HRPP Manual Section 8-3
Committee Review Procedure
Revised Common Rule Requirements (2018 Requirements)
“Except when an expedited review procedure is used (as described in §46.110), an IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.” 45 CFR 46.108(b)(2018 Requirements)
Pre-2018 Common Rule Requirements
“In order to fulfill the requirements of this policy each IRB shall:
(b) Except when an expedited review procedure is used (see §46.110) [(see § 56.110)], review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.” 45 CFR 46.108(Pre-2018 Requirements), 21 CFR 56.108 [FDA]
Committee review by the convened Institutional Review Board (IRB) is required for:
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Initial study submissions that are not eligible for exempt or expedited review procedures
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Initial study submissions that are eligible for exempt or expedited review procedures but the IRB otherwise determined convened review is required
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Modifications that are non-minor changes
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Continuing review for renewed approval (continuing review) of research studies that initially required committee review, with or without modifications to the study (with certain limited exceptions – see below)Disapproval of a research study, regardless of review level
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Issues in which resolution cannot be made between the IRB reviewer and the investigator
Committee review by the convened IRB may also be used when an IRB member seeks clarification on the eligibility of a study for expedited review procedures or recommends a study be brought to the convened IRB for review. In these instances, the convened IRB will determine whether the study qualifies for expedited review procedures or exempt review or meets the definition of human subject research. Even if the convened IRB determines that a study qualifies for expedited review, the convened IRB may determine that expedited review procedures may not be used for subsequent continuing review. The review process follows the committee review procedures provided in this section, until a determination is made by the convened IRB to permit expedited continuing review. The rationale for this determination will be documented by the IRB using a standard form.
To determine if the research study may be reviewed using the expedited or exempt review procedure, see the Human Research Protection Program (HRPP) Manual 8-1 “Exemptions” or 8-2 “Expedited Review Procedure.”
To determine if a change is non-minor, see HRPP Manual 8-6 “Modifications to an Approved Research Study.”
Research that underwent committee review during the initial review will typically not be eligible for expedited review procedures at the time of continuing review unless the research meets the criteria under expedited review and the convened IRB determines that expedited review procedures are appropriate. See HRPP Manual 8-2 “Expedited Review Procedure” for requirements.
Primary Review Procedure
For specific documents required for submission and evaluation criteria, see HRPP Manual: 8-5 “Initial Review", 8-6 “Modifications to an Approved Research Study,” and 8-7 “Renewed Approval.”
Assignment and Material Distribution
An IRB chair assigns the lead (primary reviewer) reviewer to the research study. The process for the assignment of the lead reviewer is based on expertise for committee review. It utilizes the same mechanism described in HRPP Manual 8-2 “Expedited Review,” specifically the section titled “Expertise.” See HRPP Manual 8-2 “Expedited Review” for a description of the mechanism.
The lead reviewer typically has seven days in which to review the research study.
Initial Study
One lead reviewer is assigned the research study prior to the convened IRB review. The lead reviewer is alerted of the assignment. All other members of the IRB are notified of the submission at the time of the lead review assignment and have access to all materials available to the lead reviewer. See HRPP Manual 8-5 “Initial Review” for materials provided to reviewers. The lead reviewer conducts an in-depth review of all submitted documents. The lead reviewer will also provide a summary of the research study to the committee. The summary includes a summary of the study, a brief synopsis of reviewer comments and the investigators’ responses, as well as issues that are outstanding at the time of the IRB meeting. The summary is presented to the convened IRB. The lead review assignment and/or submission of a lead review assignment may be re-assigned by the IRB chair if needed e.g., if the lead reviewer becomes unavailable.
Continuing Review With or Without Study Modification
The IRB chair is assigned lead reviewer or another reviewer is assigned as the lead reviewer if the IRB chair has assigned or previously designated their assignment. See HRPP Manual 8-7 “Renewed Approval” for materials provided to assigned reviewers.
