Research & Clinical Trial Consent

The Research & Clinical Trial Consent Form provides the comprehensive informed consent documentation required for human subjects research. It covers the essential elements mandated by the Common Rule (45 CFR 46), FDA regulations (21 CFR 50), and Institutional Review Board (IRB) requirements: study purpose and procedures, risks and benefits, alternatives, confidentiality protections, compensation details, and the right to withdraw.

The form uses a structured format that presents complex research information in an accessible way. The study description section explains the research question, what participation involves, the expected duration and number of visits, and any experimental procedures or interventions. Risks are presented with clear categorization by likelihood and severity, alongside potential benefits to the participant and to science.

Data use and privacy sections detail how participant data will be collected, stored, de-identified, and shared, including any biobanking or future use provisions. The voluntary participation section emphasizes that declining or withdrawing from the study will not affect the participant's standard medical care. This template can be customized for drug trials, device studies, observational research, and survey-based studies.