Non-medical research involves the same issues of justice, beneficence, and respect for persons that apply to non-medical research. It also may involve risk of harm to participants, and conflicts of interest for researchers. It is therefore not possible to argue that such research should be exempt from ethical review. This paper argues that…
Koepsell, D.R.; Brinkman, W.P.; Pont, S.C.
Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although
Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia
Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee. © The Author(s) 2014.
Guillemin, Marilys; Gillam, Lynn; Rosenthal, Doreen; Bolitho, Annie
Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.
Bashaw, W. L.
The APA Ethical Principles, the University of Georgia policy, standard research texts, and research literature on specific methodologies, all in relation to ethical issues in human research, are discussed. The 10 APA principles state, in essence, that the investigator is responsible for what happens, that confidentiality and the protection of the…
Beyrer, Chris; Kass, Nancy E
Although the human rights movement and the sphere of research ethics have overlapping principles and goals, there has been little attempt to incorporate external political and human rights contexts into research ethics codes or ethics reviews. Every element of a research ethics review--the balance of risks and benefits, the assurance of rights for individual participants, and the fair selection of research populations--can be affected by the political and human rights background in which a study is done. Research that at first seems to be low in risk may become high in risk if implemented in a country where the government might breach the confidentiality of study results or where results might be used to deport a refugee group. Researchers should determine whether research could or should be done by consulting human rights organisations and, when possible, a trusted colleague, to learn the background political context and human rights conditions of the settings in which they propose to do research.
Chiu, Hui-Ju; Lee, Ya-Ling; Chang, Su-Fen
Advances in medical technology rely on human subject research to test the effects on real patients of unproven new drugs, equipment and techniques. Illegal human subject research happens occasionally and has led to subject injury and medical disputes. Familiarity with the laws and established ethics related to human subject research can minimize both injury and disputes. History is a mirror that permits reflection today on past experience. Discussing the Nuremberg Code, the Declaration of Helsinki and Belmont Report, this article describes the laws, ethics, history and news related to human subject research as well as the current definition and characteristics of human subject research. Increasing numbers of nurses serve as research nurses and participate in human subject research. The authors hope this article can increase research nurse knowledge regarding laws and ethics in order to protect human research subjects adequately.
Dooly, Melinda; Moore, Emilee; Vallejo, Claudia
Qualitative research, especially studies in educational contexts, often brings up questions of ethics because the study design involves human subjects, some of whom are under age (e.g. data collected in primary education classrooms). It is not always easy for young researchers to anticipate where ethical issues might emerge while designing their…
Fleischman, Alan R
Research involving critically ill neonates creates many ethical challenges. Neonatal clinical research has always been hard to perform, is very expensive, and may generate some unique ethical concerns. This article describes some examples of historical and modern controversies in neonatal research, discusses the justification for research involving such vulnerable and fragile patients, clarifies current federal regulations that govern research involving neonates, and suggests ways that clinical investigators can develop and implement ethically grounded human subjects research. Copyright © 2016 Elsevier Inc. All rights reserved.
Pieper, Ian; Thomson, Colin J H
One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice--hether distributive or commutative--and what counts as a just distribution or exchange--are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified. We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researches on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.
Gorman, Susanna M
Australian Human Research Ethics Committees (HRECs) have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007 (NS). In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded by its linkage to the Australian Code for the Responsible Conduct of Research (2007) in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review.
This paper discusses the need for the Society of Toxicology (SOT) to develop a policy for ethical research in humans, and a review for publication of these studies. Observations on human beings have been the foundation upon which toxicologic knowledge has been built since the in...
Hossne, William Saad; Vieira, Sonia; De Freitas, Corina Bontempo Duca
In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.
The successful cloning experiments that led to Dolly in 1997 have raised many ethical and policy questions. This paper will focus on cloning research in human embryonic cells. The possible gains of the research will be judged against the moral issues of doing research on a person. This paper concludes that while the embryo has some moral status, its moral status is outweighed by the multitude of benefits that embryonic stem cell research will bring to humanity. Policy suggestions are given for dealing with this new and developing field of stem cell research.
... ethical conduct of completed human research. 26.1303 Section 26.1303 Protection of Environment... on the Ethical Conduct of Completed Human Research § 26.1303 Submission of information pertaining to ethical conduct of completed human research. Any person who submits to EPA data derived from human...
Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan
Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.
This article contextualizes the emergence of the field of research ethics in historical, social, and political events over the last 60 years. It draws a distinction between professional ethics and bioethics, focusing on the historical and philosophical precedents of the latter field. It also presents the appearance of research ethics as a result of the disclosure of cases of scientific misconduct, discussing the first regulations on research ethics, the guidelines contained in the Belmont Rep...
van der Graaf - Verhave, R.
In her PhD thesis Rieke van der Graaf has studied how we can ethically justify human subjects research. In particular she has studied two ethical fundamentals that play a key role in the justification process, that of equipoise and human dignity. Equipoise is often taken to mean that
This paper explores ethical dilemmas in situated fieldwork ethics concerning ethnographic studies of adolescent students. While consequentialist and deontological ethics form the basis of the ethical stances shared by ethnographers and research ethics committees, the interpretation of those principles may diverge in school-based ethnography with adolescent students because of the particular role of the adult ethnographer vis-à-vis developmentally immature adolescents not held legally responsible for many of their actions. School ethnographers attempt to build trust with adolescent participants in order to learn about their hidden cultural worlds, which may involve activities that are very harmful to the youths involved. They face many difficult and sometimes unexpected choices, including whether to intervene and how to represent events and adolescents in published findings. Scenarios with examples drawn from research conducted in public high schools are used to illustrate and explicate dilemmas in formal research and latent insider/outsider roles and relations involving harmful adolescent behaviors, advocacy, and psychological trauma. Also examined are analytical procedures used to construct interpretations leading to representations of research participants in the resulting publication.
De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W
Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.
de Jong, J.P.
In this thesis, Jean Philippe de Jong presents a new understanding of ethical oversight on medical research with human subjects and proposes that two philosophies for ethical oversight exist: '(dis)approving' and 'improving'. Systems for ethical oversight on medical research have been in place for
Pieper, I J; Thomson, C J H
In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices.
van Wyk, Christa
In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.
Dean, Peter J.
Provides a review of the key ethical theories and relevant empirical research relating to the practice of human performance technology. Topics addressed include ethics, morals, business ethics, ethics officers, empiricism versus normative ethical theory, consequentialism, utilitarianism, nonconsequentialism, Kohlberg model of cognitive moral…
The increasing demand of constituents to conduct analyses in order to help inform the decision-making process has led to the need for Institutional Research (IR) guidelines for community college educators. One method of maintaining the quality of research conducted by IR staff is to include professional development about ethics. This article…
Sheehan, Mark; Marti, Vernon; Roberts, Tony
This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research. © 2013 John Wiley & Sons Ltd.
Allen, Judy; Flack, Felicity
Health promotion research, quality improvement and evaluation are all activities that raise ethical issues. In this paper, the Chair and a member of human resear ch ethics committees provide an insiders' point of view on how to demonstrate ethical conduct in health promotion research and quality improvement. Several common issues raised by health promotion research and evaluation are discussed including researcher integrity, conflicts of interest, use of information, consent and privacy.
Elisabeth De Smit
Full Text Available Background Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. Aims To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs and Research Governance Offices (RGOs across Australia. Methods In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA, for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Results Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a “National Ethics Application Form” and three a “Low Negligible Risk” form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22 and panel review turnaround time (range nine to 136 days. Conclusion We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently
Full Text Available The state of evolution of attitudes in a sample of 142 Medical Students at the Pontificia Universidad Javeriana in Bogota (at the beginning, middle and ending of their studies in the field of Human Research Ethics (HRE is analytically described. A complex scale of attitudes was used, with three components: affective, beliefs-related and behavioral, further divided into three theoretical categories taken from Bioethics: Subject-End/means- Dignity, Benefit and Justice. The relationship between the current medical education process and the attitudes regarding HRE in the sample are analyzed.A small trend towards progress in all categories and in all components of attitudes throughout medical education is described; neither the Benefit nor the Subject-End/means/Dignity categories evolve in a significant way; some significant differences were observed in the Justice category (beliefs and behavioral and in the Subject-End/means-Dignity category (beliefs component. The results allow for asking about the role of formation and evolution of those attitudes throughout the academic process. In conclusion, attitudes seem to be progressing relatively, without a decisive evolution.
Cheluvappa, Rajkumar; Scowen, Paul; Eri, Rajaraman
Animals have been used in research and teaching for a long time. However, clear ethical guidelines and pertinent legislation were instated only in the past few decades, even in developed countries with Judeo-Christian ethical roots. We compactly cover the basics of animal research ethics, ethical reviewing and compliance guidelines for animal experimentation across the developed world, "our" fundamentals of institutional animal research ethics teaching, and emerging alternatives to animal research. This treatise was meticulously constructed for scientists interested/involved in animal research. Herein, we discuss key animal ethics principles - Replacement/Reduction/Refinement. Despite similar undergirding principles across developed countries, ethical reviewing and compliance guidelines for animal experimentation vary. The chronology and evolution of mandatory institutional ethical reviewing of animal experimentation (in its pioneering nations) are summarised. This is followed by a concise rendition of the fundamentals of teaching animal research ethics in institutions. With the advent of newer methodologies in human cell-culturing, novel/emerging methods aim to minimise, if not avoid the usage of animals in experimentation. Relevant to this, we discuss key extant/emerging alternatives to animal use in research; including organs on chips, human-derived three-dimensional tissue models, human blood derivates, microdosing, and computer modelling of various hues. © 2017 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.
use animals for research and experimentations to research on human subjects. Jonas upholds the ..... examples of ethical theory, the less said about it the better. But what is allowable .... Also, man seeks self-gratification and self- promotion.
Søndergaard, Dorte Marie
Human subjects and social relations are crucial in research psychologists’ ethical considerations. Lists of ethical criteria - including how to anonymize data, avoid causing harm, handle asymmetries – are pivotal. A situated ethics inspired by new materialism and poststructuralism would, however......, elaborate these focuses to include social orders, discursive power, and more comprehensive material-discursive apparatuses. I will draw on concepts developed by Barad, Foucault and Butler to discuss how ethics can be understood as an intra-acting, emergent element of the research apparatus. Barad’s notion...... the researchers’ moral narcissism in relation to the enactment of social-subjective phenomena in research; on the other hand, it leaves researchers with a broader spectrum of phenomena to include in their ethical considerations. This invites new questions: Which perspectives of human and non-human existence...
Davis, Dena S
As we aggressively pursue research to cure and prevent Alzheimer's disease, we encounter important ethical challenges. None of these challenges, if handled thoughtfully, would pose insurmountable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and do damage to research recruits and others. These challenges are (1) the necessity of very large cohorts of research subjects, recruited for lengthy studies, probably ending only in the subjects' death; (2) the creation of cohorts of 'study ready' volunteers, many of whom will be competent to consent at the beginning of the process, but move into cognitive impairment later; (3) reliance on adaptive trial design, creating challenges for informed consent, equipoise and justice; (4) the use of biomarkers and predictive tests that describe risk rather than certainty, and that can threaten participants' welfare if the information is obtained by insurance companies or long-term care providers; (5) the use of study partners that creates unique risks of harm to the relationship of subject and study partner. We need greater attention, at all levels, to these complex ethical issues. Work on these issues should be included in research plans, from the federal to the local, and should be supported through NIH in the same way that it supported work on the ethical, legal and social implications of genetic research. © 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.
Hans Jonas' thought on the ethics of research on human subjects and its implications for contemporary medical research in Nigeria was examined. The thinking and teachings of Hans Jonas was on the need for medical research to advance beyond the use animals for research and experimentations to research on human ...
Pitak-Arnnop, P; Sader, R; Hervé, C; Dhanuthai, K; Bertrand, J-Ch; Hemprich, A
This retrospective observational study investigated the frequency of reporting ethical approval and informed consent in recently published oral and maxillofacial surgery (OMS) research involving human subjects. All research involving human subjects published in the International Journal of Oral and Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, British Journal of Oral and Maxillofacial Surgery, and Journal of Cranio-Maxillofacial Surgery during January to June 2005-2007 were analysed for disclosure of ethical approval by a local ethical committee and obtaining informed consent from the subjects. 534 articles were identified; ethical approval was documented in 118 (22%) and individual patient consent in 135 (25%). 355 reports (67%) did not include a statement on ethical approval or informed consent and only 74 reports (14%) disclosed statements of both. Ethical documentation in retrospective and observational studies was scant; 12% of randomised controlled trials and 38% of non-random trials did not report both of ethical protections. Most recent OMS publications involving humans failed to mention ethical review or subjects' consent. Authors must adhere to the international research ethics guidelines and journal instructions, while editors should play a gatekeeper role to protect research participants, uphold scientific integrity and maintain public trust in the experimental process and OMS profession.
Internal irradiation of human subjects in research is discussed. Radiological protection of human subjects in medical research in a framework of radiation protection is surveyed from a viewpoint of general life-ethics and research-ethics. A workshop 'On the internal irradiation of human subjects' to summarize special and systematic knowledge was organized by Research Center for Radiation Protection, National Institute of Radiological Sciences in the beginning of 2008. Activities of this workshop are introduced. Discussion covers also (1) Research ethics and radiation protection, (2) Fundamentals and applications of risk-benefit assessment, (3) Human subjects risk assessment in ICRP recommendation, (4) Mechanism of human subjects internal irradiation assessment, and (5) Present status and future prospects in Japan. (K.Y.)
Lawrence, Dana J
To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby
Kreissl Lonfat, Bettina M; Kaufmann, Ina Maria; Rühli, Frank
As clinical research constantly advances and the concept of evolution becomes a strong and influential part of basic medical research, the absence of a discourse that deals with the use of ancient human remains in evidence-based research is becoming unbearable. While topics such as exhibition and excavation of human remains are established ethical fields of discourse, when faced with instrumentalization of ancient human remains for research (i.e., ancient DNA extractions for disease marker analyses) the answers from traditional ethics or even more practical fields of bio-ethics or more specific biomedical ethics are rare to non-existent. The Centre for Evolutionary Medicine at the University of Zurich solved their needs for discursive action through the writing of a self-given code of ethics which was written in dialogue with the researchers at the Institute and was published online in Sept. 2011: http://evolutionäremedizin.ch/coe/. The philosophico-ethical basis for this a code of conduct and ethics and the methods are published in this article. © 2015 Wiley Periodicals, Inc.
Bach, Michelle C
Research on human cadavers is an important mechanism of scientific progress and comprises a large industry in the United States. However, despite its importance and influence, there is little ethical or regulatory oversight of cadaver-based research. This lack of transparency raises important ethical questions. Thus, this paper serves as a call for ethicists and regulators to pay increased attention to cadaver research. I argue that cadaver research ought to be considered a subset of human subjects research and held accountable to higher ethical standards. After describing current practices, I argue that oversight of cadaver research as a form of human subjects research is appropriate because cadaver research is similar to other types of human research, participants in cadaver research incur risks of harm, and a current lack of oversight has allowed the cadaver industry to entice research participation through ethically questionable practices. This paper urges greater dialogue among human subjects research ethicists and regulators about what constitutes appropriate protections for participants in cadaver research.
Caroline A. Smith
Full Text Available Despite the growth of traditional Chinese medicine (TCM and western herbal medicine (WHM research in Australia, little is known about how ethics committees (HRECs assess the ethics of TCM or WHM research. The objectives of this study were to examine the experiences of TCM and WHM researchers and HRECs with the evaluation of ethics applications. Two cross-sectional surveys were undertaken of HRECs and TCM and WHM researchers in Australia. Anonymous self-completion questionnaires were administered to 224 HRECs and 117 researchers. A response confirming involvement in TCM or WHM research applications was received from 20 HRECs and 42 researchers. The most frequent ethical issues identified by HRECs related to herbal products including information gaps relating to mode of action of herbal medicines and safety when combining herbal ingredients. Researchers concurred that they were frequently requested to provide additional information on multiple aspects including safety relating to the side effects of herbs and herb-drug interactions. Overall adherence with the principles of ethical conduct was high among TCM and WHM researchers although our study did identify the need for additional information regarding assessment of risk and risk management.
Sivaraman, Mathana Amaris Fiona; Noor, Siti Nurani Mohd
Embryonic Stem Cell Research (ESCR) raises ethical issues. In the process of research, embryos may be destroyed and, to some, such an act entails the 'killing of human life'. Past studies have sought the views of scientists and the general public on the ethics of ESCR. This study, however, explores multi-faith ethical viewpoints, in particular, those of Buddhists, Hindus and Catholics in Malaysia, on ESCR. Responses were gathered via semi-structured, face-to-face interviews. Three main ethical quandaries emerged from the data: (1) sanctity of life, (2) do no harm, and (3) 'intention' of the research. Concerns regarding the sanctity of life are directed at particular research protocols which interfere with religious notions of human ensoulment and early consciousness. The principle of 'do no harm' which is closely related to ahimsa prohibits all acts of violence. Responses obtained indicate that respondents either discourage research that inflicts harm on living entities or allow ESCR with reservations. 'Intention' of the research seems to be an interesting and viable rationale that would permit ESCR for the Buddhists and Hindus. Research that is intended for the purpose of alleviating human suffering is seen as being ethical. This study also notes that Catholics oppose ESCR on the basis of the inviolability of human life.
Novaes, Maria Rita Garbi; Guilhem, Dirce; Barragan, Elena; Mennin, Stewart
The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a retrospective historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1--ethics in research (26); 2--ethical procedures and advanced technology (46); 3--ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical
Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia
For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social-psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices (Martensen in J Hist Med Allied Sci 56(2):168-175, 2001). Institutions such as Institutional Review Boards (in the U.S.) and Ethics Committees (in Europe and elsewhere) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki (World Medical Association 2008). Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants (Federman et al. in Responsible research: a systems approach to protecting research participants. National Academies Press, Washington, 2003, p. 36). The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2
Roberts, Laura Weiss; Warner, Teddy D; Green Hammond, Katherine A; Brody, Janet L; Kaminsky, Alexis; Roberts, Brian B
Investigators and institutional review boards are entrusted with ensuring the conduct of ethically sound human studies. Assessing ethical aspects of research protocols is a key skill in fulfilling this duty, yet no empirically validated method exists for preparing professionals to attain this skill. The authors performed a randomized controlled educational intervention, comparing a criteria-based learning method, a clinical-research- and experience-based learning method, and a control group. All 300 medical students enrolled at the University of New Mexico School of Medicine in 2001 were invited to participate. After a single half-hour educational session, a written posttest of ability to detect ethical problems in hypothetical protocol vignettes was administered. The authors analyzed responses to ten protocol vignettes that had been evaluated independently by experts. For each vignette, a global assessment of the perceived significance of ethical problems and the identification of specific ethical problems were evaluated. Eighty-three medical students (27%) volunteered: 50 (60%) were women and 55 (66%) were first- and second-year students. On global assessments, the criteria-focused group perceived ethical problems as more significant than did the other two groups (p evaluation skills. This work supports the potential value of empirically derived methods for preparing professionals to discern ethical aspects of human studies.
Artal, Raul; Rubenfeld, Sheldon
Biomedical research is currently guided by ethical standards that have evolved over many centuries. Historical and political events, social and legal considerations, and continuous medical and technological advances have led to the prevailing research ethics and practice. Currently, patients and research subjects have complete autonomy while under medical care or when volunteering as research subjects. Enrolling volunteers in human subjects research includes a detailed and meaningful informed consent process that follows the cardinal principles of ethics: autonomy, beneficence, nonmaleficence, and justice. These principles were gradually adopted after World War II, primarily in response to the unethical behavior of German physicians and scientists during the Third Reich. This review emphasizes the importance of historical milestones and the essential role that ethics has in contemporary medical research. Research protocols should achieve maximum benefits for the society, have clinical and scientific value, be subject to independent review, respect human dignity, and follow the principles of informed consent, and most importantly, subjects should have complete autonomy. However, current principles and regulations cannot cover every conceivable situation, particularly in view of the new advances in science and technology. New and evolving medical technology, genetic research, therapeutic interventions, and innovations challenge society to maintain the highest moral and ethical principles. Copyright © 2017. Published by Elsevier Ltd.
Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Rivas-Ruiz, Rodolfo; Talavera, Juan O
Bioethics in research is an essential part of the structured review process of an article and it is based on three fundamental principles: respect for persons, beneficence and justice. In addition to not providing valid knowledge, a research with inadequate design, execution and statistical analysis is not ethical either, since these methodological deficiencies will produce information that will not be useful and, therefore, the risks that the participants were exposed to will have been in vain. Beyond scientific validity, there are other aspects that outline if an investigation is ethical, such as the clinical and social value of a study, a fair selection of participants, favorable risk-benefit balance, an independent review, the informed consent and respect for participants and potential participants. Throughout the article here presented, the documents that profile the behavior of investigators to protect the participants, such as the Declaration of Helsinki, the national regulations that rule us and the differences between research without risk, with minimal risk and with greater than minimal risk are discussed. That like in daily life, behavior in research involving human participants must be self-regulated, ie, people with knowledge of the existence of the law discover that the man is outside the realm of nature where work is done under the necessity of natural causality, and falls within the scope of the will; only if the man is free to decide their actions may be a law regulating their action.
Iacono, T.; Carling-Jenkins, R.
Background: The history of ethical guidelines addresses protection of human rights in the face of violations. Examples of such violations in research involving people with intellectual disabilities (ID) abound. We explore this history in an effort to understand the apparently stringent criteria for the inclusion of people with ID in research, and…
Trends in ethical research involving humans emphasise the importance of collaboration, of involving research subjects, alongside the researchers in the construction and implementation of research. This paper will explore parallels derived from another tradition of investigation of the human: art and art theory. An artist's inquiry into the problems of human research will be described, followed by the application of arguments from art theory to research practice. Recently artist Christine Borland has provided examples in which the lack of collaboration in research has caused injustice. Borland's work reflects these ethical dilemmas and questions the procedures and assumptions involved. In most cases the value of subject anonymity is called into question because it reduces the subjects' control over themselves. The application of art theory, which has already considered these problems, helps question and explore the ways in which the subject turned object of artistic or scientific interpretation can maintain some control and dignity.
Portaluppi, Francesco; Smolensky, Michael H; Touitou, Yvan
This article updates the ethical standards and methods for the conduct of high-quality animal and human biological rhythm research, which should be especially useful for new investigators of the rhythms of life. The editors of Chronobiology International adhere to and endorse the Code of Conduct and Best Practice Guidelines of the Committee On Publication Ethics (COPE), which encourages communication of such updates at regular intervals in the journal. The journal accepts papers representing original work, no part of which was previously submitted for publication elsewhere, except as brief abstracts, as well as in-depth reviews. The majority of research papers published in Chronobiology International entails animal and human investigations. The editors and readers of the journal expect authors of submitted manuscripts to have made an important contribution to the research of biological rhythms and related phenomena using ethical methods/procedures and unbiased, accurate, and honest reporting of findings. Authors of scientific papers are required to declare all potential conflicts of interest. The journal and its editors endorse compliance of investigators to the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, relating to the conduct of ethical research on laboratory and other animals, and the principles of the Declaration of Helsinki of the World Medical Association, relating to the conduct of ethical research on human beings. The peer review of manuscripts by Chronobiology International thus includes judgment as to whether or not the protocols and methods conform to ethical standards. Authors are expected to show mastery of the basic methods and procedures of biological rhythm research and proper statistical assessment of data, including the appropriate application of time series data analyses, as briefly reviewed in this article. The journal editors strive to consistently achieve
Full Text Available There are growing discontinuities between the research practices of data science and established tools of research ethics regulation. Some of the core commitments of existing research ethics regulations, such as the distinction between research and practice, cannot be cleanly exported from biomedical research to data science research. Such discontinuities have led some data science practitioners and researchers to move toward rejecting ethics regulations outright. These shifts occur at the same time as a proposal for major revisions to the Common Rule—the primary regulation governing human-subjects research in the USA—is under consideration for the first time in decades. We contextualize these revisions in long-running complaints about regulation of social science research and argue data science should be understood as continuous with social sciences in this regard. The proposed regulations are more flexible and scalable to the methods of non-biomedical research, yet problematically largely exclude data science methods from human-subjects regulation, particularly uses of public datasets. The ethical frameworks for Big Data research are highly contested and in flux, and the potential harms of data science research are unpredictable. We examine several contentious cases of research harms in data science, including the 2014 Facebook emotional contagion study and the 2016 use of geographical data techniques to identify the pseudonymous artist Banksy. To address disputes about application of human-subjects research ethics in data science, critical data studies should offer a historically nuanced theory of “data subjectivity” responsive to the epistemic methods, harms and benefits of data science and commerce.
Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries. © 2011 Blackwell Publishing Ltd.
Espinoza, N.; Peterson, M.B.
The contention of this paper is that the current ethical debate over embryonic stem cell research is polarised to an extent that is not warranted by the underlying ethical conflict. It is argued that the ethical debate can be rendered more nuanced, and less polarised, by introducing non-binary
Luk, Hsiang-Ning; Ennever, John F; Day, Yuan-Ji; Wong, Chih-Shung; Sun, Wei-Zen
For this guidance article, the Ethics Review Task Force (ERTF) of the Journal reviewed and discussed the ethics issues related to publication of human research in the field of anesthesia. ERTF first introduced international ethics principles and minimal requirements of reporting of ethics practices, followed by discussing the universal problems of publication ethics. ERTF then compared the accountability and methodology of several medical journals in assuring authors' ethics compliance. Using the Taiwan Institutional Review Board system as an example, ERTF expressed the importance of institutional review board registration and accreditation to assure human participant protection. ERTF presented four major human research misconducts in the field of anesthesia in recent years. ERTF finally proposed a flow-chart to guide journal peer reviewers and editors in ethics review during the editorial process in publishing. Examples of template languages applied in the Ethics statement section in the manuscript are expected to strengthen the ethics compliance of the authors and to set an ethical culture for all the stakeholders involved in human research. Copyright © 2015. Published by Elsevier B.V.
Contributes systematic data on the attitudes of scientific experts who engage in human genetics research about the pros, cons, and ethical implications of genetic testing. Finds that they are highly supportive of voluntary testing and the right to know one's genetic heritage. Calls for greater genetic literacy. (Contains 87 references.) (Author/NB)
Fausto dos Santos Amaral Filho
Full Text Available This paper, fundamentally through the analysis and interpretation of Resolutions that have historically been regulating ethical issues that involve scientific research (CNS Resolutions N. 196/96, N. 466/2012, N. 510/2016, seeks to show the inadequacy of such Resolutions for Human and Social Sciences research. In addition, this text wants to point to the political dispute imposed by the area of biomedical sciences that apparently seems to be little concerned with ethical issues per se and seeks, first and foremost, to maintain its power.
Roof, David; Polush, Elena
This paper seeks to examine ethics, humanism, and the concept of "parrhesia" ("pa???s?a") in the context of educational research. More specifically, it surveys Foucault's lectures on ethics to explore a framework for educational research that disrupts subjectivity and traditional forms of humanism while retaining a relational…
Horner, Jennifer; Minifie, Fred D.
Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In "Research Ethics I", they present a historical overview of the evolution of…
Alirio José Abreu Suarez
Full Text Available This essay is a theoretical reflection about ethics in educational research. The same is done under a documentary approach with a literature review. Ethics in teaching is important because this is a reference for all undergraduate or graduate, as well as the need to consider education authorities at different levels and modalities in order to guide the actors in the educational process. At the same time, it can be expressed that the issue will serve as background for further studies and investigations that have to do with the issues raised. It also provides basic elements for teachers who want to make some related ethical codes, principles and injury caused the researcher studies. Similarly, ethics for being a discipline where are immersed fundamental human values such as honesty, solidarity, respect, tolerance among other aspects must be taken into account by researchers. Finally, it is worth noting that if you really want relevant research to provide new knowledge seeking social and educational transformation must begin with ethics as a relevant factor during all stages of a study.
Briers, N; Dempers, J J
Chapter 8 of the South African National Health Act 61 of 2003 (NHA) that deals with the donation of human tissue was promulgated in 2012. The new Act is perceived to impose restrictions on low-risk research involving human remains. This study aimed to identify the issues raised by a research ethics committee (REC) when reviewing protocols where human remains are used as data source. REC minutes from 2009 to 2014 were reviewed, and issues raised by the committee were categorized. In total, 127 protocols submitted to the committee over 6 years involved human remains. Queries relating to science (22.2%) and administration (18.9%) were the most common, whereas queries relating to legal issues constituted only 10.2%. Ethical issues centered on informed consent regarding sensitive topics such as HIV, DNA, and deceased children. The change in legislation did not change the number or type of legal issues identified by the REC.
Chalmers, Donald; Nicol, Dianne; Nicolás, Pilar; Zeps, Nikolajs
International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange of biospecimens and data and in monitoring compliance.
Cox, Susan M; McDonald, Michael
Despite the significant literature as well as energy devoted to ethical review of research involving human subjects, little attention has been given to understanding the experiences of those who volunteer as human subjects. Why and how do they decide to participate in research? Is research participation viewed as a form of social responsibility or as a way of obtaining individual benefits? What if anything do research subjects feel they are owed for participation? And what do they feel that they owe the researcher? Drawing on in-depth individual interviews conducted in 2006 and 2007 with 41 subjects who participated in a variety of types of health research in Canada, this paper focuses on subject perspectives on responsibility in research. Highlighting the range of ways that subjects describe their involvement in research and commitments to being a 'good' subject, we present a typology of narratives that sheds new light on the diverse meanings of research participation. These narratives are not mutually exclusive or prescriptive but are presented as ideal types typifying a set of circumstances and values. As such, they collectively illuminate a range of motivations expressed by human subjects as well as potential sources of vulnerability. The typology adds a new dimension to the literature in this area and has significant implications for researchers seeking more human-subject centred approaches to research recruitment and retention, as well as research ethics boards trying to better anticipate the perspectives of prospective participants. Copyright © 2013 Elsevier Ltd. All rights reserved.
Espinoza, Nicolas; Peterson, Martin
The contention of this paper is that the current ethical debate over embryonic stem cell research is polarised to an extent that is not warranted by the underlying ethical conflict. It is argued that the ethical debate can be rendered more nuanced, and less polarised, by introducing non-binary notions of moral rightness and wrongness. According to the view proposed, embryonic stem cell research--and possibly other controversial activities too--can be considered 'a little bit right and a little bit wrong'. If this idea were to become widely accepted, the ethical debate would, for conceptual reasons, become less polarised.
Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees, and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts, and problems in research. They were all researchers at the postdoctoral ...
This article reflects on a university human research ethics committee's unease regarding a feminist visual pilot study within the field of education. The small exploratory study proposed to explore a migrant mother's production of her son's identity through her family photograph collection. The committee requested substantial…
During the last century a large number of documents (regulations, ethical codes, treatises, declarations, conventions) were published on the subject of ethics and clinical trials, many of them focusing on the protection of research participants. More recently various proposals have been put forward to relax some of the constraints imposed on research by these documents and regulations. It is important to distinguish between risks deriving from direct interventions on human subjects and other types of risk. In Italy the Data Protection Authority has acted in the question of research using previously collected health data and biological samples to simplify the procedures regarding informed consent. The new approach may be of help to other researchers working outside Italy.
Oyarzún G, Manuel; Pinto C, María Eugenia; Raineri B, Gina G; Amigo, Hugo; Cifuentes O, Lucía; González, María Julieta; Horwitz, Nina; Marshall F, Claudia; Orellana V, Gricel
The welfare of research participants must be guaranteed by international ethical standards. This article communicates the procedures of the Research Ethics Committee of the School of Medicine, University of Chile (CEISH). The new Chilean legislation on research in human beings is also discussed. Law 20.120: "On scientific research in human beings, its genome and forbidding human cloning" establishes the ethical principles that must be accomplished in every research involving human beings. Article 28 of the Law 20.584 "Regulation of the rights and duties of health care users", forbids the participation of handicapped people who cannot express their will in scientific research. Article 13 states that people not related directly with patient care cannot have access to his clinical records (with the exception of people with notarial authorization by the patient). CEISH proposes that, in case of people with intellectual deficiency, the decision to approve a scientific research should be analyzed on an individual basis. If the person is capable of expressing his or her will or has stated his or her consent beforehand, the research can be authorized. If the person cannot express his or her will, the scientific research cannot take place. In prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records. In retrospective studies, consent should be obtained from the patient when personal information is going to be used. If the information is nameless, the consent can be disregarded.
Milos, N; Bamforth, S; Bagnall, K
A Canadian research group is establishing a human embryo and fetal tissue bank. Its purpose is to provide researchers with frozen or fixed tissue specimens for use in protein and gene expression studies. Several legal and ethical issues have arisen, including questions about consent, use of these rare tissues, cost recovery, and profit-making. These issues are discussed here in light of the present lack of legislation in Canada. We make recommendations in these areas, and suggest that the bank's operations could legally fall under the jurisdiction of the Human Tissue Gift Act.
Horner, Jennifer; Minifie, Fred D
In this series of articles--Research Ethics I, Research Ethics II, and Research Ethics III--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In Research Ethics I, they present a historical overview of the evolution of RCR in the United States then examine the evolution of human and animal experimentation from the birth of scientific medicine through World War II to the present day. They relied on authoritative documents, both historical and contemporary, insightful commentary, and empirical research in order to identify current issues and controversies of potential interest to both faculty and students. The authors have written this article from a historical perspective because they think all readers interested in RCR should appreciate how the history of science and all the good--and harm--it has produced can inform how researchers practice responsible research in the 21st century and beyond.
To better understand ethical issues involved in the field of human genetics and promote debate within the scientific community, the author surveyed scientists who engage in human genetics research about the pros, cons, and ethical implications of genetic testing. This study contributes systematic data on attitudes of scientific experts. The survey finds respondents are highly supportive of voluntary testing and the right to know one's genetic heritage. The majority consider in utero testing and consequent pregnancy termination acceptable for cases involving likelihood of serious disease but disapprove for genetic reasons they consider arbitrary, leaving a gray area of distinguishing between treatment of disorders and enhancement still to be resolved. While safeguarding patient confidentiality versus protecting at-risk third parties (kin, reproductive partners) presents a dilemma, preserving privacy from misuse by institutional third parties (employers, insurers) garners strong consensus for legislation against discrimination. Finally, a call is made for greater genetic literacy.
Gustafson, Diana L; Woodworth, Claire F
Online content is a primary source of healthcare information for internet-using adults and a rich resource for health researchers. This paper explores the methodological and ethical issues of engaging in health research using social media. A metamethod was performed on systematically selected studies that used social media as a data source for exploring public awareness and beliefs about Human Papillomaviruses (HPV) and HPV vaccination. Seven electronic databases were searched using a variety of search terms identified for each of three concepts: social media, HPV vaccine, and research method. Abstracts were assessed for eligibility of inclusion; six studies met the eligibility criteria and were subjected to content analysis. A 10-item coding scheme was developed to assess the clarity, congruence and transparency of research design, epistemological and methodological underpinnings and ethical considerations. The designs of the six selected studies were sound, although most studies could have been more transparent about how they built in rigor to ensure the trustworthiness and credibility of findings. Statistical analysis that intended to measure trends and patterns did so without the benefit of randomized sampling and other design elements for ensuring generalizability or reproducibility of findings beyond the specified virtual community. Most researchers did not sufficiently engage virtual users in the research process or consider the risk of privacy incursion. Most studies did not seek ethical approval from an institutional research board or permission from host websites or web service providers. The metamethod exposed missed opportunities for using the dialogical character of social media as well as a lack of attention to the unique ethical issues inherent in operating in a virtual community where social boundaries and issues of public and private are ambiguous. This suggests the need for more self-conscious and ethical research practices when using social media
Abdulrahman, Mahera; Nair, Satish Chandrasekhar
Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.
Buchanan, Elizabeth; Aycock, John; Dexter, Scott; Dittrich, David; Hvizdak, Erin
This paper explores the growing concerns with computer science research, and in particular, computer security research and its relationship with the committees that review human subjects research. It offers cases that review boards are likely to confront, and provides a context for appropriate consideration of such research, as issues of bots, clouds, and worms enter the discourse of human subjects review.
Full Text Available The ethics is the inner law of the individual. Its application is controlled and sacked by the self-awareness and the surrounding (by ethical codecs. The self-awareness is the inner law produced by everyday life, and is therefore changeable and adaptable to the outer reality. The ethics is a common field of marketing research, within the processes of ethical dilemmas and the marketing research process itself (identified target segments: the public the consumer, the subject ordering marketing research and marketing researchers.
Borah, B Rashmi; Strand, Nicolle K; Chillag, Kata L
As neuroscience research advances, researchers, clinicians, and other stakeholders will face a host of ethical challenges. The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has published two reports that provide recommendations on how to advance research endeavors ethically. The commission addressed, among other issues, how to prioritize different types of neuroscience research and how to include research participants who have impaired consent capacity. The Bioethics Commission's recommendations provide a foundation for ethical guidelines as neuroscience research advances and progresses. © 2016 American Medical Association. All Rights Reserved.
Full Text Available Research in business ethics is vital for the expansion and credibility of this fairly recent academic field. This article argues that there are three factors that are crucially important for research in business ethics. They are (a the ontological assumptions that research in this field is premised upon, (b the choice of research strategies and methodologies and (c the role of theory in research practice. Each of these three factors is explored and pitfalls relating to each of them are identified. The article also suggests guidelines for dealing with each of these factors in business ethics research.
