Vysnova Partners - IRB Authorization Agreement

0.1372A

Date received

IRB Authorization Agreement
Outside institution relying on a CDC IRB
This IRB authorization agreement is suitable for documenting a formal agreement between the Centers for Disease
Control and Prevention (CDC) and an institution that relies on a CDC IRB for review of the research activities
specified below. This agreement is permitted by human research regulations at 45 CFR 46.114 and 21 CFR 56.114.

1

Institution providing IRB review (Institution A)
Centers for Disease Control and Prevention (CDC)
IRB Registration #: 00000183
Federalwide Assurance (FWA) #: FWA00001413

2

Institution relying on designated IRB (Institution B)
Name of Institution B: Vysnova Partners, Inc.
FWA #:00023351

3

Registration expiration date: 9/16/2019
FWA expiration date: 9/30/2020

FWA expiration date: 8/07/2020

Scope of authorization agreement
The officials signing below agree that the Vysnova Partners, Inc. may rely on the CDC IRB both for review under
45 CFR part 46 (and 21 CFR parts 50 and 56, if applicable) and for continuing oversight of the involvement of
human subjects in the research described below:
Institution A: CDC
Institution B: Vysnova Partners,
Inc.
Title of research protocol
Zika en Embarazadas y Ninos en
Zika en Embarazadas y Ninos en
Colombia (ZEN Colombia)
Colombia (ZEN Colombia)
Protocol reference ID
6921
not yet assigned
Principal investigator
(name, phone, fax, e-mail)
Primary contact
(name, phone, fax, e-mail)

Margaret Honein, PhD, MPH
404-498-3921
[email protected]
Denise Jamieson, MD , MPH
770-488-6377
[email protected]

Sponsor or funding agency: USAID
Additional comments:

William Bertrand, PhD
504-975-3369
[email protected]
Carlos Rivera
301-830-8875
[email protected]
Award number, if any:

The review and continuing oversight performed by the CDC IRB will meet the human subjects protection
requirements of the HHS regulations (and FDA regulations, if applicable) for the protection of human subjects, as
well as the requirements of the OHRP-approved FWA at the Vysnova Partners, Inc.. The CDC IRB will follow
written procedures for reporting its findings and actions to appropriate officials. CDC will make relevant minutes of
IRB meetings and related records available to the Vysnova Partners, Inc. upon request. The Vysnova Partners, Inc.
remains responsible for ensuring compliance with the IRB’s determinations and with the terms of its FWA. This
document must be kept on file at both institutions and provided to OHRP upon request.

CDC Form 0.1372A
DRAFT Version 1.0 2006-04-13

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IRB authorization agreement: outside institution on CDC IRB

4

Signatures
Institution A: CDC

Lashonda J.
Roberson -S3

Institution B: Vysnova Partners, Inc.
Digitally signed by Lashonda J. Roberson -S3
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC,
ou=People, 0.9.2342.19200300.100.1.1=1000463851,
cn=Lashonda J. Roberson -S3
Date: 2016.09.26 10:44:39 -04'00'

Signature
Date
LaShonda Roberson
Acting Chief
Human Research Protection Office
Centers for Disease Control and Prevention
1600 Clifton Rd NE MS D-73
Atlanta GA 30333
404-639-4947 (voice)
404-639-3249 (fax)
[email protected] (e-mail)

CDC Form 0.1372A
DRAFT Version 1.0 2006-04-13

9/23/16
Signature
Date
Carlos Rivera
President
1112 16th Street N.W. Suite 540
Washington, DC 20036
301 830-8875 (voice)
301 830-8887(fax)
[email protected] (email)

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