The use of deception for the purposes of research is a widespread practice within many areas of study. If we want to avoid either absolute acceptance or absolute rejection of this practice then we require some method of distinguishing between those uses of deception which are morally acceptable and those which are not. In this article I discuss the concept of counterfactual consent, and propose a related distinction between counterfactual-defeating deception and counterfactual-compatible deception. The aim is to show that this (...) proposed distinction will be useful in furthering the debate regarding the use of deception for the purposes of research. (shrink)

Community-researcher partnerships constitute one of the most important recent developments in biomedical ethics. The partnerships protect vulnerable communities within which research is conducted and help ensure that the communities benefit from the research. At the same time, they embody deep, core values about the social nature of persons and the value of community that significantly modify the radical individualism too often associated with the prevailing concepts of autonomy and respect for persons. This article examines the burgeoning literature on community-researcher partnerships (...) to identify the main ways of thinking ethically about the obligations of investigators and the roles and rights of communities in scientific research. The paper helps to uncover the deep commonalities and differences that mark the current debate in this emerging arena of research ethics, a debate over the social nature of persons that is beginning to influence the understanding of other bioethical issues. (shrink)

Informed consent and confidentiality supposedly minimize harm for research participants in all qualitative research methodologies, inclusive of one-on-one unstructured interviews and focus groups. This is not the case for the latter. Confidentiality and informed consent uniquely manifest themselves as endemic ethical dilemmas for focus group researchers. The principle of caveat emptor (let the buyer beware) may be a more useful tool for those involved in focus group research: that is, let the researcher, the participants and the ethics committee beware that (...) the only ethical assurance that can be given to focus group participants is that there are few ethical assurances. These ethical dilemmas are not sufficiently realized in the literature, and if they are discussed, they are often dealt with within the focus group moderator’s preamble to the group discussion. This paper encourages the mandatory use of a participant information sheet sufficiently detailed to engender the participant’s active consent. Sufficient here means the participant must be made adequately aware of these endemic ethical dilemmas in advance, to allow them to consent to share responsibility for any ensuing harm. The focus group moderator is not their sole protector. (shrink)

For decades, scholars in the social sciences and humanities have questioned the appropriateness and utility of prior review of their research by human subjects' ethics committees. This essay seeks to organize thematically some of their published complaints and to serve as a brief restatement of the major critiques of ethics review. In particular, it argues that 1) ethics committees impose silly restrictions, 2) ethics review is a solution in search of a problem, 3) ethics committees lack expertise, 4) ethics committees (...) apply inappropriate principles, 5) ethics review harms the innocent, and 6) better options exist. (shrink)

In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.

In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.

Background Research is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups. Discussion Much criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness (...) of evaluating qualitative studies within the methodological and risk assessment frameworks applied to biomedical and clinical research. Less attention has been given to the different epistemologies underlying biomedical and qualitative investigation. The bioethical framework underpinning current regulatory structures is fundamentally at odds with the practice of emergent, negotiated micro-ethics required in qualitative research. The complex and shifting nature of real world settings delivers unanticipated ethical issues and (occasionally) genuine dilemmas which go beyond easy or formulaic ‘procedural’ resolution. This is not to say that qualitative studies are ‘unethical’ but that their ethical nature can only be safeguarded through the practice of ‘micro-ethics’ based on the judgement and integrity of researchers in the field. Summary This paper considers the implications of contrasting ethical paradigms for the conduct of qualitative research and the value of ‘empirical ethics’ as a means of liberating qualitative (and other) research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism, divorced from real world contexts and values. (shrink)

A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national (6/31) or (...) regional (2/31). In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems. Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project. (shrink)

Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa (...) as an initial step to a comprehensive capacity-strengthening programme. The number of members per committee ranged from 3 to 21, with an average of 11. Members of 10 institutional committees were all from the institution where the committees were based, raising prima facie questions as to whether independence and objectivity could be guaranteed in the review work of such committees. Results: The majority of the committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits and monitoring of research. The survey showed that 38% of the ERC members did not receive any form of training. In the light of the increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention. Outcome: The survey identified areas of weakness in the operations of ERCs in Africa. Consequently, AMANET is addressing the identified needs and weaknesses through a 4-year capacity-building project. (shrink)

