Ethics in public health research: protecting human subjects: the role of community advisory boards

Increasingly, researchers grapple with meaningful efforts to involve communities in research, recognizing that communities are distinct from individuals. We also struggle to ensure that individual participants in research are fully protected.Community advisory boards (CABs) offer an opportunity to adopt a relationships paradigm that enables researchers to anticipate and address the context in which communities understand risks and benefits, and individuals give consent. CABs provide a mechanism for community consultation that contributes to protecting communities and fostering meaningful research. Furthermore, CABs can help us to re-create informed consent as a process. It is critical that we conduct research to understand the role of CABs in the informed consent process.     

Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast

Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working 'in the field'.     

'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.     

Beyond informed consent

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings.     

The Role of Community Advisory Boards: Involving Communities in the Informed Consent Process

Ethical research involving human subjects mandates that individual informed consent be obtained from research participants or from surrogates when participants are not able to consent for themselves. The existing requirements for informed consent assume that all study participants have personal autonomy; fully comprehend the purpose, risks, and benefits of the research; and volunteer for projects that disclose all relevant information. Yet contemporary examples of lapses in the individual informed consent process have been reported. The authors propose the use of community advisory boards, which can facilitate research by providing advice about the informed consent process and the design and implementation of research protocols. These activities could help reduce the number of individual informed consent lapses, benefiting study participants and the scientific integrity of the research in question.     

Do Australian researchers accept committee review and conduct ethical research?

We sought researchers' views on the ethics of research practice and the Australian system of review of research proposals by research ethics committees (RECs). Researchers were found to be supportive of review of research proposals, even though they thought that the process of review was time consuming and demanding. However, our findings suggest that not all researchers present their research proposals for review by committees, and that some researchers deviate from their approved proposals without seeking approval for those deviations from an REC. Researchers supported monitoring of research by RECs.     

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, anticipatory regulation and ethnographic practice

In this paper we examine the application of informed consent to ethnographic research in health care settings. We do not quarrel with either the principle of informed consent or its translation into the requirement that research should only be carried out with consenting participants. However, we do challenge the identification of informed consent with the particular set of bureaucratic practices of ethical review which currently operate in Canada, the US and elsewhere. We argue that these anticipatory regulatory regimes threaten the significant contribution of ethnographic research to the creation of more efficient, more effective, more equitable and more humane health care systems. Informed consent in ethnographic research is neither achievable nor demonstrable in the terms set by anticipatory regulatory regimes that take clinical research or biomedical experimentation as their paradigm cases. This is because of differences in the practices of ethnographic and biomedical research which we discuss. These include the extended periods of time ethnographers spend in the research setting, the emergent nature of ethnographic research focus and design, the nature and positioning of risk in ethnographic research, the power relationships between researchers and participants, and the public and semi-public nature of the settings normally studied. Anticipatory regulatory regimes are inimical to ethnographic research and risk undermining the contribution of systematic inquiry to understanding whether institutions do what they claim to do, fairly and civilly and with an appropriate mobilisation of resources. We do not suggest that we should simply ignore ethics or leave matters to the individual consciences of researchers. Rather, we need to develop and strengthen professional models of regulation which emphasise education, training and mutual accountability. We conclude the paper with a number of suggestions about how such professional models might be implemented.     

Competent children? Minors’ consent to health care treatment and research

This paper concentrates on controversies about children's consent, and reviews how children's changing status as competent decision makers about healthcare and research has gradually gained greater respect. Criteria for competence have moved from age towards individual children's experience and understanding. Uncertain and shifting concepts of competence and its identification with adulthood and childhood are examined, together with levels of decision-making and models for assessing children's competence. Risks and uncertainties, methods of calculating the frequency and severity of risks, the concept of 'therapeutic research' and problems of expanding consent beyond its remit are considered. The paper ends by considering how strengths and limitations in children's status and capacities to consent can be mirrored in researchers' and practitioners' own status and capacities. Examples are drawn from empirical research studies about decision-making in healthcare and research involving children in the UK.     

Informed consent: court viewpoints and medical decision making

Twenty-five years of appellate court decisions about informed consent in three influential states were examined to address four issues: the criteria used to define adequate informed consent; trends in court decisions; parallels between court decision making and decision analysis; the contribution of decision analytic concepts to defining "reasonable" medical informed consent. Court standards have evolved in three phases: the "medical community" standard before 1972, the "reasonable person" standard since 1972, and recent inroads toward developing an "individual preference" standard. The latter two standards form the current basis for deciding whether a patient has been adequately informed. Decision analysis offers a framework for communication about medical outcomes and probabilities, and methods for assessing preferences. Jurists and physicians should consider whether the legal system should adopt a decision analytic perspective in the doctrine of informed consent. Researchers should address issues raised by use of decision analysis for communication between the physician and the patient.     

