Reporting Research Involving Human Subjects Policy - Northern Michigan University

Purpose:

To provide assurance that Northern Michigan University is compliant with HHS Regulations regarding the Protection of Human Research Subjects.

Applicability:

All faculty, staff and students.

Policy:

To comply with federal regulations, Northern Michigan University has established policies and procedures for the protection of human subjects in research. These policies established the Institutional Review Board (IRB) and a reporting and review procedure for all University research and experiments involving human subjects. The documents detailing these policies and procedures are available in the Office of Graduate Studies and Research or at the web site: www.nmu.edu/research. All faculty, students, and staff engaged or planning to engage in research activities involving human subjects are responsible for reporting these activities through the procedures outlined below:

1. Proposed research projects involving human subjects at Northern Michigan University fall into one of three categories: (1) they may be exempt; (2) they may be eligible for expedited review; or (3) they may require approval of the full IRB. These guidelines are listed in 45 CFR 46.101.
2. Applicants must submit an application for the conduct of research involving human subjects available at the NMU Research Web site providing adequate time for committee review and approval (at least 6 weeks is encouraged).
3. No research activities may be executed unless committee approval is received.
4. Written committee approval of exempt, expedited, or full approval will be provided.
5. All student work must be submitted with the approval of their faculty/staff advisor.
6. Faculty teaching methodology courses or student groups or University organizations may submit for approval the abbreviated format found on the web- site titled Guidelines for Course Projects, Student Groups, or University Organization Projects, or Research Methods Courses
7. There is no authority within Northern Michigan University which may substitute or overturn IRB decisions.

These procedures were developed not only to protect human subjects, but also to protect members of the University community from liability. In essence the polices protect both the subjects and the investigator. Faculty and staff are responsible for submitting reports of their activities for departmental and IRB committee review. Faculty are further responsible for submitting reports on student projects conducted under their supervision or as part of their class assignments and faculty/staff advisors are responsible for submitting reports for projects conducted in student or University organizations.