Research Professionals Resources

A guide for staff who work as research assistants, study coordinators, clinical research coordinators.

Federal Regulations

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

NIH Public Access Policy

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

National Institutes of Health (NIH)

UNC Health Sciences Library (HSL)

IRB at UNC

How to apply for IRB approval before your study.

UNC Office of Human Research Ethics (OHRE)

UNC Research Regulations

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

UNC Office of Human Research Ethics (OHRE)

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.

 

Standard Operating Procedures (SOPs)

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 (Revised 6/2/2017) which is conducted at or by UNC and its researchers.

      https://research.unc.edu/files/2017/05/SOP-June-2-2017-bookmarked-and-TOC-links.pdf

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