HRPP Manual Section 8-3

Full Board 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:

  1. Initial study submissions that are not eligible for exempt or expedited review procedures

  2. Initial study submissions that are eligible for exempt or expedited review procedures but the IRB otherwise determined convened review is required

  3. Modifications that are non-minor changes

  4. Continuing review for renewed approval of research studies that initially required committee review (with certain limited exceptions – see below)

  5. Disapproval of a research study, regardless of review level

  6. 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 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 or exempt review.. Even if the convened IRB determines that a study qualifies for expedited review, the convened IRB may determine that expedited review 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.”

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 at the time of continuing review unless the research meets the criteria under expedited review and the convened IRB determines that expedited review is 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.

Renewed Approval

The IRB chair assigns one lead reviewer to the research study prior to convened IRB review. See HRPP Manual 8-7 “Renewed Approval” for materials provided to assigned reviewers.

Non-Minor Changes

The IRB chair assigns one 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” 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.” 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 MSU IRB online system will be made available (e.g., electronically, available in the study’s file). 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, 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 Renewed Approval

IRB members access the continuing review submission, all supporting documents associated with the submission (e.g., current consent, any newly proposed consent form, status report), 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, and any newly proposed consent form 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 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, 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 upon request.

Meeting Material Distribution

See the HRPP Manual 5-5 “Meetings” for materials that will be available or distributed.

Review and Documentation of Waivers and Certain Vulnerable Populations

Additional criteria must be met and documentation must be maintained if the research involves the following:

  • Children
  • Pregnant women, fetuses, or neonates
  • Prisoners
  • Waiver or alteration of the consent procedure
  • Waiver of documentation
  • Informed consent exception for recruiting, screening, or determining eligibility
  • 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)

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-D       Waiver of Documentation

6-4-E       Informed Consent Exception for Recruiting, Screening, or Determining Eligibility

6-8-A       Pregnant Women, Human Fetuses, and Neonates

6-8-B       Prisoners

6-8-C       Children

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 letter will be sent 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 his/her response to the IRB. The investigator’s response will be brought to a subsequent IRB meeting for review.

Modifications Required to Secure Approval

Modifications required to secure approval may be granted by the IRB when additional specific changes requiring simple concurrence by the investigator are needed. A letter will be sent to the researcher, if applicable, with the specific conditions that must be met for approval. The investigator needs to address the comments and submit his/her response to the IRB office in writing. The IRB chair or designee will be given the discretion to accept those changes and determine that the conditions are met, or bring the research study back to the IRB for review. If the IRB chair or designee accepts the changes 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 and accepted by the IRB chair or designee and the approval letter is sent to and received by the investigator(s).

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 document to a PDF document, and for consent forms, adds a watermark. 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 this finalized consent form with the watermark.

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 letter will be sent to the researchers and will include a statement of the reasons for the IRB’s decision. The letter will inform the investigator of his/her opportunity to appeal the decision in writing within 30 days of when the letter was sent. 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. If the investigator would like to present their appeal to the IRB in person, the investigator may appeal the decision in person at the next IRB meeting.

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, or request for modifications to obtain approval. The determination will be communicated in writing to the investigator.

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.”

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” for a description of the procedure.

Typical Review Time

Initial Study: 4-6 weeks

Modifications: 2-4 weeks

Continuing Review: 3-6 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.

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