by Cami Gearhart

Letter from the CEO: Reforming Rules Around Collection, Storage & Use of Research Data

Institutional Bulletin vol 4,  issue 2

Every day seems to bring additional evidence of the need to reform the rules governing IRB review of data repositories. Earlier this month, for example, I attended a panel discussion about PCORNet, a collaboration founded to pursue certain objectives of the Affordable Care Act. The ACA authorized creation of the “Patient-Centered Outcomes Research Institute” (PCORI) to conduct comparative effectiveness research, and PCORI has formed PCORNet to develop national networks of clinical treatment data. Some of the speakers discussed a vision of national-level repositories of electronic clinical treatment data that can be mined for research purposes, but opined this simply “cannot be done” under current IRB and privacy rules.

I think we all can agree that an overhaul of the rules surrounding the collection, storage and use of data is overdue. A PRIM&R workgroup called for reform in 2007, saying “certain provisions of the existing regulations pose significant barriers to research using human specimens and data while offering little additional protection for the individuals from whom the specimens were obtained.”[1] SACHRP echoed the call in 2011[2]. Many of us are anxiously awaiting the agencies’ next steps after the 2011 ANPRM[3] solicited feedback about regulatory revisions affecting repository research.

Without agency action, IRBs are left to struggle through the existing crazy quilt of regulatory provisions and guidance. To help support you and your ethics board, Quorum recently presented a webinar on IRB review of biorepositories that you can find on our website under Learning Resources. One of the enclosed articles looks at the recent HIPAA/HITECH Omnibus Final Rule regarding the “future use” of data; the other article focuses on trends in FDA Warning Letters.

Please contact us if we can be of further assistance. We look forward to an opportunity to work with you!


Cami Gearhart, CEO
Quorum Review IRB


[1] Report of the Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Banking Working Group (March, 2007) at p.1(a)

[2] Attachment A to January 24, 2011 SACHRP Letter to the Secretary

[3] 76 Fed Reg 44512 (July 26, 2011)

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