1. Monitoring review and approval of projects and related documentation to ensure compliance with human subject protection requirements
2. Monitoring the performance of studies to ensure compliance with human subject protection requirements
3. Providing investigators and other relevant personnel with mandatory training and monitoring compliance with training requirements

The only exception is that the NPC Federalwide Assurance (FWA) signatory official must complete the required initial and continuing training and is responsible for ensuring that relevant NPC employees also do so.

NPC relies on VA handbooks, regulations and statutes as well as local VAMC, R&D Committee and IRB policies and procedures regarding communication among relevant parties and sharing of documentation.

This MOU is effective on date and is subject to renewal in three years.

_________________________________   _______________________
VAMC Medical Center Director                  Date

_________________________________   _______________________
IRB Chair                                                Date

_________________________________   _______________________
NPC Official                                             Date

_________________________________   _______________________
VAMC Human Protections Administrator     Date

Date

Consistent with the authority provided in 45 CFR §46.114 and 38 CFR §16.114, the NPC established under 38 USC §§7361-7368, VAMC and University wish to avoid duplication of effort in the oversight of cooperatively conducted human studies research. Recognizing that NPC research is VA-approved research subject to policies and procedures contained in VA manuals, regulations and statutes, NPC, VAMC and University agree that all oversight for such studies will be provided by VAMC and the University IRB (IRB name and number) consistent with:

1) University IRB operating policies and procedures (insert reference to documentation appropriate for University IRB); and

2) Existing or subsequent VAMC - University agreements assigning respective responsibilities.

Subject to 1) and 2) above, such VAMC and University oversight will include:

1. Monitoring review and approval of projects and related documentation to ensure compliance with human subject protection requirements
2. Monitoring the performance of studies to ensure compliance with human subject protection requirements
3. Providing investigators and other relevant personnel with mandatory training and monitoring compliance with training requirements

The only exception is that the NPC Federalwide Assurance (FWA) signatory official must complete the required initial and continuing training and is responsible for ensuring that relevant NPC employees also do so.

NPC relies on VA handbooks, regulations and statutes as well as local VAMC, R&D Committee, University and IRB policies and procedures regarding communication among relevant parties and sharing of documentation.

This MOU is effective on date and is subject to renewal in three years.

Signatories (as appropriate for local circumstances):

_________________________________    _______________________
University Official                                      Date

_________________________________    _______________________
VAMC Medical Center Director                  Date

_________________________________    _______________________
IRB Chairman                                           Date

_________________________________    _______________________
University Human Protections Administrator Date

_________________________________    _______________________
VAMC Human Protections Administrator     Date

_________________________________   _______________________
NPC Official                                             Date