Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical Trials, 27243 [2013-11034]
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Federal Register / Vol. 78, No. 90 / Thursday, May 9, 2013 / Notices
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General, (202) 619–1368.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2013–11055 Filed 5–8–13; 8:45 am]
BILLING CODE 4152–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request: Interactive Informed Consent
for Pediatric Clinical Trials
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
SUMMARY:
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:
pembertonv@nhlbi.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
DATES: Comment Due Date: Comments
regarding this information collection are
Number of
respondents
Type of respondents
Parents .............................................................................................................
Children ............................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2013–11034 Filed 5–8–13; 8:45 am]
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
VerDate Mar<15>2010
17:18 May 08, 2013
Jkt 229001
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
Number of
responses per
response
148
136
Dated: April 29, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
Michael S. Lauer,
Director, DCVS, National Institutes of Health.
BILLING CODE 4140–01–P
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.
1
1
Average
burden per
response
(in hour)
40/60
45/60
Total annual
burden hours
99
102
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA Panel:
Systems Science and Health in the
Behavioral and Social Sciences.
Date: June 6, 2013.
Time: 8:00 a.m. to 5:00 p.m.
E:\FR\FM\09MYN1.SGM
09MYN1
]]>Agencies
[Federal Register Volume 78, Number 90 (Thursday, May 9, 2013)]
[Notices]
[Page 27243]
From the Federal Register Online via the Government Printing 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: pembertonv@nhlbi.nih.gov. 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
