The Office for Human Research Protections in the Department of Health and Human Services has issued guidance governing data retention and other issues when a patient withdraws from a research study.
The guidance addresses six topics, most importantly whether an investigator can keep and use already collected data. The answer, from HHS, is that the data remains available. "The guidance document clarifies that when a subject chooses to withdraw from (i.e., discontinue his or her participation in) an ongoing research study, or when an investigator terminates a subject's participation in such a research study without regard to the subject's consent, 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The guidance comes nearly two years after HHS issued draft guidance and accepted public comment. The final guidance has several changes. For instance, all content regarding biospecimens in the draft guidance was removed to be more harmonious with U.S. Food and Drug Administration guidance that is silent on issues related to biospecimens.
The complete new guidance from the Office for Human Research Protections is available here.
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