Waiver of Consent for Planned Emergency Research

Criteria for Approval

In accordance with 21 CFR 50.24 or 45 CFR 46.101 (i), the IRB may approve planned research in an emergency setting without the informed consent of the participants or their legally authorized representatives in a limited class of emergency situations when the following criteria are met and documented:

• Potential subjects are in a life-threatening situation, and
  • available treatments are unproven or unsatisfactory and
  • collection of scientific data is required to determine the safety and effectiveness of the experimental intervention
• Obtaining informed consent is not feasible because:
  • the potential subject is not able to consent due to his/her medical condition
  • the intervention must be administered before consent from the potential subject’s authorized representative is feasible and
  • there is no reasonable way to prospectively identify potential eligible subjects
• Participation in the research study holds out the prospect of direct benefit to the subjects because:
  • the subjects are facing a life-threatening situation
  • appropriate pre-clinical and prior clinical research studies support the potential for direct benefit and
  • the risks associated with the research are reasonable relative to the risks of the subjects’ condition and the risk/benefit ratio of standard therapy for the condition
• The research could not be practicably carried out without the waiver.

Submission Requirements

The IRB recognizes the loss of the research subject’s autonomy when this waiver is granted and requires the following additional measures to be addressed by the Principal Investigator in the research protocol. These requirements include:

• A defined therapeutic window, based on scientific evidence, of the maximum length of time for which the intervention(s) must be initiated.
• A commitment to contact or attempt to contact, within this “therapeutic window”, a legally authorized representative for each subject and, if feasible, to ask this representative for consent for the subject’s participation. These efforts must be summarized by the investigator for all subjects enrolled at the time of continuing review.
• In the event of the unavailability of a legally authorized representative of the subject, a description of what attempts will be made, if feasible, to contact a member of the subject’s family to determine whether s/he objects to the subject’s participation within this therapeutic window.
• An informed consent document inclusive of the basic and applicable additional elements along with an outline of procedures to address subject enrollment with direct consent, if applicable, or with consent of the subject’s authorized representative, if available.
• Procedures to inform, at the earliest feasible opportunity, the subject (i.e., if his/her condition improves), a legally authorized representative of the subject, or a family member of the subject if such a representative is not reasonably available, of the subject’s inclusion in research, the details of the research, and the right to discontinue the subject’s participation at any time without penalty or a loss of entitled benefits.
• Appropriate procedures and information to be used in providing an opportunity for a family member to object to a subject’s participation in the research.
• Procedures to provide information about the research to the subject’s legally authorized representative or family member should a subject enrolled into the study without consent die before such individuals can be contacted.
• An independent data monitoring committee to exercise oversight of the research. See guidance on data and safety monitoring plans or additional requirements related to data and safety monitoring committees/plans for additional requirements related to data and safety monitoring committees/plans.
• Prior specific IND or IDE approval from the FDA for research involving investigational or approved drugs or devices for which the IND/IDE submission clearly indicates that the protocol(s) may include subjects who are unable to consent.
• A plan for consultation with representatives of the community (communities) in which the research will be conducted and from which the subjects will be drawn. A summary of comments/concerns raised by the community must be presented to the IRB prior to final approval being granted.
• A plan, including draft copy, for public disclosure/notification of the research to the community (communities) in which the research will be conducted and from which the subjects will be drawn. This could include meetings with focus groups, church or community organizations, newspaper articles, etc.
• A summary of comments/concerns raised during public disclosure/notification must be presented to the IRB prior to final approval being granted.

Note that public disclosure following the completion of the study to apprise the community and researchers of the study results is also required.

A licensed physician “who is a member of, or consultant to, the IRB and who is not otherwise participating in the clinical investigation” must concur that the waiver of consent is allowable.  Review of the above requirements is documented in the minutes during review by the convened IRB.

Special Additional Considerations

Research involving certain protected populations, including fetuses, pregnant women, prisoners and human in vitro fertilization, are explicitly excluded from eligibility for this waiver. If the research study does not involve an article regulated by the FDA and the IRB determines that it can approve an exception to the requirement for informed consent for emergency research as per the criteria addressed under 45 CFR 46.101 (i) (i.e., OHRP’s “Emergency Consent Waiver”), the IRB shall notify the OHRP of such approval.

If the IRB determines that the protocol does not meet the criteria outlined in 45 CFR 46.101 (i) [OHRP’s “Emergency Research Consent Waiver” to 45 CFR 46] or if applicable, 21 CFR 50.24, or because of other relevant ethical concerns disapproves the research, the IRB must promptly provide a summary of its findings to both the clinical investigator and the sponsor of the trial. The IRB recognizes that it is the sponsors’ responsibility to notify the FDA of the IRBs’ findings.

Investigators involved in the development or implementation of such research studies, wherein an exception to the requirement to obtain informed consent is an anticipated necessity, are advised to engage the assistance of the HRP as early as possible in the protocol development process.

5/19/2021