On September 21, the HHS Office for Human Research Protections (OHRP) published guidance on the withdrawal of subjects from human research. This guidance clarified 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. FDA published similar guidance in 2008 stating that when a subject withdraws from a study, the data collected on the subject up to the point of withdrawal remains part of the study database and may not be removed. Further, if a subject withdraws from the interventional portion of a study, but agrees to continued follow-up of associated clinical outcomes, the investigator must obtain the subject's informed consent for this limited participation. However, if the subject does not consent to follow-up, the investigator must not access the subject's medical record or other confidential information for purposes related to the study. FDA's guidance document explained that under applicable FDA law and regulations, data collected on human subjects enrolled in an FDA-regulated clinical trial up to the time of subject withdrawal must remain in the trial database in order for the study to be considered scientifically valid.
The recent OHRP guidance is consistent with the 2008 FDA guidance. Under the OHRP guidance, if a subject decides to withdraw from all components of a research study, the investigator must discontinue all research activities involving that subject's participation in the study. When a subject's withdrawal request is limited to discontinuation of the primary interventional component of a research study, research activities involving other types of participation for which the subject previously gave consent may continue. Likewise, if an investigator decides to terminate a subject's participation in a clinical trial without regard to the subject's consent, OHRP recommends that the investigator ask the subject whether the subject is willing to continue participation in other research activities described in the IRB-approved protocol and informed consent document, such as (1) obtaining data through interaction with the subject; or (2) obtaining identifiable private information from the subject's medical records or healthcare providers. If the subject agrees, research activities involving these types of participation may continue.
Under OHRP's guidance, investigators are permitted to retain and analyze already-collected data relating to any subject who chooses to withdraw from a research study or whose participation is terminated by an investigator without regard to the subject's consent, provided such analysis falls within the scope of the analysis described in the IRB-approved protocol. This is the case even if that data includes identifiable private information about the subject.
In summary, for HHS-conducted or supported research that is also regulated by FDA, compliance with FDA's requirements regarding data retention and subject withdrawal will not result in noncompliance with the provisions of HHS regulations for the protection of human subjects (found in 45 CFR Part 46). OHRP recommends that when seeking the informed consent of subjects, investigators should explain that for HHS-conducted or supported research that is also FDA-regulated, regardless of whether the research is subject to the HIPAA Privacy Rule, data collected about the subject up to the time of subject withdrawal will remain in the trial database and be included in the data analysis.