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
All IRB initial applications must include a detailed plan for how participants will be identified and recruited. All activities and materials must be non-coercive and the potential subjects must voluntarily participate in the recruitment process. Therefore, the Institutional Review Board (IRB) must approve the recruitment plan and all materials (flyers, email solicitations, advertisements, brochures, letters, …read more
The Principal Investigator The Principal Investigator (PI) is the primary individual responsible for the ethical design and conduct of a research study including the supervision of co-investigators and study personnel. While the PI may delegate tasks to members of their research team, they remain ultimately responsible to ensure all research activities are designed and carried …read more
Once approved, any changes to the protocol (regardless of the scope of the change) may not be implemented by the research team until they have been reviewed and approved by the HSP Office.
Review The Level of review an application receives is based on the risk assessment conducted during the pre-review process. The levels of review are outlined below. Plan ahead: It is important that you have all required supporting documents in place before you submit your application so as not to delay the review process. Some documents …read more
Obtaining Approval Does this need IRB Review? PI Responsibilities PI Eligibility Levels of Review Items to include in your IRB submission IRB Training Recruitment Informed consent Forms and Checklists Common Mistakes Single IRB After Approval Record Keeping / Data Management Modifications / Renewals Reportable Events Post Monitoring Program Study Expiration / Closure General Guidance HHS …read more
Institution Policies Institutional Review Board Policies and Procedures Federal Regulations The list below represents a few of the federal agencies from which UTD receives support for human subjects research. The links below reference federal websites or documents that contain policies, explain specific provisions, and provide links to resources for that agency. U.S. Department of Health and …read more
