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Regulatory Requirements and Information

All research is regulated by Federal, State and local agencies. Approval is required for research involving human participants or animal subjects before research activities begin. Even if you are being added to a previously approved IRB, IACUC study, you must complete all requirements and mandatory training.

The Office of Research Compliance oversees all areas of research compliance, including research that utilizes humans, animals, rDNA, radiation safety, and chemical safety. It coordinates conflict of interest, export controls and handles inquiries and investigations regarding allegations of research misconduct.

Federal regulations require that all research involving human participants must be reviewed and approved by an Institutional Review Board (IRB) before research activities can begin. The WSU Institutional Review Board (IRB) is the primary IRB of record for Wayne State University and has the responsibility to review all research that is performed by faculty, students, or employees of WSU and its affiliated institutions.

  • Medical research involving pediatric participants, researchers should submit to the MP2 or MP4 IRBs.
  • Medical research involving adults researchers should submit to the M1, MP2, or MP4 IRBS.
  • Behavioral, educational, social, business research, the researcher should submit to the B3 IRB.

The authority of the IRB extends to biomedical research and behavioral/social science research, regardless of whether the research is being funded by a federal agency, by commercial companies, by intramural entities, or supported by institutional resources. In addition, it includes research conducted on Wayne State University property or its affiliated medical institutions’ property. Designation of research as exempt from IRB review requires approval of the IRB Chair or his/her designee.

WSU Medical Affiliates:

  • Detroit Medical Center (Contract)
    • Children’s Hospital of Michigan
    • Detroit Receiving Hosiptial/University Health Center
    • Harper University Hospital
    • Huron Valley-Sinai Hospital
    • Hutzel Women’s Hospital
    • Kresge Eye Institute (operating rooms)
    • Michigan Surgical Hospital
    • Rehabilitation Institute of Michigan
    • Sinai Grace Hospital
  • John D. Dingell Veterans Affairs Medical Center (Memo of Understanding)
  • Oakwood Healthcare System (Contract)

Useful Resources:

Federal regulations require that all research involving animals must be reviewed and approved by an Institutional Animal Care and Use Committee (IACUC) before research activities begin. Wayne State University also has it’s own IACUC that reviews protocols for Wayne State University and its affiliated medical institutions. In cooperation with research scientists and veterinarians, the IACUC ensures that all research and teaching protocols using live vertebrate animals are designed and carried out in a humane manner that complies with all applicable laws, policies, and guidelines. The Division of Laboratory Animal Resources (DLAR) provides informational, species-specific and procedure-specific training sessions for researchers at various times throughout the year.

Additional information can be found at: http://www.iacuc.wayne.edu/

Please note that Henry Ford Health System has its own IRB and IACUC. Wayne State University faculty and students wishing to do research in those facilities must either submit an Administrative Application to WSU IRB or IACUC after gaining approval from HFHS (if all of the research is being performed there) or submit research proposals to BOTH WSU and the HFHS (if the research is being performed in both locations). Questions regarding the type of submission required by WSU can be directed to the IRB or IACUC Office.

Additional information can be found at: http://www.henryford.com/body.cfm?id=50274

The WSU IRB requires that all Principal Investigators, their Chairs, and all personnel working on aresearch protocolcomplete the required Collaborative Institutional TrainingInitiative (CITI)training modules before their projects can receive IRB approval. To access the online training modules from CITI go to: https://www.citiprogram.org.

The required modules for all investigators and key personnel depend on the type of study that is being conducted, the subjects being enrolled, and the setting in which the research is taking place. The basic sets of required modules for biomedical investigators include:

  • The Basic Course in Human Participant Research for biomedical investigators.
  • HIPS-Health Information Privacy and Security for investigators.
  • Responsible Conduct in Research for biomedical investigators.

For social-behavioral investigators, the required sets of modules include:

  • The Basic Course in Human Participant Research for social‚Äźbehavioral investigators.
  • Responsible Conduct in Research for social behavioral investigators.

For some studies, research personnel may be required to take modules located in the Optional Modules section (e.g Internet Research, Vulnerable Subjects, etc.). The study cannot be approved and research cannot begin until all persons listed on the submitted protocol have taken all required and necessary optional modules.

Additional information can be found at:

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