OPRS SOP 302: Administrative Review and Distribution of Materials

Approved Date

04/17/2023

Revised Date

04/17/2023

Full Details

POLICY

The efficiency and effectiveness of the IRB is supported by administrative procedures that ensure that IRB members not only have adequate time for thorough assessment of each proposed study, but that the documentation they receive is complete and clear enough to allow for an adequate assessment of study design, procedures, and conditions.

PROCEDURES

1. Procedures for Administrative Review

An administrative review (pre-review) of all new study, continuing review and amendment applications is conducted by OPRS staff using checklists developed to determine if sufficient information has been provided for IRB review. 

The assigned administrative reviewer may request revisions of the investigative staff to ensure sufficient information for the IRB review.

• New Studies - Upon completion of the pre-review for new study applications, an assigned administrative reviewer makes a primary risk assessment. Based on the primary risk assessment, the administrative reviewer proceeds with the appropriate action as described below.

Primary Risk Assessment	Review Requirements
Non-Research/Non-Human Subject Research	Review and determination completed by an OPRS staff reviewer as outlined in SOP 401.
Exempt	Review and determination completed by an OPRS staff member (who must be an IRB member) as outlined in SOP 402.
Minimal	Assigned to a Primary Reviewer for Convened Board Review (see SOP 404) unless eligible for Expedited Review. Primary and Secondary Reviewers are assigned to review studies involving vulnerable populations. If eligible for Expedited Review (see SOP 403), assigned to IRB Chair or a designated expedited reviewer for review.
Greater than Minimal Risk	Assigned to Primary and Secondary Reviewers for Convened Board Review (see SOP 404).

• Continuing Reviews - Upon completion of the pre-review for continuing review applications, an assigned administrative reviewer proceeds with the appropriate action based upon the determined risk assessment and the current status of the study. If research did not qualify for expedited review at the time of initial review, it does not qualify for expedited review at the time of continuing review except in limited circumstances as described in expedited categories (8) and (9) of 63 FR 60364-60367 (see Expedited Review of Research Guidance on the IRB website).

Determined Risk Assessment	Review Requirements
Minimal	Assigned to a Primary Reviewer for Convened Board Review (see SOP 405) unless eligible for Expedited Review. Unless determined otherwise continuing review is not required for eligible expedited review if the study was approved on or after the implementation of the Final Rule (January 21, 2019), or the study was transitioned to the Final Rule. If Expedited Review (see SOP 402) is appropriate it is assigned to IRB Chair or a designated expedited reviewer for review.
Greater than Minimal Risk	Assigned to Primary Reviewer for Convened Board Review (SOP 404) unless eligible for Expedited Review. If eligible for Expedited Review (see SOP 403), assigned to IRB Chair or a designated expedited reviewer for review.

• Amendments - Upon completion of the pre-review for amendment applications, an assigned administrative reviewer proceeds with the appropriate action based upon whether the administrative reviewer determines that the amendment proposes minor changes and involves no more than minimal risk to the participant. Amendments to exempt studies will be reviewed to determine whether the changes alter the initial exempt determination.

Amendment Type	Review Requirements
Amendments to exempt studies	Substantial changes which alter exempt status will be reviewed using initial review procedures.
Amendments proposing minor administrative changes and involve no additional risk to participants	Assigned to OPRS staff for review and approval.
Amendments proposing changes which have been requested by a convened board	Assigned to a designated expedited reviewer for review. Full board discussion is not required for these submissions.
Amendments proposing minor changes and involves no more than minimal risks to the participant	Assigned to designated expedited reviewer for review. Full Board discussion is not required for these submissions.
Amendments proposing substantial changes or may represent a greater than minimal risk to the participant	Assigned to Primary Reviewer for Convened Board Review (see SOP 405) regardless of the determined risk assessment of the study (i.e. minimal, greater than minimal).

2. Procedures for the Assignment of Reviewers and Preparation of an Agenda
   • The assignment of designated expedited reviewers, primary reviewers and secondary reviewers is the responsibility of the IRB meeting facilitator. The IRB meeting facilitator makes assignments with the help of IRB panel rosters. The IRB meeting facilitator assigns reviewers with the appropriate scientific and scholarly expertise to conduct an in-depth review of the protocol. Based upon the research proposal, the IRB meeting facilitator assigns reviewers who are knowledgeable about or experienced in working with vulnerable participants, if necessary. If the IRB meeting facilitator finds there is no IRB member with appropriate scientific and scholarly expertise to conduct an in-depth review, IRB coordinator will consult with the IRB Director for assistance in obtaining consultation or whether deferral to another IRB meeting will be required.
   • The assignment of convened board reviewers (primary and secondary reviewers) are made at least seven calendar days in advance of the convened board meeting. If the assignment is made less than seven calendar days before a convened meeting, extenuating circumstances must exist and the assignment must be made no less than two working days prior to the meeting. The assignment of designated expedited reviewers is conducted concurrently with the assignment of convened board reviewers. All reviewers receive an e-mail from the meeting facilitator with their assigments.
   • The IRB meeting facilitator creates the meeting agenda based upon the reviewer assignments and is responsible for the accuracy of the agenda and for completing any other components of the agenda. A copy of the agenda and attached materials is maintained with the meeting minutes in OPRS records.

Complete applications as described in SOP 301 (Research Submission Requirements) are available to all IRB members, via the electronic agenda beginning at least seven calendar days in advance of the convened meeting. Complete applications are made available to any alternate members attending the meeting in place of a regular member. Ad hoc consultant reviewers receive copies of material that pertain to their requested input.