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.     

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.     

The informed consent aftermath of the genetic revolution. An Italian example of implementation

A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework.     

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.     

Gaining and maintaining consent: ethical concerns raised in a study of dying patients

This article provides a frank discussion of the practical and ethical issues that emerged during the process of setting up and conducting a participant observation study within an inpatient hospice. A general overview of the participant observation approach is used to prefigure a discussion of its strengths and weaknesses when employed as a research and evaluation tool among palliative care populations. Although participant observation provided a flexible and viable means of collecting data in the hospice, it also created a number of dilemmas that in many cases could not be satisfactorily resolved. Difficulties arose, in particular, with obtaining informed consent from patients and assuming that consent remained valid after patients had deteriorated physically and mentally. Further complications stemmed from the role conflict and ambiguity inherent within an approach that requires a researcher to work simultaneously as a participant and as an observer.     

Variation in local institutional review board evaluations of a multicenter patient safety study

Several highly visible quality improvement (QI) projects led to controversy over their ethical oversight, attracting attention from institutional review boards (IRBs) and the Office for Human Research Protection. While QI research has increased dramatically, there is limited empirical evidence regarding how multiple IRBs review the same study. This paper describes the variations in local IRB reviews for the same a multicenter QI study. The study, entitled "Locating Errors through Networked Surveillance", used multiple data collection methods to identify patient safety risks in cardiovascular operating room services. This study involved 2-day site visits to 5 hospitals by the research team to observe cardiac surgery procedures and interview staff regarding clinical practice and hazards. Surveys were self-administered. The IRB process varied widely across the 5 hospitals. Reviews ranged from full committee review and approval with verbal consent required from patients and operating room staff, to an IRB determining the study exempt from review and participant consent. The time to IRB approval ranged from 6 weeks to 6 months. This variation suggests there is wide interpretation of the Federal regulations put in place to guide IRBs. The adoption of uniformity would not only reduce inefficiencies but also attenuate the perceived arbitrary nature of current IRB review processes that often inappropriately influence hypothesis-generation and study design.     

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.     

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.     

Patients' perceptions of research in emergency settings: A study of survivors of sudden cardiac death

Conditions such as stroke, sudden cardiac death, and major traumatic injury are major causes of morbidity and mortality, and there is a need for clinical research to improve treatment for these conditions. However, because informed consent is often impossible, research in these situations poses ethical concerns. Despite growing literature on the ethics of emergency research, little is known about the views of relevant patient populations regarding research in emergency settings conducted under an exception from informed consent (EFIC).     

Ethics of clinical trials in family medicine

In this paper several issues are examined that arise from conducting randomized clinical trials in a family practice setting. The distinctive research tradition in family practice involves a patient's primary care physician performing an experimental investigation that usually, though not invariably, is focused on common health problems. Representative clinical trials are presented as examples that illustrate two ethical difficulties evoked by such research: a potential violation of the primary care physician's therapeutic imperative to provide the best possible treatment for his or her patient, and the likelihood that the type of physician-patient relationship fostered in family practice significantly diminishes the capacity of the patient to give true informed consent. In an attempt to resolve these ethical difficulties, a model of moral reasoning is presented that is based on easily understood ethical principles and is applicable to actual clinical decision making. Using that model, a tentative set of rules or guidelines is offered for implementing clinical trials in family medicine.     

Informed Consent in School Health Research: Why, How, and Making It Easy

The obligation to obtain informed consent for student participation in health-related research creates a complex set of legal, ethical, and administrative responsibilities because the interests of research integrity are delicately balanced against protection of human subjects. Even the term itself sparks a range of responses depending on one's perspective and stake in the process. This paper traces the historical impetus behind obtaining informed consent, identifies key elements comprising informed consent, and reviews types of consent procedures used in schools. The authors suggest 20 ways to boost response rates while providing a realistic level of informed consent for school-based studies.     

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.     

'Informed consent' in public health activities: based on the universal declaration on bioethics and human rights, UNESCO

OBJECTIVES: The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. METHODS: The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. RESULTS: It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. CONCLUSIONS: Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.     

