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

VETERANS HEALTH ADMINISTRATION VHA Handbook Research Conducted by VHA Program Office Employees Requirements apply to all research conducted by individuals acting as VHA Program Office Employees Human, Animal, and Basic Laboratory Research Regardless of Duty Station Effective May 1,

VETERANS HEALTH ADMINISTRATION VHA Handbook 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 2

VETERANS HEALTH ADMINISTRATION VHA Handbook 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. 3

VETERANS HEALTH ADMINISTRATION VHA Handbook 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 4

VETERANS HEALTH ADMINISTRATION VHA Handbook 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 5

VETERANS HEALTH ADMINISTRATION VHA Handbook 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 6