ePROS - Enterprise Protections, Regulatory, Outreach, and Systems

Overview

The VA Office of Enterprise Protections, Regulatory, Outreach, and Systems (ePROS) is responsible for VA’s human subjects research policy, education, and support to the VA central institutional review board.

Purpose

Mission Statement

The purpose of ePROS is to contribute to the VA Research Enterprise mission of improving Veterans’ lives through research by ensuring the protection of the public, research, staff, human participants, and animals in VA-conducted research through policy, education, risk assessment, and mitigation.

ePROS supports the VA Research Enterprise by:

• Developing and managing VHA’s research regulatory policies. 
• Coordinating, prioritizing, and evaluating research education and training.  
• Developing, coordinating, and managing the enterprise-wide access to central research repositories and digital research systems (e.g., IT, data, and repository resources). 
• Ensuring the protection of VA's intellectual property and enabling commercialization efforts.
• Overseeing counterintelligence efforts to safeguard our Veterans’ data and VA’s research investment. 
• Managing electronic health record sustainment and implementation. 

Programs

• Institutional Review Board Network
  • Program Director: Don E. Workman, PhD
  • Enhances the quality of human research protection in multi-site human research projects by performing appropriate ethical and scientific review while ensuring local issues are addressed.
  • Enhances the efficiency of these reviews across participating sites.
  • Coordinates with academic and commercial institutional review boards to ensure proper research approval and oversight.

• Central Policy and Regulatory
  • Program Director: T. Howard Stone, JD
  • Establishes and revises policy and guidance that protects the public, human research participants, and research staff and promotes animal welfare.
  • Supports research privacy, biosafety, and biosecurity practices.
  • Creates processes and templates for effective and timely research agreement review for the enterprise.

• Research Education and Training
  • Program Director: Paska Permana, PhD
  • Provides required training to researchers involved in human subjects research, animal research, and laboratory research involving infectious agents, pathogens, toxins, and other biomedical materials.
  • Provides training for overview and institutional review board committee members on ethical research principles and safety.
  • Coordinates webinars and conferences to keep the VA research community informed on best practices and regulatory requirements.

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Resources

The following resources are available to researchers with access to the VA network.

* All links below are VA network access only.

Libraries and Databases

• Corporate Data Warehouse (OI&T): A collection of clinical, financial and administration data built and standardized from multiple source systems.
• HSRData-L Listserv: A virtual community of VA researchers who share their collective knowledge and experience about VA data and information systems for the betterment of research focused on Veteran’s issues.
• VA Phenomics Library CIPHER Centralized Interactive Phenomics Resource: An online knowledge-sharing platform that aims to optimize EHR data for use in research and clinical operations.
• VA Policy Search (Pilot): A library of VA national policies, VHA national policies, VA medical center policies, and policy-related information.
• VHA Data Portal/Knowledge Hub: A portal that integrates information from multiple sources into a single location to help users explore research and operations data and access policy and administrative tools.

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Services

• DocuSign: Allows secure, VA-compliance collection of eSignatures for Informed consent.
• Box: Used to manage, share, and collaborate on sensitive and non-sensitive data files with people outside the VA firewall.
• Field Enterprise Research Support Services (FERSS): Provides information on how to access research administration contractor FTE.
• Qualtrics: A platform focused on collecting, organizing, and understanding data.
• Single IRB Exceptions: Allows VA facilities to submit requests for single IRB exceptions.

Tools

• REDCap: Allows for easy creation of online databases and surveys approved for storage of PHI and PII without requiring knowledge of programming language.
• SOPHIA Knowledge Management System: A portal allowing VA employees to submit invention certification and disclosure forms.

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