Research Professionals Resources: Regulatory

Learn about US federal regulations on research.

Note: Standard form for referencing the US Code of Federal Regulations (CFR) is '[Title No.] CFR [Part No.].' Ex. '21 CFR 50', refers to Title 21 of the CFR, Part 50. When you look it up, 21 CFR 50 is on 'Protection of Human Subjects/Informed Consent'.

Dept. of Health and Human Services (DHHS)

• Read 45 CFR 46, which governs the protection of human subjects in research.

Food and Drug Administration (FDA)

• Read 21 CFR, various parts, the FDA Regulations Relating to Good Clinical Practice and Clinical Trials.

Federal Regulations, Guidelines, Policies, and Regulatory Offices

• UNC Research website provides links to the above and other federal regulations you need to know.

Find out how to comply with the NIH Public Access Policy.

National Institutes of Health (NIH)

• For definitions, explanations, and help, see NIH's PAP overview, instructions, and video tutorials.

UNC Health Sciences Library (HSL)

• Find more help in the online guide, NIH Public Access Policy and You, from your HSL librarians.

How to apply for IRB approval before your study.

UNC Office of Human Research Ethics (OHRE)

• Planning a new human research study? Get started with UNC's IRB process.
• Multi-center/multi-site study? You have the option to rely on a central IRB, explained here.
• Looking for more on IRBs and related issues? OHRE has compiled news, discussion threads, and more.

Check to make sure you comply with all applicable UNC regulations.

UNC Office of Human Research Ethics (OHRE)

• The OHRE has archived all of its university-wide regulatory documents here, including Federal Wide Assurace (FWA), Statement of Compliance, IRB Committe Member Rosters, SOPs (also linked above), and proposed OHRE regulatory reforms.

UNC Office of Clinical Trials (OCT)

• The "OCT serves as a central resource for UNC faculty, staff and departments involved in clinical trials research and for sponsors seeking to conduct clinical trials." Clinical research staff are required to complete Good Clinical Practice (GCP) training, per OCT policy. Contact the OCT with questions or for assistance.

UNC Research Compliance Program (RCP)

• The RCP "strives to promote best practices and ethical behavior and to deter activity contrary to these standards by (a) anticipating risk, and (b) encouraging strong stewardship and management accountability at all levels, in collaboration with institutional colleagues responsible for compliance implementation." Contact the RCP at any point in your research for assistance or questions on these issues.

Check to make sure you follow SOPs.

UNC Office of Human Research Ethics (OHRE)

• Review the latest university-wide SOPs for all research involving humans, conducted at or by UNC and its researchers.

http://ohresop.web.unc.edu/