Federal, State, Local Requirements

MSU is committed to follow the ethical standards described in the Belmont Report, and all applicable federal, state and local regulations and university policies and procedures.

Federal Requirements

At MSU, the Federal Policy for the Protection of Human Subjects, known as the Common Rule, is applicable to all research involving human subjects with limited exceptions. 

The United States Food and Drug Administration (FDA) regulations for the protection of human subjects and IRBs are applicable at MSU when a planned activity is a FDA regulated clinical investigation involving human subjects. The MSU BIRB review research subject to the FDA regulations for the protection of human subjects and IRBs.  In addition, the FDA has other regulations that may be applicable to a research activity, such as regulations that apply to the use of investigational new drugs and investigational devices.

• There may be additional federal requirements based on the activities' funding source.
• There may also be additional requirements based on the type of data being obtained or location of the research.

State or International Laws

In addition to federal laws, there may be state or international laws that impact the research. 

Accreditation

MSU’s HRPP achieved accreditation in 2005 from the Association for the Accreditation of Human Research Protection Programs, Inc. ® (AAHRPP). Accreditation requires MSU to meet standards set by AAHRPP.

University Requirements

MSU also has university requirements for human research or clinical investigations conducted by employees, students, or agents of MSU. MSU requirements can be found in the MSU HRPP Manual. Other university requirements may also impact human subject research, such as Mandatory Reporting Protocols and MSU's Research Data: Management, Control, and Access best practices. 

There may be other MSU offices that implement requirements or require training that may apply to the project.