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The question remains: Is full-panel review necessary?
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IRB members who are confused about whether research containing an oral history is subject to IRB review are not alone. The Office for Human Research Protections (OHRP) has written two letters on the matter, leaving some room for contradictory interpretation until guidelines are issued, possibly this year.
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Small colleges and undergraduate departments at universities are finding it increasingly important to formalize their human subject protection programs while making certain IRBs are reviewing what they should and not filling agendas with a lot of unnecessary reviews, several experts say.
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Human subjects training is typically a part of human subjects protections programs. Such training has taken the form of in-house seminars given at regular intervals and web-based activities. Regardless of the form, the objectives are simple: Give those involved in human subject research ethics and regulatory information that will promote beneficence and compliance with regulations.
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A 1999 National Institutes of Health-sponsored project to evaluate the results of a drug-testing program in Oregon public high schools was ultimately suspended after the federal Office for Human Research Protections (OHRP) decided that the goals of the research protocol appeared to have become intertwined with the drug-testing policy it was intended to study.
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Its a rare occurrence, but each year some institutions are subjected to a for-cause audit by the Office for Human Research Protections (OHRP). Such audits often turn up documentation problems and review process problems with the IRB, but occasionally they also highlight very serious problems relating to the clinical trials management, such as failure to provide adequate informed consent or failure to seek an IRB review, according to OHRP officials.
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Human subjects research protection experts agree that IRBs are overburdened and that something should be done to improve the regulations and rules governing their work. However, there is less agreement on how this could be accomplished. IRB Advisor asked IRB and research professionals to discuss how IRB regulations or the interpretation of them might be improved.
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For the University of Pennsylvania School of Medicine in Philadelphia, there was no question that the only acceptable solution to the problems in human subjects research was to establish a comprehensive program that included all areas, including investigators, IRBs, and the institutions leadership.
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IRBs need to be aware that the tools and data collection techniques used in socio-behavioral research may appear riskier than they actually are, and the public benefits may be greater; therefore, its a good idea to refrain from categorically rejecting research that involves unknown factors, suggests John Laub, PhD, a professor of criminology and criminal justice at the University of Maryland in College Park.
