Views of US researchers about informed consent in international collaborative research

Informed consent poses challenges in all settings. Challenges may be particularly great in international collaborative research, where cultural perspectives may differ, and where education levels and language may be barriers to participant understanding. We conducted a written survey and focus groups with US health researchers doing research in developing countries, asking about informed consent and other ethical issues in their research. We present here both qualitative and quantitative data relevant to informed consent. Qualitative data revealed that researchers' experiences and beliefs about informed consent fell into three paradigms: regulatory, community, and individual. The regulatory paradigm refers to researchers' views and practices relating to informed consent requirements of institutional review boards and other oversight bodies. The community paradigm refers to researchers' approach to the content and methodology of informed consent in the context of long-term relationships between research teams and study communities. Researchers emphasized the importance of these relationships for creating and maintaining communication fundamental to the informed consent process. Finally, the individual paradigm refers to researchers' views about individual participants' understanding and decision-making process regarding research. Researchers described community-level influences on participants' decision-making, but stressed the need for individual comprehension and voluntary participation. While these paradigms are distinct, they also are intertwined. Quantitative data supported the existence of these three paradigms in respondents' characterization of informed consent. Researchers frequently stated that legal language on the consent forms was meaningless (52%). Forty-four percent of researchers had consulted with community leaders, and 23% believed the consent process focuses too much on the individual, rather than on family or community. Most researchers (82%) reported that the consent process was an important means of educating participants about the study. Fifty-four percent of researchers believed participants did not understand placebos. Further research is needed to understand how culture and relationships affect research participation, and to provide information and dialogue among researchers, oversight bodies and community representatives about appropriate ways to approach informed consent in international research.     

Is my mum going to hear this? Methodological and ethical challenges in qualitative health research with young people

Ethical issues arise in all research settings. However, qualitative research with young people raises specific dilemmas that warrant special attention. In this paper we describe an ethical dilemma that arose during a qualitative project we carried out exploring self-management of chronic illness in adolescents. A participant disclosed details of poor adherence with medication, which had significant health implications. Prior to this disclosure he had been assured of confidentiality and thus we found ourselves unsure of how to proceed. Here, we analyse the case in detail, highlighting the ethically important moments, the options for action and the implications of these. We do this with the aim of facilitating ethical mindfulness and thus, ultimately, ethical research practice. As a backdrop to this case we consider the broader ethical context. We find that qualitative research is susceptible to ethical dilemmas because: (1) it is not always possible to predict all possible questions and responses; (2) the nature of the relationship between researchers and participants is amenable to sensitive disclosures; (3) the process of qualitative research can make it difficult for participants to voice concerns or withdraw; and (4) participants' identities are generally known to researchers, complicating boundary issues. Research with young people is susceptible to ethical dilemmas because: (1) young people have limited life experience; (2) consent is often required from both young people and parents; (3) issues of competence can complicate assumptions about informed consent; and (4) the power differential between researchers and participants is significant. When combining qualitative research methods and young participants, the scope for ethical risk is thus substantial.     

'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.     

Proposing modesty for informed consent

The extension of informed consent into social science research has met with considerable opposition. The history and concept of informed consent, however, is based on a substantive ethical notion of the research relationship as informed and voluntary that is appropriate for social science research relationships. Yet social science research might sometimes be different from health research in ways that justify a different approach to informed consent and research relationships. Social science research tends to have a lower magnitude of risk, usually does not need to disrupt the therapeutic assumption common in health research contexts or when researchers are health professionals, and recruitment is sometimes incremental and reflects a building of trust and development of the research participant's role. These differences may sometimes justify novel approaches to the research relationship and require case-by-case evaluation to determine their relevance to establishing the informed and voluntary nature of the relationship through the use of informed consent procedures. Ultimately, respect for research participants requires social research into practices that can support or replace informed consent. The institutional role of informed consent and the goal of informed and voluntary research participation serve modest but important roles in health and social research. Their proper role in health and social research requires flexibility and experimentation, but does not justify abdication of informed consent or the notion of informed and voluntary participation.     

