NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

Forms and Documents

Document Name	Status
Form 35 CIRB SAE Reviewer Worksheet (Attach 6K) Form and Instruction	New
Form 34 CIRB Statistical Reviewer Form (Attach 6J) Form and Instruction	New
Form 33 CIRB Pharmacy Reviewer Form (Attach 6I) Form and Instruction	New
Form 32 Pediatric CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attach 6H) Form and Instruction	New
Form 31 Adult CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attach 6G) Form and Instruction	New
Form 30 Pediatric CIRB Reviewer Findings Amendment to Cooperative Group Protocol (Attach 6F) Form and Instruction	New
Form 29 Adult CIRB Reviewer Findings Amendment Cooperative Group Protocol (Attach 6E) Form and Instruction	New
Form 28 Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6D) Form and Instruction	New
Form 27 Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6C) Form and Instruction	New
Form 26 Pediatric CIRB Reviewer Findings - Initial Review of Cooperative Group Protocol (Attach 6B) Form and Instruction	New
Form 25 Adult CIRB Reviewer Findings - Initial Review of Cooperative Group Protocol (Attach 6A) Form and Instruction	New
Form 24 Adult/Pediatric CIRB Application for Continuing Review (Attach 5E) Form and Instruction	New
Form 23 Summary of CIRB Application Revisions (Attach 5D) Form and Instruction	New
Form 22 Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5C) Form and Instruction	New
Form 21 NCI Pediatric CIRB Application (Attach 5B) Form and Instruction	New
Form 20 NCI Adult CIRB Application (Attach 5A) Form and Instruction	New
Form 19 CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E) Form and Instruction	New
Form 18 Direct Deposit Form (Attach 4) Form and Instruction	New
Form 17 CIRB New Board Member W-9 (Attach 3D) Form and Instruction	New
Form 16 CIRB New Board Member Contact Information Form (Attach 3C) Form and Instruction	New
Form 15 CIRB New Board Member Biographical Sketch Form (Attach 3B) Form and Instruction	New
Form 14 Study Review Responsibility Transfer Form (Attach 2M) Form and Instruction	New
Form 13 Facilitated Review (FR) Acceptance Form (Attach 2L) Form and Instruction	New
Form 12 Request for 30-Day Access Form (Attach 2K) Form and Instruction	New
Form 11 Institution Affiliate Institution without an IRB (Attach 2J) Form and Instruction	New
Form 10 IRB at Affiliate Institution (Attach 2I) Form and Instruction	New
Form 9 Component Institution at Signatory Institution (Attach 2H) Form and Instruction	New
Form 8 IRB at Signatory Institution (Attach 2G) Form and Instruction	New
Form 7 Research Staff at Affiliate Institution (Attach 2F) Form and Instruction	New
Form 6 Investigator at Affiliate Institution (Attach 2E) Form and Instruction	New
Form 5 Research Staff at Signatory Institution (Attach 2D) Form and Instruction	New
Form 4 Investigator at Signatory Institution (Attach 2C) Form and Instruction	New
Form 3 IRB Staff at Signatory Institution's IRB (Attach 2B) Form and Instruction	New
Form 2 NCI CIRB Institution Enrollment Worksheet (Attach 2A) Form and Instruction	New
Form 1 CIRB Helpdesk Survey (Attach 1) Form and Instruction	New
OMB SSB_CIRB_11-05-10.doc Supporting Statement B	2010-11-09
Attachment 3N-Q - Internal Operations_2009.pdf Supplementary Document	2010-11-09
Attachment 3H-M - Template Letters_110110.pdf Supplementary Document	2010-11-09
Attachment 3G - CIRB_New Member Privacy Policy.pdf Supplementary Document	2010-11-09
Attachment 3F - CIRB_New Member Orient Steps.pdf Supplementary Document	2010-11-09
Attachment 3A - CIRB_New Member Welcome Letter.pdf Supplementary Document	2010-11-09
Attachment 8 - OHSR Determination_CIRB.pdf Supplementary Document	2010-11-09
Attachment 7 - Privacy Act Memo_2009.pdf Supplementary Document	2010-11-09
Cover Memo.docx Supplementary Document	2010-11-09
OMB SSA CIRB_11-2-10.doc Supporting Statement A	2010-11-09

