MSU HRPP Manual Section 2-2

2-2, Federal Guidelines and Regulations

The Federal Policy for the Protection of Human Subjects is known as the “Common Rule” because it has been adopted by a number of federal departments and agencies. With limited exceptions specified in Human Research Protection Program (HRPP) Manual 4-11 “Applicability of the Revised Common Rule (2018 Requirements),” the 8-8 “Flexibility Initiative,” or within a specific HRPP Manual section, MSU applies the Common Rule (45 CFR 46 Subpart A) and subparts B, C, D, and E to all of its human subject research, regardless of the source of support.  See HRPP Manual 4-11 “Applicability of the Revised Common Rule (2018 Requirements)” to determine whether the Pre-2018 Common Rule or the Revised Common Rule (2018 Requirements) apply.  If the human subject research is conducted, supported, or otherwise subject to regulation by a federal department or agency, there may be requirements in addition to 45 CFR 46 that are specific to the federal department or agency. MSU will also comply with any additional human subject regulations and policies of supporting federal departments or agencies and of the Food and Drug Administration (21 CFR 50 and 56) as well as the Health Insurance Portability and Accountability Act Privacy Rule (45 CFR 160 and 164) as appropriate.

Additional Considerations

For additional federal requirements, see the following sections of the HRPP Manual:

2-2-A        U.S. Department of Defense
2-2-B        U.S. Environmental Protection Agency
2-2-C        U.S. Department of Justice
2-2-C-i,     Bureau of Prisons
2-2-C-ii,    National Institute of Justice Funded Research
2-2-D        U.S. Department of Education
2-2-D-i,     Family Educational Rights and Privacy Act
2-2-D-ii,    Protection of Pupil Rights Amendment
2-2-D-iii, Funding under 34 CFR 356 for Fellowships Involving Disability and Rehabilitation Research
2-2-E        U.S. Department of Energy
2-2-F-i,    U.S. Department of Health and Human Services, National Institutes of Health Definition of a Clinical Trial
2-2-F-ii,   U.S. Department of Health and Human Services, National Institutes of Health Good Clinical Practice Training
2-2-F-iii, Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health)

See Section 7 for additional requirements related to clinical research compliance.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 9-3-2009. Revision 2 approved by the VP Research & Graduate Studies on 7-21-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 12-2-2015. Revision 4 approved by Senior VP for Research and Innovation on 1-18-2019.

Related HRPP Manual Sections