590. Notifying Investigators and Others of Review Results

Updated July 13, 2021

In compliance with Department of Health and Human Services (DHHS) requirements at 45 CFR 46.109, item (d) for IRB review of non-exempt research, on behalf of the IRB Research Integrity staff prepare written notifications to document the IRB’s decisions to approve or disapprove human research projects; and specify the conditions and revisions required to secure IRB approval for submissions that are approved with conditions or deferred, respectively.

IRB determinations, including conditions/revisions for IRB approval and reasons for disapproval, are documented in IRB meeting minutes and published in IRBNet as letters/notifications to principal investigators (PIs). Notifications of exempt determinations are also published in IRBNet as letters/notifications to PIs.

Meeting minutes are available upon request for Institutional Officials (including those of Affiliate Institutions) seeking information about:

• actions completed during IRB meetings and
• notifications of actions completed outside of IRB meetings.

Notifications of IRB Actions

Following full committee, expedited, exempt, or administrative review, Research Integrity staff log into IRBNet, select the applicable project/package, and update the IRB Action. IRBNet template letters display the signature of the Chair/Co-Chair, and as appropriate the Research Integrity Director, reflecting the official nature of the correspondence. The template letters reflect current application of IRB practices. Research Integrity staff publish the following as Board Documents in IRBNet:

• approval and notification letters, and acknowledgements documenting IRB Actions;
• IRB determinations of noncompliance or unanticipated problems;
• date-stamped, IRB-approved consent forms; and
• approvals of HIPAA waivers of authorization.

The integrity of documentation of IRB review/approval is ensured because the design and functionality of IRBNet preclude anyone other than users with administrative privileges (i.e., Research Integrity Director and staff) from publishing any materials as Board Documents.

IRBNet automatically notifies the PI when the IRB Action for a project/package is updated and when board documents are published. Study personnel with read or full access can review the published documents.

Notification Letters

Notification, Approved: Approval letters contain the regulatory determination, (i.e., approval) and expiration dates, IRB action, review type, expedited review category if applicable, a list of approved documents (including the specific version of approved consent documents), and any IRB-specified constraints (e.g., requirement for consent to be monitored).

Notification, Approved with Conditions: Notification letters for projects/packages that are approved with conditions specify that revisions are required before approval is finalized; list the review date and type and the changes required to finalize IRB approval; and include brief instructions for investigators to submit their responses for review and final approval.

Notification, Deferred: Deferral letters specify that revisions are required before approval is finalized; lists the review date and type and the revisions required to obtain IRB approval; and include brief instructions for investigators to submit their revisions for review and approval.

Notification, Disapproved: The Deferral template is adapted when the IRB cannot approve a project. The template provides the review date and type, and determination of Disapproved. The template is revised to list the reasons for the disapproval and provide information about how the investigator may respond to the disapproval.

Notification, Exempt: Notifications of exempt determinations include the approval date, date for PI submission of annual status report (i.e., prorated expiration date), review type, and exempt category.

Acknowledgements

Acknowledgements for human research determinations include the review date, and specification that the project either:

• is not human research and does not require additional oversight by Research Integrity or IRB, or
• is human research and requires exempt determination or IRB review.

Acknowledgements of requests to use an external IRB include the review date and identify the specific external IRB serving as the IRB of Record.

Acknowledgements of changes to study personnel or sites include the review date.

IRB Approval of HIPAA Waiver of Authorization

Letters approving HIPAA waivers of authorization include the review date and confirmation that the requirements for the waiver are met.

(See the online Human Research Protection Program (HRPP) Policy Manual for information about PI notifications of noncompliance, unanticipated problems, and suspensions/terminations of IRB approval.)

Approved Consent Forms

Research Integrity staff electronically place the IRB approval date in the header or footer of each page of approved consent forms and publish the date-stamped, IRB-approved consent forms as Board Documents. These are the versions investigators must use to obtain legally effective informed consent from participants.

Approved versions remain in effect unless an amendment request includes changes to the consent form. In this case, the version that is approved with the amendment review is date-stamped and added to IRBNet as a replacement for the previously IRB-approved version. The newly approved version is then published as a Board Document for use by the researchers.

Additional Notifications of IRB Approval

After the University IRB approves or disapproves a research study, further approval/disapproval by other persons or offices is not generally required unless research funding is overseen by University Sponsored Projects (SP). SP receives information from PIs concerning IRB approval via the InfoEd software application. If there are any questions, SP may contact Research Integrity for verification.

Should approvals from ancillary committees or other persons or offices remain pending following IRB review (e.g., institutional safety committees, collaborating IRB, school districts), IRB approval will be withheld until documentation of the additional, pending approvals has been reviewed and approved by the IRB, an IRB member, or Research Integrity staff (as appropriate).