Patient Care & Bioethics

Copyright 1996-97 William L. Manning except as otherwise noted. All rights reserved.

Last updated by Bill Manning on 1/18/98

About This Page EMTALA, informed consent, and medical futility/right to die issues (among other issues) are highlighted here. Often, lawyers don't become involved in such issues until such time as a problem has arisen and clients need immediate advice or representation. It is my desire that the links here will provide lawyers and their clients with relatively easy access to information to assist them in planning for the inevitable patient care and bioethical dilemma.

  Bioethics

Institutional Review Boards (IRBs)

• Bioethics for Beginners, from Univ. of Penn. The Center for Bioethics, Bioethics Internet Project.
• Bioethics: An Introduction, Glenn McGee, Arthur L. Caplan.
• Belmont Report:, Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
• Protection Of Human Research Subjects And Creation Of National Bioethics Advisory Commission, E.O. 12975, Oct. 3, 1995 (White House).
• Institutional Protocols for Decisions About Life-Sustaining Treatments, OTA Report (July 1988).
• FDA's IRB Regulations
• IRB Operations and Clinical Investigation Requirements (FDA)
• Protecting Human Research Subjects: Institutional Review Board Guidebook from the OPRR (U. of Mich.).
• University of Michigan Medical School Institutional Review Board, (IRBMED)
  • Ethical Principles of Human Subject Research
  • General Guidelines
  • Informed Consent Process
  • Children as Research Subjects
  • Fetuses & Pregnant Women
  • Emergency Use of Test Articles
  • Test Articles in Research
• The testing and mapping of human genes push scientific boundaries into questions of personal privacy. As more is known, more may be concealed, Internal Affairs (15.9k), Summer 1995, Brian Cunningham and Douglas Haeuber, Cooley Godward LLP.

Ethics & Morality in Medicine

• Evaluation of the Oregon Medicaid Proposal, OTA Report (May 1992).
• Biomedical Ethics in U.S. Public Policy, OTA Report (June 1993).
• Sample Manual for Ethics Committee Members

  From Froedtert Memorial Lutheran Hospital & John L. Dangue Hospital, Milwaukee, WI (1994)

• The Role of Bioethics In Health Care Policy: Broadening The Bioethics Agenda, The Greenwal Foundation Conference, 5/23 and 5/24/94, Center for Biomedical Ethics, University of Minnesota Association for American Health Centers.
• Withdrawing Intensive Life-Sustaining Treatment -- Recommendations for Compassionate Clinical Management, NEJM Volume 336, Number 9, 2-27-97.
• Mandatory HIV Screening of Newborns: A Proposition Whose Time Has Not Yet Come, Suzanne M. Malloy, American University Law Review, April, 1996.
• How We Die: Reflections on Life's Final Chapter, Nuland, Sherwin B.
• The Promised End -- Constitutional Aspects of Physician-Assisted Suicide by George J. Annas, NEJM, August 29, 1996 -- Volume 335, Number 9
• Practical Ethics by Junkerman & Schiedermayer
• End of Life Decision Making The [HCFA] Administrator's Speeches (Bruce Vladek, March 12, 1996)
• Getting through the Door: Threshold Procedural Considerations in Right-to-Die Litigation, F. DiPaolo, --- Explains how judges may use mootness, ripeness and standing to avoid getting involved in right-to-die cases. Argues that this may interfere with private decision making and be counterproductive.
• Physician Assisted Suicide: The Legal and Practical Contours, Anthony J. Dangelantonio, --- Considers medical, legal and other perspectives on patients' right to assistance in dying and attends to legislative initiatives in three states.
• Eggs, Embryos & Ethics: Reproductive Technology & Policy -- Volume 6:2, Spring, 1995, The Stanford Law & Policy Review.
• Genetic Monitoring and Screening in the Workplace, OTA Report (October 1990).
• Genetic Tests and Health Insurance: Results of a Survey, OTA Report (October 1992).
• Genetic Susceptibility and state policies related to genetic screening.
• Organ Procurement and Transplantation: Ethical and Practical Issues, by Caplan A. 2(5): 1995, LDI Issue brief Leonard Davis Institute Center for Health Policy.

  Informed Consent & Patient Care

Informed Consent

• New Developments in Biotechnology: Ownership of Human Tissues and Cells, OTA Report (March 1987).
• Deciding about CPR: Do-Not-Resuscitate (DNR) Orders, A Guide for Patients and Families, Courtesy of NYS Department of Health.
• Living Will or Directive to Physicians, from University of Houston Law Center.
• Health Care Advance Directive Forms from the Bureau of Elder and Adult Services in Maine.
• An Empirical Analysis of the Medical Informed Consent Doctrine: Search for a Standard of Disclosure, F. Merz --- Evaluates the informed consent doctrine in tort cases and concludes that it is now difficult for physicians to decide what must be disclosed.

