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• Sometimes, a participant wants to withdraw from the primary interventional component of a study but is willing to continue other research activities described in the IRB-approved protocol and informed consent document that involve participation of the participant, such as the following:
  • Obtaining data about the participant through interaction with the participant (e.g., follow-up interviews, physical exams, blood tests, or radiographic imaging); or
  • Obtaining identifiable private information from the participant's medical, records or from the participant's healthcare providers.
  • When a participant'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 participant previously gave consent may continue.
• Continued participation in secondary components of a research study may be particularly important in clinical trials designed to evaluate the safety and effectiveness of specific interventions in the management of diseases or disorders. For this reason, the Office for Human Research Protections (OHRP) guidance on this topic recommends that when a participant decides to withdraw from a clinical trial, the investigator conducting the clinical trial should ask the participant to clarify whether they wish to withdraw from all components of the trial or only from the primary interventional component of the trial. If the latter, research activities involving other components of the clinical trial, such as follow-up data collection activities, for which the participant previously gave consent may continue.
• OHRP also recommends that the investigator explain to the participant who wishes to withdraw the importance of obtaining participant follow-up safety data.
• For example: Consider an IRB-approved clinical trial testing the safety and effectiveness of an experimental chemotherapy regimen in participants with lung cancer that involves the following sequential procedures for each participant:
  • Intervening with the participant by administering up to six monthly cycles of the experimental chemotherapy regimen.
  • Intervening with the participant by performing follow-up scans at intervals defined in the protocol.
  • Obtaining information about the participant's health status through interviews and physical examinations during the treatment phase and after completion of the investigational interval as defined in the protocol.
  • Analyzing data that includes identifiable private information about the participant to determine complete and partial response rates following the experimental chemotherapy.
    THEN
  • The participant tells the investigator that they want to withdraw from the study after the second monthly cycle of the experimental chemotherapy regimen because of unacceptable side effects.
  • The investigator may then ask the participant if they are willing to undergo the follow-up scans, interviews, and physical examinations that were described in the IRB-approved protocol and in the informed consent document signed by the participant.
  • If the participant agrees, these follow-up activities involving the participant may continue.

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