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Clinical Care vs. Research

Clinical Care vs. Research. CROMS. NIDCR. C linical Research Operations and Management Support Rho, Inc., Federal Division. National Institute of Dental and Craniofacial Research National Institutes of Health. Clinical Care vs. Research: Similarities.

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Clinical Care vs. Research

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  1. Clinical Care vs. Research CROMS NIDCR Clinical Research Operations and Management Support Rho, Inc., Federal Division National Institute of Dental and Craniofacial Research National Institutes of Health

  2. 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

  3. 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

  4. 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

  5. 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 2012-03-22 Version 1.0

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