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102. FDA Exceptions from General Consent Requirements (§50.23)

University and affiliate investigator may not involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. However, the FDA and University IRB recognize that obtaining informed consent may not be feasible under all circumstances and offer the following requirements for an FDA exception from general (i.e., DHHS) consent requirements.

FDA Exception from General Consent Requirements (50.23(a))

This exception may apply if before use of the test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following are true:

·        The human subject is confronted by a life-threatening situation necessitating the use of the test article.

·        Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.

·        Time is not sufficient to obtain consent from the subject's legal representative.

·        No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the life of the subject.

NOTE: If it is the investigator's opinion that immediate use of the test article is required to preserve the life of the subject, and time is not sufficient to obtain the determination of an independent physician (as describe above) in advance of using the test article, the article may be used. However, within 5 working days after the use of the article, the determinations of the clinical investigator shall be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation (50.23(b)).

Investigator Requirements for Notifying the IRB of FDA Exceptions from Informed Consent Requirements (50.23(c))

University and affiliate investigators must submit the required documentation for these exceptions to the IRB within 5 working days after the use of the test article.

Presidential Exceptions for Prior Informed Consent Requirements (50.23(d))

The President may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation.

NOTE: To date, the University IRB has never received such a request. If this situation should occur at a University or affiliate site, the IRB will refer to §50.23(d) to evaluate the request with consideration for the multiple requirements applicable to a Presidential exception to informed consent.

FDA Exceptions to Consent Requirements for Planned Emergency Research (50.24)

FDA regulations allow exceptions to consent requirements for planned emergency research under specific conditions.

NOTE: At this time, the University does not actively conduct or manage such research, nor do University IRBs review it. Investigators interested in conducting planned emergency research must contact the RIO to discuss the possibility of engaging in this type of research. As warranted, the IRB will develop and publish policy for such research.

Waivers or Alterations of the Consent Process for Activities Preparatory to Research

The DHHS waivers or alterations of the consent process do not apply to FDA-regulated research. However, at the request of the investigator and when all conditions for the waiver are met, the University IRB may waive the requirement for prior informed consent for activities preparatory to research (e.g., review of medical or other records to identify eligible persons). For details, refer to the IRB policy for waivers/alterations of the consent process.

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