FDA-Regulated Research

FDA regulations allow for one emergency use of a test article in an institution without prospective IRB review, provided that such emergency use is reported to the IRB within five working days after such use. An emergency use is defined as a single use (or single course of treatment, e.g., multiple doses of antibiotic) with one subject. "Subsequent use" would be a second use with that subject or the use with another subject.

In its review of the emergency use, if it is anticipated that the test article may be used again, the IRB should request a protocol and consent document(s) be developed so that an approved protocol would be in place when the next need arises. In spite of the best efforts of the clinical investigator and the IRB, a situation may occur where a second emergency use needs to be considered. FDA believes it is inappropriate to deny emergency treatment to an individual when the only obstacle is lack of time for the IRB to convene, review the use and give approval.

According to the FDA Guidance for Industry: Investigator Responsibilities —Protecting the Rights, Safety, and Welfare of Study Subjects, October 2009, section B,2: Reasonable Access to Medical Care: “Investigators should be available to subjects during the conduct of the trial for medical care related to participation in the study. Availability is particularly important when subjects are receiving a drug that has significant toxicity or abuse potential. For example, if a study drug has potentially fatal toxicity, the investigator should be readily available by phone or other electronic communication 24 hours a day and in reasonably close proximity to study subjects (e.g., not in another state or on prolonged travel). Study subjects should be clearly educated on the possible need for such contact and on precisely how to obtain it, generally by providing pertinent phone numbers, e-mail addresses, and other contact information, in writing. Prior to undertaking the conduct of a study, prospective investigators should consider whether they can be available to the extent needed given the nature of the trial.”  Therefore, in the case that the PI no longer meets the criteria above (for example on prolonged travel or FMLA), the study team must submit a personnel change request to change the PI to someone who is both knowledgeable and familiar with the study and can act as the PI in the former PI’s absence (DUHS Principal Investigator Agreement, Sections 3, 17, 18). The protocol must have plans for emergency contact by subjects in the event of a subject-related injury.

The IVD Regulatory Assessment Guide should be used to help determine when an In Vitro Diagnostic Device is subject to 21 CFR 812, the FDA's IDE regulations