What interests me in this study? Why would I want to or need to participate in the study? When does this study take place? Where does the study take place? How long does the study last? Is this study safe? Do I feel that I can trust the researchers? Who gains from my participation? Does …read more

The purpose of this information is to provide guidance for Exemption Category 3 of human subjects research regulations (45 CFR 46) and provide examples of “benign behavioral interventions” at The University of Texas at Dallas (UTD). Exemption Category 3 (3) (i) Research involving benign behavioral interventions in conjunction with the collection of information from an …read more

Common Rule Most Exempt Studies are not subject to Federal regulations, however must go through an administrative review process to confirm their exemption status. The Office of Human Subjects Protections (OHSP) is responsible for determining whether research involving human subjects meets the criteria for exemption as outlined in the Federal regulations (see below). Investigators may not make this …read more

Getting Started The Application After Approval Who can I talk to if I have a question about human participants research? The Office of Human Subjects Protections (OHSP) is available to provide assistance to investigators who are engaged in research with human participants. For general questions, please contact our office at HSP@utdallas.edu. When is IRB review …read more

If you have questions at any point in the submission or approval process, contact the HSP Office.

A study may be closed when all of the following apply: All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing). All subject specimens, records, or data have been obtained (no further collection of data/information from or about living individuals will be obtained). No further contact with subjects is necessary (all …read more

Any active study is subject to a post-approval review via our post-monitoring program (PMP). The purpose of the PMP is to assess the research activities conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (OHRP). This program assures human subject safety in research, provides education to research professionals, and …read more

Certificates of Confidentiality (CoC) are issued by the National Institutes of Health (NIH) to protect identifiable, sensitive information participant information collected in the course of a research study. Identifiable, sensitive information is defined as information that is about an individual and that is gathered or used during the course of research where the following may …read more

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