HRPP Manual Section 9-7
Withdrawal of Subject
The ethical principles guiding research with human subjects typically require that that no subject participates in research unless their individual participation is voluntary, based upon a full disclosure of the procedures, and their continued right to withdraw at any time.
An important caveat to the right to withdraw however is the distinction between withdrawing from further participation and withdrawing consent to use data that have already been obtained about a subject for research. That data collected from a subject up to the point of withdrawal may remain part of the study database (e.g. FDA regulated research, data subject to HIPAA). Unlike the right to withdraw completely from further participation, the right to have one’s existing data withdrawn from the research may not be feasible. Data collected from a subject up to the point of withdrawal may have to remain part of the study database (e.g. FDA regulated research, data subject to HIPAA), may not be able to be separated, or retention of such data may have been a condition of participation in the consent. The consent process should make clear what a subject’s right is in this regard.
FDA law and regulations require maintenance of complete clinical study data. This includes information on subjects who withdraw from a clinical investigation, whether the subject decides to discontinue participation in the clinical trial (21 CFR 50.25(a)(8)) or is discontinued by the investigator because the subject no longer qualifies for the research.
Depending on the nature of the study, a research subject may have more than one withdrawal option. If the intervention is a one-time interaction and the subject wishes to discontinue their participation, that request should be honored immediately and completely by the investigator. However, when a subject in a longitudinal study wishes to discontinue a specific component of the research, the investigator may ask the subject if they wish to allow follow up to continue and/or be in future data collection. As an example, a subject in a clinical trial of an experimental drug may decide they no longer want to take the experimental drug, but they would like to continue undergoing the other diagnostic study procedures and collection of information about their health status. Under this circumstance, the discussion with the subject would distinguish between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through a chart review and address the maintenance of privacy and confidentiality of subject’s information. Similarly, when a subject withdraws from the interventional portion of a clinical trial, an investigator may discuss having the subject provide continued follow-up information and/or provide further data subsequent to their withdrawal. This continued participation would generally be limited to clinical outcome information such as lab results, chart review, future medical care, and/or quality of life surveys. The aforementioned scenario may also be referred to as partial withdrawal. A consent form can be designed to incorporate the option for partial withdrawal and is recommended for long term studies. These options should be part of the consent process, especially for longitudinal studies. If such withdrawal options were not discussed in the initial consent document, the investigator must obtain the subjects’ separate and additional informed consent. The IRB must approve the consent document. See HRPP Manual 6-4 “Informed Consent.”
If a subject withdraws from the interventional portion of the study and does not consent to continued follow-up, the investigator must not access the subject’s medical record or other confidential records for research purposes. This is true even if there is valid HIPAA authorization (to access protected health information) in effect. However, an investigator may review study data related to the subject collected prior to the subject’s withdrawal from the study and may access public records to establish survival status etc.
If the study wishes to include the optional collection or use of biological specimens for future research, separate discussion and permission is necessary in the consent process. This should include an explanation of the process and conditions of withdrawal of consent to store and use these specimens for research. If identifiable specimens are stored, the subject can withdraw their consent to continue to use their specimen for research and ask that it be destroyed (or returned to the original lab in some cases). The investigator has the option of removing all identifiers from the sample and continuing to use it, but only if the subject is informed of this intent during the consent and authorization process.
Additional costs pertinent to withdrawal should be described in the informed consent.
References:
45 CFR 46.116 (5) (8), 21 CFR 50.25(c), Withdrawal of Subjects from Research: Data Retention and Other Related Issues: OHRP Guidance (2010), Guidance for Sponsors, Clinical Investigators, and IRBs, Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials (2008).
This policy and procedure supersedes those previously drafted.
Approved By: Vice President of Research and Graduate Studies, 7-19-2011. Revision 1 approved by Assistant VP Regulatory Affairs on 7-25-2016.
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