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.     

Doing participant observation in a psychiatric hospital-- research ethics resumed

Social scientists who employ participant observation methods in medical settings are often held accountable for their research methods, specifically in regard to medical research ethics. However, the medical research ethics tradition rubs uneasily against participant observation and the anthropological understanding of the research process. The underlying premise for considering research ethics in the current case is the notion of the vulnerability of psychiatric patients as a participant group. Based on this notion of vulnerability among psychiatric patients, this article discusses the epistemological grounds for vulnerability in anthropological and medical research ethics. The authors draw on their experience with the Regional Committee for Medical Research Ethics in Norway, and the consequences of the guidelines used for participant observation as a research method in a psychiatric hospital. Social science researchers are required to follow medical ethical guidelines, such as informed consent, the principle of voluntariness, and estimation of risks and benefits. Ethnographers have found these guidelines to be obstructive when doing social science research in a psychiatric hospital. The article suggests the need for reformulation of research guidelines for participant observation in medical settings.     

Ethical and Regulatory Issues with Conducting Sexuality Research with LGBT Adolescents: A Call to Action for a Scientifically Informed Approach

Lesbian, gay, bisexual, and transgender (LGBT) adolescents experience disparities in mental and sexual health. There is also a lack of research on this population relative to other adolescents, which limits our ability to effectively address these health disparities. Researchers may unfortunately avoid conducting research with this population because of anticipated or actual experiences with difficulties in obtaining IRB approval. A case example is provided to illustrate the ethical and regulatory issues related to research with LGBT adolescents. Relevant U.S. federal and local regulations related to research on sexual and mental health with adolescents is then reviewed. Data are presented demonstrating that requiring parental consent for LGBT youth under age 18 would likely alter study result. Data are also presented on participants' appraisals of the risks and discomforts associated with research participation. The provision of such empirical data on the risks of research participation is consistent with the goal of moving the IRB process of risk/benefit assessment from being entirely subjective to being evidence-based. Finally, recommendations are provided on how to approach these issues in IRB applications and investigators are called to help to build a corpus of scholarship that can advance empirical knowledge in this area.     

Randomized controlled trials in environmental health research: ethical issues

Randomized controlled trials (RCTs) are becoming increasingly common in environmental health research. Like all studies involving human subjects, environmental health RCTs raise many ethical challenges, ranging from obtaining informed consent to minimizing risks to protecting privacy and confidentiality. One of the most important issues raised by these studies is whether it is ethical to withhold effective environmental health interventions from research subjects in order to satisfy scientific objectives. Although environmental health investigators usually do not have professional obligations to provide medical care to research subjects, they have ethical obligations to avoid exploiting them. Withholding interventions from research subjects can be ethical, provided that it does not lead to exploitation of individuals or groups. To avoid exploiting individuals or groups, investigators should ensure that research subjects and study populations receive a fair share of the benefits of research.     

Ethical issues surrounding studies with vulnerable populations: a case study of South African street children

Researchers who investigate social and economic determinants of health often interact with vulnerable and marginalized populations. Great care must be taken to conduct research studies involving vulnerable persons in a manner consistent with accepted ethical principles in order to protect participants from exploitation, to build capacity, and to promote wellbeing. Children form a particularly vulnerable group, especially those who do not enjoy the protection of parents or guardians. METHODS: A research project which studied South African Sunnyside's street children was used as a case study to illustrate ethical issues surrounding research with vulnerable populations. DISCUSSION: The participants in the case study lacked the age of majority and were without any legal guardian. The researchers experienced considerable difficulty in obtaining ethical approval to conduct the study. The street children, at first, were not allowed to give informed consent for the study because of their minor age. Ethical principles of autonomy, disclosure, competence and understanding, consent and voluntariness, beneficence and non-maleficence, and justice are described and applied to this case study involving street children in a South African neighbourhood. It is suggested that by working within an ethical framework, the safety of research participants will be assured and the quality of the research will be enhanced.     

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'.