Faculty Handbook

Office of Regulatory Affairs

8/16/18

The freedom to pursue knowledge is accompanied by the responsibility to conduct ethical and sound research. Faculty are accountable for following the laws, regulations, policies and all other rules adopted by Michigan State University to protect research subjects and ensure the safety of employees.

The Michigan State University Office of Regulatory Affairs (ORA) facilitates the research oversight process in accordance with federal, state, and local laws and requirements, accreditation standards, and University requirements to protect the rights and welfare of research subjects, to protect public and investigator health and safety, and to assure proper execution of research. ORA units include the Animal Care Program, the Human Research Protection Program, the Environmental Health and Safety Program, Conflict of Interest, and Human Stem Cell Research. ORA reports to the Vice President for Research and Graduate Studies and works closely with other University units involved in the regulatory oversight of research. The Vice President serves as the Institutional Official for those regulatory programs requiring a responsible official. The Assistant Vice President for Regulatory Affairs is designated by the Vice President to oversee daily activities and regulatory responsibilities.

A culture of compliance is maintained through oversight by university committees, engagement in active training programs, collaborative post-approval monitoring programs, participation in international accreditation programs, and an institutional commitment to compliance with federal, state, and local laws and regulations.

• University regulatory committees are charged with ensuring institutional compliance with federal, state, and local laws, regulations, and guidelines to ensure the protection of research subjects and the safety of faculty, staff and students. They carry out their mission by the review of proposed protocols and the implementation of appropriate institutional guidelines and practices. Members are comprised of University faculty and staff as well as individuals unaffiliated with the University. They are appointed by the President or Vice President for Research and Graduate Studies depending on the legal requirements.
  
  The ORA regulatory review committees include:
  • Biomedical and Health Institutional Review Board (BIRB)
  • Social Science / Behavioral / Education Institutional Review Board (SIRB)
  • Institutional Stem Cell Research Committee (ISCRC)
  • Institutional Animal Care and Use Committee (IACUC)
  • Chemical Hygiene Committee
  • Institutional Biosafety Committee (IBC)
  • Radiation Safety Committee
• Training is an important part of compliance programs. Online and face-to-face training programs convey federal, state, and local requirements, University guidelines, and grants policy when applicable. Hands-on training is also provided as needed to ensure appropriate preparation to perform research procedures. Individuals conducting research programs are required to receive basic regulatory training related to the type of research. Specific training on specialized topics may be required to ensure the protection of research subjects and safety of workers.
• Post-approval monitoring or auditing programs are designed to ensure compliance. They also serve to supplement training. Monitoring is conducted by performing visits to laboratories and research sites to review activities of personnel and documentation of performance.

Individuals are encouraged to contact ORA by phone: (517) 432-4500 or email: ora@msu.edu with any questions. Additional information can be found at the ORA website: www.ora.msu.edu.