MSU HRPP Manual Section 8-6

8-6, Revisions to an Approved Research Study

Any proposed change or revision to an approved non-exempt research study that affects human subjects (with certain limited exceptions discussed below), must be reviewed and approved by the Institutional Review Board (IRB) prior to implementation of the change. To apply for approval of a revision, the investigator must complete and submit a revision application and attach any new and/or revised documents.

Revision approvals do not change the approval or expiration date of the research study.  The approval simply approves the modification or revision to the research study and allows investigators to begin using the modified or new documents, procedures, etc.  The principal investigator (PI) must receive a letter from the IRB approving the proposed revisions before the changes are implemented.

Immediate Change to Eliminate Hazard
When an immediate change in a research protocol is necessary to eliminate a hazard to subjects, the proposed change need not be reviewed by the IRB prior to its implementation. In such situations, however, investigators must report the change in protocol to the IRB immediately thereafter. See the Human Research Protection Program (HRPP) Manual 9-5 “Unapproved Change in Protocol” for policies and procedures.

Minor vs. Non-Minor Changes

45 CFR 46.110 (b), 21 CFR 56.110(b). An IRB may use the expedited review procedure to review either or both of the following:

(1) some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk

(2) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Minor Changes
A minor change is one that does not introduce risks that exceed those ordinarily encountered by the subjects in daily life or in the performance of routine physical or psychological examinations or tests. Minor changes may be reviewed using the expedited procedure. Minor modifications cannot include addition of procedures that involved more than minimal risk or do not meet the criteria for expedited categories (1) – (7) of research that could be reviewed using the expedited procedure.

Non-Minor Changes
A change that is not minor introduces risks to subjects that exceed those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. A change that does not meet the criteria for expedited categories (1) – (7) of research cannot be reviewed using the expedited procedure. A change that is not minor must be reviewed at the convened IRB meeting.

If the research study’s review level is not already full review and the change requested is considered a non-minor change, the study’s review level will be changed to full review. See HRPP Manual 8 “Types of IRB Review” for policies and procedures related to change in review level and/or category.

The IRB member reviewing the research study makes the determination on whether the change is minor or non-minor. The IRB chair, other reviewers, or other experts may be consulted to determine if the revision qualifies as non-minor and therefore needs to be sent to additional reviewers and be reviewed at the convened IRB meeting. If the revision is non-minor or when it is not clear if the revision is minor, the revision will be brought to the convened IRB for review. See HRPP Manual 8-3 “Full Board Review Procedure” for the process. If the IRB determines that the changes are minor, the research study will be reviewed using the expedited review procedure, and an approval letter may be issued once reviewer(s) approve the change. See HRPP Manual 8-2 “Expedited Review Procedure.”

Materials Required for Submission
The investigator is required to complete and submit the revision form using the MSU IRB online system. The online revision application includes a description of the change and whether the change affects the risk or consent.  The investigators are required to submit any new or modified documents with the revision application. Revision applications will not be processed if the new or modified document is missing.

Mechanism(s) for Submission
MSU IRB revision applications must be submitted via the MSU IRB online system. The MSU IRB online system will not allow submission of an incomplete application. The PI must log in and check that they have read the assurance language to submit the revision application. Only the PI may submit a revision application.

Submission Processing
The IRB staff checks for completeness (e.g., all questions answered, any new or modified documents attached). Incomplete applications will be returned.

How Review is Conducted
See the following HRPP Manual sections for review procedures: 8-2 "Expedited Review Procedure" or 8-3 "Full Board Review."

IRB Member Considerations
The IRB member(s) is required to review and approve protocols using the criteria at federal regulations 45 CFR 46 and, for FDA research studies, 21 CFR 50 and 56. If the human subject research is conducted, supported, or otherwise subject to regulation by a federal department or agency, there may be requirements in addition to 45 CFR 46 that are specific to the federal department or agency. See HRPP Manual 2-2 “Federal Guidelines and Regulations.” The criteria for IRB must be met to approve or recommend approval of the application. The IRB member(s) should utilize Section 6, “IRB Evaluation Criteria” of the HRPP Manual.

When reviewing modifications to an approved research study (revisions), the criteria for IRB approval must be met to approve the requested revision. The IRB member(s) should determine how the change may affect the IRB approval criteria (e.g., change in recruitment may affect the selection of subjects criteria for approval). The IRB member(s) should utilize HRPP Manual 6, “IRB Evaluation Criteria” to review the proposed change (e.g., informed consent section for changes to the informed consent process) as needed.

The IRB member(s) should, in particular, consider the following:

  • The type of change (modification vs. addition)

  • Whether there is a change in level of risk

  • Whether the change alters the research study’s review level and/or category (See HRPP Manual 8, “Types of IRB Review” for policies and procedures related to change in review level and/or category)

  • Overall effect of change on research study

  • Whether change requires a modification to the consent process and/or form

  • Whether the change involves:

    • Vulnerable populations

    • Addition of sensitive questions

    • Privacy and/or confidentiality considerations

  • Effect of the change on subjects’ willingness to continue the study

  • Whether information should be provided to past or currently enrolled subjects:

    • Use of an information sheet vs. re-consent

    • If provided, the adequacy of information sheet or re-consent document

  • Whether there are any significant new findings that arise from the review process and that might relate to subjects’ willingness to continue participation are provided to subjects

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 3-9-2008. Revision 3 approved by VP Research & Graduate Studies on 5-6-2008. Revision 4 approved by VP Research & Graduate Studies on 9-3-2009. Revision 5 approved by VP Research & Graduate Studies on 7-22-2011. Revision 6 approved by VP Research & Graduate Studies on 12-11-2015.

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 8-6, Revisions to an Approved Research Study.