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Institutional Review Board Manual

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Institutional Review Board Manual Institutional Review Board Manual Table of Contents Updated January 2021 Welcome to the Institutional Review Board (IRB) web page for the South Carolina Department of Mental Health (SCDMH). The department recognizes the need for safeguarding the rights and welfare of research subjects and their private health information. In accordance with Department of Health and Human Services regulations, the SCDMH has an established Institutional Review Board which is charged with these responsibilities. This web site is dedicated to providing the researcher with the tools and information necessary to protect these obligations and facilitate the approval process. About the IRB • Responsibilities of the IRB • Board Members SCDMH Documents Governing Research • What Constitutes Human Subject Research • Principles of Ethical Research Research that Requires Approval • Case Studies • Exempt Projects • Expedited Review Procedures • Full Board Review Projects • Continuing Review Requirement Approval Process • Required Protocol Information Required Informed Consent Information • Steps, Timelines and Deadlines • Required Training for Investigators • Non-DMH Employees Requesting Research Permission HIPAA and Research • What is the Privacy Rule • How it Affects Researcher • Conditions for Use/Disclosure of PHI • Obtaining Authorizations from Subjects • De-Identified Data • Criteria for and Requesting Waivers Special Population Requirements • Children • Prisoners Resource Material • Informed Consent Guidelines • Informed Consent Example #1 • Informed Consent Example #2 • Informed Consent Example #3 • Informed Consent Example #4 • Common Rule • Decision Charts Forms • Project Application for Research • Facility/Center Director Letter of Support • Unaffiliated Investigator Agreement (Non-SCDMH Employee) Privacy Practices Agreement (HIPAA) • Non-Employee Signature Page • Continuing Review Form • Request for a Waiver or an Alteration of Individual Authorization 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: 1. 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: o Ensure that subjects are adequately informed of the nature of the study; o Ensure that subjects' participation is voluntary; o Ensure that the benefits of a study outweigh its risks; o Ensure that the risks and benefits of the study are evenly distributed among the possible subject population; and o Suspend human subject activity that violates regulations, policies, procedures, or an approved protocol, and report such violation and suspension to the Institutional Official. 2. 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: o Ensure that subjects are adequately informed on what private health-related data may be released to a researcher and that the release is voluntary o Ensure that all private health-related data that is released is adequately protected from further disclosure in any individually identifiable form o Ensure that there is an adequate plan to secure and protect the private health-related data during its use by the researcher o 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. About the IRB SCDMH Institutional Review Board Members IRB MEMBERS AFFILIATION SPECIALTY AREA Monica J. McConnell, SCDMH Director of Child, Adolescent, and Psychology/Community Mental Ph.D. (Chair) Family Services Health Shirley Vickery, Ph.D. Richland School District Two Special Interest of Children (Vice Chair) Miroslav Cuturic, M.D. SCDMH Division of Inpatient Services Neurology Psychology, Special Interest of Alicia V. Hall, Ph.D. DDSN Children Leigh Ann Chmura SCDMH Information Technology Manager II Information Management Norma Jean Mobley, Community Pharmacy/Long Term Care R.Ph. SCDMH Director Forensic Evaluations Kelly Gothard, Ph.D. Psychology, Forensics Services and Outpatient Services Patricia Handley, DNP SCDMH Systems Chief Nursing Officer Nursing IRB Alternate Members Albert Patrick SCDMH Privacy Officer Privacy/Confidentiality Ruth Abramson, Ph.D. USC SOM Department of Neuropsychiatry Genetics Board Administrator, Lynelle R. Reavis, Ph.D. Office: (803) 898-8619 email: [email protected] Address: Lynelle Reavis Ph.D. Director of Quality Management and Compliance, IRB Administrator South Carolina Department of Mental Health 2414 Bull Street Suite 302 Columbia, SC 29201 Schedule of Meetings: When: Fourth Wednesday of each month, 11:00 AM Where: SCDMH Administration Building 2414 Bull Street, Columbia SC 29202 SCDMH FWA00025847 Expires 2/28/2022, IORG0000215 Expires 2/28/2022 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 On July 1, 2008, the South Carolina Department of Mental Health (DMH) implemented a 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 (State Director or designee) are authorized to sign grant proposals, grant agreements, and award documents for the South Carolina Department of Mental Health. The State Director has also authorized the Grants Administrator 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 grant policy, particularly for 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: 1. 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. 2. 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. SCDMH Documents Governing Human Subject Research Principles of Ethical Research The following principles are to be followed by the SCDMH Institutional Review Board (IRB) and all personnel in formulating and implementing research projects that involve human subjects. GENERAL PRINCIPLES A. Projects directly involving and/or individually identifying human subjects shall conform to the scientific, legal, and ethical principles which guide all research and shall emerge from a sound theoretical basis and follow accepted research design. B. Ethical aspects of the study must be clearly stated in the project design. C. Projects should be conducted only by professionally and scientifically qualified individuals. When appropriate, medical liaison or supervision should be provided. The Institutional Review Board shall determine, prior to approving the project, that the Principal Investigator is an individual of sufficient competency and maturity or judgment and is on the staff or sponsored by the facility involved in the project. D. Projects involving human subjects at risk shall not be implemented unless the anticipated risks to the subject are so outweighed by the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks. The evaluation of such risks should include not only possible physical injury, but also psychological or social injury and alterations of personality. "Subject at risk" means any individual who may be exposed to the possibility of injury,
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