580. Documentation of Reviewer Recommendations
Updated June 10, 2024
Reviewer Comments
IRBNet provides a text box for reviewers to note comments (i.e.,Reviewers Comments). Use of the reviewer comments box varies by reviewer and circumstances. Reviewers use the reviewer comments box to restate or summarize comments noted in reviewer worksheets or to provide additional comments.
Reviewer Recommendations
The following are suggestions for use of reviewer recommendations. Actual recommendations vary by reviewer and circumstances but commonly correlate with the review types available in IRBNet.
Acknowledge
This recommendation is reserved for projects/packages that do not require assessment of IRB criteria for approval; generally, applies to projects/packages assessed byAdministrative Reviewby w88 casino Integrity & Security staff, or the IRB chair or designated IRB member.
Approve
This recommendation applies toFull Committee or Expedited Reviewof new projects, and continuing review and amendment packages when the primary/expedited reviewer confirms the criteria for IRB approval have been met without the need for subsequent revisions.
Approve with Conditions
This recommendation applies toFull Committee or Expedited Reviewof new projects, and continuing review and amendment packages when the primary/expedited reviewer confirms the criteria for IRB approval have or will be met following review and approval of minor revisions or directed changes.
Close
This recommendation applies when the reviewer confirms a closure request. Closures are commonly completed viaAdministrative Review.
Defer
This recommendation applies toFull Committee Reviewof new projects, and continuing review and amendment packages when the convened IRB is unable to determine that requirements for IRB approval have been met and requests substantive revisions. May be used forExpedited Reviewwhen the reviewer requests substantive revisions that they prefer to review/approve.
Disapprove
This recommendation is limited toFull Committee Reviewof new projects, or rarely, to amendment packages. The recommendation to disapprove applies when the IRB or primary reviewer determines the w88 casino does not meet the criteria for IRB approval and significant changes would be required to protect participants.
Exempt
This recommendation applies when the reviewer determines a new project meets the criteria forExempt Reviewunder Department of Health and Human Services (DHHS) regulations a 45 CFR 46.104 or the University's IRB Flexibility Policy. The project may have been submitted for Exempt, Expedited, or Full Committee Review.
Information Required
Generally used by IRB staff when information is required to finalize IRB review but may be selected by IRB-member reviewers in lieu ofApprove with Conditions or Defer.
Modifications Required
There is no official use for this recommendation, but IRB-member reviewers may select this option in lieu ofApprove with Conditions or Defer.
Not w88 casino
There is no official use for this recommendation, but it may be selected for projects that do not meet the DHHS or FDA federal definition ofw88 casino(see Policy Manual Definitions).
Refer to Full Board
This recommendation is selected when the reviewer determines a project submitted for human w88 casino determination request, or for Exempt or Expedited Review requires review by the convened IRB.
w88 casino - Not Engaged
There is no official use for this recommendation, but it may be selected when the IRB-member reviewer determines University or Affiliate investigators are not engaged in the w88 casino components of a project (see Policy Manual Definitions).
w88 casino - Not Human Subjects w88 casino (HSR)
This recommendation is selected when an IRB-member reviewer or w88 casino Integrity & Security staff determine:
- The proposed activity, program, or project does not constitute w88 casino as defined in the regulations at 45 CFR 46.102, item (l);
- The w88 casino project does not involve human subjects as defined in the regulations at 45 CFR 46.102, item (e)(1); or
- The University or Affiliate researcher is notengagedin human w88 casino (see Policy Manual Definitions).
Most commonly applies to determination requests submitted forAdministrative Reviewbut may apply to projects reviewed as exempt or by the IRB.
Suspend
This recommendation applies when the IRB Chair or designee (as a preliminary determination) or the convened IRB determines a problem report warrants suspension of IRB approval for an approved w88 casino study or one or more aspects of an approved study.
Terminate
This recommendation applies when the IRB Chair or designee (as a preliminary determination) or the convened IRB determines a problem report warrants termination of an approved w88 casino study.
Documentation of Reviewer Recommendations
For New Projects, the Primary or Expedited Reviewer completes the New Project Review Worksheet and all applicable supplemental worksheets (e.g., federal agency requirements, vulnerable populations, drugs, devices, blood, and consent waivers).
For continuing and amendment reviews, the Primary or Expedited Reviewer completes the correlated review worksheet (i.e., Continuing Review Worksheet or Amendment Review Worksheet). Expedited Reviewers may be asked to complete supplemental worksheets if amendments involve changes to funding, populations, drugs, devices, blood, or informed consent.
After reviewing the materials in the relevant project/package, the Primary/Expedited Reviewer finalizes documentation of completed reviews.
See the Human w88 casino Protection Program (HRPP) Policy Manual for more information about review materials and worksheets.
Finalizing Documentation of IRB Review
From theSubmission Detail Pagein IRBNet, the reviewer selects the option toaddcomments and reviewer documents to open theReviewer Commentspage where they
- noteadditionalReviewer Comments(if any);
- selecttheirRecommendationfrom the drop-down list;
- checkthe box to mark their personal review complete;
- addthe relevant review worksheets and any other documents relevant to the review asReviewer Documents; and
- saveandexittheReviewer Commentspage.