Guidance on Informed Consent of in Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
Rockville, MD: U.S. Food and Drug Administration [FDA], 2006 April 25; 10 p. [Online]. Accessed: http://www.fda.gov/cdrh/oivd/guidance/1588.pdf [2006 May 3]
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Low Risk Research Using Routinely Collected Identifiable Health Information Without Informed Consent: Encounters With the Patient Information Advisory Group Metcalfe, C.; Martin, R.M.; Noble, S.; Lane, J.A.; Hamdy, F.C.; Neal, D.E.; Donovan, J.L. (2008-01)Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data ...