SOUTH CAROLINA DEPARTMENT OF MENTAL HEALTH
Columbia, South Carolina
|OFFICE OF THE STATE DIRECTOR OF MENTAL HEALTH||
DIRECTIVE NO. 896-10
TO: All Organizational Components
SUBJECT: Institutional Review Board – Policies and Procedures for the Protection of Human Research Subjects
The South Carolina Department of Mental Health recognizes the need for safeguarding the rights and welfare of research subjects. In accordance with Department of Health and Human Services regulations, the South Carolina Department of Mental Health has an established Institutional Review Board (IRB) which is charged with these responsibilities.
All research projects involving patients of SCDMH and/or its employees must have SCDMH IRB approval prior to implementation. This includes research resulting in data obtained from patients or employees, research using DMH data-bases and files, and research conducted through the auspices or name of SCDMH or any of its institutions.
A case study is a report of treatment, and, as such, usually does not meet the Common Rule definition of research (a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge). Case studies that are not considered research (see below) do not require IRB review and approval. Case studies that do not involve the receipt, disclosure or use of Protected Health Information, “PHI” (i.e., health information paired with identifiers such as name, SS#, DOB, address, etc.) do not require a signed “AUTHORIZATION TO DISCLOSE SCDMH PROTECTED HEALTH INFORMATION” or other privacy authorization to receive, disclose or use the non-PHI. Case studies that do involve the receipt, disclosure or use of PHI must be reviewed by the local Privacy Officer (and if the use involves computer PHI, it must also be reviewed by the local Security Officer) for applicable Privacy Practices and other requirements (see Privacy Practices Directive 837-03 and applicable Security Policies.) Regardless, all case studies must be reviewed by the applicable supervisor(s).
If any of the following is present, the activity is considered research rather than a case study if:
If the Case study has any of the above elements, it is considered research and will need IRB approval before it is conducted.
Exemptions: Routine program evaluation and quality improvement data analysis involving existing client/patient data is exempted from this policy unless it involves sensitive content material. The IRB will develop and publish specific guidelines differentiating program evaluation from research.
I. The SCDMH Institutional Review Board shall:
II. The SCDMH Office of Research Administration shall:
III. Allegations of Research Misconduct
Depending on the nature of the allegation/concern, the IRB shall appoint an investigator or committee to conduct an investigation and report their findings and any recommendations to the full Board. Board can seek additional information and in all instances where the allegations/concerns appear to have merit, shall give the researcher an opportunity to respond before taking action. All allegations of misconduct in research, founded or not, will be submitted to the Office of Research Integrity annually as required by federal guidelines.
This policy conforms to "Code of Federal Regulations, Title 45, Part 46" on protection of Human Subjects from Research Risks. Failure to comply with policies and procedures, as outlined in this directive, may result in the termination of a research project, the withholding of funds, or appropriate disciplinary action.
This directive supersedes Directive No. 890-09.
John H. Magill, State Director
February 22, 2010