IRB Coordination with UTHealth Components Involved in Research Oversight

POLICY

The various components of the human research protection program work closely with each other to ensure adherence to regulatory, ethical and safety standards. UTHealth has procedures for reviewing planned research, demonstration and development projects and training grants.  Proper reviews of research allow the university to maintain a safe environment, to maintain the confidence of the public, and to preserve federal and other sources of research funding. Department chairs, deans, and other individuals in the hierarchy of each operating unit have an administrative responsibility and ethical obligation to ensure individual investigator compliance with this and related policies and procedures. Researchers who fail to comply with the review requirement or who fail to conduct research in accordance with the requirements of the applicable review committee are subject to disciplinary action up to and including termination of employment. (HOOP 200 – Review of Research)

The various components of the human research protection program are:

Executive Vice President and Chief Academic Officer: Leadership for UTHealth’s research enterprise is provided by the Executive Vice President and Chief Academic Officer (EVP&CAO), Michael Blackburn, PhD. The EVP&CAO has administrative and budgetary responsibility for the HRPP.  The EVP&CAO is also responsible for keeping the UTHealth President and executive leadership informed about the HRPP’s priorities, and needs. The EVP&CAO is responsible for the human research protection program including the Institutional Review Boards, conflict of interest program and clinical research education.

Institutional Review Board: The Vice President, HRPP, Anne Dougherty, MD, is the Institutional Official for UTHealth. Dr. Dougherty is also the Chair of the CPHS Executive Committee which is a committee comprised of Chairs and Vice Chairs of the four IRB panels. The Institutional Official is responsible for IRB policies and procedures, number and composition of IRBs, dealing with reports of undue influence and complaints from researchers and research staff.

Research Conflict of Interest Program – Financial conflicts of interests program is administered by the conflicts of interest office under the auspices of the EVP & CAO. The office supports two faculty led committees – the Research Conflicts of Interest (RCOI) Committee, which is responsible for reviewing significant financial interests related to research and the Institutional Conflict of Interest (ICOI) Committee, which is responsible for managing institutional conflicts of interest. When reviewing research involving human subjects, the Committee applies a rebuttable presumption standard where it assumes individuals with significant financial interests may not conduct the research unless there are compelling circumstances to approve it. The Committee’s recommendations for these studies are forwarded to the EVP & CAO and the CPHS before the protocol receives final CPHS review and approval, and the CPHS may request revision of the recommended management plan if it feels the conflict cannot be managed or the proposed plan is insufficient.  The CPHS makes the final determination as to whether the research should be approved.

Research Compliance, Education and Support Services – Research compliance staff assist researchers with regulatory processes – IND/IDE submissions, clinicaltrials.gov registration, DSMB coordination.  Several basic, intermediate, and advanced training courses in good clinical practice (GCP) for researchers and research staff are coordinated by this group.  Research compliance group also helps coordinate educational programs for IRB members and staff. Research compliance staff conduct routine post approval study reviews and for cause audits as directed by the IRB.

Clinical Research Unit - The mission of the Clinical Research Unit is to facilitate clinical research by providing investigators with specialized facilities, personnel, and advice.  The UTHealth CRU at Memorial Hermann—Texas Medical Center offers 6 outpatient and 4 inpatient rooms;  skilled nursing assistance; assistance with processing of laboratory samples; scheduling diagnostic tests and procedures; a research dietician; a chart room; and a physician charting area. The Brownsville CRU is in the Professional Building of the Valley Baptist Hospital-Brownsville, adjacent to the main hospital buildings. The unit is dedicated for outpatient services, and includes a waiting room, 4 examination rooms, a laboratory area for sample processing and storage, an area for charting by staff and investigators, office space for patient scheduling and follow-up, and  an interview/conference room for long patient interviews, staff in-services, and investigator meetings.

Office of Institutional Compliance – The mission of the Office of Institutional Compliance is to pro-actively promote compliance with all applicable legal and regulatory requirements. The compliance program strives to foster and help ensure ethical conduct and provide education, training, and guidance to all faculty and staff members. The office manages the compliance hotline. The office also manages mandatory institution training including HIPAA and data security. The Chief Compliance Officer works very closely with the EVP&CAO on research related matters. The Institutional Compliance Office is responsible for coordinating the Executive Compliance Committee.

