75 FR 157 pgs. 49938-49940 - Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
Type: NOTICEVolume: 75Number: 157Pages: 49938 - 49940
FR document: [FR Doc. 2010-20167 Filed 8-13-10; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: National Institutes of Health
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
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), the 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.
Proposed Collection: Title: NIH NCI Central Institutional Review Board (CIRB). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: The CIRB was created to reduce the administrative burden on local IRBs and investigators while protecting human research participants. To accomplish this, the CIRB uses several information collection tools to ensure that CIRB operations occur with high level of reviewer and board member satisfaction and is absent of conflicts of interest with the protocols under review. Tools utilized to accomplish this include the new member packets which are completed once a new member joins the CIRB to provide background information on workflow and processes of CIRB operations as well as a non-disclosure agreement. A conflict of interest form is completed occasionally or each time the reviewer is requested to serve as a reviewer for a study. CIRB helpdesk surveys measure satisfaction of helpdesk users and is conducted occasionally or each time the person contacts the helpdesk. Frequency of Response: Once, except for the SAE Reviewer Worksheet. Affected Public: Includes the Federal Government, business or other for-profits and not-for-profit institutions. Type of Respondents: Respondents include any customer who contacts the CIRB Helpdesk, institutional review board members and CIRB review participants. The annual reporting burden is estimated at 2221 hours (see Table below for the estimated time burden). The average annual cost to the government over a 12 month period is approximately $153,574 per year for a six year contract. This includes total annualized capital/start up costs of $25,108 and operating costs of $150,637.
| Type of respondents | Survey instrument | Number of respondents | Frequency of response | Average time per response (Min/Hr) | Annual burden hours |
|---|---|---|---|---|---|
| Participants/Board Members | CIRB Helpdesk Survey (Attachment 1) | 1500 | 1 | 10/60 (.17 hour) | 255 |
| Participants | NCI CIRB Institution Enrollment Worksheet (Attachment 2A) | 30 | 1 | 3.5 hours | 105 |
| Participants | IRB Staff at Signatory Institution's IRB (Attachment 2B) | 65 | 1 | 10/60 (.17 hour) | 11 |
| Participants | Investigator at Signatory Institution (Attachment 2C) | 65 | 1 | 10/60 (.17 hour) | 11 |
| Participants | Research Staff at Signatory Institution (Attachment 2D) | 65 | 1 | 10/60 (.17 hour) | 11 |
| Participants | Investigator at Affiliate Institution (Attachment 2E) | 65 | 1 | 10/60 (.17 hour) | 11 |
| Participants | Research Staff at Affiliate Institution (Attachment 2F) | 65 | 1 | 10/60 (.17 hour) | 11 |
| Participants | IRB at Signatory Institution (Attachment 2G) | 65 | 1 | 10/60 (.17 hour) | 11 |
| Participants | Component Institution at Signatory Institution (Attachment 2H) | 65 | 1 | 10/60 (.17 hour) | 11 |
| Participants | IRB at Affiliate Institution (Attachment 2I) | 65 | 1 | 10/60 (.17 hour) | 11 |
| Participants | Institution Affiliate Institution without an IRB (Attachment 2J) | 65 | 1 | 10/60 (.17 hour) | 11 |
| Participants | Request for 30-Day Access Form (Attachment 2K) | 50 | 1 | 10/60 (.17 hour) | 9 |
| Participants | Facilitated Review (FR) Acceptance Form (Attachment 2L) | 1450 | 1 | 10/60 (.17 hour) | 247 |
| Participants | Study Review Responsibility Transfer Form (Attachment 2M) | 120 | 1 | 10/60 (.17 hour) | 20 |
| Board Members | CIRB New Board Member Biographical Sketch Form (Attachment 3B) | 16 | 1 | 30/60 (.5 hour) | 8 |
| Board Members | CIRB New Board Member Contact Information Form (Attachment 3C) | 16 | 1 | 15/60 (.25 hour) | 4 |
| Board Members | CIRB New Board Member W-9 (Attachment 3D) | 16 | 1 | 15/60 (.25 hour) | 4 |
| Board Members | CIRB New Board Member Non-Disclosure Agreement (NDA) (Attachment 3E) | 16 | 1 | 15/60 (.25 hour) | 4 |
| Board Members | Direct Deposit Form (Attachment 4) | 16 | 1 | 15/60 (.25 hour) | 4 |
| Participants | NCI Adult CIRB Application (Attachment 5A) | 150 | 1 | 2 hours | 300 |
| Participants | NCI Pediatric CIRB Application (Attachment 5B) | 62 | 1 | 2 hours | 124 |
| Participants | Adult/Pediatric CIRB Application-Ancillary Studies (Attachment 5C) | 10 | 1 | 2 hours | 20 |
| Participants | Summary of CIRB Application Revisions (Attachment 5D) | 20 | 1 | 30/60 (.5 hour) | 10 |
| Participants | Adult/Pediatric CIRB Application for Continuing Review (Attachment 5E) | 230 | 1 | 1 hour | 230 |
| Board Members | Adult CIRB Reviewer Findings-Initial Review of Cooperative Group Protocol (Attachment 6A) | 20 | 1 | 4 hours | 80 |
| Board Members | Pediatric CIRB Reviewer Findings-Initial Review of Cooperative Group Protocol (Attachment 6B) | 12 | 1 | 4 hours | 48 |
| Board Members | Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attachment 6C) | 25 | 1 | 1 hour | 25 |
| Board Members | Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attachment 6D) | 70 | 1 | 1 hour | 70 |
| Board Members | Adult CIRB Reviewer Findings Amendment Cooperative Group Protocol (Attachment 6E) | 130 | 1 | 1.5 hours | 195 |
| Board Members | Pediatric CIRB Reviewer Findings Amendment to Cooperative Group Protocol (Attachment 6F) | 50 | 1 | 1.5 hours | 75 |
| Board Members | Adult CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attachment 6G) | 150 | 1 | .5 hour | 75 |
| Board Members | Pediatric CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attachment 6H) | 110 | 1 | .5 hour | 55 |
| Board Members | CIRB Reviewer Form (Attachment 6I) | 20 | 1 | 2 hours | 40 |
| Board Members | CIRB Statistical Reviewer Form (Attachment 6J) | 20 | 1 | 2 hours | 40 |
| Board Members | CIRB SAE Reviewer Worksheet (Attachment 6K) | 10 | 15 | 30/60 (.5 hour) | 75 |
| Total | 2221 |
Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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.
FOR FURTHER INFORMATION CONTACT:
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Michael Montello, Pharm. D., CTEP, 6130 Executive Blvd., Rockville, MD 20852. At non-toll-free number 301-435-9206 or e-mail your request, including your address to: montellom@mail.nih.gov.
Comments 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.
Dated: August 9, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-20167 Filed 8-13-10; 8:45 am]
BILLING CODE 4140-01-P