Protect voluntary choice
The FDA states that participation is voluntary and that participants may leave a study. Read the FDA participant fact sheet (opens in a new tab). Ask how declining or withdrawing affects clinical care, compensation already earned, return of study products, and recommended safety follow-up.
Take the time you need within the study’s enrollment window. Pressure, threats, punishment, or misleading claims have no place in informed consent. Payment can influence a decision; the consent process must still support clear evaluation of risks and demands.
Ask for information you can understand
Request plain-language explanations of the purpose, procedures, research design, risks, possible benefits, alternatives, costs, payment, privacy, injury process, contacts, and withdrawal. Ask for an interpreter or translated materials when needed. Ask for accessibility support before the visit.
Keep a copy of the signed consent and later revisions. When new information could affect your willingness to continue, ask how it changes risk, procedures, alternatives, or follow-up.
Know which contact solves which problem
| Contact | Use it for |
|---|---|
| Emergency services | Call local emergency services first for an emergency. Then follow the consent form’s study-notification instructions. |
| Study coordinator or research team | Scheduling, instructions, procedures, payment, routine questions, and reporting symptoms |
| Study doctor or after-hours clinical contact | Medical questions and non-emergency study-related symptoms under the study’s instructions |
| IRB, research ethics committee, or participant-rights contact | Rights, pressure, consent, unresolved complaints, privacy concerns, or questions you do not want to raise with the study team |
| Your clinician | How participation may affect your health, medications, alternatives, and ongoing care |
Understand what an IRB does
An institutional review board reviews research involving people under applicable rules. It evaluates issues such as risks, consent, subject selection, privacy, and safeguards. Approval does not guarantee that an intervention works, that no harm will occur, or that the study fits you.
The consent form should provide a participant-rights or IRB contact when required. A central IRB may review research conducted at many locations, so its name may differ from the hospital or clinic.
Document a concern before escalating it
Record dates, people, study identifiers, consent version, instructions, symptoms, missed contacts, payment entries, and the resolution you requested. Preserve messages and receipts. Describe observable facts before conclusions.
Start with the research team when safe and appropriate. Contact the IRB or institution’s human research protection office for rights concerns or unresolved issues. OHRP recommends (opens in a new tab) contacting the research team, reviewing IRB, and institution’s human research protection office before filing a federal complaint when the issue falls under OHRP oversight.
Recognize the limits of federal complaint paths
OHRP handles research within its jurisdiction under HHS regulations or an institution’s assurance. Other agencies oversee other research. Privacy, professional licensing, billing, fraud, and consumer complaints may use different channels. The OHRP complaint page lists alternatives.
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. About Research Participation (opens in a new tab).
- Office for Human Research Protections. Questions to Ask About Volunteering for a Research Study (opens in a new tab).
- Office for Human Research Protections. Informed Consent FAQs (opens in a new tab).
- Office for Human Research Protections. Submitting a Complaint About Research Involving Humans (opens in a new tab).
- National Institute on Aging. Clinical Research: Benefits, Risks, and Safety (opens in a new tab).