Non-Minor Changes
The IRB chair is assigned lead reviewer or the IRB chair assigns another lead reviewer. See HRPP Manual 8-6 “Modifications to an Approved Research Study” for materials provided to assigned reviewers.
Review Comments Prior to Convened Meeting
Any IRB member may submit a comment prior to the convened IRB meeting. The process for review comments generated by reviewers prior to the convened IRB meeting occurs using the same procedure provided in HRPP Manual 8-2 “Expedited Review,” specifically the section titled “Review Comments Procedure.” See HRPP Manual 8-2 “Expedited Review Procedure” for a description of the procedure.
Recommending Disapproval
If a reviewer indicates that they would not recommend approval of the research study, the procedure for bringing disapprovals to the convened IRB follows the section titled “Recommending Disapproval in HRPP Manual 8-2 “Expedited Review Procedure.” See HRPP Manual 8-2 “Expedited Review” for a description of the procedure.
Convened IRB Review
Pre-Meeting Materials Distribution
All materials required for convened IRB review of a research study will typically be available online to all IRB members, including alternates, at least 10 days prior to the meeting date. See HRPP Manual 5-5 “Meetings” for more information about convened meetings. Comments may be sent to the investigators from any member of the IRB via the review process described above prior to the meeting. Materials not available via the Michigan State University (MSU) IRB online system will be made available (e.g., electronically, available in the study’s file) as needed. See HRPP Manual 3-1, MSU Human Research Protection Program Plan for a description of the MSU IRB online system.
Initial Study Submissions
IRB members access the initial study submission, all supporting documents associated with the research study, reviewer(s) comment(s), and investigator(s) response(s) via the MSU IRB online system. For initial review of research by the convened IRB, all IRB members, including alternate members anticipated to attend the meeting, are expected to review the submission for initial review, the proposed consent form(s), and recruitment materials in enough depth to discuss the information when present at the convened IRB meeting. The lead reviewer is expected to review all submitted documents.
Submissions for Continuing Review With our Without Modifications
Some continuing review submissions include modifications. IRB members access the continuing review or modification/continuing review submission, all supporting documents associated with the submission (e.g., current consent, , status report, when modifying the study any newly proposed consent form(s) and/or any new or revised documents), reviewer(s) comment(s), and investigator(s) response(s) via the MSU IRB online system. For continuing review by the convened IRB, all IRB members, including alternate members anticipated to attend the meeting, are expected to review the submission history, the continuing review submission, the current consent form(s), and for continuing reviews that include modifications, any newly proposed consent form(s) and/or new or revised documents, in enough depth to discuss the information when present at the convened meeting. The complete protocol including any protocol modifications previously approved by the IRB is available to the lead reviewer and any IRB member through the MSU IRB online system or for legacy studies, upon request.
Non-Minor Changes
IRB members access the modification submission, all supporting documents associated with the submission (e.g., the revised and/or modified documents such as the consent form, instrument), reviewer(s) comment(s), and investigator(s) response(s) via the MSU IRB online system. For review of modifications to previously approved research by a convened IRB, all IRB members, including alternate members anticipated to attend the meeting, are expected to review all modified documents in enough depth to discuss the information when present at the convened meeting. The complete protocol including any protocol modifications previously approved by the IRB is available to the lead reviewer and any IRB member through the MSU IRB online system or for legacy studies, upon request.
Meeting Material Distribution
See the HRPP Manual 5-5 “Meetings” for materials that will be available or distributed.
Additional Review Criteria and Documentation
Additional criteria must be met and documentation must be maintained if the research involves the following:
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Children
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Pregnant women, fetuses, or neonates
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Prisoners
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Individuals with diminished capacity to consent
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Waiver or alteration of the consent procedure
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Waiver of documentation of consent
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Informed consent exception for recruiting, screening, or determining eligibility
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Alteration to, or waiver, in whole or in part, of the individual authorization required by 164.508 for use or disclosure of protected health information (PHI)
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Significant risk or nonsignificant risk device determination
To determine whether the criteria have been met, the convened IRB shall review the submission and determine if the appropriate criteria have been satisfied. The investigator may be asked to explain and provide rationale for why a criterion is met.
