[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]
-----------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response Total annual
respondents response (in hour) burden hours
----------------------------------------------------------------------------------------------------------------
Parents......................................... 148 1 40/60 99
Children........................................ 136 1 45/60 102
----------------------------------------------------------------------------------------------------------------
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