Historically, the vast majority of human subjects research at Lehigh University is social, behavioral, or educational, and not FDA-regulated. FDA-regulated clinical investigations involving drugs or devices are more common at universities with academic medical centers and clinical faculty. Lehigh investigators who believe their research may be subject to FDA regulations should contact the Office of Research Integrity as soon as possible. IRB approval is necessary prior to engaging in any research which is subject to FDA (or HHS) regulations.
An FDA-regulated clinical investigation is "any experiment that involves a test article and one or more human subjects and that either:
- is subject to requirements for prior submission to the FDA as a medical product within the United States (e.g. a drug, device, biologic, etc) or
- is not subject to requirements for prior submission to the FDA, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of a subsequent application for a research or marketing permit."
Note: the FDA considers the related terms "research," "clinical research," "clinical study," and/or "study" to be synonymous with clinical investigations.
Additional Information
A clinical investigation is defined as "any experiment that involves a test article and one or more human subjects and that either:
- is subject to requirements for prior submission to the FDA as a medical product within the United States (e.g. a drug, device, biologic, etc) or
- is not subject to requirements for prior submission to the FDA, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an subsequent application for a research or marketing permit."
Note: the FDA considers the related terms "research," "clinical research," "clinical study," and/or "study" to be synonymous with clinical invesigations.
Any clinical investigation which first meets the requirements for prior submission to the FDA, or is considered in support of an application for a research or marketing permit, must have been reviewed and approved by, and remain subject to continuing review by, the IRB.
Human subject is defined as "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."
Test article is defined as "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 Federal Food, Drug, and Cosmetic Act (CFR Title 21)."
Drug is defined as:
- articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them or
- articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals or
- articles (other than food) intended to affect the structure or any function of the body of man or other animals or
- articles intended for use as a component of any article specified in (A), (B), or (C).
Medical device is defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:
- recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, or
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and
- which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes."