Committee For the Protection of Human Subjects

Environmental Protection Agency

POLICY

It is the policy of UTHSC-H that when human subjects research is funded or supported by the Environmental Protection Agency (EPA), CPHS will ensure compliance with EPA specific regulations.

 

PROCEDURE

Research Involving Intentional Exposure of Any Human Subject - The EPA prohibits research involving intentional exposure of pregnant women, a nursing women, or a child to any substance. Other adults who voluntarily choose to participate are protected under the EPA’s rule, “Protections for Subjects in Human Research”, which requires proposed protocols describing intentional exposures be reviewed by EPA and its Human Studies Review Board.

Observational research involving pregnant women or fetuses is allowable if the IRB determines that all criteria for approval are met as per the Initial Review policy.

Observational research not involving greater than minimal risk is allowable only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.

Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects is allowable only if the IRB finds that (see policy on Research Involving Children):

1.       The intervention or procedure holds out the prospect of direct benefit to the individual subject or is likely to contribute to the subject's well-being;

2.       The risk is justified by the anticipated benefit to the subjects;

3.       The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

4.       Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.

 

Final Review by EPA - EPA policy requires submission of IRB determinations and approval to the EPA Human Subjects Research Review official for final review and approval before the research can begin.

 

Research Not Conducted or Supported By Any Federal Agency - For research not conducted or supported by any federal agency that has regulations for protecting human research participants and for which the intention of the research is submission to the EPA, the EPA regulations protecting human research participants apply, including:

1.       EPA extends the provisions of the 40 CFR 26 to human research involving the intentional exposure of non-pregnant, non-nursing adults to any substance.

2.       EPA prohibits the intentional exposure of pregnant women, nursing women, or children to any substance.

REFERENCE TO OTHER POLICIES

1.       Initial Review

ATTACHMENTS

1.       None

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

 

Document Number:

101-C19

Document Name:

Research Involving Environmental Protection Agency

Approved by:

ORSC Director

Effective:

1 Nov 2011

Revision History:

 


CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
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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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