Proposal Guide: Compliance Issues
Conflict of Interest
The federal government has recently increased requirements regarding institutional oversight of potential or real conflicts of interest with regard to research activities and other institutional responsibilities. Both the National Science Foundation and the Public Health Service have published updated regulations dealing with this issue, and other funding agencies have adopted the same or similar policies. These regulations and university policy require investigators to disclose the existence of certain financial interests annually and within 30 days of acquiring a new interest. Disclosures of third party sponsored travel and additional training requirements may also apply. The UH Conflict of Interest Committee is charged with reviewing these disclosures and advising the Vice President for Research and Technology Transfer regarding real or potential conflicts exist, as well as recommending mechanisms to manage, reduce, or eliminate the conflict.
The University of Houston’s conflict of interest policy was most recently updated in August 2012 to comply with current regulatory requirements. Under the policy, principal investigators, co-investigators, key personnel, and any other university employee who is responsible for the design, conduct, or reporting of research or educational activities must file a conflict of interest certification. The certification and any applicable disclosures must be on file prior to submitting a project proposal to any funding agency. It is very important that any reported conflict of interest be resolved prior to the University’s receipt of an award. Repercussions for not doing so can not only affect the investigator’s opportunities to receive funding, but also the university’s.
View the University of Houston’s policy on Conflict of Interest.
The Division of Research (DOR) is the campus office charged with adherence to rules and regulations concerning safety matters relating to research. DOR cooperates with the Environmental Health and Life Safety (EHLS) Department, as necessary, to ensure compliance with these regulations, where appropriate. Individuals proposing research projects that contemplate the use of carcinogenic or toxic compounds, animals, human subjects, biological agents or toxins, recombinant/synthetic nucleic acid molecules, or radioactive materials, radiation producing devices (x-ray and lasers) in their research projects should contact DOR for further information about any of the areas listed below.
Animal Care and Use Committee
All procedures involving live vertebrate animals, whether instructional or conducted in the research laboratory, are governed by federal regulations, principles, and guidelines that embody the proper procedures for the ethical care and use of these animals. The University is currently accredited by the American Association of Accreditation of Laboratory Animal Care, International (AAALAC). The animal care and use program is overseen by the Institutional Animal Care and Use Committee (IACUC), Animal Care Operations (ACO), and the Institutional Official (IO).
University policy requires that all projects involving the use of live animals are reviewed by the IACUC prior to the initiation of the research. Note that the IACUC review and approval process should be started as soon as the PI anticipates that an award will be made to allow time for committee review and feedback. For general information about the IACUC and for copies of the current IACUC application form, refer to the IACUC webpage.
Institutional Biosafety Committee
The Institutional Biosafety Committee serves as a compliance oversight committee to the Vice Chancellor for Research and Technology Transfer for the purpose reviewing and approving proposed research involving biological agents , recombinant/synthetic nucleic acid molecules and other potentially hazardous biological work to ensure compliance with NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (March 2013), Biosafety in Microbiological and Biomedical Laboratories (5th Edition) and the UH Biosafety Manual.
The Biological Safety Officer (BSO) is the primary liaison between the campus community and the Committee. Biological safety policies and forms are available from the Environmental Health and Life Safety Department. Contact the Biological Safety Officer for assistance at email@example.com.
Institutional Review Board
The UH Institutional Review Board (IRB) and/or the IRB office are charged with the responsibility for reviewing all research involving the use of human subjects and data related to human subjects (including projects considered “exempt,”) regardless of funding source. Research is reviewed in accordance to regulations set forth by the Department of Health and Human Services (DHHS), the U.S. Food and Drug Administration, and must be consistent with the principles of the Belmont Report (respect for persons, beneficence, and justice). Additional protections are required for vulnerable populations, including but not limited to children, prisoners, and the cognitively impaired.
Note that the process of obtaining approval from the IRB needs should start as soon as the PI is notified of a pending award; no funds may be expended until the project receives a final approval letter from the IRB. For more, refer to the IRB website, which includes required human subjects training information and committee deadlines and meeting dates.
Radiation Safety Committee
University of Houston (UH) maintains a Radiation Safety Committee (RSC) to oversee the Radiation Safety Program, ensuring compliance with state rules and other applicable regulations. The Campus Radiation Safety Committee, under the functional authority of the Vice Chancellor /Vice President for Research & Technology Transfer serves to establish policies and standards of practice relating to radioactive materials and radiation devices, consistent with the Radiation Control Program of the Texas Department of State Health Services, the Texas Radiation Control Act and the Federal Radiation Control for Health and Safety Act of 1968. The Committee also regulates the receipt, possession, use, transfer, disposal or acquisition of source(s) of ionizing or non-ionizing radiation and radiation producing devices.
