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AAU and APLU Submit Comments on NIH Draft Policy on Central IRBs

First and foremost, AAU and APLU applaud NIH’s effort to streamline regulations in order to improve efficiency without compromising the protection of human subjects. The administrative burden across the research enterprise has grown appreciably due to a significant increase in regulations and reporting obligations promulgated by Federal agencies and a lack of harmonization among those regulations. Policies and regulations related to human subjects protection are among the most frequently cited causes of the increased burden and cost associated with research, and certainly the inefficiencies caused by duplication of IRB review in multi-site trials is a substantial part of that.

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