Description
The Institutional Review Board (IRB) should determine that the risks to subjects are reasonable in relation to anticipated benefits [21 CFR 56.111(a)(2)] and that the consent document contains an adequate description of the study procedures [21 CFR 50.25(a)(1)] as well as the risks [21 CFR 50.25(a)(2)] and benefits [21 CFR 50.25(a)(3)].
Scope & Applicability
Product Classes
3Medical devices intended for human use; Approved or cleared medical devices
Clinical investigations of drugs, including human drugs and biological products
Products for which batch/lot information is particularly important
Stakeholders
3Payment and Reimbursement to Research Subjects
Individuals responsible for monitoring and reporting protocol deviations
Governs top dose in clinical studies
Related CFR Sections (3)
- 21CFR50.20§ 50.20 General requirements for informed consent.
Except as provided in §§ 50.22 , 50.23 , and 50.24 , no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An invesRead full regulation →
- 21CFR50.25§ 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →
- 21CFR56.111§ 56.111 Criteria for IRB approval of research.
(a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →
Related Warning Letters (4)
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2023-06-06
Investigational Device Exemptions (Clinical Investigator)
Mobeen Mazhar, M.D.
See Also (8)
- Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry (Status: Final)
- Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry (Status: Draft)
- Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for Industry (Status: Final)
- CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals (Status: Draft)
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry (Status: Final)
- IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry (Status: Draft)