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IV.05 |
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Exception from Informed Consent Requirements for Emergency Research |
PURPOSE
1. The purpose of this policy and procedure is to describe the process for review and approval of emergency research involving exception from informed consent requirements.
SCOPE
2. This policy and procedure is applicable to investigators, CPHS members and ORSC Staff.
DEFINITIONS
3. 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.
POLICY
4. 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:
4.1. 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.
4.2. Participation in the research holds out the prospect of direct benefit to the subjects because:
a. Subjects are facing a life-threatening situation that necessitates intervention;
b. 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
c. 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.
4.3. The clinical investigation could not practicably be carried out without the exception to the informed consent requirements.
4.4. An independent data monitoring committee will exercise oversight of the clinical investigation.
4.5. 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.
5. Informed Consent – CPHS shall document that obtaining informed consent is not feasible because:
6.1. 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.
6.2. Even when an emergency exception for informed consent is granted, 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.
6.3. CPHS shall 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.
6.4. CPHS shall 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 shall 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.
6.5. 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.
7. Community Consultation: For research involving emergency exception from informed consent, CPHS requires community consultations that include:
7.1. The exception from informed consent is explicitly excluded when the research involves protected populations including pregnant women, fetuses or prisoners.
PROCEDURE
8. 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.
9. In addition to the criteria for approval in policy and procedure on initial review, CPHS shall 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.
10. 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:
10.2. 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.
RESPONSIBILITY
11. 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.
12. CPHS Responsibilities – In addition to the criteria for approval, CPHS will shall verify and document that regulatory conditions outlined in this policy for exception from informed consent are met.
13. ORSC Staff Responsibilities – ORSC Staff will conduct a pre-screening of the proposal and ensure that the investigator has submitted all required documents. ORSC Staff will also ensure that the IND/IDE for the protocol allows emergency exception from informed consent.
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Applicable Regulations and Guidelines 1. 21 CFR 50.24 |
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Updated 2/2009, Report
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