Bamber, Greg J; Sappey, Jennifer
To protect the welfare and rights of participants in research and to facilitate research that will be of benefit, as well as protect them against litigation, universities and research-funding agencies in Australia adopted the National Statement on Ethical Conduct in Research Involving Humans (NHMRC 1999). In many other countries there are similar statements. However, the ways in which such statements are often implemented by Human Research Ethics Committees (HRECs) are in conflict with an important stream of industrial sociological research. This stream seeks to deconstruct workplaces and de-layer management rhetoric to understand the realities and complexities of the social relations of production. There is a pluralist basis for much industrial sociology that challenges the unitarist view of the workplace as essentially harmonious. While views of workplaces as being conflictual and exploitative have to be tempered with an understanding of the accommodative and cooperative nature of workplace relations, there is nevertheless a general recognition of acts of resistance, as well as those of cooperation. The way in which the National Statement is typically implemented in Australia means that many HRECs require written, informed consent, which in the first instance will usually be that of management. An unintended consequence is a research focus on consensus, which is at best one-sided and at worst seriously misleading. It is unlikely that managerial consent will be granted unless there is a 'good news story' guaranteed. This article explores the ways in which HRECs may influence workplace research. The publication of the revised National Statement provides a valuable opportunity not to be missed by HRECs to implement more effective and efficient practices which would not have the unintended consequences of the earlier version. This would deserve the support of researchers in industrial sociology and other branches of the social sciences.
Harnett, John D; Neuman, Richard
This chapter describes the history of the development of modern research ethics. The governance of research ethics is discussed and varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. The paramount importance of protecting the privacy and confidentiality of research participants is discussed at length. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of research in vulnerable populations is touched upon and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards. Issues related to scientific misconduct and research fraud are not dealt with in this paper.
Roberts, Laura Weiss
There are many tasks ahead in the area of ethics and mental illness research. We face unknown challenges in psychiatric genetics projects, studies of psychopharmacological interventions in children, controversial scientific designs (e.g., symptom challenge, medication-free interval), and cross-disciplinary research incorporating goals and methods of health services, epidemiology, and social and behavioral science endeavors. Boundaries between innovative clinical practices and research-related experimentation will become increasingly difficult to distinguish, as will the roles between clinicians, clinical researchers, and basic scientists. Moreover, the institutions and systems in which research occurs are being rapidly and radically revised, raising new questions about oversight responsibilities and standards. Our ability to identify and respond to the ethical questions arising in this uncharted territory will depend on our willingness to self-reflect, to integrate the observations and insights of the past century, to think with great clarity, and to anticipate novel ethical problems that keep company with scientific advancements. It will also depend on data. Empirical study of ethical dimensions of human research is essential to anchor and attune the intuitions and theoretical constructs that we develop. Science and ethics have changed over the past 100 years, as they will over the next century. It is ironic that the ethical acceptability of psychiatric research is so much in question at this time, when it holds so much promise for advancing our understanding of mental illness and its treatment. The tension between the duty to protect vulnerable individuals and the duty to perform human science will continue to grow, as long as ethics and science are seen as separable, opposing forces with different aims championed by different heroes. The profession of psychiatry is poised to move toward a new, more coherent research ethics paradigm in which scientific and
George, Robert P
The author, a member of the U.S. President's Council on Bioethics, discusses ethical issues raised by human cloning, whether for purposes of bringing babies to birth or for research purposes. He first argues that every cloned human embryo is a new, distinct, and enduring organism, belonging to the species Homo sapiens, and directing its own development toward maturity. He then distinguishes between two types of capacities belonging to individual organisms belonging to this species, an immediately exerciseable capacity and a basic natural capacity that develops over time. He argues that it is the second type of capacity that is the ground for full moral respect, and that this capacity (and its concomitant degree of respect) belongs to cloned human embryos no less than to adult human beings. He then considers and rejects counter-arguments to his position, including the suggestion that the capacity of embryos is equivalent to the capacity of somatic cells, that full human rights are afforded only to human organisms with functioning brains, that the possibility of twinning diminishes the moral status of embryos, that the fact that people do not typically mourn the loss of early embryos implies that they have a diminished moral status, that the fact that early spontaneous abortions occur frequently diminishes the moral status of embryos, and that his arguments depend upon a concept of ensoulment. He concludes that if the moral status of cloned human embryos is equivalent to that of adults, then public policy should be based upon this assumption.
Bevan, Joan C
This review will examine research ethics in the context of globalization of clinical trials and recent rapid developments in bioscience. It will focus on international ethical guidelines and the functions of research ethics review boards in research governance. Consent issues in genetic research, which must comply with privacy laws by protecting confidentiality and privacy of personal health data, will be discussed. There has been a rapid expansion of genomic and proteonomic research and biotechnology in the last decade. International ethical guidelines have been updated and the bioscience industry has developed ethics policies. At the same time, problems in academic anesthesia in the US and UK have been identified, leading to recommendations to train physician-scientists in anesthesia to stimulate research activity in the future. Anesthesiologists are joining interdisciplinary research teams and the concept of evidence-based translational research is emerging. Anesthesiologists are moving towards participation in interdisciplinary research teams. They are well placed to speed the translation of research discovery into clinical practice and provide evidence-based perioperative care. This review provides the ethical framework that anesthesiologists will need to meet the challenges of this changing pattern of practice.
The Weatherall report on the use of non-human primates in research was published in 2006. Its main conclusion was that there is a strong scientific case for the use of non-human primates in some cases, but the report stressed the importance of evaluating each case in the light of the availability of alternatives. In addition to arguing for the scientific necessity of using non-human primates in research, the report also provided an ethical justification. As could be expected, the report was harshly criticised by animal rights groups, but in the academic literature, only two critical replies appeared. In what follows, I will describe the ethical justification for non-human primate research as it is laid out in the Weatherall report and then consider the criticism in the academic literature. I conclude that the report's ethical justification for the use of non-human primates in research, in particular in basic neuroscientific research, has not been convincingly challenged by its critics. Since the criticism of the report is limited and represents only a small part of the academic discussion about the use of non-human primates in research, and a still smaller part of the ethical discussion about animal research, it is important that the discussion continue both at the academic and social level. © 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.
Silverman, Henry J; Lemaire, Francois
The past few years have witnessed several controversies regarding the ethics of conducting research involving critically ill patients, and such research is ethically challenging. Research ethics is a changing field, one that is influenced by empirical data, contemporary events, and new ideas regarding aspects of clinical trial design and protection of human subjects. We describe recent thoughts regarding several aspects of research ethics in the critical care context. The ability of the research community to conduct research ethically and to maintain public trust would benefit from heightened awareness to the principles and requirements that govern such research.
Taking into account the state of the science, the ethics committee has to decide in research projects with study-related radiation exposure, whether a compelling need for the research project exists. During the critical appraisal, further ethical and legal aspects have to be considered. Even without an application according to X-ray Ordinance (RoeV) or Radiation Protection Ordinance (StrlSchV), the Ethics Committee should advise the applicant whether from their perspective the project requires an approval according to RoeV and StrlSchV. This requires the regular involvement of expert members.
de Albuquerque Rocha, Karina; Vasconcelos, Sonia M R
Ethics regulation for human-subject research (HSR) has been established for about 20 years in Brazil. However, compliance with this regulation is controversial for non-biomedical sciences, particularly for human and social sciences (HSS), the source of a recent debate at the National Commission for Research Ethics. We hypothesized that for these fields, formal requirements for compliance with HSR regulation in graduate programs, responsible for the greatest share of Brazilian science, would be small in number. We analyzed institutional documents (collected from June 2014 to May 2015) from 171 graduate programs at six prestigious Brazilian universities in São Paulo and Rio de Janeiro, the states that fund most of the science conducted in Brazil. Among these programs, 149 were in HSS. The results suggest that non-compliance with standard regulation seems to be the rule in most of these programs. The data may reflect not only a resistance from scientists in these fields to comply with standard regulations for ethics in HSR but also a disciplinary tradition that seems prevalent when it comes to research ethics in HSR. However, recent encounters between Brazilian biomedical and non-biomedical scientists for debates over ethics in HSR point to a changing culture in the approach to research ethics in the country.
In this strictly academic book, David. Kirchhoffer processes the complex issues surrounding the concept of human dignity through a clearly defined ethical method. At the outset, he questions whether it is possible to use human dignity as a normative criterion, when empirical research has shown there is no evidence that an ...
Full Text Available In order to reflect on some ethical improprieties which I had committed during the data collection phase of an information systems research study, I conducted an heuristic and psychologically-oriented self-study. As part of this heuristic reflection, I engaged in a number of self dialogues in the form of a conversation between various characters. Reported in this paper is one of these dialogues, concerning broad issues of ethics and research and discussing the notion of wisdom, maturity, meaning, and virtue. Ethical considerations are always of primary importance, and I would assert that this is even more so when considering research investigating and using new media, such as the world wide web, in which acceptable ethical practices have yet to be established and consolidated.
This chapter joins the voices that consider research ethics to be a matter of situated, responsible judgment, rather than a matter of universal principles and rigid guidelines. When collecting data about or in digitally saturated contexts, we need to consciously choose between what is available......, findable and collectable, and what should be found, collected and used for research. Thus, this chapter will not offer a set of rules; rather, it advocates for systematic (self) reflexivity in ethical qualitative inquiry. In the following I outline some of the persistent ethical issues that scholars...... involved in internet research are faced with. Classical ethical concepts like informed consent, confidentiality, anonymity, privacy, publicity and harm are difficult to operationalize in a socio-technical context that is persistent, replicable, scalable, and searchable. Examples from my own work...
Full Text Available Abstract Assessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed. This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach
Dumez, Birgit; Van Damme, Karel; Casteleyn, Ludwine
Assessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed.This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach. This will not only increase
Williams, John R; Sprumont, Dominique; Hirtle, Marie; Adebamowo, Clement; Braunschweiger, Paul; Bull, Susan; Burri, Christian; Czarkowski, Marek; Fan, Chien Te; Franck, Caroline; Gefenas, Eugenjius; Geissbuhler, Antoine; Klingmann, Ingrid; Kouyaté, Bocar; Kraehenbhul, Jean-Pierre; Kruger, Mariana; Moodley, Keymanthri; Ntoumi, Francine; Nyirenda, Thomas; Pym, Alexander; Silverman, Henry; Tenorio, Sara
This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Jetter, Karen M; Yarborough, Mark; Cassady, Diana L; Styne, Dennis M
To develop a research ethics training course for American Indian/Alaskan Native health clinic staff and community researchers who would be conducting human subjects research. Community-based participatory research methods were used in facilitated discussions of research ethics centered around topics included in the Collaborative Institutional Training Initiative research ethics course. The community-based participatory research approach allowed all partners to jointly develop a research ethics training program that was relevant for American Indian/Alaskan Native communities. All community and clinic partners were able to pass the Collaborative Institutional Training Initiative course they were required to pass so that they could be certified to conduct research with human subjects on federally funded projects. In addition, the training sessions provided a foundation for increased community oversight of research. By using a collaborative process to engage community partners in research ethics discussions, rather than either an asynchronous online or a lecture/presentation format, resulted in significant mutual learning about research ethics and community concerns about research. This approach requires university researchers to invest time in learning about the communities in which they will be working prior to the training. © 2014 Society for Public Health Education.
Vallance, Roger J.
Research ethics is not only a matter of doing no harm, or even abiding by the guidelines of the Ethics Review Board of the institution. While these matters are important and legal requirements, there is much more at stake in discussions of research ethics. Research ethics establish the foundation upon which research rests. Taking the social…
Newcombe, J P; Kerridge, I H
Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.
Mizuno, Hiroshi; Akutsu, Hidenori; Kato, Kazuto
Human-animal chimeric embryos are embryos obtained by introducing human cells into a non-human animal embryo. It is envisaged that the application of human-animal chimeric embryos may make possible many useful research projects including producing three-dimensional human organs in animals and verification of the pluripotency of human ES cells or iPS cells in vivo. The use of human-animal chimeric embryos, however, raises several ethical and moral concerns. The most fundamental one is that human-animal chimeric embryos possess the potential to develop into organisms containing human-derived tissue, which may lead to infringing upon the identity of the human species, and thus impairing human dignity. The Japanese Expert Panel on Bioethics in the Cabinet Office carefully considered the scientific significance and ethical acceptability of the issue and released its "Opinions regarding the handling of research using human-animal chimeric embryos". The Panel proposed a framework of case-by-case review, and suggested that the following points must be carefully reviewed from the perspective of ethical acceptability: (a) Types of animal embryos and types of animals receiving embryo transfers, particularly in dealing with non-human primates; (b) Types of human cells and organs intended for production, particularly in dealing with human nerve or germ cells; and (c) Extent of the period required for post-transfer studies. The scientific knowledge that can be gained from transfer into an animal uterus and from the production of an individual must be clarified to avoid unnecessary generation of chimeric animals. The time is ripe for the scientific community and governments to start discussing the ethical issues for establishing a global consensus.
Gallagher, Cathal T; McDonald, Lisa J; McCormack, Niamh P
Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, in itself, justify such risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval.
Júlio César Schmitt Rocha
Full Text Available The objective here is to point out ethics in Physical Education research against a backdrop of individual and collective human conduct. Since Plato, the question of ethics in the Western world has been an incessant search for the virtues to harmonize personal and social wellbeing and for the absolute principles of conduct: Autonomy, Beneficence and Justice. Physical Education cannot exempt itself from these and its countless areas of research. In addition to the moral education that develops and solidifies within social groups, the characteristic of which is action on an individual level, we must also consider ethical principles such as those defended by the Physical Education World Manifesto and those that regulate the professional activities of Physical Education professionals. Irrespective of the area investigated, Research in Physical Education will always clash with institutionalized ethical principles enforced by ethics committees, councils and the values accepted by the researchers. Committees strive to preserve the integrity and dignity of the people enrolled on research studies while the researchers challenge the limits of knowledge at an uncomfortable frontier between the acceptable and the unacceptable within a given context of academic vision and needs.
Dyck, Murray; Allen, Gary
Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear that review boards do not respect researchers or each other, lack merit and integrity, are not just and are not beneficent. The few benefits of mandatory ethical review come at a much greater, but mainly hidden, social cost. It is time that responsibility for the ethical conduct of research is clearly transferred to researchers, except possibly in that small proportion of cases where prospective research participants may be so intrinsically vulnerable that their well-being may need to be overseen.
In the absence of a cure for AIDS, attention has turned to the possibility of developing a preventive vaccine for HIV infection. Yet many scientific, ethical, legal, and economic obstacles remain. At the current rate, the development and production of an effective vaccine could take 15 to 20 years or longer. If tens of millions more HIV infections and deaths are to be avoided in the coming decades, vaccine research needs to be greatly expedited. Furthermore, it must be undertaken ethically, and the products of this research must benefit people in developing countries. This article, an edited and updated version of a paper presented at "Putting Third First," addresses challenges arising in HIV preventive vaccine research in developing countries. It does not address clinical research in developing countries relating to treatments or therapeutic vaccines. Nor does it address legal and ethical issues relating to HIV vaccine research in industrialized countries, although similar issues arise in both contexts. The article concludes that while ethical codes are silent on the obligation to undertake research and development, international law provides strong legal obligations--particularly with regard to industrialized states--that should be invoked to accelerate HIV vaccine development, and distribution.
Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts and problems in research. They were all researchers at the post-doctoral l...
Ferdowsian, Hope R; Gluck, John P
In 1966, Henry K. Beecher published an article entitled "Ethics and Clinical Research" in the New England Journal of Medicine, which cited examples of ethically problematic human research. His influential paper drew attention to common moral problems such as inadequate attention to informed consent, risks, and efforts to provide ethical justification. Beecher's paper provoked significant advancements in human research policies and practices. In this paper, we use an approach modeled after Beecher's 1966 paper to show that moral problems with animal research are similar to the problems Beecher described for human research. We describe cases that illustrate ethical deficiencies in the conduct of animal research, including inattention to the issue of consent or assent, incomplete surveys of the harms caused by specific protocols, inequitable burdens on research subjects in the absence of benefits to them, and insufficient efforts to provide ethical justification. We provide a set of recommendations to begin to address these deficits.
Full Text Available This paper examines ethical issues specific to research into virtual communities. Drawing on an empirical case with online forums of education experts, we identify the following key issues: publicity versus privacy of the community; the definition of human subjects research; participant recruitment; informed consent; and ethical questions associated with observing virtual communities, and with reporting and disseminating research results. We maintain that different research cultures in different countries can present challenges when studying global forums. Acknowledging the ephemeral characteristics of Internet contexts, this paper argues that ethical considerations should be more case-based, instead of relying on one model for all solutions. We suggest that local ethics committees or institutional review boards could, with their expert knowledge of ethics, provide valuable support for researchers operating in the complex and dynamic terrain of Internet research, as well as in fields and research settings where an ethical review is not a standard part of the research process.
Salter, D C
What should one do, and why? Anyone asking such questions--and everyone does so hundreds of time each day--is concerned with ethics. Product development and testing raise many ethical questions. Particularly since the rise of 'green consumerism', these are of increasing concern to people outside the cosmetics industry, and so should be of interest to those inside it. The major problem seems to be that of reaching agreement on moral and ethical issues. Overcoming this problem involves investigating what is meant by 'ethics', and how decisions depend not on facts but on 'facts-as-perceived'. These in turn depend on many factors, with one's philosophy being the most fundamental. The range of philosophical options is reviewed and it is proposed that wider discussion is the only just way to achieve agreement. Yet some things are not negotiable. There are certain key moral concepts in terms of which discussion must take place for it to be relevant. In ethics of human testing, 'respect for others', that is, avoiding exploitation, is the principal one. Some synthesis of the key moral concepts like that of Immanuel Kant is therefore recommended as the soundest and most widely acceptable basis for the necessary discussion. Defining the responsible use of human subjects covers a range of issues, moral, historical, legal and professional. For example, there may be ethical difficulties in deliberate damage induction as in SPF and irritancy testing. But above all, to avoid exploitation, there is a moral and also a legal requirement that subjects are truly volunteers. This is the basis of the concept of 'informed consent', required but not generally explained in current professional codes of practice. It is unjustified to exploit those who may be under duress, such as 'in-house volunteers' and those with low incomes. Hence in conclusion, criteria for obtaining valid informed consent are briefly reviewed. By considering issues such as these, we can help ensure that cosmetic
Millum, Joseph; Sina, Barbara
NIH's Fogarty International Center has provided grants for the development of training programs in international research ethics for low- and middle-income (LMIC) professionals since 2000. Drawing on 12 years of research ethics training experience, a group of Fogarty grantees, trainees, and other ethics experts sought to map the current capacity and need for research ethics in LMICs, analyze the lessons learned about teaching bioethics, and chart a way forward for research ethics training in a rapidly changing health research landscape. This collection of papers is the result.
Bellver Capella, Vicente
If the prediction of some scientists comes true, then we are only few years away from the appearance of the first generation of human beings who will be able to add one year to each remaining year of life expectancy. Faced with this possibility, it seems appropriate to give thought to the public policies that should be adopted. It is better to anticipate the various future scenarios than react to a reality which is a fait accompli. To date, the debate has mainly focused on the ethical question: is it good or bad for us humans to achieve immortal life? Until now, neither legal guidelines at State level nor those of international organisations which deal with bioethical issues have concerned themselves with this matter. But before discussing policies, two other matters should be addressed: first, to show how the prolongation of human life can be as much the unwanted outcome of legitimate efforts in search of healthy aging, as one of the aims of the post-humanist project; second, to present the most consistent and shared ethical reasons for rejecting the human immortality project.
Feudtner, Chris; Brosco, Jeffrey P
People with intellectual disability (ID) have a long history of discrimination and stigmatization, and a more recent history of pride and self-advocacy. The early history suggests that people with ID are a vulnerable population and deserve special research protections as do some other groups; the disability rights movement of the late 20th century aligns people with ID more closely with the principle of autonomy that has guided clinical and research ethics for the last 40 years. In examining the history of people with ID and the prevailing framework of human subjects research protections in the United States, we conclude that people with ID do not require special protection in human subjects research. The protections that have already been put in place for all individuals, if conscientiously and effectively implemented, achieve the right balance between safeguarding the interest of human research subjects and empowering individuals who choose to do so to participate in research. Copyright © 2012 Wiley Periodicals, Inc.
McKee, Heidi A.; Porter, James E.
What are the key ethical issues involved in conducting archival research? Based on examination of cases and interviews with leading archival researchers in composition, this article discusses several ethical questions and offers a heuristic to guide ethical decision making. Key to this process is recognizing the person-ness of archival materials.…
Jeffers, Brenda Recchia
Review of professional nursing statements, federal policy, and recommendations for protection of human research subjects resulted in a topic and content outline for research ethics training for nurses. Suggestions for continuing education programs on research ethics were formulated. (SK)
Sanmukhani, J; Tripathi, C B
Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.
Consejo-Y Chapela, Carolina; González-Martínez, José Francisco
In this editorial we initially expose the agreements that have set the mechanisms to guarantee safety and fair treatment to human subjects in research. Later on, we offer alternatives from translational and multidisciplinary research to promote education and humanities research in health.
Karakaya, Ahmet; Ilkilic, Ilhan
Turkey, with a Muslim population of officially over 99 %, is one of the few secular states in the Muslim world. Although state institutions are not based on Islamic juridical and ethical norms, the latter play a significant role in defining people's attitudes towards controversial issues in the modern world, especially when backed by opinions of Muslim scholars living in Turkey. Accordingly, opinions of Muslim scholars undoubtedly have an important effect on bioethical decisions made by institutions and individuals. To explore the ethical positions of Muslim scholars living in Turkey and their arguments used in the ethical assessment of embryonic stem cell research; to discuss the biological-moral tensions arising in medical research on human embryos. Qualitative study. Muslim scholars located in different parts of Turkey. Qualitative method, involving the collection of opinions of various scholars, by means of 15 individual semi-structured interviews, evaluated using thematic qualitative analysis. Positions regarding embryonic stem cell research differ among Muslim scholars in Turkey. On the other hand, even where positions are similar, they are often supported by different arguments. Despite the heterogeneity of the arguments presented, the dominant position considers embryonic stem cell research as morally acceptable.
Hammer, Marilyn J
The ethical conduct of research includes, in part, patient agreement to participate in studies and the protection of health information. In the evolving world of data science and the accessibility of large quantities of web-based data created by millions of individuals, novel methodologic approaches to answering research questions are emerging. This article explores research ethics in the context of big data.
Deaver, Sarah P.
By having their research proposals reviewed and approved by Institutional Review Boards (IRBs), art therapists meet important ethical principles regarding responsibility to research participants. This article provides an overview of the history of human subjects protections in the United States; underlying ethical principles and their application…
Chan, David K
Despite criticism that dignity is a vague and slippery concept, a number of international guidelines on bioethics have cautioned against research that is contrary to human dignity, with reference specifically to genetic technology. What is the connection between genetic research and human dignity? In this article, I investigate the concept of human dignity in its various historical forms, and examine its status as a moral concept. Unlike Kant's ideal concept of human dignity, the empirical or relational concept takes human dignity as something that is affected by one's circumstances and what others do. I argue that the dignity objection to some forms of genetic research rests on a view of human nature that gives humans a special status in nature - one that is threatened by the potential of genetic research to reduce individuals to their genetic endowment. I distinguish two main philosophical accounts of human nature. One of these, the Aristotelian view, is compatible with the use of genetic technology to help humans realize their inherent potential to a fuller extent. © 2014 John Wiley & Sons Ltd.
Bredenoord, Annelien L.; Clevers, Hans; Knoblich, Juergen A.
The ability to generate human tissues in vitro from stem cells has raised enormous expectations among the biomedical research community, patients, and the general public. These organoids enable studies of normal development and disease and allow the testing of compounds directly on human tissue.
Parsell, Mitch; Ambler, Trudy; Jacenyik-Trawoger, Christa
Many educational researchers have experienced challenges in obtaining ethics approval. This article explores some of the reasons why this is the case, looking specifically at the participatory action research methodology. The authors' experience of seeking ethics approval for a project intended to introduce peer review as an enhancement process is…
Lategan, Laetus; Hooper, Peter
The focus of this paper is to reflect on research ethics practices at universities and particularly on the additional considerations needed as "enterprise" becomes a key driver across the sector internationally. The outcome of the paper is to identify suitable guidelines for dealing with the management of research ethics in this changing…
Conceptual in nature, this paper revisits the debate on the nature and ethical implication of what it means to conduct research with/in immigrant communities. The view from "inside" is different from the view from "outside," I am contending, and both are mediated by what I am calling "I-Thou Research Ethics." This is…
Valdivia-Gómez, Gilberto Guzmán; Velasco-Jiménez, María Teresa; Domínguez-González, Alejandro; Meneses-Ruíz, Dulce María; Padilla-García, Raúl Amauri
Research projects must demonstrate not only a rigorous scientific methodology, but also the ethical aspects that require profound reflection of the reviewers. Current regulations establish criteria for research projects on human health, but many of these aspects are subjective. How can the evaluation of such projects be standardized? This is the main subject of the current project. This project comprises two phases. First, the design and construction of an instrument of evaluation based on the fundamental principles of bioethics, which are autonomy, beneficence, non-maleficence, and justice, and other aspects. The second phase consists of content validation through expert. During the phase of reviewing the instrument, it was necessary to make changes by adding, removing, or changing the concepts or criteria, which lead to the construction of the second version of the format. This new instrument was reviewed and analyzed by using the AGREE II instrument, and this version was validated by experts by greater than 95%. There are some recommendations to analyze the ethical aspects in research protocols involving human subjects, but they define the concepts and criteria to be evaluated. By presenting the criteria to be evaluated individually, the "La Salle instrument" allows the evaluation to be more objective and standardized.
justice have long been associated with social practices such as punishment, taxation and political The Human Volunteer in Military Biomedical Research...suspension of eligibility to receive research funding, to use investigational interventions, or to practise medicine. Unless there are persuasive reasons to do
Valenzuela, Carlos Y
True cloning is fission, budding or other types of asexual reproduction. In humans it occurs in monozygote twinning. This type of cloning is ethically and religiously good. Human cloning can be performed by twinning (TWClo) or nuclear transfer (NTClo). Both methods need a zygote or a nuclear transferred cell, obtained in vitro (IVTec). They are under the IVTec ethics. IVTecs use humans (zygotes, embryos) as drugs or things; increase the risk of malformations; increase development and size of abnormalities and may cause long-term changes. Cloning for preserving extinct (or almost extinct) animals or humans when sexual reproduction is not possible is ethically valid. The previous selection of a phenotype in human cloning violates some ethical principles. NTClo for reproductive or therapeutic purposes is dangerous since it increases the risk for nucleotide or chromosome mutations, de-programming or re-programming errors, aging or malignancy of the embryo cells thus obtained.
Langlais, Philip J
Despite the importance of scientific integrity to the well-being of society, recent findings suggest that training and mentoring in the responsible conduct of research are not very reliable or effective inhibitors of research misbehavior. Understanding how and why individual scientists decide to behave in ways that conform to or violate norms and standards of research is essential to the development of more effective training programs and the creation of more supportive environments. Scholars in business management, psychology, and other disciplines have identified many important factors that affect ethical behavior, including individual, contextual, and organizational factors. Surprisingly little research has been conducted to examine the role of these factors in either the development of ethical decision-making skills, or their applicability to ethical issues commonly encountered in research and other scholarly and professional activities. Interdisciplinary approaches combined with research and discipline relevant paradigms should greatly enhance understanding of the individual contextual and organizational factors involved in ethical and unethical research conduct. Such studies will inform and facilitate the development of more effective ethics education programs in the sciences and engineering professions.
In the debate on the ethical evaluation of the stem cell research three levels can be differentiated. The first level of argumentation is that of weighing up goods: The possible therapeutical success for thousands of humans seems to justify the consumption of a few embryos. It is show, that this, however, already presupposes - on a second argumentation level - a judgement on the moral status of the embryo. Different moments of time, when human dignity and life protection are ascribe to the embryo, have already been discussed, but in spite of all rationality of the arguments a consensus has not been reached. On this third level of argumentation two fundamental meanings of reality can be differentiated. The empirical-observing and the communicative-participating view. These lead to a different moral evaluation of the embryo. This contribution votes for the priority of the communicative-participating view. It receives addition support by theology and Christian faith.
Ackerman, Terrence F; Winsett, Rebecca P
This article explores the role of ethics and regulation in human research conducted by organ procurement agencies; basic ethical principles for human research are outlined. Organ procurement agencies are not required to observe federal regulations; however, voluntary adherence will ensure that procurement research is conducted according to current standards of ethical practice. Although most organ procurement research will qualify for exempt status, this determination should be made by an institutional review board. Even if studies qualify for exempt status, there is a moral presumption that informed consent should be sought, unless certain narrow conditions for waiver of consent are satisfied. Finally, when future research utilizing organ procurement records is anticipated, procurement coordinators should provide sufficiently detailed information to families about such plans to permit their advance informed consent to research activities.
Bailes, Marion J; Minas, I Harry; Klimidis, Steven
In this paper we examine ethical issues relevant to conducting mental health research with refugees and immigrant communities that have cultural orientations and social organisation that are substantially different to those of the broader Australian community, and we relate these issues to NH&MRC Guidelines. We describe the development and conduct of a mental health research project carried out recently in Melbourne with the Somali community, focusing on ethical principles involved, and relating these to the NH&MRC National Statement on Ethical Conduct in Research Involving Humans, and the NH&MRC document Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research. The experience of conducting mental health research with the Somali community highlights the fact that the principles of inclusion and benefit enunciated in the NH&MRC document Values and Ethics are particularly pertinent when conducting research with refugees and immigrant communities that are culturally distant to those of the broader Australian community. These principles inform issues of research design and consent, as well as guiding respectful engagement with the participating community and communication of the research findings.
Pickersgill, Martyn; Hogle, Linda
For some time now, bioethicists have paid close attention to issues associated with 'enhancement'; specifically, the appropriate use and regulation of substances and artefacts understood by some to improve the functioning of human bodies beyond that associated with 'normal' function. Medical humanities scholars (aside from philosophers and lawyers) and social scientists have not been frequent participants in debates around enhancement, but could shine a bright light on the range of dilemmas and opportunities techniques of enhancement are purported to introduce. In this paper, we argue that empirical research into the notion and practice of enhancement is necessary and timely. Such work could fruitfully engage with-and further develop-existing conceptual repertoires within the medical humanities and social sciences in ways that would afford benefit to scholars in those disciplines. We maintain that empirical engagements could also provide important resources to bioethicists seeking to regulate new enhancements in ways that are sensitive to societal context and cultural difference. To this end, we outline an empirical agenda for the medical humanities and social sciences around enhancement, emphasising especially how science and technology studies could bring benefits to-and be benefitted by-research in this area. We also use the example of (pharmaceutical) cognitive enhancement to show how empirical studies of actual and likely enhancement practices can nuance resonant bioethical debates. 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/
Full Text Available Con el objetivo de plantear la necesaria reflexión moral sobre la responsabilidad personal que asume cada investigador cuando realiza investigación científica en seres humanos, se presenta un ensayo de temática científica y moral, utilizando información de la literatura científica y ética pertinentes. En torno a los conceptos de ética heterónoma y ética autónoma, se plantea que, en última instancia y allende el consentimiento Informado y los cursos de adiestramiento sobre ética en investigación, la conducta del/de la investigador/a dependerá de su propia responsabilidad moral puesta a prueba en diversos contextos situacionales. Se utilizan dos modelos explicativos para comprender esta dinámica, el de normalidad en salud mental y el del desarrollo moral del hombre. Se concluye que el proceso de investigación en seres humanos constituye una actividad científica y moral que, dependiendo de diversas situaciones de conflicto de interés, pondrá siempre a prueba los controles morales del investigador.In order to propose the necessary moral reflection about the personal responsibility that each researcher assumes when he performs scientific research in human beings, an essay of moral and scientific themes is presented, using information from the relevant scientific and ethical literature. Around the concepts of heteronomous and autonomous ethics, it is proposed that ultimately and beyond informed consent and training courses on research ethics, the behavior of the researcher will depend on his/her own moral responsibility, tested in different situational contexts. Two explanatory models are used in order to understand this dynamic, the one of normality in mental health and the one of moral development of men. We conclude that the research process in human beings is a scientific and moral activity that, depending in various situations of conflicts of interest, will always test the researcher’s moral controls.
Lo, Bernard; Parham, Lindsay
Stem cell research offers great promise for understanding basic mechanisms of human development and differentiation, as well as the hope for new treatments for diseases such as diabetes, spinal cord injury, Parkinson’s disease, and myocardial infarction. However, human stem cell (hSC) research also raises sharp ethical and political controversies. The derivation of pluripotent stem cell lines from oocytes and embryos is fraught with disputes about the onset of human personhood. The reprogramm...
Resnik, David B
Most approaches to promoting integrity in research are principle-based in that they portray ethical conduct as consisting of adherence to ethical rules, duties, or responsibilities. Bruce MacFarlane has recently criticized the principle-based approach to promoting integrity in research and offered a virtue-based alternative. MacFarlane argues that principle-based approaches do not provide adequate guidance for ethical decision-making and are not very useful in moral education. In this article, I examine and critique MacFarlane's defense of the virtue-based approach. I argue that virtue-based and principle-based approaches to ethics are complementary and that they both can help promote research integrity.
Valle Mansilla, José Ignacio
Biomedical researchers often now ask subjects to donate samples to be deposited in biobanks. This is not only of interest to researchers, patients and society as a whole can benefit from the improvements in diagnosis, treatment, and prevention that the advent of genomic medicine portends. However, there is a growing debate regarding the social and ethical implications of creating biobanks and using stored human tissue samples for genomic research. Our aim was to identify factors related to both scientists and patients' preferences regarding the sort of information to convey to subjects about the results of the study and the risks related to genomic research. The method used was a survey addressed to 204 scientists and 279 donors from the U.S. and Spain. In this sample, researchers had already published genomic epidemiology studies; and research subjects had actually volunteered to donate a human sample for genomic research. Concerning the results, patients supported more frequently than scientists their right to know individual results from future genomic research. These differences were statistically significant after adjusting by the opportunity to receive genetic research results from the research they had previously participated and their perception of risks regarding genetic information compared to other clinical data. A slight majority of researchers supported informing participants about individual genomic results only if the reliability and clinical validity of the information had been established. Men were more likely than women to believe that patients should be informed of research results even if these conditions were not met. Also among patients, almost half of them would always prefer to be informed about individual results from future genomic research. The three main factors associated to a higher support of a non-limited access to individual results were: being from the US, having previously been offered individual information and considering
Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems
Full Text Available Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies, appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening
Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems
The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.
Lamas, Eugenia; Ferrer, Marcela; Molina, Alberto; Salinas, Rodrigo; Hevia, Adriana; Bota, Alexandre; Feinholz, Dafna; Fuchs, Michael; Schramm, Roland; Tealdi, Juan-Carlos; Zorrilla, Sergio
The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining 'ethics regulation system for biomedical research' as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities.
Tindana, Paulina; Molyneux, Catherine S; Bull, Susan; Parker, Michael
For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials such as DNA, for use in biomedical research, has been central in understanding the nature and transmission of diseases across the globe. However, the limitations of current ethical and regulatory frameworks in sub-Saharan Africa to govern the collection, export, storage and reuse of these samples have resulted in inconsistencies in practice and a number of ethical concerns for sample donors, researchers and research ethics committees. This paper examines stakeholders' perspectives of and responses to the ethical issues arising from these research practices. We employed a qualitative strategy of inquiry for this research including in-depth interviews and focus group discussions with key research stakeholders in Kenya (Nairobi and Kilifi), and Ghana (Accra and Navrongo). The stakeholders interviewed emphasised the compelling scientific importance of sample export, storage and reuse, and acknowledged the existence of some structures governing these research practices, but they also highlighted the pressing need for a number of practical ethical concerns to be addressed in order to ensure high standards of practice and to maintain public confidence in international research collaborations. These concerns relate to obtaining culturally appropriate consent for sample export and reuse, understanding cultural sensitivities around the use of blood samples, facilitating a degree of local control of samples and sustainable scientific capacity building. Drawing on these findings and existing literature, we argue that the ethical issues arising in practice need to be understood in the context of the interactions between host research institutions and local communities and between collaborating institutions. We propose a set of 'key points-to-consider' for research institutions, ethics committees and funding agencies to address these issues.
Bain, Luchuo Engelbert
Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.
Trace, Samantha; Kolstoe, Simon Erik
Background The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Sha...
van der Geest, S.
The paper discusses the application of ethnocentric ethical rules in anthropological research. The ethnocentrism lies in the fact that North American and European definitions of right and wrong are imposed on anthropological research everywhere in the world. Apparently - and ironically - some
Feb 22, 2006 ... Western cultures' anthropocentrism (or human centeredness), though it .... ethics doesn't have to be paralysed by perpetual self-doubt and/or relativism. .... I didn't ascribe to this story, at least as a complete theory, as a moral ...
Background Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies. Methods The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning. Results The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research. Conclusion The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. PMID:22873761
Kjellström, S; Ross, S N; Fridlund, B
Conducting ethically sound research is a fundamental principle of scientific inquiry. Recent research has indicated that ethical concerns are insufficiently dealt with in dissertations. To examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations. Analyses of ethical content and complexity of ethical reasoning were performed on 64 Swedish nurses' PhD dissertations dated 2007. A total of seven ethical topics were identified: ethical approval (94% of the dissertations), information and informed consent (86%), confidentiality (67%), ethical aspects of methods (61%), use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection (14%). Four of those of topics were most frequently addressed: the majority of dissertations (72%) included 3-5 issues. While many ethical concerns, by their nature, involve systematic concepts or metasystematic principles, ethical reasoning scored predominantly at lesser levels of complexity: abstract (6% of the dissertations), formal (84%) and systematic (10%). Research ethics are inadequately covered in most dissertations by nurses in Sweden. Important ethical concerns are missing, and the complexity of reasoning on ethical principles, motives and implications is insufficient. This is partly due to traditions and norms that discount ethical concerns but is probably also a reflection of the ability of PhD students and supervisors to handle complexity in general. It is suggested that the importance of ethical considerations should be emphasised in graduate and post-graduate studies and that individuals with capacity to deal with systematic and metasystematic concepts are recruited to senior research positions.
How does one conduct, measure and record a ‘good’ ethical review of biomedical research? To what extent do ethics committees invoke professionalism in researchers and in themselves, and to what extent do they see competence as adherence to a set of standard operating procedures for ethical review......? Drawing on ethnographic fieldwork with the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a capacity-building NGO that runs ethics committee trainings and reviews in the Asia Pacific region, I develop an analysis of ethical review and its effects. I focus on a ‘second-order audit’ run...... readings of ‘ethics’. I begin and end with a reflection on the ethical effects of a measurement practice that takes ethics itself as its object....
Research administration and leadership, above all, directly serve the needs of researchers, scientists, research programs, institutions and their leaders, and the public trust itself. Research administration is therefore an expansive and all encompassing profession. It integrates all of the diverse arts and sciences that are foundational to…
Fletcher, J C; Richter, G
This paper examines some key ethical issues raised by trials of human gene therapy in the perinatal period--i.e., in infants, young children, and the human fetus. It describes five resources in ethics for researchers' considerations prior to such trials: (1) the history of ethical debate about gene therapy, (2) a literature on the relevance of major ethical principles for clinical research, (3) a body of widely accepted norms and practices, (4) knowledge of paradigm cases, and (5) researchers' own professional integrity. The paper also examines ethical concerns that must be met prior to any trial: benefits to and safety of subjects, informed assent of children and informed parental permission, informed consent of pregnant women in fetal gene therapy, protection of privacy, and concerns about fairness in the selection of subjects. The paper criticizes the position that cases of fetal gene therapy should be restricted only to those where the pregnant woman has explicitly refused abortion. Additional topics include concerns about genetic enhancement and germ-line gene therapy.
Hunt, Matthew; Schwartz, Lisa; Pringle, John; Boulanger, Renaud; Nouvet, Elysée; O'Mathúna, Dónal; Arya, Neil; Bernard, Carrie; Beukeboom, Carolyn; Calain, Philippe; de Laat, Sonya; Eckenwiler, Lisa; Elit, Laurie; Fraser, Veronique; Gillespie, Leigh-Anne; Johnson, Kirsten; Meagher, Rachel; Nixon, Stephanie; Olivier, Catherine; Pakes, Barry; Redwood-Campbell, Lynda; Reis, Andreas; Renaldi, Teuku; Singh, Jerome; Smith, Maxwell; Von Schreeb, Johan
This paper maps key research questions for humanitarian health ethics: the ethical dimensions of healthcare provision and public health activities during international responses to situations of humanitarian crisis. Development of this research agenda was initiated at the Humanitarian Health Ethics Forum (HHE Forum) convened in Hamilton, Canada in November 2012. The HHE Forum identified priority avenues for advancing policy and practice for ethics in humanitarian health action. The main topic areas examined were: experiences and perceptions of humanitarian health ethics; training and professional development initiatives for humanitarian health ethics; ethics support for humanitarian health workers; impact of policies and project structures on humanitarian health ethics; and theoretical frameworks and ethics lenses. Key research questions for each topic area are presented, as well as proposed strategies for advancing this research agenda. Pursuing the research agenda will help strengthen the ethical foundations of humanitarian health action. PMID:25687273
ACRE seeks a Research Awardee to study research ethics in an ... The following topics are examples of issues that could be ... advance their career goals, and recognize the dual nature of the position—applied research activity and general ...
While medical research ethics guidelines frame participants as individual and autonomous, anthropologists emphasize the relational nature of health research participation. I analyze interviews with Mexican male HPV study participants and their wives to examine how research participants themselves focus on relationships when imagining research-related benefits. I argue that couples incorporated the local trope of the Mexican citizenry as a biologically homogeneous national body, which individual members help or harm through their gendered health behavior to understand these benefits. I use the concept of "ethical intercorporeality" to discuss spouses' understandings of themselves as parts of bio-social wholes-the couple, family, and society-that they believed men's research participation could aid both physically and socially. This finding extends the insight that focusing on relationships rather than individuals is necessary for understanding the consequences of medical research by showing how participants themselves might apply this perspective in context-specific ways. © 2016 by the American Anthropological Association.
Full Text Available Writing policy that applies to First Nations, Inuit and Métis peoples in Canada has become more interactive as communities and their representative organizations press for practical recognition of an Aboriginal right of self-determination. When the policy in development is aimed at supporting “respect for human dignity” as it is in the case of ethics of research involving humans, the necessity of engaging the affected population becomes central to the undertaking.
Koocher, Gerald P
This commentary addresses the emotionally powerful account of Nicole Taus Kluemper from the perspective of a psychologist familiar with the administrative operation of the American Psychological Association (APA) and the ethics of the profession. The application of the APA's Ethical Principles of Psychologists and Code of Conduct to the case is discussed, and alternative methods of response that researchers who have concerns about case studies might use are offered. The author concludes that existing ethical principles-the aspirational standards in particular-do bear upon the matter in question. However, the enforceable code of conduct is not sufficiently clear about obligations to those whom psychologists publicly discuss when the psychologist does not have a specific duty of care to an individual. © The Author(s) 2014.
This chapter intends to lay out some essential ethics questions that might frame the next step of space exploration. In this, I undertake two sorts of tasks. The first is to respond to the core ethic question: Is it ethical to travel in space? The second, assuming for the moment that I can convince you that the first premise can be justified, is to comment on what ethical challenges will face us there. It is appropriate to have a philosopher comment on this at the fortieth anniversary celebration, since it was also in 1962 that the National Academy of Science first convened a panel of philosophers to comment on space travel. They asked at that time whether it was indeed a worthwhile pursuit to travel in space and what might be expected of such an effort. What is at stake in any such boundary crossing is how the changing of essential human perimeters changes our own moral status. Will such boundary crossing worsen our human condition, or will it enhance it? In this way, the geopolitical quest is then linked to the quest for ontology, Pisarro hunting for the fountain of youth, for gold, and for territory. What follows are a series of ethical claims that link the problem of discovery in the larger world and the attendant ethical dilemmas of our explorations, as well as how this exploration alters our concepts of life on Earth. In this, the role of the ethicist is to function as both a skeptic and a stranger, aware of the optimism of science and the pessimism of philosophy.
Background: All research involving human participants should be reviewed by a competent and independent institutional research and ethics committee. Research conducted at Makerere University College of Health Sciences should be subjected to a rigorous review process by the ethics committee in order to protect ...
Jordan, Sara R; Gray, Phillip W
While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.
This paper takes a research orientation towards ethics and, in so doing, frames ethics as processes of inquiry and stories to be told. First, it explores ways that ethics might be 'reimagined', situated in everyday contexts and interpreted in ways that allow its stories to do work and invite readers and listeners to consider ethics.
de Jong, Jean Philippe; van Zwieten, Myra C. B.; Willems, Dick L.
Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We
Full Text Available Qualitative social research designed to develop ways of understanding and explaining lived experience of human beings is a reflexive human endeavor. It is reflexive in that as researchers attempt to better understand their participants, they also come to better understand themselves. Consequently, research ethics itself becomes an ethical project, for it pertains to participant and researcher at the same time: Both are subjects, knower and known. Particularly in case of research on learning, reflexivity arises from the fact that the research itself constitutes learning about learning. How is ethics in research on learning reflexive of, in its praxis and praxeology, ongoing events and changes of the human learning? In this study, from our experience of conducting a project designed to inquire into "learning in unfamiliar environments," we develop pertinent ethical issues through a dialectical process—not unlike that used by G.W.F. HEGEL in Phenomenology of Spirit—grounded in our lived experience and developed in three theoretical claims concerning a praxeology of ethics. First, ethics is an ongoing historical event; second, ethics is based on the communicative praxis of material bodies; and third, ethics involves the creation of new communicative configurations. We conclude that ethics is grounded in a fundamental answerability of human beings for their actions, which requires communicative action that itself is a dialectical process in opening up possibilities for acting in an answerable manner. URN: urn:nbn:de:0114-fqs0501198
In this article I examine the ethics of conducting literacy research, beyond what is typically addressed in current ethical guidelines. Using a few studies as examples, I analyse how the conception of research that underlies literacy research is grounded in ethics based on individual autonomy that allow researchers to disregard their social…
Ekuma, Kelechi; Akobo, Loliya
The global nature of competition, new and ever changing employee expectations, changing societal values and constant revisions of employment law have propelled human resource management (HRM) as one of the critical business function for continued organisational competitiveness in contemporary times. This increased importance of HRM has arguably added new set of responsibilities for HR practitioners with wide-ranging implications. In specific terms, the emergence of HRM as a useful tool for in...
Shaw, Ian Frank
Ethics and the practice of qualitative research? Qualitative Social Work 7 (4): 400-414. Reprinted......Ethics and the practice of qualitative research? Qualitative Social Work 7 (4): 400-414. Reprinted...
Sílvia Helena Koller
Full Text Available This paper examines some ethical issues in research with human beings, especially addressing the area of Psychology, such as the use of ethical codes; minimum risk; informed consent; debriefing; confidentiality; and ethical committees. It suggests ways for researchers to increase understanding and the proper use of the ethical codes, to guarantee their own protection, and to avoid abuses of power. Special attention is given to methodological issues related to ethics.Este artigo examina alguns aspectos éticos em pesquisa com seres humanos, especialmente endereçando a área da Psicologia, tais como o uso de resoluções éticas; risco mínimo; consentimento livre e esclarecido; decepção; confidencialidade e atuação de comitês de ética. Sugere caminhos aos pesquisadores para incrementar o entendimento e o uso apropriado de códigos de ética, para garantir sua própria proteção e evitar abuso de poder. Atenção especial é dada a assuntos metodológicos relacionados à ética.
Haahr, Anita; Norlyk, Annelise; Hall, Elisabeth Oc
Nurse researchers engaged in qualitative interviews with patients and spouses in healthcare may often experience being in unforeseen ethical dilemmas. Researchers are guided by the bioethical principles of justice, beneficence, non-maleficence, respect for human rights and respect for autonomy through the entire research process. However, these principles are not sufficient to prepare researchers for unanticipated ethical dilemmas related to qualitative research interviews. We describe and discuss ethically challenging and difficult moments embedded in two cases from our own phenomenological interview studies. We argue that qualitative interviews involve navigation between being guided by bioethics as a researcher, being a therapist/nurse and being a fellow human being or even a friend. The researchers' premises to react to unexpected situations and act in a sound ethical manner must be enhanced, and there is a need for an increased focus on the researchers' ethical preparation and to continually address and discuss cases from their own interviews.
Dyck and Allen claim that the current model for mandatory ethical review of research involving human participants is unethical once the harms that accrue from the review process are identified. However, the assumptions upon which the authors assert that this model of research ethics governance is justified are false. In this commentary, I aim to correct these assumptions, and provide the right justificatory account of the requirement for research ethics review. This account clarifies why the subsequent arguments that Dyck and Allen make in the paper lack force, and why the 'governance problem' in research ethics that they allude to ought to be explained differently.
Paradise, Louis V.
This paper briefly examines research on the ethical behavior of counselors, demonstrating that new directions in this area are needed, and that new research questions must be asked if significant information relating to counseling and ethics is to advance. Areas of inquiry and methods for investigation are suggested. (Author)
Magalhães-Sant'Ana, M.; Sandøe, Peter; Olsson, I. A. S.
While it has the potential to deliver important human benefits, animal-based pain research raises ethical questions, because it involves inducing pain in sentient beings. Ethical decision-making, connected with this variety of research, requires informed harm-benefit analysis, and the aim of this...
Weyrich, Laura S; Harvill, Eric T
Limited time dedicated to each training areas, irrelevant case-studies, and ethics "checklists" have resulted in bare-bones Responsible Conduct of Research (RCR) training for present biomedical graduate student researchers. Here, we argue that science graduate students be taught classical ethical theory, such as virtue ethics, consequentialist theory, and deontological theory, to provide a basic framework to guide researchers through ethically complex situations and examine the applicability, implications, and societal ramifications of their research. Using a relevant biomedical research example to illustrate this point, we argue that proper ethics training for graduate student researchers not only will enhance current RCR training, but train more creative, responsible scientists.
Quiroz, Estela; Médica oftalmóloga, docente de ética y metodología de la investigación, Coordinadora de la Red Peruana de Comités de Ética de la Investigación. Hospital Nacional Hipólito Unanue. Lima, Perú.
Ethics committees in biomedical research have the responsibility to ensure the protection of human participants in the studies. In order to improve the quality of their work they must undergo audit procedures commissioned by the sponsors and inspections done by the regulatory authorities. Through these procedures, improvement of their functions should be guaranteed, so they can optimize their tasks and accomplish in the best way the purpose for which they were created. Los comités de ét...
Trace, Samantha; Kolstoe, Simon Erik
The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called "Shared Ethical Debate" (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes. We present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published "mystery shopper" exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise. Our analysis highlights qualitative differences between the ShED 19, ShED 20 and "mystery shopper" exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises. ShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be.
Harris, Raychelle; Holmes, Heidi M.; Mertens, Donna M.
Codes of ethics exist for most professional associations whose members do research on, for, or with sign language communities. However, these ethical codes are silent regarding the need to frame research ethics from a cultural standpoint, an issue of particular salience for sign language communities. Scholars who write from the perspective of…
Kralik, Debbie; Warren, Jim; Price, Kay; Koch, Tina; Pignone, Gino
The aim of this paper is to identify and discuss the ethical considerations that have confronted and challenged the research team when researchers facilitate conversations using private electronic mail discussion lists. The use of electronic mail group conversations, as a collaborative data generation method, remains underdeveloped in nursing. Ethical challenges associated with this approach to data generation have only begun to be considered. As receipt of ethics approval for a study titled; 'Describing transition with people who live with chronic illness' we have been challenged by many ethical dilemmas, hence we believe it is timely to share the issues that have confronted the research team. These discussions are essential so we can understand the possibilities for research interaction, communication, and collaboration made possible by advanced information technologies. Our experiences in this study have increased our awareness for ongoing ethical discussions about privacy, confidentiality, consent, accountability and openness underpinning research with human participants when generating data using an electronic mail discussion group. We describe how we work at upholding these ethical principles focusing on informed consent, participant confidentiality and privacy, the participants as threats to themselves and one another, public-private confusion, employees with access, hackers and threats from the researchers. A variety of complex issues arise during cyberspace research that can make the application of traditional ethical standards troublesome. Communication in cyberspace alters the temporal, spatial and sensory components of human interaction, thereby challenging traditional ethical definitions and calling to question some basic assumptions about identity and ones right to keep aspects of it confidential. Nurse researchers are bound by human research ethics protocols; however, the nature of research by electronic mail generates moral issues as well as ethical
Chapman, Audrey R
Just as human embryonic stem cell research has generated controversy about the uses of human embryos for research and therapeutic applications, human embryonic stem cell patents raise fundamental ethical issues. The United States Patent and Trademark Office has granted foundational patents, including a composition of matter (or product) patent to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison's intellectual property office. In contrast, the European Patent Office rejected the same WARF patent application for ethical reasons. This article assesses the appropriateness of these patents placing the discussion in the context of the deontological and consequentialist ethical issues related to human embryonic stem cell patenting. It advocates for a patent system that explicitly takes ethical factors into account and explores options for new types of intellectual property arrangements consistent with ethical concerns.
In modern day, Human Resource Management (HRM) is seen as a mere variant of management control aiming intentionally to ‘colonize’ the identity of the individual employee which points to the contradictions between the idealised HRM theories and its practice commonly referred to as the difference between rhetoric and reality. These critical analyses suggest that HRM reflects a historical shift in the way work is defined and managed and research has to be undertaken on how morality and ethics ma...
Hernández-Marrero, Pablo; Martins Pereira, Sandra; de Sá Brandão, Patrícia Joana; Araújo, Joana; Carvalho, Ana Sofia
Introduction Antimicrobial resistance (AMR) is a challenging global and public health issue, raising bioethical challenges, considerations and strategies. Objectives This research protocol presents a conceptual model leading to formulating an empirically based bioethics framework for antibiotic use, AMR and designing ethically robust strategies to protect human health. Methods Mixed methods research will be used and operationalized into five substudies. The bioethical framework will encompass and integrate two theoretical models: global bioethics and ethical decision-making. Results Being a study protocol, this article reports on planned and ongoing research. Conclusions Based on data collection, future findings and using a comprehensive, integrative, evidence-based approach, a step-by-step bioethical framework will be developed for (i) responsible use of antibiotics in healthcare and (ii) design of strategies to decrease AMR. This will entail the analysis and interpretation of approaches from several bioethical theories, including deontological and consequentialist approaches, and the implications of uncertainty to these approaches.
Prof. Ph.D. Cãtãlina Bonciu
Full Text Available In the contemporary business world ethics represents one of the most exciting challenges,precisely because there is still no universally valid modality for solving a problem of this kind. Adopting anethic personal behavior does not always ensure winning in the problems regarding the actual business, norin the organizational behavior itself. The personal values, either native or gained by an individual throughouthis socializing do not represent a support or advantage in the attitude towards the economic life. What is it that actually concerns the managers:to succeed in their activity or to have an ethic activity? A successful business is necessarily an ethic one, or one lacking ethics? In particular, should the human resources manager choose the human factor of solid moral and ethic grounds, or the one exclusively focused on money quantifiable performance?
Sampson, Deborah A; Caldwell, Dennis; Taylor, Andre D; Taylor, Jacquelyn Y
In this paper, we examine the implementation and difficulties when conducting genetics research in a rural, traditional West African culture within the frame of the United States' grounded research ethics. Research challenges are highlighted by Western researchers following U.S. Institutional Review Board (IRB) guidelines and practices in a non-Western country. IRB concepts are culture bound in Western ideals that may not have synchronicity and compatibility with non-Western cultures. Differences in sociocultural norms, traditions, language, and geography were influencing factors that can affect application of IRB principles. Suggestions for change are offered, which will potentially aid researchers considering application of IRB requirements when conducting research in non-Westernized, non-industrialized countries.
J Sanmukhani; C B Tripathi
Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organiza...
Khanlou, N; Peter, E
This paper addresses the distinctive nature of participatory action research (PAR) in relation to ethical review requirements. As a framework for conducting research and reducing health disparities, PAR is gaining increased attention in community and public health research. As a result, PAR researchers and members of Research Ethics Boards could benefit from an increased understanding of the array of ethical concerns that can arise. We discuss these concerns in light of commonly held ethical requirements for clinical research (social or scientific value, scientific validity, fair subject/participant selection, favourable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled participants) and refer to guidelines specifically developed for participatory research in health promotion. We draw from our community-based experiences in mental health promotion research with immigrant and culturally diverse youth to illustrate the ethical advantages and challenges of applying a PAR approach. We conclude with process suggestions for Research Ethics Boards.
The act of engaging in sound and ethical practitioner research, regardless of context, encourages and indeed demands an alignment between the ethical framework employed in the research enterprise and the "everyday ethics" of practice. This paper explores the ethical dimensions of what Cochran-Smith and Lytle have termed the dialectic of…
Specker Sullivan, L.; Illes, J.
Objective. Sophisticated signal processing has opened the doors to more research with human subjects than ever before. The increase in the use of human subjects in research comes with a need for increased human subjects protections. Approach. We quantified the presence or absence of ethics language in published reports of brain-computer interface (BCI) studies that involved human subjects and qualitatively characterized ethics statements. Main results. Reports of BCI studies with human subjects that are published in neural engineering and engineering journals are anchored in the rationale of technological improvement. Ethics language is markedly absent, omitted from 31% of studies published in neural engineering journals and 59% of studies in biomedical engineering journals. Significance. As the integration of technological tools with the capacities of the mind deepens, explicit attention to ethical issues will ensure that broad human benefit is embraced and not eclipsed by technological exclusiveness.
Honan, Eileen; Hamid, M. Obaidul; Alhamdan, Bandar; Phommalangsy, Phouvanh; Lingard, Bob
The gap between theoretical expectations of research ethics as outlined in the bureaucratic processes associated with University Ethics Committees and the situated realities of students undertaking studies within their own sociocultural contexts is explored in this paper. In particular, the authors investigate differences in ethical norms and…
However, if there is no adequate evidence of benefit to the patient, then ... In fact, international and local ethical guidelines for research involving human participants do not have specific ... they can be applied as and when they are needed at.
Sørensen, Nelli Øvre; Øye, Christine; Glasdam, Stinne
Abstract Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies...... research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research...... ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop....
Sharp, Richard R; Taylor, Holly A; Brinich, Margaret A; Boyle, Mary M; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin
The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.
Sharp, Richard R.; Taylor, Holly A.; Brinich, Margaret A.; Boyle, Mary M.; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin
The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include: assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical Translational Science Award (CTSA) Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: 1) managing multiple institutional roles and responsibilities, 2) managing sensitive information, and 3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services. PMID:25607942
Wolpe, Paul Root; Rommelfanger, Karen S.; Borenstein, Jason
Recent developments in bioengineering promise the possibility of new diagnostic and treatment strategies, novel industrial processes, and innovative approaches to thorny problems in fields such as nutrition, agriculture, and biomanufacturing. As modern genetics has matured and developed technolog......-producing countries of the world, offers a set of ethical principles to contribute to the ethical conversation about human cellular biotechnological research moving forward....
Maísa Araujo Costa
Full Text Available Objective: the study aims to analyze the social representations on the ethical and bioethical aspects in the research elaborated by academics of the Dentistry Course. Methods: it is a qualitative research based on the Theory of Social Representations carried out with 80 academics of the Dentistry course. The data were collected through a semi-structured interview script, processed in the IRaMuTeQ and analyzed by the Descending Hierarchical Classification. The study followed the ethical standards recommended by Resolution n. 466/2012, obtaining approval from the Ethics Committee of UNINOVAFAPI University Center. Results: The corpus analyzed in the study is composed of 79 units of initial context (UCI with use of 62%. The results are presented in four classes, namely: 4. The understanding of Ethics and Bioethics in research; 3. Researcher's social position; 1. Legal responsibilities of the researcher and 2. Normative aspects of research ethics - legal basis. Conclusion: Scholars represent ethical and bioethical aspects in research as essential to respect human dignity and protect the lives of research participants, with a focus on normative aspects of research ethics through Research Committees. Their attitudes are guided by their conditions of life, their beliefs and cultures of different social contexts. Keywords: Bioethics, ethics, social psychology.
Haahr, Anita; Norlyk, Annelise; Hall, Elisabeth
Nurse researchers engaged in qualitative interviews with patients and spouses in healthcare may often experience being in unforseen ethical dilemmas. Researchers are guided by the bioethical principles of justice, beneficence, non-maleficence respect for human rights and respect for autonomy...... through the entire research process. However, these principles are not sufficient to prepare researchers for unanticipated ethical dilemmas related to qualitative researchs interviews. We describe and discuss ethically challenging and difficult moments embedded in two cases from our own phenomenological...... interview studies. We argue that qualitative interviews involve navigation between being guided by bioethics as a researcher, being a therapist/nurse and being a fellow human being or even a friend. The researchers' premises to react to unexpected situations and act in a sound ethical manner must...
This article is meant to describe and analyze some of the ethical difficulties encountered in a pilot research on treatment decisions of patients with chronic viral hepatitis C infection in Romania. It departs from an overview of the main ethics codes, and it shows that social health research on patients falls in between institutional codes of ethics. Furthermore, the article moves on to analyze so-called "important moments" of empirical research, such as the implementation of the ethical protocol, dealing with informal payments and with information on shady actions, as well as requests of information from interviewed patients and deciding when and if to breach confidentiality. In an attempt to evaluate the ad hoc solutions found in the field, the concluding remarks discuss these issues at the threshold of theory and practice.
Marcia Patton-Mallory; Kathleen Franzreb; Charles Carll; Richard Cline
The USDA Forest Service recently developed and adopted a code of ethical conduct for scientific research and development. The code addresses issues related to research misconduct, such as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results, as well as issues related to professional misconduct, such...
Licata, Marta; Monza, Francesca
In recent years, archaeologists and anthropologists involved in the study of human remains have had to take into consideration ethical issues, which have come to the fore. The aim of this study is to illustrate the ethical and religious issues involved in relation to the positions of researchers. Ethical issues involve the different study phases of human remains: archaeological excavation, anthropological analysis and, finally, museum display. Osteoarchaeological remains may find a place in museums. However, in recent years, even the display of human remains museum has had to face new important ethical issue involving previously ignored or neglected aspect. The adoption of Native American Grave Protection Act in 1990 in the United States and the Human Tissue Act in 2004 in England, has created new scenarios relating to the storage of human remains in museum. All this caused a series of changes in the study of human remains, but many issues remain open to debate.
Liaw, Siaw-Teng; Tam, Chun Wah Michael
The underlying moral principles and values, and the virtues held as desirable for a researcher, should be reflected upon and embedded in the research. The foundation step is to download the National Health and Medical Research Council's (NHMRC's) National Statement on Ethical Conduct in Human Research and the NHMRC's Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research to use as references. This paper draws on the experience of The Royal Australian College of General Practitioners' (RACGP's) National Research and Evaluation Ethics Committee to provide an eight-step approach to the research ethics process. The researcher should use the research ethics process as an opportunity to foster and guide the development and conduct of ethical research.
Malaria vector research presents several dilemmas relating to the various ways in which humans are used in the malaria vector research enterprise. A review of the past and present practices reveals much about the prevailing attitudes and assumptions with regard to the ethical conduct of research involving humans.
In exceptional cases, the German Stem Cell Act allows research on human embryonic stem cells. However, it does not allow the implementation of the research results if this in turn requires the use of further embryonic stem cell lines. It has, in the meantime, transpired that such research results could be of concrete use. Thus, in the distant future, it could be used in the clinical treatment of patients. Already in the nearer future the use of human embryonic stem cell lines can be envisaged for both the development and testing of medicines as well as in the field of toxicology. To this end, research concerning embryo toxicity and neurotoxicity is ground-breaking. The toxicological and pharmacological use of human embryonic stem cell lines should serve the protection of human health as well as the safe and reliable use of medicines. In addition, animal experiments could be reduced, which is desirable from a point of view of animal protection ethics. Since research on human embryonic stem cell lines is actually permitted in Germany, the use of the respective research results should be allowed all the more. This follows from the basic human right to health protection and health care. Legal ambiguities, which still exist in this respect, should be removed.
[International regulation of ethics committees on biomedical research as protection mechanisms for people: analysis of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research of the Council of Europe].
de Lecuona, Itziar
The article explores and analyses the content of the Council of Europe's Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research regarding the standard legal instrument in biomedical research, issued by an international organization with leadership in bioethics. This implies ethics committees are mechanisms of protection of humans in biomedical research and not mere bureaucratic agencies and that a sound inescapable international regulatory framework exists for States to regulate biomedical research. The methodology used focuses on the analysis of the background, the context in which it is made and the nature and scope of the Protocol. It also identifies and analyses the characteristics and functions of ethics committees in biomedical research and, in particular, the information that should be provided to this bodies to develop their functions previously, during and at the end of research projects. This analysis will provide guidelines, suggestions and conclusions for the awareness and training of members of these committees in order to influence the daily practice. This paper may also be of interest to legal practitioners who work in different areas of biomedical research. From this practical perspective, the article examines the legal treatment of the Protocol to meet new challenges and classic issues in research: the treatment of human biological samples, the use of placebos, avoiding double standards, human vulnerability, undue influence and conflicts of interest, among others. Also, from a critical view, this work links the legal responses to develop work procedures that are required for an effective performance of the functions assigned of ethics committees in biomedical research. An existing international legal response that lacks doctrinal standards and provides little support should, however, serve as a guide and standard to develop actions that allow ethics committees -as key bodies for States- to advance in
The complexities of the ethics and truth in archival research are often unrecognised or invisible in educational research. This paper complicates the process of collecting data in the archives, as it problematises notions of ethics and truth in the archives. The archival research took place in the former Czechoslovakia and its turbulent political…
This paper addresses ethical issues in educational research with a focus on the interplay between research ethics and both internal and external quality of research. Research ethics is divided into three domains: (1) ethics "within" the research community; (2) ethics concerning relationships with "individuals and groups directly…
Condell, Sarah L
Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as an early \\'rite of passage\\' in the category of \\'labouring the doctorate\\'. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of \\'medicalized\\' research ethics is further explored including its meaning for nursing or midwifery research.
Cho, Mildred K.; Tobin, Sara L.; Greely, Henry T.; McCormick, Jennifer; Boyce, Angie; Magnus, David
Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. PMID:18570086
The aim of my talk is to discuss how we can consider Michel Foucault’s concept of ethos and his endeavor for endless critique as an important contribution to research ethics in educational research. First, I intend to outline Foucault’s concept of ethos and its link to his concept of critique....... Second, I intend to demonstrate how it can fruitfully be applied to the established research ethics within qualitative research. This will occur through examples culled from a qualitative research project on the application of project studies (PBL) as a method at two Danish universities. The findings...... students. This had a significant impact on the possibilities and educational success of the students: while some students were marginalized or even excluded from the groups (and maybe even from the university) others were subjectivated as successful students. Thus, the findings points at ethics in general...
Warrell, Jacqueline G.; Jacobsen, Michele
A growing number of education and social science researchers design and conduct online research. In this review, the Internet Research Ethics (IRE) policy gap in Canada is identified along with the range of stakeholders and groups that either have a role or have attempted to play a role in forming better ethics policy. Ethical issues that current…
Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers. A problem-solving approach was used in this study. It began with problem identification, evaluation of the action-oriented research goal, investigation of the constraints to the problem, and recommendation of some relevant alternatives to address the central issue. Ethical Consideration: The approval for conducting the action-oriented research that being investigated in this work was only obtained from the Head of local district. Some ethical issues were found in this case. No special protection for this population, no informed consent was obtained from the participants, exposure to social and economic risks, no future benefits for the subjects, and conflict of interests. Lack of control from the local research ethics committee and lack of competence of local researchers on human subject research were considered as the constraints to the problems. Creating an independent research ethics committee, providing research ethics training to the local researchers, obtaining written/video consents from underserved populations, and meeting local health needs were recommended alternatives to solve these problems. Indonesian government bodies should reform their international collaborative system on research involving human subjects. Exploitation may not occur if all participants as well as all local and national governing bodies
Rhett H. Bennett
Full Text Available Collection of data from animals for research purposes can negatively impact target or by-catch species if suitable animal ethics practices are not followed. This study aimed to assess the ethical requirements of peer-reviewed scientific journals that publish primary literature on fishes, and review the ethical considerations and animal care guidelines of national and international documents on the ethical treatment of animals for research, to provide an overview of the general ethical considerations for field research on fishes. A review of 250 peer-reviewed, ISI-rated journals publishing primary research on fishes revealed that nearly half (46% had no mention of ethics, treatment of animals or ethical requirements for publication in their author guidelines or publication policies. However, 18% of the journals reviewed identify a specific set of ethical guidelines to be followed before publishing research involving animals. Ethical considerations for investigators undertaking field research on fishes, common to most animal care policies, legislation and guiding documents, include adhering to relevant legislation, minimising sample sizes, reducing or mitigating pain and distress, employing the most appropriate and least invasive techniques and accurately reporting methods and findings. This information will provide potential investigators with a useful starting point for designing and conducting ethical field research. Application of ethical best practices in field sampling studies will improve the welfare of study animals and the conservation of rare and endangered species. Conservation implications: This article provides a list of ethical considerations for designing and conducting field research on fishes. By reviewing sampling techniques and processes that are frequently used in field research on fishes and by highlighting the potential negative impacts of these sampling techniques, this article is intended to assist researchers in planning
Hansson, Sven Ove
Research is subject to more stringent ethical requirements than most other human activities, and a procedure that is otherwise allowed may be forbidden in research. Hence, risk-taking is more restricted in scientific research than in most non-research contexts, and privacy is better protected in scientific questionnaires than in marketing surveys. Potential arguments for this difference are scrutinized. The case in its favour appears to be weak. A stronger case can be made in favour of a difference in the opposite direction: If perilous or otherwise problematic activities have to be performed it is usually better to perform them in a research context where they are properly evaluated so that guidance is obtained for the future. However, retreating from current ethical demands on research is not a desirable direction to go. Instead, research ethics can serve to inspire the introduction of more stringent ethical principles in other social sectors.
Ivanov, Luba L; Oden, Tami L
Public health nursing has a code of ethics that guides practice. This includes the American Nurses Association Code of Ethics for Nurses, Principles of the Ethical Practice of Public Health, and the Scope and Standards of Public Health Nursing. Human rights and Rights-based care in public health nursing practice are relatively new. They reflect human rights principles as outlined in the Universal Declaration of Human Rights and applied to public health practice. As our health care system is restructured and there are new advances in technology and genetics, a focus on providing care that is ethical and respects human rights is needed. Public health nurses can be in the forefront of providing care that reflects an ethical base and a rights-based approach to practice with populations. © 2013 Wiley Periodicals, Inc.
Dove, Edward S.; Knoppers, Bartha M.; Zawati, Ma'n H.
Although increasingly global, data-driven genomics and other ‘omics’-focused research hold great promise for health discoveries, current research ethics review systems around the world challenge potential improvements in human health from such research. To overcome this challenge, we propose a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data-driven international research projects while respecting globally transposable research ethics norms and principles. The Safe Harbor would consist in part of an agency supporting an International Federation for Ethics Review (IFER), formed by a voluntary compact among countries, granting agencies, philanthropies, institutions, and healthcare, patient advocacy, and research organizations. IFER would be both a central ethics review body, and also a forum for review and follow-up of policies concerning ethics norms for international research projects. It would be built on five principle elements: (1) registration, (2) compliance review, (3) recognition, (4) monitoring and enforcement, and (5) public participation. The Safe Harbor would create many benefits for researchers, countries, and the general public, and may eventually have application beyond (gen)omics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks. PMID:27774154
Full Text Available This article contextualizes the emergence of the field of research ethics in historical, social, and political events over the last 60 years. It draws a distinction between professional ethics and bioethics, focusing on the historical and philosophical precedents of the latter field. It also presents the appearance of research ethics as a result of the disclosure of cases of scientific misconduct, discussing the first regulations on research ethics, the guidelines contained in the Belmont Report, and its influence on the creation of bioethical principlism. The article also analyzes the functioning of research ethics committees and possible limitations to scientific activity. Finally, it highlights some issues that remain unsolved, such as payment to research participants, the conduct of research on unconscious people, using children in experiments for testing new drugs or new therapeutic indications, the definition of minimum risk, and the way bioethics has been taking place in developing countries.
Colvin, Jan; Lanigan, Jane
With rapidly increasing public use of the Internet and advances in Web technologies, family and consumer sciences researchers have the opportunity to conduct Internet-based research. However, online research raises critical ethical issues concerning human subjects that have an impact on research practices. This article provides a review of the…
Background: Scandals have occurred over time involving conduct of research in different parts of the world. This study was aimed at exploring researchers' perception, understanding, appreciation and practice of research ethics during research on human subjects. Methods: A qualitative approach using the exploratory and ...
The author purports the need to treat moral education as a serious academic subject and suggests ways educators can manage it in an intellectually defensible way. Ethical education must avoid indoctrination, yet it should not be a mere training in philosophical ethics. The domain of moral education should include four partially interdependent…
Jennifer B McCormick
Full Text Available Research ethics consultation programs are being established with a goal of addressing the ethical, societal, and policy considerations associated with biomedical research. A number of these programs are modelled after clinical ethics consultation services that began to be institutionalized in the 1980s. Our objective was to determine biomedical science researchers' perceived need for and utility of research ethics consultation, through examination of their perceptions of whether they and their institutions faced ethical, social or policy issues (outside those mandated by regulation and examination of willingness to seek advice in addressing these issues. We conducted telephone interviews and focus groups in 2006 with researchers from Stanford University and a mailed survey in December 2006 to 7 research universities in the U.S.A total of 16 researchers were interviewed (75% response rate, 29 participated in focus groups, and 856 responded to the survey (50% response rate. Approximately half of researchers surveyed (51% reported that they would find a research ethics consultation service at their institution moderately, very or extremely useful, while over a third (36% reported that such a service would be useful to them personally. Respondents conducting human subjects research were more likely to find such a service very to extremely useful to them personally than respondents not conducting human subjects research (20% vs 10%; chi(2 p<0.001.Our findings indicate that biomedical researchers do encounter and anticipate encountering ethical and societal questions and concerns and a substantial proportion, especially clinical researchers, would likely use a consultation service if they were aware of it. These findings provide data to inform the development of such consultation programs in general.
Petrick, Joseph A.