Fetal conditions and fatal decisions: ethical dilemmas in ultrasound screening in Vietnam

This paper situates discussion of the ethics of ethnographic research against the background of a theoretical and methodological debate about the relationship between ethics and method, and about the relationships between research methods and their objects. In particular, the paper investigates the implications of folding together the ethical and the empirical in research and argues that this requires the development of new ethico-ethnographic methods for the investigation of ethico-moral objects. The paper falls into three main parts. The first considers calls for what has come to be known as empirical ethics, that is, for a more empirically informed bioethics, by way of an exploration of the integration of ethnographic methods in bioethics, and concludes that approaches which see the ethical and the empirical as 'complementary' do not do justice to the methodological implications of enfolding the ethical and the ethnographic. The second part juxtaposes this with calls for the integration of ethics in ethnography and, similarly, argues that the enfolding of the ethical and the empirical in ethnography calls for the development of new methods. The paper goes on to problematise the 'negotiational' approaches to informed consent preferred by many ethnographers, arguing that the concept of negotiation, rather than offering a solution to the problem of consent, is itself ethically complex and in need of analysis. The paper argues that, in the context of ethnographic research, the possibility of negotiational forms of consent depends upon engagement between researchers and researched, with unavoidably 'ethical' concepts such as 'respect', 'recognition', 'dignity', 'justice' and so on, and that this poses methodological challenges to ethnography. The paper's third section explores the implications of these arguments for research practice, using The Genethics Club as an example.     

Review of ethical aspects in biomedical research. The experience of the Ethics Committee of the Center for Toxic Oil Syndrome and Rare Diseases [CISATER]

This Field Note aims to make known the decisions taken by the Ethics Committee of the Instituto de Salud Carlos III for Toxic Oil Syndrome regarding the secondary use of research specimens in biological research when informed consent is lacking. This is a common concern in the field of biomedical research. After debating the ethical suitability of the secondary use of these samples, our main conclusion is that researchers conducting prospective studies should expressly solicit written informed consent from participants in the study about i) whether there will or could be any secondary use of the samples and, if so, ii) whether such secondary use would be conditional on the type of research.     

Trust me,I’m a researcher!: The role of trust in biomedical research

In biomedical research lack of trust is seen as a great threat that can severely jeopardise the whole biomedical research enterprise. Practices, such as informed consent, and also the administrative and regulatory oversight of research in the form of research ethics committees and Institutional Review Boards, are established to ensure the protection of future research subjects and, at the same time, restore public trust in biomedical research. Empirical research also testifies to the role of trust as one of the decisive factors in research participation and lack of trust as a barrier for consenting to research. However, what is often missing is a clear definition of trust. This paper seeks to address this gap. It starts with a conceptual analysis of the term trust. It compares trust with two other related terms, those of reliance and trustworthiness, and offers a defence of Baier’s attribute of ‘good will’ a basic characteristic of trust. It, then, proceeds to consider trust in the context of biomedical research by examining two questions: First, is trust necessary in biomedical research?; and second, do increases in regulatory oversight of biomedical research also increase trust in the field? This paper argues that regulatory oversight is important for increasing reliance in biomedical research, but it does not improve trust, which remains important for biomedical research. It finishes by pointing at professional integrity as a way of promoting trust and trustworthiness in this field.     

Ethics of Informed Consent for Pragmatic Trials with New Interventions

Objectives: Pragmatic trials evaluate the comparative benefits, risks, and burdens of health care interventions in real-world conditions. Such studies are now recognized as valuable to the perimarketing stage of drug development and evaluation, with early pragmatic trials (EPTs) being explored as a means to generate real-world evidence at the time of regulatory market approval. In this article, we present an analysis of the ethical issues involved in informed consent for EPTs, in light of the generally recognized concern that traditional ethical rules governing randomized clinical trials, such as lengthy informed consent procedures, could threaten the “real world” nature of such trials. Specifically, we examine to what extent modifications (waivers or alterations) to regulatory consent for EPTs would be ethical. Methods: We first identify broadly accepted necessary conditions for modifications of informed consent (namely, the research involves no more than minimal risk of harm, the research is impracticable with regulatory consent, and the alternative to regulatory consent does not violate legitimate patient expectations) and then apply those criteria to the premarket and early postmarket contexts. Results and Conclusions: The analysis shows that neither waivers nor alterations of regulatory consent for premarket EPTs will be ethically permissible. For postmarket EPTs with newly approved interventions, waivers of consent will be ethically problematic, but some studies might be conducted in an ethical manner with alterations to regulatory consent.     

