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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 the Inova Office of Research.
The Inova Health System Federalwide Assurance FWA00000573 has been approved by the Office for Human Research Protections (OHRP) and expires on December 5, 2021. The Institutional Signatory Official for Inova is Patrick L Christiansen PhD, CEO, Inova Fairfax Medical Campus; EVP, Inova Health System.
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.
IRB Committees
There are three 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.
Alternate IRBs
The Inova IRB Administrative Office interacts with Western IRB (WIRB), WIRB-Copernicus, Quorum and Schulman IRBs and has a dedicated HRPP-liaison. Alternate IRBs are an option for reviewing sponsored and funded protocols. The Inova IRB Office takes an active role in tracking protocols being reviewed by the alternate IRBs; adverse event reports, and compliance concerns. Recommendations from the alternate IRBs are actively reviewed for potential local action.
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