[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Notices]
[Pages 59943-59944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23755]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-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. The 60-day FRN was published 05/9/2013 (Vol. 78, No. 90, page
27243). No public comments were received. The purpose of this notice is
to allow an additional 30 days for public comment. The National
Institute of Dental and Craniofacial Research (NIDCR), National
Institutes of Health, may not conduct or sponsor, and the respondent is
not required to respond to, an information collection that has been
extended, revised, or implemented on or after October 1, 1995, unless
it displays a currently valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, [email protected] or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Victoria Pemberton, Clinical Trials
Specialist, NHLBI, 6701 Rockledge Drive, Room 8102, MSC 7940, Bethesda,
MD 20892 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.
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 190.
[[Page 59944]]
Estimated Annualized Burden Hours
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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 43/60 106
Children........................................ 136 1 37/60 84
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Dated: September 23, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael S. Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013-23755 Filed 9-27-13; 8:45 am]
BILLING CODE 4140-01-P