Scientific integrity: critical issues in environmental health research

Environmental health research is a relatively new scientific area with much interdisciplinary collaboration. Regardless of which human population is included in field studies (e.g., general population, working population, children, elderly, vulnerable sub-groups, etc.) their conduct must guarantee well acknowledged ethical principles. These principles, along with codes of conduct, are aimed at protecting study participants from research-related undesired effects and guarantee research integrity. A central role is attributed to the need for informing potential participants (i.e., recruited subjects who may be enrolled in a study), obtaining their written informed consent to participate, and making them aware of their right to refuse to participate at any time and for any reason. Data protection is also required and communication of study findings must respect participant's willingness to know or not know. This is specifically relevant for studies including biological markers and/or storing biological samples that might be analysed years later to tackle research objectives that were specified and communicated to participants at the time of recruitment or that may be formulated after consent was obtained.Integrity is central to environmental health research searching for causal relations. It requires open communication and trust and any violation (i.e., research misconduct, including fabrication or falsification of data, plagiarism, conflicting interests, etc.) may endanger the societal trust in the research community as well as jeopardize participation rates in field projects.     

Does the new EU Regulation on clinical trials adequately protect vulnerable research participants?

Vulnerable research participants deserve special protection because of their increased risks of being wronged. Yet, paradoxically, the conduct of trials involving vulnerable groups is sometimes inescapable to develop safe and efficient therapies suitable to these groups. The key question is therefore how to protect vulnerable research participants from harm and exploitation without excluding the populations they belong to from the benefits of research. The European Union faced this challenge in April 2014 when adopting the new Regulation on clinical trials, which will replace the currently applicable 2001 Clinical Trials Directive in 2016. In order to assess the protection of vulnerable persons in the new Regulation, this paper makes four suggestions: first, the need to adopt a risk-based approach to vulnerability in biomedical research; second, to better distinguish between decisional vulnerabilities and health-related vulnerabilities; third, to emphasise the need to preserve the freedom of consent of subjects with decisional vulnerability, who are more susceptible to undue influence; and finally to assert the need of actively promoting specific clinical trials involving people with physical or psychological vulnerabilities. In conclusion, this paper claims that the protection of vulnerable subjects still needs to be improved in the new EU Regulation.     

Ethical challenges in efficacy trials of vaginal microbicides for HIV prevention.

This paper discusses some of the ethical challenges raised by advanced clinical trials designed to assess the safety and efficacy of vaginal microbicides in protecting women from HIV infection. The ethical principles that guide clinical research involving human subjects require that all participants in such trials be provided available measures known to reduce the risk of HIV infection. However, this will reduce the ability of the study to assess the protective effect of the test microbicide. In addition, providing extensive services to trial participants may be construed as an undue inducement if the study is being conducted among vulnerable groups such as sex workers or women from disadvantaged communities. Suggestions are provided to resolve this dilemma in the planning and implementation of HIV prevention services for trial participants.     

Health, human rights, and the conduct of clinical research within oppressed populations

Background  

Clinical trials evaluating interventions for infectious diseases require enrolling participants that are vulnerable to infection. As clinical trials are conducted in increasingly vulnerable populations, issues of protection of these populations become challenging. In settings where populations are forseeably oppressed, the conduct of research requires considerations that go beyond common ethical concerns and into issues of international human rights law.     

Ethical Issues in Measuring Biomarkers in Children’s Environmental Health

Background

Studying the impact of environmental exposures is important in children because they are more vulnerable to adverse effects on growth, development, and health. Assessing exposure in children is difficult, and measuring biomarkers is potentially useful. Research measuring biomarkers in children raises a number of ethical issues, some of which relate to children as research subjects and some of which are specific to biomarker research.

Objective

As an international group with experience in pediatric research, biomarkers, and the ethics of research in children, we highlight the ethical issues of undertaking biomarker research in children in these environments.

Discussion

Significant issues include undertaking research in vulnerable communities, especially in developing countries; managing community expectations; obtaining appropriate consent to conduct the research; the potential conflicts of obtaining permission from an ethics review board in an economically developed country to perform research in a community that may have different cultural values; returning research results to participants and communities when the researchers are uncertain of how to interpret the results; and the conflicting ethical obligations of maintaining participant confidentiality when information about harm or illegal activities mandate reporting to authorities.

Conclusion

None of these challenges are insurmountable and all deserve discussion. Pediatric biomarker research is necessary for advancing child health.     

Retreat from Nuremberg: can we prevent unethical medical research?

