Emergency Research and Exception from Informed Consent

POLICY

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:

Exception from informed consent is explicitly excluded when the research involves protected populations including pregnant women, fetuses or prisoners.

Key Terms:

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.

PROCEDURE

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:

 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:

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:

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.

APPLICABLE REGULATIONS

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

ATTACHMENTS

1.          None.

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

Document Number:

101-D05

Document Name:

Exemption from Informed Consent Requirements for Planned Emergency Research

Approved by:

Executive Director, Research Compliance

Effective:

1 Aug 2008

Revision History:

1 Aug 2011, 1 Jun 2016, 1 Jul 2019


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