Treat consent as a conversation that continues
OHRP describes informed consent (opens in a new tab) as an active exchange of information that begins with the approach to a potential participant and can continue through the study. A signature documents a decision when documentation is required. It does not end the duty to answer questions or share new information that may affect willingness to continue.
Ask who will conduct the consent discussion, how much time is available, whether you can take the document home, how questions are answered later, and when re-consent may occur. For electronic consent, confirm how you move backward, save progress, obtain a copy, verify identity, and reach a person. Federal electronic-consent guidance (opens in a new tab) emphasizes time to consider and access to questions.
Read the key information before the details
Identify why the study is being done, why you are being asked, what will happen, how long participation lasts, the most important risks or discomforts, possible benefits, and available alternatives. Write one sentence for each. If you cannot explain the study to yourself, pause the signature and ask for clarification.
Compare the consent summary with the schedule of activities. A short description of “blood tests” may represent many draws across several time points. “Questionnaires” may include daily entries and long follow-up surveys.
Mark what happens because of research
Highlight investigational interventions, randomization, placebo or comparator use, washouts, extra tests, specimen collection, genetic analysis, imaging, recordings, devices, app permissions, home visits, and medical-record access. Ask which activities would happen in ordinary care and which exist only for research.
Build a visit-by-visit table. Include the expected duration, preparation, restrictions, amount of blood drawn when relevant, recovery or observation, transportation limits, and at-home work.
Separate risks, possible benefits, and alternatives
Read foreseeable risks by intervention and procedure. Ask about frequency when known, severity, reversibility, uncertainty, interaction with current care, reproductive risk, privacy risk, and what the team does to reduce each risk. Ask what remains unknown.
Possible benefit may be absent. Research is designed to create knowledge, and an experimental intervention may not help. Review alternatives to participation, including standard care, another study, supportive care, or no intervention when applicable. Discuss personal medical implications with your clinician.
Read costs, payment, and injury language line by line
Separate routine-care costs, research-paid procedures, insurance billing, travel reimbursement, compensation for time and burden, and completion incentives. Record when each amount accrues and when it is issued. Ask about payment after withdrawal or removal by the investigator.
Find the study-related injury section. Record whom to call, where urgent care should occur, which costs the sponsor or institution may cover, whether compensation is offered, and whether insurance may be billed. Do not interpret vague language on your own. Ask the study team and insurer for clarification before participation. Then use the injury, medical-cost, and insurance guide to build a service-by-service cost map.
Trace data and specimens beyond the visit
Identify who receives identifiable information: the site, sponsor, contract research organization, monitors, laboratories, technology vendors, regulators, or others described in the document. Ask how information is coded, how long it is kept, whether it crosses borders, and what happens after a breach.
For specimens, identify required and optional uses, future research, genetic or whole-genome analysis, commercial use, sharing with other researchers, recontact, return of individual findings, and destruction options. Ask what withdrawal can still change after data have entered an analysis or specimens have been shared.
Save three contacts and the withdrawal steps
Save the research-team contact for study questions, the participant-rights or IRB contact for rights concerns, and the medical or after-hours contact for symptoms and urgent study-related issues. Put them in your phone before the first study activity.
Read the voluntary-participation and withdrawal sections. Ask how to stop the intervention, whether safety follow-up is recommended, how to return drugs or devices, what data remain in the study, what happens to specimens, and how accrued payment is handled.
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.
- Office for Human Research Protections. Informed Consent FAQs (opens in a new tab).
- HHS Office for Human Research Protections and FDA. Use of Electronic Informed Consent: Questions and Answers (opens in a new tab).
- Office for Human Research Protections. Questions to Ask About Volunteering for a Research Study (opens in a new tab).
- U.S. Food and Drug Administration. Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors (opens in a new tab).
- U.S. Food and Drug Administration. Clinical Trial Participation (opens in a new tab).