The National Institutes of Health defines clinical research as “Research with human subjects that is:
- Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
- Epidemiological and behavioral studies.
- Outcomes research and health services research
Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.
An NIH video provides an overview of recent NIH policies affecting Human Subjects Research and Clinical Trials.
One of the recent policies affecting clinical research requires applicants to submit a plan for the dissemination of NIH-funded clinical trial information that will address how expectations of the policy were met. The NIH Policy on Dissemination of Clinical Trial information applies to applications submitted on or after January 18, 2017 that request support for the conduct of a clinical trial. The ORA Guidance on the Dissemination Plan provides guidance on NIH's review of the dissemination plan and terms of award.
Clinical research entails various UM offices, forms and policies shown in the links below. Faculty and administrators should become familiar with these areas which involve contracting, budgeting and billing.