Surveys literature on organizational moral development and describes research methodology employed, summarizes research findings, and examines career implications for human resource professionals. Contends that institutionalizing an ethics program can impact favorably on both the organization and the career of the implementing human resource…
ACRE observes IDRC's Corporate Principles on Research Ethics. ... various published statements on the management of environmental research. ... equity while remaining sensitive to the cultural norms and practices of the localities where the ...
Stewart, Robert J; Reider, Bruce
This article explores the background and foundations of ethics in research. Some important documents and codes are mentioned, such as The Belmont Report and the International Conference of Harmonisation. Some influential historical events involving research ethics are recounted. The article provides a detailed discussion of the Declaration of Helsinki, which is considered the international standard for guidelines in medical research ethics. The most salient features of the Declaration are described and related to orthopaedic surgery and sports medicine. Some of the most controversial aspects of the Declaration are discussed, which helps examine contentious areas of research in sports medicine. Copyright © 2016 Elsevier Inc. All rights reserved.
Driessen, A.; Sollie, Paul; Düwell, Marcus
This chapter summarizes the reflections of a scientist active in optical communication about the need of ethical considerations in technological research. An optimistic definition of ethics, being the art to make good use of technology, is proposed that emphasizes the necessarily involvement of not
Page, Alice K
Human subjects research has been the focus of numerous controversies over the years. The dilemma lies between the potential harm to individuals who participate in research and the knowledge to be gained from the research study that might benefit society. When research is conducted in developing countries by researchers and sponsors from the United States and other industrialized countries, differences in history, culture, politics, wealth, and power between the countries give rise to unique challenges. In this Article, the author identifies several ethical issues to be considered when research is conducted in developing countries and provides the legal and ethical framework for their resolution.
Mondragón Barrios, Liliana; Guarneros García, Tonatiuh; Jiménez Tapia, Alberto
The objective of this article is to compare various ethical issues considered by social scientists and research ethics committees in the evaluation of mental health social research protocols. We contacted 47 social scientists and 10 members of ethics committees in Mexico with two electronic national surveys that requested information from both groups related to the application of ethical principles in mental health social research. The results showed no significant difference between these groups in the value placed on the ethical issues explored. Based on this finding, we make proposals to strengthen the collaboration between the two groups.
... Care Genomic Medicine Working Group New Horizons and Research Patient Management Policy and Ethics Issues Quick Links for Patient Care Education All About the Human Genome Project Fact Sheets Genetic Education Resources for ...
Goldenberg, Shira M; Brouwer, Kimberly C; Jimenez, Teresita Rocha; Miranda, Sonia Morales; Mindt, Monica Rivera
Migrant sex workers are often highly marginalized and disproportionately experience health and social inequities, including high prevalence of HIV, sexually transmitted infections, and human rights violations. In recent years, research involving migrant sex workers has increased, yet many knowledge gaps remain regarding how best to protect research participant rights and welfare. Our objective was to identify key challenges and opportunities related to the responsible conduct of HIV research with migrant sex workers. Focus groups and interviews conducted with 33 female sex workers ≥18 years old at the Guatemala-Mexico border from June 2013-February 2014 were analyzed. Participants were recruited through community outreach by a local HIV prevention organization to sex work establishments such as bars, hotels, street corners, and truck stops. Key themes influencing research engagement for migrant sex workers included researcher mistrust and fear related to research participation, rooted in the social isolation frequently faced by recent migrants; intersecting concerns related to immigration status, fear of criminalization, and compliance with sex work regulations; and perceived benefits and risks of HIV/STI testing for migrants (e.g., immigration implications, stigma) represent potential barriers and opportunities for the responsible conduct of research involving migrant sex workers. Results highlight the intersection between the human rights vulnerabilities of migrant sex workers and barriers to research participation, including social isolation of migrants and policy/legal barriers related to immigration and sex work. Findings illustrate the need for researchers to develop population-tailored procedures to address fears related to immigration and criminalization, and to reinforce positive and non-stigmatizing relationships with migrant sex workers. Community-led efforts to reduce stigma and foster community organization and supports for migrant sex workers are
Shira M Goldenberg
Full Text Available Migrant sex workers are often highly marginalized and disproportionately experience health and social inequities, including high prevalence of HIV, sexually transmitted infections, and human rights violations. In recent years, research involving migrant sex workers has increased, yet many knowledge gaps remain regarding how best to protect research participant rights and welfare. Our objective was to identify key challenges and opportunities related to the responsible conduct of HIV research with migrant sex workers.Focus groups and interviews conducted with 33 female sex workers ≥18 years old at the Guatemala-Mexico border from June 2013-February 2014 were analyzed. Participants were recruited through community outreach by a local HIV prevention organization to sex work establishments such as bars, hotels, street corners, and truck stops.Key themes influencing research engagement for migrant sex workers included researcher mistrust and fear related to research participation, rooted in the social isolation frequently faced by recent migrants; intersecting concerns related to immigration status, fear of criminalization, and compliance with sex work regulations; and perceived benefits and risks of HIV/STI testing for migrants (e.g., immigration implications, stigma represent potential barriers and opportunities for the responsible conduct of research involving migrant sex workers.Results highlight the intersection between the human rights vulnerabilities of migrant sex workers and barriers to research participation, including social isolation of migrants and policy/legal barriers related to immigration and sex work. Findings illustrate the need for researchers to develop population-tailored procedures to address fears related to immigration and criminalization, and to reinforce positive and non-stigmatizing relationships with migrant sex workers. Community-led efforts to reduce stigma and foster community organization and supports for migrant
Researchers using qualitative methodologies appear to be particularly prone to having their study designs called into question by research ethics or funding agency review committees. In this paper, the author considers the issue of communicating qualitative research study designs in the context of institutional research ethics review and offers…
Mortari, Luigina; Harcourt, Deborah
This article will explore some of the ethical dilemmas that confront researchers when they seek to invite children's participation in research. It firstly tracks the historical landscape of ethical research and will examine the influence of the United Nations Convention on the Rights of the Child (UNCRC) on participatory research with children.…
Full Text Available Ethical issues that appear in researching children are the subject matter of relatively rich scientific literature, as well as a multitude of national and professional ethical codices. The broad thematization of ethical principles is indeed instigated by the rise of awareness of the seriousness of this problem, as well as by growing fears of potential abuse of children in contemporary research projects. General assertion that children are a vulnerable category of subjects that require special attention and protection from misuse in research projects prevails in literature. The main objective of this paper is to present general ethical issues that various areas of expertise researchers face when children and youth are the subjects of their studies. The principle of voluntary participation, the principle of balanced researcher - respondent relationship, and the principles of privacy, confidentiality and anonymity in studies of children are particularly presented.
Ensign, Josephine; Ammerman, Seth
This paper is a report of a study to document researcher, healthcare provider and programme administrators' experiences with ethical issues in research with homeless youths in North America. While there are legal and ethical guidelines for research with adolescents and with vulnerable populations in general, there are no specific guidelines for the ethical conduct of research with homeless youths. Using a web-based questionnaire, healthcare and social service providers, programme administrators and researchers working with homeless young people throughout the United States of America and Canada were surveyed in 2005. The survey group consisted of 120 individuals; a total of 72 individuals completed the survey. Survey questions included experiences with using incentives in research with homeless youths, consent and experiences with ethics review boards. Numerical data were analysed using frequencies and cross-tabulations. Text data were analysed qualitatively. Researchers doing mental health and/or substance use research tended to use money as a research incentive, whereas healthcare providers and programme administrators tended to use non-monetary incentives. The majority of respondents reported using written consent for research from homeless youths, including minors. Respondents reporting difficulties with ethics review boards were mainly involved with intervention research. Consensus is needed from a variety of stakeholders, including homeless youths and service providers, on use of various types of research incentives for different types of research, as well as use of consent for homeless youths who are minors.
Sep 12, 2012 ... Research Award: Advisory Committee on Research Ethics. Deadline: ... The Research Awardee will spend one year at IDRC and work approximately 50% of the time on her/his own research and 50% on ACRE-related tasks.
Grass, Guido [Koeln Univ. (Germany). Ethik-Kommission der Medizinischen Fakultaet
Taking into account the state of the science, the ethics committee has to decide in research projects with study-related radiation exposure, whether a compelling need for the research project exists. During the critical appraisal, further ethical and legal aspects have to be considered. Even without an application according to X-ray Ordinance (RoeV) or Radiation Protection Ordinance (StrlSchV), the Ethics Committee should advise the applicant whether from their perspective the project requires an approval according to RoeV and StrlSchV. This requires the regular involvement of expert members.
Full Text Available Social engineering is deeply entrenched in the fields of both computer science and social psychology. Knowledge is required in both these disciplines to perform social engineering based research. Several ethical concerns and requirements need...
This chapter discusses the main research ethical concerns that arise in internet research and reviews existing research ethical guidance in the Irish context in relation to its application to internet research. The chapter begins with a brief outline of high profile cases in the early history of the internet that highlighted specific emerging…
Biggs, John S. G.; Marchesi, August
The principal ethics committee in Australia's Capital, Canberra, underwent a major revision in the last three years based on changes debated in the literature. Committee or Board structure varies widely; regulations determining minimum size and membership differ between countries. Issues such as the effectiveness of committee management,…
Rivera, Roberto; Borasky, David; Rice, Robert; Carayon, Florence
The demand for basic research ethics training has grown considerably in the past few years. Research and education organizations face the challenge of providing this training with limited resources and training tools available. To meet this need, Family Health International (FHI), a U.S.-based international research organization, recently developed a Research Ethics Training Curriculum (RETC). It was designed as a practical, user-friendly tool that provides basic, up-to-date, standardized training on the ethics of human research. The curriculum can easily be adapted to different audiences and training requirements. The RETC was reviewed by a group of international experts and field tested in five countries. It is available in English, French, and Spanish as a three-ring binder and CD-ROM, as well as on the Web. It may be used as either an interactive self-study program or for group training.
Jacob Dahl Rendtorff
Full Text Available This paper presents the concept of ethical economy (Wirtschaftsethik and the relation between ethics and economics on the basis of the work of the German ethical economist Peter Koslowski. The concept of ethical economy includes three levels: micro, meso and macro levels; and it also deals with the philosophical analysis of the ethical foundations of the economy. After the discussion of these elements of the ethical economy, the paper presents some possible research topics for a research agenda about economic ethics or ethical economy.
Sunderland, Mary E; Nayak, Rahul Uday
It is widely accepted that translational research practitioners need to acquire special skills and knowledge that will enable them to anticipate, analyze, and manage a range of ethical issues. While there is a small but growing literature that addresses the ethics of translational research, there is a dearth of scholarship regarding how this might apply to engineers. In this paper we examine engineers as key translators and argue that they are well positioned to ask transformative ethical questions. Asking engineers to both broaden and deepen their consideration of ethics in their work, however, requires a shift in the way ethics is often portrayed and perceived in science and engineering communities. Rather than interpreting ethics as a roadblock to the success of translational research, we suggest that engineers should be encouraged to ask questions about the socio-ethical dimensions of their work. This requires expanding the conceptual framework of engineering beyond its traditional focus on "how" and "what" questions to also include "why" and "who" questions to facilitate the gathering of normative, socially-situated information. Empowering engineers to ask "why" and "who" questions should spur the development of technologies and practices that contribute to improving health outcomes.
Valenzuela, Carlos Y
A scientific article censured by superposing obstacles to its reading remembers the censure of Galileo made by the Inquisition. The censure followed the failure to obtain the informed consent (IC) to disclose results of old samples. At present, the use of collected data or samples for a new research needs a new IC, in most ethical protocols. The Helsinki Code allows the research ethics committees the authorization for the use of that information. This norm is founded rather in commercial, legal or protective arguments than in ethical bases. This article criticizes this norm from the Scientific Ethics viewpoint because: i) the ownership of the genome and environment that originate a person is not of such person but of the human society and Homo sapiens species, ii) a person is not the unique owner of that information; laboratories, institutions, health services and research teams add constituents to it, iii) several violations to this norm occurring in medical, labor, legal and social practice show it as biased against science, iv) if this stored information and its use are beneficial for humankind (its proper owner) it is ethically obligatory to use it. It is proposed to create an anonymous World Bank for Human Information with open access and universal transparency. This universal collection of data handled under universal accepted ethical norms should prevent exclusive private use of public information, non-publication of negative results, illicit and unethical use of human data.
Bolt, Barbara; Vincs, Robert
In Australia, the university ethics approval process is guided by the "National Statement on Ethical Conduct in Human Research." The "National Statement" does not provide a hurdle to be overcome or avoided, nor is it a Godzilla-like monster that must be slain for "truth" to survive. Rather the "National…
Crozier, G K D; Schulte-Hostedde, Albrecht I
We argue that the ecological research community should develop a plan for improving the ethical consistency and moral robustness of the field. We propose a particular ethics strategy--specifically, an ongoing process of collective ethical reflection that the community of ecological researchers, with the cooperation of applied ethicists and philosophers of biology, can use to address the needs we identify. We suggest a particular set of conceptual (in the form of six core values--freedom, fairness, well being, replacement, reduction, and refinement) and analytic (in the forms of decision theoretic software, 1000Minds) tools that, we argue, collectively have the resources to provide an empirically grounded and conceptually complete foundation for an ethics strategy for ecological research. We illustrate our argument with information gathered from a survey of ecologists conducted at the 2013 meeting of the Canadian Society of Ecology and Evolution.
Ethics, a branch of philosophy, has a place in the regulatory framework of human subjects research. Sometimes, however, ethical concepts and arguments play a more central role in scientific activity. This can happen, for example, when violations of research norms are also ethical violations. In such a situation, ethical arguments can be marshaled to improve the quality of the scientific research. I explore two different examples in which philosophers and scientists have used ethical arguments to plead for epistemological improvements in the conduct of research. The first example deals with research dishonesty in pharmaceutical development. The second example is concerned with neuropsychological research using fMRI technology.
London, Alex John; Carlisle, Benjamin
Phase IV studies are often criticized for poor scientific standards. Yet they provide an important resource for addressing evidence shortfalls in drug safety, comparative effectiveness, and real-world utility. Current research ethics policies, and contemplated revisions to them, do not provide an adequate framework for preventing social harms that result from poor post-marketing research practice. Rather than focus exclusively on the welfare and interests of human volunteers, research policies and ethics should also safeguard the integrity of the research enterprise as a system for producing reliable medical evidence. We close by briefly describing how an integrity framework might be implemented for phase IV studies. PMID:22556237
Haintz, Greer Lamaro; Graham, Melissa; McKenzie, Hayley
Health promotion researchers must consider the ethics of their research, and are usually required to abide by a set of ethical requirements stipulated by governing bodies (such as the Australian National Health and Medical Research Council) and human research ethics committees (HRECs). These requirements address both deontological (rule-based) and consequence-based issues. However, at times there can be a disconnect between the requirements of deontological issues and the cultural sensitivity required when research is set in cultural contexts and settings etic to the HREC. This poses a challenge for health promotion researchers who must negotiate between meeting both the requirements of the HREC and the needs of the community with whom the research is being conducted. Drawing on two case studies, this paper discusses examples from cross-cultural health promotion research in Australian and international settings where disconnect arose and negotiation was required to appropriately meet the needs of all parties. The examples relate to issues of participant recruitment and informed consent, participants under the Australian legal age of consent, participant withdrawal when this seemingly occurs in an ad hoc rather than a formal manner and reciprocity. Although these approaches are context specific, they highlight issues for consideration to advance more culturally appropriate practice in research ethics and suggest ways a stronger anthropological lens can be applied to research ethics to overcome these challenges.
Dhital, S R; Aro, R A; Sapkota, K
Female trafficking is a social and public health problem, associated with physical and sexual abuse, psychological trauma, injuries from violence, sexually transmitted infections, adverse reproductive outcomes and substance misuse. It faces several challenges ranging from the hidden nature of the problem to ethical and human rights issues. The objectives of this paper are to analyze health impact of trafficking; ethical and research issues and anti-trafficking strategies in the Nepalese context. We collected published and unpublished data assessing the public health, ethical burden and research needs from different sources. Trafficked female involved in sex-industry that face grave situation as depicted and it might a reservoir of sexually transmitted diseases. Ethical issues related to survey of assessing the burden are difficult to carry out. The best ways to prevent and control these problems are to enhance anti- trafficking laws and raise awareness, empower and mobilize females and establish organizational capacity.
Lunnay, Belinda; Borlagdan, Joseph; McNaughton, Darlene; Ward, Paul
Increasingly, qualitative health researchers might consider using social media to facilitate communication with participants. Ambiguity surrounding the potential risks intrinsic to social media could hinder ethical conduct and discourage use of this innovative method. We used some core principles of traditional human research ethics, that is, respect, integrity, and beneficence, to design our photo elicitation research that explored the social influences of drinking alcohol among 34 underage women in metropolitan South Australia. Facebook aided our communication with participants, including correspondence ranging from recruitment to feeding back results and sharing research data. This article outlines the ethical issues we encountered when using Facebook to interact with participants and provides guidance to researchers planning to incorporate social media as a tool in their qualitative studies. In particular, we raise the issues of privacy and confidentiality as contemporary risks associated with research using social media. © The Author(s) 2014.
Ethical principles with regard to animal experimentation are referred to in European Union (EU) legislation and other official documents. Therefore, applications for funding of research under the EU's research programme may undergo an ethical review that is carried out by so-called ethics panels, consisting of experts chosen by the European Commission. The work of these panels differs substantially from that of other ethical committees, as they exist on the institutional, local, regional or national level. Their main purpose is not to decide whether a proposed research can be regarded legal, and therefore should be endorsed or licensed; instead, it is to help the Commission in prioritising its funding. The panels may examine other ethical aspects than those of animal experimentation or animal welfare alone, such as the use of human volunteers. This is reflected by the composition of the panels. Their decisions are normally based on consensus. Even though these decisions may refer to EU legislation, the criteria applied are not restricted to those provided by this legislation. Nevertheless, the various aspects of the Commission's ethical evaluation system (e.g. formal and practical basic conditions, information content of applications, type of decisions taken, lacking of any quality control) offers opportunities for improvement.
Doody, Owen; Noonan, Maria
Ethics is fundamental to good research practice and the protection of society. From a historical point of view, research ethics has had a chequered past and without due cognisance there is always the potential for research to do harm. Research ethics is fundamental to research practice, nurse education and the development of evidence. In conducting research, it is important to plan for and anticipate any potential or actual risks. To engage in research, researchers need to develop an understanding and knowledge of research ethics and carefully plan how to address ethics within their research. This article aims to enhance students' and novice researchers' research ethics understanding and its application to nursing research.
Shapiro, Robyn S
With little prospect of developing a sufficient supply of human transplantable organs to meet the large and growing demand, attention has turned to xenotransplantation, as well as stem cell and cloning research, as possible approaches for alleviating this allograft shortage. This article explores ethical and legal issues that surround developments in these fields.
ten Have, H A; Lelie, A
The main object of criticism of present-day medical ethics is the standard view of the relationship between theory and practice. Medical ethics is more than the application of moral theories and principles, and health care is more than the domain of application of moral theories. Moral theories and principles are necessarily abstract, and therefore fail to take account of the sometimes idiosyncratic reality of clinical work and the actual experiences of practitioners. Suggestions to remedy the illness of contemporary medical ethics focus on re-establishing the connection between the internal and external morality of medicine. This article discusses the question how to develop a theoretical perspective on medical ethical issues that connects philosophical reflection with the everyday realities of medical practice. Four steps in a comprehensive approach of medical ethics research are distinguished: (1) examine health care contexts in order to obtain a better understanding of the internal morality of these practices; this requires empirical research; (2) analyze and interpret the external morality governing health care practices; sociological study of prevalent values, norms, and attitudes concerning medical-ethical issues is required; (3) creation of new theoretical perspectives on health care practices; Jensen's theory of healthcare practices will be useful here; (4) develop a new conception of bioethics that illuminates and clarifies the complex interaction between the internal and external morality of health care practices. Hermeneutical ethics can be helpful for integrating the experiences disclosed in the empirical ethical studies, as well as utilizing the insights gained from describing the value-contexts of health care practices. For a critical and normative perspective, hermeneutical ethics has to examine and explain the moral experiences uncovered, in order to understand what they tell us.
Morrow, David R; Kopp, Robert E; Oppenheimer, Michael
Climate engineering (CE), the intentional modification of the climate in order to reduce the effects of increasing greenhouse gas concentrations, is sometimes touted as a potential response to climate change. Increasing interest in the topic has led to proposals for empirical tests of hypothesized CE techniques, which raise serious ethical concerns. We propose three ethical guidelines for CE researchers, derived from the ethics literature on research with human and animal subjects, applicable in the event that CE research progresses beyond computer modeling. The Principle of Respect requires that the scientific community secure the global public's consent, voiced through their governmental representatives, before beginning any empirical research. The Principle of Beneficence and Justice requires that researchers strive for a favorable risk-benefit ratio and a fair distribution of risks and anticipated benefits, all while protecting the basic rights of affected individuals. Finally, the Minimization Principle requires that researchers minimize the extent and intensity of each experiment by ensuring that no experiments last longer, cover a greater geographical extent, or have a greater impact on the climate, ecosystem, or human welfare than is necessary to test the specific hypotheses in question. Field experiments that might affect humans or ecosystems in significant ways should not proceed until a full discussion of the ethics of CE research occurs and appropriate institutions for regulating such experiments are established.
Morrow, David R.; Kopp, Robert E.; Oppenheimer, Michael
Climate engineering (CE), the intentional modification of the climate in order to reduce the effects of increasing greenhouse gas concentrations, is sometimes touted as a potential response to climate change. Increasing interest in the topic has led to proposals for empirical tests of hypothesized CE techniques, which raise serious ethical concerns. We propose three ethical guidelines for CE researchers, derived from the ethics literature on research with human and animal subjects, applicable in the event that CE research progresses beyond computer modeling. The Principle of Respect requires that the scientific community secure the global public's consent, voiced through their governmental representatives, before beginning any empirical research. The Principle of Beneficence and Justice requires that researchers strive for a favorable risk-benefit ratio and a fair distribution of risks and anticipated benefits, all while protecting the basic rights of affected individuals. Finally, the Minimization Principle requires that researchers minimize the extent and intensity of each experiment by ensuring that no experiments last longer, cover a greater geographical extent, or have a greater impact on the climate, ecosystem, or human welfare than is necessary to test the specific hypotheses in question. Field experiments that might affect humans or ecosystems in significant ways should not proceed until a full discussion of the ethics of CE research occurs and appropriate institutions for regulating such experiments are established.
Mahon, Pamela Young
As practice in the educational and clinical settings seeks to be evidence based, faculty are increasingly required to conduct research and publish the results to advance the science of our profession. The purpose of this article is to discuss transformative research ethics because Internet use is an increasing component of current research studies. How nurse educators can engage in research-utilizing methodologies inclusive of technology while adhering to ethical standards developed before the advance of the Internet is reviewed. Recommendations are cited to address the new questions that arise at institutional review board meetings resulting from potential ethical implications of using students or research participants in cyber space. © 2014.
Schuppli, C A; Fraser, D
Research ethics committees - animal ethics committees (AECs) for animal-based research and institutional research boards (IRBs) for human subjects - have a key role in research governance, but there has been little study of the factors influencing their effectiveness. The objectives of this study were to examine how the effectiveness of a research ethics committee is influenced by committee composition and dynamics, recruitment of members, workload, participation level and member turnover. As a model, 28 members of AECs at four universities in western Canada were interviewed. Committees were selected to represent variation in the number and type of protocols reviewed, and participants were selected to include different types of committee members. We found that a bias towards institutional or scientific interests may result from (1) a preponderance of institutional and scientist members, (2) an intimidating atmosphere for community members and other minority members, (3) recruitment of community members who are affiliated with the institution and (4) members joining for reasons other than to fulfil the committee mandate. Thoroughness of protocol review may be influenced by heavy workloads, type of review process and lack of full committee participation. These results, together with results from the literature on research ethics committees, suggested potential ways to improve the effectiveness of research ethics committees.
Eberl, Jason T; Ballard, Rebecca A
This paper addresses several questions related to the nature, production, and use of animal-human (a-h) chimeras. At the heart of the issue is whether certain types of a-h chimeras should be brought into existence, and, if they are, how we should treat such creatures. In our current research environment, we recognize a dichotomy between research involving nonhuman animal subjects and research involving human subjects, and the classification of a research protocol into one of these categories will trigger different ethical standards as to the moral permissibility of the research in question. Are a-h chimeras entitled to the more restrictive and protective ethical standards applied to human research subjects? We elucidate an Aristotelian-Thomistic metaphysical framework in which to argue how such chimeras ought to be defined ontologically. We then examine when the creation of, and experimentation upon, certain types of a-h chimeras may be morally permissible.
Chimirri, Niklas Alexander
an epistemological as well as an ontological necessity. The paper discusses how a renegotiation of ethics is particularly difficult whilst engaging in a project investigating everyday media experiences of young children (aged 3-6) at a German day care centre. Albeit the children were explicitly considered co......-researchers to the research questions, the most visible negotiations of enacted ethics took place among the participating adults: researcher, parents, and pedagogues – thereby potentially shunning the children’s perspectives on the research process. Nevertheless does the paper argue that an iterative renegotiation of ethics...... took place also with the children, and that the principle challenge lies in rendering these renegotiations visible in academic publications. It proposes conceptual developments that draw on both New Materialism and the Psychology from the Standpoint of the Subject in order to tackle this challenge....
Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; van Delden, Johannes J M
In research ethics, the most basic question would always be, "which is an ethical issue, which is not?" Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that. We extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative. We found that there is no consensus on the majority of the imperatives and that in only 8.2% of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least. There was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences.
Eide, Phyllis; Kahn, David
Qualitative research poses ethical issues and challenges unique to the study of human beings. In developing the interpersonal relationship that is critical to qualitative research, investigator and participant engage in a dialogic process that often evokes stories and memories that are remembered and reconstituted in ways that otherwise would not occur. Ethical issues are raised when this relationship not only provides qualitative research data, but also leads to some degree of therapeutic interaction for the participant. The purpose of this article is to examine some of the controversies inherent in the researcher's dilemma when this occurs, set within the context of a nursing caring theory (Swanson), and the International Council of Nurses Code of ethics for nurses, which provides guidance on global nursing practice.
Iedema, Rick A M; Allen, Suellen; Britton, Kate; Hor, Suyin
This paper describes the ethics approval processes for two multicentre, nationwide, qualitative health service research projects. The paper explains that the advent of the National Ethics Application Form has brought many improvements, but that attendant processes put in place at local health network and Human Research Ethics Committee levels may have become significantly more complicated, particularly for innovative qualitative research projects. The paper raises several questions based on its analysis of ethics application processes currently in place. WHAT IS KNOWN ABOUT THE TOPIC? The complexity of multicentre research ethics applications for research in health services has been addressed by the introduction of the National Ethics Application Form. Uptake of the form across the country's human research ethics committees has been uneven. WHAT DOES THIS PAPER ADD? This paper adds detailed insight into the ethics application process as it is currently enacted across the country. The paper details this process with reference to difficulties faced by multisite and qualitative studies in negotiating access to research sites, ethics committees' relative unfamiliarity with qualitative research , and apparent tensions between harmonisation and local sites' autonomy in approving research. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners aiming to engage in research need to be aware that ethics approval takes place in an uneven procedural landscape, made up of variable levels of ethics approval harmonization and intricate governance or site-specific assessment processes.
Carol Levine has stated that research ethics was 'born in scandal .... that subjects are able to protect themselves, with Principle 9 giving the subject as ... or advice which could weaken physical or mental resistance of a human being may be ...
Krishan, Kewal; Kanchan, Tanuj; Singh, Bahadur
Editing human germline genes may act as boon in some genetic and other disorders. Recent editing of the genome of the human embryo with the CRISPR/Cas9 editing tool generated a debate amongst top scientists of the world for the ethical considerations regarding its effect on the future generations. It needs to be seen as to what transformation human gene editing brings to humankind in the times to come.
Robley, Lois R.
Ethical issues in qualitative nursing research include the following: what to study, which participants, what methods, how to achieve informed consent, when to terminate interviews and when to probe, when treatment should supersede research, and what and how to document in case studies. (SK)
This article seeks to commence and encourage discussion around the upcoming ethical challenges of virality in network structures. When the call for participation in a research project on lupus in Ireland went from an advertisement in a newsletter to a meme (unit of transmissible information) on a closed Facebook page, the ethical considerations of virality were raised. The article analyzes the Association of Internet Researchers guidelines, Facebook policies, and the context of privacy in relation to virality. Virality creates the leverage for methodological pluralism. The nature of the inquiry can determine the method rather than the other way around. Viral ethical considerations are evolving due to the cyber world becoming the primary meme of communication, with flexibility in the researcher's protocol providing opportunities for efficient, cost-effective, and diverse recruitment. © The Author(s) 2016.
Gross, Dominik; Tolba, René H
In recent years, there have been a number of new demands and regulations which have reignited the discussion on ethics in animal-based research. In the light of this development, the present review first presents an overview of underlying core ethical questions and issues. This is followed by an outline of the current discussion on whether animals (used for experimentation) should have rights ascribed to them and whether animals need to have certain characteristics in order to be the beneficiaries of rights. The discourse on concepts of sentience and the 'sociozoological scale' in particular is mapped out in this regard. There follows an outline of relevant ethical positions and current moral approaches to animal-based research (animal rights position, utilitarianism, 'convergence position', intrinsic cultural value of fundamental research, 'contractarianism', anthropocentrism, principle of the three Rs). 2015 S. Karger AG, Basel.
Full Text Available Abstract Background Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. Discussion Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices. The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals. Conclusion Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of
D.R. Gasper (Des)
markdownabstract__Abstract__ Work on global ethics looks at ethical connections on a global scale. It should link closely to environmental ethics, recognizing that we live in unified social-ecological systems, and to development ethics, attending systematically to the lives and interests of
Junod, V; Elger, B
Retrospective research is conducted on already available data and/or biologic material. Whether such research requires that patients specifically consent to the use of "their" data continues to stir controversy. From a legal and ethical point of view, it depends on several factors. The main criteria to be considered are whether the data or the sample is anonymous, whether the researcher is the one who collected it and whether the patient was told of the possible research use. In Switzerland, several laws delineate the procedure to be followed. The definition of "anonymous" is open to some interpretation. In addition, it is debatable whether consent waivers that are legally admissible for data extend to research involving human biological samples. In a few years, a new Swiss federal law on human research could clarify the regulatory landscape. Meanwhile, hospital-internal guidelines may impose stricter conditions than required by federal or cantonal law. Conversely, Swiss and European ethical texts may suggest greater flexibility and call for a looser interpretation of existing laws. The present article provides an overview of the issues for physicians, scientists, ethics committee members and policy makers involved in retrospective research in Switzerland. It aims at provoking more open discussions of the regulatory problems and possible future legal and ethical solutions.
The ethical implications of human clones have been much alluded to, but have seldom been examined with any rigour. This paper examines the possible uses and abuses of human cloning and draws out the principal ethical dimensions, both of what might be done and its meaning. The paper examines some of the major public and official responses to cloning by authorities such as President Clinton, the World Health Organisation, the European parliament, UNESCO, and others and reveals their inadequacies as foundations for a coherent public policy on human cloning. The paper ends by defending a conception of reproductive rights of "procreative autonomy" which shows human cloning to be not inconsistent with human rights and dignity. PMID:9451604
Kim, Jongyoung; Park, Kibeom
The Hwang affair, a dramatic and far reaching instance of scientific fraud, shocked the world. This collective national failure prompted various organizations in Korea, including universities, regulatory agencies, and research associations, to engage in self-criticism and research ethics reforms. This paper aims, first, to document and review research misconduct perpetrated by Hwang and members of his research team, with particular attention to the agencies that failed to regulate and then supervise Hwang's research. The paper then examines the research ethics reforms introduced in the wake of this international scandal. After reviewing American and European research governance structures and policies, policy makers developed a mixed model mindful of its Korean context. The third part of the paper examines how research ethics reform is proactive (a response to shocking scientific misconduct and ensuing external criticism from the press and society) as well as reactive (identification of and adherence to national or international ethics standards). The last part deals with Korean society's response to the Hwang affair, which had the effect of a moral atomic bomb and has led to broad ethical reform in Korean society. We conceptualize this change as ethical modernization, through which the Korean public corrects the failures of a growth-oriented economic model for social progress, and attempts to create a more trustworthy and ethical society.
Pope, Kenneth S
Research shows that many organizations overlook needs and opportunities to strengthen ethics. Barriers can make it hard to see the need for stronger ethics and even harder to take effective action. These barriers include the organization's misleading use of language, misuse of an ethics code, culture of silence, strategies of justification, institutional betrayal, and ethical fallacies. Ethics placebos tend to take the place of steps to see, solve, and prevent problems. This article reviews relevant research and specific steps that create change.
Zhang, J. J.
This paper aims to achieve two objectives. Firstly, it elicits some of the concerns for universal research ethics. It is argued that ethical codes are never universal; they are geographically sensitive. As such, it is important to "develop authentic individual responses to potentially unique circumstances". Secondly, in going beyond a…
Loui, M. C.
Created with support from the National Science Foundation, EthicsCORE (www.natonalethicscenter.org) is an online resource center for ethics in science and engineering. Among the resources, EthicsCORE hosts short video vignettes produced at the University of Nebraska - Lincoln that dramatize problems in the responsible conduct of research, such as peer review of journal submissions, and mentoring relationships between faculty and graduate students. I will use one of the video vignettes in an interactive pedagogical demonstration. After showing the video, I will ask participants to engage in a think-pair-share activity on the professional obligations of researchers. During the sharing phase, participants will supply the reasons for these obligations.
Caulfield, Timothy; Ogbogu, Ubaka; Nelson, Erin; Einsiedel, Edna; Knoppers, Bartha; McDonald, Michael; Brunger, Fern; Downey, Robin; Fernando, Kanchana; Galipeau, Jacques; Geransar, Rose; Griener, Glenn; Grenier, Glenn; Hyun, Insoo; Isasi, Rosario; Kardel, Melanie; Knowles, Lori; Kucic, Terrence; Lotjonen, Salla; Lyall, Drew; Magnus, David; Mathews, Debra J H; Nisbet, Matthew; Nisker, Jeffrey; Pare, Guillaume; Pattinson, Shaun; Pullman, Daryl; Rudnicki, Michael; Williams-Jones, Bryn; Zimmerman, Susan
This article is a consensus statement by an international interdisciplinary group of academic experts and Canadian policy-makers on emerging ethical, legal and social issues in human embryonic stem cells (hESC) research in Canada. The process of researching consensus included consultations with key stakeholders in hESC research (regulations, stem cell researchers, and research ethics experts), preparation and distribution of background papers, and an international workshop held in Montreal in February 2007 to discuss the papers and debate recommendations. The recommendations provided in the consensus statement focus on issues of immediate relevance to Canadian policy-makers, including informed consent to hESC research, the use of fresh embryos in research, management of conflicts of interest, and the relevance of public opinion research to policy-making.
Rodríguez Yunta, Eduardo
Research with animals presents ethical questions both for being used as models of human diseases and for being a prerequisite for trials in humans, as in the introduction of genetic modifications. Some of these questions refer to the fact that, as models, they do not fully represent the human condition; that conducting toxicity tests causes great harm to animals; that their nature is altered by genetic modifications and that introducing genetically modified organisms is a risk. The use of animals in research for the benefit of humans imposes the moral responsibility to respect them, not making them suffer unnecessarily, since they are living beings capable of feeling.
Rahimzadeh, Vasiliki; Bartlett, Gillian; Longo, Cristina; Crimi, Laura; Macdonald, Mary Ellen; Jabado, Nada; Ells, Carolyn
This paper defends the ethical and empirical significance of direct engagement with terminally ill children and adolescents in PPC research on health-related quality of life. Clinical trials and other forms of health research have resulted in tremendous progress for improving clinical outcomes among children and adolescents diagnosed with a life-threatening illness. Less attention has been paid, however, to engaging this patient population directly in studies aimed at optimizing health-related quality of life in PPC. Though not restricted to care at the end of life, PPC--and by extension PPC research--is in part dependent on recognizing the social complexities of death and dying and where health-related quality of life is a fundamental element. To explore these complexities in depth requires partnership with terminally ill children and adolescents, and acknowledgement of their active social and moral agency in research. Principles of pediatric research ethics, theoretical tenets of the "new sociology of the child(hood)," and human rights codified in the United Nations Convention on the Rights of the Child (UNCRC) underpin the position that a more engagement-centered approach is needed in PPC research. The ethics, sociologies and human rights of engagement will each be discussed as they relate to research with terminally ill children and adolescents in PPC. Qualitative method(ologies) presented in this paper, such as deliberative stakeholder consultations and phenomenology of practice can serve as meaningful vehicles for achieving i) participation among terminally ill children and adolescents; ii) evidence-bases for PPC best practices; and iii) fulfillment of research ethics principles. PPC research based on direct engagement with PPC patients better reflects their unique expertise and social epistemologies of terminal illness. Such an approach to research would strengthen both the ethical and methodological soundness of HRQoL inquiry in PPC.
Full Text Available Erich Fromm contributed to social science mostly by his detailed theory of social character. Besides, he was interested in ethics. Even more - considering Fromm, human nature is strictly connected with ethics. He asks if there is foundation to establish some universal, absolute ethic? What is authority, and is there a connection between authority and ethics, and humanity and ethics? Is character of any relevance to ethics? Is human good or bad? What is the connection between human nature and social value? Fromm defines terms clearly, and this paper is brief introduction to those terms and to answers that Fromm gave to upper questions.
