NIH Clinical Center, FY2000 Annual Report/Clinical Bioethics

Summary of Work: This protocol is designed to determine organ procurement organizations' practices and policies regarding consent (family or individual) for cadaveric organ donation and the reasons behind these practices and policies. The study has been Institute Review Board approved. Since we are proposing to survey more than nine individuals with whom we do not have an existing clinical relationship, this project falls under the Paperwork Reduction Act and thus had to receive the Office of Management and Budget's approval. Approval was granted. Sixty-one individuals were surveyed. Surveying is completed and we are currently writing up the results.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10502-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
Survey of Individuals at Risk for Alzheimer's Disease

Principal Investigator:
D. Wendler, Ph.D.
DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
E.J. Emanuel, M.D., Ph.D., Chief, DCB

Collaborating Unit:
None

Staff-Years:
1.0

Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors x (a2) Interviews

Summary of Work: This protocol seeks to survey individuals at risk for Alzheimer's disease with respect to their (1) willingness to participate in clinical research should they develop Alzheimer's disease, (2) willingness to utilize research advance directives, (3) attitudes toward research with stored tissues, (4) attitudes toward confidentiality of research results, and (5) experience with genetic counseling. We surveyed 504 individuals. Surveying is complete. We are currently writing up the results.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10503-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
Influences on HIV-infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent

Principal Investigator:
C. Grady, Ph.D.
DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
N. Dickert, B.A., Fellow, DCB
D. Rock, CCMD

Collaborating Units:
NCI (J. Lietzau)
NIAID (G. Kelly)

Staff-Years:
1.0

Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors x (a2) Interviews

Summary of Work: Protocol was terminated in May 2000. We had some difficulty recruiting an adequate number of subjects from comparable protocols. Nonetheless, we obtained interesting data about the motivations and experience of informed consent from 41 subjects. Data are being analyzed.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10504-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
Policies and Practices of Payment to Research Subjects

Principal Investigator:
C. Grady, Ph.D.
DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
N. Dickert, B.A., Fellow, DCB
E. Emanuel, M.D., Ph.D., Chief, DCB

Collaborating Unit:
None

Staff-Years:
1.0

Human Subjects:
(a) Human subjects (b) Human tissues x (c) Neither
(a1) Minors (a2) Interviews

Summary of Work: We have completed a review and analysis of policies and guidelines regarding payment of research subjects from 32 research organizations around the country. A manuscript has been submitted for publication. We have also completed a review of 467 randomly selected protocols obtained through the Institute Review Boards of 11 different organizations. Data are being analyzed.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10505-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
Patient Perspectives on Health Insurance

Principal Investigator:
M. Danis, M.D. (Head)
Section on Ethics and Health Policy, DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
None

Collaborating Units:
Univ. of Michigan (S.D. Goold, M.D., M.S.H.A., M.A.)
Multilogue Corporation (R. Duke, Ph.D.; C. Hall)
Praxis Learning Corporation (V. Prewitt)

Staff-Years:
0.2

Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors x (a2) Interviews

Summary of Work: This protocol was intended to (1) design a research tool (simulation model) to facilitate group decision making and (2) utilize this tool to examine how patients enrolled in managed care organizations would choose to define their health insurance benefit package. Thus far, the study instrument has been designed and has been pilot tested. The study design has been completed. Study subjects were recruited and 50 group exercises have been conducted. Data collection was complete on June 23, 2000. Data are being processed and analyzed.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10506-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
Defining a Health Insurance Package for the Uninsured

Principal Investigator:
M. Danis, M.D. (Head)
Section on Ethics and Health Policy, DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
None

Collaborating Units:
Univ. of Michigan (S. Dorr, M.D., M.S.H.A., M.A.)
Univ. of North Carolina (A. Biddle, Ph.D.)
Praxis Learning Corporation (V. Prewitt)

Staff-Years:
0.2

Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors x (a2) Interviews

Summary of Work: This protocol is designed to determine how uninsured patients would choose to define their health insurance benefit package. Thus far, the study instrument has been designed and has been pilot tested. The study design has been completed. Patient recruitment is scheduled to begin in July 1999. Study subjects were recruited and 20 group exercises have been conducted. Data collection was complete as of June 4, 2000. Data are being processed and analyzed. Two abstracts have been presented at national meetings.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10507-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
Physician Resolution of Ethical Problems

Principal Investigator:
M. Danis, M.D. (Head)
Section on Ethics and Health Policy, DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
G. DuVal, SJD, DCB (left NIH March 30, 2000 and is now a collaborator at the Univ. of Toronto)

Collaborating Unit:
Center for Survey Research

Staff-Years:
0.6

Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors x (a2) Interviews

Summary of Work: This protocol is designed to identify the most frequent and difficult ethical problems encountered by physicians; to examine how physicians resolve these ethical problems; to examine how physicians utilize ethics consultation services, and to determine what barriers or deterrents physicians perceive in utilizing ethics consultation services. Data collection for this study has now been completed and data analysis is in progress.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10508-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
Comparison of End-of-Life Costs Between Managed Care and Fee-for-Service

Principal Investigator:
E.J. Emanuel, M.D., Ph.D. (Senior Investigator)
DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
None

Collaborating Units:
Boston Univ. (A. Ash, Ph.D.; W. Liu, Ph.D.)
Harvard Pilgrim Health Care (G. Gazelle, M.D.)

