This application from the University of Miami seeks support to enhance and expand its activities in support of the Human Subjects Research Program. The University has seen an increase in the volume of reports including protocols, adverse event reports, approvals for soliciting subjects, and other required documents. It is critical that our infrastructure be strengthened to protect human subjects involved in research including safety, health, ethical, and moral considerations. The enhancements will strengthen our review processes for complex scientific protocols, broaden our educational efforts, and ensure regulatory compliance. The overall philosophy of the University is to create an """"""""atmosphere of compliance"""""""" in order for all faculty, staff, administrators, and students to understand their roles and responsibilities. The specific requests are primarily for personnel to carry out the objectives stated in the application and the University of Miami is committed to continue these enhancements at the end of this grant period. We look forward to this partnership with the National Institutes of Health to enhance human subjects research, to protect human subjects enrolled in experimental protocols, and to promote the highest scientific quality, ethical and moral standards with the ultimate goal of improving human health and quality of life.
| Braunschweiger, Paul; Goodman, Kenneth W (2007) The CITI program: an international online resource for education in human subjects protection and the responsible conduct of research. Acad Med 82:861-4 |
| Dominguez, Roberto A; Feaster, Daniel J; Twiggs, Leo B et al. (2005) Searching for an efficient institutional review board review model: Interrelationship of trainee-investigators, funding, and initial approval. J Lab Clin Med 145:65-71 |
