Define what you want to stop
Tell the study team whether you want to stop the investigational intervention, all in-person procedures, questionnaires, record access, future contact, optional follow-up, or every activity you can withdraw from. These choices may have different safety and data consequences.
The investigator can also end participation for safety, protocol, enrollment, or other reasons described in consent. Ask for the reason and the transition plan.
Discuss safety before ending contact
Ask whether stopping a study drug, device, diet, procedure series, or behavioral program requires tapering, observation, final testing, device removal, or transition to regular care. Involve your clinician when the change affects treatment.
A follow-up visit may protect safety even after you stop the intervention. Ask which parts are recommended for safety and which remain optional research. For an urgent problem, use the after-hours or emergency instructions.
Notify the right people in writing
Contact the coordinator or investigator through the verified channel. State the study identifier, date, and scope of withdrawal. Ask for written confirmation, return instructions, safety guidance, and the final payment schedule.
If you cannot reach the team or feel pressured, contact the participant-rights or IRB contact in the consent form. Keep records of calls and messages.
Ask what happens to data and specimens
For nonexempt research conducted or supported by HHS and covered by 45 CFR part 46, OHRP withdrawal guidance (opens in a new tab) explains that investigators may retain and analyze data already collected to preserve study integrity, while future interaction or collection may require continued agreement. Ask which rules govern the study and how it treats existing data, future record access, optional follow-up, and data required for safety reporting.
Ask whether stored specimens can be destroyed or withdrawn from future use. Samples already distributed, analyzed, or de-identified may be impossible to retrieve. Ask for the specific limit.
Return products and close access
Follow written instructions for returning investigational products, devices, chargers, diaries, badges, or shipping materials. Do not discard an investigational product unless instructed. Confirm whether apps should be deleted, accounts closed, permissions revoked, or devices reset.
Remove study appointments from shared calendars after preserving needed records. Keep consent and contact information for future safety questions.
Reconcile accrued payment and expenses
List completed screening, visits, calls, diaries, confinement, travel, and approved expenses. Ask which amounts accrued, when payment is issued, and how a completion incentive is handled. For FDA-regulated research, FDA guidance supports prorating compensation for completed participation rather than withholding the full amount until study completion.
Submit receipts within the stated deadline and keep copies. Use the IRB or rights contact if the payment practice conflicts with the consent terms or appears to pressure continued participation.
Sources for this guide
Official guidance controls regulatory claims. Peer-reviewed research is identified when participant experience requires evidence beyond agency guidance. Links were checked September 5, 2026.
- U.S. Food and Drug Administration. Clinical Trial Participation (opens in a new tab).
- Office for Human Research Protections. Guidance on Withdrawal of Subjects from Research (opens in a new tab).
- Office for Human Research Protections. Informed Consent FAQs (opens in a new tab).
- U.S. Department of Health and Human Services. HIPAA Privacy Rule and Research (opens in a new tab).
- Secretary’s Advisory Committee on Human Research Protections (SACHRP), HHS. Addressing Ethical Concerns: Offers of Payment to Research Participants (opens in a new tab).