DISSEMINATION TO RESEARCH SUBJECTS: OPERATIONALIZING INVESTIGATOR ACCOUNTABILITY

Abstract

Recent articles have argued from principles of bioethics for the right of research subjects to receive the results of the studies in which they have participated. We argue that accountability is a powerful tool of meso-level analysis appropriate to reasoning about answerability in research ethics, and that it captures the responsibility of researchers to disseminate study results to research subjects. We offer the following features of the research situation as relevant to the manner of dissemination to study subjects, in addition to factors already proposed in the literature (risk and impact on health outcome): (a) features of the research subject in relation to identity, personal investment, disease, and community; (b) characteristics of the research study and field of inquiry in relation to certainty and significance; and (c) relationships among the research subjects and the healthcare workers involved in their care and in the research.

Keywords:

• accountability
• dissemination
• clinical trial
• research
• ethics

Randi Zlotnik Shaul collected data, analyzed data, and wrote and edited this paper. Lynette Reid collected data, analyzed data, and wrote and this edited paper. Beverley Essue collected data, analyzed data, wrote and edited this paper. Julie Gibson analyzed data, and wrote and edited this paper. Velma Marzinotto analyzed data and wrote and edited this paper. Denis Daneman analyzed data and wrote and edited this paper.

Notes

Code of Federal Regulations, Title 45, Part 46: Protection of Human Subjects 116(b)(5)

Medical Research Council of Canada, National Science and Engineering Research Council of Canada, Social Science and Humanities Research Council of Canada. (1998, with 2000, 2002 updates) Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (Ottawa: Author)