Regulatory Knowledge and Support

Mission: To foster a culture within iRISE that assigns the highest priority to protection for the rights and welfare of human subjects and fastidious compliance with all pertinent federal regulations, state law, and applicable local policies, while at the same time creating mechanisms to efficiently implement this priority.

Strategic Goals

The RKSU of iRISE will

  1. Assure integration of comprehensive regulatory knowledge and compliance with innovation in the development and execution of research studies, especially the informed consent process.
  2. Develop administrative structures and resources for assuring an efficient regulatory review, approval and monitoring process.

Governance & Organizational Structure

Governance

The RKSU is led by Terrence F. Ackerman, PhD. Dr. Ackerman is Professor of Bioethics at UTHSC and Chair of our Institutional Research Board (IRB). His work is focused on the ethics and regulation of human subjects research, especially research with children.

Organizational Structure

The Director has overall responsibility for the operation of the unit and the performance of other staff members. The RKSU works with the Liason to Trial Innovation Centers and Liason to Recruitment Innovation Centers modules to facilitate regulatory issues for multi-site studies and troubleshoot ethical or logistical issues with recruitment of research participants, particularly special populations.

Human Subject Protections Coordinator

An HSPC within the RKSU will be responsible for consultations with investigators on ethical and regulatory compliance, presentation of educational programs, and ongoing auditing and monitoring of regulatory compliance in research studies being conducted within iRISE. The HSPC works with investigators to design appropriate corrective action plans when necessary to meet regulatory requirements with regard to protection for the rights and welfare of human subjects.

During protocol development period the HSPC is available to provide assistance to investigators in addressing all issues related to regulatory compliance and protection for the rights and welfare of subjects during the design of protocols and the development of consent procedures, for example advice on appropriate screening of using eligibility checklists, monitoring procedures to minimize risk to subjects, procedures for adverse event reporting , types of information that prospective subjects should be provided during the informed consent process, and proper use of monetary incentives.

IRB Pre-Review

The UTHSC IRB utilizes a pre-review process that allows investigators to make revisions in their applications based on the reviewer assessments prior to the date when the study is presented to the full Board. During IRB application pre-review, the HSPC liaises with the IRB to clarify the critical assessments of reviewers and the precise contours of the revisions that are necessary to secure final IRB approval.

HSPC Audits

After a study is under way, the HSPC conducts routine audits of iRISE studies on a semi-annual basis.

Chair of UTHSC IRB Dr. Ackerman is Chair of the UTHSC IRB and Professor of Bioethics in the College of Medicine.
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