|
I.02 |
|
Coordination with other UTHealth Committees
|
PURPOSE
1. The purpose of this policy and procedure is to describe the process for coordination of CPHS review and approval with other UTHealth Committees that have oversight for research.
SCOPE
2. This policy and procedure is applicable to investigators, CPHS members and ORSC Staff.
POLICY
3. It is the policy of UTHealth CPHS to work in coordination with other UTHealth committees to provide protections to human participants. CPHS functions independently but in coordination with other UTHealth Committees that have oversight of research.
RESEARCH OVERSIGHT COMMITTEES
4. Research Conflict of Interest Committee – This Committee reviews conflicts of interest disclosures to determine if investigators have conflicts of interest that might affect, or appear to affect, the design, conduct or reporting of research and recommend how conflicts should be managed, reduced, or eliminated through conflict of interest management plans.
5. 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.
6. 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.
7. 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.
8. 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.
9. Internal Scientific Advisory Committee – This Committee evaluates the scientific merits of investigator initiated human subjects research that has not been peer reviewed.
PROCEDURE
10. Identifying Necessary Approvals: The CPHS submission packet requires key study personnel to declare if they have any conflict of interest 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.
11. 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 ORSC Staff may hold CPHS approval until all necessary approvals have been obtained.
RESPONSIBILITY
12. The Principal Investigator is responsible for obtaining approvals from all applicable Committees prior to initiating the research.
|
Applicable Regulations and Guidelines None
|
|
Return to Policies and Procedures Home Page
|
|
Updated 2/2009, Report
broken links
|