Trust and informed consent: insights from community members on the Kenyan coast

Trust is an important theme running through the literature on the ethics of biomedical research, but it is rarely given centre stage. In this paper, we present data gathered from a study aimed at exploring community views regarding the informed consent processes carried out by a large research centre on the Kenyan Coast. The findings point to the centrality of trust and elements of mistrust in general community views, in parents' (mis)understanding of studies they consent their children to be involved in, in refusals and concerns, and in community members' views about whether informed consent is a relevant and practical model to follow. Tentative ideas on how trust and a healthy mistrust might be balanced highlight the importance of strengthening communication surrounding basic health care as well as research, and of fostering 'an inner generated ethic of service'. The latter is particularly fundamental, but cannot be built and regulated through the laws, policies and guidelines that currently govern biomedical research practice.     

Parents' experiences of sharing neonatal information and decisions: consent, cost and risk

This paper is about the care of babies with confirmed or potential neurological problems in neonatal intensive care units. Drawing on recent ethnographic research, the paper considers parents' experiences of sharing information and decisions with neonatal staff, and approaches that support or restrict parents' involvement. There are growing medico-legal pressures on practitioners to inform parents and involve them in their babies' care. Data are drawn from observations in four neonatal units in southern England, and interviews with the parents of 80 babies and with 40 senior staff. The paper compares standards set by recent guidance, with parents' views about their share in decision-making, their first meetings with their babies, 'minor' decision-making, the different neonatal units, being a helpless observer and missed opportunities. Parents' standards for informed decisions are summarised, with their reported views about two-way decision-making, and their practical need to know. Whereas doctors emphasise distancing aspects of the consent process, parents tend to value 'drawing together' aspects.     

Risk perception and decision processes underlying informed consent to research participation

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

A model designed to enhance informed consent: experiences from the HIV prevention trials network

HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health. This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment.     

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.     

Meaningful informed consent with young children: looking forward through an interactive narrative approach

Ideas about ethical research with young children are evolving at a rapid rate. Not only can young children participate in the informed consent process, but researchers now also recognize that the process must be meaningful for them. As part of a larger study, this article reviews children's rights and informed consent literature as the foundation for the development of a new conceptual model of meaningful early childhood informed consent. Based on this model, an ‘interactive narrative’ approach is presented as a means to inform three- to eight-year-old children about what their participation might involve and to assist them to understand and respond as research participants. For use with small groups, this approach revolves around a storybook based on research-related factual images delivered via interactive (re)telling. This narrative approach to informed consent is unique in its holistic design which seeks to address the specific needs of young children in research.     

Being a qualitative researcher

This article, from a keynote address, is the result of some of the things which I learned about qualitative research during my many years of doing and teaching it. The main point I make is that qualitative researchers should present a good story which is based on evidence but focused on meaning rather than measurement. In qualitative inquiry, the researchers' selves are involved, their experiences become a resource. Researchers cannot distance themselves from the other participants, although they cannot fully present their meaning and experience. I also discuss voice, paradigm, and innovation as potentially problematic issues in qualitative research. These are terms often used but not always examined for their meaning in qualitative inquiry. If researchers are aware and sensitive, rather than overemotional or self-absorbed, qualitative research can be enlightening, person-centered, and humanistic.     

Defining the "community" in community consultation for emergency research: findings from the community VOICES study

This article explores the application of the concept "community consultation" in the context of emergency medical research. Emergency medicine researchers are permitted, by the World Medical Association regulations and in the United States by U.S. Federal Regulations, to conduct emergency medical research on individuals with a life-threatening condition without obtaining their consent or that of their surrogates if certain conditions are met. Among these conditions is the requirement that researchers observe a number of special protections for the participants, including "community consultation and notification" prior to the initiation of such studies. The term "community" is not defined clearly and the process for conducting community consultations is not specified in these regulations. This study explores the feasibility of conducting community consultation in the context of emergency medical research by examining: research participant's definitions of community in New York, the factors that help shape their definitions of community and the people they would authorize to render participation decisions on their behalves. Findings from this study suggest that participants' definitions of community vary as a function of the purpose of the definition and the demographics of the respondents. Most significantly, this study reveals that although respondents can identify potential spokespersons for their communities, these community spokespersons were rarely identified as those who should have decision-making authority in medical emergencies. Finally, this article explores the implications of these findings for the definition of community as it applies to community consultation for emergency medical research.     

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.