IRB Authorization Agreement

Centralized Institutional Review for the CDC Expanded Access Investigational New Device (EA-IND) for "Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections.

CDC_IRB_Authorization_Agreement_FINAL

IRB Authorization Agreement (COMPLETION)

OMB: 0920-1366

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IRB Authorization Agreement

This Institutional Review Board (IRB) authorization agreement is intended to document a formal agreement between the Centers
for Disease Control and Prevention (CDC) and an institution that relies on the CDC IRB for review of the activities specified below.
This agreement is permitted by the Food and Drug Administration (FDA) regulations governing the protection of human
subjects, IRBs, and the conduct of clinical investigations at 21 CFR parts 50, 56, and 312.

1 Institution Providing IRB Review (CDC IRB)
Centers for Disease Control and Prevention (CDC)
IRB Registration #: 00002724
Federalwide Assurance (FWA) #: FWA00001413

Registration expiration date: 12/17/2024
FWA expiration date: 12/02/2026

2 Institution Relying on CDC IRB (Relying Institution)
Name of Relying Institution:
IRB Registration #:

IRB Registration Expiration Date:

3 Authorization
The officials signing below agree that
may rely on the CDC IRB for review under 21 CFR parts 50, 56 and 312 and for continuing oversight, where applicable, of the
involvement of human subjects as described below:
CDC IRB

Relying Institution:

Title of IND:
Reference ID:
Principal/Site Investigator:
(name, phone, e-mail)
IRB Office Contact:
(name, phone, e-mail)
Sponsor:

Award number, if any:

The review and oversight performed by the CDC IRB will meet the human subjects protection and IRB requirements of the FDA regulations
cited above, as applicable. The Relying Institution remains responsible for ensuring compliance with the CDC IRB’s determinations and with
the terms of its own IRB registration as applicable. This agreement must be kept on file at both institutions and must be provided to FDA upon
request.

Both parties agree to the following:
This agreement becomes fully executed upon signatures of the relevant institution's signatory official or designee and remains in effect for as long as the
review of the protocol by the reviewing IRB is required or until terminated under the following circumstances:

⁃ Both parties mutually agree to terminate.
⁃ Either party terminates its participation under this agreement; any such unilateral termination must be communicated by the terminating party to the
other party thirty (30) business days prior to the effective date of termination.

⁃ The CDC IRB or Relying Institution's IRB registration is suspended, restricted, terminated, or expires; any such suspension, restriction, termination
or expiration must be communicated between parties promptly and no later than 2 business days from occurrence.

4 Signatures
Reviewing Institution: CDC IRB

CDC Institutional Official for Human Subjects Protections

Relying Institution:

Date Signed

Official Title and Contact Information

1600 Clifton Rd NE MS D-73 Atlanta GA 30333
404-639-7270
[email protected] (e-mail)
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IRB Authorization Agreement: Relying Institution on CDC IRB (FDA)
CDC IRB Responsibilities (this list is not exhaustive; please see applicable human subjects regulations):
1. IRB Registration and Membership. Maintain the CDC IRB registration and IRB membership in compliance with FDA requirements and other applicable
federal regulations or policies.
2. Policies and Procedures. Make available to the Relying Institution, when applicable and upon request, the relevant policies and procedures of CDC and
the CDC IRB.
3. Review and Oversight. In accordance with 21 CFR parts 50, 56, and 312 and any other applicable requirements, CDC IRB will provide:
a. initial and continuing review of materials related to the Expanded Access IND;
b. review of amendments to materials related to the Expanded Access IND;
c. review of local context considerations as provided by the Relying Institution;
d. review of potential unanticipated problems involving risk to subjects or others as reported to the CDC IRB;
e. review of serious or continuing noncompliance as reported to the CDC IRB; and
f. oversight of the conduct of the Expanded Access IND to include the informed consent process.
4. Informed Consent. The CDC IRB will provide to each Relying Institution informed consent documents for use by the Relying Institution where the CDC
IRB has determined that such an informed consent form(s) is required. The CDC IRB will permit a Relying Institution to fill in only limited site-specific
sections of the form, generally the sections on the availability of treatment and compensation for Expanded Access IND-related injury, payment or
reimbursement of Expanded Access IND-related costs incurred by human subjects, and local contact information. All such modifications must be approved
by the CDC IRB, which will then provide a final approved informed consent form(s) to the Relying Institution for use.
5. Notifications. The CDC IRB will promptly notify the Relying Institution of:
a. findings of serious and/or continuing noncompliance with applicable human subjects protection regulations or with the requirements or
determinations of the CDC IRB pertaining to the Relying Institution as well as any actions the Relying Institution must take to address such
noncompliance, including any actions the CDC IRB deems necessary for remediation of the noncompliance at the Relying Institution;
b. any remediation actions pertaining to findings related to the Relying Institution if the CDC IRB finds that such findings or actions relate to or may
affect the conduct of the Expanded Access IND or the safety, rights, or welfare of human subjects participating in the Expanded Access IND at the
Relying Institution(s); and
c. any restriction or suspensions of the CDC IRB's authorization to review or any suspension or termination of CDC IRB approval.
6. Reporting. The CDC IRB will notify a Relying Institution in advance if the CDC IRB determines that under applicable regulations a report related to the
Relying Institution is required to be made to FDA, the sponsor, funding agency, and/or other oversight authority of any unanticipated problems involving
risks to human subjects or others, serious and/or continuing noncompliance with applicable human subjects protection regulations or with the requirements
or determinations of the CDC IRB.
7. Recordkeeping. The CDC IRB will maintain records of its membership, its review, determinations, meeting minutes other records as required by
applicable federal regulations and the policies of the CDC IRB, and make such records accessible to designated officials at the Relying Institution(s), upon
reasonable request.

