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Office of Research Oversight

Office of Research Oversight. VHA Handbook 1058.06 - Research Conducted by VHA Program Office Employees Effective May 1, 2012. October 28, 2011. VHA Handbook 1058.06 - Research Conducted by VHA Program Office Employees.

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Office of Research Oversight

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  1. Office of Research Oversight VHA Handbook 1058.06 - Research Conducted by VHA Program Office Employees Effective May 1, 2012 October 28, 2011

  2. VHA Handbook 1058.06 -Research Conducted by VHA Program Office Employees Requirements apply to all researchconducted by individuals acting as VHA Program Office Employees • Human, Animal, and Basic Laboratory Research • Regardless of Duty Station • Effective May 1, 2012

  3. VHA Handbook 1058.06 -Research Conducted by VHA Program Office Employees Documentation Requirement — • All research conducted by individuals acting as VHA Program Office employees requires supervisor documentation • 1-page documentation form available on ORO website • The responsible research review committee (IRB, IACUC, SRS, R&DC) must receive the documentation

  4. VHA Handbook 1058.06 -Research Conducted by VHA Program Office Employees Basic Laboratory and Animal Research — • May be conducted in a VA lab (or lab routinely utilized by a VA facility under an MOU, lease, etc) • Requires facility appointment and research scope practice • Requires oversight by facility research review committees • May be conducted in a non-VA lab (or non VA-utilized lab) • Requires agreement signed by the Program Office Director and the Institutional Official (IO) responsible for the lab (copy to ORO) • Requires oversight by the lab’s research review committees • Program Office Director and ORO must be notified of noncompliance determinations.

  5. VHA Handbook 1058.06 -Research Conducted by VHA Program Office Employees Human Research – Must be conducted: • Within a VA Human Research Protection Program (HRPP) OR • In a non-VA Federal facility • Requires agreement signed by the Program Office Director and the Institutional Official (IO) responsible for the non-VA facility (copy to ORO and PDUSH) • Requires oversight by the facility research review committees • Program Office Director and ORO must be notified of noncompliance determinations

  6. VHA Handbook 1058.06 -Research Conducted by VHA Program Office Employees Human Research – Must be conducted within: • VHACO HRPP or VA Facility HRPP • VHACO HRPP (existing) — Additional PDUSH Responsibilities • Arranging for scientific review, ISO review, PO review • Designating IRB(s) • Appointing Program Office Research Committee (akin to R&DC) • Arranging for RCO audits

  7. VHA Handbook 1058.06 -Research Conducted by VHA Program Office Employees Non-Clinical Human Research – HRPP Options: • VHACO HRPP • HRPP at a VA research facility where the employee holds an appointment and research scope of practice • HRPP of another VA investigator involved in the study • Requires written acknowledgement of HRPP, separately or by specific reference in the approved study protocol Clinical Research – VA Facility HRPP: • Requires facility appointment, privileges, scope of practice

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