Skip to main content

Termination Notices, Stop-Work Orders, Requests or Directions for Change(s) in Terms and/or Scope of Work: Human Research Protection Program Considerations

May 16, 2025

Michigan State University Sponsored Programs Administration

The Michigan State University Sponsored Programs Administration (SPA) provides information on federal updates resulting from the administration transition. This includes processes for termination notices, stop-work orders, requests or directions for change(s) in terms and/or scope of work. Please follow the processes described by SPA. https://www.spa.msu.edu/PL/Portal/5114/FederalUpdatesResultingFromAdministrationTransition

Human Research Protection Program Considerations

In addition, the following considerations have been developed to help assist researchers whose human research studies may be impacted. Because each study and circumstance are unique, the MSU Human Research Protection Program (HRPP) will help assist researchers on a study specific basis. Please contact the HRPP office with any questions (email: irb@msu.edu or phone: 517-355-2180).

  • Report New Information (RNI): If termination notices, stop-work orders, requests or directions for change(s) in terms and/or scope of work may require modification, study closure and/or may involve potential risks to subjects or others, please submit a Report of New Information (RNI) in Click. This will allow the HRPP to provide project specific guidance on next steps.

  • Risk to Participants: If participants could be placed at risk (e.g., inability of participants to obtain study drug or inability of participants to continue study visits which would result in a risk), please submit an RNI in Click. Please also feel free to contact the HRPP.

  • External IRB: For research relying on an External IRB (MSU IRB is not the IRB of record), please check and follow the External IRB’s requirements. Please also submit an RNI in Click so the HRPP can help determine whether any updates are needed to MSU’s External IRB submission.

  • Changes: While the HRPP will work with researchers on a study specific basis, researchers may want to consider the following:

    • If a study is being stopped, are changes needed to safely stop study procedures with participants?

    • Will participants need to be reconsented or notified?

    • Do changes in study procedures require changes to IRB approved documents or the IRB submission (including the HRP-503)?

    • Do consent form(s), parental permission form(s), or child assent information need to be modified?

    • Will other collaborating institutions, sites, or personnel be impacted?

    • Are updates needed to clinicaltrials.gov, if the MSU PI is the responsible party?

  • Changes Necessary to Eliminate an Apparent Immediate Hazard: For non-exempt research, changes must be approved in advance by the IRB as a modification to the study, unless they are necessary to eliminate an apparent immediate hazard to participants.

    • For research approved by the MSU IRB, if a change in protocol is made to eliminate an apparent immediate hazard to participants, it must be reported immediately thereafter. Please submit an RNI through Click, explaining why the change was necessary to ensure the participants’ welfare.

    • For research relying on an External IRB (MSU IRB is not the IRB of record), please check and follow the External IRB’s requirements for changes necessary to eliminate an apparent immediate hazard.

  • Federal Agency Specific Human Research Requirements: Some federal agencies have additional human research protection requirements. If federal funding is terminated, the HRPP will work with the researcher to determine if changes are needed because of the agency specific requirements (e.g., Certificates of Confidentiality issued as a term and condition of an award for some NIH funded studies).

Questions

For human research protection related questions, please contact the HRPP office. Please note that questions may also be referred to Sponsored Programs Administration or the Office of the General Counsel when needed.

Email: irb@msu.edu

Phone : 517-355-2180