Policy Number: 200
Review of Research
I. POLICY AND GENERAL STATEMENT
To ensure adherence to ethical standards and to safeguard subjects' rights and safety, The University of Texas Health Science Center at Houston Committee for the Protection of Human Subjects ("CPHS") reviews all research, demonstration or development projects and clinical training grants contemplating the use of human subjects and/or human derived data and tissue in which a member of The University of Texas Health Science Center at Houston ("university") faculty, staff, or student body participates. It is the responsibility of faculty members, staff and students participating in such research to see that the study is reviewed and approved by the CPHS before the project is initiated. Participation shall be defined to include service as principal investigator, co-investigator or collaborator. Those who are uncertain if their participation is sufficient to warrant approval should contact the chairperson of CPHS or the Office for Support of Research Services.
Cooperative research projects are those projects involving more than one institution. In the case of cooperative research projects conducted by the faculty, staff or students of the university, both the university and the cooperating institution are responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. All cooperative research projects involving university students, staff and faculty must be submitted for review and approval by the CPHS. In the case of cooperative research carried out exclusively at another institution that also has an IRB, the CPHS may at its discretion enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort in those instances where dual review is unnecessarily burdensome. In the case of cooperative research carried out exclusively at another institution that does not have an IRB, the other institution must obtain a Federal Wide Assurance ("FWA") Number from the Office for Human Research Protections ("OHRP"). In the FWA, the other institution would name the CPHS as the IRB of record and agree to comply with federal regulations governing human subject research. Along with the FWA, an IRB Authorization Agreement would be entered into by both institutions.
Failure to have research reviewed may be unethical, create an unsafe environment at the university, result in the loss of federal funds, cause the university to incur financial or other penalties, and/or cause the public to lose confidence in the university's research programs.
Researchers who fail to comply with the review requirement are subject to disciplinary action up to and including termination of employment. Department chairs, deans, and other individuals in the hierarchy of each operating unit have an administrative responsibility and ethical obligation to insure individual investigator compliance with this and related policies and procedures.
A. Committee for the Protection of Human Subjects
All research, demonstration, or development projects and clinical training grants involving human subjects and/or human derived data and tissue must be reviewed and approved by the Committee for the Protection of Human Subjects before the project is initiated. (Research involving educational strategies in educational settings or educational testing in which it is impossible to identify the participants are exempt from this review, but may require notification of the committee.)
Researchers who are proposing the use of human subjects and/or human derived data and tissue in their research must submit the following to the Committee for the Protection of Human Subjects:
- CPHS forms;
- Protocol/Grant Application;
- informed consent documents, releases, and translations;
- background materials as applicable; letters of approval and cooperation used to recruit subjects, to use records, data, and specimens not controlled by the investigator, and to use facilities and personnel of another department;
- a copy of a Review and Approval Form signed by an authorized individual when monetary and non-monetary extramural support is received;
- letters, bulletins, board announcements, and advertisements to be used in recruitment; questionnaires, surveys, and rating scales; and case report forms.
Certain projects that utilize human material that does not contain any identifiers may be administratively approved by the CPHS without submission of the above materials. Investigators must contact the CPHS to see if their projects quality for such administrative review/approval.
Changes in protocol of human subjects research projects after initial approval by the CPHS require additional review and approval by the committee.
B. Animal Welfare Committee
A research project using vertebrate animals must be reviewed and approved by the Animal Welfare Committee before the project is initiated. The researcher must submit an Animal Protocol Review form that provides a complete description of animal manipulations and a justification for the use of animals. Researchers who use animals must be familiar with the National Institutes of Health Guidelines for the Care and Use of Lab Animals, the university Public Health Service Animal Welfare Assurance, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the Federal Animal Welfare Act.
To initiate the review process for the use of animals, contact the Animal Welfare Committee ("AWC") by telephone at (713) 500-7943.
Changes in protocol of animal subjects research projects after initial approval by the AWC require additional review and approval by the committee.
