Benign Behavioral Interventions

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

Exemption Categories 

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

We Are Using Soundwaves to Sensitize Tumors

Neuroblastoma is the most common extracranial solid tumor found in children. If you’re not familiar with this form of cancer, the term neuro refers to nerves, and blastoma is cancer that starts in immature or developing cells. High-risk neuroblastoma is particularly deadly, with cure rates of only 50%. Hearing that their child has neuroblastoma could be a frightening and …read more

Frequently Asked Questions

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

Common Mistakes to Avoid

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

Post Monitoring Program (PMP)

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

Reportable Events

The IRB requires PI to promptly report (within 5 days) a summary of reportable events (including unanticipated problems and deviations) using the Reportable Events Report in Cayuse IRB.  Examples of events that require reporting to the IRB include but are not limited to the following: Information that indicates a new or increased risk, or a new …read more

HHS Resources

Office for Human Research Protections (OHRP) Office for Human Research Protections (OHRP) Educational Videos Research Use of Human Biological Specimens and Other Private Information Reviewing and Reporting Unanticipated Problems and Adverse Events Investigator Responsibilities FAQs (OHRP) Research with Children FAQs (OHRP) Prisoner Research FAQs (OHRP) International Compilation of Human Research Standards Compilation of European GDPR …read more

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