IC Document Collections

IC ID	Document Title	Status
195558	CIRB SAE Reviewer Worksheet (Attach 6K) Form and Instruction	New
195557	CIRB Statistical Reviewer Form (Attach 6J) Form and Instruction	New
195556	CIRB Pharmacy Reviewer Form (Attach 6I) Form and Instruction	New
195555	Pediatric CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attach 6H) Form and Instruction	New
195554	Adult CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attach 6G) Form and Instruction	New
195553	Pediatric CIRB Reviewer Findings Amendment to Cooperative Group Protocol (Attach 6F) Form and Instruction	New
195552	Adult CIRB Reviewer Findings Amendment Cooperative Group Protocol (Attach 6E) Form and Instruction	New
195551	Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6D) Form and Instruction	New
195550	Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6C) Form and Instruction	New
195549	Pediatric CIRB Reviewer Findings - Initial Review of Cooperative Group Protocol (Attach 6B) Form and Instruction	New
195548	Adult CIRB Reviewer Findings - Initial Review of Cooperative Group Protocol (Attach 6A) Form and Instruction	New
195547	Adult/Pediatric CIRB Application for Continuing Review (Attach 5E) Form and Instruction	New
195546	Summary of CIRB Application Revisions (Attach 5D) Form and Instruction	New
195545	Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5C) Form and Instruction	New
195544	NCI Pediatric CIRB Application (Attach 5B) Form and Instruction	New
195543	NCI Adult CIRB Application (Attach 5A) Form and Instruction	New
195542	CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E) Form and Instruction	New
195541	Direct Deposit Form (Attach 4) Form and Instruction	New
195540	CIRB New Board Member W-9 (Attach 3D) Form and Instruction	New
195539	CIRB New Board Member Contact Information Form (Attach 3C) Form and Instruction	New
195538	CIRB New Board Member Biographical Sketch Form (Attach 3B) Form and Instruction	New
195537	Study Review Responsibility Transfer Form (Attach 2M) Form and Instruction	New
195536	Facilitated Review (FR) Acceptance Form (Attach 2L) Form and Instruction	New
195535	Request for 30-Day Access Form (Attach 2K) Form and Instruction	New
195534	Institution Affiliate Institution without an IRB (Attach 2J) Form and Instruction	New
195533	IRB at Affiliate Institution (Attach 2I) Form and Instruction	New
195532	Component Institution at Signatory Institution (Attach 2H) Form and Instruction	New
195531	IRB at Signatory Institution (Attach 2G) Form and Instruction	New
195530	Research Staff at Affiliate Institution (Attach 2F) Form and Instruction	New
195529	Investigator at Affiliate Institution (Attach 2E) Form and Instruction	New
195528	Research Staff at Signatory Institution (Attach 2D) Form and Instruction	New
195527	Investigator at Signatory Institution (Attach 2C) Form and Instruction	New
195526	IRB Staff at Signatory Institution's IRB (Attach 2B) Form and Instruction	New
195525	NCI CIRB Institution Enrollment Worksheet (Attach 2A) Form and Instruction	New
195524	CIRB Helpdesk Survey (Attach 1) Form and Instruction	New

ICR Details

OMB Control No: 0925-0625	ICR Reference No: 201012-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/17/2011
	Date Received in OIRA: 12/02/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2014	36 Months From Approved
Responses	5,044	0	0
Time Burden (Hours)	2,210	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Central Institutional Review Board Initiative (CIRB www.ncicirb.org) was created to better support medical research efforts by reducing the administrative burden on local Institutional Review Boards and medical researchers while protecting human research participants. Beginning in January 2001, the Adult CIRB has been meeting twice monthly to review Phase 3 Cooperative Group trials. The Pediatric CIRB began reviewing all NCI-approved COG Phase 2, 3 and Pilot protocols beginning in November 2004. Both Boards are composed of individuals who represent a broad range of oncology scientific and nonscientific disciplines covering the public health sector. These may include health professionals such as oncology physicians, nurses, patient representatives, pharmacists, ethicists, and attorneys. As none of the Board members are NCI employees, the Board collectively is made up of public members. There are 6 general areas in which forms are completed. These include CIRB: helpdesk, enrollment, membership, direct deposit, application, and reviewer forms. The enrollment form was developed to collect information for any new sites that are interested in enrolling into the CIRB Initiative. The membership documents were created to collect information on the members of the CIRB. There are currently two Boards (Adult and Pediatric), with 18 members on the Adult Board and 15 members on the Pediatric Board. The application forms are required to be submitted to the CIRB in order to complete a submission for review. The reviewer forms are completed by the Board Members when they submit their reviews. The CIRB Helpdesk Survey seeks to collect information that can be used by the CIRB in a systematic fashion to improve operations and enhance reviewer satisfaction with the initiative. The remainders of the forms are necessary in order to facilitate a complete review of protocols by the CIRB with the absence of conflict of interest in place.

