Key Requirements and Guidance
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Any protocol involving human subjects and a drug or biologic as the object of the study falls under Food & Drug Administration (FDA) regulations. Thi…
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All medical devices in the United States are regulated by the Food & Drug Administration (FDA) and understanding the FDA’s definition of a medical de…
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Humanitarian Use Devices (HUDs) are FDA-designated medical devices intended to treat or diagnose rare conditions affecting small patient populations.…
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Expanded Access is a way for patients with immediately life-threatening conditions or serious diseases to access investigational medical products (dr…
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Single patient expanded access is a pathway for patients with serious or life-threatening conditions to access an investigational drug or device outs…
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IND Safety Reports are communications from a sponsor that provide important safety information about an investigational drug. These reports may descr…
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The use of Artificial Intelligence (AI) in research involving human subjects is growing quickly. Like many new technologies, it offers exciting oppor…
Policies
FDA definition of research within the context of human subjects research
FDA has defined clinical investigation to be synonymous with research. Clinical investigation 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 FDA...or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit."
Test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act.
Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. The FDA regulations that are specific to use of investigational devices defines "subject" as a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.
The sponsor of FDA regulated research
A sponsor for FDA-regulated research is a person or entity who starts a clinical investigation but does not actually conduct the investigation. This means another person directly gives the test article to the subject or uses it with the subject. If a company or agency starts a clinical investigation and uses its own employees to run the study, the company or agency is the sponsor, and the employees are the investigators.
You can be a sponsor if you are an individual, a pharmaceutical company, a government agency, an academic institution, a private organization, or another group. As a sponsor, you do not actually run the investigation unless you are a sponsor-investigator. Sponsor-investigator studies are not allowed in the NIH IRP. However, you may have sponsor responsibilities if the regulations require it.
Related Resources
FDA-Regulated Studies: What Investigators Need to Know
Presented by Rita Misra, PhD, MPH