Subject Withdrawal from Research

If a research subject notifies the study team that they wish to withdraw from the study, the study team must then stop all research activities involving the subject, including:

• Interacting or intervening with the subject: Stop any activities like giving an experimental drug, performing a tissue biopsy, or drawing blood.
• Obtaining or accessing additional identifiable private information: Stop collecting or receiving any new identifiable information about the subject from sources like medical or other confidential records for study-related purposes. However, you can review the data already collected before the withdrawal and check public records, such as those confirming survival status.
• Collecting additional identifiable private information by observation: Stop any further observation or recording of the subject's private behavior without their interaction or intervention.

Sometimes, a subject may want to stop the primary intervention part of the study but still agrees to take part in some clinical outcome research activities. These limited participation activities should be clearly explained in the IRB-approved protocol and the consent form they signed before joining the study. If follow-up procedures are not clearly listed in the consent form, you may need to get additional informed consent.

Here are examples of activities that can continue with limited participation:

• Collecting data through interaction: This includes follow-up interviews, physical exams, blood tests, scans, or radiographic imaging.
• Collecting identifiable private information: This involves gathering information from the subject's medical records or from their healthcare providers.

As the PI or a member of the study team, you need to make sure that the subject's withdrawal is documented accurately and promptly in the electronic medical record.

Here’s what you need to do:

• Record whether the subject chose to withdraw or if the investigator made the decision and include the reasons if known.
• Note if the withdrawal is from the entire study or just the main part.
• Document any required follow-up as per the protocol and ensure all follow-up activities are completed.
• Make sure your documentation is complete, accurate, and includes all relevant dates, especially the date the subject withdrew.
• If your study requires ongoing review, inform the IRB about the subject's withdrawal during the next review.

According to OHRP guidance, you can keep and analyze the data already collected from a subject who withdraws or is terminated, even if it includes identifiable private information. This is allowed if the analysis is within the scope of the IRB-approved protocol. You don't need the subject's consent to do this.

In an FDA-regulated clinical trial, if a subject withdraws from the study, the data collected about them up to that point will stay in the study database and cannot be removed. This process follows the FDA's guidelines on data retention for clinical trials.

For research that is not regulated and reviewed by the FDA, you can choose to honor a subject's request to exclude their data from any analysis. For instance, if you are studying social networks in a community and a subject asks you to omit their data, you may agree to do so.

OHRP: Withdrawal of Subjects from Research Guidance

FDA Guidance: Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials