Fordham University            The Jesuit University of New York
 


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IRB Challenges










Challenges of IRB Review


IRB Decision-Making Autonomy: Federal guidelines grant the IRB autonomy in the interpretation of regulations. Thus each IRB must apply its own discretion when deciding how a research proposal will be judged to meet the ethical criteria listed above. And, in the case of informed consent, 45 CFR 46 allows the IRB to waive this requirement under a variety of circumstances. This means that each IRB must independently determine the nature of research risks and research benefits, the extent to which risks to subjects are "reasonable" in relation to anticipated benefits, when research risks and benefits justify modification in the informed consent requirement, and what constitutes equitable subject selection.

Tension Among Stakeholders: There is a natural tension among the various stakeholders in the research enterprise. IRB members want to insure that federal standards are met, and that research under their auspices protects participant autonomy and provides participants with maximum benefits and minimal risk. Investigators who share these ethical goals, are also concerned that IRB's will impose impractical demands that will impede the researcher's ability to meet standards of good scientific practice, and in some cases threaten their economic livelihood. Institutional administrators want their IRB's to adhere to federal guidelines and minimize the institution's legal liability without unduly creating barriers to the receipt of public and private grant monies. Prospective research participants may believe that IRB approval is simply a rubber stamp for the research activities of members of the academy and have very different views on what constitute research risks and benefits. And, community leaders may see a "reasonable" risk-benefit balance as one that ensures that dissemination of research results leads to positive policies directed toward their institutions and neighborhoods and does not stigmatize community members.

IRB Credibility: The success of an IRB lies in its credibility both within the institution and the surrounding community. Such credibility depends upon the competence and actions of IRB members, the degree of cooperation between the investigator and the IRB, the importance granted the IRB by the institutional administration, and the extent to which IRB decisions reflect sensitivity to participant and community perspectives.


References:

DHHS (Effective August 1991). Code of Federal Regulations Title 45 Part 46-Protection of Human Subjects (45 CFR 46).

Greenwald, R. A., Ryan, M. K., & Mulvihill, J. E. (Eds.) (1982). Human subjects research: A handbook for institutional review boards. New York: Plenum Press.

Seiber, J. E. (1992). Planning ethically responsible research: A guide for students and internal review boards. Newbury Park, CA: Sage Publications.


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