Komić, Dubravka; Marušić, Stjepan Ljudevit; Marušić, Ana
Professional codes of ethics are social contracts among members of a professional group, which aim to instigate, encourage and nurture ethical behaviour and prevent professional misconduct, including research and publication. Despite the existence of codes of ethics, research misconduct remains a serious problem. A survey of codes of ethics from 795 professional organizations from the Illinois Institute of Technology's Codes of Ethics Collection showed that 182 of them (23%) used research integrity and research ethics terminology in their codes, with differences across disciplines: while the terminology was common in professional organizations in social sciences (82%), mental health (71%), sciences (61%), other organizations had no statements (construction trades, fraternal social organizations, real estate) or a few of them (management, media, engineering). A subsample of 158 professional organizations we judged to be directly involved in research significantly more often had statements on research integrity/ethics terminology than the whole sample: an average of 10.4% of organizations with a statement (95% CI = 10.4-23-5%) on any of the 27 research integrity/ethics terms compared to 3.3% (95% CI = 2.1-4.6%), respectively (Porganizations should define research integrity and research ethics issues in their ethics codes and collaborate within and across disciplines to adequately address responsible conduct of research and meet contemporary needs of their communities.
Komić, Dubravka; Marušić, Stjepan Ljudevit; Marušić, Ana
Professional codes of ethics are social contracts among members of a professional group, which aim to instigate, encourage and nurture ethical behaviour and prevent professional misconduct, including research and publication. Despite the existence of codes of ethics, research misconduct remains a serious problem. A survey of codes of ethics from 795 professional organizations from the Illinois Institute of Technology’s Codes of Ethics Collection showed that 182 of them (23%) used research integrity and research ethics terminology in their codes, with differences across disciplines: while the terminology was common in professional organizations in social sciences (82%), mental health (71%), sciences (61%), other organizations had no statements (construction trades, fraternal social organizations, real estate) or a few of them (management, media, engineering). A subsample of 158 professional organizations we judged to be directly involved in research significantly more often had statements on research integrity/ethics terminology than the whole sample: an average of 10.4% of organizations with a statement (95% CI = 10.4-23-5%) on any of the 27 research integrity/ethics terms compared to 3.3% (95% CI = 2.1–4.6%), respectively (Pethics concepts used prescriptive language in describing the standard of practice. Professional organizations should define research integrity and research ethics issues in their ethics codes and collaborate within and across disciplines to adequately address responsible conduct of research and meet contemporary needs of their communities. PMID:26192805
RESNIK, DAVID B.; ZELDIN, DARRYL C.; SHARP, RICHARD R.
This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects. PMID:16220621
W. Bos (Wendy)
markdownabstractPaediatric research ethics evolves around a central dilemma. Either one has to accept that many childhood diseases cannot be (properly) treated and that many children receive treatments that are not (properly) tested in children, or one has to accept that children, i.e. vulnerable
Shaver, Frances M.
The challenges involved in the design of ethical, nonexploitative research projects with sex workers or any other marginalized population are significant. First, the size and boundaries of the population are unknown, making it extremely difficult to get a representative sample. Second, because membership in hidden populations often involves…
Journal Home > Vol 8, No 2 (1992) >. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register. Ethics and epidemiological research. T Cullinan. Abstract. No Abstract. Full Text: EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL ...
Hans Thulesius, M.D., G.P., Ph.D.
Full Text Available I have participated in writing ethical approval applications for research projects in Sweden a dozen times. I am also since some years a member of the local ethics advisory board in a mostly rural area serving 180.000 people. From that position I advise on what types of local project applications will have to be sent further to the regional ethics committee, REPN in Sweden. With that background I will try to give a brief Swedish perspective on research ethics reviews in general and regarding CGT (classic grounded theory studies using qualitative data in particular.The most famous Swedish example of unethical research is the 1947-1951 Vipeholm sugar trial (Krasse, 2001. Several hundred intellectually and mentally challenged persons at the Vipeholm institution were for years given an excess amount of sugar, mostly in the shape of candy. This resulted in caries that totally ruined the teeth of 50 persons. Of course participants did not give informed consent. Yet, at the time the research was not considered unethical. At least there was no debate about it.
Duvell, F.; Triandafyllidou, A.; Vollmer, B.
This paper is concerned with the ethical issues arising for researchers engaged in the study of irregular migration. Irregular migration is by definition an elusive phenomenon as it takes place in violation of the law and at the margins of society. This very nature of the phenomenon raises important
Teixeira-Poit, Stephanie M.; Cameron, Abigail E.; Schulman, Michael D.
How can instructors use experiential learning strategies to enhance student understanding of research ethics and responsible research conduct? In this article, the authors review literature on using experiential learning to teach research ethics and responsible research conduct. They present a three-step exercise for teaching research ethics and…
Heimer, Carol A
Using ethnographic material collected between 2003 and 2007 in five HIV clinics in the US, South Africa, Uganda, and Thailand, this article examines "official ethics" and "ethics on the ground." It compares the ethical conundrums clinic staff and researchers confront in their daily work as HIV researchers with the dilemmas officially identified as ethical issues by bioethicists and people responsible for ethics reviews and compliance with ethics regulations. The tangled relation between ethical problems and solutions invites a comparison to Rittel and Webber's "wicked problems." Official ethics' attempts to produce universal solutions often make ethics problems even more wickedly intractable. Ethics on the ground is in part a reaction to this intractability. Copyright © 2012 Elsevier Ltd. All rights reserved.
Research involving prisoners repeatedly went astray during the last century, culminating in the cruel medical experiments inside the Nazi concentration camps that gave rise to the Nuremberg Code. However, prisoners continued to become victims of scientific exploitation by the rapidly evolving biomedical research industry. The common roots of these abuses were the flawed philosophy that the needs of the society outweigh the needs of the individual and the researchers' view that prisoners are cheap, easy to motivate and stable research subjects. Prisoners are vulnerable to exploitation and abuse by research because their freedom for consent can easily be undermined, and because of learning disabilities, illiteracy and language barriers prevailing within prisoner populations. Therefore, penal laws of some countries supported by a number of internationally agreed documents prohibit research involving prisoners completely. However, prisoners must also be regarded as vulnerable to the specific health problems in prisons, e.g. transmissible diseases, mental disorders and suicide - problems that need to be addressed by research involving prisoners. Additionally, the participation of prisoner patients in research they directly can benefit from should be provided. Hence, it must be a common objective to find the right balance between protection from exploitation and access to research beneficial to prisoners.
Lipworth, Wendy; Mason, Paul H; Kerridge, Ian; Ioannidis, John P A
Biomedical innovation and translation are increasingly emphasizing research using "big data." The hope is that big data methods will both speed up research and make its results more applicable to "real-world" patients and health services. While big data research has been embraced by scientists, politicians, industry, and the public, numerous ethical, organizational, and technical/methodological concerns have also been raised. With respect to technical and methodological concerns, there is a view that these will be resolved through sophisticated information technologies, predictive algorithms, and data analysis techniques. While such advances will likely go some way towards resolving technical and methodological issues, we believe that the epistemological issues raised by big data research have important ethical implications and raise questions about the very possibility of big data research achieving its goals.
Research in critical care patients is an ethical obligation. The ethical conflicts of intensive care research arise from patient vulnerability, since during ICU admission these individuals sometimes lose all or part of their decision making capacity and autonomy. We therefore must dedicate effort to ensure that neither treatment (sedation or mechanical ventilation) nor the disease itself can affect the right to individual freedom of the participants in research, improving the conditions under which informed consent must be obtained. Fragility, understood as a decrease in the capacity to tolerate adverse effects derived from research must be taken into account in selecting the participants. Research should be relevant, not possible to carry out in non-critical patients, and a priori should offer potential benefits that outweigh the risks that must be known and assumable, based on principles of responsibility. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.
Frew, Deborah; Martlew, Ainsley
For many years there has been discussion regarding the problems confronting our current ethics review system. Commentators have identified numerous issues that threaten the sustainability of Australia's voluntary HREC system. Various ad hoc solutions to these problems have been posed, but have not resulted in any significant advances. However, in recent years, discourse regarding research governance has become prominent in the Australian research environment. The application of research governance principles is gaining momentum amongst the regulators of research, including research institutions and their governing bureaucracies. We argue that this is potentially the most significant development in several years towards creating a sustainable HREC system in Australia. The recognition by research institutions and their governing bureaucracies that the responsibility for overall research governance lies with them, rather than solely with their HRECs, is leading to a range of initiatives which should significantly lessen the burden on Australian ethics committees, and improve their ability to undertake their core task of reviewing the ethical aspects of research proposals.
Sheehan, Mark; Dunn, Michael; Sahan, Kate
There is a growing body of literature that has sought to undermine systems of ethical regulation, and governance more generally, within the social sciences. In this paper, we argue that any general claim for a system of research ethics governance in social research depends on clarifying the nature of the stake that society has in research. We show that certain accounts of this stake-protecting researchers' freedoms; ensuring accountability for resources; safeguarding welfare; and supporting democracy-raise relevant ethical considerations that are reasonably contested. However, these accounts cannot underpin a general claim in favour of, or against, a system of research ethics governance. Instead, we defend governance in social research on the grounds that research, as an institutionalised form of enquiry, is a constitutive element of human flourishing, and that society ought to be concerned with the flourishing of its members. We conclude by considering the governance arrangements that follow from, and are justified by, our arguments. © 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.
Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other…
Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking.
Brandon, Anna R; Shivakumar, Geetha; Lee, Simon Craddock; Inrig, Stephen J; Sadler, John Z
To review the background of current ethical standards for the conduct of perinatal mental health research and describe the ethical challenges in this research domain. Current literature reflects a growing sentiment in the scientific community that having no information regarding the impact of psychiatric treatment on the mother and developing fetus/infant poses dangers that may exceed the risks involved in research. However, without sufficient consensus across the scientific community, both regulatory bodies and perinatal researchers find themselves without a framework for decision making that satisfactorily limits the risks and facilitates the benefits of participation of pregnant and lactating women in clinical research. Psychiatric research in perinatal mental health is critically important as it enables clinicians and patients to participate in informed decision-making concerning treatment for psychiatric disorders. Specific areas of concern include fetal safety, maternal risk, the therapeutic misconception, commercial interests, forensic/legal issues, the informed consent process, and study design. Developing guidelines that address ethical challenges and include the views and concerns of multiple stakeholders could improve the access of perinatal women to the benefits of participation in mental health research in addition to providing evidence-based mental healthcare for this subpopulation.
Waisel, David B
This review describes advances in rising and continuing ethical issues in research in patients in pain. Although some of the issues focus directly on pain research, such as research in neonatal pain management, others focus on widespread ethical issues that are relevant to pain research, such as scientific misconduct, deception, placebo use and genomics. Scientific misconduct is more widespread than realized and requires greater awareness of the markers of misconduct like irreproducibility. More education about what qualifies as misconduct, such as consent violations, plagiarism and inappropriate patient recruitment along with data falsification needs to be implemented. Wayward researchers may attend a rehabilitation conference to improve their practices. Studies in neonatal pain management do not require comparing an intervention with the inadequate analgesia of a placebo; comparing with a standard approach is sufficient. Deception of research patients may be acceptable under narrow circumstances. The legitimacy of using broad informed consent for biobanking and genomic studies are being challenged as changes to the Common Rule are being considered. Increasing complexity and the desire to further medical knowledge complicates research methods and informed consent. The ethical issues surrounding these and offshoot areas will continue to develop.
Tilburt, Jon C; Kaptchuk, Ted J
Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal me...
Full Text Available The purpose of the investigation was to interpret training in ethics for action business students an introduction to the economy of the Faculty of Social and Economic Sciences at the University of Carabobo, as part of professional development in business studies. The investigation was addressed within the paradigm post positivist using ethnographic and hermeneutic method, descriptive mode of scientific research and technique participant-observation. It concludes that training in ethics management must transcend the economic theories located in the teleological by financial or economic interests toward the teleological including humanism.
Ronen, Gabriel M; Rosenbaum, Peter L
Our goals in this reflection are to (i) identify the ethical dimensions inherent in any clinical encounter and (ii) bring to the forefront of our pediatric neurology practice the myriad of opportunities to explore and learn from these ethical questions. We highlight specifically Beauchamp and Childress's principles of biomedical ethics. We use the terms ethics in common clinical practice and an ethical lens to remind people of the ubiquity of ethical situations and the usefulness of using existing ethical principles to analyze and resolve difficult situations in clinical practice. We start with a few common situations with which many of us tend to struggle. We describe what we understand as ethics and how and why developments in technology, novel potential interventions, policies, and societal perspectives challenge us to think about and debate ethical issues. Individual patients are not a singular population; each patient has their own unique life situations, culture, goals, and expectations that need to be considered with a good dose of humanity and humility. We believe that using an ethical lens-by which we mean making an explicit effort to identify and consider these issues openly-will help us to achieve this goal in practice, education, and research.
This article addresses the question of whether human reproductive cloning could be ethically justifiable in at least some cases involving infertile couples who would choose cloning as a way to have a genetically related child. At present, the risk of congenital anomalies constitutes a compelling argument against human reproductive cloning. The article explores whether reproductive cloning could be ethically justifiable if, at some future time, cloning becomes possible without an elevated risk of anomalies. It is argued that freedom to use cloning is a form of procreative freedom and, as such, deserves respect. All of the objections that have been raised against human reproductive cloning fall under three main categories: those that appeal to the interests of the child, those based on consequences for society, and those arising from teleological views. Objections that appeal to the child's interests are, in turn, of two main kinds: consequentialist and deontological. All of these types of objections are examined, and it is found that each involves serious problems that prevent it from being a reasonable objection in the context of the infertility cases considered. It is concluded that human reproductive cloning would be ethically justifiable in at least some cases involving infertile couples, provided that it could be performed without an elevated risk of anomalies.
This book explores recent developments and debates around researching ethically and with integrity, and complying with ethical requirements, and has been updated and expanded to now cover issues relating to international, indigenous, interdisciplinary and internet research.
Ethical Medical and Biomedical Practice in Health Research in Africa ... of research studies that do not conform with international ethical standards and ... Journal articles ... IDRC congratulates first cohort of Women in Climate Change Science ...
Feudtner, Chris; Brosco, Jeffrey P.
People with intellectual disability (ID) have a long history of discrimination and stigmatization, and a more recent history of pride and self-advocacy. The early history suggests that people with ID are a vulnerable population and deserve special research protections as do some other groups; the disability rights movement of the late 20th century…
This paper considers the role of ethics and ethics review processes in the development of health promotion quality assurance and evaluation activities involving human participants. The Australian National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research and associated documents provide the framework for the ethical conduct and independent review of research (including quality assurance and evaluation) involving humans in Australia. Identifying the level of risk to which participants may be exposed by participation in quality assurance and evaluation activities is essential for health promotion workers undertaking such activities. Organisations can establish processes other than review by a Human Research Ethics Committee for negligible and low risk research activities. Health promotion quality assurance and evaluation activities often involve negligible and low risk to participants. Seven triggers that indicate the need for ethics review of quality assurance and evaluation activities and a procedural checklist for developing ethical quality assurance and evaluation activities are provided. Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research. When ethical considerations underpin the planning and conduct of all quality assurance and evaluation from the very beginning, the activity is the better for it, independent 'ethics approval' can mostly be secured without much trouble and workers' frustration levels are reduced. So what? Health promotion quality assurance and evaluation activities must be ethically justified. Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research and should use it when developing health promotion quality assurance and evaluation activities.
A sound knowledge of the nature of qualitative research, along with an appreciation of some special ethical considerations, is needed for rigorous reviews to be conducted. The overall character of qualitative research is described with an emphasis on the tendency of qualitative researchers to explore sensitive topics using theoretically informed methods. A number of specific features of qualitative that require additional ethical attention and awareness are also examined including the following: 1) participants are frequently quite vulnerable and require protection because the data collection methods, such as in-depth interviews, can delve into personally and politically charged matters; 2) naturalistic observation can raise concerns regarding privacy and consent; 3) the potential for the identifiability of the results of this research may require extra efforts to maintain confidentiality. Ultimately, Reseach Ethics Committee members must be knowledgeable about qualitative approaches to be able to assess the potential harms and benefits in a protocol carefully. Without this knowledge gaining ethics approval can be overly difficult for researchers and the best practices for protecting human participants can be overlooked.
Full Text Available Abstract A sound knowledge of the nature of qualitative research, along with an appreciation of some special ethical considerations, is needed for rigorous reviews to be conducted. The overall character of qualitative research is described with an emphasis on the tendency of qualitative researchers to explore sensitive topics using theoretically informed methods. A number of specific features of qualitative that require additional ethical attention and awareness are also examined including the following: 1 participants are frequently quite vulnerable and require protection because the data collection methods, such as in-depth interviews, can delve into personally and politically charged matters; 2 naturalistic observation can raise concerns regarding privacy and consent; 3 the potential for the identifiability of the results of this research may require extra efforts to maintain confidentiality. Ultimately, Reseach Ethics Committee members must be knowledgeable about qualitative approaches to be able to assess the potential harms and benefits in a protocol carefully. Without this knowledge gaining ethics approval can be overly difficult for researchers and the best practices for protecting human participants can be overlooked.
Jeong, Ihn Sook; Gu, Mee Ock; Kim, Keum Soon; Lee, Kwang Ja; Yang, Soo
This study aimed to investigate the educational needs of research ethics among nursing researchers. Convenience sample of 161 nursing professors and 262 master or doctoral nursing students participated in the study. Data was collected with self-reported questionnaire from June to August 2009, and analyzed with descriptive statistics using SPSS WIN (version 14.0). Among 161 nursing professors, about 31.7% has educated nursing ethics in the postgraduate course. The most common course was nursing research or methodology (62.7%), and median education time was 2 hr. Areas that showed difficulty in understanding was the conflict of interest and plagiarism for professors and falsification and fabrication for graduate students. Average knowledge on the research ethics was 75.4 points for professors and 61.6 points for students based on the 100 points. Educational needs of research ethics among nursing professors and students in the postgraduate course was high. We recommend both basic and advanced research ethics educational programs for the nursing researchers. The basic course should be at least 6 hr and include various cases and something to discuss.
In their practice, physicians and veterinarians need to resort to an array of ethical competences. As a teaching topic, however, there is no accepted gold standard for human medical ethics, and veterinary medical ethics is not yet well established. This paper provides a reflection on the underlying aims of human and veterinary medical ethics…
Brogt, Erik; Foster, Tom; Dokter, Erin; Buxner, Sanlyn; Antonellis, Jessie
We present an argument for, and suggested implementation of, a code of ethics for the astronomy education research community. This code of ethics is based on legal and ethical considerations set forth by U.S. federal regulations and the existing code of conduct of the American Educational Research Association. We also provide a fictitious research…
The Human Genome Project has been completed thanks to a massive use of computer techniques, as well as the adoption of the open-source business and research model by the scientists involved. This model won over the proprietary model and allowed a quick propagation and feedback of research results among peers. In this paper, the author will analyse some ethical and legal issues emerging by the use of such computer model in the Human Genome property rights. The author will argue that the Open Source is the best business model, as it is able to balance business and human rights perspectives.
Pr RenĂŠ Frydman
Full Text Available Reproductive medicine is a new important field in all the countries. The possibilities are tremendous, therefore we have to decide if limits are necessary or should we consider that everything that have been initiated (as clone, gene transfer... can be apply in humans. That will be the challenge of a global ethical approach in each country with their culture, morality, guidelines or laws.
Mills Edward J
Full Text Available Abstract Humanitarian agencies are increasingly engaged in research in conflict and post-conflict settings. This is justified by the need to improve the quality of assistance provided in these settings and to collect evidence of the highest standard to inform advocacy and policy change. The instability of conflict-affected areas, and the heightened vulnerability of populations caught in conflict, calls for careful consideration of the research methods employed, the levels of evidence sought, and ethical requirements. Special attention needs to be placed on the feasibility and necessity of doing research in conflict-settings, and the harm-benefit ratio for potential research participants.
Horner, Jennifer; Minifie, Fred D.
Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. Method: In "Research Ethics III", they review the RCR domains of publication…
Cloyes, Kristin Gates
Nursing literature is replete with discussions about the ethics of research interviews. These largely involve questions of method, and how careful study design and data collection technique can render studies more ethical. Analysis, the perennial black box of the research process, is rarely discussed as an ethical practice. In this paper, I introduce the idea that analysis itself is an ethical practice. Specifically, I argue that political discourse analysis of research interviews is an ethical practice. I use examples from my own research in a prison control unit to illustrate what this might look like, and what is at stake.
MUNIR HOSSAIN TALUKDER
Full Text Available Currently, most health researchers or donor organizations considerinducement as a vital part in promoting research. They propose benefits, such as post research free medical treatment, food, insurance facilities, or even cash, in order to meet sufficient number of subjects. So, inducement may influence one to participate in a research. Is it ethical to offer inducement to human subjects? What are the risks in such practice? What will happen if the donor agencies use subjects by hiding possible risks from them? When an inducement can satisfy ethical criteria? The CIOMS, FDA, and other ethical guidelines hold that inducement is unethical because it involves enough risk for voluntary informed consent. Supporting this position, a group of ethicists has argued that inducement undermines voluntariness especially when subjects are poor and vulnerable, and thus, unethical. In contrast to them, others argue that inducement contributes to discover new knowledge which can improve miserable condition of the poor. In their view, an inducement maintains all ethical criteria including subject’s autonomy, and therefore, morally permissible. The paper focuses this debate and analyzes both types ofargument. It examines whether inducement invalidate informed consent.Even if inducement may not violate the basic components of informedconsent, the paper concludes, subjects may claim a prima facie right to enjoy research outcomes.
We discuss the general findings of the audit and the complex issues arising from HIV-vaccine research, specifically. Lastly, we propose specific ways in which the ethical/legal frameworks guiding research with human participants in these countries can be improved. Keywords: Africa, clinical trials, country profiles, ethics, ...
Bachani, Abdulgafoor M; Rattani, Abbas; Hyder, Adnan A
Currently, health systems research (HSR) is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees (RECs), as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted (of the responses (n=29), no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step (to better understand the current status) towards a larger dialogue on the topic. © 2016 John Wiley & Sons Ltd.
Cheung, I.; Yalcin, K.
Many undergraduate research training programs incorporate research ethics into their programs and some are required. Engaging students in conversations around challenging topics such as conflict of interest, cultural and gender biases, what is science and what is normative science can difficult in newly formed student cohorts. In addition, discussing topics with more distant impacts such as science and policy, intellectual property and authorship, can be difficult for students in their first research experience that have more immediate concerns about plagiarism, data manipulation, and the student/faculty relationship. Oregon State University's Research Experience for Undergraduates (REU) in Ocean Sciences: From Estuaries to the Deep Sea as one model for incorporating a research ethics component into summer undergraduate research training programs. Weaved into the 10-week REU program, undergraduate interns participate in a series of conversations and a faculty mentor panel focused on research ethics. Topics discussed are in a framework for sharing myths, knowledge and personal experiences on issues in research with ethical implications. The series follows guidelines and case studies outlined from the text, On Being A Scientist: Responsible Conduct In Research Committee on Science, Engineering, and Public Policy, National Academy of Sciences.
Davis, Jeffrey R.
This viewgraph presentation describes the challenges that space exploration faces in terms of medicine, research and ethics. The topics include: 1) Effects of Microgravity on Human Physiology; 2) Radiation; 3) Bone; 4) Behavior and Performance; 5) Muscle; 6) Cardiovascular; 7) Neurovestibular; 8) Food and Nutrition; 9) Immunology and Hematology; 10) Environment; 11) Exploration; 12) Building Block Approach; 13) Exploration Issues; 14) Life Sciences Contributions; 15) Health Care; and 17) Habitability.
Human subjects research ethics were developed to ensure responsible conduct when university researchers learn by interacting with community members. As service-learning students also learn by interacting with community members, a similar set of principles may strengthen the ethical practice of service-learning. This article identifies ethical…
Sim, Kang; Sum, Min Yi; Navedo, Deborah
Past didactic pedagogy on biomedical research ethics and informed consent in our program had resulted in passive memorization of information and disengaged learning within psychiatry residents and clinical researchers. The question is how do we better motivate and engage learners within the session. Thus, we incorporated narratives into the learning environment and hypothesised that the use of narratives in the teaching of biomedical research ethics and informed consent would be associated with greater engagement, motivation, understanding, reflective learning and effectiveness of the teaching session. The narratives were chosen from the history of research ethics and the humanities literature related to human subject research. Learners were asked to provide post-session feedback through an anonymised questionnaire on their learning session. An outcomes logic model was used for assessment with focus on immediate outcomes such as engagement, motivation, understanding and reflective learning. Overall, 70.5% (N = 273) of the learners responded to the questionnaire. Amongst the respondents, 92.6% (N = 253) of the participants ranked use of narratives as most helpful in appreciating the historical context of research ethics and informed consent in research. The majority felt engaged (89.8%, N = 245), more motivated to learn (77.5%, N = 212) and better equipped (86.4%, N = 236) about the subject matter. Better appreciation of the learning topic, engagement, motivation to learn, equipping were strongly correlated with the promotion of reflective learning, effectiveness of teaching, promotion of critical thinking and overall positive rating of the teaching session on research ethics (all p ethics and informed consent, and address underlying motivational factors behind learning and understanding of research ethics.
Jain, Kewal K
Ethical and regulatory issues concerning embryonic stem (ES) cell research are reviewed here a year after the controversy became a public and political issue in the US. The background of various issues are examined and the current regulations in various countries are reviewed. In the US, the debate is linked with abortion, as well as the status of a fetus as a human being, and is politically driven. Obtaining stem cells from embryonic tissues involves destruction of the embryo, to which objections are raised. Religious beliefs are examined and no serious impediments to ES cell research could be identified. Regulations vary from one country to another and it is unlikely that there will ever be any universally uniform ethical and regulatory standards for ES cell research. Currently, the most liberal and favourable environments for ES cell research are in the UK, Singapore, Sweden, India, Israel and China. Unless the US liberalises ES cell research, it may lose its lead in ES cell research and investments in this area may drift to countries with better environments for research. Suggestions are offered in this review to improve the ethical environment for ES cell research.
Over the last decade, research ethics has developed in Benin partly through a partnership with Quebec. This partnership has evolved using TCPS2, the Canadian framework in research ethics. In doing so, three main values were put forward : respect for human dignity, respect for cultural diversity and solidarity. Over that time period, research ethics in Benin has structured through new Research Ethics Committees (REC) and though participation of those involved in research with human beings. REC members, researchers and students have acquired the needed tools to resolve most of the ethical dilemmas that could arise in the future making it one of the positive results of this partnership. Retrospectively, it has also been a situation where the Van Rensselaer Potter's perspective on bioethics has emerged in a French-speaking context where the spoken language and the French cultural approach is of great importance.
Tansey, Catherine M; Anderson, James; Boulanger, Renaud F; Eckenwiler, Lisa; Pringle, John; Schwartz, Lisa; Hunt, Matthew
The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee (REC) members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries (LMICs) perceive as the key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants' vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster
Prichard, Jeremy; Hall, Wayne; de Voogt, Pim; Zuccato, Ettore
To discuss the need to develop ethical guidelines for researchers using sewage epidemiology to monitor drug use in the general population and specific precincts, including prisons, schools and workplaces. Describe current applications of sewage epidemiology, identify potential ethical risks associated with this science, and identify key means by which these risks may be mitigated through proportionate ethical guidance that allows this science to be fully developed. A rapidly advancing field of research is sewage epidemiology (SE) - the analysis of wastewater samples to monitor illicit drug use and other substances. Typically this research involves low ethical risks because individual participants cannot be identified and, consequently, review has been waived by human research ethics committees. In the absence of such oversight, ethical research guidelines are recommended for SE teams, peer reviewers and journal editors; guidelines will assist them to mitigate any risks in general population studies and studies of prisons, schools and workplaces. Potential harms include the stigmatisation of participants and, in the prison setting, austere policy responses to SE data that impact negatively upon inmate-participants. The risk of harm can be managed through research planning, awareness of the socio-political context in which results will be interpreted (or, in the case of media, sensationalised) and careful relations with industry partners. Ethical guidelines should be developed in consultation with SE scholars and be periodically amended. They should include publication processes that safeguard scientific rigour and be promulgated through existing research governance structures. Guidelines will assist to promote an ethical research culture among SE teams and scholars involved in the publication process and this will work to protect the reputation of the field. Copyright © 2014 Elsevier B.V. All rights reserved.
Full Text Available Infants have a complex set of nutrient requirements to meet the demands of their high metabolic rate, growth, and immunological and cognitive development. Infant nutrition lays the foundation for health throughout life. While infant feeding research is essential, it must be conducted to the highest ethical standards. The objective of this paper is to discuss the implications of developments in infant nutrition for the ethics of infant feeding research and the implications for obtaining informed consent. A search was undertaken of the papers in the medical literature using the PubMed, Science Direct, Web of Knowledge, Proquest, and CINAHL databases. From a total of 9303 papers identified, the full text of 87 articles that contained discussion of issues in consent in infant feeding trials were obtained and read and after further screening 42 papers were included in the results and discussion. Recent developments in infant nutrition of significance to ethics assessment include the improved survival of low birth weight infants, increasing evidence of the value of breastfeeding and evidence of the lifelong importance of infant feeding and development in the first 1000 days of life in chronic disease epidemiology. Informed consent is a difficult issue, but should always include information on the value of preserving breastfeeding options. Project monitoring should be cognisant of the long term implications of growth rates and early life nutrition.
Full Text Available In a globalizing world, what role can social science research – particularly action research – play in order to address the risks of exclusion, poverty, social and physical insecurity and environmental deprivation? More specifically, how can this type of research be conducted in a participatory, responsible, transparent and scientific way? In other words: what about the ethics and standards in action research? This was the main focus of the World Congress on Action Research and Action Learning (August 2006 organized by the University of Groningen and the Higher Education Group of the Northern Netherlands. We begin by discussing the core characteristics of action research with reference to theory and practice. Reflection and action are key constituents of the process through the enactment of action research. The middle section draws upon the research findings presented at the congress and published in a book [B. Boog, J. Preece, M. Slagter and J. Zeelen (Eds. (2008 Towards Quality Improvement of Action Research. Developing Ethics and Standards, Rotterdam/Taipei: Sense Publishers]. Citing authors who contributed chapters to the book mentioned above, we analyze four important subthemes: ‘participation, power and rapport’; ‘quality of research and quality management’; ‘learning to solve your own problems in complex responsive social systems, and ‘heuristics (rules of thumb for action research practice’. Finally, we comment on possible quality improvements for action research. Our remarks relate to the problems of implementing the concept of participation, the ambition of action research to contribute to both knowledge production and social change and the need for systematic reconstruction (scientific validation of action research.
Ndebele, Paul; Wassenaar, Douglas; Benatar, Solomon; Fleischer, Theodore; Kruger, Mariana; Adebamowo, Clement; Kass, Nancy; Hyder, Adnan A.; Meslin, Eric M.
The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards’ documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees’ leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees’ background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program. PMID:24782070
Ndebele, Paul; Wassenaar, Douglas; Benatar, Solomon; Fleischer, Theodore; Kruger, Mariana; Adebamowo, Clement; Kass, Nancy; Hyder, Adnan A; Meslin, Eric M
The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards' documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees' leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees' background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.
This paper outlines a theoretical context for research into "the subject of ethics" in terms of how students come to see themselves as self-reflective actors. I maintain that the "subject of ethics," or ethical subjectivity, has been overlooked as a necessary aspect of creating politically transformative spaces in education. At…
For most of its existence, the field of computer science has been lucky enough to avoid ethical dilemmas by virtue of its relatively benign nature. The subdisciplines of programming methodology research, microprocessor design, and so forth have little room for the greater questions of human harm. Other, more recently developed sub-disciplines, such as data mining, social network analysis, behavioral profiling, and general computer security, however, open the door to abuse of users by practitioners and researchers. It is therefore the duty of the men and women who chart the course of these fields to set rules for themselves regarding what sorts of actions on their part are to be considered acceptable and what should be avoided or handled with caution out of ethical concerns. This paper deals solely with the issues faced by computer security researchers, be they vulnerability analysts, privacy system designers, malware experts, or reverse engineers.
Full Text Available Abstract Research in psychopharmacology for children and adolescents is fraught with ethical problems and tensions. This has practical consequences as it leads to a paucity of the research that is essential to support the treatment of this vulnerable group. In this article, we will discuss some of the ethical issues which are relevant to such research, and explore their implications for both research and standard care. We suggest that finding a way forward requires a willingness to acknowledge and discuss the inherent conflicts between the ethical principles involved. Furthermore, in order to facilitate more, ethically sound psychopharmacology research in children and adolescents, we suggest more ethical analysis, empirical ethics research and ethics input built into psychopharmacological research design.
The International Association for Dental Research, in 2009, adopted a code of ethics. The code applies to members of the association and is enforceable by sanction, with the stated requirement that members are expected to inform the association in cases where they believe misconduct has occurred. The IADR code goes beyond the Belmont and Helsinki statements by virtue of covering animal research. It also addresses issues of sponsorship of research and conflicts of interest, international collaborative research, duty of researchers to be informed about applicable norms, standards of publication (including plagiarism), and the obligation of "whistleblowing" for the sake of maintaining the integrity of the dental research enterprise as a whole. The code is organized, like the ADA code, into two sections. The IADR principles are stated, but not defined, and number 12, instead of the ADA's five. The second section consists of "best practices," which are specific statements of expected or interdicted activities. The short list of definitions is useful.
Carlos M Albornoz López del Castillo
Full Text Available La ética de la experimentación con seres humanos no es sólo una de las áreas fundamentales de la bioética, sino también una de las problemáticas que le dieron origen. Se describen en este trabajo algunas implicaciones éticas de la experimentación en seres humanos; se analizan el origen y evolución de la bioética, los aspectos regulatorios para la realización de ensayos clínicos y su valoración moral, los tipos de experimentación; la realidad mundial y cubana en cuanto a investigación clínica y tecnología y el consentimiento informado. Se concluye que el criterio ético fundamental de las investigaciones en seres humanos es su disposición al servicio del hombreThe ethics of experimentation with human beings is not only one of the fundamental areas of bioethics, but also one of the problems that originated this field. In this work some ethical implications of experimentation in human beings are described; the origin and evolution of bioethics are analyzed, the regulatory aspects for the realization of clinical trials and their moral valuation, the experimentation types; international and Cuban reality as for clinical investigation and technology and the informed consent. It is assumed that the fundamental ethical approach of the investigations with human beings is its disposition to serve mankind
López Moratalla, Natalia
The neurobiological processes underlying moral judgement have been the focus of Neuroethics. Neurosciences demonstrate which cerebral areas are active and inactive whilst people decide how to act when facing a moral dilemma; in this way we know the correlation between determined cerebral areas and our human acts. We can explain how the ″ethical endowments″ of each person, common to all human beings, is ″embedded″ in the dynamic of cerebral flows. Of central interest is whether emotions play a causal role in moral judgement, and, in parallel, how emotion related areas of the brain contribute to moral judgement. The outcome of man's natural inclinations is on one hand linked to instinctive systems of animal survival and to basic emotions, and on the other, to the life of each individual human uninhibited by automatism of the biological laws, because he is governed by the laws of freedom. The capacity to formulate an ethical judgement is an innate asset of the human mind.
Adams, Kevin; Martin, Sandie
Following legislative changes in 2004 and the establishment of the Human Tissue Authority, access to human tissues for biomedical research became a more onerous and tightly regulated process. Ethical Tissue was established to meet the growing demand for human tissues, using a process that provided ease of access by researchers whilst maintaining the highest ethical and regulatory standards. The establishment of a licensed research tissue bank entailed several key criteria covering ethical, legal, financial and logistical issues being met. A wide range of stakeholders, including the HTA, University of Bradford, flagged LREC, hospital trusts and clinical groups were also integral to the process.
Wynn, L L
In the human sciences, a student research-centered pedagogy is constrained by institutional ethics review, yet there is little research on the impact of ethics review on research-led teaching. This article documents a range of ways that Australian universities are responding to ethics review of undergraduate human research. Forty teachers and administrators were interviewed at 14 universities using purposive sampling to document the range of ways teachers are avoiding ethics review or incorporating it into their curriculum. Some reported halting undergraduate research or evading ethics review, regarding it as meaningless bureaucracy divorced from actual ethical thinking. Those who incorporated ethics review into student research did so by collaborating with administrators. Institutions can facilitate research-led teaching by designing dedicated forms and decentralized review procedures for student research. © The Author(s) 2016.
Cordner, Alissa; Ciplet, David; Brown, Phil; Morello-Frosch, Rachel
Community-engaged research on environmental problems has reshaped researcher-participant relationships, academic-community interaction, and the role of community partners in human subjects protection and ethical oversight. We draw on our own and others’ research collaborations with environmental health and justice social movement organizations to discuss the ethical concerns that emerge in community-engaged research. In this paper we introduce the concept of reflexive research ethics: ethical guidelines and decision-making principles that depend on continual reflexivity concerning the relationships between researchers and participants. Seeing ethics in this way can help scientists conduct research that simultaneously achieves a high level of professional conduct and protects the rights, well-being, and autonomy of both researchers and the multiple publics affected by research. We highlight our research with community-based organizations in Massachusetts, California, and Alaska, and discuss the potential impacts of the community or social movement on the research process and the potential impacts of research on community or social movement goals. We conclude by discussing ways in which the ethical concerns that surface in community-engaged research have led to advances in ethical research practices. This type of work raises ethical questions whose answers are broadly relevant for social movement, environmental, and public health scholars. PMID:22690133
Newson, Ainsley J; Lipworth, Wendy
Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.