The prosecution of doctors guilty of appalling human rights abuses at Nuremberg was achieved on the mistaken premise that the research community already had a code of conduct which, if applied, would have made such abuses impossible. In fact, not only was there no such code but when the 'Nuremberg Code' was published after the trial it continued to be ignored by many doctors for some thirty years afterwards. Indeed its central principle of informed consent has itself been eroded by subsequent international agreements on the ethics of medical research. This review shows that the mechanisms for approval of medical research which have now been promulgated in England and Wales, in practice, are applied on a very variable basis. Research in vulnerable groups unable to give fully informed consent such as children, prisoners and the incompetent elderly require the application of more rigorous standards of ethical control than those currently in operation. The use of vulnerable populations in the developing world and the application of international standards to them is also considered. A number of suggestions for improvements in current procedures in all these areas are put forward. The proposals for the United Kingdom would meet the requirements of the European Convention on bioethical research and the recent government consultation paper on medical treatment and research in incompetent adults.     

Ethical dilemmas in research on Internet communities

There has been a rapid growth in the number of articles using Internet data sources to illuminate health behavior. However, little has been written about the ethical considerations of online research, especially studies involving data from Internet discussion boards. Guidelines are needed to ensure ethical conduct. In this article, the authors examine how a youth-focused research program negotiated ethical practices in the creation of its comprehensive health site and online message board. They address three situations in which ethical predicaments arose: (a) enrolling research participants, (b) protecting participants from risk or harm, and (c) linking public and private data. Drawing on the ethical principles of autonomy, nonmaleficence, justice, and beneficence, the authors present practical guidelines for resolving ethical dilemmas in research on Internet communities.     

Version française des recommandations de la déclaration d'Ottawa sur la conception et la conduite éthique d'essais randomisés en clusters,dans le contexte législatif français

IntroductionThere is growing evidence on the ethical challenges raised by cluster randomized trials. This specificity is not reflected in the legal texts regulating research, which creates difficulties for researchers implementing these experimental designs. The Ottawa Statement (Weijer et al. 2012) aims to provide detailed guidance on the ethical design, conduct and assessment of cluster trials. More broadly aims to help research stakeholders and decision-makers to make informed ethical decisions regarding the particularity of these experimental designs. It seems that this international statement, written in English, is not sufficiently accessible to all of the French professionals involved in health research. The aim of this article is to provide these professionals with a contextualized and illustrated French translation of the "Ottawa statement".Method. The "complex design" working group of the RECaP network (Research in Clinical Epidemiology and Public Health), carried out this work. A first version was discussed by the authors in several meetings. It was completed by contextual explanations and examples of French studies currently conducted by the authors. The final version was obtained by consensus and validated by the group.Results. This work reports 15 recommendations grouped into 7 key questions: How to justify cluster design? How to submit an article to an ethics committee? How to identify research participants? How and when to obtain informed consent? Who are the gatekeepers? How to assess benefits and harm? How to protect vulnerable participants? Each of these recommendations is specific to cluster trials. The recommendations are explained and detailed through concrete examples.ConclusionWithout interfering with current French laws, this work provides a framework for the organization, conduct and ethical assessment of cluster randomized trials in France. In the present-day context, it is essential that all concerned groups can base their decisions on recommendations in line with the elementary principles of health research ethics.     

Therapeutic Misconception: Hope,Trust and Misconception in Paediatric Research

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a ‘collective’ TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism.     

A consumer perspective on informed consent and third-party issues.

Our two children were diagnosed with a rare genetic disorder, which led us to establish a research foundation. This led to in-depth consideration of issues surrounding informed consent from a consumer perspective. Third-party issues arose as central to the formulation of ethical policy in the establishment of a blood and tissue bank and an epidemiologic study. We suggest that a number of myths--privacy is possible, samples can be stripped of identifiers, humans are subjects, voluntary informed consent is attainable, genetics is about the individual only, genetic information is different than other medical information, research is altruistic, the public will learn truths about genetic research via media, and research is culturally competent--make it difficult to resolve the issues intrinsic to informed consent. A number of important elements could make policy decisions less complicated. These include conducting culturally competent research; conveying noncoercive hope, not hype; contacting the voluntary informant only; asking the informant to extend contact to other family members; requiring a comprehensive informed consent process for all contacted; and engaging in state-of-the-art data protections. There is a need for a "Genomic Hippocratic Oath," creating an ethical basis for research similar to the one vowed by health care professionals. Establishing ethical policies as a result of the collaboration of policy makers, researchers, and consumers will allow research to progress ethically at a rapid rate. If regulations are oppressive, they will thwart research; if they are too lenient, participants will not receive protections needed to participate safely.     

