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

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

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

Modifications All changes to an approved research protocol (including changes to consent forms, recruitment scripts / flyers, study measures, personnel, protocol procedures / activities, etc.) must be reviewed and approved prior to the changes taking effect, except when necessary to eliminate immediate hazards to subjects.  Modifications must be submitted through Cayuse. All changes must be …read more

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Use of deception and incomplete disclosure generally goes against a basic principle of human subjects research: to treat individuals as autonomous agents by disclosing complete and truthful information about a study. However, the IRB recognizes it can be a useful tool, especially in behavioral and social research. The information below provides guidance on the appropriate …read more

The following tables outline PI eligibility for UTD affiliated personnel. Expedited / Full Board Review Titles and Appointments Principal Investigator Eligibility Tenure/Tenure Track Faculty (Assistant, Associate, Professor) Yes Clinical Professors Yes Visiting Faculty (Assistant, Associate, or Professor) No, except with a Faculty Sponsor Adjunct (Assistant, Associate, or Professor) No, except with a Faculty Sponsor   …read more

Record Keeping The Principal Investigator (PI) must maintain a file of all documents relevant to their IRB approved study for at least 3 years after a Closure request is submitted and the study is closed by the Office of Human Subjects Protections (OHSP). The PI’s records should contain all documents submitted by the research team …read more

Investigators must obtain the legally effective informed consent of a research participant or the participant’s legally authorized representative (LAR). Consent must be obtained prior to the research activities and documented as approved by the Institutional Review Board (IRB). The Consent Process. Informed consent is more than just a signature on a form, it is a …read more