Activities Requiring IRB Review
FDA Regulated Research
Questions to ask yourself to help determine if the activity is FDA regulated research:
- Does the activity involve the use of a drug (including an approved drug or an over-the-counter drug), other than the use of an approved drug in the course of medical practice?
- Does the activity involve the use of a medical device (including an approved medical device), other than the use of an approved medical device in the course of medical practice? (Note that medical devices generally include devices intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, and devices intended to affect the structure or any function of the body of humans or other animals.
- Will data be submitted to the FDA or held for their inspection?
If the answer to one of the above questions is “yes,” then your study is FDA regulated and may need an IND or IDE from the FDA before the IRB will be able to approve the study.
“Research” as defined by DHHS is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
DHHS regulations specify that the following activities are NOT research:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security mission.
“Research” (which is synonymous with Clinical Investigation) as defined by FDA means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]
- “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act” means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
- “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act” means any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)]
“Intervention” as defined by DHHS regulations means 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. [45 CFR 46.102(f)]
“Interaction” as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
“Private information” as defined by DHHS regulations means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]
“Identifiable information” as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
Resources to Help Decide if an Activity must be Submitted to the IRB
- Examples of activities that may or may not be human subjects research
- OHRP Decision Chart: Is an Activity Research Involving Human Subjects?
If you are unsure and would like help making a determination before submitting to the IRB, contact the IRB staff via email or online chat.