AAHRPP Submits Comments on the Advance Notice

In response to the Advance Notice of Proposed Rulemaking entitled, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators”, AAHRPP has submitted extensive comments for consideration. Before addressing specific provisions, AAHRPP would like to emphasize what we consider the three overriding issues:

• Protection is paramount. AAHRPP appreciates and, even, agrees that the regulations should be amended to reduce the burdens on IRBs, researchers, organizations, sponsors, and others throughout the research enterprise. However, the first consideration, always, must be the protection of research participants.
• Oversight should vary depending on the potential risk of the research. One reason the current system is overly burdensome is that studies often receive the same level of review, regardless of the potential risk to participants. In some cases, low-risk studies are over-scrutinized; in others, high-risk studies do not receive enough attention.
• Harmonization is critical. Conflicting regulations have long been a source of confusion. The ANPRM presents an opportunity to harmonize the regulations for all Common Rule agencies, increasing the likelihood that IRBs would comprehend and comply with the requirements. This, in turn, would result in improved protections.

On the remaining pages, AAHRPP provides more detailed comments and recommendations on the following:

I. Need for OHRP to Request Additional Information 

II. Purpose of the ANPRM

III. Scope of the ANPRM

IV. Proposed Excused Category of Research 

V. Harmonization

VI. Reduction of Burden

VII. Requirement for Single IRB Review

VIII. Need for Education Requirement

IX. Need for Delineation of Researcher and Research Staff Responsibilities

X. Other Issues

To read the comments in their entirety, please click here.

AAHRPP encourages everyone to comment, and as a reminder comments must be received by October 26, 2011.