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700-25-Administrative Pre-Review

Title: Administrative Pre-Review
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: Administrative procedures ensure that IRB members not only have adequate time for a thorough assessment of each proposed study but also that the documentation they receive is complete and allows for an adequate assessment of study design, procedures, and conditions.

Purpose: This policy details how IRB submissions are administratively pre-reviewed to determine completeness and how materials are distributed to IRB members.

Procedures:

  1. Pre-Review for a New Project/Study
    1. An administrative pre-review of all submissions is conducted by the IRB Chair (or designee) using the IRB Administrative Pre-Review Checklist to determine if sufficient information has been provided for IRB review. The IRB Chair (or designee) may request revisions to ensure sufficient information for the IRB review.
      1. New Submission - Upon completion of the pre-review for new submissions, the IRB Chair (or designee) makes an initial decision as described below. Note: If the research involves USU data or research with USU constituents, approval from the Committee of Internal Research must be included with the submission (see Policy 211: Research on USU Constituents).
  • Not Human Subject Research - review and determination completed by the IRB Chair (or designee) as outlined in 700-13: Not Human Subject Research.
  • Exempt Research - review and determination completed by the IRB Chair (or designee) as outlined in 700-21: Exempt Research.
  • Eligible for Expedited Review - assigned to IRB Chair or a designated expedited reviewer for review as outlined in 700-22: Expedited Review.
  • Minimal Risk Studies that do not fit into the above categories - assigned to a Primary Reviewer for Convened Board Review (see 700-23: Full Board Review). Secondary Reviewers are assigned to review studies involving vulnerable populations.
  • Greater than Minimal Risk Studies – Study not accepted for review per 700-3: USU as a Minimal Risk Institution.

b. Continuing Reviews - Upon completion of the pre-review for continuing review form, the IRB Chair (or designee) proceeds as follows:

i. Study is assigned to a Primary Reviewer for Convened Board Review (see 700-23: Full Board Review) unless eligible for Expedited Review. If an expedited review is appropriate, it is assigned to the IRB Chair or a designated expedited reviewer.

c. Review of Amendment Forms - Upon completion of the pre-review for an Amendment Form, the IRB Chair or designee proceeds with the appropriate action based upon whether the amendment proposes minor changes and involves no more than minimal risk to the participants.

i. Amendments to submissions originally determined to be “not human subject research” or “exempt research” will be reviewed to determine whether the changes alter the initial determination. Amendments to “not human subject research” or “exempt research” with substantial changes that alter exempt status will be reviewed using initial review procedures.

ii. Amendments proposing minor administrative changes that involve no additional risk to participants will be reviewed by the IRB Chair or designee.

iii. Amendments proposing changes that have been requested by a convened board will be assigned to a designated expedited reviewer for review. Full board discussion is not required for these submissions.

iv. Amendments proposing minor changes that involve no more than minimal risks to the participant will be assigned to a designated expedited reviewer for review. Full Board discussion is not required for these submissions.

v. Amendments that may present a greater than minimal risk to the participant are rejected (see 700-3: USU as a Minimal Risk Institution).

d. Review of Event Reporting Forms –Event Reporting Forms are reviewed by the IRB Chair or designee, and pending the reported incident, the applicable policy(ies) are followed (see 700-29: Amendments/Changes to Protocol and 700-31: Unanticipated Problems Involving Risks to Participants or Others).

e. Review of Final Report Form – Reviews of Final Report Forms are conducted by the IRB Chair or designee (see 700-30: Final Reports).

Scope: This policy applies to all IRB submissions, including new submissions, as well as reviews for continuation, amendments, event reporting forms, and final reports.

Documents and Forms:

IRB Pre-Review Checklist (available on IRB Google Drive)

Continuing Review Form

Amendment Form

Event Reporting Form

Final Report Forms