Regulations & References

Regulation/Reference Description
Combination Products FDA definition of “combination product” and associated regulations.
The Common Rule [PDF] The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. The Common Rule includes additional protections for certain vulnerable research subjects.
Continuing Review Guidance This guidance is intended to assist IRBs in carrying out their continuing review responsibilities under 45 CFR part 46 by providing recommendations regarding, among other things, the approval criteria, process, and frequency for continuing review to assure the protection of the rights and welfare of human subjects participating in research. The guidance also is intended to help investigators and others involved in the review, conduct, or oversight of research better understand their responsibilities related to continuing review.
Device Classification FDA guidance on device classification.
Engagement of Institutions in Human Subjects Research This guidance is relevant for determining whether an institution’s activities are covered by the HHS protection of human subjects regulations (45 CFR part 46), and whether the institution is engaged in human subjects research.
Family Educational Rights and Privacy Act (FERPA) This link discusses the Federal law that protects the privacy of student education records.
Good Clinical Practices (ICH GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects to ensure that the RIGHTS, SAFETY and WELLBEING of the trial subjects are protected. Ensure the CREDIBILITY of clinical trial data.
Health Insurance Portability and Accountability Act of 1996 (HIPPA) Learn about the Rules' protection of individually identifiable health information, the rights granted to individuals, etc.
HIPAA Resources (NIH) The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is the first comprehensive Federal protection for the privacy of personal health information. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. This website provides information on the Privacy Rule for the research community.
International Compilation of Human Research Standards The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations. Many of the listings embed hyperlinks to the source document.
In-Vitro Diagnostic [PDF] FDA guidance document intended to assist investigators in the development of IVD studies.
Medical Device Definition FDA guidance regarding medical devices regulated by the FDA. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device.
"Off Label" and Investigational Use of Drugs and Devices Information Sheet FDA guidance on off-label and investigational drug and device use.
OHRP Guidance on Continuing Review This document describes the requirements of Department of Health and Human Services (HHS) regulations at 45 CFR 46.109(e) for the continuing review of human subjects research by an Institutional Review Board (IRB) at intervals appropriate to the degree of risk, but not less than once per year.
Utah State Mandatory Disease Reporting Information This rule outlines a multidisciplinary approach to communicable and infectious disease control and emphasizes reporting, surveillance, isolation, treatment and epidemiological investigation to identify and control preventable causes of infectious diseases. Reporting requirements and authorizations are specified for communicable and infectious diseases, outbreaks, and unusual occurrence of any disease.