Ethical dilemmas of social science research on AIDS and orphanhood in Western Kenya

This paper is based on the experiences drawn from a long-term social science research programme on the impact of the AIDS pandemic on orphanhood in western Kenya. It discusses the ethical dilemma of maintaining a delicate balance between research ethics, the expectations of the study population and negotiating the community's vested interests in a health related research project in a low-income society. I argue that informed consent and the intended benefits of the study to the participants continue to be major challenges facing the justification of social research with people affected by or living with AIDS in low-income societies. The paper underscores the importance of community feedback sessions as a way of enhancing chances of acceptability of research efforts and obtaining informed consent. It further shows how community feedback sessions contribute to local knowledge of the problem being studied, creating opportunities for advocacy. This discussion adds to the existing ethical debate on the wider contexts within which research on vulnerable people affected by AIDS is conducted by arguing that research practice is inseparable from epistemological concerns of knowledge production. I suggest that ethnographers should enhance efforts to innovatively design action research projects to serve the twin purposes of data collection and deal with ethical challenges that are experienced when doing long-term research on vulnerable groups.     

Conducting research with young children: some ethical considerations

The recent foundation of a 'Young Children's Perspectives' special interest group in the European Early Childhood Education Research Association (EECERA) reflects a general move in social research towards the respectful and inclusive involvement of children in the research process. However, established education research guidelines often provide no more than a loose ethical framework, appearing to focus on avoiding poor ethical conduct rather than proposing ways forward for making children's participation in research a positive experience. This short paper draws on my own experiences of conducting ESRC-funded ethnographic video case studies on the ways four three-year-old children express their understandings at home and in a preschool playgroup during their first year of early years education. The paper reflects on the processes of negotiating initial and ongoing consent, problematises the notion of 'informed' consent in exploratory research with young children, and considers questions of anonymity when collecting and reporting on visual data. The paper proposes that by adopting a flexible, reflective stance, early years researchers can learn much from children, not only about their perspectives, but also about how to include young children in the research process.     

Privacy and ethics in pediatric environmental health research-part II: protecting families and communities

BACKGROUND: In pediatric environmental health research, information about family members is often directly sought or indirectly obtained in the process of identifying child risk factors and helping to tease apart and identify interactions between genetic and environmental factors. However, federal regulations governing human subjects research do not directly address ethical issues associated with protections for family members who are not identified as the primary "research participant." Ethical concerns related to family consent and privacy become paramount as pediatric environmental health research increasingly turns to questions of gene-environment interactions. OBJECTIVES: In this article I identify issues arising from and potential solutions for the privacy and informed consent challenges of pediatric environmental health research intended to adequately protect the rights and welfare of children, family members, and communities. DISCUSSION: I first discuss family members as secondary research participants and then the specific ethical challenges of longitudinal research on late-onset environmental effects and gene-environment interactions. I conclude with a discussion of the confidentiality and social risks of recruitment and data collection of research conducted within small or unique communities, ethnic minority populations, and low-income families. CONCLUSIONS: The responsible conduct of pediatric environmental health research must be conceptualized as a goodness of fit between the specific research context and the unique characteristics of subjects and other family stakeholders.     

医学期刊编辑对生物医学研究伦理问题的处理方式调研及建议

【目的】 探讨医学期刊编辑处理生物医学研究伦理问题的方式,为推动确立医学期刊伦理审查规范提供参考。【方法】 通过问卷星向国内医学期刊编辑发放调查问卷,对审稿时和论文出版后处理医学伦理相关问题的方式展开调研。【结果】 共回收问卷230份。调查显示:在审稿阶段,在保护患者隐私方面,英文期刊、中英双语期刊的编辑更注重要求作者提供授权同意相关证明材料;中、英文期刊以及中英双语期刊的编辑对涉及人体试验伦理问题的处理方式都比较规范。但是,对于研究是否获得患者知情同意、动物实验研究是否经过伦理委员会审查、回顾性研究是否需要伦理审查、涉及人的研究是否在临床试验注册中心注册等问题,编辑还需要进一步重视。在论文出版后,编辑发现的医学伦理问题主要是“涉及人的研究未说明是否经过伦理委员会审查”。对论文出版后发现的没有保护患者隐私和没有在临床试验注册中心注册的问题,大部分期刊缺乏相关处理方案。【结论】 编辑应加强对论文知情同意、动物实验伦理、回顾性研究伦理的审查,并审查涉及人的研究是否在临床试验注册中心注册,以推动我国医学期刊的高质量发展。     

Children in medical research: Australian ethical standards

Summary This paper examines standards for the use of children as research participants in medical research which are relevant to Australia and relates the standards to pivotal ethical issues. The standards include the National Health and Medical Research Council's NHMRC Statement and Supplementary Notes, professional codes of ethics, international human rights conventions, United Kingdom and United States codes of ethics, and statute and case law. The key ethical issues of potential risk and benefit to the child, and consent to research participation are discussed. Suggestions for the improvement of the NHMRC Statement are made.     

