Form 18 NCI CIRB AA DivofResps

Authorization Agreement and Division of Responsibilities
Between the NCI Central Institutional Review Board and the Signatory Institution

OMB #0925-xxxx Expiration Date: xx/xx/xxxx
Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your
participation in the NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties
for not participating or withdrawing from the NCI CIRB at any time. Refusal to participate will not affect your benefits in
any way. The information collected will be kept private to the extent provided by law. Names and other identifiers will not
appear in any report of the NCI CIRB. Information provided will be combined for all participants and reported as summaries.
You are being requested to complete this instrument so that we can conduct activities involved with the operations of
NCI CIRB Initiative

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705

Authorization Agreement Section
A.

Name of Organization Providing IRB Review: National Cancer Institute Central Institutional Review Board
(CIRB)
NCI CIRB’s Organization Number: IORG0000460
Adult CIRB – Late Phase Emphasis IRB Registration Number: IRB00000781
Adult CIRB – Early Phase Emphasis IRB Registration Number: IRB00009430
Pediatric CIRB IRB Registration Number: IRB00004296
Cancer Prevention and Control CIRB IRB Registration Number: IRB00010018

B.

Name of Signatory Institution Relying on the NCI CIRB: Insert Signatory Institution Name
Signatory Institution’s OHRP Federalwide Assurance (FWA) Number: Insert FWA#
1. A Signatory Institution’s “Component Institution” is defined by the NCI CIRB as meeting all of the
following criteria:
a. the Component Institution operates under a different name than the Signatory Institution but the Signatory
Institution has legal authority for the Component Institution;
b. the FWA number for the Component Institution is the same as the Signatory Institution;
c. the local context considerations of the Component Institution are the same as the Signatory Institution;
d. the boilerplate language and institutional requirements of the Component Institution are the same as the
Signatory Institution; and
e. the conduct of research at the Component Institution is monitored by the same office as the Signatory
Institution.
List the Signatory Institution’s Component Institution(s) by name:
1. Insert Component Institution Name(s), or state "none"

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2. A Signatory Institution’s “Affiliate Institution” is defined by the CIRB as meeting all of the following
criteria:
a. the local context considerations of the Affiliate Institution are the same as the Signatory Institution;
b. the boilerplate language and institutional requirements of the Affiliate Institution are the same as the
Signatory Institution; and
c. the conduct of research at the Affiliate Institution is monitored by the same office as the Signatory
Institution.
List the Signatory Institution’s Affiliate Institution(s) by name:
1. Insert Affiliate Institution Name(s) and FWA #, or state "none"

C.

Authorization

The review performed by the NCI CIRB will meet the human subject protection requirements of Insert Signatory
Institution Name’s OHRP-approved FWA. The NCI CIRB will follow written procedures for reporting its findings and
actions to appropriate officials at Insert Signatory Institution Name. Relevant minutes of CIRB meetings and supporting
documents are available to the Signatory Institution via a secure website at any time. Insert Signatory Institution Name

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Authorization Agreement and Division of Responsibilities
Between the NCI Central Institutional Review Board and the Signatory Institution
remains responsible for ensuring compliance with the NCI CIRB’s determinations and with the terms of the Signatory
Institution’s OHRP-approved FWA. This document should be kept on file at the Signatory Institution and at the CIRB
Operations Office and must be provided to OHRP upon request.
The Officials signing below agree that the NCI CIRB provides IRB review as described in the Division of Responsibilities
Section of this document for Insert Signatory Institution Name and all Component and Affiliate Institutions identified.
This document will go into effect upon the signatures of the Signatory Official for the Signatory Institution and the
Signatory Official for the NCI.
Name and Title of Signatory Official for the Signatory Institution:

Name

Title

Signature

Date
Name and Title of Signatory Official for the NCI:
Jeffrey S. Abrams, M.D.
Name
Acting Director for Clinical Research
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Title

Signature

Date

Send 2 originals to the NCI CIRB Operations Office:
NCI CIRB Operations Office
c/o The EMMES Corporation
401 N. Washington Street, Suite 700
Rockville, MD 20850

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Authorization Agreement and Division of Responsibilities
Between the NCI Central Institutional Review Board and the Signatory Institution
Division of Responsibilities Section
The responsibilities of the NCI CIRB are to:
1)

Maintain an NCI CIRB membership that satisfies the requirements of 45 CFR 46 and 21 CFR 56 and provides
special expertise as needed to adequately assess all aspects of each study;
a) Post the roster of NCI CIRB membership on the public side of the NCI CIRB website;

2)

Conduct initial, amendment, and continuing review of studies as well as review of any other study-specific
documents submitted by the Study Chair to the NCI CIRB;

3)

Conduct review of local context considerations as outlined in the following Worksheets:
a) Annual Signatory Institution Worksheet About Local Context;
b) Annual Principal Investigator Worksheet About Local Context; and
c) Study-Specific Worksheet About Local Context;

