[Federal Register Volume 66, Number 38 (Monday, February 26, 2001)]
[Notices]
[Page 11592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Study of Physician 
Researchers Concerning Research and Clinical Care Activities

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 Department of Clinical 
Bioethics, 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.
    Proposed Collection: Title: Study of Physician Researchers 
Concerning Research and Clinical Care Activities. Type of Information 
Collection Request: New. Need and Use of Information Collection: In 
order to understand the sometimes-conflicting obligations of physicians 
involved in clinical research, it is important to study their own 
understanding of their work and responsibilities as researchers and as 
clinicians treating patients. This study aims to gather this 
information through interviews with physicians involved in clinical 
research and other experts knowledgeable about their work. In 
particular, the study aims to identify and examine what physicians 
experience as the nature of the conflict between their roles as 
caregiver and researcher, physicians' most recent case of conflict 
between treatment and research, pressures on physicians involved in 
research and how they address or resolve them, conflict between caring 
for patients and gaining generalizable knowledge, and the influence of 
the work and institutional setting on physicians undertaking medical 
research. Frequency of Response: Once for the survey administration and 
for individuals interviewed and on occasion thereafter. Affected 
Public: Individuals. Type of Respondents: Physicians involved in 
clinical research and other interviewees knowledgeable about their 
practices. Annual Reporting Burden: The annual reporting burden follows 
in the table below. Annualized Cost to Respondents: The annualized cost 
to respondents is estimated at: $11,000. Capital Costs: There are no 
capital costs to report. Operating or Maintenance Costs: There are no 
operating or maintenance costs to report.

                                   Respondent and Burden Estimate Information
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                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
              Type of  respondents                   number of     response per      hours per     burden hours
                                                    respondents     respondent       response        requested
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Physician Researchers...........................             250               1              .5             125
Physician Researchers...........................              80               1               1              80
Non-Physician-Researcher Interviewees...........              20               1               1              20
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    Total.......................................                                                             225
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    Request for Comments: 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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Dr. Elaine Draper, Ph.D., J.D., Department of 
Clinical Bioethics, NIH, Building 10, Room 1C118F, 9000 Rockville Pike, 
Bethesda, MD 20892, or call non-toll-free number (301) 435-8715 or E-
mail your request, including your address to: [email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received on or before 
April 27, 2001.

    Dated: February 14, 2001.
David K. Henderson,
Deputy Director for Clinical Care.
[FR Doc. 01-4619 Filed 2-23-01; 8:45 am]
BILLING CODE 4140-01-M