The Committee advises the Chancellor/President, the Senior Vice Chancellor/Vice President for Administration and Finance, the Senior Vice Chancellor/Vice President for Academic Affairs and Provost, and the Vice Chancellor / Vice President for Research & Technology Transfer about radiation hazards at the University of Houston. Research, teaching and university operations involving radioactive materials, x-ray machines, Class 3b and 4 lasers must receive prior approval from the RSC.
The Radiation Safety Officer (RSO) is the primary liaison between the campus community and the Radiation Safety Committee. Radiation safety policies and forms are available from the Environmental Health and Life Safety Department. Contact the Radiation Safety Officer for assistance at firstname.lastname@example.org.
While a proposal for funding is pending at a federal agency, federal regulations prohibit university officials and principal investigators from offering future employment, money, gratuities, or other items of value to agency procurement officials or from soliciting proprietary or source selection information from government officials. This regulation applies to all contracts.
A University faculty member or administrator, while paid from federal funds or traveling on federal grant or contract funds, may not lobby for the award of a specific grant or contract. Additionally, if a university faculty or staff member lobbies using non-federal funds for any specific grant or contract, such lobbying activity must be reported on a quarterly basis via the Office of Contracts and Grants to appropriate federal officials. It is not the intent of these regulations to prohibit the normal interchange between a faculty or staff member and a program or contract officer at an agency. However, UH faculty and staff must be aware that certain discussions of a new or renewal award may be interpreted as lobbying.
Debarment and Suspension
The federal government is precluded from making awards to institutions or their principals (faculty members and their colleagues) who are debarred or suspended, or in the process of being debarred or suspended, by the federal government. Any individual who is debarred or suspended is required to notify the Office of Contracts and Grants.
Intellectual Property (Patent Disclosure)
Board of Regents policy provides that the University of Houston owns all rights to intellectual property created with University resources (including sponsored funds) that is produced as part of normal university responsibilities. This is a matter of State of Texas law and is comparable with the existing laws of most states. In keeping with a long-standing academic tradition nationwide, the University normally claims no ownership in textbooks, literary, scholarly or artistic works, unless the specific terms of a grant or contract provide otherwise.
With regard to potentially patentable technology, this policy is implemented by the formal assignment of such technology to the University of Houston. This assignment is required of all faculty members prior to the processing of proposals to external agencies and prior to the processing of salary payments from contract and grant funds. In addition, the university requires that faculty, staff, and students submit patent disclosures to the Intellectual Property Committee for institutional review and action. The University’s Faculty Handbook includes the details of the policy and further information is available from the Office of Contracts and Grants. Learn about the Office of Intellectual Property Management.
Responsible Conduct of Research (RCR)
The University of Houston is committed to supporting responsible and ethical conduct of research and scholarship among its faculty, staff and students. Responsible conduct of research should foster a climate of intellectual honesty and a commitment to ethical responsibilities by academia. All members of the University community share equally in the responsibility for developing and maintaining standards to assure ethical conduct of research and detection of abuse of these standards; in addition, awards supported by both the National Science Foundation (NSF) and the National Institutes of Health (NIH) must comply with specific requirements to ensure appropriate training in the responsible conduct of research.
The University provides information and resources to assist faculty in understanding these requirements and in locating on- and off-campus opportunities for such training during all career stages. To learn more, refer to the Responsible Conduct of Research website.
Research Congruency Review
Research congruency reviews are performed by the DOR Office of Research Policies, Compliance and Committees (ORPCC) prior to grant or contract funds being made available to the investigator for research use. This review compares the research proposal or contract detail side by side with corresponding compliance protocol(s) for all research involving human subjects (IRB), animals (IACUC) and hazardous or recombinant biological agents (Biosafety). The review is performed to ensure that the proposed research is congruent with the appropriate protocols and that these protocols are fully approved by the corresponding oversight committee(s). If a protocol is not approved, or has not been created, then the compliance review will be placed on hold until all approvals have been secured. Note that research congruency reviews are also performed on Sponsored Research Agreements and Material Transfer Agreements. These reviews can be conducted early upon request if the required protocols are already in place. Note that an error in marking the correct research categories (humans, animals, biohazards) on the pre-award documentation may cause delay in this review. For more information, refer to the Research Congruency Review website.
Material Transfer Agreements
MTAs, or Material Transfer Agreements, are legal documents that govern the transfer of research material, including data, between two entities, for use by the recipient in their research activities. The MTA defines the rights of the provider to the recipient with respect to the materials and any derivatives of the research in which the materials were utilized. MTAs should be completed for research materials such as, but not limited to:
- Human subject materials (i.e. tissue, blood, cells, urine, etc.)
- Human subject data (data gathered through intervention or interaction, and/or identifiable private information)
- Human Cell lines
- Animals and Animal Cell Lines
- DNA Libraries
- Growth factors
MTAs involving human subject materials/data, animals, and bio-hazardous materials will go through a compliance review to ensure that the proper oversight committee protocols and any additional safety precautions or measures are in place prior to the arrival of the material.