If the applicable criteria have been satisfied, documentation that the criteria have been met and the research study specific information justifying why each criterion have been met shall be recorded in the minutes of the convened IRB meeting. Standard forms shall be used for documentation.
For applicable criteria, see the following sections of the HRPP Manual:
6-4-B Waiver or Alteration of Informed Consent
6-4-C Parental Permission and Child Assent
6-4-E Informed Consent Exception for Recruiting, Screening, or Determining Eligibility
6-8-A Pregnant Women, Human Fetuses, and Neonates
7-2 Significant Risk and Nonsignificant Risk Medical Devices
7-6-B Alteration or Waiver of Individual Authorization
Actions by the Convened IRB and Communication of Actions
Approval will be granted when a majority of members present vote for approval at a convened meeting. A majority of members present may also vote for modifications required to secure approval, deferral, or disapproval of research studies. The communication of actions taken by the IRB will depend upon the action taken. Typically, the IRB administrator or IRB staff assists the IRB chair or vice-chair in drafting the communication.
Deferral
Deferral occurs when the IRB cannot make the determinations required by the IRB according to 45 CFR 46.111 and 21 CFR 56.111 as appropriate. These may include substantive clarifications or modifications regarding the research study or the informed consent form(s) that are directly relevant to the determinations required by the IRB according to 45 CFR 46.111 and 21 CFR 56.111 as appropriate. A notification will be sent and a letter will be available through the MSU IRB online system to the researchers, with an explanation of what is needed for the IRB to consider the study for approval at a subsequent meeting. The investigator needs to address the comments and submit their response through the MSU IRB online system. The investigator’s response will be brought to a subsequent IRB meeting for review.
Modifications Required to Secure “Approved”
The MSU IRB online system requires use of the Modifications Required to Secure “Approved” determination to allow edits to the study (e.g., upload of revised document). As a result, Modifications Required to Secure “Approved” may be granted by the IRB when the IRB, as a condition of approval, requires that the investigator make specified changes to the research protocol or informed consent document(s), confirm specific assumptions or understandings on the part of the IRB regarding how the research will be conducted, or submit additional document(s), such that, based on the assumption that the conditions are satisfied, the IRB is able to make all the determinations required for approval under the IRB regulations (e.g., 45 CFR 46.111, 21 CFR 56.111, and if applicable, subparts B, C, or D). A notification will be sent and a letter will be available through the MSU IRB online system to the researcher with the specific conditions that must be met for approval. The investigator needs to address the conditions and submit their response through the MSU IRB online system. The IRB chair or designee will be given the discretion to accept those changes or response and determine that the conditions are met or bring the study back to the IRB for review. Any substantive changes or requirements, requests for more information for IRB consideration, and other issues related to the criteria for approval require review and approval by the convened IRB. If the IRB chair or designee accepts the changes or response and determines the conditions are met, an approval letter with approved consent form(s) if applicable will be made available to the researchers through the MSU IRB online system. The approval date is the date the convened IRB approved the research study. However, research may not begin until the conditions are met (effective date) and accepted by the IRB chair or designee and the approval letter is made available through the MSU IRB online system.
Approval
Approval may be granted if the IRB determines that appropriate approval criteria have been met. The approval date is the date the majority of the convened IRB voted to approve the research study.
A standard approval letter shall be used to communicate such approval to researchers in writing. The approval letter and IRB approved consent form(s) if applicable will be made available to the researchers through the MSU IRB online system. The MSU IRB Online system includes the ability to finalize documents. Finalizing documents converts the document from a Word or other type of document to a PDF document, and for consent forms, adds a watermark that indicates MSU IRB approval. While documents included as part of the submission are approved, only consent forms are finalized. After a submission is approved, the approved documents are in the Documents tab in the main study workspace in the Draft column. Finalized consent forms, if applicable, are in the Documents tab in the main study workspace in the Final column, and when applicable, investigators must typically use the finalized consent form with the watermark. A notification is sent when the letter and any finalized documents are available.
