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
- NIH Required Education in the Protection of Human Research Participants
- Office of Biotechnology Activities
- 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
- FDA: A Guide to Informed Consent Information Sheet
- FDA Information Sheets
- Expedited Review List
- Drug Approval Application Process
- Investigational Device Exemption (IDE)
- FDA: Women in Clinical Trials
FDA Guidance Documents
- FDA Guidance on Adverse Event Reporting to IRBs Jan. 2009
- 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