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NPC-SPECIFIC INSTRUCTIONS FOR A FEDERALWIDE ASSURANCE (FWA)
Updated June 2004
How to Apply for a Federalwide Assurance (FWA)
of Protection for Human Subjects from the Department of Health & Human
Services Office for Human Research Protections (OHRP)
Each VA-affiliated nonprofit research and
education corporation (NPC) that administers federal research grants
involving human subjects is required to obtain an approved OHRP
Federalwide Assurance (FWA) prior to expiration of its existing
assurances, such as Multiple Project Assurances (MPAs). VA medical
centers were required to complete the FWA application process by
September 30, 2001.
An NPC may not “share” an FWA with a VA
medical center or a university; each NPC must have its own FWA.
However, underlying the FWA, there must be a written document detailing
each institution’s respective responsibilities in assuring oversight.
OHRP maintains that in the event of an investigation, it will hold an
institution responsible only for oversight for which it is legitimately
responsible. However, respective responsibilities must be
specified in an agreement with the VAMC. This document is not part
of the FWA application, but it is likely to be the first one
investigators will request if they ever conduct a site visit.
Click
here for sample MOUs - one for a VA IRB and one for a university IRB
- that may be modified as needed to suit local circumstances to satisfy
this requirement. [Note: This MOU is intended only to address OHRP
requirements. It is not intended to be a comprehensive statement
of VA/NPC human subject oversight relationships or responsibilities.]
Please note that the FWA replaces the OHRP
Multiple Project Assurance (MPA), Single Project Assurance (SPA),
Cooperative Project Assurance (CPA), and the VA Multiple Project
Assurance (VA MPA).
In consultation with the VA Office of
General Counsel, in 2001 NAVREF negotiated with OHRP revisions to the
earliest version of the FWA application that address the close relationship between
an
NPC and its affiliated VAMC. These modifications clarified that an
NPC is responsible for aspects of human studies research oversight to
the extent allowed by its authorizing statute. It also clarified
that an NPC is responsible for its own employees, not VA employees.
NPC-Specific FWA
Application.
Subsequently, OHRP revised
the standard FWA application and removed the components that could have
been construed to overstate an NPC's ability to assume responsibility
for human subject protections. As a result, NPCs may now use the
standard OHRP application or the NPC-specific application for new or
renewed FWAs. The standard application and a great deal of useful
information are available on the
OHRP web site.
At this writing, new FWA
applications may be submitted electronically, but renewals must be
submitted manually.
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Step 1
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Download and
review OHRP’s information about FWAs.
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Go to the
OHRP web site.
Become familiar with the information on
the “Assurances and IRB Registration" page.”
Please note that NPCs may use the NPC-specific
or standard OHRP FWA application (see Step 6) and do not need to
complete the “Sample Dept. of Veterans Affairs, ORCA Clearance
Document.” |
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Step 2
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Your NPC will
use the IRB(s) designated by your affiliated VAMC. Determine whether
the IRB(s) are registered and obtain the registration number.
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On the
OHRP web site, check the OHRP IRB registration listings (see
link "Organizations with Registered Institutional Review Boards"
to verify that your designated IRB(s) are registered. Your VAMC may
have more than one IRB of record.
IRB's at
institutions holding MPAs in their name should have been
automatically registered by OHRP and should appear on the list with
a registration number. This number goes on your application.
VA medical
centers with institutional (in house) IRBs and no OHRP MPA in the
name of the VA must register their IRBs and receive a registration
number. Every designated IRB must be registered. |
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Step
3
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Determine status
quo and timing for FWA application.
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If your OHRP MPA
is held by an affiliated university, determine what their plans are
for applying for their new FWA. Some institutions may elect to wait
until their current MPA expires.
Determine when
to apply for an FWA. ORCA required VAMCs to obtain FWAs by
September 30, 2001.
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Step
4
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Satisfy Training
Requirements.
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The FWA requires
signatory officials to personally complete training
requirements. OHRP has designed a web based training module to be
completed online. The link to training “OHRP Recommended Assurance Training Modules for Signatory Officials, IRB Chairs, Human Protections Administrators” can be found on the
assurances page on the OHRP Home Page”
under "Filing a Federalwide Assurance."
The
Institutional Signatory Official must complete the appropriate
modules. Others listed must complete their designated modules. Most of these will be VA
employees. However, an NPC is responsible for verifying that these
individuals have completed the appropriate training.
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Step
5
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Satisfy the
requirements of the Assurance
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Review your operations to be sure you
are in compliance with the federal regulations and the terms of
assurance including VA-specific regulations, manuals and
directives. Because NPC-funded research is VA research, much
of the compliance oversight may be the responsibility of VA. However, every NPC must have a detailed written agreement with its
VAMC and if applicable, the affiliated university, specifying each institution’s respective responsibilities. |
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Step
6
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Complete the
paperwork |
Submit
the standard or special
NPC-Specific FWA
Application to OHRP. In completing Item #2, note that
38 CFR Part 16 is VA's equivalent to 45 CFR Part 46. Therefore, NPCs
may indicate that they will follow 45 CFR Part 46 by checking the
upper box. NPCs do not need to check "Other."
Regardless
of which form is used, NPCs may wish to attach a statement indicating that the
applicant is a VA-affiliated nonprofit research and education
corporation established under
38 USC §7361-7368).
In
Item #6, OHRP recommends that the Human Protections Administrator be
an institution employee, but does not require it. He/she may
be an "agent" of the organization. Regardless, the
HPA should have "comprehensive knowledge of all aspects of the
institution’s systemic protections for human subjects."
See Item 9 in the OHRP document called IRB and Federalwide
Assurance Q&A (http://ohrp.osophs.dhhs.gov/humansubjects/assurance/faq.htm)
Original applications may be submitted
electronically using the OHRP web site and standard form.
Renewals must be submitted manually to:
Office for Human Research Protections
Department of Health and Human Services
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Contact OHRP for
Questions or Additional Information
Phone: 301- 496-7005
Fax: 201-402-0527
Email: ohrp@osophs.dhhs.gov
Upon receipt of
the approved FWA, send a copy to ORCA:
Department of
Veterans Affairs
Office of Research Compliance and Assurance (10R)
811 Vermont Avenue, NW, Suite 574
Washington, DC 20420
Contact: Priscilla A. Craig (202) 565-8162
Priscilla.Craig@hq.med.va.gov
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Step
7
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Be sure your FWA
and agreement with VA are accessible
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Provide copies
of the approved FWA and agreement to investigators and staff
involved in the research process. File copies with the IRB SOP
documents.
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Step
8
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Update/renew
Assurance
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Update when
there is a change or every 36 months. Initiate the renewal process
at least 30 days before the FWA expires so that research can continue
uninterrupted. Contact ORCA or OHRP at any time for further
information.
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