The influence of informed consent content on study participants' contraceptive knowledge and concerns

Little is known about how the information presented in the informed consent process influences study outcomes among participants. This study examines the influence of informed consent content on reported baseline contraceptive knowledge and concerns among two groups of HIV-serodiscordant and seroconcordant HIV-positive couples enrolled in research projects at an HIV research center in Lusaka, Zambia. We found significant differences in the reporting of contraceptive knowledge and concerns between couples viewing consent materials that included detailed information about contraception and those viewing consent materials that lacked the detailed information. We conclude that the design of informed consent materials should strike a balance between ensuring that participants give truly informed consent and educating participants in ways that do not compromise the assessment of the impact of behavioral interventions.     

Beyond the informed consent procedure: continuing consent in human research

An ethnographic field study about informed consent in hepatitis C clinical trials provides insight into how changes in protocol requirements and patient health status triggered the actions and decisions of researchers and human subjects during the conduct of these trials. U.S. federal guidelines recommend that informed consent should be conceptualized as more than a one-time event. Rather, a process of continuing consent should be the standard but little is understood about how exactly this process should unfold. We used a proposed typology of continuing consent to frame our analysis and were able to document that only some of the proposed types took place at the site of our study. The most frequent practice involved the researchers' re-consent of their subjects for major protocol revisions. Only one subject dissented and chose to withdraw even though he was technically eligible to continue in the study. Two other types of continuing consent were not observed. We discovered an additional type of continuing consent not described in the typology whereby subjects gave implied consent through their cooperation and adherence to the on-going requirements of the protocols. Implications for the informed consent process and the need for further research are presented.     

Informed consent and the history of inclusion of women in clinical research

The purposes of this paper are to (a) discuss the troubled history of informed consent for research on women and its ramifications for women's participation in clinical trials; (b) interrogate current informed consent practices as to their accountability and justice in the treatment of women; and (c) recommend to nurse researchers and clinical nurses ways of improving the practice of informed consent in research with women.     

Changing constructions of informed consent: qualitative research and complex social worlds

Informed consent is a concept which attempts to capture and convey what is regarded as the appropriate relationship between researcher and research participant. Definitions have traditionally emphasised respect for autonomy and the right to self-determination of the individual. However, the meaning of informed consent and the values on which it is based are grounded in society and the practicalities of social relationships. As society changes, so too do the meaning and practice of informed consent. In this paper, we trace the ways in which the meaning and practice of informed consent has changed over the last 35 years with reference to four qualitative studies of parenting and children in the UK which we have undertaken at different points in our research careers. We focus in particular on the shifting boundaries between the professional and personal, and changing expressions of agency and power in a context of heightened perceptions of risk in everyday life. We also discuss developments in information and communication technologies as a factor in changing both the formal requirements for and the situated practicalities of obtaining informed consent. We conclude by considering the implications for informed consent of both increasing bureaucratic regulation and increasingly sophisticated information and communication technologies and suggest strategies for rethinking and managing 'consent' in qualitative research practice.     

INFORMED CONSENT AND THE HISTORY OF INCLUSION OF WOMEN IN CLINICAL RESEARCH

The purposes of this paper are to (a) discuss the troubled history of informed consent for research on women and its ramifications for women's participation in clinical trials; (b) interrogate current informed consent practices as to their accountability and justice in the treatment of women; and (c) recommend to nurse researchers and clinical nurses ways of improving the practice of informed consent in research with women.     

Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges

Despite multiple initiatives in post-acute and long-term nursing home care settings (NHs) to improve the quality of care while reducing health care costs, research in NHs can prove challenging. Extensive regulation for both research and NHs is designed to protect a highly vulnerable population but can be a deterrent to conducting research. This article outlines regulatory challenges faced by NHs and researchers, such as protecting resident privacy as well as health information and obtaining informed consent. The article provides lessons learned to help form mutually beneficial partnerships between researchers and NHs to conduct studies that grow and advance NH research initiatives and clinical care.     

