[Federal Register: June 5, 2003 (Volume 68, Number 108)]
[Page 33717-33718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 

[[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 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                                Annual Frequency       Total Annual
     No. of Respondents           per Response          Responses        Hours per Response      Total Hours
9 (pre-test)                                1                    9                    0.5                  4.5
741 (consumer survey)                       1                  741                    0.25               185.25
Total                         ...................  ...................  ...................              189.75
\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]