580. Documentation of Reviewer Recommendations

Updated July 1, 2019

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 by Administrative Review by RI staff, or the IRB chair or designated IRB member.

Approve

This recommendation applies to Full Committee or Expedited Review of 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 to Full Committee or Expedited Review of 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 via Administrative Review.

Defer

This recommendation applies to Full Committee Review of 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 for Expedited Review when the reviewer requests substantive revisions that she/he prefers to review/approve.

Disapprove

This recommendation is limited to Full Committee Review of new projects, or rarely, to amendment packages. The recommendation to disapprove applies when the IRB or primary reviewer determines the research 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 for Exempt Review under DHHS regulations a 45 CFR 46.111, item (b) 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 of Approve with Conditions or Defer.

Modifications Required

There is no official use for this recommendation but IRB-member reviewers may select this option in lieu of Approve with Conditions or Defer.

Not Research

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 of research (see Policy Manual Definitions).

Refer to Full Board

This recommendation is selected when the reviewer determines a project submitted for human research determination request, or for Exempt or Expedited Review requires review by the convened IRB.

Research - 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 research components of a project (see Policy Manual Definitions).

Research - Not HSR

This recommendation is selected when an IRB-member reviewer or RI staff determine:

  • The proposed activity, program, or project does not constitute research as defined in the regulations at 45 CFR 46.102, item (d);
  • The research project does not involve human subjects as defined in the regulations at 45 CFR 46.102, item (f); or
  • The University or Affiliate researcher is not engaged in human subject research (see Policy Manual Definitions).

Most commonly applies to determination requests submitted for Administrative Review but 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 research 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 research 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, 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 HRPP Policy Manual for more information about review materials and worksheets.

Finalizing Documentation of IRB Review

From the Submission Detail Page in IRBNet, the reviewer selects the option to Add comments and reviewer documents to open the Reviewer Comments page where she/he

  • notes additional Reviewer Comments (if any);
  • selects her/his Recommendation from the drop-down list;
  • checks the box to mark her/his personal review complete;
  • adds the relevant review worksheets and any other documents relevant to the review as Reviewer Documents; and
  • saves and exits the Reviewer Comments page.