4)

Conduct review of potential unanticipated problems and/or serious or continuing noncompliance when the
Signatory Institution or other entity reports an incident, experience, or outcome to the CIRB;
a) This review includes reporting any unanticipated problem and/or serious or continuing noncompliance
determination to OHRP, the FDA, and the Signatory Official for the NCI;

5)

Report any suspension or termination of CIRB approval to OHRP, FDA, and the Signatory Official for the NCI;

6)

Conduct review of individual Adverse Event Reports for studies without a Data and Safety Monitoring Board
(DSMB) or equivalent monitoring body;

7)

Post all study-wide documents related to CIRB reviews to a secure website and notify research staff and
institutional designees of the postings;

8)

Provide institution-specific documents related to CIRB reviews via email to research staff and institutional
designees;

9)

Notify the Signatory Institution immediately if there is ever a suspension or restriction of the CIRB’s
authorization to review a study; and

10)

Post the NCI CIRB Standard Operating Procedures on the public side of the CIRB website.

The responsibilities of the Signatory Institution are to:
1)

Comply with the NCI CIRB’s requirements and directives;

2)

Report to the NCI CIRB the names of any Component or Affiliate Institutions that meet the following definitions:
a) Component Institutions are defined by the NCI CIRB as meeting all of the following criteria:
• The Component Institution operates under a different name than the Signatory Institution, but the
Signatory Institution has legal authority for the Component Institution;
• The FWA number for the Component Institution is the same as the Signatory Institution;
• The local context considerations of the Component Institution are the same as the Signatory Institution;
• The boilerplate language and institutional requirements of the Component Institution are the same as the
Signatory Institution; and

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Authorization Agreement and Division of Responsibilities
Between the NCI Central Institutional Review Board and the Signatory Institution
•

The conduct of research at the Component Institution is monitored by the same office as the Signatory
Institution;
b) Affiliate Institutions are defined by the NCI CIRB as meeting all of the following criteria:
• The local context considerations of the Affiliate Institution are the same as the Signatory Institution;
• The boilerplate language and institutional requirements of the Affiliate Institution are the same as the
Signatory Institution; and
• The conduct of research at the Affiliate Institution is monitored by the same office as the Signatory
Institution;
3)

Ensure the safe and appropriate performance of the research at the Signatory Institution and at all Component and
Affiliate Institutions. This includes, but is not limited to:
a) Ensuring the initial and ongoing qualifications of investigators and research staff;
b) Overseeing the conduct of the research;
c) Monitoring protocol compliance;
d) Maintaining compliance with state, local, or institutional requirements related to the protection of human
subjects;
e) Providing a mechanism to receive and address concerns from local study participants and others about the
conduct of the research; and
f) Investigating, managing, and providing notification to the NCI CIRB of any study-specific incidence,
experience, or outcome that seems to rise to the level of an unanticipated problem and/or serious or
continuing noncompliance. When notifying the NCI CIRB of a potential unanticipated problem and/or
serious or continuing noncompliance, the institution must provide a plan to manage the incident, experience,
or outcome, including measures to prevent similar occurrences;
NOTE: As part of ensuring safe and appropriate performance of research the Signatory Institution has the
authority to observe any aspect of the research process including observing the consent process. The CIRB
retains the authority to direct this to be done when necessary.

4)

Provide updates in a timely manner to the NCI CIRB whenever a Signatory Institution Principal Investigator is
replaced. The CIRB requires submission and approval of the Annual Principal Investigator Worksheet About
Local Context prior to finalizing the replacement Principal Investigator;

5)

Notify the NCI CIRB when a regulatory deficiency has been cited on an audit that occurred during the time that
the NCI CIRB was responsible for study review;

6)

Complete and submit the Annual Signatory Institution Worksheet About Local Context, the Annual Investigator
Worksheet About Local Context, and any other worksheets/forms required by the NCI CIRB for participation;

7)

Have CIRB-approved Principal Investigators complete and submit the Study-Specific Worksheet About Local
Context to open a study;

8)

Incorporate NCI CIRB-approved boilerplate language into the NCI CIRB-approved model consent form to create
the consent form to use for a specific study:
a) Make no language changes to the consent form with the exception of NCI CIRB-approved boilerplate
language;
b) Obtain NCI CIRB approval of changes to the boilerplate language prior to implementation; and
c) Obtain NCI CIRB approval of translations of the consent form prior to implementation;

9)

Maintain a regulatory file for each study under NCI CIRB purview as per local institution and sponsor policy; and

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Authorization Agreement and Division of Responsibilities
Between the NCI Central Institutional Review Board and the Signatory Institution
10)

Conduct full board review of any study enrolling prisoners, since the NCI CIRB is not constituted to review
studies enrolling prisoners.

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