This is the first in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. The first considers the rationale for having ethics review by committee at all; seeking to explain why ethics committees, as we currently have them, are so important to the wider system of governing research.

BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

This article concerns the ways in which authors from various fields conceptualise the ethical issues arising in the conduct of research. We reviewed critically and systematically the literature concerning the ethics of conducting research in order to engage in a reflection about the vocabulary and conceptual categories used in the publications reviewed. To understand better how the ethical issues involved in conducting research are conceptualised in the publications reviewed, we 1) established an inventory of the conceptualisations reviewed, and 2) we (...) critically assessed them. We found that the publications reviewed mostly showed examples of descriptive ethics, in that most authors describe ethical issues without reflecting much on them, which could be explained both by 1) a lack of ethical education in research contexts, and 2) by the fact that we do not know what researchers know (or do not) about ethical issues. Additionally, the definitions identified in the publications are scarce and at times imprecise, but this seems more to point out the ethical vocabulary’s difficulties in certain contexts. Further, very few authors offer proper conceptualisations of the ethical issues arising in conducting research. When dealing with vast arrays of ethical issues to conceptualise, perhaps one ought to remember that some typologies already exist that could guide further reflection and help understand other realities for which the current ethical vocabulary may be lacking. We believe that combining the reviewed typologies, both with other well-developed typologies and critical reflection, could help support better ethical practice in conducting research. (shrink)

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or (...) limit adolescent participation, jeopardizing study findings’ validity. This paper presents recommendations on when researchers and Institutional Review Boards should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible. (shrink)