Institutional Review Board Manual
SCDMH Documents Governing Human Subject Research
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
On July 1, 2008, the South Carolina Department of Mental Health (DMH) implemented a new grant process under the Grants Administration Division to provide proper acquisition, administration, and monitoring of public and private funds for the agency.
The grant process requires the Grant Steering Committee to review all grant proposals to determine if the opportunity supports or advances the mission of the agency.
Pursuant to agency policy, only designated individuals (Mr. John H. Magill and Mr. Geoffrey Mason) are authorized to sign grant proposals, grant agreements, and award documents for the South Carolina Department of Mental Health. Mr. Magill has also authorized Ms. Brenda Hart and Mr. Geoffrey Mason to sign sub-recipient agreements and federal grant contracts for the agency. It is important to remember that only the above individuals can obligate the agency to state or federal grants/contracts. All principal investigators (PI’s), project directors, grant employees, and any staff who process grant related paperwork must adhere strictly to the new grant policy, particularly for new federal grant or contract awards.
What Constitutes Research?
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to common knowledge. Some demonstration and service programs may include research activities which must be reviewed by the Institutional Review Board.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual.
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
- Identifiable private information.
Individuals can reasonably expect that observations, notes, and/or recordings about their behavior will be kept private. If the individual can be identified by the researcher or anyone else (directly or indirectly through a coding system linking the research subject to the information), the information is deemed private.