IRB Advisor – January 1, 2003
January 1, 2003
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Conflict of interest issues require more IRBs and institution attention in future
In the best of all worlds, there wouldnt be research conflicts of interest. Investigators would be focused on the intent of research uncovering previously unknown information. However, the reality falls a little short of the ideal, which is why many IRBs have had to deal with conflict of interest issues in addition to their primary goals and duties. -
AAMC issues its guidelines concerning financial COI
The Task Force on Financial Conflicts of Interest in Clinical Research for the Association of American Medical Colleges (AAMC) of Washington, DC, has issued new guidelines. Called Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institutions Financial Interests in Human Subjects Research, the October 2002 recommendations contain the following points. -
Key potential conflicts of interest
Institutional and individual conflicts of interest perhaps always will plague human subjects research. Until there are uniform rules that all institutions must follow, it will be up to conflict of interest committees and IRBs to make certain that ethical abuses do not result from conflicts of interest that are both unacceptable and preventable. -
Consult fathers, too, in research involving fetuses
Changes to federal regulations regarding research protections for pregnant women and fetuses now require investigators to obtain the informed consent of a fetus or neonates father before certain types of research may proceed. -
Exempt or nonexempt? IRB must make the call
Certain broad categories of research are exempt from full review of an institutional review board. Though federal regulations regarding exemptions are spelled out for investigators and IRBs alike, IRBs still are responsible for reviewing proposed protocols and approving exemptions. -
News Briefs
Study says schools often stray from set guidelines; Bioterrorism funding up, clinical relevance goal.