Graduate Student Research

Graduate student research refers to research conducted to fulfill graduate degree requirements, i.e., preparation of master’s theses and doctoral dissertations. Graduate student research involving human subjects is subject to the Michigan State University (MSU) Institutional Review Board (IRB) submission and review requirements.

Graduate students who conducted human subject research for their thesis/dissertation must provide a copy of their IRB approval letter to the Graduate school with their form for final submission of their thesis/dissertation.

When should I submit?

MSU IRB review and approval or an exempt determination is required for all projects that involve research or clinical investigations with human subjects conducted by faculty, staff, students, or agents of MSU before initiation of any human subject research activities.

It is important to note that research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge, and at MSU, masters’ theses and Ph.D. dissertations are considered to present generalizable knowledge. If you are unsure whether your activity is human subject research, please contact the IRB office.

For those projects that may qualify as exempt from IRB approval, an exempt determination must be obtained from the MSU IRB office prior to initiation of the human subject research. For those projects that do not qualify as exempt, IRB approval must be obtained prior to initiation of the human subject research.

For more information on defining research with human subjects, please visit our website at https://hrpp.msu.edu/help/required/human-research.html.

What should I submit?

A new study application must be submitted through the Click™ Research Compliance System. At minimum, the HRP-503-Template-Protocol must be completed for each new study submission. The HRP-503, along with other Click Templates, are available at: https://hrpp.msu.edu/templates/index.html

The additional materials required as part of the new study submission and review process differs based on the type of review and submission type.

There are three main types of initial review:

• Exempt

• Expedited

• Full Board

Federal regulations define what research activities may qualify for exempt or expedited review. Projects that do not meet the criteria for exempt or expedited are full board.

NOTE: Clinical investigations involving human subjects also require IRB review and approval.

For more information on the exempt categories, please visit our website at https://hrpp.msu.edu/help/required/exempt-categories.html. A list of the expedited categories can also be found on our website at https://hrpp.msu.edu/help/required/exp-categories.html.

Who can be the PI?

In the case of graduate student research for theses or dissertations, the graduate student’s major advisor or another faculty member should be designated on the IRB application as the principal investigator (PI) and the graduate student should be designated as a co-investigator. Only faculty members and fixed-term faculty employees with the rank of assistant professor or higher may be designated as the PI on the IRB application.

The PI can also assign study team members to the role of PI Proxy. A PI Proxy can submit the study to the IRB, submit clarifications requested, and submit modifications and continuing reviews. A PI Proxy also receives the Click system generated notifications that are sent to the PI. While more than one individual can be designated as a PI Proxy on a study, the PI Proxy designation is specific for each study. 

For more information on designating a PI Proxy, please visit https://hrpp.msu.edu/_assets/click-resources/designate-proxy.pdf.

Even if you are not designated as PI Proxy, you may still receive Click system generated notifications by assigning yourself as the “Primary Contact.” The Primary Contact will receive notifications in addition to the PI or PI Proxy.

How long will the IRB process take?

Exempt Review

Once an exempt determination request is submitted, IRB staff will review the application to determine if the activity meets the federal definition of research and/or clinical investigation with human subjects. If the project is human subject research, they will then determine if the defined project meets the exemption criteria. The staff may consult or refer the research study to the IRB chair or members who will make the determination of whether the research meets the exemption criteria.

If the research study is determined to meet the criteria for exempt status, the PI will be notified that the exempt determination letter is available.

Processing of applications for exempt status is estimated to take 7-9 working days. Processing time may increase if the application is incomplete, unclear, or lacks all necessary supporting documents (e.g., consent process information, instruments).  The application is not considered submitted to the IRB office until all necessary supporting documents are received. In addition, the time line can be extended due to unaddressed comments.

More information about exempt review is available on the Exempt Process webpage, located at https://hrpp.msu.edu/help/process/exempt.html.

Expedited Review

Projects that qualify for expedited review can be reviewed and approved by the IRB chair or by one or more experienced reviewers designated by the chair from among members of the IRB. This means that the project does not need to be reviewed by the convened IRB to receive approval and can be approved between convened IRB meetings.

Typical Review Time

Initial Studies: 2 – 4 weeks

Modifications to An Approved Research Study: 10 – 15 working days

Renewed Approval (if applicable): 10 – 15 working days

More information about expedited review is available on the Expedited Process webpage, located at https://hrpp.msu.edu/help/process/expedited.html.

Full Board Review

If an activity is a non-exempt human subject research study and/or clinical investigation, the project is subject to the regulations for the protection of humans involved in research and/or clinical investigation. The human research regulations require review by the convened IRB, unless the research qualifies for expedited review.  At MSU, review by the convened IRB is called “full review” and are reviewed at convened IRB meetings. See the Events page for meeting dates. Approval will be granted when a majority of members present vote for approval at a convened meeting.

Are there templates to help create a consent form?

Yes, informed consent templates are available at: https://hrpp.msu.edu/templates/consent.html

These documents include standard language and can be customized to your study.