Institutional Review Board Manual
SOUTH CAROLINA DEPARTMENT OF MENTAL HEALTH
Columbia, South Carolina
|OFFICE OF THE STATE DIRECTOR OF MENTAL HEALTH||
DIRECTIVE NO. 891-09
TO: All Organizational Components
SUBJECT: Approval Process for Conducting Research
POLICY: The South Carolina Department of Mental Health recognizes the need for research. It also recognizes that research conducted at SCDMH must have clear current and/or potential value to the patients and staff as well as the person, institution or agency requesting to conduct human subject research. The Research Approval Committee (RAC) is charged with ensuring that research conducted at SCDMH furthers the Agency's mission.
All research projects involving patients of SCDMH and/or its employees must have RAC approval prior to submission to the SCDMH Institutional Review Board (IRB). This includes research resulting in data obtained from patients or employees, research using SCDMH data-bases and files, and research conducted through the auspices or name of SCDMH or any of its facilities or centers. It also includes all requests for IRB full board, expedited, or exempt approval
Research applications must be submitted to the IRB Administrator no later than the first Wednesday of the month. Completed applications will include:
- A completed SCDMH Institutional Review Board “Project Application for Research Involving Human Subjects”
- Letter(s) of approval from the appropriate center, facility or institutional directors where the research is to be conducted.
- All required forms for non SCDMH employees: the Unaffiliated Investigator Agreement and Privacy Practices Agreement.
- Any additional letters of approval by all bodies governing the researcher that are external to SCDMH (i.e., university IRB, dissertation committee, etc.)
The IRB Administrator and/or IRB chair will then submit the project application to the RAC for their review.
The SCDMH Research Approval Committee (RAC) will:
- Be composed of members who are sufficiently qualified to review proposals and ascertain the acceptability of meeting the organizational mission. These members will include but are not limited to the following divisional directors or their designated appointee:
- SCDMH Medical Director
- SCDMH Deputy Director of Inpatient Services
- SCDMH Deputy Director of Community Mental Health Services
- SCDMH General Counsel
- Ensure that all research conducted at the SCDMH has clear present and/or potential value to patients and staff and meets the agency's mission.
- Review research applications for approval submitted to the committee by the IRB administrator. Application reviews and approval make take place either in face-to-face meetings or via internet. The majority of the members must approve application before it can be submitted to the Institutional Review Board for human subject protection review and approval.
- Permit or request researchers to appear before the Committee for discussion.
- Forward a list approved research proposals to the following:
- The SCDMH IRB administrator for IRB approval,
- The SCDMH State Directors Office.
- The Grants Steering Committee
- Be given a report, by the IRB chair or administrator, of each active project at least annually.
The Office of Grants Administration and the SCDMH IRB Chair will create linkages between the Grants Steering Committee, the RAC and the IRB procedures to ensure research meets the Agency’s mission and protects the rights and privacy of subjects involved in research. Further the SCDMH Office of Grants Administration and the SCDMH IRB Chair will work in partnership to publicize research efforts at SCDMH.
John H. Magill
State Director of Mental Health
March 19, 2009