BackgroundThe increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public (...) health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer.MethodsThis is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries.ResultsThirty three of the 41 countries responded. Thirty of respondent countries had a national ethics review committee ; 79 % of which were established by law. Twenty-five NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research ethics; and allocation of funds for administrative and secretariat support.ConclusionsDespite the existing training initiatives, the Region still experiences a shortage of professionals trained in health research ethics/ethicists. Committees continue to face various capacity needs especially for evaluating clinical trials, for monitoring ongoing research, database management and for accrediting institutional ethics committees. Given the growing number of clinical trials involving human participants in the African Region, there is urgent need for supporting countries without NECs to establish them; capacity strengthening where they exist; and creation of a regional network and joint ethical review mechanisms, whose membership would be open to all NECs of the Region. (shrink)

Western laws and codes of ethics frequently require that private health information be treated confidentially. However, cross-cultural research shows that it is not always easy to determine what members of a culture consider to be private or how they wish private information to be handled. This article begins by presenting an ethnographic study of patient-healer relationships in Sri Lanka; researchers were surprised to find that participants' views of health and privacy differed greatly from typical Western views, and that the privacy (...) protections they had put in place caused discomfort among participants. Building on this ethics case study, the article explores two main questions. First, can a single definition of privacy possibly do justice to the cultural variations that exist, or does a conceptual definition inevitably run the risk of ethnocentrism? Second, to what extent is strict compliance with research regulations or ethics codes ethically justifiable when following the rules will obviously cause unease in international participants? (shrink)

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees. The urgent need for continued capacity development in Africa has necessitated research initiatives to identify existing capacity. This discussion paper describes the mapping of RECs in Africa through MARC project, second (...) phase and discusses the findings. MARC provides a platform and tool on COHRED's Health Research HRWeb, which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. (shrink)

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent (...) need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed.This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development's (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa. (shrink)

Debriefing is a standard ethical requirement for human research involving the use of deception. Little systematic attention, however, has been devoted to explaining the ethical significance of debriefing and the specific ethical functions that it serves. In this article, we develop an account of debriefing as a tool of moral accountability for the prima facie wrong of deception. Specifically, we contend that debriefing should include a responsibility to promote transparency by explaining the deception and its rationale, to provide an apology (...) to subjects for infringing the principle of respect for persons, and to offer subjects an opportunity to withdraw their data. We also present recommendations concerning the discussion of deception in scientific articles reporting the results of research using deception. (shrink)

Although written primarily for medical research, the Belmont principles have permeated clinical medicine as well. In fact, they are part of a broad cultural shift that has dramatically reworked the relationship between doctor and patient. In the early 1950s, medicine was about making the patient better and maintaining optimism when the patient could not get better. By the 1990s, medicine was about the treatment of specific physiological systems, as directed by the patient, but as limited by the society's concern for (...) justice. (shrink)

ABSTRACT Does the fact that deception is widely practised – even though there is a general prohibition against deception – provide insight into the ethics of deceptive methods in research, especially for social‐behavioral research? I answer in the affirmative. The ubiquity of deception argument, as I will call it, points to the need for a concrete and nuanced understanding of the variety of deceptive practices, and thus promises an alternative route of analysis for why some deception may be permissible in (...) social‐behavioral research. As an alternative argument it also promises to break the stalemate that emerges in debates on the ethics of deceptive methods in social‐behavioral research. In the current paper I (1) motivate and articulate the ubiquity argument in order to clarify the significance of ubiquity and discharge some initial objections. Then, on the recommendations of the ubiquity argument, I (2) highlight the importance of interpersonal relationships for understanding the ethics of deception. Following this insight I (3) provide an analysis of several features of the researcher‐participant relationship relevant to the understanding of the ethics of deception in research. I then (4) conclude the argument with some recommendations for the ethical use of deceptive methods in social‐behavioral research. (shrink)

What is the ethical significance of debriefing in deceptive research? The standard view of debriefing is that it serves to disclose the deception to the participant and is a means of evaluating and mitigating potential harms that may have resulted from involvement in the research. However, as the article by Miller, Gluck, and Wendler in this issue of the Kennedy Institute of Ethics Journal points out, there has been little systematic attention to the ethics of debriefing, particularly with regard to (...) the role of debriefing in addressing the prima facie moral wrong of deception itself. They argue that in addition to mitigating the harms of deception, debriefing should include an apology to participants for being deceived. In the current paper, I argue that an apology is not morally obligatory in most research contexts. Debriefing should be considered an opportunity to further define the researcher-participant relationship without the need to be remorseful about the research practice. (shrink)

This textbook emphasises a hands-on, multimethod, interdisciplinary approach to behavioural research. This edition uses particularly strong observational approaches.

Background Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis) in southern Ethiopia. Methodology/Principal Findings We adapted (...) a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO) working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent. Conclusions Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis. (shrink)