CROMS C linical Research Operations and Management Support Rho Inc Federal Division NIDCR National Institute of Dental and Craniofacial Research National Institutes of Health The same personnel can sometimes serve in both capacities ID: 731004
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Clinical Care vs. Research
CROMS
C
linical Research Operations and Management SupportRho, Inc., Federal Division
NIDCR
National Institute of
Dental and Craniofacial Research
National Institutes of HealthSlide2
The same personnel can sometimes serve in both capacities
Similar settings – clinics, hospitals, outreach situations
Treatments, procedures, tools may be the same or similarSafety and protection of patients, participants, subjectsClinical Care vs. Research: Similarities
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2012-03-22Slide3
Clinical Care
Goal is to provide benefit to the individual
Ethical principles:Therapeutic beneficenceTherapeutic nonmaleficence – “do no harm”New knowledge generated is incidental to overriding goal of care and treatment for the individualCare is individualized to each patient
2012-03-22
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Goal is new knowledge that can help future patients
Ethical principles:
NonmaleficenceBalancing of risks and benefitsTherapeutic benefit to individual, while important, is secondary to overriding goalStandardized procedures for all study participants (not patients)Study procedures must be consistent and data must be reproducibleResearch
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2012-03-22Slide5
Research, cont’d.
Additional expectations of documentation in research
Potential for application of research results to suggest changes in clinical careCourse of care is outlined in the IRB-approved protocolVersion 1.0
2012-03-22
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