580. Documentation of w88 slot Recommendations

Updated June 10, 2024

w88 slot Comments

IRBNet provides a text box for reviewers to note w88 slot (i.e., Reviewers w88 slot). Use of the w88 slot comments box varies by w88 slot and circumstances. Reviewers use the w88 slot comments box to restate or summarize comments noted in w88 slot worksheets or to provide additional comments.

w88 slot Recommendations

The following are suggestions for use of w88 slot recommendations. Actual recommendations vary by w88 slot 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 w88 slot criteria for approval; generally, applies to projects/packages assessed by Administrative w88 slot by w88 slot Integrity & Security staff, or the IRB chair or designated IRB member.

Approve

This w88 slot applies to w88 slot or Expedited w88 slot of new projects, and continuing review and amendment packages when the primary/expedited w88 slot confirms the criteria for IRB approval have been met without the need for subsequent revisions.

Approve with Conditions

This w88 slot applies to w88 slot or Expedited w88 slot of new projects, and continuing review and amendment packages when the primary/expedited w88 slot 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 w88 slot confirms a closure request. Closures are commonly completed via Administrative w88 slot.

Defer

This w88 slot applies to w88 slot w88 slot of new projects, and continuing w88 slot 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 w88 slot when the w88 slot requests substantive revisions that they prefer to review/approve.

Disapprove

This w88 slot is limited to Full Committee w88 slot of new projects, or rarely, to amendment packages. The recommendation to disapprove applies when the IRB or primary w88 slot 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 w88 slot determines a new project meets the criteria for Exempt w88 slot under 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 w88 slot.

Information Required

Generally used by IRB staff when information is required to finalize IRB w88 slot 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 w88 slot-member reviewers may select this option in lieu of Approve with Conditions or Defer.

Not w88 slot

There is no official use for this w88 slot, but it may be selected for projects that do not meet the DHHS or FDA federal definition of w88 slot (w88 slot Definitions).

Refer to Full Board

This recommendation is selected when the w88 slot determines a project submitted for human research determination request, or for Exempt or Expedited Review requires review by the convened IRB.

w88 slot - Not Engaged

There is no official use for this recommendation, but it may be selected when the IRB-member w88 slot determines University or Affiliate investigators are not engaged in the research components of a project (see Policy Manual Definitions).

w88 slot - Not Human Subjects w88 slot (HSR)

This recommendation is selected when an IRB-member w88 slot or Research Integrity & Security staff determine:

  • The proposed activity, program, or project does not constitute w88 slot as defined in the regulations at 45 CFR 46.102, item (l);
  • The w88 slot project does not involve human subjects as defined in the regulations at 45 CFR 46.102, item (e)(1); or
  • The w88 slot or Affiliate researcher is not engaged in human w88 slot (see Policy Manual Definitions).

Most commonly w88 slot to determination requests submitted for Administrative w88 slot but may apply to projects reviewed as exempt or by the w88 slot.

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 slot 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 slot study.

Documentation of w88 slot Recommendations

For New Projects, the Primary or Expedited w88 slot 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 w88 slot 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 w88 slot finalizes documentation of completed reviews.

See the Human w88 slot Protection Program (HRPP) Policy Manual for more information about review materials and worksheets.

Finalizing Documentation of IRB w88 slot

From the Submission Detail Page in IRBNet, the w88 slot selects the option to add comments and w88 slot documents to open the w88 slot Comments page where they

  • noteadditional w88 slot Comments (if any);
  • select their w88 slot from the drop-down list;
  • check the box to mark their personal w88 slot complete;
  • addthe relevant w88 slot worksheets and any other documents relevant to the w88 slot as w88 slot Documents; and
  • saveand exitthe w88 slot Comments page.