New scientific review requirement for some clinical research studies

Concerns have been raised that some human subject scientific protocols that do not receive external peer review have limitations that slow their progress through the IRB.  As the IRB is charged with protecting human subjects, rather than as a scientific review committee, this lack of review slows the process and adds work for researchers and regulators alike.  And this problem is not just local, but nationwide.  In response to several recent examples here at OHSU, the Senior Vice President for Research has committed to addressing this problem by convening a new scientific review committee under the auspices of the Oregon Clinical and Translational Research Institute.  

Beginning October 1, 2016, if your full board human subjects protocol was not otherwise externally peer-reviewed–including unfunded studies and studies conducted under some career development grants–they will be required to undergo internal scientific review by the new OHSU Clinical Research Scientific Review Committee. This committee will review full board human subject protocols prior to IRB review. It is chaired by Mary Samuels, M.D., professor in the Division of Endocrinology in the School of Medicine and director of the Clinical and Translational Research Center. The goal of this review is to improve quality without delaying approval, and committee will work hard to satisfy this goal. Protocols for FDA-regulated studies, NIH-funded research grants, and studies receiving scientific review through other means, such as the Knight Cancer Institute Clinical Research Review Committee, will not require additional review. 

Protocols meeting the criteria to require committee review will be automatically triaged upon submission to the IRB in the eIRB system, so you do not need to submit anything separately. The committee will let you know through the eIRB system of the result of the review.

Serendipitously, at the same time, OCTRI has been invited to participate in a nationwide trial of prior scientific review of scientific protocols to determine whether this could improve overall turnaround time and ease of processing. It is hoped that the data derived from this trial will inform NIH policies in the future. 

OHSU is also soliciting applications for investigators to join the committee as reviewers; please contact Dr. Samuels (samuelsm@ohsu.edu) or Darlene Kitterman (kitterma@ohsu.edu) if you are interested or have further questions.

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Comments

  1. I don’t quite understand.

    If I’m reading this right, there will be a new scientific review screening of protocols going through the IRB, with hopes of speeding up the process and relieving some of that work from staff only charged with protecting human subjects?

    Also, I don’t understand the second paragraph regarding “…if your protocol was not otherwise externally peer-reviewed…they will be required to undergo internal scientific review by the new committee”.

  2. Let’s see if this helps. If you are writing a protocol that requires IRB review and you are not having any scientific review of it prior to submitting the protocol, then your protocol will get a scientific review before it goes to the IRB. This could apply to, for example, some kinds of student projects, projects that are funded out of department sources (rather than grant-funded projects), and so on. It wouldn’t apply if your protocols are funded with NIH grants, because your project would be getting a scientific review as part of the grant process. Does that make sense?

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