- OHRP Releases Final Guidance Document on Withdrawal of Subjects from Research
- September 28, 2010 | Author: Juliet M. McBride
- Law Firm: King & Spalding LLP - Houston Office
On September 21, 2010, the Department of Health and Human Services Office for Human Research Protections (OHRP) released its formal guidance document related to subject withdrawal from non-exempt human subjects research conducted or supported by HHS entitled, “Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues.”
The guidance clarifies that when a subject withdraws from an ongoing research study, either voluntarily or when an investigator terminates the subject’s participation, “the investigator may retain and analyze already collected data relating to that subject, even if that data includes identifiable private information about the subject.” The guidance also covers what the withdrawal of a subject from research means, whether subject withdrawal should be documented, and the relationship of the final guidance to FDA’s guidance on this issue and to the HIPPA Privacy Rule, among other things.
The final guidance revises the draft guidance issued by OHRP on December 1, 2008 (73 Fed. Reg. 72804) by removing all content related to biospecimens making the final guidance more in line with the FDA’s corresponding guidance entitled, “Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials,” emphasizing the applicability of the guidance to social and behavioral research activities in addition to biomedical research, and including a recommendation that investigators prepare for the possibility that subjects will withdraw from research. OHRP advises that individuals with questions related to biospecimens obtained from subjects who later withdraw should contact OHRP.
Primarily intended for institutional review boards, investigators, and funding agencies, OHRP states that the guidance should be viewed as recommendations unless specific regulatory requirements are cited.