MSU HRPP Manual Section 2-2

2-2, Federal Guidelines and Regulations

Michigan State University (MSU), under its assurance to the U.S. Office for Human Research Protections (OHRP), has committed “that whenever it engages in human subjects research conducted or supported by any federal department or agency that has adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule, the Institution will comply with the Terms of the Federalwide Assurance for Institutions Within the United States . . ., unless the research is otherwise exempt from the requirements of the Common Rule or a department or agency conducting or supporting the research has determined that the research shall be covered by a separate assurance.” Federalwide Assurance (FWA) for the Protection of Human Subjects for Institutions within the United States

With limited exceptions specified in Human Research Protection Program (HRPP) Manual 8-8, “Flexibility Initiatives,” MSU applies 45 CFR 46 and all of its subparts to all of its human subject research regardless of source of support. 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-D       U.S. Department of Education
2-2-E       U.S. Department of Energy

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.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 2-2, Federal Guidelines and Regulations.