Committee For the Protection of Human Subjects

Coordination With Other UTHSC-H Committees

POLICY

It is the policy of CPHS to work in coordination with other UTHSC-H committees to provide protections to human participants.  CPHS functions independently but in coordination with other UTHSC-H Committees that have oversight of research.

Key Terms:

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.

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 UTHSC-H. This Committee is also responsible for recommending training requirements for UTHSC-H 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 UTHSC-H. Research involving hazardous chemicals in humans must be reviewed by the Chemical Safety Committee.

Internal Scientific Advisory Committee – This Committee evaluates the scientific merits of investigator initiated human subjects research that has not been peer reviewed.

 

PROCEDURE

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.

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.

APPLICABLE REGULATIONS

1.                   None.

REFERENCES TO OTHER POLICIES

1.                   None.

ATTACHMENTS

1.                   None.

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

 

Document Number:

101-A01

Document Name:

Coordination with Other UTHSC-H Committees

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Aug 2011

 


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Committee for the Protection of Human Subjects
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713.500.7943
Fax     713.500.7951
Email cphs@uth.tmc.edu 

IRIS Support 713.500.7960

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