Description
The emergency use of test articles frequently prompts questions from Institutional Review Boards (IRBs) and investigators. This information sheet addresses three areas of concern: emergency Investigational New Drug (IND) requirements; IRB procedures; and informed consent requirements.
Scope & Applicability
Product Classes
2Products distributed in the United States subject to DSCSA
Category of products subject to emergency IND requirements
Stakeholders
2Individuals responsible for monitoring and reporting protocol deviations
Bodies responsible for evaluating trial risks and benefits for pregnant participants.; IRBs experienced in this population may advise on compensation.
Related CFR Sections (5)
- 21CFR50.24§ 50.24 Exception from informed consent requirements for emergency research.
(a) The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is Read full regulation →
- 21CFR50.23§ 50.23 Exception from general requirements.
(a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:Read full regulation →
- 21CFR56.104§ 56.104 Exemptions from IRB requirement.
The following categories of clinical investigations are exempt from the requirements of this part for IRB review:Read full regulation →
- 21CFR56.102§ 56.102 Definitions.
As used in this part:Read full regulation →
- 21CFR312.310§ 312.310 Individual patients, including for emergency use.
Under this section, FDA may permit an investigational drug to be used for the treatment of an individual patient by a licensed physician.Read full regulation →
See Also (8)
- Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards (Status: Draft)
- Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for Industry (Status: Draft)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c): Guidance for Sponsors, Investigators, and Institutional Review Boards (Status: Final)
- Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (Status: Final)
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff (Status: Final)