Clinical Trial Informed Consent & Agreement
Consent document for participation in a clinical research trial, compliant with FDA regulations and the Common Rule (45 CFR 46).
Instructions
Include all eight required elements under 45 CFR 46.116: purpose of research, expected duration, procedures, foreseeable risks, benefits, alternative treatments, confidentiality protections, and contact information. Explain that participation is voluntary and may be withdrawn at any time without penalty. The document must be approved by an Institutional Review Board (IRB). Provide a copy to the participant.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.