Research
0711: Institutional Review Boards and Investigational Use of Drugs 0229: Clinical Investigation of Drugs Used in Elderly and Pediatric Patients
Source: Council on Pharmacy Practice
To support mandatory education and training on human subject protections and research bioethics for members of institutional review boards (IRBs), principal investigators, and all others involved in clinical research; further,
To advocate that principal investigators discuss their proposed clinical drug research with representatives of the pharmacy department before submitting a proposal to the IRB; further,
To advocate that IRBs include pharmacists as voting members; further,
To advocate that IRBs inform pharmacy of all approved clinical research involving drugs within the hospital or health system; further,
To advocate that pharmacists act as liaisons between IRBs and pharmacy and therapeutics committees in the management and conduct of clinical drug research studies; further,
To strongly support pharmacists' management of the control and distribution of drug products used in clinical research.
This policy supersedes ASHP policy 0230.
Source: Council on Professional Affairs
To advocate increased enrollment of pediatric and geriatric patients in clinical trials of new medications; further,
To encourage pharmacodynamic and pharmacokinetic research in geriatric and pediatric patients to facilitate the safe and effective use of medications in these patient populations.
This policy was reviewed in 2006 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriate.
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