This Mentored Scientist Development Award in Research Ethics will support detailed, comparative ethnographic research of Institutional Review Boards. The research has two aims: 1) to promote the development of the applicant as a scholar in the ethics of research on human subjects, and 2) to address an important problem in the field of research ethics: the behavior and effectiveness of Institutional Review Boards (IRBs). Institutional Review Boards were created to protect humans from exploitation as research subjects. Although there is near universal agreement that IRBs have been an important tool for the protection of human subjects. Although there is near universal agreement that IRBs have been an important tool for the protection of human subjects, continuing reports about research abuses have created concern about failures in the review process. Improvement of the IRB review process requires empirical knowledge of the variables that shape the conduct of IRBs, that affect the content and style of their deliberations, and that determine levels of compliance with their recommendations. The formal rules and regulations that govern IRBs are well publicized, but the internal processes of decision making remain a mystery. There has been a plethora of research surveying members of IRBs and recording and analyzing the number of proposals considered, numbered approved., or recommendations made. But a thorough understanding of the operation and effect of Institutional Review Boards requires careful consideration of the day-to-day work of these groups. This research uses ethnographic and historical research methods to examine the inner workings of IRBs, the negotiations and patterns of interaction that characterize their meetings, the factors that explain their role, and effectiveness of IRBs in the larger institution. In-depth qualitative analysis of three IRBs will be done allowing important variables that explain the behavior of review boards to be isolated. This study, with its use of ethnographic and historical research methods and its careful consideration of several sources of data, will allow description of the social influences on IRBs and the decisions generated there. These findings will improve our understanding of the ethics review process and will allow us to better realize the goal of protecting human subjects.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Scientist Development Award - Research & Training (K01)
Project #
5K01AT000054-03
Application #
6375392
Study Section
Special Emphasis Panel (ZRG1-SSS-B (02))
Program Officer
Hopp, Craig
Project Start
1999-09-30
Project End
2003-08-31
Budget Start
2001-09-01
Budget End
2002-08-31
Support Year
3
Fiscal Year
2001
Total Cost
$122,850
Indirect Cost
Name
St. Olaf College
Department
Social Sciences
Type
Schools of Arts and Sciences
DUNS #
041201070
City
Northfield
State
MN
Country
United States
Zip Code
55057
Martinson, Brian C; Crain, A Lauren; Anderson, Melissa S et al. (2009) Institutions' expectations for researchers' self-funding, federal grant holding, and private industry involvement: manifold drivers of self-interest and researcher behavior. Acad Med 84:1491-9
Anderson, Melissa S; Ronning, Emily A; De Vries, Raymond et al. (2007) The perverse effects of competition on scientists'work and relationships. Sci Eng Ethics 13:437-61
Anderson, Melissa S; Horn, Aaron S; Risbey, Kelly R et al. (2007) What do mentoring and training in the responsible conduct of research have to do with scientists'misbehavior? Findings from a National Survey of NIH-funded scientists. Acad Med 82:853-60
De Vries, Raymond; Lemmens, Trudo (2006) The social and cultural shaping of medical evidence: case studies from pharmaceutical research and obstetric science. Soc Sci Med 62:2694-706
De Vries, Raymond (2004) How can we help? From ""sociology in"" to ""sociology of"" bioethics. J Law Med Ethics 32:279-92, 191
De Vries, Raymond; DeBruin, Debra A; Goodgame, Andrew (2004) Ethics review of social, behavioral, and economic research: where should we go from here? Ethics Behav 14:351-68
De Vries, Raymond G; Bosk, Charles L (2004) The bioethics of business: rethinking the relationship between bioethics consultants and corporate clients. Hastings Cent Rep 34:28-32
De Vries, Raymond G; Forsberg, Carl P (2002) What do IRBs look like? What kind of support do they receive? Account Res 9:199-216
De Vries, Raymond; Forsberg, Carl P (2002) Who decides? A look at ethics committee membership. HEC Forum 14:252-8