ELEMENT I.7.C.

ELEMENT I.7.C.: The organization has and follows written policies and procedures for compliance with legal and regulatory requirements governing emergency use of an investigational or unlicensed test article.

This Element applies only to organizations that use investigational or unlicensed test articles in emergency situations, and the use constitutes research and is regulated. The Element also applies to independent IRBs or ECs that review research involving the emergency use of test articles.

Under the U.S. FDA regulations, the use of an investigational test article in an emergency situation is usually exempt from prior IRB or EC review. This exemption is used in a life-threatening situation in which no standard acceptable treatment is available and in which there is insufficient time to obtain IRB or EC approval.

Even without IRB or EC review, the consent of the participant or the participant’s legally authorized representative should be obtained in order to use the investigational article. There are situations in which an exception can be made to the requirement to obtain consent.

An organization should allow researchers to notify the organization in advance of an emergency use to obtain guidance. The organization should review these notifications to determine whether the circumstances will follow regulatory or legal requirements for the emergency use of

a test article.

The IRB or EC should be notified of all emergency uses within five days of the use and notified in writing of all exceptions to the requirement for consent within five days of the exception. IRBs or ECs should review these reports to determine whether the circumstances follow regulatory requirements for the emergency use of a test article, and whether consent was obtained in accordance with regulations or the circumstances met the exception to the requirement for consent.

The organization should monitor the emergency use of test articles to ensure that continued use does not occur, which constitutes research.

Regulatory and guidance references

FDA: 21 CFR 50.23, 21 CFR 50.24, 21 CFR 50.25(d), 21 CFR 56.102(d), 21 CFR 56.104(c), FDA Information Sheets: Frequently Asked Questions: IRB Procedures, FDA Information Sheets: Emergency Use of an Investigation Drug or Biologic, Emergency Use of Unapproved Medical Devices
VA: VHA Directive 1200.05(3) Section 3; VHA Directive 1200.01(1)

Required written materials

Essential requirements:
1. In order to use a test article in an emergency situation, policies and procedures describe the criteria that permit the emergency use of a test article.
  1. Policies and procedures indicate consent will be obtained in accordance with regulations or laws or meet the requirements for an exception to obtain consent.
  2. Policies and procedures describe the role of the IRB or EC as appropriate.
When following DHHS regulations:
1. Policies and procedures state that patients receiving a test article in an emergency use as defined by FDA regulations may not be considered to be a research participant.
2. DHHS regulations do not permit data obtained from patients to be classified as human participants research, nor permit the outcome of such care to be included in any report of a research activity subject to DHHS regulations.
When following FDA regulations:
1. In order to use a test article in a life-threatening situation without prior IRB or EC review, policies and procedures include the following criteria:
  1. The participant is in a life-threatening or severely debilitating situation.
  2. No standard acceptable treatment is available.
  3. There is not sufficient time to obtain IRB or EC approval.
  4. The use is reported to the IRB or EC within five working days.
  5. Any subsequent use of the test article is subject to IRB or EC review.
    1. Policies and procedures indicate consent will be obtained in accordance with FDA regulations, or the circumstances meet the exception to the requirement for consent in FDA regulations.
    2. Policies and procedures state that under FDA regulations, the emergency use of a test article, other than a medical device, is a clinical investigation, the patient is a participant, and the FDA may require data from an emergency use to be reported in a marketing application.
When following VA requirements:
1. Any emergency use of a test article does not require R&D Committee approval or oversight but is VA research.

Common types of materials that may be used to meet the element

Policies and procedures

Outcomes

Emergency uses of investigational or unlicensed test articles follow regulations or laws.

Proceed To: STANDARD I-8

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.7.C.