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  • 1.  Full Board Review

    Posted 12 days ago

    When conducting a Full Board Review, what is the best way to give comments to the researcher, if needed?  Is it better to put all the findings in that section of the letter or put the comments into the relevant section in the actual submission?


    Leigh Schectman
    IRB Coordinator
    California Lutheran University

  • 2.  RE: Full Board Review

    Posted 11 days ago

    Hi Leigh,

    We do both.  Put the comments under the relevant section in the submission and in a letter.  That way the PI sees the letter with the comments and it's more formal than our exempt and expedited reviews.  Additionally, putting the comments under the section helps us to make sure we have each item corrected. PIs are notorious for missing items.  I hope this helps!

    Shannon Marquess
    Senior Research Compliance Coordinator
    University of Texas at San Antonio

  • 3.  RE: Full Board Review

    Posted 11 days ago
    Edited by Daniel Kirienko 11 days ago

    Hello Dr. Schectman,

    This is a good question. First, I would suggest checking the standard operating procedures and policies for your university. As outlined in 45 CFR46.108(a)(3)(1), "The IRB must establish and follow written procedures for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution (emphasis added)". So there should be a written practice for how your institution will carry this out.

    Additionally, there are regulations at 46 CFR46.109(d) that state, "An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing."

    So while there are clearly requirements of what needs to be communicated and that the method needs to be established and written down, the regulations do not stipulate how. That being said, best practices (in my mind at least) are to include it in any Decision Letter that you make. You can probably also include it in the IRB record itself, but the Decision Letter is the formal communication and written record that OHRP and/or the FDA will expect to find if there is any audit. In practice, we put them in the Decision Letter after the review and in the protocol during an administrative pre-review. We also often provide an email with the same information, just to make sure that we're maintaining good lines of communication, but your policies and practices may vary. 

    Daniel Kirienko
    Compliance Administrator II
    Rice University

  • 4.  RE: Full Board Review

    CAB Member
    Posted 11 days ago

    Hi Leigh,

    We usually add detailed comments to the relevant section of the actual submission (e.g., "Add the following language to the data confidentiality section of the consent form:  abc xyz...) and then provide a summary list in the letter (e.g., "Revisions to the data confidentiality section of the consent form").

    Hope that helps.


    Scott Fisher \
    Director, Human Research Protection Program
    New York University (NYU)