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Authorizing Statute(s): US Code: 42 USC 411 (285a) Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 49938	08/16/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 70268	11/17/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 35

IC Title	Form No.	Form Name
CIRB Helpdesk Survey (Attach 1)	1	CIRB Helpdesk Survey
NCI CIRB Institution Enrollment Worksheet (Attach 2A)	2	NCI CIRB Institution Enrollment Worksheet
IRB Staff at Signatory Institution's IRB (Attach 2B)	3	RB Staff at Signatory Institution's IRB
Investigator at Signatory Institution (Attach 2C)	4	Investigator at Signatory Institution
Research Staff at Signatory Institution (Attach 2D)	5	Research Staff at Signatory Institution
Investigator at Affiliate Institution (Attach 2E)	6	Investigator at Affiliate Institution
Research Staff at Affiliate Institution (Attach 2F)	7	Research Staff at Affiliate Institution
IRB at Signatory Institution (Attach 2G)	8	IRB at Signatory Institution
Pediatric CIRB Reviewer Findings Amendment to Cooperative Group Protocol (Attach 6F)	30	Pediatric CIRB Reviewer Findings Amendment to Cooperative Group Protocol
Adult CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attach 6G)	31	Adult CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol
Pediatric CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attach 6H)	32	Pediatric CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol
CIRB New Board Member W-9 (Attach 3D)	17	CIRB New Board Member W-9
Direct Deposit Form (Attach 4)	18	Direct Deposit Form
CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E)	19	CIRB Non-Disclosure Agreement
NCI Adult CIRB Application (Attach 5A)	20	NCI Adult CIRB Application
NCI Pediatric CIRB Application (Attach 5B)	21	NCI Pediatric CIRB Application
Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5C)	22	Adult/Pediatric CIRB Application - Ancillary Studies
Summary of CIRB Application Revisions (Attach 5D)	23	Summary of CIRB Application Revisions
CIRB Pharmacy Reviewer Form (Attach 6I)	33	CIRB Pharmacy Reviewer Form
CIRB Statistical Reviewer Form (Attach 6J)	34	CIRB Statistical Reviewer Form
CIRB SAE Reviewer Worksheet (Attach 6K)	35	CIRB SAE Reviewer Worksheet
Component Institution at Signatory Institution (Attach 2H)	9	Component Institution at Signatory Institution
IRB at Affiliate Institution (Attach 2I)	10	IRB at Affiliate Institution
Institution Affiliate Institution without an IRB (Attach 2J)	11	Institution Affiliate Institution without an IRB
Request for 30-Day Access Form (Attach 2K)	12	Request for 30-Day Access Form
Facilitated Review (FR) Acceptance Form (Attach 2L)	13	Facilitated Review (FR) Acceptance Form
Study Review Responsibility Transfer Form (Attach 2M)	14	Study Review Responsibility Transfer Form
CIRB New Board Member Biographical Sketch Form (Attach 3B)	15	CIRB New Board Member Biographical Sketch Form
CIRB New Board Member Contact Information Form (Attach 3C)	16	CIRB New Board Member Contact Information Form
Adult/Pediatric CIRB Application for Continuing Review (Attach 5E)	24	Adult/Pediatric CIRB Application for Continuing Review
Adult CIRB Reviewer Findings - Initial Review of Cooperative Group Protocol (Attach 6A)	25	Adult CIRB Reviewer Findings - Initial Review of Cooperative Group Protocol
Pediatric CIRB Reviewer Findings - Initial Review of Cooperative Group Protocol (Attach 6B)	26	Pediatric CIRB Reviewer Findings - Initial Review of Cooperative Group Protocol
Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6C)	27	Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review
Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6D)	28	Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review
Adult CIRB Reviewer Findings Amendment Cooperative Group Protocol (Attach 6E)	29	Adult CIRB Reviewer Findings Amendment Cooperative Group Protocol

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	5,044	0	0	0	0	5,044
Annual Time Burden (Hours)	2,210	0	0	0	0	2,210
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $153,574

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/02/2010

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