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Proposed Collection; 60-day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

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SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: CAPT Michael Montello, Pharm. D., MBA, Cancer Therapy Evaluation Program, Operations and Informatics Branch, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number (240) 276-6080 or Email your request, including your address to: mike.montello@nih.gov. Formal requests for additional plans and instruments must be requested in writing.

Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

Proposed Collection: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 0925-0625, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH).

Need and Use of Information Collection: The National Cancer Institute (NCI) Central Institutional Review Board (CIRB) provides a centralized approach to human subject protection and provides a cost efficient approach avoiding duplication of effort at each institution. The CIRB provides the services of a fully constituted IRB and provides a comprehensive and efficient mechanism to meet regulatory requirements pertaining to human subject protections including: Initial reviews, continuing reviews, review of amendments, and adverse events. The Initiative consists of three central IRBs: Adult CIRB—late phase emphasis, Adult CIRB—early phase emphasis, and Pediatric CIRB. CIRB membership includes oncology physicians, surgeons, nurses, patient advocates, ethicists, statisticians, pharmacists, attorneys and other health professionals. The benefits of the CIRB Initiative reaches research participants, investigators and research staff, Institutional Review Boards (IRB), and Institutions. Benefits include: Study participants having dedicated review of NCI-sponsored trials for participant protections, access to more trials more quickly and access to trials for rare diseases, accrual to trials begin more rapidly, ease of opening trials, elimination of need to submit study materials to local IRBs, and elimination of the need for a full board review. The benefits to the National Clinical Trials Network and Experimental Therapy-Clinical Trials Network include a cost efficient approach that avoids duplication of efforts at each institution. A variety of information collection tools are needed to support NCI's CIRB activities which include: Worksheets, forms and a survey that is provided to all customers contacting the CIRB helpdesk.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,199.Start Printed Page 52205

Estimates of Annual Burden Hours

Form nameType of respondentsNumber of respondentsFrequency of responses per respondentAverage burden per response (in hours)Total annual burden hours
CIRB Customer Satisfaction SurveyParticipants/Board Members1500110/60250
Request for 30 Day Web site Access FormParticipants25110/604
Authorization Agreement and Division of Responsibilities between the NCI CIRB and Signatory InstitutionParticipants340130/60170
NCI CIRB Signatory Enrollment FormParticipants4014160
IRB Staff at Signatory Institution's IRBParticipants25110/604
Investigator at Signatory InstitutionParticipants65110/6011
Research Staff at Signatory InstitutionParticipants65110/6011
Investigator at Affiliate Institution with an IRBParticipants25110/604
Research Staff at Affiliate Institution with an IRBParticipants25110/604
Investigator at Affiliate Institution without an IRBParticipants25110/604
Research Staff at Affiliate Institution without an IRBParticipants25110/604
Institutional Contact for Signatory InstitutionParticipants65110/6011
IRB at Signatory InstitutionParticipants25110/604
Component Institution at Signatory InstitutionParticipants65110/6011
IRB at Affiliate InstitutionParticipants25110/604
Affiliate Institution without an IRBParticipants25110/604
Facilitated Review Acceptance FormParticipants300110/6050
Study Review Responsibility Transfer FormParticipants80110/6013
Annual Signatory Institution Worksheet About Local ContextParticipants120120/6040
Annual Principal Investigator Worksheet About Local ContextParticipants120120/6040
Study-Specific Worksheet About Local ContextParticipants220120/6073
Study Closure or Transfer of Study Review Responsibility FormParticipants120110/6020
Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting FormParticipants120115/6030
Add or Remove Signatory and/or Component Institution PersonnelParticipants120110/6020
Add or Remove Affiliate Institution PersonnelParticipants120110/6020
Add or Remove Component InstitutionParticipants120110/6020
Add or Remove Affiliate InstitutionParticipants120110/6020
One Time Study Roll Over WorksheetParticipants120110/6020
Change of Signatory Institution PI FormParticipants120110/6020
CIRB Board Member Biographical Sketch FormBoard Members25115/606.25
CIRB Board Member Contact Information FormBoard Members25110/604
CIRB Board Member W-9Board Members25115/606
CIRB Board Member Non-Disclosure Agreement (NDA)Board Members25110/604
CIRB Direct Deposit FormBoard Members25115/606
NCI Adult/Pediatric CIRB Application for Treatment StudiesParticipants251250
NCI Adult/Pediatric CIRB Application for Ancillary StudiesParticipants101220
NCI Adult/Pediatric CIRB Application for Continuing ReviewParticipants801180
Summary of CIRB Application RevisionsParticipants20130/6010
Locally-Developed Material Submission FormParticipants15115/604
Application Request to Review Translated DocumentsParticipants15115/604
Adult Initial Review of Cooperative Group ProtocolBoard Members151460
Pediatric Initial Review of Cooperative Group ProtocolBoard Members151460
Adult Continuing Review of Cooperative Group ProtocolBoard Members13011130
Pediatric Continuing Review of Cooperative Group ProtocolBoard Members701170
Adult Amendment of Cooperative Group ProtocolBoard Members101220
Pediatric Amendment of Cooperative Group ProtocolBoard Members101220
Adult Cooperative Group Response to CIRB ReviewParticipants151115
Pediatric Cooperative Group Response to CIRB ReviewParticipants101110
Adult Pharmacist's Review of a Cooperative Group StudyBoard Members101220
Pediatric Pharmacist's Review of a Cooperative Group StudyBoard Members201240
CIRB Statistical Reviewer FormBoard Members30130/6015
Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN)Board Members40110/607
Adult Expedited Amendment ReviewBoard Members350130/60175
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Ped Expedited Amendment ReviewBoard Members150130/6075
Adult Expedited Continuing ReviewBoard Members120130/6060
Ped Expedited Continuing ReviewBoard Members70130/6035
Adult Expedited Study ClosureBoard Members20120/607
Ped Expedited Study ClosureBoard Members20120/607
Adult Expedited Study Chair Response to Required ModBoard Members350115/6088
Ped Expedited Study Chair Response to Required ModBoard Members150115/6038
Reviewer Worksheet of Translated DocumentsBoard Members15115/604
Reviewer Advertisement ChecklistBoard Members10120/603
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Dated: August 15, 2013.

Vivian Horovitch-Kelley,

Program Analyst, National Institutes of Health.

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[FR Doc. 2013-20415 Filed 8-21-13; 8:45 am]

BILLING CODE 4140-01-P