For externally sponsored studies with an unexecuted contract that includes terms that could impact the consent form (e.g., subject injury language), the consent form is not finalized and released at initial approval unless the contract is executed prior to IRB approval. To assure congruence between the contract and consent form, the consent is not finalized and released until a modification with an executed contract is approved. See HRPP Manual 3-1, MSU Human Research Protection Program Plan for more information about the contract and consent review process.
Researchers will be sent a notification of the approval and of the availability of the approval letter and consent form(s) if applicable from the MSU IRB online system.
Disapproval
The IRB may disapprove a research study. If a research study is disapproved, the investigator will be notified in writing. A notification will be sent and a letter will be made available to the researchers through the MSU IRB online system and will include a statement of the reasons for the IRB’s decision. The letter will inform the investigator of their opportunity to appeal the decision in writing within 30 days of when the letter was made available. The written request to appeal the decision should clearly address the reasons provided for the IRB’s decision, indicating the facts or the interpretation in dispute, providing supporting evidence where applicable. Within the response, the investigator notifies the IRB if they would like to present their appeal in person to the IRB or if the IRB is meeting remotely, through web conferencing or teleconferencing. If the investigator would like to present their appeal to the IRB in person or through web conferencing or teleconferencing, the investigator may appeal the decision in person or through web conferencing or teleconferencing at the next IRB meeting or at an agreed upon IRB meeting date.
If the investigator responds only in writing, the appeal will be discussed at the next IRB meeting. The IRB determines whether to change the disapproval determination after the appeal. The range of actions may include disapproval, approval, deferral, or request for modifications to obtain approval. The determination will be communicated in writing to the investigator. Once the IRB has made a determination on an appeal, that determination is final. There is no mechanism for any further appeal.
Approval Action Definitions
The definitions for approval actions are the same as the definitions provided in HRPP Manual 8-2 “Expedited Review,” specifically the section titled “Approval Action Definitions.”
Other Determinations
The IRB may also make determinations related to exemptions or not human subject research, or whether a study requires committee review or whether the study qualifies for the expedited review procedure. The determination (e.g., whether a study qualifies for exemption, whether a study is human subject research, whether a study requires convened IRB review or may be reviewed through the expedited review procedure) is made when a majority of members present vote for the determination at a convened meeting. See HRPP Manual 4-3, Determination of Human Subject Research and 8-1, Exemptions for how determinations are communicated.
Further Institutional Review
Further institutional review is applicable to research approved by the convened IRB in the same way as expedited approvals. See HRPP Manual 8-2 “Expedited Review,” specifically the section titled “Further Institutional Review.” See HRPP Manual 8-2 “Expedited Review Procedure” for a description of the procedure.
Typical Review Time
Initial Study: 8-12 weeks
Modifications: 2-4 weeks
Continuing Review: 2-4 weeks
Applicability of the Revised Common Rule (2018 Requirements)
See HRPP Manual Section 4-11 “Applicability of the Revised Common Rule (2018 Requirements)” for a description of whether the Revised Common Rule (2018 Requirements) or the Pre-2018 Common Rule Requirements apply.
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 1-11-2010. Revision 6 approved by VP Research & Graduate Studies on 7-22-2011.Revision 7 approved by VP Research & Graduate Studies on 2-25-2015. Revision 8 approved by Assistant VP Regulatory Affairs on 10-6-2015. Revision 9 approved by VP Research & Graduate Studies on 12-11-2015. Revision 10 approved by Assistant VP Regulatory Affairs on 6-27-2018. Revision 11 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 12 approved by Assistant VP Regulatory Affairs on 8-26-2020. Revision 13 approved by Assistant VP Regulatory Affairs on 11-29-2021.