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Application and Review Process

The DHSIRB application process starts with the submission of Form 20AD085E, DHSIRB Application and Instructions, and other required materials and supporting documentation. The board strives to take action on all applications within two months after submission of a complete application packet.  Investigators are notified in writing of the DHSIRB decisions within two weeks of DHSIRB action.

Actions taken impacting research project applications, including Full Review of research proposals, will occur at regularly scheduled meetings of the DHSIRB.  These meetings are scheduled to take place the first Tuesday of every month.

All study submissions must be sent to:

Requirements for exempt submissions

DHSIRB does not review activities that do not involve the disclosure of protected information to non-DHS staff and do not involve greater than minimal risk.  Research involving human subjects in one or more of the categories listed in the DHSIRB Rules, Requirements for exempt submissions, are exempt from DHSIRB review.

Requirements and procedures for expedited review
DHSIRB may use an expedited procedure to review research that presents no more than minimal risk to participants per 45 C.F.R. 46.110.  The research types and circumstances under which an expedited procedure may be used are listed in the DHSIRB Rules, Requirements and procedures for expedited review

Requirements and procedures for full review
Proposals that do not qualify for exempt or expedited review are reviewed at regularly scheduled meetings of the DHSIRB. The requirements for the full DHSIRB review protocol can be found here.  Each proposed research project shall include: a detailed description of the research design and procedures as they affect human subjects; a list of precautions necessary to safeguard the subjects' welfare; a precise description of the subject population involved in the research; a description of the informed consent process and all consent forms used; and methods used to protect data confidentiality and subject privacy.

For guidance on the consent process and forms, see FAQs.  

Review criteria

Following review of the proposal, the DHSIRB will arrive at one of the following decisions:

  • Approved.  Research is approved as submitted.  Investigators whose proposals are approved can begin work immediately.
  • Conditionally approved.  Research is conditionally approved until investigators comply with items identified by the DHSIRB for final approval.  There are no structural problems with the study.
  • Deferred.  DHSIRB does not have enough information to make a determination.  Investigators whose proposals receive a deferral must resubmit the entire application to address the required changes.
  • Not approved.  The magnitude and/or number of concerns is such that conditional approval is not appropriate.  Investigators whose work is disapproved cannot conduct the research or resubmit their proposals.

In order to approve a research proposal, the DHSIRB will also review the investigator's qualifications to conduct and supervise the proposed research.  This process may include:

  • Reviewing the curriculum vitae of the investigator, sub-investigators, and other necessary research staff, verifying professional associations and licenses.  It may also include a review of the investigator's previous specific experience as demonstrated by recent presentations or publications;
  • using previous DHSIRB experience with the investigator; and
  • Requesting additional information confirming the investigator's qualifications from the administrator of an institution associated with the investigator.   

Additional information about the review and approval processes can be found here.

Application form and other files can be found and downloaded on the forms page.

Review Timelines
The following DHSIRB application review timelines are provided for applications that do not require clarifications or additional information during the review process.

The times are estimates only and assume the proposal, as required1, is submitted to the DHSIRB no less than 14 calendar days prior to the next regularly scheduled meeting. The first two rows apply to all submissions regardless of the review procedure in place. Unanticipated factors may impact the timing of the events outlined below.

To facilitate review times, investigators are encouraged to review the submission requirements, application documents, and review criteria.

Process/Type of Review Description Estimated Process/Review Time
Application confirmation The DHSIRB Administrator provides email confirmation that the submitted application was received by the DHSIRB. 24 hours
Application completeness confirmation The DHSIRB Administrator assesses completeness of the submission and communicates the results to the applicant.  2 business days
Exempt review The DHSIRB reviewer(s) determine whether or not the proposal falls under the scope of the DHSIRB (i.e. it is/it is not exempt from review). Within 6 business days from confirmation of an accepted application
  The applicant is notified of the exempt review outcome. Within 14 business days of exempt review determination2
Expedited review The DHSIRB reviewer(s) determines whether the proposal is eligible for expedited procedure. The applicant is notified of the eligibility outcome.  Within 6 business days from confirmation of an accepted application
  The DHSIRB reviewer(s) assesses the proposal using the expedited procedure. Within 6 business days of expedited review eligibility determination
  The applicant is notified of the expedited review outcome. Within 14 business days of DHSIRB action1
Full review The DHSIRB reviewer(s) determines whether the proposal qualifies for full review. The applicant is notified about the full review qualification. Within 6 business days from confirmation of an accepted application
  The proposal is reviewed at the next regularly scheduled meeting of the DHSIRB.

1 -23 business days of full board review eligibility determination

  The applicant is notified of the DHSIRB's decision.3 Within 14 business days of DHSIRB action1

[1] OAC 340:2-39-12(a).
[2] OAC 340:2-39-12.
[3] OAC 340:2-39-12

Last Modified on Jun 08, 2022
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