Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

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.

Table A.12-1—Estimates of Annual Burden Hours

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