Full Text Available Background: There is an assumption that sexual health research has great influence on the quality of human life through elevating sexual health standards, and their results will eliminate the burden of sexual health challenges on family relationships. The aim of this study was to review ethical considerations in sexual health research. Materials and Methods: This narrative review was conducted between January 1990 and December 2017 based on the five-step approach of York University. The keywords used to search for the studies included ethical issues, research, sexual health, reproductive health, and sensitive topics. The language of the literatures was English and the search process was performed on PubMed, Elsevier, Ovid, Springer, Google Scholar, ResearchGate, SAGE Publishing, ProQuest, WHO website, Kinsey Confidential, and Worldsexology. Results: After assessing the quality and eligibility of 94 articles, 13 were selected. The results of the present study showed that the most important ethical considerations were protecting the confidentiality and privacy of participants, obtaining informed consent, and paying attention to vulnerable people. Conclusions: The review of literature exhibited several considerations that sexual health researchers are faced with. In order to manage these considerations, the researcher should have sufficient understanding of them. The important matter is that strategies to manage these challenges should be completely rational and practical according to each context. These strategies can also be applied in other societies with great similarities in their context.
Fernanda Spanier Amador
Full Text Available Neste artigo discuto a ética e os direitos humanos na e pela pesquisa e extensão universitárias, transversalizando os conceitos de tempo e de subjetividade, sobretudo a partir das contribuições de Deleuze, Guattari e Foucault. Abordando a ética, os direitos humanos, a produção de conhecimento e a vida em sua instigante indiscernibilidade, convido a refletir sobre a assunção de uma postura, enquanto pesquisadores e extensionistas, em devir, ou seja, cedendo lugar à experimentação e acionando a diferença. Discuto sobre o tema no plano das epistemologias propondo a promoção da ética e dos direitos humanos na esfera mesma da produção de conhecimento.In this article ethics and the human rights are discussed in and through university research, crossing the concepts of time and subjectivity, following the theoretical references of Deleuze, Guattari and Foucault. Approaching ethics, human rights, "knowledge production" and life as intertwined notions, it proposes the possibility of the attitude of "researchers to be", which involves the possibility of working with experimentation and "difference". The discussion is carried out in the plan of epistemologies and proposes the promotion of ethics and human rights in the same sphere of "knowledge production".
Full Text Available Research conducted through computer-mediated communication is challenging traditional definitions of what is ethical research. In this article the author examines the changing role of assent/consent, confidentiality, and participant observation in qualitative research conducted in cyberspace. She concludes that REBs (research ethic boards might be becoming more conservative in their decisions at the very moment that Internet research requires more flexibility and broader ethical definitions.
Yanagawa, Hiroaki; Katashima, Rumi; Takeda, Noriaki
The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions. J. Med. Invest. 62: 114-118, August, 2015.
Benjamin J. Warnick
Full Text Available The last two decades have been a time of significant development for the academic business ethics community. While a number of scholars have contributed to advances in the field, the work of the individuals who have contributed to its progress and growth through their business ethics research is still not comprehensively understood within the academic business ethics community. This study identifies those individuals who have made major contributions to the business ethics field by ranking authors who have published business ethics-related research in the following six journals over the past 20 years: the Journal of Business Ethics, the Academy of Management Review, the Academy of Management Journal, the Business Ethics Quarterly, the Administrative Science Quarterly; and Business & Society. The results of the study should be of interest to a number of constituencies as they provide the academic business ethics community with a better understanding of the history and evolution of the field and its development towards academic maturity.
Yonas, Michael A; Jaime, Maria Catrina; Barone, Jean; Valenti, Shannon; Documét, Patricia; Ryan, Christopher M; Miller, Elizabeth
This report describes the development and implementation of a tailored research ethics training for academic investigators and community research partners (CRP). The Community Partnered Research Ethics Training (CPRET) and Certification is a free and publicly available model and resource created by a university and community partnership to ensure that traditional and non-traditional research partners may study, define, and apply principles of human subjects' research. To date, seven academic and 34 CRP teams have used this highly interactive, engaging, educational, and relationship building process to learn human subjects' research and be certified by the University of Pittsburgh Institutional Review Board (IRB). This accessible, flexible, and engaging research ethics training process serves as a vehicle to strengthen community and academic partnerships to conduct ethical and culturally sensitive research. © The Author(s) 2016.
Coleman, Doriane Lambelet
Since the mid- to late 1990s, the scientific and medical research community has sought to increase its access to healthy children for research protocols that involve harm or a risk of harm. This move reverses longstanding policy within that community generally to exclude healthy children from such protocols on the grounds that the research as to them is non-therapeutic, that they are particularly vulnerable to research-related abuses, and that they are unable themselves to give informed consent to their participation. The research community's new posture has been supported by prominent pediatric bioethicists who have argued that unless healthy children are included as research subjects in harmful or risky research, the pediatric population will continue to suffer relative to the adult population in the extent to which it benefits from modern advances in science and medicine. In their view, it is possible for the research community to self-administer a rule that strikes a balance between protecting healthy children from research-related abuses and allowing their inclusion in cutting-edge pediatric research. In this scheme, parental consent is central to the research community's claims about child protection. This Article explores the flaws inherent in this ethics of pediatric research. Specifically, it challenges the view from ethics that the law permits parents to consent to their children's inclusion in harmful or risky research to the extent that related invasions would meet legal maltreatment standards. More broadly, it challenges the movement to increase access to healthy children for harmful and risky research on the ground that it risks two important regressions: First, in its willingness to risk harm to individual children in the interests of the group, it threatens the progress the law has made in its development of the concept of the child as an individual worthy of respect in his or her own right, a concept that imagines parents as fiduciaries and that
Ethical considerations are made when an experiment is planned and take a regulatory system of moral principles into account. Ethical considerations should first and foremost be made in order to protect the individual subject/animal from being exposed to any unethical and perhaps even illegal intervention and to ensure that the experimental conditions used are appropriate. The main role of research ethics committees is to assess the scientific and ethical aspects of submitted protocols and follow up the trial until its closure.
Monzon, Jorge E; Monzon-Wyngaard, Alvaro
This paper discusses some guidelines for use with the accepted fundamental canons of ethics for engineers. We present some rules of practice and professional obligations emerging from these canons. Basic recommendations for engineers dissenting on ethical grounds are also presented. Ethical issues relating to Biomedical Engineering research are illustrated. We mention some cases that could be used to further understanding the ethical implications of biomedical engineering practice.
Valdez-Martínez, Edith; Lifshitz-Guinzberg, Alberto; Medesigo-Micete, José; Bedolla, Miguel
To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and functions. A cross-sectional descriptive study was conducted from January-December 2005. A survey was sent by e-mail to the hospitals and family medicine centers with at 10 practices within the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) (n=437) and the Institute for Security and Social Services for State Employees (Seguridad y Servicios Sociales de los Trabajadores del Estado) (n=167) and to the Mexican Ministry of Health's most important health care centers (n=15). The following items were analyzed: name of the committee, date of formation, current status, composition, functions, and level of authority. In all, 116 committees were identified, with various names. Of these, 101 (87.1%) were active. The committees were formed from 1985-2006, with a spike occurring in 2004-2005. Of the active committees, 59 (58.4%) were charged with ethical problems/dilemmas related to clinical practice as well as those related to research projects. Of the committee members, 357 (59.0%) held managing positions in the establishment to which the committee pertained; most were medical professionals (71.5%), followed by nursing staff (11.9%). Among the members of the active committees, 77.9% had not received training in ethics. Legal conflicts can be expected, mainly within the organizations whose committees have the authority to determine a course of action. An integrated plan is needed that will set standards for the composition and proceedings of Mexico's ethics committees and the improved training of committee members.
Global Ethics Applied’ in four volumes is a reader of 88 selected articles from the author on 13 domains: Vol. 1 Global Ethics, Economic Ethics; Vol. 2 Environmental Ethics; Vol. 3 Development Ethics, Political Ethics, Dialogue and Peace Ethics, Innovation and Research Ethics, Information and Communication Ethics; Vol. 4 Bioethics and Medical Ethics, Family Ethics and Sexual Ethics, Leadership Ethics, Theological Ethics and Ecclesiology, Methods of Ethics. It concludes with the extended Bibli...
Brandenburg, Robyn; Gervasoni, Ann
The ethical practice underpinning self-study research has been addressed extensively in the literature of self-study of teacher education practices. Less attention has been paid to how researchers deal with ethical tensions and dilemmas when they arise unexpectedly during self-study research. In this article, we examine how the extrapolation and…
Sweeney, Aldrin E
Continuing advances in human ability to manipulate matter at the atomic and molecular levels (i.e. nanoscale science and engineering) offer many previously unimagined possibilities for scientific discovery and technological development. Paralleling these advances in the various science and engineering sub-disciplines is the increasing realization that a number of associated social, ethical, environmental, economic and legal dimensions also need to be explored. An important component of such exploration entails the identification and analysis of the ways in which current and prospective researchers in these fields conceptualize these dimensions of their work. Within the context of a National Science Foundation funded Research Experiences for Undergraduates (REU) program in nanomaterials processing and characterization at the University of Central Florida (2002-2004), here I present for discussion (i) details of a "nanotechnology ethics" seminar series developed specifically for students participating in the program, and (ii) an analysis of students' and participating research faculty's perspectives concerning social and ethical issues associated with nanotechnology research. I conclude with a brief discussion of implications presented by these issues for general scientific literacy and public science education policy.
Full Text Available Abstract Background Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist’s potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics. Method Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed. Results Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77% and informed consent in 77 (47.83%. Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01% and was not reported in any Bachelors’ degree dissertation. Informed consent was also highly reported in MD theses (64.58% followed by undergraduate theses (31.58%. Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned. Conclusions Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE be incorporated in the curriculum of universities in Cameroon in order that the next generation of
Sullivan, Sarah; Aalborg, Annette; Basagoitia, Armando; Cortes, Jacqueline; Lanza, Oscar; Schwind, Jessica S
In Bolivia, there is increasing interest in incorporating research ethics into study procedures, but there have been inconsistent application of research ethics practices. Minimal data exist regarding the experiences of researchers concerning the ethical conduct of research. A cross-sectional study was administered to Bolivian health leaders with research experience (n = 82) to document their knowledge, perceptions, and experiences of research ethics committees and infrastructure support for research ethics. Results showed that 16% of respondents reported not using ethical guidelines to conduct their research and 66% indicated their institutions did not consistently require ethics approval for research. Barriers and facilitators to incorporate research ethics into practice were outlined. These findings will help inform a comprehensive rights-based research ethics education program in Bolivia. © The Author(s) 2015.
This article outlines a researcher's struggles with conducting "ethical" research when her case study reveals racializations faced by a minority teacher in a Canadian ESL program. How might becoming privy to research participants' experiences of inequity in ESL education complicate the notion of research ethics when "doing the right…
Goodrich, Kristopher M.; Luke, Melissa
This article provides a primer for researchers exploring ethical issues in the research of group work. The article begins with an exploration of relevant ethical issues through the research process and current standards guiding its practice. Next, the authors identify resources that group work researchers can consult prior to constructing their…
This special issue is dedicated to Nowadays Applied Ethics in Society, and falls in the field of social sciences and humanities, being hosted both theoretical approaches and empirical research in various areas of applied ethics. Applied ethics analyzes of a series of morally concrete situations of social or professional practice in order to make / adopt decisions. In the field of applied ethics are integrated medical ethics, legal ethics, media ethics, professional ethics, environmental ethic...
The paper provides description of the system of ethical review for biomedical research in Belarus, with special emphasis on its historical background, legal and regulatory framework, structure and functioning. It concludes that the situation with research ethics in Belarus corresponds to the tendency of bureaucratic approach to establishment of systems of ethical review for biomedical research, observed in a number of countries of Central and Eastern Europe. Different social, economical and political factors of transition have major impact on capacities of the Belarusian RECs to ensure adequate protection of human subjects. Among the main problems identified are non-equivalent stringency of ethical review for different types of biomedical research; lack of independence, multidisciplinarity, pluralism and lay representation experienced by RECs; low level of research ethics education and transparency of RECs activities. Recommendations are made to raise the issue of research ethics on the national agenda in order to develop and maintain the research ethics system capable to effectively protect research participants and promote ethical conduct in research.
Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E
A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. 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/
West, C C; Murray, I R; González, Z N; Hindle, P; Hay, D C; Stewart, K J; Péault, B
Access to human tissue is critical to medical research, however the laws and regulations surrounding gaining ethical and legal access to tissue are often poorly understood. Recently, there has been a huge increase in the interest surrounding the therapeutic application of adipose tissue, and adipose-derived stem cells. To facilitate our own research interests and possibly assist our local colleagues and collaborators, we established a Research Tissue Bank (RTB) to collect, store and distribute human adipose tissue derived cells with all the appropriate ethical approval for subsequent downstream research. Here we examine the legal, ethical and practical issues relating to the banking of adipose tissue for research in the UK, and discuss relevant international guidelines and policies. We also share our experiences of establishing an RTB including the necessary infrastructure and the submission of an application to a Research Ethics Committee (REC). Copyright © 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Full Text Available Purpose – Last two decades have seen a marked increase in the interest given to the field of business ethics, particularly, marketing ethics. Marketing ethics provides an innumerable amount of materials and topics for open discussion, as well as for application in practice. Our intention is to open up a space within which to promote timely debate on contemporary marketing education. Design/Methodology/Approach – Monitoring of academic journals in the area of marketing ethics tuition accessible in electronic databases (EBSCO, ProQuest, Web of Science, Google Scholar by means of the Centre for scientific-technical information SR portal. The work is based on the analysis of thematic categories, and the number of publications and citations. Results are presented in a comprehensive and illustrative manner. Findings and implications – Discussions about marketing ethics and ethical issues are useful. Students need preparation, mentoring and counselling while solving ethical problems, which occur during marketing ethics tuition in the academic field, but also in practice. Academic and scientific sources in the area of marketing ethics education are an excellent “instruction”. Limitations – The limitation of this research can be seen in the fact that we focused especially on the marketing aspect of the ethics education. In further research, other fields of interest should be addressed, for example management or practices in commerce, etc. Originality – The aim of the article is to map current trends in research in the field of marketing ethics education, as presented in scientific journals.
believe that it is ethical to perform abortion or euthanasia, whatever the circumstances. The problem inherent in discussing these core beliefs is that almost all debate is based on the premise that the sanctity of human life is paramount, and that to kill a human being, whether by abortion or euthanasia, is ethically wrong.
Cross, Douglas W; Carton, Robert J
Silicofluorides, widely used in water fluoridation, are unlicensed medicinal substances, administered to large populations without informed consent or supervision by a qualified medical practitioner. Fluoridation fails the test of reliability and specificity, and, lacking toxicity testing of silicofluorides, constitutes unlawful medical research. It is banned in most of Europe; European Union human rights legislation makes it illegal. Silicofluorides have never been submitted to the U.S. FDA for approval as medicines. The ethical validity of fluoridation policy does not stand up to scrutiny relative to the Nuremberg Code and other codes of medical ethics, including the Council of Europe's Biomedical Convention of 1999. The police power of the State has been used in the United States to override health concerns, with the support of the courts, which have given deference to health authorities.
This article identifies and discusses ethical dilemmas inherent when undertaking research with children or other vulnerable populations: power relations, risks and benefits, and informed consent and confidentiality (Maguire, 2005). Ethical dilemmas often arise when researchers attempt to merge the interests of their research and the interests of…
Lenette, Caroline; Botfield, Jessica R; Boydell, Katherine; Haire, Bridget; Newman, Christy E; Zwi, Anthony B
Visual research methods like photography and digital storytelling are increasingly used in health and social sciences research as participatory approaches that benefit participants, researchers, and audiences. Visual methods involve a number of additional ethical considerations such as using identifiable content and ownership of creative outputs. As such, ethics committees should use different assessment frameworks to consider research protocols with visual methods. Here, we outline the limitations of ethics committees in assessing projects with a visual focus and highlight the sparse knowledge on how researchers respond when they encounter ethical challenges in the practice of visual research. We propose a situated approach in relation to visual methodologies that encompasses a negotiated, flexible approach, given that ethical issues usually emerge in relation to the specific contexts of individual research projects. Drawing on available literature and two case studies, we identify and reflect on nuanced ethical implications in visual research, like tensions between aesthetics and research validity. The case studies highlight strategies developed in-situ to address the challenges two researchers encountered when using visual research methods, illustrating that some practice implications are not necessarily addressed using established ethical clearance procedures. A situated approach can ensure that visual research remains ethical, engaging, and rigorous.
Aközer, Mehmet; Aközer, Emel
A "no ethics" principle has long been prevalent in science and has demotivated deliberation on scientific ethics. This paper argues the following: (1) An understanding of a scientific "ethos" based on actual "value preferences" and "value repugnances" prevalent in the scientific community permits and demands critical accounts of the "no ethics" principle in science. (2) The roots of this principle may be traced to a repugnance of human dignity, which was instilled at a historical breaking point in the interrelation between science and ethics. This breaking point involved granting science the exclusive mandate to pass judgment on the life worth living. (3) By contrast, respect for human dignity, in its Kantian definition as "the absolute inner worth of being human," should be adopted as the basis to ground science ethics. (4) The pathway from this foundation to the articulation of an ethical duty specific to scientific practice, i.e., respect for objective truth, is charted by Karl Popper's discussion of the ethical principles that form the basis of science. This also permits an integrated account of the "external" and "internal" ethical problems in science. (5) Principles of the respect for human dignity and the respect for objective truth are also safeguards of epistemic integrity. Plain defiance of human dignity by genetic determinism has compromised integrity of claims to knowledge in behavioral genetics and other behavioral sciences. Disregard of the ethical principles that form the basis of science threatens epistemic integrity.
Tilburt, Jon C; Kaptchuk, Ted J
Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social value, scientific validity and favourable risk-benefit ratio. Significant challenges exist in determining shared concepts of social value, scientific validity and favourable risk-benefit ratio across international research collaborations. However, we argue that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can, and should be, resolved. By "cross-training" investigators, and investing in safety-monitoring infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine research that contributes to global health.
Research using human embryonic stem cells raises an array of complex ethical issues, including, but by no means limited to, the moral status of developing human life. Unfortunately much of the public discussion fails to take into account this complexity. Advocacy for liberal and conservative positions on human embryonic stem cell research can be simplistic and misleading. Ethical concepts such as truth-telling, scientific integrity, and social justice should be part of the debate over federal support for human embryonic stem cell research. Moreover, the debate should be conducted in accord with principles of deliberative democracy, including respect for people holding competing views.
Newman, Elana; Risch, Elizabeth; Kassam-Adams, Nancy
ETHICAL DECISION-MAKING ABOUT TRAUMA-RELATED STUDIES requires a flexible approach that counters assumptions and biases about victims, assures a favorable ethical cost-benefit ratio, and promotes advancement of knowledge that can benefit survivors of traumatic stress. This paper reviews several ethical issues in the field of traumatic stress: benefit and risks in trauma-related research, whether trauma-related research poses unique risks and if so what those might be, informed consent and mandatory reporting, and supervision of trauma-related research. For each topic, we review potential ethical issues, summarize the research conducted thus far to inform ethical practice, and recommend future practice, research questions and policies to advance the field so that research on trauma can continue to be a win-win situation for all stakeholders in the research enterprise.
Trials, 2006; and Ethics in Health Research Principles, Structures and Procedures, 2015) regarding caregivers' consent in research involving minors as research ..... 11. Jeff H, Ramesh R, Sanjay MB. Pediatric airway management.
Longstaff, Holly; Schuppli, Catherine A; Preto, Nina; Lafrenière, Darquise; McDonald, Michael
This paper describes findings from an ethics education project funded by the Canadian Stem Cell Network (SCN). The project is part of a larger research initiative entitled "The Stem Cell Research Environment: Drawing the Evidence and Experience Together". The ethics education study began with a series of focus groups with SCN researchers and trainees as part of a "needs assessment" effort. The purpose of these discussions was to identify the main ethical issues associated with stem cell (SC) research from the perspective of the stem cell community. This paper will focus on five prominent themes that emerged from the focus group data including: (1) the source of stem cells; (2) the power of stem cells; (3) working within a charged research environment; (4) the regulatory context; and (5) ethics training for scientists. Additional discussions are planned with others involved in Canadian stem cell research (e.g., research ethics board members, policy makers) to supplement initial findings. These assessment results combined with existing bioethics literature will ultimately inform a web-based ethics education module for the SCN. We believe that our efforts are important for those analyzing the ethical, legal, and social issues (ELSI) in this area because our in depth understanding of stem cell researcher perspectives will enable us to develop more relevant and effective education material, which in turn should help SC researchers address the important ethical challenges in their area.
Full Text Available Scientists' moral responsibilities have become a focus for the scientific community over the postwar decades. International and regional networks of leading academic bodies have responded to a widely perceived increase in scientific fraud and the ensued loss of public trust in science during the 1980s, and initiated a discussion with a view to codifying good practice in research. While scientists' “external” responsibilities towards society and the humankind have been variously addressed, codes drafted since then mainly dwell on problems of misconduct concerning scientists' “internal” responsibilities towards science and to the scientific community. They also reflect an ethical pluralism, which declines justifying moral standards in research with reference to universal ethical principles. However, the need for such justification has been first recognized decades ago, during the Doctor's Trial in Nuremberg, where the shortcomings of the established ethos of science and the inadequacy of the Hippocratic ethics in safeguarding human rights in research had become flagrant, with the resultant Nuremberg Code of 1947 introducing a human rights perspective into Hippocratic ethics. This paper argues for the necessity of an integral ethical justification of scientists' both external and inner responsibilities, as put down or assumed by internationally acclaimed codes of conduct. Such necessity is validated by the evidence that a historical current to monopolize ethical thinking in the name of science and nullify philosophical ethics lies at the root of an anti–morality that relativized human worth and virtually legitimized human rights violations in scientific practice. Kantian ethics based on humans' absolute inner worth, and Popperian epistemology rooted in respect for truth and for humans as rational beings, pledge an ethical justification of moral norms in science so as to reinforce the latter against intrusions of anti–morality. The paper
Spash, Clive L.; Gattringer, Clemens
Human induced climate change poses a series of ethical challenges to the current political economy, although it has often be regarded by economists as only an ethical issue for those concerned about future generations. The central debate in economics has then concerned the rate at which future costs and benefits should be discounted. Indeed the full range of ethical aspects of climate change are rarely even discussed. Despite recent high profile and lengthy academic papers on t...
This paper examines the ethics of international clinical collaboration in stem cell research by focusing on the AlloStem project. AlloStem is an international research programme, financed by the European Union under the Sixth Framework Programme, with the aim of advancing the use of stem cells in treating leukaemia and other haematological diseases. Several areas of ethical importance are explored. Research justification and the need to consider both deontological and teleological aspects are examined. Ethical sensitivity in research and the requirement to respond to areas of ethical concern identified by the European Commission, such as the involvement of human beings, the use of human tissue, and the use of animals are also explored. Ethical issues around project structure and management, such as ethical standardization in international research, and achieving set targets are discussed. The ethical importance of dissemination of findings and teaching in clinical research is also considered. Finally, the distribution of benefits is addressed and the importance of distributive justice is emphasized.
Sonia Maria Oliveira de Barros
Full Text Available This is a review article on the origin of the ethical analysis ofresearch protocols, the Brazilian and International legislation,including the Research Ethics Committee of Hospital IsraelitaAlbert Einstein. Since 1997, when the Committee was validatedits role has been recognized as that of a consultant and educator,participating on local and national scientific events andcollaborating with researchers in order to improve their projectsand learn to recognize ethical dilemmas in their protocols.
Haverkamp, Beth E.
The present article explores ethical issues that emerge in qualitative research conducted by applied psychologists. The utility and relevance of the Ethical Principles of Psychologists and Code of Conduct (American Psychological Association, 2002) for qualitative research are examined. The importance of psychology's fiduciary relationship with…
Stevenson, Fiona A; Gibson, William; Pelletier, Caroline; Chrysikou, Vasiliki; Park, Sophie
UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research. We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the 'iterative' paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of 'quality', which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on 'outcomes' may be regarded as problematic. We show that the alternative 'iterative' paradigm offers a useful starting point for moving beyond these limited views. We conclude that a 'one size fits all' standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be
Paavilainen, Eija; Lepistö, Sari; Flinck, Aune
Research ethics is always important. However, it is especially crucial with sensitive research topics such as family violence. The aim of this article is to describe and discuss some crucial issues regarding intimate partner violence and child maltreatment, based on the authors' own research experiences. We focus on and discuss examples concerning the definition of family violence, research design, ethical approval, participant recruitment and safety and data collection and processing. During the research process, the significance of teamwork is emphasized. Support provided by the participants to each other and support given by experienced researchers within the team is very important for high ethical standards.
Paradise, Louis V.
The ethical behavior of counselors is an issue of current importance to those in the profession. This paper briefly examines the literature in this area. While considerable descriptive research on ethical behavior exists, the conspicuous absence of any experimental methodologies and theoretically-based investigations were noted. The need for new…
Blažun Vošner, Helena; Železnik, Danica; Kokol, Peter; Vošner, Janez; Završnik, Jernej
There have been a number of debates in the field of nursing ethics. Researchers have focused on various aspects of nursing ethics, such as professional ethics, professional, nursing and ethical values. Within this research, a variety of literature reviews have been conducted, but to the best of our knowledge, bibliometric mapping has not yet been used. This article aims to analyse the production of literature within nursing ethics research. In order to examine publishing patterns, we focused on publishing dynamics, prolific research entities and the most-cited articles. We additionally visualised the content of the literature using a novel mixed-method approach, combining bibliometric analysis and mapping with thematic analysis. Ethical considerations: In our study, ethical review was not required. A total of 1416 information sources were found in the Scopus database. Overall, literature production has increased; however, in recent years, the quantity of published material has begun to decrease. The most prolific countries are the United States, the United Kingdom and Canada, and the most prolific source titles are Nursing Ethics, Journal of Advanced Nursing and Nursing Times. Lately, research in the field of nursing ethics has been focused more on life care (providing for the basic needs of older residents), moral distress and community nursing. The dynamics of research literature production showed an exponential rise in the number of published information sources - a rise which started in the period between 1974 and 1998. Since that period, the trend has stabilised, which might indicate that nursing ethics research is starting a transition to a mature phase. The innovative use of bibliometric analysis and mapping, together with thematic analysis, is a useful tool for analysis of research production in the field of nursing ethics. The results presented can be an excellent starting point for literature reviews and more exhaustive data, information and knowledge
Eckenwiler, Lisa; Pringle, John; Boulanger, Renaud; Hunt, Matthew
Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises--particularly in resource-poor settings--is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees (RECs). Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like--how it might be conceptualized and utilized--using the concept of real-time responsiveness (RTR). The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. © 2015 John Wiley & Sons Ltd.
The aim of regenerative medicine is to reconstruct tissue that has been lost or pathologically altered. Therapeutic cloning seems to offer a method of achieving this aim; however, the ethical debate surrounding human therapeutic cloning is highly controversial. Artificial parthenogenesis—obtaining embryos from unfertilised eggs—seems to offer a way to sidestep these ethical pitfalls. Jacques Loeb (1859–1924), the founding father of artificial parthogenesis, faced negative public opinion when he published his research in 1899. His research, the public's response to his findings, and his ethical foundations serve as an historical argument both for the communication of science and compromise in biological research. PMID:16319240
For centuries, religion and philosophy have been the primary basis for efforts to guide humans to be more ethical. However, training in ethics and religion and imparting positive values and morality tests such as those emanating from the categorical imperative and the Golden Rule have not been enough to protect humankind from its bad behaviors. To improve ethics education educators must better understand aspects of human nature such as those that lead to "self-deception" and "personal bias." Through rationalizations, faulty reasoning and hidden bias, individuals trick themselves into believing there is little wrong with their own unethical behavior. The application of science to human nature offers the possibility of improving ethics education through better self-knowledge. The author recommends a new paradigm for ethics education in contemporary modern society. This includes the creation of a new field called "applied evolutionary neuro-ethics" which integrates science and social sciences to improve ethics education. The paradigm can merge traditional thinking about ethics from religious and philosophical perspectives with new ideas from applied evolutionary neuro-ethics.
Sieber, J E
A code of ethics has 2 largely incompatible objectives: to set forth enforceable minimal standards of conduct and to teach about or invoke ethical conduct. The section of the new American Psychological Association code dealing with research ethics achieves the former to some degree. However, it neither provides needed education in the ethics of research nor states where the reader might turn for such information. The code is particularly deficient in the following areas: privacy and confidentiality; institutional review boards; deception; debriefing; data sharing; and research on marginal populations, on children and adolescents, and in organizational contexts. Suggestions are offered for providing a bibliographic resource, in hard copy and on-line, that would stimulate independent interest, scholarship, education, and research on research ethics.
Chang, Rosemary L.; Gray, Kathleen
The unique features and educational affordances of Web 2.0 technologies pose new challenges for conducting learning and teaching research in ways that adequately address ethical issues of informed consent, beneficence, respect, justice, research merit and integrity. This paper reviews these conceptual bases of human research ethics and gives…
Jeong, Ihn Sook
This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.
Curzer, Howard J; Wallace, Mark C; Perry, Gad; Muhlberger, Peter J; Perry, Dan
The commonsense ethical constraints on laboratory animal research known as the three Rs are widely accepted, but no constraints tailored to research on animals in the wild are available. In this article, we begin to fill that gap. We sketch a set of commonsense ethical constraints on ecosystem research parallel to the constraints that govern laboratory animal research. Then we combine the animal and ecosystem constraints into a single theory to govern research on animals in the wild.
Simon, Christian; Mosavel, Maghboeba
‘Researcher identity’ affects global health research in profound and complex ways. Anthropologists in particular have led the way in portraying the multiple, and sometimes tension-generating, identities that researchers ascribe to themselves, or have ascribed to them, in their places of research. However, the central importance of researcher identity in the ethical conduct of global health research has yet to be fully appreciated. The capacity of researchers to respond effectively to the ethical tensions surrounding their identities is hampered by lack of conceptual clarity, as to the nature and scope of the issues involved. This paper strives to provide some clarification of these ethical tensions by considering researcher identity from the perspective of (1) Guillemin and Heggen’s (2009) key distinction between procedural ethics and ethics in practice, and (2) our own distinction between perceptions of identity that are either symmetrical or asymmetrical, with the potential to shift research relationships toward greater or lesser ethical harmony. Discussion of these concepts is supported with ethnographic examples from relevant literature and from our own (United States (US) Government-funded) research in South Africa. A preliminary set of recommendations is provided in an effort to equip researchers with a greater sense of organization and control over the ethics of researcher identity. The paper concludes that the complex construction of researcher identity needs to be central among the ethical concerns of global health researchers, and that the conceptual tools discussed in the paper are a useful starting point for better organizing and acting on these ethical concerns. PMID:21426482
Gardusi, Claudia; Aquino, Afonso Rodrigues de
The purpose of this work is to reflect about actions that may contribute to the creation of mechanisms to protect the environment in the development of research projects at research institutions, specifically the Nuclear and Energy Research Institute - IPEN. A brief review of part of the ethical values applied to the process of scientific development during the old, medieval and modern periods is presented, showing the split of the nature ethical principles. It is also reported an overview of the creation of codes of ethics applied to research institutions. Moreover, criteria are presented to settle guidelines to protect the environment during the development of research projects. (author)
Linda M. Ferguson
Full Text Available Faculty who engage students as participants in their qualitative research often encounter methodological and ethical problems. Ethical issues arise from the fiduciary relationship between faculty and their students, and violations of that relationship occur when the educator has a dual role as researcher with those students. Methodological issues arise from research designs to address these ethical issues. This conflict is particularly evident in faculty research on pedagogy in their own disciplines, for which students are necessary as participants but are captive in the relationship. In this article, the authors explore the issues of double agency when faculty involve students as participants in their research.
Transgenic banana has been developed to prevent hepatitis B through vaccination. Its production seems to be an ideal alternative for cheaper vaccines. The objective of this paper is to assess the ethical perception of transgenic banana which involved the transfer of human albumin gene, and to compare their ethical ...
Seth, Misago; Saguti, Fredy
The significance of animals in research cannot be over-emphasized. The use of animals for research and training in research centres, hospitals and schools is progressively increasing. Advances in biotechnology to improve animal productivity require animal research. Drugs being developed and new interventions or therapies being invented for cure and palliation of all sorts of animal diseases and conditions need to be tested in animals for their safety and efficacy at some stages of their development. Drugs and interventions for human use pass through a similar development process and must be tested pre-clinically in laboratory animals before clinical trials in humans can be conducted. Therefore, animals are important players in research processes which directly and indirectly benefit animals and humans. However, questions remain as to whether these uses of animals consider the best interests of animals themselves. Various research and training institutions in Tanzania have established some guidelines on animal use, including establishing animal ethics committees. However, most institutions have not established oversight committees. In institutions where there may be guidelines and policies, there are no responsible committees or units to directly oversee if and how these guidelines and policies are enforced; thus, implementation becomes difficult or impossible. This paper endeavours to raise some issues associated with the responsible use of animals in research and training in Tanzania and highlights suggestions for improvement of deficiencies that exist in order to bridge the gap between what ought to be practised and what is practised. © 2012 John Wiley & Sons Ltd.
Gelinas, Luke; Pierce, Robin; Winkler, Sabune; Cohen, I Glenn; Lynch, Holly Fernandez; Bierer, Barbara E
Full Text Available Abstract The use of human samples to assess environmental exposure and uptake of chemicals is more than an analytical exercise and requires consideration of the utility and interpretation of data as well as due consideration of ethical issues. These aspects are inextricably linked. In 2004 the EC expressed its commitment to the development of a harmonised approach to human biomonitoring (HBM by including an action in the EU Environment and Health Strategy to develop a Human Biomonitoring Pilot Study. This further underlined the need for interpretation strategies as well as guidance on ethical issues. A workshop held in December 2006 brought together stakeholders from academia, policy makers as well as non-governmental organisations and chemical industry associations to a two day workshop built a mutual understanding of the issues in an open and frank discussion forum. This paper describes the discussion and recommendations from the workshop. The workshop developed key recommendations for a Pan-European HBM Study: 1. A strategy for the interpretation of human biomonitoring data should be developed. 2. The pilot study should include the development of a strategy to integrate health data and environmental monitoring with human biomonitoring data at national and international levels. 3. Communication strategies should be developed when designing the study and evolve as the study continues. 4. Early communication with stakeholders is essential to achieve maximum efficacy of policy developments and facilitate subsequent monitoring. 5. Member states will have to apply individually for project approval from their National Research Ethics Committees. 6. The study population needs to have sufficient information on the way data will be gathered, interpreted and disseminated and how samples will be stored and used in the future (if biobanking before they can give informed consent. 7. The participants must be given the option of anonymity. This has an impact
Reymond, Marc A; Steinert, Ralf; Eder, Frank; Lippert, Hans
Over the last two decades, medical research has begun to make extensive use of products of human origin in therapeutics, oncology, and most recently, in genetic diseases. This has raised many ethical issues involving patient rights, including issues of consent. Besides informed consent, researchers should address several topics when designing studies using human tissues. Reward for the patient should be kept minimal. Sample transfer should be organized along non-profit lines, at least in Europe. Sampling procedures should be at no risk for human volunteers, and at minimal risk for patients. Biosafety aspects should be addressed, in particular when international collaborations are intended or when collaboration is existing between academia and industry. Regulations on importation and exportation of human tissues should be observed. Data acquisition and storage should be addressed in accordance with national data protection regulations, in particular when using computerized databases. If follow-up information is to be taken, the authorization for such information should be requested. The right for patient's information (or for no information) on the research results should also be addressed. The issues of validation and patenting should be also solved, usually by informing the patient that he/she will have no commercial rights on potential research results. The patient should be told if the samples are transferred to another research laboratory or private company. Samples and related data should be destroyed on request at any time point during the course of the study. If possible, traceability of the donor should be ensured.
