Clinical trial consent: questions to ask before deciding

Understand the purpose and your choices

Ask what researchers want to learn, which procedures are experimental, and what alternatives you have. Informed consent is a conversation as well as a document. Ask for explanations in language you understand and take time to consider the information.

Ask about the commitment

How many visits are planned, how long will they last, and what tests or procedures are involved? Ask about preparation, travel, and whom to contact if you cannot attend. Your schedule and questions matter when considering whether a study fits your circumstances.

Clarify risks, costs and compensation

Request the study-specific explanation of foreseeable risks, possible benefits, costs and any compensation. Ask what happens if an injury related to research occurs and how information will be protected. Benefits and payment are not guaranteed by contacting IHR.

Know how to ask for help or withdraw

Participation is voluntary. Ask who handles questions about the research and your rights, how to stop participating, and whether a final safety visit or other follow-up is recommended. Discuss medication or treatment changes with your treating clinician.

Start with a call to IHR

Call 305-927-5049 or email integratehealthresearch@gmail.com to ask about study availability and the next step. Do not send medical records through general email. An inquiry does not enroll you, and this guide does not replace a study consent form.

Sources and further reading

• FDA: Informed Consent
• NIH: Guiding Principles for Ethical Research