Institutional Review Board Manual
About the IRB
Responsibilities of the IRB for Human Research Subject Protections
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.
The SCDMH IRB is responsible for and the approving authority to:
- Protect the rights and welfare of human subjects involved in research. These are protections for the person (the subject) and protections for the information the subject provides. Responsibilities:
- Ensure that subjects are adequately informed of the nature of the study;
- Ensure that subjects' participation is voluntary;
- Ensure that the benefits of a study outweigh its risks;
- Ensure that the risks and benefits of the study are evenly distributed among the possible subject population; and
- Suspend human subject activity that violates regulations, policies, procedures, or an approved protocol, and report such violation and suspension to the Institutional Official.
- Protect access to the subject’s private health-related information and data, e.g., diagnosis, treatment records, health status, billing records (HIPAA defined categories of information). Responsibilities:
- Ensure that subjects are adequately informed on what private health-related data may be released to a researcher and that the release is voluntary
- Ensure that all private health-related data that is released is adequately protected from further disclosure in any individually identifiable form
- Ensure that there is an adequate plan to secure and protect the private health-related data during its use by the researcher
- When it is not feasible to secure individual authorization for the release of private health-related information from a subject, ensure that all standards for de-identifying the data have been met or that requirements for a waiver of the authorization are met.