Staff-Years:
2.0

Human Subjects:
(a) Human subjects (b) Human tissues x (c) Neither
(a1) Minors (a2) Interviews

Summary of Work: This study is designed (1) to determine the comparative costs and resources utilization over the last year of life for patients treated by managed care, fee-for-service, and Medicare, (2) to compare sites of death, (3) to compare utilization of hospice and hospital beds, and (4) to compare care provided to those over 65 and those under 65. A full set of data has been obtained from two managed care companies and from Medicare. Some problems with the data sets are that use of hospice is not fully recorded in one data set and hospitalization prior to death is not fully recorded in another. However, preliminary observations indicate (1) no difference between managed care and fee-for-service in site of death (i.e., hospital versus home) and (2) managed care has a slightly higher proportion of cancer deaths than deaths from heart disease. Full results are expected within the next 12 months.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10509-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
Protecting Communities in Biomedical Research

Principal Investigator:
E.J. Emanuel, M.D., Ph.D. (Senior Investigator)
DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
None

Collaborating Unit:
Dalhousie Univ. (C. Weijer, M.D., Ph.D.)

Staff-Years:
2.0

Human Subjects:
(a) Human subjects (b) Human tissues x (c) Neither
(a1) Minors (a2) Interviews

Summary of Work: This project is examining protections that should be afforded to communities in research. It entails two phases of work. In the first phase, existing protections for communities have been identified and analyzed. This analysis indicates that there are 17 different declarations about protecting communities that delineate five broad groups with a total of 23 different protections. These protections are appropriate to aboriginal communities, such as Native American communities, but do not necessarily seem appropriate to other types of communities. The second phase focuses on determining what protections are appropriate for different types of communities. It entails four steps: (1) Delineating the key characteristics that define communities. (2) Use these characteristics to develop a typology of different types of communities. This step recognizes that the term "communities" encompasses a diverse set of groups that are not necessarily homogenous. Seven different types of communities are identified. (3) Delineating the 23 protections identified for the aboriginal communities and indicating the type of characteristics necessary to implement each protection. (4) The different types of communities are linked to appropriate protections through the characteristics that are shared, permitting the definition of the types of protections in research that are appropriate to the different types of communities. The first phase of research has been submitted for publication; the second phase of research is ongoing.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10510-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
BEST: Best Ethical Strategies in Managed Care

Principal Investigator:
E.J. Emanuel, M.D., Ph.D. (Senior Investigator)
DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
L. Randel, M.D., DCB
S.A. Green, M.D.

Collaborating Unit:
Harvard Pilgrim Health Care (S. Pearson, M.D.; J. Sabin, M.D.)

Staff-Years:
4.0

Human Subjects:
(a) Human subjects (b) Human tissues x (c) Neither
(a1) Minors (a2) Interviews

Summary of Work: This project begins with the observation that most of the controversy about managed care, such as gag rules, financial incentives, limits on care, and confidentiality, can be viewed as ethics problems. It is unlikely that criticism, a patient's bill of rights, or other approaches will get managed care organizations to be more ethical. The BEST project is based on the idea that by showing managed care plans a list of best practices regarding these ethical issues, they might adopt them. A consortium of 12 managed care plans was established, including for-profit, not-for-profit, academic, "Blues," and religious-based plans. Nine different ethical dimensions were identified: (1) community benefit, (2) care of vulnerable populations, (3) end-of-life care, (4) confidentiality, (5) organization ethics, (6) benefit design and adjudication, (7) technology assessment, (8) financial incentives, and (9) member disclosure and participation. So far, four different site visits have been completed and preliminary "best practices" have been identified for a number of areas. A conference delineating best practices was held in February 2000.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10511-02 CB
October 1, 1999 to September 30, 2000

Title of Project:
Managing Pharmacy Benefits in Managed Care

Principal Investigator:
E.J. Emanuel, M.D., Ph.D. (Senior Investigator)
DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
L. Randel, M.D., DCB
K. Titlow, M.A., DCB

Collaborating Unit:
None

Staff-Years:
1.0

Human Subjects:
(a) Human subjects (b) Human tissues x (c) Neither
(a1) Minors (a2) Interviews