Relying Institution's Responsibilities (this list is not exhaustive; please see applicable human subjects regulations):
1. Comply with CDC IRB Decisions and Requirements. The Relying Institution will comply with the decisions and requirements of the CDC IRB. The Relying
Institution may not initiate, change, or deviate from the approved Expanded Access IND, informed consent, or other approved materials, except where necessary to
eliminate apparent immediate hazards to subjects, without first receiving prior approval from the CDC IRB.
2. Review and Oversight. The Relying Institution will also oversee the safe and appropriate conduct of the Expanded Access IND at its institution and will ensure
compliance with applicable federal, state, local or institutional requirements related to the protection of human subjects, which may include investigating and
managing any incidence, experience, or outcome that may rise to the level of an unanticipated problem and/or serious or continuing noncompliance. Should any
such requirements conflict with the decisions or requirements of the CDC IRB, the Relying Institution must raise those conflicts for consideration by the CDC
IRB. The Relying Institution will also provide all information about conduct of the Expanded Access IND at the Relying Institution that the CDC IRB requires to
meet its review and reporting requirements. The Relying Institution will establish a mechanism that allows human subjects and others to report concerns about the
conduct of the Expanded Access IND.
3. Local Context Considerations. Communicate to the CDC IRB the requirements of all applicable state or local laws, regulations, institutional policies, standards,
or other local factors, including local ancillary reviews, relevant to the Expanded Access IND (“Local Context Considerations”) that would affect the conduct or
approval of the investigation at the Relying Institution. This information should be communicated to the CDC IRB through the CDC Principal Investigator.
4. Informed Consent. Relying Institution will ensure that CDC IRB-approved language is used to create the consent form for use at a specific site and will comply
with the following:
a. not make any changes to language in the informed consent form(s);
b. submit the informed consent form(s) with any necessary site-specific sections filled in for CDC IRB approval through the CDC Principal Investigator;
and

c. use CDC IRB-approved translations of the informed consent form(s) when available or provide the CDC IRB with a copy of a version translated for use
by the Relying Institution for approval.

5. Notification. The Relying Institution will promptly notify the CDC IRB through the CDC Principal Investigator of any of the following:
a. unanticipated problems that may involve risks to human subjects or others;
b. new safety-related information made known to the Relying Institution;
c. injuries related to the Expanded Access IND reported to the Relying Institution;
d. potential serious or continuing noncompliance (e.g., protocol deviations) that occur at the Relying Institution.
6. Reporting. The Relying Institution will assist the CDC IRB in preparing any reports or notifications to FDA or other applicable agencies about serious
noncompliance, continuing noncompliance or unanticipated problems involving risk to humans subjects or others, suspension or termination of CDC IRB
approval.
7. Recordkeeping. The Relying Institution will maintain a regulatory and/or administrative file in accordance with FDA requirements and other applicable federal,
state, or local laws, and the Relying Institution's recordkeeping policies.
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File Title1373: IRB Authorization Agreement—Other Institution on CDC IRB
AuthorHRPO
File Modified2022-08-02
File Created2019-01-14

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