Research involving human subjects should be reviewed for ...
Select one of the following methods for independent peer review that applies to your IRB application.
Method 1
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MACROBUTTON HTMLDirect [pic] I. Funding organization (NIH, NSF, foundations), when the research protocol has been subjected to full peer review (eg, review by a study section or grant committee). The actual protocol (which describes in detail the involvement of human subjects) being submitted to the IRB must have been reviewed in its current form. Peer review of a grant that describes a clinical trial in general terms does not satisfy this criterion.
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(Note: industry-sponsored clinical trials designed by the sponsor with or without external consultants do not satisfy this criterion for independent peer-review.)
Name of organization performing the review: ______________________________________________
How was the review panel selected by the organization? (do not need to describe for NIH study sections or for AHC Seed or FRD grants; for others the simple description of the review process taken from the grant announcement will suffice) ______________________________________________________________
____________________________________________________________________________________
MACROBUTTON HTMLDirect [pic] II. UCSF scientific review committee:
MACROBUTTON HTMLDirect [pic] Cancer Center Protocol Review Committee
MACROBUTTON HTMLDirect [pic] Clinical Research Services (CRS) Scientific Advisory Committee (required for studies conducted in the Clinical Research Center)
Attach the letter from the university committee that states that scientific review has been performed.
Method 2
MACROBUTTON HTMLDirect [pic] I. A departmental or collegiate appropriately constituted peer review committee. An appropriate review committee has the following features:
▪ A minimum of two reviewers (three or more is preferred)
▪ Consensus regarding the scientific acceptability of the project (if there is not initial consensus, some group discussion regarding the project must take place)
▪ Documentation of the review process (dates, participants, method of review and discussion, decision).
▪ Student research projects may have students included on the review committee, if desired. Evaluations of student research projects can be done by the advisor. The review may also be done within the context of a course, provided that all the criteria below are considered.
Attach the signed form documenting that departmental or collegiate scientific peer review of the attached research protocol has been performed. Link to approval letter template here – Marlene, I don’t think I’ve seen a template for approval yet. Can you please provide?
Sign
I attest that the above information is correct and that, to the best of my knowledge, scientific review and approval of the attached research protocol has been performed by a group of independent peer reviewers
______________________________________________________________________
Principal Investigator Date
*Please Include this form as “Other Study Documents” with the IRB application in iMedRIS
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