Even for an emergency use, the investigator is required to obtain informed consent of the subject or the subject’s legally authorized representative, unless both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following [21 CFR 50.23(a)]:
- The subject is confronted by a life-threatening situation necessitating the use of the test article.
- Informed consent cannot be obtained because of an inability to communicate with or to 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 subject’s life.
If an investigator believes immediate use of the test article is required to preserve the subject’s life and there is insufficient time to obtain an independent physician’s determination that the four conditions above apply, the clinical investigator may alone make the decision to use the test article. The investigator must then have his/her decision reviewed and an evaluation made in writing by a physician not participating in the clinical investigation. This review and evaluation must be made within 5 working days of the use of the test article. The investigator must also notify the IRB within 5 working days after the use of the test article [21 CFR 50.23(c)].
When non-therapeutic or therapeutic research that does not involve the use of a non-approved drug or device is considered in an emergency setting (not necessarily for the purpose of the emergency itself), proper consent procedures must be followed. Federal regulations offer some flexibility for such research; however, there are still appreciable requirements for which adherence is mandatory. In addition, Florida statutes (in particular the Medical Practice Act) are more restrictive for research in emergency settings than are federal regulations and may override the latter.
A template “Investigational Product Consent Form,” which may be amended to specific situations, is available on the HSRO website.