# Presentation: 905693

## INTERNATIONAL RESEARCH IN THE DEPARTMENT OF VETERANS AFFAIRS

- Brenda Cuccherini, Ph.D., M.P.H.       Office of Research & Development
- Joan P. Porter, D.P.A., M.P.H.            Office of Research Oversight
- Society of Research Administrators International
- October 17, 2005

## What is International Research? 

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- What is International Research?

-    Any VA research approved by an R&D Committee that involves human subjects, human biological specimens, or human data conducted at international sites (not within the United States, its territories or Commonwealths).

## Multi-Site Trials

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- Considered international research when:
- VA is the sponsor, or
- VA functions as the coordinating center, or
- VA subcontracts to a foreign site, or
- The primary investigator for the total project is a VA investigator
- Not considered international research when:
- VA is only one of the participating sites and does not meet one of the above conditions

## Why Have a Policy?

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- Ensure:
- Appropriate ethical review
- Compliance with the Common RuleGood international relationships
- VA’s PIs, IRBs & R&D Committees understand local context of research
- Sufficient, efficient, & timely communications
- Clearly defined roles for all at VA & at international sites
- Define minimal information necessary for IRB  and R&D Committee reviews
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## Recently Identified Issues with International Research 

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- Recently Identified Issues with International Research

- Scenario 1: Children entered into research at foreign site without IRB knowledge or without obtaining an informed consent
- Scenario 2: OHRP suspends one of its international assurances
- Scenario 3: Research is insufficiently monitored on site and data are rejected by FDA; adverse events are not reported properly so data validity suspect
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## International Research: ORD’s Activities

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- International Research: ORD’s Activities

- Drafted new VHA policy: All new studies require permission of the CRADO
- Consultation with ORO, Ethics, other Federal Agencies
- Status of draft policy
- Developing guidance & required information for submission of request to CRADO

## Information Required (draft)

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- Protocol with description of human subjects involvement
- Risks and benefits
- Interventions
- Source of data or biological specimens
- Description of each foreign site
- Facilities
- Investigators
- Principles governing research
- Ethics committee
- Assurances, if any
- Copy of approvals from foreign site(s)

## Information Required (draft) 2

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- Communication plan
- Financial arrangements
- Liability issues
- Monitoring reports
- Frequency
- Reviewed by whom
- Plan for oversight
- Informed consents
- IRB/ethics/R&D Committee approvals

## As We Begin

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-    “It is better to know some of the questions then all the answers.”
- 				James Thurber 1894-1961

## With Experience Comes Answers

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- Many questions remain
- Few absolutes in how to apply equivalent protections
- Need to continue exploring how best to protect subject regardless of geographic location
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## A New Geographic Location for Research

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-   “We are in Transylvania, and Transylvania is not England. Our ways are not your ways, and there shall be to you many strange things.”
-                                             Bram Stoker
-                                                                               _Dracula_

## ORO’s Current Role 

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- ORO’s Current Role

- Survey currently active research
- Routine reviews
- For cause reviews
- Close communication with ORD
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## Future Steps

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- ORD develops more information based on
- Experience with new policy
- Federal-wide committee activities
- ORO receives information
- Site visits,reviews
- Inquires
- ORO may include International Assurances in their assurance handbook
- ORD & ORO continue to share information
- ORD will develop a more detailed Handbook and guidance
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## Other Initiatives

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- HSRS evaluating other Federal Agencies’ and Departments’ policies and procedures
- VA Office of Intergovernmental Relations developing its role within VA and procedures for reporting international sites to Department of State
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-    “There is a loftier ambition than merely to stand high in the world.  It is to stoop down and lift mankind a little.”
-        American clergyman, educator & author