Appendix Z Federal-Wide Assurance (FWA) Certificate

APPENDIX Z
FEDERAL-WIDE ASSURANCE (FWA) CERTIFICATE

FWA #:

FWA00000664

Institution:

Abt Associates Inc.

Expires:

06/08/2022

OMB No. 0990-0278
Approved for use through August 31, 2017

Federalwide Assurance (FWA)
for the Protection of Human Subjects
1. Institution Filing Assurance
Legal Name:
City:

Abt Associates Inc.

Cambridge

State/Province:

MA

Country:

USA

2. Institutional Components
List below all components over which the Institution has legal authority that operate under a different name. Also list
with an asterisk (*) any alternate names under which the Institution operates.
NOTE: The Signatory Official signing this Assurance must be legally authorized to represent the Institution providing
this Assurance and all components listed below.
Name of Component or
Alternate Names Used
Abt Associates Inc.

City
BETHESDA

State
(or Country if Outside U.S.)
MD

A

3. Statement of Principles
This Institution assures that all of its activities related to human subjects research, regardless of the source of support,
will be guided by the following statement of principles governing the institution in the discharge of its responsibilities
for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution. (indicate
below)
The Belmont Report

4. Applicability
(a) This Assurance applies whenever this Institution becomes engaged in human subjects research conducted or
supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of
Human Subjects (also known as the Common Rule), unless the research is otherwise exempt from the requirements of
the Common Rule or the department or agency conducting or supporting the research determines that the research shall
be conducted under a separate assurance.

(a) This Assurance applies whenever this Institution becomes engaged in human subjects research conducted or
supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of
Human Subjects (also known as the Common Rule), unless the research is otherwise exempt from the requirements of
the Common Rule or the department or agency conducting or supporting the research determines that the research shall
be conducted under a separate assurance.
(b) Optional: This Institution elects to apply the following to all of its human subjects research regardless of the source
of support, except for research that is covered by a separate assurance:

The Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR part 46

5. Assurance of Compliance with the Terms of the Federalwide Assurance
(a) This Institution assures that whenever it engages in research to which this Assurance applies, it will comply with the
Terms of the Federalwide Assurance (contained in a separate document on the Office for Human Research Protections
(OHRP) website).

6. Designation of Institutional Review Boards (IRBs)
This Institution assures that it will rely upon only IRBs registered with OHRP for review of research to which this FWA
applies. This institution (a) designates the following internal IRB(s) for review of research under this Assurance; or (b)
does not have an internal IRB and designates the following external IRB for review of all research to which this FWA
applies or, if multiple external IRBs are relied upon, the following external IRB that reviews the largest percentage of
research to which this FWA applies.
NOTE: Institutions designating internal IRBs do not need to designate any of the external IRBs upon which it relies.

HHS IRB
Registration
Number
IRB00001281

Is the IRB Internal or
External to the Institution?

Name of IRB as Registered with HHS
ABT Associates, Inc. IRB #1

I

7. Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person)
First Name:

Teresa

Degrees or Suffix:

Last Name: Doksum

Middle Initial:
Ph.D., M.P.H.

Institution:
Telephone: 617 349-2896

Institutional Title:

IRB Chair

Abt Associates Inc.

FAX:

617 386-8551

E-Mail:

[email protected]

Country:

USA

Address: 55 Wheeler Street
City:

Cambridge

State/Province:

MA

8. Signatory Official (i.e., Official Legally Authorized to Represent the Institution)
I have read and agree to the Terms of the Federalwide Assurance.
I recognize that providing research investigators, IRB members and staff, and other relevant personnel with appropriate
initial and continuing education and training about human subject protections will help ensure that the requirements of
this Assurance are satisfied.
Acting officially in an authorized capacity on behalf of this Institution and with an understanding of the Institution’s
responsibilities under this Assurance, I assure protections for human subjects as specified above. The IRB(s) that this
institution relies upon will comply with the Terms of the Federalwide Assurance when reviewing research covered by
this Assurance and possess appropriate knowledge of the local context in which this Institution’s research will be
conducted.
All information provided with this Assurance is up-to-date and accurate. I am aware that false statements could be cause
for invalidating this Assurance and may lead to other administrative or legal action.

Signature:

Mark Spranca Ph.D.

Date:

06/07/2017

First Name:

Mark

Degrees or Suffix:

Last Name: Spranca

Middle Initial:
Ph.D.

Institution:
Telephone: 617 349-2634

Institutional Title:

Vice President of Reputational Capital and
Technical Leadership

Abt Associates Inc.

FAX:

617 386-7650

E-Mail:

[email protected]

Country:

USA

Address: 55 Wheeler St
City:

State/Province:

Cambridge

MA

9. FWA Approval
The Federalwide Assurance for the Protection of Human Subjects for Institutions Within the United States submitted to
HHS by the above Institution is hereby approved.
Assurance Number:

FWA00000664

Signature of HHS Approving Official: Gail Holloway

Expiration Date: 06/08/2022
Date: 06/08/2017

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