Office of Sponsored Projects Administration – The Office of Sponsored Projects is responsible for reviewing and approving all research contracts and grants submitted by UTHealth faculty and trainees and for verifying that UTHealth can meet the terms and conditions of grants/contracts awarded to the institution.  If the research involves human subjects or human derived materials and requires CPHS approval, the principal investigator must provide the Office a copy of the CPHS approval letter before a research account can be set up and funds expended to support the proposed research. The clinical trial contract team ensures that clinical trial contracts have appropriate language on research related injury, publication, dissemination of results, and sharing of data safety monitoring board reports.  The Clinical Research Finance team works with the research staff to develop coverage analysis for clinical trials. The preliminary and final coverage analysis are sent to the IRB staff and uploaded in iRIS.

Human Embryonic Stem Cell Research Oversight Committee – This Committee addresses ethical, scientific, and regulatory issues related to human embryonic stem (hES) cell research. Its responsibilities include reviewing research protocols involving hES cells, monitoring approved studies as appropriate and maintenance of registries research involving hES that are conducted at UTHealth. This Committee is also responsible for recommending training requirements for UTHealth investigators involved in hES cell research.

Institutional Biosafety Committee – This Committee addresses ethical, scientific and regulatory issues related to infectious diseases and biological agents. Research involving biological agents must be reviewed by the Institutional Biosafety Committee.

Radiation Safety Committee – This Committee formulates and recommends policy for the use of radioactive materials and other sources of radiation. Research involving use of radioactive materials in humans must be reviewed by the Radiation Safety Committee. 

Chemical Safety Committee – This Committee recommends policy for the use of chemicals that may be hazardous in the research, clinical and educational activities at UTHealth. Research involving hazardous chemicals in humans must be reviewed by the Chemical Safety Committee.

Pathology Review Process – Pathology department is required to document that a proposed study will not compromise pathologic evaluation of tissues required for current or future clinical care as biopsies are becoming smaller so there is less tissue available. Any research study involving tissues collection or request for specimen stored in Pathology requires review by the Pathology department. The IRB office checks for this approval letter before proceeding with IRB review.

Radiology Review Process - Department of Diagnostic Intervention and Imaging (DII) requires approval of imaging being performed for research, to ensure that imaging resources are available and  billing occurs appropriately. Researchers are required to seek approval from DII for all research projects that utilize diagnostic imaging procedures, whether the research is initiated by a DII faculty member or is being conducted by members of other departments, schools, or institutions. Prior approval needs to be obtained for any study involving the use of Radiology and Medical Physics services(e.g., interpretation, reporting, processing, establishing imaging equipment performance/compliance etc.) that are NOT required for patient care and are performed for research purposes only. Any studies that involve the non?routine use of Radiology (e.g., in the assessment of a new implant or device), non?routine imaging methods or new/improved contrast methods also need departmental approval. As with standard of care imaging, all research imaging performed on MHHS imaging equipment needs to be read by a UTHealth radiologist.

 PROCEDURE

The CPHS submission packet for each research study requires key study personnel to declare if they have any related financial interests at initial and continuing review. The CPHS application includes screening questions for Institutional Biosafety Committee, Radiation Safety Committee and Chemical Safety Committee. If the investigator indicates that the research involves a substance or agent that needs review by any of these Committees, the investigator is given directions to obtain approval from these Committees. The human embryonic stem cell oversight committee has representation from the IRB to ensure that human subjects research protocols involving hES obtain the necessary approvals.

Investigators may submit their research proposal simultaneously to the Committee for the Protection of Human Subjects and the other Committees. For research proposals that do not involve grants or contracts, the IRB Staff may hold CPHS approval until all necessary approvals have been obtained.

The Office of Sponsored Projects Administration requires Review and Approval forms within the UT Start grants and contracts management system.  R&A forms are internal forms required for all sponsored research projects. R&As must be submitted to SPA for all grant proposals and applications, and for all industry-sponsored projects. The R&A form has questions about human subjects research, safety committees and conflict of interest. Research accounts are not opened until all institutional approvals are complete. IRB staff have access to the UT Start system.

 APPLICABLE REGULATIONS

1. None

REFERENCES TO OTHER POLICIES

1. HOOP Policy 90 – Review of Research

ATTACHMENTS

1. None 

If you find errors in this document, contact cphs@uth.tmc.edu

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link

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