Guidance on Determining if Activities Meet Organizational Definition of Human Subjects Research

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Under NYU SoM IRB policies and procedures an activity is human research if it is described in any one of the following:

HUMAN SUBJECT RESEARCH UNDER FDA REGULATION
Activities are human research under FDA regulations when they meet the FDA definition of “research” and involve a “subject” as defined in FDA regulations. Under FDA regulations activities are “research” when they involve:

1. Use of a drug other than the use of an approved drug in the course of medical practice 
2. Use of a medical device other than the use of an approved medical device in the course of medical practice (Food, Drug and Cosmetic Act §530(g)(3)(a)(i)) 
3. Gather data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product. (21 CFR §50.1(a), or 21 CFR §56.101(a))

In the above criteria “approved” means “approved by the FDA for marketing.”

Under FDA regulations, individuals are considered “subjects” when they become a participant in research, either as a recipient of the test article or as a control. If the research involves a medical device, individuals are considered “subjects” when they participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.

The following activities also require IRB review under FDA Regulations: emergency use of an investigational drug, device, or biologic under 21 CFR 56.104(c) and 21 CFR 50.23 and humanitarian device use under 21 CFR 814.3(n) and 814.124.

HUMAN SUBJECT RESEARCH UNDER HHS REGULATIONS

Activities are human subject research under HHS regulations when they meet the HHS definition of “research” (§46.102(d)) and involve a “subject” as defined in DHHS regulations (§46.102(f)).

Under DHHS regulations activities are “research” when they are a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (§46.102(d)).  

Under DHHS regulations “subjects” means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (§46.102(f)).
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (§46.102(f)).

Interaction includes communication or interpersonal contact between investigator and subject (§46.102(f)).