[Federal Register: June 5, 2003 (Volume 68, Number 108)]
[Notices]
[Page 33717-33718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jn03-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0202]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Assessment of Public Perceptions and Knowledge of
Clinical Trials and Informed Consent Human Subject Protection
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on a proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on a survey of U.S. consumers' knowledge and
attitudes about clinical research and informed consent in clinical
research.
DATES: Submit written or electronic comments on the collection of
information by August 4, 2003.
ADDRESSES: Submit electronic comments on the collection of information
via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of
information to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collections of
information set forth in this document.
With respect to each of the following collections of information,
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA'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 respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Assessment of Public Perceptions and Knowledge of Clinical Trials
and Informed Consent
FDA regulates clinical research of products subject to section 505
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355)
and title 21 of the Code of Federal Regulations (21 CFR) to ensure that
products approved for marketing are safe and effective for use. FDA is
also charged with ensuring protection of the rights and welfare of
human subjects participating in clinical research. Matters involving
human subject protection during clinical drug trials are evaluated
within the Division of Scientific Investigations in FDA's Center for
Drug Evaluation and Research.
FDA regulations describe the requirements for informed consent of
study subjects in clinical research in part 50 (21 CFR part 50). Part
50 requires that, to protect clinical research subjects, subjects must
be adequately informed before they consent to participate in clinical
research. The informed consent process, which is an essential part of
human subject protection in clinical trials, is a process of
information exchange: A person who is considering participating in
clinical
[[Page 33718]]
research learns about the research, makes an educated decision about
participating, and is provided with additional information on a
continuing basis, as needed, so as to remain adequately informed
throughout participation in the study.
Examination of the available medical literature provides little
information on the extent to which persons who may consider
participating in FDA regulated clinical research understand clinical
research or the informed consent process. We (FDA) propose to perform a
survey, the goal of which is to gain information about the general
public's perceptions and knowledge about clinical research and informed
consent. To accomplish this goal, a sample of the general public will
be asked to answer a questionnaire in a mall-intercept survey.
Seven hundred and fifty adult males and females (over the age of
18) who come from varied socioeconomic, ethnic, and educational
backgrounds will be recruited for participation. A sample of nine
subjects will be interviewed in a 30-minute pretest that will be used
to help refine the questionnaire as needed, based on feedback from the
pretest participants. Thereafter, the remaining subjects will
participate in 15-minute interviews conducted at appropriate facilities
in three geographically distributed shopping malls in the United
States: Northeast, Midwest, and West.
Individuals who appear to be age appropriate will be approached by
recruiters in public areas of the shopping malls. The recruiters will
be clearly identified with name badges or other identification showing
their affiliation with the study contractor. The recruiter will briefly
explain the purpose of the study and ask the individuals if they are
interested in participating in the interview. Those who agree to
participate will be interviewed.
The survey questionnaire that will be used is available for review
upon request.
Results of the proposed research will be used to help design a plan
to educate U.S. consumers about clinical research, human subject
protection, and the role of the informed consent process in clinical
trials. It is expected that future consumer education programs will
enhance protection for future research subjects by making subjects
better informed about the clinical research process, their rights in
clinical research, and the importance of the informed consent process
to their protection.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual
No. of Respondents per Response Responses Hours per Response Total Hours
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9 (pre-test) 1 9 0.5 4.5
741 (consumer survey) 1 741 0.25 185.25
Total ................... ................... ................... 189.75
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14216 Filed 6-4-03; 8:45 am]
BILLING CODE 4160-01-S