Emergency Research and Exception from Informed Consent
It is the policy of UTHealth that CPHS may approve an investigator to conduct research without requiring informed consent of all research subjects, if CPHS (with the concurrence of a licensed physician who is a member of or consultant to the CPHS and who is not otherwise participating in the clinical investigation) determines and documents each of the following:
- The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.
- Participation in the research holds out the prospect of direct benefit to the subjects because:
- Subjects are facing a life-threatening situation that necessitates intervention;
- Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects; and
- Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.
- The clinical investigation could not practicably be carried out without the exception to the informed consent requirements.
- An independent data monitoring committee will exercise oversight of the clinical investigation.
- For research not subject to FDA regulations, CPHS will find and document that the research was not subject to regulations codified by the FDA at 21 CFR 50 and that the criteria were applied in accordance with DHHS criteria.
Exception from informed consent is explicitly excluded when the research involves protected populations including pregnant women, fetuses or prisoners.
Family member: For purposes of this policy, family member means any one of the following legally competent persons: spouses; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the participant is the equivalent of a family relationship.
Investigator Responsibilities - The Investigator is responsible for providing all study documents, the community consultation plan, and any additional materials requested by CPHS for review and approval. The investigator is responsible for conducting community consultation and public disclosure of the proposed research. When the Investigator is unable to locate a legally authorized representative prior to enrolling a subject, the Investigator will attempt to contact, within the therapeutic window, a family member to ask whether he or she objects to the individual’s participation. A summary of efforts to contact the legally authorized representative and family members is made available to the IRB at the time of continuing review.
Investigator should provide scientific evidence for length of the potential therapeutic window; and then provide a plan to contact a legally authorized representative for each subject within that window of time. If feasible, the investigator should ask the legally authorized representative for consent. The investigator should summarize efforts made to contact legally authorized representatives and make this information available to CPHS at the time of continuing review, if applicable.
The investigator should provide an informed consent document and procedure for obtaining informed consent from the subject or legally authorized representative consistent with policy and procedure on Informed Consent. These procedures and the informed consent document are to be used where feasible.
If a subject dies before a legally authorized representative can be contacted, information about participation in the research study should still be provided to the legally authorized representative.
Community Consultation: For research involving emergency exception from informed consent, CPHS requires that the investigator conduct community consultations that include:
- Consultation with representatives of the communities in which the research study will be conducted and from which the subjects will be drawn;
- Public disclosure to the communities in which the research study will be conducted and from which the subjects will be drawn, prior to initiation of the research study, of plans for the investigation and its risks and expected benefits; and
- Public disclosure of sufficient information following completion of the research study to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results.
CPHS Responsibilities: ORSC Staff will determine the investigational new drug (IND) or investigational device exemption (IDE) application allows inclusion of subjects who are unable to consent. ORSC Staff will schedule research proposals requesting for emergency exception from informed consent requirements for review at a full board meeting. ORSC Staff will ensure that research proposals with the inclusion of subjects who are unable to consent have been submitted in a separate IND/IDE even if an IND/IDE for the same drug or device already exists.
CPHS will document that obtaining informed consent is not feasible because:
- The subjects will not be able to give their informed consent as a result of their medical condition;
- The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and
- There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.
CPHS will ensure that procedures are in place to inform, at the earliest opportunity, each subject or legally authorized representative, that the subject was enrolled in a research study. The investigator should discuss the informed consent document with the subject or legally authorized representative.
CPHS will also ensure that there is a procedure to inform the subject or legally authorized representative that participation may be discontinued at any time without penalty or loss of benefits to which the subject is otherwise entitled. CPHS will ensure that procedures are in place to inform the subject, or if the subject remains incapacitated, a legally authorized representative, or if such a representative was not reasonably available, a family member, that he or she might discontinue the subject’s participation at any time without penalty or loss of benefits to which the subject was otherwise entitled.
In addition to the criteria for approval in policy and procedure on initial review, CPHS will review and approve the community consultation plan provided by the investigator. Following completion of the consultation as per the proposed plan, based on the response from these consultations, CPHS will make a determination whether the study can be approved or if additional consultations are needed.
If CPHS determines that it cannot approve a research study because it does not meet the criteria for exception from informed consent requirements for emergency research or because of other relevant ethical concerns, CPHS shall provide these findings promptly in writing to the investigator. CPHS will require the investigator to notify the sponsor to disclose this information to:
- Other investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation of the sponsor,
- Other IRB's that have been, or are, asked to review this or a substantially equivalent investigation by that sponsor.
- When research is not subject to FDA regulations, but follows DHHS regulations, the IRB finds, documents, and reports to DHHS that the conditions of this policy have been met relative to the research.
The IRB will instruct investigators to provide the sponsor with a copy of the information that has been publicly disclosed if they haven’t already done so.
If another IRB reviewing this or a substantially equivalent investigation by the sponsor determine that it cannot approve a clinical investigation because the investigation does not meet the criteria for exception from informed consent requirements for emergency research or because of other ethical concerns, the sponsor must notify CPHS.
1. 21 CFR 50.24
2. 45 CFR 46.116(f)
3. Waiver of Informed Consent Requirements in Certain Emergency Research (Federal Register, Vol. 61, No. 192, pp 51531-51533, Oct 2, 1996)
REFERENCES TO OTHER SOP
1. Initial Review
2. Informed Consent
If you find errors in this document, contact email@example.com
Exemption from Informed Consent Requirements for Planned Emergency Research
Executive Director, Research Compliance
1 Aug 2008
1 Aug 2011, 1 Jun 2016, 1 Jul 2019
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
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