Office of Office of Research & Development (ORD)Research & Development (ORD)

Local Accountability Local Accountability

of Research 2009of Research 2009 Baltimore, Maryland January 13-14, 2009Baltimore, Maryland January 13-14, 2009

“ “Meeting the Current Challenges of Meeting the Current Challenges of Research”Research”

Presented by the Office of Research Oversight (ORO) Presented by the Office of Research Oversight (ORO) Dr. Tom Puglisi, Chief OfficerDr. Tom Puglisi, Chief Officer

Dr. Joan Porter, Deputy Chief OfficerDr. Joan Porter, Deputy Chief Officer

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Research Compliance Officers (RCO) Face Research Compliance Officers (RCO) Face “Many New Requirements and Challenges”“Many New Requirements and Challenges”

Quick review of Quick review of Why? – What? – Why? – What? – When? – How? – Who? –Where?When? – How? – Who? –Where?

Time for your questions and ORO Time for your questions and ORO advice to you andadvice to you and

Time for our questions to you and Time for our questions to you and your advice to ORO and others . . .your advice to ORO and others . . .

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Why – Why – do we need to do this?do we need to do this? To ensure compliance in VA To ensure compliance in VA

research for stellar and ethical research for stellar and ethical achievement in researchachievement in research

To protect and benefit our veterans To protect and benefit our veterans to the greatest extent possibleto the greatest extent possible

Generated with stimulus from Generated with stimulus from Secretary in great detail and Secretary in great detail and focused.focused.

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What – What – are we supposed to do?are we supposed to do? ORO requirementsORO requirements

Explained by the Executive Explained by the Executive Career Field (ECF) launched for FY Career Field (ECF) launched for FY 20092009

All types of research — human All types of research — human subjects, animals, biotechnology, subjects, animals, biotechnology, and safetyand safety

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What . . . What . . . continuedcontinued

Conduct audits and reviews to ensure compliance Conduct audits and reviews to ensure compliance with all VA and other Federal requirements for the with all VA and other Federal requirements for the conduct of research includingconduct of research including

– Annual audits of all active Annual audits of all active studies to insure that studies to insure that informed consentinformed consent has been has been properly obtained and properly obtained and documented for each subject documented for each subject since the previous audit, andsince the previous audit, and

– Regulatory compliance auditsRegulatory compliance audits for all active studies at least for all active studies at least every 3 years.every 3 years.

Sample Informed Consent Audit Template

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ECF specified all RCOs must be in place by Dec. 31, 2008.ECF specified all RCOs must be in place by Dec. 31, 2008.

– This may not happen by then – hiring delays, transitions, This may not happen by then – hiring delays, transitions, etc.etc.

Details are needed for all the work to be accomplished Details are needed for all the work to be accomplished until new hiring or transfers can be completed.until new hiring or transfers can be completed.

The first year of The first year of informed consent reportinginformed consent reporting for protocols for protocols in place for Jan. 1 – May 31, 2009in place for Jan. 1 – May 31, 2009

The first year to begin The first year to begin protocol audit reportingprotocol audit reporting is Jan. 1– is Jan. 1– May 31, 2009. Report July 1 on completed audits for all May 31, 2009. Report July 1 on completed audits for all protocols that will expire in Jan. 1 – May 31, 2009.protocols that will expire in Jan. 1 – May 31, 2009.

When – When – does this need to be done?does this need to be done?

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RCOs will serve as local resources for regulations, RCOs will serve as local resources for regulations, policies, memoranda, alerts, and other VA and Federal policies, memoranda, alerts, and other VA and Federal requirements related to research compliance.requirements related to research compliance.

Will serve as non-voting members of the Institutional Will serve as non-voting members of the Institutional Review Board, Institutional Animal Care and Use Review Board, Institutional Animal Care and Use Committee, Biosafety Committee, and Research and Committee, Biosafety Committee, and Research and Development Committee.Development Committee.

Provide education to investigators and research staff Provide education to investigators and research staff regarding regulations and policy requirements.regarding regulations and policy requirements.

How – How – can we assure compliance?can we assure compliance?

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How . . . How . . . continuedcontinued

Assure prompt reporting with all applicable Assure prompt reporting with all applicable policies to OROpolicies to ORO

Promptly forward all auditing and Promptly forward all auditing and monitoring reports on any non-compliance monitoring reports on any non-compliance to Facility Director and ORO to Facility Director and ORO

– Copies to the Veterans Integrated Service Network Copies to the Veterans Integrated Service Network (VISN) Research Compliance Officer, Chief of Staff, (VISN) Research Compliance Officer, Chief of Staff, Associate Chief of Staff for Research, Research & Associate Chief of Staff for Research, Research & Development Committee Chair, Institutional Review Development Committee Chair, Institutional Review Board Chair, Chief Officer of Research & Board Chair, Chief Officer of Research & Development.Development.

