[Federal Register Volume 78, Number 90 (Thursday, May 9, 2013)]
[Notices]
[Page 27243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11034]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request: Interactive Informed 
Consent for Pediatric Clinical Trials

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 Institute Heart, 
Lung, and Blood Institute (NHBLI), 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.
    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: Ms. 
Victoria Pemberton, Clinical Trials Specialist, National Heart, Lung, 
and Blood Institute, NIH, 6701 Rockledge Drive, Room 8102, MSC 7940, 
Bethesda, MD, or call non-toll-free number 301-435-0510, or Email your 
request, including your address to: [email protected]. Formal 
requests for additional plans and instruments must be requested in 
writing.

DATES: 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: Interactive Informed Consent for Pediatric 
Clinical Trials, 0925-New, National Heart, Lung, and Blood Institute 
(NHLBI), National Institutes of Health (NIH).
    Need and Use of Information Collection: This study will compare 
parents' and children's understanding of information about a 
hypothetical clinical trial presented using either a standard paper 
consent document or an interactive computer-based consent program. 
Parents' and children's understanding, regardless of whether they 
received the standard consent or the interactive computer-based 
program, will be assessed by face-to-face interview. In addition, 
parents' and children's perceptions of, and satisfaction with, the 
information presented will be evaluated by completion of a short 
questionnaire. The primary hypothesis to be tested is that interactive 
computer-based research consent information is better understood and 
accepted by parents and children compared with the standard paper 
consent document. Given that many individuals have difficulty reading 
and interpreting standard written consent documents, this technology 
holds promise as a means to optimize the consent and assent process 
particularly among individuals with low literacy and numeracy skills.
    OMB approval is requested for 18 months. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 201.

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                                                                     Number of    Average burden
               Type of respondents                   Number of     responses per   per response    Total annual
                                                    respondents      response        (in hour)     burden hours
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Parents.........................................             148               1           40/60              99
Children........................................             136               1           45/60             102
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    Dated: April 29, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael S. Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013-11034 Filed 5-8-13; 8:45 am]
BILLING CODE 4140-01-P