IRB Wish List: What New PIs Should Know Before Their First IRB Submission

This month's Feature Article presents a practical wish list from the BMC/BUMC IRB staff: the foundational knowledge, habits, and resources that, if understood at the outset, would meaningfully improve the quality and efficiency of IRB submissions from Principal Investigators new to research or new to the institution. Topics include identifying the correct level of review, harmonizing application materials, operationalizing recruitment and consent, and making the most of key institutional resources.

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THINGS TO KNOW

  • NEW/REVISED HRPP Policies and Procedures

GETTING TO KNOW ClinicalTrials.gov

  • NIH has Refined the Definition of an ‘Intervention’

SPOTLIGHT ON SOPs

  • Research Training

DEAR IRB

Question(s):

  • Q. I am co-investigator and site PI of a newly funded grant that involves specimens and data from deceased individuals. The responsibilities of the BUMC team are statistical analysis of data and manuscript-writing.  

    1. Based on the helpful definition of human subjects research you have provided on your website, I have concluded that this study does not meet that definition. So seeking IRB approval is not needed.  Is this correct?
    2. Data will be collected outside of BU at external institutions, so I assume we should proceed with a DUA. Do you agree?

THE CRRO CORNER

  • Consistency Matters: Avoiding a Common IRB Submission Pitfall