The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). These revisions became effective in 2018, so although the general compliance date was advanced to January 21, 2019, the regulations are referred to as the "Pre-2018 Requirements" and the "2018 Requirements."
As the Food and Drug Administration (FDA) has not yet revised its regulations, and the Department of Justice (DOJ) has not signed onto the revised Common Rule, the Pre-2018 Requirements currently apply to research that is FDA-regulated or DOJ-supported.
The general compliance date for the Revised Common Rule is January 21, 2019.
Revised Common Rule (2018 Requirements)
2018 Requirements: 45 CFR 46 - Protection of Human Subjects
The term "2018 Requirements" refers to the Common Rule as published in the July 19, 2018 edition of the e-Code of Federal Regulations. The 2018 Requirements were originally published on January 19, 2017 and further amended on January 22, 2018 and June 19, 2018. The 2018 Requirements may also be referred to as the "2018 Rule" and the "revised Common Rule."
Excerpts from Subpart A:
- Exempt Research Categories
- Expedited Review Categories
- Criteria for IRB Approval of Research
- General Requirements for Informed Consent
Waiver of Elements of Informed Consent- Waiver of Documentation of Informed Consent
- Cooperative Research
The 2018 revisions have been made to Subpart A only. Subparts B, C and D remain in effect for all applicable protocols approved before, on or following January 21, 2019. (For more information see: How do the updates to the Common Rule affect the HHS subparts?)
- Subpart B: Additional Protections for Pregnant Women, Human Fetuses & Neonates Involved in Research
- Subpart C: Additional DHHS Protections Pertaining to Biomedical & Behavioral Research Involving Prisoners as Subjects
- Subpart D: Additional DHHS Protections for Children Involved as Subjects in Research
Common Rule Requirements (pre-2018)
Pre-2018 Requirements: - 45 CFR 46 - Protection of Human Subjects
The term "pre-2018 Requirements" refers to subpart A of 45 CFR 46 (i.e., the Common Rule) as published in the 2016 edition of the Code of Federal Regulations. The pre-2018 Requirements were originally promulgated in 1991, and subsequently amended in 2005. The pre-2018 Requirements may also be referred to as the "pre-2018 Rule" and the "pre-2018 Common Rule."
Excerpts from Subpart A
HHS Office of Human Research Protection (OHRP)
HIPAA Privacy Rule (45 CFR 164, Subpart E)
21 CFR Regulations
- FDA Regulations Search
- 21 CFR 50 - Protection of Human Subjects
- 21 CFR 54 - Financial Disclosure by Clinical Investigators
- 21 CFR 56 - Institutional Review Boards
- 21 CFR 312 - Investigational New Drugs
- 21 CFR 600 - Biological Products
- 21 CFR 812 - Investigational Device Exemptions
- 21 CFR 814 - Premarket Approval of Medical Devices
FDA Guidance Documents
NYS/NJ Regulations & Guidance
NYS/NJ Regulations for Research with Human Subjects
- 14 CRR-NY 27.10 (mental health patients in NY)
- NYS Civil Rights Law: Section 79-L (genetic research)
- Tissue Banks and Nontransplant Anatomic Banks (NYS Title 10, Part 52) (specimen storage/distribution)
- NJSA 18A:36-34 (student surveys in NJ)
NYS Guidance for the Conduct of Human Subjects Research
Additional Regulations that Impact the Conduct of Human Subjects Research
International Regulations
- NIH ClinRegs (country-specific clinical research regulations)
Student Rights
- Protection of Pupil Rights Amendment (PPRA) (34 CFR 98) (student surveys)
- Family Educational Rights and Privacy Act (FERPA) (34 CFR 99) (student records)
- NJSA 18A-36-34 (student surveys in NJ)
Helpful Resources
The FDA provides a Comparison of FDA and HHS Human Subject Protection Regulations side-by-side for ease of comparison.