Salloch, Sabine; Vollmann, Jochen; Schildmann, Jan
Empirical studies on people's moral attitudes regarding ethically challenging topics contribute greatly to research in medical ethics. However, it is not always clear in which ways this research adds to medical ethics as a normative discipline. In this article, we aim to provide a systematic account of the different ways in which attitudinal research can be used for normative reflection. In the first part, we discuss whether ethical judgements can be based on empirical work alone and we develop a sceptical position regarding this point, taking into account theoretical, methodological and pragmatic considerations. As empirical data should not be taken as a direct source for normative justification, we then delineate different ways in which attitudes research can be combined with theoretical accounts of normative justification in the second part of the article. Firstly, the combination of attitudes research with normative-ethical theories is analysed with respect to three different aspects: (a) The extent of empirical data which is needed, (b) the question of which kind of data is required and (c) the ways in which the empirical data are processed within the framework of an ethical theory. Secondly, two further functions of attitudes research are displayed which lie outside the traditional focus of ethical theories: the exploratory function of detecting and characterising new ethical problems, and the field of 'moral pragmatics'. The article concludes with a methodological outlook and suggestions for the concrete practice of attitudinal research in medical ethics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Ethics has an established place within the medical curriculum. However notable differences exist in the programme characteristics of different schools of medicine. This paper addresses the main differences in the curricula of medical schools in South East Europe regarding education in medical ethics and bioethics, with a special emphasis on research ethics, and proposes a model curriculum which incorporates significant topics in all three fields. Teaching curricula of Medical Schools in Bulgaria, Bosnia and Herzegovina, Croatia, Serbia, Macedonia and Montenegro were acquired and a total of 14 were analyzed. Teaching hours for medical ethics and/or bioethics and year of study in which the course is taught were also analyzed. The average number of teaching hours in medical ethics and bioethics is 27.1 h per year. The highest national average number of teaching hours was in Croatia (47.5 h per year), and the lowest was in Serbia (14.8). In the countries of the European Union the mean number of hours given to ethics teaching throughout the complete curriculum was 44. In South East Europe, the maximum number of teaching hours is 60, while the minimum number is 10 teaching hours. Research ethics topics also show a considerable variance within the regional medical schools. Approaches to teaching research ethics vary, even within the same country. The proposed model for education in this area is based on the United Nations Educational, Scientific and Cultural Organization Bioethics Core Curriculum. The model curriculum consists of topics in medical ethics, bioethics and research ethics, as a single course, over 30 teaching hours.
Matar, Amal; Silverman, Henry
The recent increase in research in the Middle East has been associated with the establishment of research ethics committees (RECs). Our aim was to obtain perspectives of RECs regarding the challenges that impede their effective functioning. We conducted in-depth interviews using a semi-structured interview guide. We transcribed and analyzed the interviews to uncover major themes and subthemes. We identified the following themes: membership composition; training needs of members; availability of human and capital resources; role of the national government; concerns with the informed consent process; government scrutiny of research; investigator-related issues; and concerns with transfer of biological samples to other countries. Our interview study revealed several barriers that need to be considered by appropriate stakeholders to enhance adequate functioning of RECs.
Strous, Rael D
Psychopharmacology is a powerful tool in psychiatry; however, it is one that demands responsibility in order to deal with the ethical complexities that accompany advances in the field. It is important that questions are asked and that ethical mindfulness and sensitivity are developed along with clinical skills. In order to cultivate and deepen ethical awareness and subsequently solve issues in optimal fashion, investment should be made in the development of an ethical decision-making process as well as in education in the ethics of psychopharmacology to trainees in the field at all stages of their educational development. A clear approach to identifying ethical problems, engaging various ethical concepts in considering solutions and then applying these principles in problem resolution is demanded. An openness in identifying and exploring issues has become crucial to the future development and maturation of psychopharmacologists, both research and clinical. Consideration must be given to the social implications of psychopharmacological practice, with the best interests of patients always paramount. From both a research and clinical perspective, psychopharmacology has to be practised with fairness, sensitivity and ethical relevance to all. While ethical issues related to psychopharmacological practice are varied and plentiful, this review focuses on advances in technology and biological sciences, personal integrity, special populations, and education and training.
Full Text Available Declaration of Helsinki code of ethics on human experimentation, states that the desin and peformance of experimental procedures involving human should be clearly formulated in an experimental protocol, Todeterminewhetheraninvestigationin accordancewiththe code of conductin a researchthen letusconsider the contentofthe declarationhelsinkiasour referencein conductingaclinicalstudyusinghuman subjects. In journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian.
Nordentoft, Helle Merete; Kappel, Nanna
, leaving both professionals and researchers in ethical and moral dilemmas. In this article, we specifically focus on the methodological challenges of obtaining informed consent from drug users and terminally ill cancer patients in our PhD research. The question is how to illuminate the needs and problems......Ethical guidelines for conducting research are embedded in the Helsinki Declaration of 1964. We contend that these abstract and intentionally universal guidelines need to be appropriated for social and healthcare research, in which purpose and methods often deviate from medical research....... The guidelines appear to be instrumental and over-simplistic representations of the often ‘messy’ realities surrounding the research process that is often guided by relational and local negotiations of ethical solutions. Vulnerable participants, for instance, challenge both professional and research ethics...
Full Text Available In the mid 1980s education researchers began exploring the use of the Internet within teaching and learning practices, now commonly referred to as e-learning. At the same time, many e-learning researchers were discovering that the application of existing ethical guidelines for qualitative research was resulting in confusion and uncertainty among both researchers and ethics review board members. Two decades later we continue to be plagued by these same ethical issues. On reflection on our research practices and examination of the literature on ethical issues relating to qualitative Internet- and Web-based research, the authors conclude that there are three main areas of confusion and uncertainty among researchers in the field of e-learning: (a participant consent, (b public versus private ownership, and (c confidentiality and anonymity.
Cassidy, V R
Discussions in the literature assert that nurses are becoming increasingly cognizant of their ethical responsibilities, but that they are often ill prepared to participate in ethical decision making. A review of selected research literature from 1970 to 1987 was undertaken to validate these assertions. A total of 12 studies related to ethical responsibilities was identified in the review; all studies were published between 1980 and 1987. The majority of studies were at the descriptive and exploratory levels and employed Kohlberg's cognitive theory of moral development as their conceptual framework. Significant findings related to educational level and ethical responsibilities were consistent across studies. Findings related to age and clinical experience were mixed; the effects of economic level, religion-religiosity, ethnicity, and other variables on ethical responsibilities were not significant. Issues raised in the light of the existing research include the use of Kohlberg's theory as a conceptual orientation in nursing groups and limited data on the reliability and validity of instruments used in measuring ethical constructs. Recommendations for future research on ethical responsibilities include the validation of Kohlberg's theory for nursing investigations, exploration of other frameworks for developing a multidimensional view of ethical responsibilities, and the use of qualitative research designs.
Wahlberg, Ayo; Rehmann-Sutter, Christoph; Sleeboom-Faulkner, Margaret; Lu, Guangxiu; Döring, Ole; Cong, Yali; Laska-Formejster, Alicja; He, Jing; Chen, Haidan; Gottweis, Herbert; Rose, Nikolas
One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved. Copyright © 2013 Elsevier Ltd. All rights reserved.
Henderson, Gail E; Juengst, Eric T; King, Nancy M P; Kuczynski, Kristine; Michie, Marsha
Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty--that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted "in the public square." © 2012 American Society of Law, Medicine & Ethics, Inc.
Schopper, Doris; Dawson, Angus; Upshur, Ross; Ahmad, Aasim; Jesani, Amar; Ravinetto, Raffaella; Segelid, Michael J; Sheel, Sunita; Singh, Jerome
Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out
Wolf, Susan M.; Burke, Wylie; Koenig, Barbara A.
Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation. PMID:26479558
Paradis, E K
This paper presents a feminist and community psychology analysis of ethical concerns that can arise throughout the process of doing research with women who are homeless. The unique contexts of the lives of women who are homeless demand that researchers redefine traditional ethical constructs such as consent, privacy, harm, and bias. Research that fails to do this may perpetuate the stereotyping, marginalization, stigmatization, and victimization homeless women face. Feminist and community research ethics must go beyond the avoidance of harm to an active investment in the well-being of marginalized individuals and communities. Using feminist and community psychology ethics, this paper addresses some common problems in research with women who are homeless, and argues for the transformation of research from a tool for the advancement of science into a strategy for the empowerment of homeless women and their communities.
This article identifies the key ethical issues that need to be addressed in any research study involving children and young people, accessed through the NHS. It makes specific reference to the Declaration of Helsinki and to additional guidance developed for researchers from a variety of disciplines, both within healthcare and in other fields of study. The focus of the paper is on defining the key ethical issues, identifying the complexities in the legislative framework underpinning research involving this patient group and offering practical advice on when, and how, ethical approval needs to be sought
Addissie, Adamu; Davey, Gail; Newport, Melanie; Farsides, Bobbie; Feleke, Yeweyenhareg
One of the challenges in the process of ethical medical research in developing countries, including Ethiopia, is translating universal principles of medical ethics into appropriate informed consent documents and their implementation. Rapid Ethical Assessment (REA) has been suggested as a feasible approach to meet this application gap. In the past few years REA has been employed in few research project in Ethiopia and have been found to be a useful and practical approach. Feasibility assessment of REA for the Ethiopian research setting was conducted between 2012-2013 in order to inform the subsequent introduction of REA into research ethics review and governance system in the country. REA was found to be an appropriate, relevant and feasible venture. We argue that REA can be integrated as part of the ethics review and governance system in Ethiopia. REA tools and techniques are considered relevant and acceptable to the Ethiopian research community, with few practical challenges anticipated in their implementation. REA are considered feasible for integration in the Ethiopian ethics review system.
Andersen, Mads Lund; Chimiri, Niklas Alexander; Søndergaard, Dorte Marie
Session: Sociomaterial complexities in digital-analog spaces Abstract: Analytical and ethical complexities in video game research A central issue that video game research seldom explicitly articulates is the ethical complexities involved in its empirical and analytical work. The presentation...... explores common research questions posed and analytical foci chosen by video game researchers subscribing to either the media effects tradition, represented by (ref.) or to interdisciplinary Game Studies. Both fields, which tend to depict themselves as polar-opposites, build on ethical assumptions...... of theoretical or analytical arrogance. The relevance of acknowledging and situating ethical complexity becomes pertinent when alternatively taking a sociomaterial perspective on doing empirical and analytical work on video gaming. From an agential realist point of view, for instance, a researcher...
Célia Alcantara Cunha Lima
Full Text Available This work addressed the norms of ethics for human experimentation in Brazil, operationalized by the National Research Ethics Commission (CONEP of the National Health Council (CNS. It analyzed international principles of bioethics as a theoretical framework for the Brazilian regulation. National and international publications were reviewed, by Capes periodicals, relating to historical ethical infractions, such as reflection to the current day. It analyzed the law (PL 200/2015 of the Senate, which proposes flexibilities in Brazilian legislation and concluded that the requested changes should be discussed in depth by bioethicists, scientists and Brazilian lawyers with extended discussion to society.
Molyneux, Sassy; Geissler, P. Wenzel
The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more ‘situated ethics’ of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in ‘doing ethics’ in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting
Mathews, D J H; Sugarman, J; Bok, H; Blass, D M; Coyle, J T; Duggan, P; Finkel, J; Greely, H T; Hillis, A; Hoke, A; Johnson, R; Johnston, M; Kahn, J; Kerr, D; Kurtzberg, J; Liao, S M; McDonald, J W; McKhann, G; Nelson, K B; Rao, M; Regenberg, A; Siegel, A W; Smith, K; Solter, D; Song, H; Vescovi, A; Young, W; Gearhart, J D; Faden, R
Attempts to translate basic stem cell research into treatments for neurologic diseases and injury are well under way. With a clinical trial for one such treatment approved and in progress in the United States, and additional proposals under review, we must begin to address the ethical issues raised by such early forays into human clinical trials for cell-based interventions for neurologic conditions. An interdisciplinary working group composed of experts in neuroscience, cell biology, bioethics, law, and transplantation, along with leading disease researchers, was convened twice over 2 years to identify and deliberate on the scientific and ethical issues raised by the transition from preclinical to clinical research of cell-based interventions for neurologic conditions. While the relevant ethical issues are in many respects standard challenges of human subjects research, they are heightened in complexity by the novelty of the science, the focus on the CNS, and the political climate in which the science is proceeding. Distinctive challenges confronting US scientists, administrators, institutional review boards, stem cell research oversight committees, and others who will need to make decisions about work involving stem cells and their derivatives and evaluate the ethics of early human trials include evaluating the risks, safety, and benefits of these trials, determining and evaluating cell line provenance, and determining inclusion criteria, informed consent, and the ethics of conducting early human trials in the public spotlight. Further study and deliberation by stakeholders is required to move toward professional and institutional policies and practices governing this research.
Khodyakov, Dmitry; Mikesell, Lisa; Schraiber, Ron; Booth, Marika; Bromley, Elizabeth
The transfer of new discoveries into both clinical practice and the wider community calls for reliance on interdisciplinary translational teams that include researchers with different areas of expertise, representatives of health care systems and community organizations, and patients. Engaging new stakeholders in research, however, calls for a reconsideration or expansion of the meaning of ethics in translational research. We explored expert opinion on the applicability of ethical principles commonly practiced in community-engaged research (CEnR) to translational research. To do so, we conducted 2 online, modified-Delphi panels with 63 expert stakeholders who iteratively rated and discussed 9 ethical principles commonly used in CEnR in terms of their importance and feasibility for use in translational research. The RAND/UCLA appropriateness method was used to analyze the data and determine agreement and disagreement among participating experts. Both panels agreed that ethical translational research should be "grounded in trust." Although the academic panel endorsed "culturally appropriate" and "forthcoming with community about study risks and benefits," the mixed academic-community panel endorsed "scientifically valid" and "ready to involve community in interpretation and dissemination" as important and feasible principles of ethical translational research. These findings suggest that in addition to protecting human subjects, contemporary translational science models need to account for the interests of, and owe ethical obligations to, members of the investigative team and the community at large. Copyright © 2016 Elsevier Inc. All rights reserved.
The human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic in Africa has raised important ethical issues for both researchers and clinicians. The most notorious controversy has been related to the zidovudine (AZT) trials in Africa in the late 1990s, in which the control groups were given a placebo rather than an effective drug to prevent vertical transmission. This raised concerns in the sponsoring country about exploitation of subjects, injustice and an ethical double standard between donor countries and resource-poor settings. However, the real double standard is between clinical practice standards in Western versus African countries, which must be addressed as part of the increasing global inequity of wealth both between countries and also within countries. There are important limitations to ethical declarations, principles and guidelines on their own without contextual ethical reasoning. The focus on research ethics with the HIV epidemic has led to a relative neglect of ethical issues in clinical practice. Although the scientific advances in HIV/AIDS have changed the ethical issues since the 1990s, there has also been progress in the bioethics of HIV/AIDS in terms of ethical review capability by local committees as well as in exposure to ethical issues by clinicians and researchers in Africa. However, serious concerns remain about the overregulation of research by bureaucratic agencies which could discourage African research on specifically African health issues. There is also a need for African academic institutions and researchers to progressively improve their research capacity with the assistance of research funders and donor agencies. © 2011 The Author. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).
Serour, G I
Sexual and reproductive rights of women are essential components of human rights. They should never be transferred, renounced or denied for any reason based on race, religion, origin, political opinion or economic conditions. Women have the right to the highest attainable standard of health care for all aspects of their reproductive and sexual health (RSH). The principle of autonomy emphasizes the important role of women in the decision-making. Choices of women in reproduction, after providing evidence based information, should be respected. Risks, benefits and alternatives should be clearly explained before they make their free informed consent. Justice requires that all be treated with equal standard and have equal access to their health needs without discrimination or coercion. When resources are limited there is tension between the principle of justice and utility. Islamic perspectives of bioethics are influenced by primary Sharia namely the Holy Quran, authenticated traditions and saying of the Profit Mohamed (PBUH), Igmaa and Kias (analogy). All the contemporary ethical principles are emphasized in Islamic Shariaa, thus these principles should be observed when providing reproductive and sexual health services for Muslim families or communities. The Family is the basic unit in Islam. Safe motherhood, family planning, and quality reproductive and sexual health information and services and assisted reproductive technology are all encouraged within the frame of marriage. While the Shiaa sect permits egg donation, and surrogacy the Sunni sect forbids a third party contribution to reproduction. Harmful practices in RSH as FGM, child marriage and adolescent pregnancy are prohibited in Islam. Conscientious objection to treatment should not refrain the physician from appropriate referral.
Objective. To examine process error rates in applications for ethics clearance of health research. Methods. Minutes of 586 general research applications made to a human health research ethics committee (HREC) from April 2008 to March 2009 were examined. Rates of approval were calculated and reasons for requiring ...
Advances in cloning technology and successful cloning experiments in animals raised concerns about the possibility of human cloning in recent years. Despite many objections, this is not only a possibility but also a reality. Human cloning is a scientific revolution. However, it also introduces the potential for physical and psychosocial harm to human beings. From this point of view, it raises profound ethical, social and health related concerns. Human cloning would have an impact on the practice of nursing because it could result in the creation of new physiological and psychosocial conditions that would require nursing care. The nursing profession must therefore evaluate the ethics of human cloning, in particular the potential role of nurses. This article reviews the ethical considerations of reproductive human cloning, discusses the main reasons for concern, and reflects a nursing perspective regarding this issue.
Strosberg, Martin A; Gefenas, Eugenijus; Loue, Sana; Philpott, Sean
The post-Communist countries of Central and Eastern Europe and Central Asia are at various stages of development with respect to their capacity to protect human research participants. We examined the impact of two Fogarty-funded programs in this region, the Union Graduate College-Vilnius University Advanced Certificate Program and the Case Western Reserve University Master's Degree Program, by surveying these programs' graduates and by examining alumni activities. Alumni have served in leadership roles on research ethics committees, developed and taught new courses in research ethics, and contributed to scholarship. However, political, social, and economic challenges impede the ability of graduates to maximize their effectiveness. Additional curricular attention is needed in research methodology, policy development and implementation, and the interplay between research ethics and human rights.
Horner, Jennifer; Minifie, Fred D.
Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In "Research Ethics II", the authors review the RCR domains of mentoring,…
Dec 1, 2017 ... CIOMS International Ethical Guidelines for Biomedical Research Involving ... mention of public health in relation to social value. • The new guideline 7, .... reports, can be obtained from conventional media sources such as.
Hey, Spencer Phillips
All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Full Text Available Experimental animal models offer possibilities of physiology knowledge, pathogenesis of disease and action of drugs that are directly related to quality nursing care. This integrative review describes the current state of the instrumental and ethical aspects of experimental research with animal models, including the main recommendations of ethics committees that focus on animal welfare and raises questions about the impact of their findings in nursing care. Data show that, in Brazil, the progress in ethics for the use of animals for scientific purposes was consolidated with Law No. 11.794/2008 establishing ethical procedures, attending health, genetic and experimental parameters. The application of ethics in handling of animals for scientific and educational purposes and obtaining consistent and quality data brings unquestionable contributions to the nurse, as they offer subsidies to relate pathophysiological mechanisms and the clinical aspect on the patient.
Favre-Inhofer, A; Rafii, A; Carbonnel, M; Revaux, A; Ayoubi, J M
Uterine transplantation is the solution to treat absolute uterine fertility. In this review, we present the historical, medical, technical, psychological and ethical perspectives in human uterine transplantation research. We reviewed the PubMed database following PRISMA guidelines and added data presented by several research teams during the first international congress on uterine transplantation. Copyright © 2018. Published by Elsevier Masson SAS.
Melbøe, Line; Hansen, Ketil Lenert; Johnsen, Bjørn-Eirik; Fedreheim, Gunn Elin; Dinesen, Tone; Minde, Gunn-Tove; Rustad, Marit
A study of disability among the indigenous Sami people in Norway presented a number of ethical and methodological challenges rarely addressed in the literature. The main study was designed to examine and understand the everyday life, transitions between life stages and democratic participation of Norwegian Sami people experiencing disability. Hence, the purpose of this article is to increase the understanding of possible ethical and methodological issues in research within this field. The article describes and discusses ethical and methodological issues that arose when conducting our study and identifies some strategies for addressing issues like these. The ethical and methodological issues addressed in the article are based on a qualitative study among indigenous Norwegian Sami people experiencing disability. The data in this study were collected through 31 semi-structured in-depth interviews with altogether 24 Sami people experiencing disability and 13 next of kin of Sami people experiencing disability (8 mothers, 2 fathers, 2 sister and 1 guardian). The researchers identified 4 main areas of ethical and methodological issues. We present these issues chronologically as they emerged in the research process: 1) concept of knowledge when designing the study, 2) gaining access, 3) data collection and 4) analysis and accountability. The knowledge generated from this study has the potential to benefit future health research, specifically of Norwegian Sami people experiencing disability, as well as health research concerning indigenous people in general, providing scientific-based insight into important ethical and methodological issues in research with indigenous people experiencing disability.
Fontes, L A
This article examines ethical issues in cross-cultural research on family violence. It suggests ways for researchers to increase understanding and avoid abuses of power. Special attention to informed consent, definition of the sample, composition of the research team, research methods, and potential harm and benefit are considered key to designing ethical cross-cultural research. The discussion is illustrated with examples from the literature and from the author's experiences conducting research on sexual abuse in a shanty town in Chile and with Puerto Ricans in the U.S.
Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara
Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to
Dyer, A R
Gene therapy for a particular disease like Parkinson's involves ethical principles worked out for other diseases. The major ethical issues for gene therapy (and the corresponding ethical principles) are safety (nonmalfeasance), efficacy (beneficence), informed consent (autonomy), and allocation of resources (justice). Yet genetic engineering (germ-line interventions or interventions to enhance human potentialities) raises emotions and fears that might cause resistance to gene therapies. Looking at these technologies in a postmodern perspective helps one to appreciate the issues at stake in social and cultural change with a new technology such as gene therapy. While "modern" technology and ethics have focused on the autonomy of the individual, we are beginning to see a lessening of such emphasis on individualism and autonomy and more emphasis on the health of the population. Such a social change could cause technologies about which society may currently be cautious (such as human genetic interventions) to become more acceptable or even expected.
Full Text Available “E-waste” is a popular, informal name for electronic products nearing the end of their “useful life”. This includes discarded computers, televisions, VCRs, stereos, copiers, fax machines, electric lamps, cell phones, audio equipment and batteries. E-wastes are considered dangerous, as certain components of some of these electronic products contain materials; such as lead; that are hazardous, depending on their condition and density. If improperly disposed, E-wastes can leach lead and other substances into soil and groundwater posing a threat to human health and environment. Many of these electronic products can be reused, refurbished, or recycled in an environmentally sound manner so that they are less harmful to the ecosystem. This paper highlights the types and hazards of E-wastes particularly the computers’ waste. The dimensions and ethicality of the problem in the third-world countries are reviewed. The needs for the appropriate management of e-waste and options that can be implemented are discussed. After reviewing the Islamic concepts for environmental protection, ethical implications for curriculum development as well research directions are highlighted. Elements for a course on e-waste as well as some across-the-curriculum topics are proposed. This is specially tailored to suit the faculty of Engineering at the International Islamic University-Malaysia.
This article complicates how Canadian universities are pressured to capitalize on research and how these same pressures affect both the collaborative and community-based research within the academy by privileging one type of research and relationships within community over others. Through examining historical influences on Research Ethics Boards…
McDonald, Katherine E.; Kidney, Colleen A.
There are important benefits to including adults with intellectual disabilities in research. Calls for their increased participation in research co-occur with notable discussion about how to conduct ethically strong research with adults with intellectual disabilities, a population widely considered vulnerable in the context of research. The…
McGinn, Michelle K.; Niemczyk, Ewelina K.; Saudelli, Mary Gene
Scant research evidence is available about the day-to-day workings of research assistantships or the educational possibilities they provide for research assistants and their academic supervisors. This case study documents the equitable, educative, and ethical nature of one research assistantship at a Canadian university. Data sources include audio…
During the past two decades, Iran has experienced a noteworthy growth in its biomedical research sector. At the same time, ethical concerns and debates resulting from this burgeoning enterprise has led to increasing attention paid to biomedical ethics. In Iran, Biomedical research ethics and research oversight passed through major periods during the past decades, separated by a paradigm shift. Period 1, starting from the early 1970s, is characterized by research paternalism and complete reliance on researchers as virtuous and caring physicians. This approach was in concordance with the paternalistic clinical practice of physicians outside of research settings during the same period. Period 2, starting from the late 1990s, was partly due to revealing of ethical flaws that occurred in biomedical research in Iran. The regulatory and funding bodies concluded that it was not sufficient to rely solely on the personal and professional virtues of researchers to safeguard human subjects' rights and welfare. The necessity for independent oversight, emphasized by international declarations, became obvious and undeniable. This paradigm shift led to the establishment of research ethics committees throughout the country, the establishment of academic research centers focusing on medical ethics (MEHR) and the compilation of the first set of national ethical guidelines on biomedical research-one of the first and most important projects conducted by and in the MEHR. Although not yet arrived, 'period 3' is on its way. It is predictable from the obvious trends toward performance of high-quality clinical research and the appearance of a highly educated new generation, especially among women. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.
Goulart, Maria Carolina Vaz; Iano, Flávia Godoy; Silva, Paulo Maurício; Sales-Peres, Silvia Helena de Carvalho; Sales-Peres, Arsênio
The molecular biology has provided the basic tool for geneticists deepening in the molecular mechanisms that influence different diseases. It should be noted the scientific and moral responsibility of the researchers, because the scientists should imagine the moral consequences of the commercial application of genetic tests, since this fact involves not only the individual and their families, but the entire population. Besides being also necessary to make a reflection on how this information from the human genome will be used, for good or bad. The objective of this review was to bring the light of knowledge, data on characteristics of the ethical application of molecular biology, linking it with the rights of human beings. After studying literature, it might be observed that the Human Genome Project has generated several possibilities, such as the identification of genes associated with diseases with synergistic properties, but sometimes modifying behavior to genetically intervene in humans, bringing benefits or social harm. The big challenge is to decide what humanity wants on this giant leap.
Gough, Noel P.
This discussion of home economics as a discipline which should focus on its affective foundations, covers the following areas: Affective context of home economics education, the adequacy of the home economics value complex for coping with environmental problems, and toward an acceptable environmental ethic. (SH)
in the UN Global Compact. Philanthropy has many dimensions; these include ethical, juridical, political, economic and cultural dimensions. In the last years, a lot has been written about philanthropy from a political, sociological, anthropological and managerial perspective. However, an essential question...
Meslin, Eric M; Cho, Mildred K
With the completed sequence of the human genome has come the prospect of substantially improving the quality of life for millions through personalized medicine approaches. Still, any advances in this direction require research involving human subjects. For decades science and ethics have enjoyed an allegiance reflected in a common set of ethical principles and procedures guiding the conduct of research with human subjects. Some of these principles emphasize avoiding harm over maximizing benefit. In this paper we revisit the priority given to these ethical principles - particularly the principles that support a cautious approach to science - and propose a reframing of the 'social contract' between science and society that emphasizes reciprocity and meeting public needs.
Coleman, Carl H; Ardiot, Chantal; Blesson, Séverine; Bonnin, Yves; Bompart, Francois; Colonna, Pierre; Dhai, Ames; Ecuru, Julius; Edielu, Andrew; Hervé, Christian; Hirsch, François; Kouyaté, Bocar; Mamzer-Bruneel, Marie-France; Maoundé, Dionko; Martinent, Eric; Ntsiba, Honoré; Pelé, Gérard; Quéva, Gilles; Reinmund, Marie-Christine; Sarr, Samba Cor; Sepou, Abdoulaye; Tarral, Antoine; Tetimian, Djetodjide; Valverde, Olaf; Van Nieuwenhove, Simon; Strub-Wourgaft, Nathalie
Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel 'pre-review' process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. © 2014 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.
Technological advances in basic biological research have been instrumental in recent biomedical discoveries, such as in the understanding and treatment of cancer, HIV/AIDS, and heart disease. However, many of these advances also raise several new ethical challenges. For example, genetic research may pose no physical risk beyond that of obtaining the initial blood sample, yet it can pose significant psychological and economic risks to research participants, such as stigmatization, discrimination in insurance and employment, invasion of privacy, or breach of confidentiality. These harms may occur even when investigators do not directly interact with the person whose DNA they are studying. Moreover, this type of basic research also raises broader questions, such as what is the definition of a human subject, and what kinds of expertise do Institutional Review Boards (IRBs) need to review the increasingly diverse types of research made possible by these advances in technology. The National Bioethics Advisory Commission (NBAC), a presidentially appointed federal advisory committee, has addressed these and other ethical, scientific and policy issues that arise in basic science research involving human participants. Two of its six reports, in particular, have proposed recommendations in this regard. "Research Involving Human Biological Materials: Ethical and Policy Guidance" addresses the basic research use of human tissues, cells and DNA and the protection of human participants in this type of research. In "Ethical and Policy Issues in the Oversight of Human Research" NBAC proposes a definition of research involving human participants that would apply to all scientific disciplines, including physical, biological, and social sciences, as well as the humanities and related professions, such as business and law. Both of these reports make it clear that the protection of research participants is key to conducting ethically sound research. By ensuring that all participants in
McCormick, Jennifer B; Sharp, Richard R; Ottenberg, Abigale L; Reider, Carson R; Taylor, Holly A; Wilfond, Benjamin S
Emphasis on translational research to facilitate progression from the laboratory into the community also creates a dynamic in which ethics and social policy questions and solutions are ever pressing. In response, academic institutions are creating Research Ethics Consultation Services (RECS). All Clinical Translational Science Award institutions were surveyed in early 2010 to determine which institutions have a RECS in operation and what is their composition and function. Of the 46 institutions surveyed, 33 (70%) have a RECS. Only 15 RECS have received any consult requests in the last year. Issues that are common among these relatively nascent services include relationships with institutional oversight committees, balancing requestor concerns about confidentiality with research integrity and human subjects protection priorities, tracking consult data and outcomes, and developing systems for internal evaluation. There is variability in how these issues are approached. It will be important to be attentive to the institutional context to develop an appropriate approach. Further data about the issues raised by requestors and the recommendations provided are necessary to build a community of scholars who can navigate and resolve ethical issues encountered along the translational research pathway. © 2012 Wiley Periodicals, Inc.
Foster, Kenneth R; Jaeger, Jan
This article reviews the use of implantable radiofrequency identification (RFID) tags in humans, focusing on the VeriChip (VeriChip Corporation, Delray Beach, FL) and the associated VeriMed patient identification system. In addition, various nonmedical applications for implanted RFID tags in humans have been proposed. The technology offers important health and nonhealth benefits, but raises ethical concerns, including privacy and the potential for coercive implantation of RFID tags in individuals. A national discussion is needed to identify the limits of acceptable use of implantable RFID tags in humans before their use becomes widespread and it becomes too late to prevent misuse of this useful but ethically problematic technology.
ANDREAE, Michael H; RHODES, Evelyn; BOURGOISE, Tylor; CARTER, George; WHITE, Robert S.; INDYK, Debbie; SACKS, Henry; RHODES, Rosamond
We examine the ethical, social and regulatory barriers that may hamper research on therapeutic potential of certain controversial controlled substances like marijuana, heroin or ketamine. Hazards for individuals and society, and their potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of certain substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may hinder research on their considerable therapeutic potential. We review the surprisingly sparse literature and address the particular ethical concerns of undue inducement, informed consent, risk to participants, researchers and institutions, justice and liberty germane to the research with illicit and addictive substances. We debate the disparate research stakeholder perspectives and why they are likely to be infected with bias. We propose an empirical research agenda to provide a more evidentiary basis for ethical reasoning. PMID:26982922
DuBois, James M; Kraus, Elena M; Gursahani, Kamal; Mikulec, Anthony; Bakanas, Erin
No published curricula in the area of medical business ethics exist. This is surprising given that physicians wrestle daily with business decisions and that professional associations, the Institute of Medicine, Health and Human Services, Congress, and industry have issued related guidelines over the past 5 years. To fill this gap, the authors aimed (1) to identify the full range of medical business ethics topics that experts consider important to teach, and (2) to establish curricular priorities through expert consensus. In spring 2012, the authors conducted an online Delphi survey with two heterogeneous panels of experts recruited in the United States. One panel focused on business ethics in medical practice (n = 14), and 1 focused on business ethics in medical research (n = 12). Panel 1 generated an initial list of 14 major topics related to business ethics in medical practice, and subsequently rated 6 topics as very important or essential to teach. Panel 2 generated an initial list of 10 major topics related to business ethics in medical research, and subsequently rated 5 as very important or essential. In both domains, the panel strongly recommended addressing problems that conflicts of interest can cause, legal guidelines, and the goals or ideals of the profession. The Bander Center for Medical Business Ethics at Saint Louis University will use the results of the Delphi panel to develop online curricular resources for each of the highest rated topics.
Pérez De Nucci, Armando M
This article aims to show the existence of important failures in the field of Human Rights and equal possibilities in health. Human rights are analyzed an developed in the field of public and social health in our country. Ethics is the main field proposed to reach solutions in the context on EPEP (Etica para la erradicación de la pobreza).
Thus, there is a relationship between religion, ethics and humanity. However, more often than not, religion is alleged for being a root cause of all human predicaments; that it provides viable and abundant fuel for conflict such that in every continent of the world, there are troubled spots rooted in religious conflicts. Although ...
Human Service Education: A Journal of the National Organization for Human Service Education, 1996
Describes a code of ethics that reflects the unique history of the human service profession. Provides a definition for human services and gives guidelines in meeting responsibility to clients, to the community and society, and to colleagues. Also provides statements guiding responsibility to the profession, to employers, and to self. (RJM)
Ferguson, Aidan; Clark, James J
Research ethics provide important and necessary standards related to the conduct and dissemination of research. To better understand the current state of research ethics discourse in social work, a systematic literature search was undertaken and numbers of publications per year were compared between STEM, social science, and social work disciplines. While many professions have embraced the need for discipline-specific research ethics subfield development, social work has remained absent. Low publication numbers, compared to other disciplines, were noted for the years (2006-2016) included in the study. Social work published 16 (1%) of the 1409 articles included in the study, contributing 3 (>1%) for each of the disciplines highest producing years (2011 and 2013). Comparatively, psychology produced 75 (5%) articles, psychiatry produced 64 (5%) articles, and nursing added 50 (4%) articles. The STEM disciplines contributed 956 (68%) articles between 2006 and 2016, while social science produced 453 (32%) articles. Examination of the results is provided in an extended discussion of several misconceptions about research ethics that may be found in the social work profession. Implications and future directions are provided, focusing on the need for increased engagement, education, research, and support for a new subfield of social work research ethics.
This article starts with an overview of the author's personal involvement--as an Operations Research consultant--in several engineering case-studies that may raise ethical questions; e.g., case-studies on nuclear waste, water management, sustainable ecology, military tactics, and animal welfare. All these case studies employ computer simulation models. In general, models are meant to solve practical problems, which may have ethical implications for the various stakeholders; namely, the modelers, the clients, and the public at large. The article further presents an overview of codes of ethics in a variety of disciples. It discusses the role of mathematical models, focusing on the validation of these models' assumptions. Documentation of these model assumptions needs special attention. Some ethical norms and values may be quantified through the model's multiple performance measures, which might be optimized. The uncertainty about the validity of the model leads to risk or uncertainty analysis and to a search for robust models. Ethical questions may be pressing in military models, including war games. However, computer games and the related experimental economics may also provide a special tool to study ethical issues. Finally, the article briefly discusses whistleblowing. Its many references to publications and websites enable further study of ethical issues in modeling.
Ethical Medical and Biomedical Practice in Health Research in Africa. African countries have an urgent need for research to battle the diseases that ravage their populations and hamper their economic and social development. This research entails both benefits and risks for the people involved. Particular effort must be ...
Stephen M. Ritchie
Full Text Available In small-scale studies of coteaching, there are few genuine ethical dilemmas for researchers providing participants are engaged in ongoing dialogue about the purposes and emerging results of the research. When studies are up-scaled for teacher education programs, the territory is uncharted. This adds uncertainty about the ethical codes of practice for a teacher education program director who initiates such research. If the research is likely to lead to valued learning experiences for participating interns without harm to other participants, it may be ethical to proceed. In this paper I suggest that even though getting the balance right will continue to challenge researchers, it will be essential to establish and maintain dialogue between all participants. URN: urn:nbn:de:0114-fqs0604218
Zheng, Yue Liang
Human induced pluripotent stem cells can be obtained from somatic cells, and their derivation does not require destruction of embryos, thus avoiding ethical problems arising from the destruction of human embryos. This type of stem cell may provide an important tool for stem cell therapy, but it also results in some ethical concerns. It is likely that abnormal reprogramming occurs in the induction of human induced pluripotent stem cells, and that the stem cells generate tumors in the process of stem cell therapy. Human induced pluripotent stem cells should not be used to clone human beings, to produce human germ cells, nor to make human embryos. Informed consent should be obtained from patients in stem cell therapy.
Neyda Ibañez; Rubén Castillo
The purpose of the investigation was to interpret training in ethics for action business students an introduction to the economy of the Faculty of Social and Economic Sciences at the University of Carabobo, as part of professional development in business studies. The investigation was addressed within the paradigm post positivist using ethnographic and hermeneutic method, descriptive mode of scientific research and technique participant-observation. It concludes that training in ethics manage...
C. A. Caramori
Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.
van den Hoonaard, Will C; Connolly, Anita
DESPITE CLAIMS THAT RESEARCH-ETHICS review is changing or discouraging social research, there are no studies that have tested this assumption. Examining Canadian Master's theses in anthropology between 1995 and 2004, this paper explores the extent to which the theses represent a change in number, topic, or methodology in relation to formal ethicsreview guidelines that came into force in Canada in 2001. ProQuest Digital Dissertations reveals that the number of theses has increased, and that there has not been a noticeable shift from research involving humans to research based on archival data, or theoretical or review theses. However, there has been a very significant increase in research that is called ethnography, but that relies exclusively on interviews. Possible reasons for the halving of percent of ethnographic or participantobservation research are explored.
