POLICY
The various components of the human research protection program (HRPP) at UTHealth Houston work closely with each other to ensure adherence to regulatory, ethical and safety standards. UTHealth Houston 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.
The various components of the human research protection program are:
Senior Vice President of Academic and Faculty Affairs Leadership for UTHealth Houston’s research enterprise is provided by the Senior Vice President, Academic and Faculty Affairs, The SVP Academic and Faculty Affairs has administrative and budgetary responsibility for the HRPP and is responsible for allocating resources, space and personnel to the HRPP. The SVP Academic and Faculty Affairs is also responsible for keeping the UTHealth Houston President and executive leadership informed about the HRPP’s priorities, and needs. The SVP Academic and Faculty Affairs is responsible for the human research protection program including the institutional review board, conflict of interest program, and clinical research education.
Institutional Official: The Vice President, HRPP is the Institutional Official (IO) for UTHealth Houston. 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.
Institutional Review Boards: The primary duty of Institutional Review Board (IRB) is the protection of the rights, safety and welfare of human research subjects in accordance with the principles outlined in the Belmont Report and applicable regulations.
Research Conflict of Interest Program: The financial conflicts of interest program is administered by the Conflicts of Interest (COI) office under the auspices of the SVPAFA. 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 COI 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 COI committee’s recommendations for these research studies are forwarded to IRB before the protocol receives final IRB review and approval. The IRB may request revision of the recommended management plan if it feels the conflict cannot be managed or the proposed plan is insufficient. The IRB 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 –Investigational New Drug and Investigational Device determinations and ClinicalTrials.gov registration. 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 Center for Clinical and Translational Science Clinical Research Unit (CRU) helps to facilitate clinical research by providing investigators with specialized facilities, personnel, and advice. There are CRUs at various locations and investigators may use any of the CRUs, depending on the location of their patients and availability of services.
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 topics such as the Health Insurance Portability and Accountability Act (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.
Sponsored Projects Administration –The Sponsored Projects Administration (SPA) office is responsible for reviewing and approving all research contracts and grants submitted by UTHealth Houston faculty and trainees and for verifying that UTHealth Houston 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 IRB approval, the principal investigator must provide SPA a copy of the IRB approval letter before a research account can be set up and funds expended to support the proposed research. The clinical trials 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 Clinical Research Finance team shares the coverage analysis with the IRB office by email and designated IRB staff can access the coverage analysis in the SPA system.
Human Stem Cell Research Oversight Committee: The human Stem Cell Research Oversight (SCRO) Committee addresses ethical, scientific, and regulatory issues related to human stem cell research. Its responsibilities include reviewing research protocols that involve human pluripotent stem cells or their derivatives [including human embryonic stem cells (hESCs), human induced pluripotent stem cells (iPSCs), and their derivatives] that are proposed by UTHealth Houston employees (regardless of location) and/or involving the use of UTHealth Houston facilities or resources. Additionally, UTHealth Houston’s SCRO monitors approved studies as appropriate; maintains a registry of research involving hESCs, hiPSCs, or their derivatives; and maintains a registry of hESCs possessed by UTHealth Houston investigators.
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 Houston. 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 Memorial Hermann Health System (MHHS) imaging equipment needs to be read by a UTHealth Houston radiologist.
Scientific Review: The departmental review process provides the IRB with information to support its review of the proposed research. Department review assesses the scientific validity of the proposed research and includes a feasibility assessment, with particular attention to the ability to meet enrollment target. In addition to the initial review, a robust departmental oversight mechanism should monitor the progress of the research and assist the research team in identifying and resolving issues that arise during the course of the study.
NICU Feasibility and Scientific Team Review: The NICU Feasibility and Scientific Team Review (FASTR) group is made up of a multidisciplinary team of healthcare providers and parents that oversee the conduct of learning healthcare projects involving infants at Children’s Memorial Hermann Hospital.
IT Security Review: The IT security team provides the IRB with expert assessment of the information technology systems and data security measures used in a research study. This review evaluates whether appropriate safeguards are in place to protect the confidentiality, integrity, and availability of research data, including the secure collection, storage, transmission, and access to electronic information.
PROCEDURE
The IRB submission packet for each research study requires key study personnel to declare if they have any related financial interests. The IRB 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 stem cell oversight committee has representation from the IRB to ensure that human subjects research protocols involving hESCs or iPSCs have necessary approvals.
Investigators may submit their research proposal simultaneously to the Committee for the Protection of Human Subjects and the other Committees
The Office of Sponsored Projects Administration requires submission of an intake form through the UT Start grants and contracts management system. The intake form is an internal requirement for all sponsored research projects and must be completed for all grant proposals and applications, as well as for all industry-sponsored projects. The intake form includes questions related to human subjects research, required safety committee reviews, and conflicts of interest. Research accounts are not established until all institutional approvals are complete. IRB staff have access to the UT Start system. For projects that are not funded, the IRB office may hold IRB approval until all institutional approvals are complete.
REFERENCES
- HOOP Policy 200 – Review of Research
If you find errors in this document, contact [email protected]
|
Document Number: |
101-A02 |
|
Document Name: |
Components of the Human Research Protection Program |
|
Reviewed by: |
Associate Vice President, Research Compliance |
|
Effective: |
1 Aug 2008 |
|
Revision History: |
1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021, 1 Jun 2026 |
Please contact the IRB office for answers to questions, express concerns, and convey suggestions regarding human subjects protections.
IRB Office House: Thursdays, 1–4pm via Teams Room
Email: [email protected]
IRB Helpline: 713-500-7943 (please leave a message and we will get back to you as soon as possible)
iRIS Helpline: 713-500-7960
IRB Review Feedback: IRB Survey
Houston, Texas 77030
Phone: 713-500-7943
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
