Real Impact
•Research may be done if:
–No PHI is needed
–A limited data set is used (need data use agreement)
–Approval (authorization) from patient to do prospective research
–May do “preparatory research” w/o IRB approval
–“Waiver of Consent” is needed in retrospective studies and with a Limited Data Set
•All patients need to sign additional paper for approval of information for prospective research