Recorded presentation

Joanna K. Weinberg, JD, LLM, Associate Adjunct Professor of Health Law, Policy and Ethics, UC San Francisco- Department of Social and Behavioral Sciences, Box 0646 Laurel Heights Suite 340, San Francisco, CA 94118, 415-502-5204, weinbgj@itsa.ucsf.ed and Robert I Sinaiko, MD, Dept. of Medicine, UC California, ∑ Assistant Clinical Professor, School of Medicine, University of California, San Francisco, 3333 California St. Suite 340, San Francisco, CA 94118.

This paper examines the role of Institutional Review Board (IRB) culture in shaping official IRB actions involving the protection of human research subjects and ensuring the ethical conduct of research. Using data gathered from two IRB listserv archive databases, with a combined total of over 8000 participants, the paper provides a window into IRB culture. The conceptual framework for this work developed from studies recognizing the increased importance of IRBs as the administrative bodies chiefly responsible for representing and protecting the interests and rights of human research subjects, and in fostering the responsible conduct of research.

In recent years there have been significant changes in the character, quantity, and funding patterns of research, and social and behavioral studies, qualitative research, and research with underserved communities. IRB functions have also expanded to include oversight of the ethical conduct of research. Each IRB exhibits operational characteristics (structures, procedures, policies, prevailing attitudes and points of view) that, taken collectively, comprise its organizational culture. The listserv analyses serves as a window to pinpoint the areas of controversy and debate among and across different types of IRBs.

The analysis reveals significant variation in IRB culture, and suggests that to some degree this can be traced to IRB structure and mission. Some IRBs are relatively homogeneous, while others reflect an interplay among component subcultures. The objective in studying IRB culture is to examine whether operational and cultural differences among IRBs flow from their organizational affiliations and whether those differences significantly impact the official actions of IRBs.

Learning Objectives:

(
• To acquaint participants with the evolving nature of IRB culture, as IRBs take on greater roles in ensuring integrity of research in different settings; (
• To describe the methodological approach – listserv analysis – that frames a critical element of this research process; (
• To encourage an exchange of ideas and experiences among participants who have either been IRB members or who have come before IRBs as researchers, to develop institution-specific analyses of IRB culture.

Keywords: Research Ethics, Behavioral Research

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

Recorded presentation