# Presentation: 807932

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VHA Handbook 1058.03
Assurance of Protection for Human Subjects May 10, 2007

- VHA Handbook 1058.03
- Assurance of Protection for Human Subjects May 10, 2007

*Office of Research Oversight*

## 
Each entity engaged in human research conducted or supported by VA must provide a written Assurance to comply with the Federal Policy for the Protection of Human Subjects (38 CFR Part 16)
VA Facilities
Non-VA Institutions

- Each entity engaged in human research conducted or supported by VA must provide a written Assurance to comply with the Federal Policy for the Protection of Human Subjects (38 CFR Part 16)
- VA Facilities
- Non-VA Institutions

*VHA 1058.03 **§2b(1)&(2)**Assurance Required*

## 
Includes all components within the facility’s management control
Regardless of physical location
Space owned, leased, rented by VA
Space “shared” with non-VA entity, unless leased to the non-VA entity and not used by VA for research

- Includes all components within the facility’s management control
- Regardless of physical location
- Space owned, leased, rented by VA
- Space “shared” with non-VA entity, unless leased to the non-VA entity and not used by VA for research

*VHA 1058.03 **§4b**VA Facility Operated by VA*

## 
Entities operated under a contract from a VA (eg, Contract CBOC)
VA-Affiliated Non-Profit Research and Education Corporations (NCPs)
Contract Research Organization (CRO)
Industry or Private Sponsor
Public or private company, foundation, or group

- Entities operated under a contract from a VA (eg, Contract CBOC)
- VA-Affiliated Non-Profit Research and Education Corporations (NCPs)
- Contract Research Organization (CRO)
- Industry or Private Sponsor
- Public or private company, foundation, or group

*VHA 1058.03 **§4i(1)**Non-VA Operated Institution*

## 
Any individual conducting human research while acting under a VA appointment 
Full Time
Part Time
Without Compensation (WOC)
Intergovernmental Personnel Act (IPA)

“Non-VA Investigator” => anybody else

- Any individual conducting human research while acting under a VA appointment
- Full Time
- Part Time
- Without Compensation (WOC)
- Intergovernmental Personnel Act (IPA)
- “Non-VA Investigator” => anybody else

*VHA 1058.03 **§4j**VA vs Non-VA Investigator*

## 
Assurance for VA Facilities
OHRP Federalwide Assurance (FWA)
ORO may rarely issue Special Assurance or recognize other Common Rule Assurance
Assurance signed by Facility Director as Institutional Official
Signature cannot be delegated for short-term absences
VA Addendum signed by ORO
Signed by Facility Director & VISN Director

- Assurance for VA Facilities
- OHRP Federalwide Assurance (FWA)
- ORO may rarely issue Special Assurance or recognize other Common Rule Assurance
- Assurance signed by Facility Director as Institutional Official
- Signature cannot be delegated for short-term absences
- VA Addendum signed by ORO
- Signed by Facility Director & VISN Director

*VHA 1058.03 **§5a**Assurances & VA Addenda*

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Submitted through ORO
initial, renewal, modified
May be restricted or suspended by ORO Chief Officer
Must cover all research conducted at facility
Must cover all research conducted by the facility’s investigators acting as VA employees

- Submitted through ORO
- initial, renewal, modified
- May be restricted or suspended by ORO Chief Officer
- Must cover all research conducted at facility
- Must cover all research conducted by the facility’s investigators acting as VA employees

*VHA 1058.03 **§5a-g**Assurances for VA Facilities*

## 
May be applied to employee of another VA Facility with approval of ORO and ORD (rare)
May not include or apply to a non-VA institution or non-VA personnel without approval of 
CRADO
ORO Chief Officer
VHACO Office of General Counsel (OGC)

- May be applied to employee of another VA Facility with approval of ORO and ORD (rare)
- May not include or apply to a non-VA institution or non-VA personnel without approval of
- CRADO
- ORO Chief Officer
- VHACO Office of General Counsel (OGC)

*VHA 1058.03 **§5a-g**Assurances for VA Facilities*

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VA-operated, affiliate-operated, or other per VHA 1200.5
Registration, renewal, and modification of  VA-operated IRBs submitted through ORO
VA facility must notify ORO of roster changes within 30 days, regardless of operating entity
IRB must comply with all VA requirements
VA-operated IRBs may not be used by non-VA entities

- VA-operated, affiliate-operated, or other per VHA 1200.5
- Registration, renewal, and modification of  VA-operated IRBs submitted through ORO
- VA facility must notify ORO of roster changes within 30 days, regardless of operating entity
- IRB must comply with all VA requirements
- VA-operated IRBs may not be used by non-VA entities

*VHA 1058.03 **§6a-e**IRBs for VA Facilities*

## 
MOU needed where IRB is operated by a non-VA entity
MOU = OHRP IRB Authorization Agreement
Signed MOU submitted to ORO with initial/renewal FWAs