C. Radiation Safety Committee
Before an investigator may acquire any quantity of radioactive material or any radiation-producing device for use in a research project, he or she must submit an application for approval. The application for the use of radioactive materials (excluding human use) requires the submission of four forms. Necessary forms can be accessed via the Research homepage.
The forms must be submitted to Environmental Health and Safety where staff will review the information on them and investigate the request. After this initial review, the Environmental Health and Safety staff will forward the application to the Radiation Safety Committee for consideration and approval. (Refer to the Radiation Safety Manual.)
D. Institutional Biosafety Committee
Any use of any potentially infectious agents or non-exempt recombinant DNA ("rDNA") must be reviewed and approved by the Institutional Biosafety Committee ("IBC") before any procedure is initiated. The researcher must submit forms for research procedure; information on the agent to be used; and a protocol with references for the laboratory procedures to be followed when using the agent, including details of the safety practices to be followed, decontamination procedures, and methods for handling wastes.
Environmental Health and Safety assists researchers with determining which agents and rDNA molecules are considered to be non-exempt. For assistance, contact Environmental Health and Safety at OCB 1.330 or by telephone at 713-500-8100. Necessary forms can be accessed via the Research Administration homepage.
E. Chemical Safety Committee
Any use of acutely toxic chemicals must be reviewed and approved by the Chemical Safety Committee before any procedure is initiated. The researcher must submit forms for research procedure; information on the chemical to be used; and a protocol with references for the laboratory procedures to be followed when using the chemical, including details of the safety practices to be followed for addressing losses of containment, and methods for handling wastes.
Environmental Health and Safety assists researchers with determining which chemicals are classified as acutely toxic and warrant committee review. For assistance, contact Environmental Health and Safety at OCB 1.330 or by telephone at 713-500-8100. Necessary forms can be accessed via the Research homepage.
F. Intellectual Property Committee
The Intellectual Property Committee ("IPC") reviews all disclosures and patent inquiries, and when required, makes recommendations to the President through the Executive Vice President for Academic and Research Affairs ("EVPARA").
Whenever intellectual property is created by an employee of The University of Texas, it is a requirement that the employee disclose his/her intellectual property to the IPC of the university (Section 5.21). The IPC, which operates in confidence, reviews the intellectual property in order to determine The University of Texas' interest and rights in the creative effort. The scientific merit and commercial applicability are also considered in this review.
If the university IPC recommends that the university pursue its interests in the intellectual property, appropriate steps are taken. If the IPC recommends that the university not pursue its interests, and if the recommendation is approved by the university President, the Office of the Executive Vice Chancellor and the System Intellectual Property Office, then the intellectual property may be released to the inventor with or without certain stipulations. For assistance, contact Technology Management.
G. Research Conflicts of Interest Committee
All grants and research contracts submitted through the Office of Sponsored Projects ("OSP") and/or the Office of Legal Affairs must include a completed Research Conflicts of Interest Certification for all investigators responsible for the design, conduct, or reporting of the proposed research. The Certification indicates whether or not investigators have significant financial interests (defined in HOOP Policy 94 Research Conflicts of Interest) related to the proposed research. Applications submitted to the CPHS must also indicate if key personnel have financial interests in the proposed research.
Investigators with significant financial interests related to the proposed research complete and submit with the Review and Approval Form a Research Conflict of Interest Disclosure Form. Disclosures completed during the CPHS application process are submitted to the CPHS with the application.
The OSP, Office of Legal Affairs, and CPHS forward the financial disclosures to the EVPARA, and, in most cases, the EVPARA forwards the Disclosures to the Research Conflicts of Interest Committee for review. The Committee advises the EVPARA if there are conflicts of interest that should be eliminated, reduced, and/or managed, but the EVPARA makes the final decision of whether any conditions or restrictions are required to resolve or manage conflicts. The review must be complete and any required management plan implemented before funds are expended for a grant or contract with research related financial interests.
Updated Disclosures must also be submitted to the EVPARA during the award/contract period if new reportable interests are obtained during the award period.
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