 73.1% (245/335). Of all respondents 81.9% reported a vaccination rate above 80%. Almost 50% reported a vaccination rate above 90%. Most respondents considered herd immunity to be an important consideration for institutional policy. Freedom of choice for residents was considered important by almost all. Nevertheless, 106 out of 245 respondents follow a tacit consent procedure, according to which vaccination will be administered unless the resident or her proxy refuses. These institutions show significantly higher vaccination rates (p tacit consent procedures can be morally justifiable. Such procedures assume that vaccination is good for residents either as individuals or as a group. Even though this assumption may be true for most residents, there are good reasons for preferring express consent procedures.

Using digital multimedia to improve parents' and children's understanding of clinical trials.

Science.gov (United States)