- MOU needed where IRB is operated by a non-VA entity
- MOU = OHRP IRB Authorization Agreement
- Signed MOU submitted to ORO with initial/renewal FWAs

*VHA 1058.03 **§6a-e**IRBs for VA Facilities*

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Designation of new IRB(s) under FWA
Transition MOUs and SOPs as practicable
New MOUs and SOPs
New IRB must review all projects for which it will assume oversight
Remove old IRB(s) from FWA

- Designation of new IRB(s) under FWA
- Transition MOUs and SOPs as practicable
- New MOUs and SOPs
- New IRB must review all projects for which it will assume oversight
- Remove old IRB(s) from FWA

*VHA 1058.03 **§7a-e**Changing Review Arrangements*

## VA-Supported Research / Assurance Needed:

Use of VA facilities, resources, or equipment
Transfer from or through VA of funds, equipment, or other tangible resources
Transfer to, from, or through VA of human biological specimens or private information unless deidentified under HIPAA and not identifiable under human subject protection regulations
Intellectual contributions meriting publication authorship

- Use of VA facilities, resources, or equipment
- Transfer from or through VA of funds, equipment, or other tangible resources
- Transfer to, from, or through VA of human biological specimens or private information unless deidentified under HIPAA _and_ not identifiable under human subject protection regulations
- Intellectual contributions meriting publication authorship

*VHA 1058.03 **§8a**Assurances for Non-VA Entities*

## VA-Supported Research / Assurance Needed:

Study-wide VA sponsorship of trial
VA or VA employee holds IND or IDE
VA employee serves as study-wide PI
VA facility serves as study-wide operations or    statistical center
VA facility operates study-wide data or specimen repository, unless deidentified under HIPAA and not identifiable under human subject protection regulations

- Study-wide VA sponsorship of trial
- VA or VA employee holds IND or IDE
- VA employee serves as study-wide PI
- VA facility serves as study-wide operations or    statistical center
- VA facility operates study-wide data or specimen repository, unless deidentified under HIPAA _and_ not identifiable under human subject protection regulations

*VHA 1058.03 **§8a**Assurances for Non-VA Entities*

## Not VA Supported / No Assurance Needed:

Transfer to or from a VA facility of human biological specimens or private information that are both deidentified under HIPAA and not identifiable under human subject protection regulations
Intellectual, professional, or non-research contributions that do not merit authorship credit
Participation by a VA facility as a research site in a multisite clinical trial (except as noted previously)

- Transfer to or from a VA facility of human biological specimens or private information that are both deidentified under HIPAA _and_ not identifiable under human subject protection regulations
- Intellectual, professional, or non-research contributions that do not merit authorship credit
- Participation by a VA facility as a research site in a multisite clinical trial (except as noted previously)

*VHA 1058.03 **§8b**Assurances for Non-VA Entities*

## Not VA Supported / No Assurance Needed, but
VA Facility should seek confirmation that:

Participating institutions adhere to appropriate national, international, or study-wide standards
Deidentified / Not Identifiable data and/or specimens have been obtained in accordance with widely accepted human protection standards

- VA Facility should seek confirmation that:
- Participating institutions adhere to appropriate national, international, or study-wide standards
- Deidentified / Not Identifiable data and/or specimens have been obtained in accordance with widely accepted human protection standards

*VHA 1058.03 **§8f**Assurances for Non-VA Entities*

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Contact ORO RO and ORD ASAP
Notify ORO CO through VISN in writing
Notify ORD through VISN in writing
R&D Committee Established
R&D Committee
Identify/Establish/Train IRB for FWA
Submit FWA 
No Human Research until FWA approved

- Contact ORO RO and ORD ASAP
- Notify ORO CO through VISN in writing
- Notify ORD through VISN in writing
- R&D Committee Established
- R&D Committee
- Identify/Establish/Train IRB for FWA
- Submit FWA
- No Human Research until FWA approved

*VHA 1058.03 **§9a**Initiating Human Research Program*

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Contact ORO RO and ORD ASAP
Notify ORO CO through VISN in writing
Notify ORD through VISN in writing
IRB and R&D Committee Supervise transfer or termination of studies
Maintain IRB & R&D Committee oversight until all studies transferred or closed
ORO officially deactivates Assurance and IRB

- Contact ORO RO and ORD ASAP
- Notify ORO CO through VISN in writing
- Notify ORD through VISN in writing
- IRB and R&D Committee Supervise transfer or termination of studies
- Maintain IRB & R&D Committee oversight until all studies transferred or closed
- ORO officially deactivates Assurance and IRB

*VHA 1058.03 **§9b**Closing Human Research Program*

## Office of Research Oversight

**http://www.1.va.gov/oro/ **
- 811 Vermont Avenue, N.W., Suite 574 (10R)
- Washington, D.C.  20420
- PHONE: (202) 565-5184
- FAX: (202) 565-9194