Corley, Elizabeth A; Kim, Youngjae; Scheufele, Dietram A
Scientists' sense of social responsibility is particularly relevant for emerging technologies. Since a regulatory vacuum can sometimes occur in the early stages of these technologies, individual scientists' social responsibility might be one of the most significant checks on the risks and negative consequences of this scientific research. In this article, we analyze data from a 2011 mail survey of leading U.S. nanoscientists to explore their perceptions the regarding social and ethical responsibilities for their nanotechnology research. Our analyses show that leading U.S. nanoscientists express a moderate level of social responsibility about their research. Yet, they have a strong sense of ethical obligation to protect laboratory workers (in both universities and industry) from unhealthy exposure to nanomaterials. We also find that there are significant differences in scientists' sense of social and ethical responsibility depending on their demographic characteristics, job affiliation, attention to media content, risk perceptions and benefit perceptions. We conclude with some implications for future research.
Redman, Barbara A; Fry, Sara T
The aims of this study were to identify (1) the ethics and human rights issues experienced by nurses in leadership roles (NLs); (2) how frequently these issue occurred in the NLs'practices; and (3) how disturbed the NLs were by the issues. Dillman's Total Design Method (1978) for mailed surveys guided the study design. Data analysis was performed on 470 questionnaires from New England RNs in nursing leadership roles. The most frequently experienced ethics and human rights issues during the previous 12 months were (1) protecting patient right and human dignity; (2) respecting or not respecting informed consent to treatment; (3) use or nonuse of physical or chemical restraints; (4) providing care with possible risks to the RN's health; (5) following or not following advance directives; and (6) staffing patterns that limit patient access to nursing care. The most disturbing ethics and human rights issues experienced by the NLs were staffing patterns that limited patient access to nursing care, prolonging the dying process with inappropriate measures, working with unethical, incompetent, or impaired colleagues, implementing managed care policies that threaten quality of care, not considering quality of the patient's life, and caring for patients and families who are uninformed or misinformed about treatment, prognosis, or medical alternatives. Nearly 39% of the NLs reported experiencing ethics and human rights issues one to four times a week or more, and more than 90% handled their most recent ethics issue by discussing it with nursing peers. Study findings have implications for ethics education and resource support for nurses in leadership roles, and for further research on how NLs handle ethics and human rights issues in the workplace.
Full Text Available Conducting research in the area of sexual violence has complex ethical and practical challenges for the researcher. Managing ethical issues in sexual violence is important and can be achieved through the use of pilot studies. The primary purpose of the pilot study was to identify and manage potential ethical and practical problems that could jeopardise the main study or violate the ethical and human rights of participants in the main study on women’s journey of recovery from sexual assault. The secondary purpose was to collect preliminary data in order to determine the human, financial and time resources needed for a planned study. The methods and processes used in conducting the pilot study in the study on women’s journey of recovery are discussed according to each of the objectives of the pilot study, methods used to achieve the objective, observations or findings made during the pilot study, and implications for the main study. This article aims to demonstrate how a pilot study was used to manage identified potential ethical and practical research issues during the recruitment of participants and data collection for the research that was conducted by the first author to investigate women’s journey of recovery from sexual assault trauma within the first week following sexual assault.
Luis Fernando Aragón-Vargas
Full Text Available This paper reviews how we arrived at the current state of affairs in the ethical practice of scientific research, discussing some issues that are particularly pertinent to the exercise scientist. The paper focuses on two major areas of ethics in science. The ethical principles for biomedical research involving human subjects are presented and discussed using the three basic principles from the Belmont Report (autonomy, beneficence, and justice as a guide. The ethical presentation and publication of data are discussed as an update or expanded comment on the ten topics covered by Roy Shephard in his Ethics in Exercise Science Research paper from 2002. The manuscript closes with a reflection on personal responsibility and its importance in every scientific endeavor: placing all responsibility for action on those scientists or physicians doing the experiments was not sufficient to prevent all types of human research abuses in the first half of the twentieth century. However, intricate and cumbersome external review and approval procedures generate the perception that the system should be more than enough to ensure good practices, a perception that may dangerously prevent the scientists from assuming their individual responsibility.
Ćurković, Marko; Živković, Maja; Radić, Krešimir; Vilibić, Maja; Ćelić, Ivan; Bagarić, Dario
Permissibility of placebo controls in psychiatric research is raising everlasting controversies. The main ethical issue remains: whether, when, under what conditions, and to what extent is it justifiable to disregard subject's present (best) interest for the presumably "greater" ones. In relation to this main ethical concern, two distinct arguments arose: proponents of placebo controls trials (placebo ortxodoxy) and proponents of active controls trials (active-control orthodoxy). More recently, in new ethical guidelines, Declaration of Helsinki and International Ethical Guidelines for Biomedical Research Involving Human Subjects, a "middle way" approach was formulated, acceptable to both sides of the argument, saying placebo controls can be justified under certain conditions: when and only when, they firstly present undisputed methodological reasoning, and secondly, fulfill certain ethical considerations - mainly regarding the permissibility of accompanied risks. These ethical evaluations are inevitably contextual and evoke the need for the principle of proportionality. In scope of recent findings of substantial and progressively increasing placebo response in psychiatric research, contextual factors are identified and both theoretical and practical challenges are discussed.
MUHAMMAD NUMAN ALI KHAN; DANISH JAMIL,
This paper explores the ethics behind ethical hacking and whether there are problems that lie with this new field of work. Since ethical hacking has been a controversial subject over the past few years, the question remains of the true intentions of ethical hackers. The paper also looks at ways in which future research could be looked intoto help keep ethical hacking, ethical.
Hack, Catherine J.
Undergraduate research projects in the life sciences encompass a broad range of studies, some of which may require the participation of human subjects or other activities which may raise ethical concerns. As universities are accountable for all projects undertaken under their auspices they must ensure that these projects adhere to legal…
Mamzer, Marie-France; Duchange, Nathalie; Darquy, Sylviane; Marvanne, Patrice; Rambaud, Claude; Marsico, Giovanna; Cerisey, Catherine; Scotté, Florian; Burgun, Anita; Badoual, Cécile; Laurent-Puig, Pierre; Hervé, Christian
The research program CARPEM (cancer research and personalized medicine) brings together the expertise of researchers and hospital-based oncologists to develop translational research in the context of personalized or "precision" medicine for cancer. There is recognition that patient involvement can help to take into account their needs and priorities in the development of this emerging practice but there is currently no consensus about how this can be achieved. In this study, we developed an empirical ethical research action aiming to improve patient representatives' involvement in the development of the translational research program together with health professionals. The aim is to promote common understanding and sharing of knowledge between all parties and to establish a long-term partnership integrating patient's expectations. Two distinct committees were settled in CARPEM: an "Expert Committee", gathering healthcare and research professionals, and a "Patient Committee", gathering patients and patient representatives. A multidisciplinary team trained in medical ethics research ensured communication between the two committees as well as analysis of discussions, minutes and outputs from all stakeholders. The results highlight the efficiency of the transfer of knowledge between interested parties. Patient representatives and professionals were able to identify new ethical challenges and co-elaborate new procedures to gather information and consent forms for adapting to practices and recommendations developed during the process. Moreover, included patient representatives became full partners and participated in the transfer of knowledge to the public via conferences and publications. Empirical ethical research based on a patient-centered approach could help in establishing a fair model for coordination and support actions during cancer research, striking a balance between the regulatory framework, researcher needs and patient expectations. Our approach addresses
Beaulieu, Anne; Estalella, Adolfo
An important feature of e-research is the increased mediation of research practices, which changes not only the objects and tools of research, but also the relation between researcher and object, between researchers, and between researchers and their constituencies and stakeholders. This article
Radenko Maric; Jelena Vemic- Djurkovic
In this paper the importance of practice of human resource management as of a significant driver of business ethics in companies has been considered. The basic premise of the paper is the fact that the company’s main source of unethical behaviour is situated in its people’s activities which further implies that many measures aimed to apply and improve business ethics belong to the domain of human resource management. Based on research results on a sample of 36 enterprises, the paper attempts...
Mole, Calvin Gerald; Heyns, Marise
A moral dilemma exists in biomedical research relating to the use of animal or human tissue when conducting scientific research. In human ethics, researchers need to justify why the use of humans is necessary should suitable models exist. Conversely, in animal ethics, a researcher must justify why research cannot be carried out on suitable alternatives. In the case of medical procedures or therapeutics testing, the use of animal models is often justified. However, in forensic research, the justification may be less evident, particularly when research involves the infliction of trauma on living animals. To determine how the forensic science community is dealing with this dilemma, a review of literature within major forensic science journals was conducted. The frequency and trends of the use of animals in forensic science research was investigated for the period 1 January 2012-31 December 2016. The review revealed 204 original articles utilizing 5050 animals in various forms as analogues for human tissue. The most common specimens utilized were various species of rats (35.3%), pigs (29.3%), mice (17.7%), and rabbits (8.2%) although different specimens were favored in different study themes. The majority of studies (58%) were conducted on post-mortem specimens. It is, however, evident that more needs to be done to uphold the basic ethical principles of reduction, refinement and replacement in the use of animals for research purposes.
Then, they will propose an ethical framework for health research and put forward the basic elements of a training course for professionals, researchers and decision-makers in the area of bioethics and health and the environment. The work will be carried out in three West African Countries (Bénin, Cameroon and Nigeria), ...
Dresden, Elissa; McElmurry, Beverly J.; McCreary, Linda L.
Case studies depict dilemmas in nursing research involving protection of community rights and community informed consent. Outlines research guidelines derived from communitarian ethical frameworks that consider beneficence, justice, and respect for autonomy in the context of community. (Contains 58 references.) (SK)
Ayodele, Freida Ozavize; Yao, Liu; Haron, Hasnah
In the management academic research, academic advancement, job security, and the securing of research funds at one's university are judged mainly by one's output of publications in high impact journals. With bogus resumes filled with published journal articles, universities and other allied institutions are keen to recruit or sustain the appointment of such academics. This often places undue pressure on aspiring academics and on those already recruited to engage in research misconduct which often leads to research integrity. This structured review focuses on the ethics and integrity of management research through an analysis of retracted articles published from 2005 to 2016. The study employs a structured literature review methodology whereby retracted articles published between 2005 and 2016 in the field of management science were found using Crossref and Google Scholar. The searched articles were then streamlined by selecting articles based on their relevance and content in accordance with the inclusion criteria. Based on the analysed retracted articles, the study shows evidence of ethical misconduct among researchers of management science. Such misconduct includes data falsification, the duplication of submitted articles, plagiarism, data irregularity and incomplete citation practices. Interestingly, the analysed results indicate that the field of knowledge management includes the highest number of retracted articles, with plagiarism constituting the most significant ethical issue. Furthermore, the findings of this study show that ethical misconduct is not restricted to a particular geographic location; it occurs in numerous countries. In turn, avenues of further study on research misconduct in management research are proposed.
Scialfa, Charles T.; Lyndon, Jaci
As part of a Canadian Institutes for Health Research (CIHR)-funded Strategic Training Grant, we have developed and delivered a brief course in research ethics directed toward postgraduate students in experimental gerontology. In this paper, we report on the initial offering, its content and delivery, and student reactions to the course. We…
de Graaf, M.M.A.
Currently, human-robot interactions are constructed according to the rules of human-human interactions inviting users to interact socially with robots. Is there something morally wrong with deceiving humans into thinking they can foster meaningful interactions with a technological object? Or is this
Glackin, Shane Nicholas
Can biological facts explain human morality? Aristotelian 'virtue' ethics has traditionally assumed so. In recent years Alasdair MacIntyre has reintroduced a form of Aristotle's 'metaphysical biology' into his ethics. He argues that the ethological study of dependence and rationality in other species--dolphins in particular--sheds light on how those same traits in the typical lives of humans give rise to the moral virtues. However, some goal-oriented dolphin behaviour appears both dependent and rational in the precise manner which impresses MacIntyre, yet anything but ethically 'virtuous'. More damningly, dolphin ethologists consistently refuse to evaluate such behaviour in the manner MacIntyre claims is appropriate to moral judgement. In light of this, I argue that virtues--insofar as they name a biological or ethological category--do not name a morally significant one.
Birgden, Astrid; Cucolo, Heather
Public policy is necessarily a political process with the law and order issue high on the political agenda. Consequently, working with sex offenders is fraught with legal and ethical minefields, including the mandate that community protection automatically outweighs offender rights. In addressing community protection, contemporary sex offender treatment is based on management rather than rehabilitation. We argue that treatment-as-management violates offender rights because it is ineffective and unethical. The suggested alternative is to deliver treatment-as-rehabilitation underpinned by international human rights law and universal professional ethics. An effective and ethical community-offender balance is more likely when sex offenders are treated with respect and dignity that, as human beings, they have a right to claim.
This paper describes research underpinning a course, developed in Australia, on ethics for engineers. The methodology used, that of identifying the principal ethical issues facing the discipline and designing the course around these issues, would be applicable to other disciplines and in other countries. The course was based on the assumption that identifying the major ethical issues in the discipline, and subsequently presenting and analysing them in the classroom, would provide the future professional with knowledge of the ethical problems that they were likely to face on graduation. The student has then to be given the skills and knowledge to combat these concerns, should he/she wish to. These findings feed into several components of the course, such as the development of a code of ethics, the role of a professional society or industry association and the role of ethical theory The sources employed to identify the issues were surveys of the literature and about 30 case studies, in Australia and overseas. The issues thus identified were then put before a sample of engineering managers to assess the relevance to the profession.
On March 29, 2001, the Ethical Guidelines for Human Genome and Genetic Sequencing Research were established. They have intended to serve as ethical guidelines for all human genome and genetic sequencing research practice, for the purpose of upholding respect for human dignity and rights and enforcing use of proper methods in the pursuit of human genome and genetic sequencing research, with the understanding and cooperation of the public. The RadGenomics Project has prepared a research protocol and informed consent document that follow these ethical guidelines. We have endeavored to protect the privacy of individual information, and have established a procedure for examination of research practices by an ethics committee. Here we report our procedure in order to offer this concept to the patients. (authors)
Guta, Adrian; Nixon, Stephanie A; Wilson, Michael G
In this paper we examine "ethics creep", a concept developed by Haggerty (2004) to account for the increasing bureaucratization of research ethics boards and institutional review boards (REB/IRBs) and the expanding reach of ethics review. We start with an overview of the recent surge of academic interest in ethics creep and similar arguments about the prohibitive effect of ethics review. We then introduce elements of Michel Foucault's theoretical framework which are used to inform our analysis of empirical data drawn from a multi-phase study exploring the accessibility of community-engaged research within existing ethics review structures in Canada. First, we present how ethics creep emerged both explicitly and implicitly in our data. We then present data that demonstrate how REB/IRBs are experiencing their own form of regulation. Finally, we present data that situate ethics review alongside other trends affecting the academy. Our results show that ethics review is growing in some ways while simultaneously being constrained in others. Drawing on Foucauldian theory we reframe ethics creep as a repressive hypothesis which belies the complexity of the phenomenon it purports to explain. Our discussion complicates ethics creep by proposing an understanding of REB/IRBs that locates them at the intersection of various neoliberal discourses about the role of science, ethics, and knowledge production. Copyright © 2012 Elsevier Ltd. All rights reserved.
Yap, Siew Fong; Dawson, Vaille
This research focuses on the use of ethical frameworks as a pedagogical model for socio-scientific education in implementing the "Science as a Human Endeavour" (SHE) strand of the Australian Curriculum: Science in a Year 10 biology class in a Christian college in metropolitan Perth, Western Australia. Using a case study approach, a mixed…
Kim, Jane Paik; Roberts, Laura Weiss
Empirical ethics inquiry works from the notion that stakeholder perspectives are necessary for gauging the ethical acceptability of human studies and assuring that research aligns with societal expectations. Although common, studies involving different populations often entail comparisons of trends that problematize the interpretation of results. Using graphical model selection - a technique aimed at transcending limitations of conventional methods - this report presents data on the ethics of clinical research with two objectives: (1) to display the patterns of views held by ill and healthy individuals in clinical research as a test of the study's original hypothesis and (2) to introduce graphical model selection as a key analytic tool for ethics research. In this IRB-approved, NIH-funded project, data were collected from 60 mentally ill and 43 physically ill clinical research protocol volunteers, 47 healthy protocol-consented participants, and 29 healthy individuals without research protocol experience. Respondents were queried on the ethical acceptability of research involving people with mental and physical illness (i.e., cancer, HIV, depression, schizophrenia, and post-traumatic stress disorder) and non-illness related sources of vulnerability (e.g., age, class, gender, ethnicity). Using a statistical algorithm, we selected graphical models to display interrelationships among responses to questions. Both mentally and physically ill protocol volunteers revealed a high degree of connectivity among ethically-salient perspectives. Healthy participants, irrespective of research protocol experience, revealed patterns of views that were not highly connected. Between ill and healthy protocol participants, the pattern of views is vastly different. Experience with illness was tied to dense connectivity, whereas healthy individuals expressed views with sparse connections. In offering a nuanced perspective on the interrelation of ethically relevant responses, graphical
White, Julie; Fitzgerald, Tanya
The tales we tell here focus on the ethical issues arising from our research practice with vulnerable young participants and those for whom research has been inextricably linked with European imperialism and colonialism. The importance of relational obligations, temporality and potential for a continuing narrative approach to ethical research…
The author discusses the use of role-play to teach research ethics in three semesters of a research methods class. Small groups of students were assigned one of nine ethical norms discussed in the course textbook and the American Sociological Association Code of Ethics. Each group role-played the violation of their assigned ethic to the class. The…
Some ethical questions about molecular biology and human radiation studies are raised. The questions relate to the following: genetic epidemiology leading to possible stigmatization of certain groups; protection of medical information, including samples, and respect for privacy; effect of genetic characterization on standards and procedures relating to occupational exposure; exclusion of vulnerable groups from research studies. On the positive side, there is increased funding within Canada for studies of ethical, legal and social issues, and internationally ethical standards are being developed
Kutsch, Werner Leo
The mission of the Integrated Carbon Observation System (ICOS RI) is to enable research to understand the greenhouse gas (GHG) budgets and perturbations. The ICOS RI provides the long-term observations required to understand the present state and predict future behaviour of the global carbon cycle and GHG emissions. Technological developments and implementations, related to GHGs, will be promoted by the linking of research, education and innovation. In order to provide this data ICOS RI is a distributed research infrastructure. The backbones of ICOS RI are the national measurement stations such as ICOS atmosphere, ecosystem and ocean stations. ICOS Central Facilities are the European level ICOS RI Centres, which have the specific tasks in collecting and processing the data and samples received from the national measurement networks. During the establishment of ICOS RI ethical guidelines were developed. These guidelines describe principles of ethics in the research activities that should be applied within ICOS RI. They should be acknowledged and followed by all researchers affiliated to ICOS RI and should be supported by all participating institutions. The presentation describes (1) the general challenge to develop ethical guidelines in a complex international infrastructure and (2) gives an overview about the content that includes different kinds of conflicts of interests, data ethics and social responsibility.
Harrowing, J N; Mill, J; Spiers, J; Kulig, J; Kipp, W
High-quality research is essential for the generation of scientific nursing knowledge and the achievement of the Millennium Development Goals. However, the incorporation of Western bioethical principles in the study design may not be suitable, sufficient or relevant to participants in low-income countries and may indeed be harmful and disrespectful. Before engaging in global health studies, nurses must consider carefully the cultural and social context and values of the proposed setting in order to situate the research within the appropriate ethical framework. The purpose of this paper was to examine the ethical principles and considerations that guide health research conducted in international settings using the example of a qualitative study of Ugandan nurses and nurse-midwives by a Canadian researcher. The application of Western bioethical principles with their emphasis on autonomy fails to acknowledge the importance of relevant contextual aspects in the conduct of global research. Because ethics is concerned with how people interact and live together, it is essential that studies conducted across borders be respectful of, and congruent with, the values and needs of the community in which it occurs. The use of a communitarian ethical framework will allow nurse scientists to contribute to the elimination of inequities between those who enjoy prosperity and good health, and those who do not.
Yusuf Setiawan Syukur
Full Text Available According to the 1945 Constitution, the Audit Board of the Republic of Indonesia (BPK has an important role in fostering good governance and combating corruption in Indonesia’s public sector through its audit works. To be successful, BPK must implement and enforce ethical behaviours within the organisation. There are laws and regulations (e.g., civil servants’ code of ethics and employee discipline and systems, policies, and practices set up by authorities at BPK (e.g., BPK’s code of ethics, whistle-blowing procedure, the Honourary Council of BPK’s Code of Ethics (MKKE, and ethics training that regulate and influence behaviours of employees and members of the board. When reviewing literature, this paper attempts to understand the antecedents of ethical/unethical behaviours in organisations and look for best practices (including human resource management practices in developing ethical behaviours in organisations. It turns out that the ethical frameworks within BPK have a strong theoretical support. Despite the strong theoretical support from the literature, this study attempts to identify gaps between the best practices and ethical frameworks within BPK. In response to the gaps, this study attempts to offer recommendations so as to close the gaps and improve the ethical frameworks within BPK. In the end, this study produces seventeen recommendations. KEYWORDS code of ethics, ethical behaviours, human resource management, ethics audit, and ethical climate survey. ABSTRAK Berdasarkan Undang-undang Dasar 1945, Badan Pemeriksa Keuangan Republik Indonesia (BPK mempunyai peran penting dalam meningkatkan tata kelola pemerintahan yang baik dan memberantas korupsi di sektor publik di Indonesia melalui kegiatan pemeriksaannya. Agar sukses dalam mencapai tujuan tersebut, BPK harus menerapkan dan menegakkan perilaku etis di dalam organisasi. Ada undang-undang dan peraturan peraturan (contoh: kode etik Pegawai Negeri Sipil (PNS dan peraturan disiplin
Bryan, Hazel; Burstow, Bob
The notion of the "teacher as researcher" has been in the education lexicon since the mid-1970s. School-based research, we suggest, is currently enjoying something of a renaissance, flourishing within the emerging, complex school landscape. This empirical research engages with 25 school leaders to explore the ways in which…
Doyle, Elaine; Buckley, Patrick
The evolution of enquiry-based teaching and learning has broadened the range of research carried out by university students. As a result, the boundaries between teaching and learning and academic research are being blurred to a degree not experienced heretofore. This paper examines whether research undertaken as part of course work should fall…
Roche, Eric; King, Romaine; Mohan, Helen M; Gavin, Blanaid; McNicholas, Fiona
Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Postal survey of all RECs in Ireland. Response rate was 62.5% (n=50). 80% of RECs reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants.
Glass, Kathleen Cranley; Kaufert, Joseph
CONTEMPORARY RESEARCH ETHICS REVIEW COMMITTEES (RECs) are heavily influenced by the established academic or health care institutional frameworks in which they operate, sharing a cultural, methodological and ethical perspective on the conduct of research involving humans. The principle of autonomous choice carries great weight in what is a highly individualistic decision-making process in medical practice and research. This assumes that the best protection lies in the ability of patients or research participants to make competent, voluntary, informed choices, evaluating the risks and benefits from a personal perspective. Over the past two decades, North American and international indigenous researchers, policy makers and communities have identified key issues of relevance to them, but ignored by most institutional or university-based RECs. They critique the current research review structure, and propose changes on a variety of levels in an attempt to develop more community sensitive research ethics review processes. In doing so, they have emphasized recognition of collective rights including community consent. Critics see alternative policy guidelines and community-based review bodies as challenging the current system of ethics review. Some view them as reflecting a fundamental difference in values. In this paper, we explore these developments in the context of the political, legal and ethical frameworks that have informed REC review. We examine the process and content of these frameworks and ask how this contrasts with emerging Aboriginal proposals for community-based research ethics review. We follow this with recommendations on how current REC review models might accommodate the requirements of both communities and RECs.
Katz, Douglas S; Gardner, James B; Hoffmann, Jason C; Patlas, Michael N; Bhargava, Puneet; Moshiri, Mariam; Remer, Erick M; Gould, Elaine S; Smith, Stacy
Although some research and publication practices are clearly unethical, including fraud and plagiarism, other areas of research and publication, such as informed consent and conflicts of interest, fall into grayer areas. The purposes of this article are, therefore, to review a variety of relevant ethical issues in radiology-related journalism, peer review, and research; to review the radiology literature to date that has addressed these issues; and to present position statements and potential solutions to these problems.
Millar-Schijf, Carla C.J.M.; Cheng, Philip Y.K.; Choi, Chong-Ju
Despite the importance of the co-evolution approach in various branches of research, such as strategy, organisation theory, complexity, population ecology, technology and innovation (Lewin et al., 1999; March, 1991), co-evolution has been relatively neglected in international business and ethics
Bowman, Laura L.; Anthonysamy, Angela
Differences in perceptions of research ethics between Malaysian and American students were assessed using a questionnaire that measured perceptions of voluntary informed consent for adults and children, assessment of the risk/benefit ratio, issues of deception, and issues of privacy and confidentiality. As predicted, Malaysian students had less…
The Nuffield Council on Bioethics, an independent body in the United Kingdom, has published a 2005 report titled The Ethics of Research Involving Animals. The Report, produced by a Working Party that represented a wide range of views, seeks to clarify the debate that surrounds this topic and aims to help people identify and analyze the relevant scientific and ethical issues. The Working Party considered the arguments surrounding whether animal research yields useful results, and recommends that its predictability and transferability should be evaluated more fully, particularly in controversial areas. Commonly encountered ethical questions and arguments were considered in order to understand what lies behind disagreement on the moral justification of animal research. Four possible ethical positions on animal research, which represent points on a continuum, are described. Despite the range of views that exist among members of the Working Party, the Report presents a "Consensus Statement" that identifies agreement on several important issues. Building on this statement, recommendations are made for improving the quality of the debate and promoting the 3Rs (refinement, reduction, and replacement).
Güngör, Semra Kiranli; Özkara, Funda
The aim of the research is to reveal the opinions of the school administrators about the administration ethics. In this study, 30 administrators working in the middle schools of Eskisehir province center in the 2016-2017 academic year were reached. In the study, data were gathered by interview technique which is one of the qualitative research…
... culturally sensitive to the needs of the victims of the humanitarian crisis. In emergency situations, the roles of Institutional Review Boards (IRBs) may have to be modified without compromising the ethical standards that health researchers have globally attempted to achieve. Malawi Medical Journal Vol. 20 (2) 2008: pp.
Rennie, Stuart; Groves, Allison K; Hallfors, Denise Dion; Iritani, Bonita J; Odongo, Fredrick S; Luseno, Winnie K
Assessment of benefits is traditionally regarded as crucial to the ethical evaluation of research involving human participants. We conducted focus group discussions (FGDs) with health and other professionals engaged with adolescents, caregivers/parents, and adolescents in Siaya County, Kenya, to solicit opinions about appropriate ways of conducting HIV research with adolescents. Our data revealed that many focus group participants have a profoundly positive conception of participation in health research, including studies conferring seemingly few benefits. In this article, we identify and analyze five different but interrelated types of benefits as perceived by Kenyan adolescent and adult stakeholders in HIV research, and discuss their ethical significance. Our findings suggest that future empirical and conceptual research should concentrate on factors that may trigger researcher obligations to improve benefit perceptions among research participants.
Nebeker, Camille; Harlow, John; Espinoza Giacinto, Rebeca; Orozco-Linares, Rubi; Bloss, Cinnamon S; Weibel, Nadir
Vast quantities of personal health information and private identifiable information are being created through mobile apps, wearable sensors, and social networks. While new strategies and tools for obtaining health data have expanded researchers' abilities to design and test personalized and adaptive health interventions, the deployment of pervasive sensing and computational techniques to gather research data is raising ethical challenges for Institutional Review Boards (IRBs) charged with protecting research participants. To explore experiences with, and perceptions about, technology-enabled research, and identify solutions for promoting responsible conduct of this research we conducted focus groups with human research protection program and IRB affiliates. Our findings outline the need for increased collaboration across stakeholders in terms of: (1) shared and dynamic resources that improve awareness of technologies and decrease potential threats to participant privacy and data confidentiality, and (2) development of appropriate and dynamic standards through collaboration with stakeholders in the research ethics community.
Kwon, Hyuk; Hahn, K. W.; Nam, Y. M.; You, B. H.; Min, B. J.
The report briefly considers the generous ethical issues such as the background of philosophy, the issues of research ethics, the research integrity, the role of citation, the program and the code of research ethics. The report introduces the background of philosophy of science and elements of research ethics. It also considers the precedents of misconduct in research ethics and the ingredients to preserve the research integrity. Especially, the citation with obscure boundary between proper citation and plagiarism is carefully explored through several examples. Finally, the domestic ethics conditions are investigated on the research integrity and educational program on the responsible conduct of research. To compare the domestic situation, the educational program and the system of research integrity in EU and USA are deeply searched in Ch. 6 and Appendix III and V. To develop an educational program of research ethics and integrity, Nuclear Training Centre(NTC) collects and arranges the material and resource for research ethics
Kwon, Hyuk; Hahn, K. W.; Nam, Y. M.; You, B. H.; Min, B. J
The report briefly considers the generous ethical issues such as the background of philosophy, the issues of research ethics, the research integrity, the role of citation, the program and the code of research ethics. The report introduces the background of philosophy of science and elements of research ethics. It also considers the precedents of misconduct in research ethics and the ingredients to preserve the research integrity. Especially, the citation with obscure boundary between proper citation and plagiarism is carefully explored through several examples. Finally, the domestic ethics conditions are investigated on the research integrity and educational program on the responsible conduct of research. To compare the domestic situation, the educational program and the system of research integrity in EU and USA are deeply searched in Ch. 6 and Appendix III and V. To develop an educational program of research ethics and integrity, Nuclear Training Centre(NTC) collects and arranges the material and resource for research ethics.
Schlehofer, Deirdre; Thew, Denise
Deaf American Sign Language (ASL) users represent a small population at risk for marginalization from research and surveillance activities resulting from cultural, language, and ethical challenges. The Deaf community’s view of deafness as a cultural identity, rather than a disability, contradicts the medical community’s perception of deafness as a disease or deficiency in need of correction or elimination. These differences continue to have significant cultural and social implications within the Deaf community, resulting in mistrust of research opportunities. Two particularly contentious ethical topics for the Deaf community are the absence of community representation in genetic research and the lack of accessible informed consents and research materials. This article outlines a series of innovative strategies and solutions to these issues, including the importance of community representation and collaboration with researchers studying deaf populations. PMID:24134363
McWhirter, Rebekah E; Mununggirritj, Djapirri; Marika, Dipililnga; Dickinson, Joanne L; Condon, John R
Indigenous populations, in common with all populations, stand to benefit from the potential of genetic research to lead to improvements in diagnostic and therapeutic tools for a wide range of complex diseases. However, many Indigenous communities, especially ones that are isolated, are not included in genetic research efforts. This situation is largely a consequence of the challenges of ethically conducting genetic research in Indigenous communities and compounded by Indigenous peoples' negative past experiences with genetic issues. To examine ways of addressing these challenges, we review one investigation of a cancer cluster in remote Aboriginal communities in Arnhem Land, Australia. Our experiences demonstrate that genetic research can be both ethically and successfully conducted with Indigenous communities by respecting the authority of the community, involving community members, and including regular community review throughout the research process. Copyright © 2012 Elsevier Ltd. All rights reserved.
Full Text Available There are codes of ethics in psychology that explicitly refer to human rights. There are also psychologists interested in the protection and promotion of human rights who are calling for the explicit inclusion of references to human rights in all psychology ethics codes. Yet, references to human rights in ethics documents have rarely been the focus of attention in psychological ethics. This article represents the first part of a two-part article series focusing on critical issues associated with the inclusion of references to human rights in the ethical codes of psychologists, and recommendations about how psychological ethics and the human rights movement can work together in serving humanity. The first part of the article series examines issues pertaining to the interpretation of references to human rights in codes of ethics for psychologists, and the justifications for including these references in psychological ethics codes. The second part of the article series examines how the Universal Declaration of Ethical Principles for Psychologists can be used to extend or supplement codes of ethics in psychology, how ethical principles and human rights differ and complement each other, and how psychological ethics and the human rights movement can work together in serving humanity and improving the welfare of both persons and peoples.
Dockett, Sue; Perry, Bob; Kearney, Emma; Hampshire, Anne; Mason, Jan; Schmied, Virginia
This article draws on an Australian project engaging with families with complex support needs as their children start school. The project itself is focused on developing collaborative research relationships between families, community support agencies and researchers with the aim of investigating what happens for families during the transition to…
Nugent, Allison C; Miller, Franklin G; Henter, Ioline D; Zarate, Carlos A
Mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD), are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including patients' motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.
Manzar, Nabeel; Manzar, Bushra; Hussain, Nuzhat; Hussain, M Fawwad Ahmed; Raza, Sajjad
To determine the knowledge, attitude, and ethical concerns of medical students and graduates with regard to Embryonic Stem Cell (ESC) research. This questionnaire based descriptive study was conducted at the Civil Hospital Karachi (CHK), Pakistan from February to July 2008. A well structured questionnaire was administered to medical students and graduate doctors, which included their demographic profile as well as questions in line with the study objective. Informed consent was taken and full confidentiality was assured to the participants. Data were entered in a Statistical Package for Social Sciences (SPSS version.12) and analyzed. A total of 204 male and 216 female medical students and doctors were administered questionnaires out of which 105 males (51.4%) and 108 females (50%) were aware of the embryonic stem cell research and its ethical implications. Forty percent males and 47% of females were of the opinion that life begins at conception. Forty-six percent males and 39% females were in favor of stem cell research while only 31% males and 28% females supported the ESC research. Less than 1/3 of students supported using frozen embryos for research purposes while more than 2/3 indicated that they were unlikely to support abortion for stem cell research purposes. The majority of the students were in favor of stem cell research with some reservations regarding ESC research. A sizeable number of students withheld their views, reflecting their poor understanding of medical ethics. The result of the study indicates a need for incorporating bioethics into the medical curriculum.
There is growing recognition and evidence that health care professionals regularly encounter-though they may not identify-victims of human trafficking in a variety of health care settings. Identifying and responding appropriately to trafficking victims or survivors requires not only training in trauma-informed care but also consideration of the legal and ethical issues that arise when serving this vulnerable population. This essay examines three areas of law that are relevant to this case scenario: criminal law, with a focus on conspiracy; service provider regulations, with a focus on mandatory reporting laws; and human rights law. In addition to imposing a legal mandate, the law can inform ethical considerations about how health care professionals should respond to human trafficking. © 2017 American Medical Association. All Rights Reserved.
Full Text Available Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs, in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries.We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques.Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process.Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be
Ogunrin, Olubunmi A; Daniel, Folasade; Ansa, Victor
Responsibility for protection of research participants from harm and exploitation rests on Research Ethics Committees and principal investigators. The Nigerian National Code of Health Research Ethics defines responsibilities of stakeholders in research so its knowledge among researchers will likely aid ethical conduct of research. The levels of awareness and knowledge of the Code among biomedical researchers in southern Nigerian research institutions was assessed. Four institutions were selected using a stratified random sampling technique. Research participants were selected by purposive sampling and completed a pre-tested structured questionnaire. A total of 102 biomedical researchers completed the questionnaires. Thirty percent of the participants were aware of the National Code though 64% had attended at least one training seminar in research ethics. Twenty-five percent had a fairly acceptable knowledge (scores 50%-74%) and 10% had excellent knowledge of the code (score ≥75%). Ninety-five percent expressed intentions to learn more about the National Code and agreed that it is highly relevant to the ethical conduct of research. Awareness and knowledge of the Code were found to be very limited among biomedical researchers in southern Nigeria. There is need to improve awareness and knowledge through ethics seminars and training. Use of existing Nigeria-specific online training resources is also encouraged.
Moreno, Megan A; Goniu, Natalie; Moreno, Peter S; Diekema, Douglas
Social media Websites (SMWs) are increasingly popular research tools. These sites provide new opportunities for researchers, but raise new challenges for Institutional Review Boards (IRBs) that review these research protocols. As of yet, there is little-to-no guidance regarding how an IRB should review the studies involving SMWs. The purpose of this article was to review the common risks inherent in social media research and consider how researchers can consider these risks when writing research protocols. We focused this article on three common research approaches: observational research, interactive research, and survey/interview research. Concomitant with these research approaches, we gave particular attention to the issues pertinent to SMW research, including privacy, consent, and confidentiality. After considering these challenges, we outlined key considerations for both researchers and reviewers when creating or reviewing SMW IRB protocols. Our goal in this article was to provide a detailed examination of relevant ethics and regulatory issues for both researchers and those who review their protocols.
Tan, Kate M; Flack, Felicity S; Bear, Natasha L; Allen, Judy A
In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee (HREC). A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network (PHRN) and HREC members in Australia. Five one-day face to face workshops were delivered in the study period to a total of 98 participants. Participants in the workshops represented all six categories of HREC membership composition listed in the National Health and Medical Research Centres' (NHMRC) National Statement on Ethical Conduct in Human Research. Participants were assessed at three time points, prior to the training (T1), immediately after the training (T2) and 8 to 17 months after the training (T3). Ninety participants completed the pre and post questionnaires; 58 of them completed the deferred questionnaire. Participants reported significant improvements in levels of knowledge, understanding and skills in each of the eight areas evaluated. The training was beneficial for those with prior experience in the area of ethics and data linkage as well as those with no prior exposure. Our preliminary work in this area demonstrates that the provision of intensive face to face ethics training in data linkage is feasible and has a significant impact on participant's confidence in reviewing HREC applications.
Kowalski, Charles J; Hutchinson, Raymond J; Mrdjenovich, Adam J
The Belmont Report's distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: email@example.com.