Why do people cooperate with medical research? Findings from three studies

In this paper, we distinguish decisions about cooperation with medical research from decisions about research participation. We offer an empirical and theoretical exploration of why people in three different UK-based medical research projects chose to cooperate. Data analysis of the accounts of 128 participants across the three studies was based on the constant comparative method. Participants' cooperation was engaged by a perception that they would be contributing to the ‘public good’, but they also wanted to justify their decision as sensible and safe. Critical to their cooperation was their belief that researchers would fulfil their side of the cooperative bargain, by not exposing participants to risks of harm or exploitation. Although participants were generally unaware of the details of the regulatory regime for research, they demonstrated a generalised reliance on regulation as a feature of everyday life that would provide a safe context for cooperation. In their assessment of particular projects, participants made judgements about whether to cooperate based on more specific cues, which acted as signs to assure them that researchers shared their cooperative intentions. These cues included organisational and professional credentials, the role identities and perceived trustworthiness of those involved in recruiting to research, and visible signs of reasonable practice mandated by regulatory systems. Thus participants drew on their understandings of an institutional field that was much broader than that of research alone. We propose that the social organisation of research is fundamental to the judgements people make about cooperation with research. Cooperation may be a more useful way of thinking about how people come to engage in collaboratively oriented actions such as research participation, rather than currently dominant individualistic models. Attention to the institutional context of research is critical to understanding what makes cooperation possible, and has important implications for the design of regulatory regimes for research.     

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。     

A Troubled Past? Reassessing Ethics in the History of Tissue Culture

Recent books, articles and plays about the ‘immortal’ HeLa cell line have prompted renewed interest in the history of tissue culture methods that were first employed in 1907 and became common experimental tools during the twentieth century. Many of these sources claim tissue cultures like HeLa had a “troubled past” because medical researchers did not seek informed consent before using tissues in research, contravening a long held desire for self-determination on the part of patients and the public. In this article, I argue these claims are unfair and misleading. No professional guidelines required informed consent for tissue culture during the early and mid twentieth century, and popular sources expressed no concern at the widespread use of human tissues in research. When calls for informed consent did emerge in the 1970s and 1980s, moreover, they reflected specific political changes and often emanated from medical researchers themselves. I conclude by arguing that more balanced histories of tissue culture can make a decisive contribution to public debates today: by refuting a false dichotomy between science and its publics, and showing how ethical concepts such as informed consent arise from a historically specific engagement between professional and social groups.     

药物临床研究中痴呆受试者知情同意过程探析

目的为我国痴呆药物临床研究受试者知情同意的规范化提供参考依据。方法对近年来我院关于痴呆药物的临床研究知情同意过程中所存在的问题及其原因进行分析,探究其解决方法。结果随机双盲安慰剂对照研究或针对中重度痴呆患者的研究中,受试者及其知情者的知情同意过程困难,不良事件发生率高,反之随机双盲阳性药对照或轻度痴呆患者的研究上述情况则较少出现。结论建议通过对受试者、知情者的健康教育及对研究者的法制教育,构造完善的法律法规保障制度,健全伦理委员会监督机制等措施来保护受试者及其知情者的权益。     

Navigating the ethics of cross‐cultural health promotion research

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.     

Stem cells clinical trials for cardiac repair: regulation as practical accomplishment

Macro-analyses on the regulation of new biomedical objects tend to focus on discursive structures and legislative categories in science policy debates at national and cross-national levels, but overlook how actors engage in regulatory practices on an everyday basis. Based on data from ethnographic fieldwork in British and German clinics, and 32 interviews with medical staff, this article provides an insight into the regulation of adult stem cell research and its clinical implementation. The argument illustrates the enactment of regulation at different stages and highlights the accompanying interpretative strategies employed by the medical personnel involved in the management of clinical trials using patients' own (autologous) stem cells to regenerate damaged cardiac tissue. We argue that the implementation of regulation is a practical accomplishment in both national contexts. The complexities present in this process are instanced by the gradual crystallisation of practices within the organisation of clinical trials. This crystallisation is dependent on exchanges between members of medical teams and external agencies, and is set within a strategic ordering of regulatory measures that are mobilised to legitimise clinical research and reinforce professional interests.