Summary of Work: One of the major dilemmas facing managed care organizations and health insurers is managing pharmacy benefits. Many new drugs are being introduced, drug prices are rising rapidly, and the pressure to cover pharmacy costs is intense. The dilemma has been most clearly manifest in the controversy surrounding the coverage of Viagra. Data collection has been completed and analyzed. This study examines what coverage decisions insurers make and the information and processes used in making these decisions. Fifty-three organizations, differing in size, tax status, and region, were asked about their policies for four new and controversial drugs: Viagra, Enbrel, Zyban, and Celebrex. Enbrel and Celebrex were much more likely to be covered than Viagra and Zyban. In addition, coverage of Enbrel and Celebrex was limited, through strategies such as prior authorization, to encourage medically appropriate use of these agents, whereas coverage of Viagra and Zyban was limited predominantly through generalized exclusion or through restrictions on quantity or duration of use. Value judgments, rather than cost, seem to play a central, though largely unspoken, role in these coverage decisions.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10512-01 CB
October 1, 1999 to September 30, 2000

Title of Project:
Minnesota CHAT: Public Perspectives on Health Insurance in Minnesota

Principal Investigator:
M. Danis, M.D. (Head)
Section on Ethics and Health Policy, DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
None

Collaborating Units:
Univ. of Michigan (S.D. Goold, M.D., M.S.H.A., M.A.)
Univ. of North Carolina (A. Biddle, Ph.D.)
Health Strategies Group and the Allina Foundation (E. Benavides)

Staff-Years:
0. 2

Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors x (a2) Interviews

Summary of Work: This protocol is designed to determine how residents of Minnesota would choose to define their health insurance benefit package. The results are intended to inform the managed care industry in Minnesota to attend to rising costs and dissatisfaction with choices in health care. The study instrument has been designed. The study design has been completed. Participant recruitment is currently ongoing. Thirty group exercises are expected to be complete by July 19, 2000. Data processing and data analysis is expected to begin July 20, 2000.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10513-01 CB
October 1, 1999 to September 30, 2000

Title of Project:
A Comparative Study of Ethical Issues in Multinational Clinical Research: IRB/REC Chairs, PIs and Co-PIs, CPA Contacts, and Subjects

Principal Investigator:
E.J. Emanuel, M.D., Ph.D. (Senior Investigator)
DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
C. Grady, Ph.D., DCB
D. Wendler, Ph.D., DCB
H. Forster, J.D., DCB

Collaborating Units:
NIAID (J. Killen, M.D.; J. Tavel, M.D.; L. McNay)
MRC London (J. Darbyshire, M.D.)
Brussels, Belgium (N. Clumeck, M.D.)
ESPRIT Research Team

Staff-Years:
N/A

Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors x (a2) Interviews

Summary of Work: This study seeks to inform deliberation and resolution of ethical issues related to multinational clinical research through interviewing various participants of the ESPRIT study. ESPRIT is a multinational collaborative clinical trial of Interleukin-2 in HIV disease. Our study will interview four groups participating in ESPRIT: (1) chairs of the Institute Review Board (IRB) or REC which reviewed ESPRIT; (2) principal investigators implementing ESPRIT; (3) persons who negotiated the Cooperative Project Assurances with the U.S. government; and (4) selected subjects participating in ESPRIT. The purpose is to compare their attitudes and experiences regarding important ethical issues associated with ESPRIT. Protocol has been reviewed by the NIAID IRB. Survey instruments are being developed and pretested.

Return to Index

INTRAMURAL RESEARCH PROJECT
Z01 CL-10514-01 CB
October 1, 1999 to September 30, 2000

Title of Project:
Promises of Benefit in Phase I Oncology Informed Consent Forms

Principal Investigator:
E.J. Emanuel, M.D., Ph.D. (Senior Investigator)
DCB, CC, NIH
Bethesda, MD 20892

Other Personnel:
C. Grady, Ph.D.
B. Wilfond, M.D.
J. Rackoff

Collaborating Unit:
None

Staff-Years:
N/A

Human Subjects:
(a) Human subjects (b) Human tissues x (c) Neither
(a1) Minors (a2) Interviews

Summary of Work: This protocol will analyze consent forms for Phase I oncology trials to assess the manner in which the nature, risks, and potential benefits are communicated. Phase I consent forms are being sought from all of the NCI-designated comprehensive cancer centers and from major pharmaceutical companies that conduct Phase I oncology trials. Institutions have been contacted by phone and are sending consent forms. Data gathering is just beginning.

Index: Annual Report of Clinical Research Activities FY 2000

Home | Public/Patients | Professionals/Scientists | Staff | Contact Us | Site Map | Search

For more information about the Clinical Center,
e-mail Contact Us, or call Clinical Center Communications, 301-496-2563.

NIH Clinical Center
National Institutes of Health
Bethesda, Maryland 20892-7511