Patient Care

• Medical Malpractice Rulings Stir a Healthy Debate, By Martin Kassman. The Recorder 1-06-97, about a recent Second District Court of Appeal decision applying California's medical malpractice damage cap to a federal patient-dumping claim. Click here for the opinion in Barris v. County of Los Angeles, 97 C.D.O.S. 9725.  
• Life-Sustaining Technologies and the Elderly, OTA Report (July 1987).
• Contesting Inappropriate Limitations on Care, Fred Burg, Univ. of Penn. Center for Bioethics.
• Quality-Of-Care Data from Managed-Care Organizations, 2-6-97, NEJM.
• BehaveNetTM Behavioral Health Law
• Deciding Who Needs Emergency Care: Triage Guidelines and Gatekeeping, by Lowe R. 2(6):1995.
• Prescription Drugs: Implications of Drug Labeling and Off-Label Use, by Sarah F. Jaggar, Director of Health Services Quality and Public Health Issues, before the Subcommittee on Human Resources and Intergovernmental Relations, House Committee on Government Reform and Oversight. (GAO/T-HEHS-96-212, Sept. 12.)
• Disease State Management and Its Influence on Health Systems Today
• Doctors at Risk: A Problem as Viewed by Decision Analysis, Leonard P. Caccamo, Kimbroe J. Carter, Barbara A. Erickson, William R. Johnson & Edward Kessler, --- a case analysis to argue that medical peer review fails to encourage cost effective behavior and may decrease the quality of medical care.
• Terminating a Patient Relationship, Fall 1996 Risk Review, from The Princeton Insurance Companies

  Medical Devices, Procedures & Drugs

Medical Devices, Procedures and Drugs

• The FDA Medical Devices Bulletin
• FDA Quality Mammography Standards; Final Rule, 21 CFR Parts 16 and 900, October 28, 1997 (Volume 62, Number 208).  
• GAO Report: Human Tissue Banks: FDA Taking Steps to Improve Safety, but Some Concerns Remain. HEHS-98-25. 35 pp. plus 3 appendices (13 pp.), December 5, 1997 (Adobe *.pdf format).
• Proposed Rules: Medical Devices; Refurbishers, Rebuilders, Reconditioners, Servicers, and ``As Is'' Remarketers of Medical Devices; Review and Revision of Compliance Policy Guides and Regulatory Requirements; Request for Comments and Information, FR, pp. 67011-67013  
• Reinventing the Regulation of Human Tissue, FDA.
• Debate Rages Over Who Can Wield Laser to Improve Your Eyesight, by Linda Cramper, 7-31-96, from CNN online.
• FDA Requires Date Of Informed Consent, Reuters, 11-06-96
  • Get The Final Regulation here (Protection Of Human Research Subjects;Informed Consent Verification, Effective 11-05-96); 21 CFR Parts 50, 312, and 812
• Search the Releasable 510(k) Database from the FDA.

  In The News

Recently In the News

• Medical Malpractice Rulings Stir a Healthy Debate, By Martin Kassman. The Recorder 1-06-97, about a recent Second District Court of Appeal decision applying California's medical malpractice damage cap to a federal patient-dumping claim. Click here for the opinion in Barris v. County of Los Angeles, 97 C.D.O.S. 9725.  
• FDA Seeks Public Comment on Informed Consent Rules in Combat Situations 7-29-97. The FDA invited comment on significant ethical and regulatory issues involved in the waiving of informed consent for the use of investigational medications for troops engaged in combat situations.
• Patients Resist Discussing End-of-Life CareStrategic Health Review, 7-07-97.
• Court Ruling Highlights a Burden of Faith, Washington Post, 7-05-97.
• More communication needed for living wills to be effective, 4-24-97.
• Reinventing the Regulation of Human Tissue, FDA.
• AAHP Welcomes the Appointment of President Clinton’s Bipartisan Advisory Commission on Consumer Protection and Quality in the Health Care Industry, AAHP, March 26, 1997.

 Explore These Relevant Links

• Univ. of Penn. The Center for Bioethics, Bioethics Internet Project.
• Confidentiality and Information Links.
• MCW Bioethics HomePage
• Medical Risk Management
• State Legislative Profiles, MGMA representatives and state legislative information.
• EMTALA.COM An excellent resource on EMTALA issues.
• NLM - National Library of Medicine's HyperDOC
• FDA, Center for Devices and Radiological Health
• Latest News from the FDA
• United States Circuit Court of Appeals Decisions (Searchable)
• Other Legal Resources: FindLaw (index)

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