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How . . . How . . . continuedcontinued

ORO issuing instructions as soon as possible on ORO issuing instructions as soon as possible on how to conduct and reporthow to conduct and report– Informed consent auditingInformed consent auditing– Human subjects protocols auditingHuman subjects protocols auditing– Animal protocol auditing – coming soonAnimal protocol auditing – coming soon– Safety auditing – coming soonSafety auditing – coming soon

ORO is committed to education — at least 5 ORO is committed to education — at least 5 major training sessions for RCOs per year; web-major training sessions for RCOs per year; web-site information; ListServ reports, new site information; ListServ reports, new handbooks as necessary; revisions to audit handbooks as necessary; revisions to audit worksheets; RCO telephone calls regularly; worksheets; RCO telephone calls regularly; counseling via email, phone, etc. counseling via email, phone, etc.

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How . . . How . . . continuedcontinued

RCOs follow their job RCOs follow their job descriptions — descriptions — samples have been samples have been distributed for RCOs in distributed for RCOs in facilities and VISNs by facilities and VISNs by the ListServ and ORO’s the ListServ and ORO’s Research Compliance Research Compliance Officer Education Page Officer Education Page at:at:http://www1.va.gov/orhttp://www1.va.gov/oro/page.cfm?pg=142o/page.cfm?pg=142

.. ORO/Research Compliance Education Page

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Research Compliance Officer(s) in each VA facility with Research Compliance Officer(s) in each VA facility with any research protocols.any research protocols.

Research Compliance Officers in each VISNResearch Compliance Officers in each VISN

Position Levels can be GS 11-15 or Title 38.Position Levels can be GS 11-15 or Title 38.

The ORO’s Research Compliance Officer Education The ORO’s Research Compliance Officer Education ProgramProgramstaff (5 new positions in Central Office)staff (5 new positions in Central Office)

ORO Regional Officers also receive reports of serious ORO Regional Officers also receive reports of serious non-compliance and yearly report (July 1) on non-compliance and yearly report (July 1) on compliance in the conduct of research.compliance in the conduct of research.

Who – Who – are the key persons here?are the key persons here?

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Who – Who – can be an RCO?can be an RCO? No researchersNo researchers

No voting members of IRBs, IACUCS, No voting members of IRBs, IACUCS, Research and Development Research and Development Committee, etc.Committee, etc.

No Associate Chiefs of Staff for No Associate Chiefs of Staff for Research and DevelopmentResearch and Development

No Administrative OfficersNo Administrative Officers

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Who . . . Who . . . continuedcontinued

RCO can be a part-time RCO RCO can be a part-time RCO ONLYONLY with the approval of with the approval of the Under Secretary for the Under Secretary for Health!Health!

JUST ISSUED! Memo signed Friday, January 9,

2009 —

A copy of this memo detailing procedures for requesting a waiver was

sent out to the ListServ and can be found on ORO’s website!

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Waiver for Full-Time RCOWaiver for Full-Time RCO Case by case basis for RCO position to be either Case by case basis for RCO position to be either

part-time or combined with other related dutiespart-time or combined with other related duties..

Facility Director goes through the VISN DirectorFacility Director goes through the VISN Director

– Then to CRADO and Chief Officer, OROThen to CRADO and Chief Officer, ORO

– Through Deputy Under Secretary for Health for Operations and Through Deputy Under Secretary for Health for Operations and ManagementManagement

– Through Principal Deputy Under Secretary for Health for Through Principal Deputy Under Secretary for Health for Operations and ManagementOperations and Management

– The through the Under Secretary for Health for The through the Under Secretary for Health for approval/disapproval.approval/disapproval.

Description and justification is required.Description and justification is required.

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RCOs in facilities report to RCOs in facilities report to Medical Center DirectorsMedical Center Directors!!Not the Chief of Staff, not associate Chiefs of Staff for Not the Chief of Staff, not associate Chiefs of Staff for Research and Development, not Administrative Research and Development, not Administrative Officers, not Directors of Financial Compliance — Officers, not Directors of Financial Compliance — They They work with all this individuals, but report to the Medical work with all this individuals, but report to the Medical Center Directors!Center Directors!

VISN RCOs report to VISN DirectorsVISN RCOs report to VISN Directors

Where – Where – do RCOs report?do RCOs report?

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Questions on Why? – What? Questions on Why? – What? – When? – How? – Who? –– When? – How? – Who? –Where?Where? What to convey to ORO? ORD? What to convey to ORO? ORD?

DSHOM? The Under Secretary for DSHOM? The Under Secretary for Health? The Secretary?Health? The Secretary?

What to convey to your researchers What to convey to your researchers and research staff to help them?and research staff to help them?

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