Handbook of Operating Procedures > Series 300 Faculty and Academic Policies > 3.7.0 Governance of Human Subjects' Research

3.7.0 Governance of Human Subjects' Research

A. Purpose

 To provide a framework that ensures human subjects' research conducted in a manner that protects subjects and that the work is compliant with all relevant regulatory requirements governing the protection of human research participants including but not limited to Title 45 CFR 46 (45 CFR 46 | HHS.gov), Title 21 CFR 56 (eCFR :: 21 CFR Part 56 -- Institutional Review Boards), and Title 21 CFR 50 (eCFR :: 21 CFR Part 50 -- Protection of Human Subjects).

B. Scope

To describe the organizational structure and function for conducting human subjects' research sponsored by UT Tyler.

C. Policy

Introduction

• Research is a core mission of UT Tyler and is comprised of multiple types of research, including basic science and human subjects' research (i.e., clinical, health services, social, behavioral, and epidemiological).
• The conduct of human subjects' research is a complex process that requires strong institutional support and oversight.

Requirements for Conducting Human Subjects' Research

The major institutional components for conducting human subjects’ research include the Principal Investigator (PI), Human Research Protections Program/Institutional Review Board (HRPP/IRB), the Offices of Research and Scholarship (ORS) and Sponsored Programs (OSP), and the Center for Clinical Research (CCR). The major responsibilities and functions of each of these components are as follows:

• Principal Investigator: A significant burden of responsibility rests with the PI when using human subjects in research. The PI’s responsibilities include but are not limited to:
  • Completing proposals for funding in accordance with requirements of the funding agencies.
  • Assuring projects are performed in accordance with funded proposals and IRB approved protocols.
  • Ensuring IRB approvals have been obtained as well as any other institutional approvals required.
  • Providing annual updates to the IRB when required.
  • Ensuring changes to protocols have been approved by the IRB in accordance with IRB policies.
  • Ensuring that all personnel involved with a research project utilizing human subjects are trained in the ethical principles, relevant federal regulations, and institutional policy governing human research.
• Human Research Protections Program (HRPP): The HRPP is responsible for protecting the rights and welfare of participants who take part in UT Tyler research as well as ensure that scientific research is conducted ethically and in compliance with all federal, state, local regulations and institutional policies.The following responsibilities are within the scope of the UT Tyler HRPP:
  • IRB Review
  • Reliance Review/Single IRB Review
  • Training/Education
  • Monitoring and Quality Assurance of Human Subjects Research
• Institutional Review Board (IRB):The IRB is responsible for the regulatory oversight, evaluation, and assurance of compliance of the institution’s human research protection program. In addition to protocol review, the IRB has additional authority in these areas:
  • Approve, require modifications to secure approval, or disapprove all human subjects research activities overseen and conducted by the organization.
  • Suspend or terminate approval of research not being conducted in accordance with IRB requirements or associated with unanticipated events related to research involving human subjects.
  • Observe, or have a third party observe the consent process.
  • Observe, or have a third party observe the conduct of research.

• The Offices of Sponsored Programs (OSP) and Research & Scholarship (ORS): The OSP/ORS offices provide financial oversight for human subjects’ research. The OSP assists Investigators in preparation and submission of research grant applications for federal and non-federal funding agencies. Once a proposal is funded, the OSP and ORS offices monitor reporting compliance of the award and financial oversight of the project. The OSP and ORS also assist with preparing and submitting necessary progress reports to funding agencies per required deadlines.
• Center for Clinical Research (CCR): The CCR is responsible for assisting Investigators in the preparation of research proposals including the review for feasibility, budgets and clinical trial agreements.The CCR’s services include ensuring standardized training and appropriate certifications for the investigators and research staff.The CCR provides operational support for all industry sponsored research.The CCR department provide internal compliance monitoring and feedback to PI’s conducting human subjects’ research according to policies and procedures of the IRB, CCR, OSP/ORS, and the Institutional Research Compliance Committee.
  • Investigator-initiated and agency-sponsored research: The PI has the discretion to determine the degree to which the services of the CCR will be utilized.
  • Industry-sponsored research: Effective June 1, 2013, all industry-sponsored clinical research will be managed through the CCR.

The successful completion of human subjects’ research requires a team approach that includes the Principal Investigator, their research team, the IRB, the OSP/ORS, and the CCR.