Review Process FAQs

Frequently Asked Questions (FAQs) specific to the IRB review processes are available below. For all available FAQs, please visit the Main FAQ page. This page includes an index with links to all specific FAQ pages.

• Will my study require an IRB application?

  At MSU, all research and/or clinical investigations involving human subjects must be reviewed and approved by an Institutional Review Board before initiation. This is based on federal regulations, university policies, and accreditation standards.

  If you have any questions on whether an activity requires IRB review, contact the IRB office by phone: 517-355-2180 or email: irb@msu.edu.

  More information can be found in the HRPP Manual, 4-3, Determination of Human Subject Research.

• Can I be Principal Investigator on an IRB project?

  Only certain persons may be designated as the Principal Investigator on a human subject research study. These include MSU regular faculty, emeritus faculty, and fixed term faculty employees with rank of assistant professor or higher.

  Students, staff, and individuals holding other appointment titles, such as research associate, specialist, post-doctoral fellow, visiting, adjunct, or clinical faculty, may be designated on the IRB application as an additional investigator, but not as the PI.

  In the case of graduate student research for theses or dissertations, the student's major advisor or another faculty member should be designated on the IRB application as the PI and the graduate student as an additional investigator.

  There are some exceptions to these general requirements.

  More information can be found in the HRPP Manual, Section 4-9, “Designation of Principal Investigator.” 

• What kinds of changes to my approved IRB project require submission of a Modification?

  Any proposed change (modification) to an approved, non-exempt IRB project that affects human subjects (with certain limited exceptions) must be reviewed and approved by the Institutional Review Board prior to implementation of the change. These changes can be minor or non-minor changes.

  This includes, but is not limited to:

  • Alteration of study design, methodology, or recruitment methods
  • Changes to any instruments, including surveys and questionnaires
  • Changes to consent documents
  • Changes to the study population
  • Changes in funding
  • Addition or removal of study personnel
  • Addition or removal of research performance sites

  More information can be found in the HRPP Manual Section 8-6, Revisions to an Approved Project.

• Where can I find information on developing a consent document?

  Templates for informed consent documents are available at the Informed Consent Template page.

  Be sure to also consider the consent process as you develop the consent form; you will be asked to describe the process in the IRB application.

• When do I close my IRB project?

  If all research activities involving human subjects, including data collection and analysis of identifiable private data, are complete, the principal investigator may close the research project.

  More information can be found in the HRPP Manual Section 8-9, Closure.

• What should I do if I don't intend to renew my IRB approval?

  The Principal Investigator must complete and submit a Continuing Review submission, along with the HRP-528 - Template - Closure Report in Click.

  More information can be found in the HRPP Manual Section 8-9, Closure.

• Can I continue to work on my IRB project if my approval has expired?

  No. If a Principal Investigator (PI) does not provide continuing review information to the IRB or the IRB has not approved a continuing review application by the expiration date:

  • All research activities must stop. Stopping all research activities includes recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and analysis of identifiable private data.
  • Interventions and interactions on current subjects can continue only when the IRB finds an over-riding safety concern or ethical issue involved such that it was in the best interests of individual subjects to continue.
  • Under no circumstances can the IRB allow the enrollment of new subjects into expired research studies.

  PIs who would like to continue non-exempt human research and/or a clinical investigation beyond the expiration of IRB approval must submit and receive renewed approval prior to the research study’s expiration.