Methodological,practical, and ethical challenges to inner-city health research

Inner-city health research can be challenging because it deals wit vulnerable populations and sometimes puts investigators in difficult situations. Some challenges are methodological, including selecting the optimal research design, implementing effective methods of recruitment and retention, and determining the best approach to data analysis. Other issues are practical, including addressing potential biases in social research; dealing with conflicting research agendas among investigators, community agencies, and funding agencies; and disseminating research findings effectively. Another set of issues relates to the ethical conduct of, research, including ensuring privacy, maintaining confidentiality, and obtaining consent that is informed, not coerced, and not influenced by undue inducements. Throughout the research endeavor, the inner-city health researcher must carefully balance the roles of investigator, advocate, activist, and caregiver.     

When people matter: The ethics of qualitative research in the health and social sciences

When research involves people, ethics are fundamental. In the health and social sciences, when qualitative methodologies are used, in addition to ensuring an ethical process approved by the ethics review board, it is also necessary to guarantee an ethical practice capable of responding adequately to the complex questions and dilemmas which arise as the study progresses. This theoretical article analyses some of the most sensitive issues involved in qualitative research and discusses the following questions: (a) How should ethics be approached when working with vulnerable groups? (b) Is informed consent enough? (c) Should we rethink anonymity? (d) What is the difference between confidentiality and anonymity? (e) What exactly do we mean by relational ethics? (f) How can we avoid hurting people, yet remain honest? In the conclusions, we discuss some basic aspects for ensuring ethical studies. This paper, therefore, may be of interest to all health and social researchers concerned about ensuring that their studies comply with ethical principles which recognise, protect and respect participants’ rights.     

'Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!': community voices on the notion and practice of informed consent for biomedical research in developing countries

Ethical dilemmas in biomedical research, especially in vulnerable populations, often spark heated debate. Despite recommendations and guidelines, many issues remain controversial, including the relevance, prioritisation and application of individual voluntary informed consent in non-Western settings. The voices of the people likely to be the subjects of research have been notably absent from the debate. We held discussions with groups of community members living in the rural study area of a large research unit in Kenya. Discussions were facilitated by three research study vignettes outlining one field-based and two hospital-based studies being planned or taking place at the time. In addition to gathering general views about the aims and activities of the research unit, questions focused on whether consent should be sought for studies, and if so from whom (chiefs, elders, men/women, children), and on ascertaining whether there are any special concerns about the physical act of signing consent forms. The findings revealed the community's difficulty in distinguishing research from clinical investigations conducted in clinical settings. There was a spectrum of views regarding perceived appropriateness of consent procedures, in part because of difficulty in disentangling clinical from research aims, and because of other challenges to applying consent in practice. Debates between community members highlight the inadequacy of simplistic assumptions about community members' views on informed consent, and the complexity of incorporating lay opinions into biomedical research. Failure to appreciate these issues risks exaggerating differences between settings, and underestimating the time and resources required to ensure meaningful community involvement in research processes. Ultimately, it risks inadequately responding to the needs and values of those on whom the success of most biomedical research depends. Although compliance with community views does not necessarily make the research more ethical, it is argued that community opinions on local issues and practices should inform ethical decision-making in health research.     

从贝尔蒙报告审视医疗器械临床试验的伦理问题

医疗器械临床试验是最直接最有效地检测医疗器械性能的方式，贝尔蒙报告是对基本的道德原则及方针的陈述，用来帮助在解决涉及人体实验对象的科研中所产生的道德问题。本文从贝尔蒙报告角度来审视医疗器械临床试验的伦理问题，介绍了贝尔蒙报告产生的背景概念和医疗器械临床试验的概念及基本流程；贝尔蒙报告中的三项原则尊重个人、善行和平等公正原则在医疗器械临床试验中的体现以及针对贝尔蒙报告来解决医疗器械临床试验中产生的伦理问题的重大意义。通过知情同意的具体体现、对风险和好处的评估及受试者的选择和研究成果的分配三方面来解决临床试验中产生的伦理问题。