South Carolina Department of Mental Health

Institutional Review Board Manual

Approval Process
Steps, Timelines & Deadlines To Getting A Research Project Approved

Proposals must be approved by all bodies governing the researcher that are external to DMH (i.e., university IRB, dissertation committee, etc.) prior their submission to the DMH Institutional Review Board (IRB).

The following steps, which are also presented graphically below, outline the procedure for approving research proposals in the South Carolina Department of Mental Health.

  1. Submit the proposal to the appropriate DMH facility for site approval (Community Mental Health Center Director or In-patient Facility Director). The Center or Facility Director should then submit the Estimated Research Costs Form and a letter of support to their respective Division Director using the Facility/Center Director Letter of Support. The Division Director indicates on the same form his/her approval/disapproval of the project. If the Division Director approves, proceed to step #2 below. IRB approval does not ensure that any particular DMH facility will allow a research project to be conducted at their site.

  2. Submit the SCDMH “Project Application for Research Involving Human Subjects”, Facility/Center Director Letter of Support and the Estimated Research Costs Form to the Office of General Counsel, South Carolina Department of Mental Health, Room 402, 2414 Bull Street, Columbia, SC 29201.
    These two documents must be submitted by the first Wednesday of the month to be eligible to be reviewed during that month's IRB meeting. Non-SCDMH employees must sign and submit the Unaffiliated Investigator Agreement and Privacy Practices Agreement.

  3. If the research proposal is approved by the Research Approval Committee it will be reviewed by the IRB Chair to determine it’s status (as either Exempt, Expedited, Full Board Review).

  4. If the project meets the criteria for Exemption from IRB review, you will receive written notification within about four days from the Office of General Counsel.

  5. If the proposal is eligible for Expedited Review, it will be reviewed within about four days and the researcher notified.  If it is not eligible for Expedited Review, or if concerns are raised by the reviewers, full IRB review is required.

  6. The SCDMH IRB meets at 11:00 am on the fourth Wednesday of each month. The researcher is encouraged to attend this meeting. Proposals to be reviewed by the SCDMH IRB must be submitted to the Office of General Counsel by the first Wednesday of each month in order to be reviewed by IRB that same month. Submissions received after the first Wednesday of a given month will be reviewed by the IRB the following month.

  7. Following review, the DMH IRB will exercise one of three options: full approval of proposal; disapproval of proposal; or approval pending receipt of modifications to the proposal.  If modifications are required, they are explicitly communicated to the researcher who, upon fulfilling the requirements, does not usually have to resubmit the proposal for full IRB review.  Upon receipt of the modified proposal, IRB approval is given.

Researchers should be aware that any modifications to research proposals which may be required by DMH could necessitate re-approval by the researcher's governing body and/or any other IRB that has authority over the research.

Note: Any grant funded research project must be coordinated through the DMH Grants Coordinator, as specified in the DMH Grant’s Directive. http://dmhhome/coneducation/grant.htm

 

 

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