Clinical Care vs Research CROMS Clinical Research Operations
- Slides: 5
Clinical Care vs. Research CROMS Clinical Research Operations and Management Support Rho, Inc. , Federal Division NIDCR National Institute of Dental and Craniofacial Research National Institutes of Health
Clinical Care vs. Research: Similarities The same personnel can sometimes serve in both capacities Similar settings – clinics, hospitals, outreach situations Treatments, procedures, tools may be the same or similar Safety and protection of patients, participants, subjects 2012 -03 -22 2
Clinical Care Goal is to provide benefit to the individual Ethical principles: ◦ Therapeutic beneficence ◦ Therapeutic nonmaleficence – “do no harm” New knowledge generated is incidental to overriding goal of care and treatment for the individual Care is individualized to each patient 2012 -03 -22 3
Research Goal is new knowledge that can help future patients Ethical principles: ◦ Nonmaleficence ◦ Balancing of risks and benefits Therapeutic benefit to individual, while important, is secondary to overriding goal Standardized procedures for all study participants (not patients) ◦ Study procedures must be consistent and data must be reproducible 2012 -03 -22 4
Research, cont’d. Additional expectations of documentation in research Potential for application of research results to suggest changes in clinical care Course of care is outlined in the IRB-approved protocol Version 1. 0 2012 -03 -22 5
