MSU HRPP Manual Section 8-5

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 electronic notification to print the approval letter and IRB-approved consent form(s) (if applicable). 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) must submit an initial application for expedited or full board review to the IRB.

Materials Required for Submission
To evaluate the research study, the IRB members must have the initial application and all applicable supporting documents. The following supporting documents must be included whenever applicable:

  • 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

  • Use of Protected Health Information Application

  • Health Insurance Portability and Accountability Act authorization form(s) when MSU is the covered entity

  • Investigator brochure(s)

  • U.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

  • Involvement of Prisoners in a Research Study Form

  • MRI Screening Form – Women

  • 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 application must be completed and submitted using the MSU IRB online system. The initial application must be completed in full; all questions must be completed. The MSU IRB online system will not allow submission of an incomplete application. An approval letter will not be released until the IRB office is in receipt of confirmation from the PI through which the PI accepts responsibility for the research study.

Submission Processing
The HRPP staff assigns the initial application an IRB number. The HRPP staff checks for completeness (e.g., appropriate documents attached). Incomplete applications will be returned. HRPP staff verifies current training for researchers listed on the research study. HRPP staff will notify the PI 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.

Change in Review Level
Investigators indicate on the application which level of review (expedited or full board) and category (for expedited) they believe the research study falls into, but the IRB chair or members may change the category if the selection is not appropriate. See HRPP Manual 8 “Types of IRB Review” for policies and procedures related to change in review level and/or category.

Materials Provided to IRB Members
Assigned reviewer(s) may access the initial application 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 applications, the criteria for IRB approval must be met to approve or recommend approval of the application. 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
With limited exceptions specified in HRPP Manual 8-8 “Flexibility Initiative,” an IRB may not approve a research study for more than one year. Typically, the approval period is 364 days. However, 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.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 8-5, Initial Review.