Human Research Protection Program
Conducting research at Inova
The Human Research Protection Program (HRPP, formerly IRB) is an oversight body established and supervised by the Board of Directors of Inova. Inova's IRB function is supported by IRB's administrative office which is a component of Inova Research Center.
The Inova Health System Federalwide Assurance FWA00000573 has been approved by the Office for Human Research Protections (OHRP) and expires on July 20, 2016.
What is research involving human subjects?
The Department of Health and Human Services regulations define research at 45 CFR 46.102(d) as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generic knowledge.
A human subject is defined as a living individual about whom an investigator obtains data through intervention or interaction with the individual or identifiable private information (45 CFR 46.102 (f)). Activities that meet this definition constitute research, whether or not they are conducted or supported under a program that is considered research for other purposes.
Executive IRB Committee
This important oversight committee reviews research policies, conflict of interest issues and research misconduct issues. The committee is comprised of 14 individuals from various professional backgrounds including medicine, science, ethics, administration, and community service. The Committee meets on a bi-monthly basis.
There are two IRB committees that assure that all research activities involving human participation, conducted at any Inova facility adequately protect the rights and welfare of the human participants recruited to participate in these activities. These committees independently decide whether to approve or disapprove the research study based upon whether or not the protocol adequately protects the rights and welfare of human participants. These committees meet monthly (except during August) on an alternating schedule.
Western IRB (WIRB)
The Inova IRB Administrative Office interacts with WIRB and has a dedicated WIRB liaison. WIRB is an option for reviewing sponsored and funded protocols. The Inova IRB Office takes an active role in tracking protocols being reviewed by WIRB; adverse event reports, compliance concerns and recommendations from WIRB are actively reviewed for potential local action.
Inova IRB Administrative Staff
- Laura Miller, MSHA, CIP, IRB manager
- Kathy Ababio, BS, CHES, IRB coordinator
- Hae-Ri Kang, BA, IRB coordinator
- Heather Huryk, IRB coordinator
- Elizabeth "BJ" Pulsipher, RN, IRB coordinator
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