Research Regulations Resources

Health & Human Services Office for Human Research Protections (OHRP)

• Office for Human Research Protections. Federal agency that regulates IRBs and human subjects’ research.
• The Code of Federal Regulations (45CFR46). Federal regulations governing protection of human subjects
• OHRP Guidance on Unanticipated Problems and Adverse Events
• OHRP’s Frequently Asked Questions
• Expedited Review Categories of Research
• IRB Guidebook
• OHRP Policy Guidance by Topic
• OHRP Guidance on Coded Private Information and Biological Specimens
• Engagement of Institutions in Research
• Links to reference documents, historical materials and Common Rule departments/agencies. A list maintained by OHRP.
• Comparison Table of HHS & FDA Regulations
• NIH Decision Chart on Applying OHRP Guidance on Coded Info/Specimens
• Engagement of Institutions in Research
• Links to reference documents, historical materials and Common Rule departments/agencies. A list maintained by OHRP.
• The International Compilation of Human Research Standards 2020 Edition- PDF, a listing of the laws, regulations, and guidelines that govern human subjects’ research in many countries around the world.

National Institutes of Health:

• NIH Decision Chart on Applying OHRP Guidance on Coded Info/Specimens
• NIH Policy for Data & Safety Monitoring
• National Institutes of Health
  1. IRBs and HIPAA Privacy Rule
  2. Protecting Personal Health Information in Research Understanding the HIPAA Privacy Rule
• NIH Required Education in the Protection of Human Research Participants
• National Cancer Institute
• National Human Genome Research Institute
• National Institutes of Environmental Health Sciences
• National Library of Medicine

Food & Drug Administration:

• 21CFR50. FDA regulations for protection of human subjects
• 21CFR56. FDA regulations governing IRBs
• Drug Approval Application Process
• Investigational Device Exemption (IDE)
• FDA: Women in Clinical Trials

FDA Guidance Documents

• FDA Guidance on IND Safety Reports Dec. 2012
• FDA Decisions for Investigational Device Exemption Clinical Investigations Aug. 2014
• Information Sheet Guidance: Significant Risk and Nonsignificant Risk Medical Device Studies Jan. 2006
• Custom Device Exemption Guidance Document Sept. 2014
• Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs) Guidance June 2015
• FAQs about Medical Devices Jan. 2006
• In Vitro Diagnostic Studies Using Leftover Specimens Apr. 2006
• Mobile Medical Applications Guidance Document Feb. 2015

Other Agencies

• American Council on Science and Health
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• Association of American Medical Colleges
• Association of American Universities
• Biological Safety and the Institutional Biosafety Committee
• Certificate of Confidentiality
• Centers for Disease Control and Prevention
• CoC Flow Chart
• Department of Education
• Department of Health and Human Services
• Environment, Health and Safety
• The Hastings Center
• HHS Office of Civil Rights: HIPAA
• HHS Office Of Human Research Protections (OHRP) Regulations
• HHS Office of Research Integrity (ORI)
• Institute of Medicine
• Kennedy Institute of Ethics
• National Academy of Sciences
• NRP New Coordinator Orientation (recordings of 5 workshops sponsored by NC TraCS, UNC OCT, and NCRP)
• Office for Civil Rights – HIPAA
• Office of Clinical Trials
• Office of Research Integrity
• Oncology Protocol Review Committee
• Public Responsibility in Medicine and Research (PRIM&R)
• Research at Carolina
• Radiation Safety and the Radiation Safety Committee
• Unanticipated problems & Adverse Events
• UNC Hospitals Policy on Investigational Devices
• UNC School of Medicine’s Office of Diversity, Education, and Inclusion