INSTITUTIONAL REVIEW BOARD AND INVESTIGATIONAL USE OF DRUGS

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 for the pharmacist’s roles in ethical clinical research, including but not limited to serving as a principal investigator, developing protocols, executing research, determining rational-use decisions for the off-label use of drug products, and publishing research findings, and for adequately resourced, sustainable models for filling those roles; 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 support pharmacists’ management of drug products used in clinical research. 

Rationale

The Food and Drug Administration (FDA), under its regulations, defines an institutional review board (IRB) as a group of people that have been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

Human subjects research is codified in 45 CFR Section 46, and 45 CFR Section 46.102(e)(1) states that a human subject is:

a living individual about whom an investigator (whether professional or student) conducting research:

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Evidence-based healthcare decisions are highly dependent on sound principles of research and investigation. ASHP believes the healthcare workforce needs to be competent in understanding the research process and the protection of human subjects involved in research trials. In addition, hospitals and health systems are home to investigational drug services that support the conduct of clinical trials involving medication use. Pharmacists are critical to the successful management of these trials and therefore need to be engaged in decisions related to developing, conducting, and evaluating research within their institutions.