# Presentation: 923487

## Public Responsibility in Medicine and Research (PRIM&R)

- Hot Topics, Thorny Problems, and Practical Solutions

- Joan P. PorterDeputy Chief Officer, Office of Research OversightDepartment of Veterans AffairsNovember 18, 2008

## Research Compliance Officers (RCOs)!

- Important Contributors to Quality Research in the Department of Veterans Affairs
*How many here are RCOs?*

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## Executive Career Field (ECF) Performance Plans for FY 2009Require

- At least one full time RCO per each VA facility conducting research
- _Full-time_

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## The New RCO Requirement Includes:

- Dedicated auditing
- Monitoring
- Reporting on the conduct of _all_ VA research

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## FY 2009 Executive Career Field (ECF) Performance Plan Requires

- Audits for compliance with all VA and other federal requirements
- Annual audits of all active studies for information consent, and
- Regulatory compliance audits for all active studies at least every 3 years.

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## RCOs Have Many Responsibilities

- Regulations
- Policies
- Memoranda
- Alerts
- Other VA and federal requirements on research compliance

- Serve as a local resource for:

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## Many Responsibilities —

- Institutional Review Board (IRB)
- Institutional Animal Care and Use Committee
- Biosafety Committee
- Research and Development Committee

- Serves as a non-voting member on the:

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## Provide education to investigators and research staff about regulatory and policy requirements

- Many Responsibilities —

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## Many Responsibilities —

- Ensure prompt reporting to the Office of Research Oversight (ORO) in accordance with all policies
- Promptly forwarding all auditing and monitoring reports in which any non-compliance is identified to the Facility Director and ORO

- Copies at the same time to Facility Director, Facility Chief of Staff, Associate Chief of Staff for Research, Research and Development Committee Chair, Institutional Review Board Chair, and the Office of Research and Development

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## Classification

- At least GS-11; mostly GS-12 – 13; could be GS-14 or 15 depending on qualifications and size of program
- Can also be nurses, physicians, pharmacists

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## Reporting Auditing

- The process for reporting annual _informed consent_ auditing is out (Oct. 31, 2008)
- Next release is process for reporting other audits (about 1/3 of protocols every year).  Goal for human subjects protocols – Dec. 5!

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## Impressive help from Research Compliance Officers who are premier members of the ORO Advisory Group

- Membership will be expanded in the future.

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## Reports come to ORO in two ways: 

- Via the VHA Facility Directors Annual Certification of Research Oversight (due July 1)
- Via VHA Handbook 1058.01 – Requirements for Reporting Research Events to Local Oversight Committees and the Office of Research Oversight

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## VHA Facility Directors Annual Certification of Research Oversight

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## VHA Handbook 1058.01ORO must have reports of serious noncompliance to ORO Regional Offices right away — not waiting for summaries every year.

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## Any Changes Contemplated?

- How to report to ORO?
- What to report to ORO?
- What happens if we are in a VA with many protocols?  with few protocols?

- This is all new — and there are so many questions!

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## More Questions . . .

- Can an RCO be a contractor?
- Can an RCO be from the affiliate IRB?

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## Is there any waiver to the requirement for a full-time Compliance Officer?

- VA Directive 2008-064* published October 16, 2008, requires that the Director of each VA facility conducting human subjects research appoint a full-time Research Compliance Officer.
- The possibility of a waiver for a full-time RCO is under consideration by the Under Secretary for Health.  High level approval on a case-by-case basis would be needed.

- * VHA Directive 2008-064 – Research Compliance Officers and the Auditing of VHA Human Subjects Research to Determine Compliance with Applicable Laws, Regulations, and Policies.

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## ORO’s Commitments —ORO Central Office is establishing a new Research Compliance and Education Staff

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## Slide 20

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## ORO’s Research Compliance Education Staff

- Associate Director
- Health Science Specialist
- Health Science Specialist
- Program Analyst (filled)
- Staff Assistant (filled)

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## ORO’s Goal for Filling Vacancies is Dec. 31, 2008

- Vacancy Announcements for the unfilled positions will be out soon!  Watch for these announcements on ORO’s website and/or USAJOBS.Gov!

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## Spring 2009 —ORO’s goal for initial training program for RCOs

- ORO will conduct compliance education through meetings, calls, literature, website, ListServs, etc. . .

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## Other Targets:

- Development of basic animal and human subjects regulatory audit approaches and report to ORO:  Dec. 31, 2008
- Meeting of Research Compliance Officers at the VA Office of Research and Development 2009 Local Accountability for Research Meeting in Baltimore, Jan. 13-14, 2009
- ORO will participate and give RCO presentations

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## Long Term Goals:

- Development of basic common auditing tools for all RCOs based on regulations and VA policies
- Reporting that will improve research compliance in VA facilities and VA-wide
- Help for investigators and their staff in doing compliant activities and capturing it appropriately

- Continued on next page . . .

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## Long Term Goals (cont.):

- Reporting to ORO so we can know what to emphasize in education — by the RCOs and ORO Central Office Education Program, RCO Advisory Group members, ORO Regional Office participants . . .
- Ultimately improve the quality of research for benefit to subjects, VA patients, veterans, and the total population
- Emphasis and the benefits and ethics of doing research right!

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## ORO Will Have Much to Evaluate!

- We may at first have more knowledge of noncompliance because there is more examination.
- What is the most effective education for RCOs?  for investigators?  for Medical Center Directors?  for IRBs?

**. . . This is a big, exciting job for many people . . .**

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## If you are an RCO and have questions that ORO can address in telephone or e-mail guidance, list-serves, or other ways, please contact Paula Waterman at:

- Email:  _[Paula.Waterman@va.gov](mailto:Paula.Waterman@va.gov)_
- Phone:  (202) 266-4581
- Fax:  (202) 266-4560

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## Need more information?

- Please see the Office of Research Oversight website at:
- Intranet — _[http://vaww1.va.gov/oro/](http://vaww1.va.gov/oro/)_
- Internet — _[http://www1.va.gov/oro/](http://www1.va.gov/oro/)_

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## Questions?

*Thoughts?*

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