In a recent paper, Holly A. Taylor reports the results of a study on the role of the NIH inclusion guidelines and the attitudes of IRB administrators. Administrators of Research Ethics Boards (REBs) agree that the topic of including women, minorities, and children in research is “often discussed by their Boards”. While most REB administrators believe the NIH inclusion guidelines were “in part responsible” for IRB attention to inclusion/exclusion issues for special populations (nearly 60%), these administrators do not think that the guidelines are responsible for an increase in the number of women, children, and minorities in research. So, are the guidelines doing their job? Maybe. Graduates of ethics courses are more likely to think the NIH guidelines are adequate, but (more importantly, perhaps) administrators who had NOT taken an ethics course, were more likely to attribute attention to issues of inclusion to the guidelines. Given the somewhat mixed review, Taylor observes that small increases on the local level may not seem adequate to administrators, but these could contribute to improvements at the national level.
Reference:
Taylor HA. Inclusion of Women, Minorities, and Children in Clinical Trials: Opinions of Research Ethics Board Administrators. J Empir Res Hum Res Ethics. 2009 Jun;4(2):65-73. PMID: 19480593.
Related:
National Institutes of Health. (1998). NIH policy and guidelines on the inclusion of children as participants in research involving human subjects. http://grants.nih.gov/grants/guide/notice-files/not98-024.html
National Institutes of Health. (2001). Amendment: NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html
National Institutes of Health. (2003). Outreach Notebook for the Inclusion, Recruitment and Retention of Women and Minority Subjects in Clinical Research. NIH Publication NO. 03-7036. http://orwh.od.nih.gov/inclusion/outreach.pdf
Other Recent Research Ethics Articles
Note: This post is the first in a series (category REAL – “Research Ethics in the Academic Literature”) sharing research ethics articles with the readers the newsletter Research Ethics News Digest, a service of Bioethics and Subject Advocacy Program, Indiana CTSI. To learn more about this new service, see Research Ethics News Digest from the Indiana University Center for Bioethics or browse the posts in the category REND.
