Informed consent is one of the most important protections a research participant has. It is the process by which a study team explains, in plain language, what a trial involves — and by which a participant confirms, freely and without pressure, that they understand and choose to take part.
Consent is a process, not a form
Signing the consent document is only one moment in a much longer conversation. Before you enroll, a member of the research team should walk you through the purpose of the study, what will happen at each visit, the expected duration, any known risks and potential benefits, alternative options, how your information will be protected, and how you will be compensated for your time.
What the consent document should cover
- The study's purpose and what researchers hope to learn.
- Procedures involved, including which are experimental.
- Reasonably foreseeable risks and discomforts.
- Potential benefits — both to you and to future patients.
- Alternatives to participating.
- How your privacy and health information will be protected.
- Compensation, if any, and who to contact with questions.
- Your right to withdraw at any point, without affecting your regular medical care.
The right to ask questions
A good research team welcomes questions and takes the time to answer them. If something in the consent document is unclear, ask. If a term is unfamiliar, ask. Consider bringing the document home to review with family or your personal physician before deciding.
Withdrawal at any time
Participation in research is always voluntary. You may withdraw at any point, for any reason, and you do not owe an explanation. Withdrawing will not affect your access to standard medical care.
Oversight that protects you
Independent Institutional Review Boards — often called IRBs — review every research protocol before enrollment begins, and continue to monitor studies while they are active. Their role is to ensure that participant rights and welfare are protected.
Informed consent works best when it is treated as an ongoing dialogue. You should feel comfortable raising concerns throughout the study — not just at enrollment.
