Policy for Review of Human Subject Research
 
Purpose | Definition | Applicability | Responsibility | References and other relevant information
 
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PURPOSE

The University’s human subject research program is directed by three basic ethical principles of respect for persons, beneficence, and justice, in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979, created by the National Research Act, Pub. L. 93-348, July 12, 1974 and all criteria for the use of human subjects in research covered by 45 CFR 46


DEFINITION




APPLICABILITY

All research sponsored or sanctioned by the University involving any human subjects, whether funded or non-funded, conducted by faculty, students or staff, using any property or facility owned or controlled by the University, or involving the use of non-public information maintained by the University to identify or contact human research subjects will be conducted in compliance with 45 CFR 46. Research involving human subjects may not be performed unless the requirements of this federal policy have been satisfied and written certification of the University’s review and approval of the research is obtained.


RESPONSIBILITY

The Vice President for Research is authorized to review all proposed research, and decide whether the University will permit the research, as appropriate to the role and scope of the University. All human subject research will be reviewed by the University’s Institutional Review Board (IRB). The involvement of human subjects in research projects will not be permitted to begin until the IRB has approved the research protocol, the informed consent document, the testing instruments, and the appropriate consents from subjects which have been obtained by the Principal Investigator. Previously approved protocols must be reviewed annually by the IRB. Interim changes to approved protocols must be reviewed and approved by the IRB prior to implementation.

If human subjects involved in research projects approved by the IRB are harmed, including any physical or psychological injury, any adverse events, improper disclosure of private information, economic loss, and other harmful or potentially harmful occurrences, the Principal Investigator must notify the IRB and the Office of Research and Sponsored Projects immediately. ORSP will, in turn, notify the Office of Human Research Protections, Department of Health and Human Services.


REFERENCES AND OTHER RELEVANT INFORMATION

Institutional Review Board (IRB) at UTEP
IRBNet
Office for Human Research Protections (OHRP) - Policy Guidelines
OHRP - FAQ's on Exempt Research Determination
OHRP - Compliance Oversight Procedures for Evaluating Institutions



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