HRPP Manual Section 8-5

Initial Review

If an activity requires review by a Michigan State University (MSU) Institutional Review Board (IRB), research may not be conducted until the IRB has reviewed and approved the research study and the researchers have received notification of approval and the availability to access the approval letter and IRB-approved consent form(s) (if applicable) through the study workspace. See the Human Research Protection Program (HRPP) Manual 4-3 “Determination of Human Subject Research” and 4-1, “Applicability” for the policies and procedures on when a research study must be submitted to the IRB. See HRPP Manual 8-1 “Exemption” for policies and procedures on the submission and review of exempt research.

To apply for approval of a non-exempt research study, the principal investigator (PI) or PI proxy must submit an initial study for review to the IRB.

Materials Required for Submission

To evaluate the research study, the IRB members must have the initial submission and all applicable supporting documents. The following supporting documents must be included whenever applicable:

  • HRP-503 - Template – Protocol

  • HRP-508 - Template - Site Supplement to Sponsor Protocol (use instead of the HRP-503 for multi-center sponsored studies that use a sponsor created protocol that is the same for all sites)

  • Instrument(s) or measures (e.g. survey(s), interview questions, questionnaire(s), case report(s), protocol)

  • Consent form(s) or script(s) for verbal consent (unless requesting waiver of consent)

  • Assent form(s)

  • Recruitment material(s), including advertisement(s), ResearchMatch message, etc.

  • Contract or grant application and MSU Office of Sponsored Programs (OSP) number for externally funded research

  • Debriefing form(s)

  • Translation of instrument(s) and consent(s) provided to non-English speaking subjects

  • HRP-537 – Template - Use of Protected Health Information Application

  • HRP-538 – Template – MSU Authorization to Use of Disclose Health Information when MSU is the covered entity

  • Investigator brochure(s)

  • S. Department of Health and Human Services (DHHS) approved sample informed consent(s) and complete DHHS approved protocol(s) (when one exists)

  • If submitted to other IRB(s), that institution(s) approval letter(s)

  • Package insert(s) if using a U.S. Food and Drug Administration approved drug/device/diagnostic test

  • FDA form 1572

  • Curriculum vitae when research is more than minimum risk

  • Data safety monitoring plan

  • Non-MSU Employee Conflict of Interest Disclosure Form

  • HRP-541 – Template - Involvement of Prisoners in a Research Study Form

  • MRI Screening Form – Women

  • HRP-540 – Template ICH-GCP – For Investigators (International Conference on Harmonization – Good Clinical Practice Form)

  • Abbreviated IDE Form

  • Form(s) for federal agency specific requirements

  • Any other pertinent documents related to the proposed research study

Mechanism(s) for Submission

For research studies submitted to the MSU IRB, the initial study must be completed and submitted using the MSU IRB online system. The initial study submission must be completed in full; all required questions must be completed. The MSU IRB online system will not allow submission of an incomplete submission.  See HRPP Manual 3-1 “MSU Human Research Protection Program Plan” for a description of the MSU IRB online system.

Submission Processing

The MSU IRB online system automatically assigns the initial study a Study number. The HRPP staff checks for completeness (e.g., appropriate documents attached). Incomplete submissions will be returned. HRPP staff verifies current HRPP training for researchers listed on the research study. HRPP staff will provide notification of any individuals without current training and those individuals must have current training before the approval letter can be issued. Staff in the Office of Regulatory Affairs may assist in submission processing as needed.


The IRB coordinator will conduct a pre-review of the new study submission. The pre-review includes but is not limited to, determining if the activity is research involving human subjects, whether the study may qualify for exemption, identifying whether the activity may involve waivers, vulnerable populations, or ancillary reviews, and a pre-review of informed consent document(s). Researchers may be provided comments or clarifications as part of the pre-review process.

Ancillary Review(s)

Ancillary reviewers are assigned to studies that may require additional MSU or other institutional reviews (e.g. hospital partners, biosafety review, raffle or drawings), that may utilize MSU resources (e.g. MSU Radiology), or that may be subject to additional federal requirements (e.g. Compliance office for U.S. Food and Drug Administration requirements, clinical research billing compliance). The ancillary reviewer(s) is assigned to the study by the IRB coordinator. Depending on the ancillary review type and need, a response may be needed from the ancillary reviewer before an approval letter can be released.

Review Level

See HRPP Manual 8 “Types of IRB Review” for policies and procedures related to review level and/or category.

Materials Provided to IRB Members

Assigned reviewer(s) may access the initial study and supporting documents associated with the research study (e.g., consent, instruments) via the MSU IRB online system. Any document(s) not accessible online will be provided to the reviewer(s).

How Review is Conducted

For review procedures, see HRPP Manual 8-2 “Expedited Review Procedure” or 8-3 “Full Board Review.”

IRB Member Considerations

When reviewing initial submissions, the criteria for IRB approval must be met to approve or recommend approval of the submission. The IRB member(s) should utilize HRPP Manual 6 “IRB Evaluation Criteria.”

In addition, IRB members should utilize the additional criteria for approval if research subjects include vulnerable populations such as pregnant women, human fetuses, neonates, children, or prisoners, as well as if investigators have requested a waiver or alteration of informed consent or waiver of documentation.

Additional Considerations

In studies where any of the following conditions are likely to prevail, the IRB may require review more often than annually:

  • Phase I trials

  • Clinical studies where risks to health are considered life threatening

  • Behavioral studies where stress to subjects could threaten health

  • Studies where data monitoring and security issues may warrant more frequent review

  • Others as the IRB sees fit

If the IRB chair, member, or staff recommends that a protocol requires review more often than annually, it will be referred to the convened IRB. When the IRB determines review is needed more often than annually, that determination will be communicated to the researcher(s) in writing and documented in the minutes.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 4-5-2006. Revision 2 approved by VP Research & Graduate Studies on 2-10-2009. Revision 3 approved by VP Research & Graduate Studies on 9-3-2009. Revision 4 approved by VP Research & Graduate Studies on 7-22-2011. Revision 5 approved by Assistant VP Regulatory Affairs on 1-22-2015. Revision 6 approved by Assistant VP Regulatory Affairs on 12-4-2015. Revision 7 approved by Assistant VP Regulatory Affairs on 6-27-2018.

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