OHRP: IRB Records, Part Two

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

In this Office for Human Research Protections (OHRP) video, all of the characters are fictional. This video provides information regarding the IRB records requirements described at 45 CFR part 46. The institution portrayed in the video hired a consultant to evaluate its human subjects protections program. The consultant made a number of observations and findings regarding the institution's compliance with the requirements of the regulations.

In this video a consultant, Ms. Williams, meets with Mr. Cash, the new Director of the institution's IRB office, to review in detail the deficiencies she observed and requirements related to the IRB meeting minutes and other IRB records.

OHRP Educational Videos-Additional Information

OHRP educational videos were developed by the OHRP Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46. The videos represent OHRP's current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.

More more information, please visit: http://www.hhs.gov/ohrp

From the U.S. Department of Health and Human Services (HHS) http://www.hhs.gov

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