The Values Underlying Informed Consent
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Library of Congress card number 82-600637 For sale by the Superintendent of Documents U.S. Government Printing Office Washington, D.C. 20402 Making Health Care Decisions A Report on the Ethical and Legal Implications of Informed Consent in the Patient- Practitioner Relationship Volume One: Report October 1982 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Morris B. Abram, M.A., J.D., LL.D., Chairman, New York, N.Y. H. Thomas Ballantine, M.D., Daher B. Rahi, D.O. M.S., D.Sc. * St. Clair Shores, Michigan Harvard Medical School Anne A. Scitovsky, M.A. † George R. Dunlop, M.D. Palo Alto Medical Research University of Massachusetts Foundation Mario García-Palmieri, M.D. † Seymour Siegel, D.H.L. University of Puerto Rico Jewish Theological Bruce K. Jacobson, M.D. * Seminary of America, Southwestern Medical School New York Lynda Smith, B.S. Albert R. Jonsen, S.T.M., Ph.D. † Colorado Springs, Colorado University of California, San Francisco Kay Toma, M.D. * Bell, California John J. Moran, B.S. * Houston, Texas Charles J. Walker, M.D. Nashville, Tennessee Arno G. Motulsky, M.D. University of Washington Carolyn A. Williams, Ph.D. † University of North Carolina, Chapel Hill * Sworn in August 12, 1982. † Term expired August 12, 1982. Staff Alexander M. Capron, LL.B., Executive Director Deputy Director Administrative Officer Barbara Mishkin, M.A., J.D. Anne Wilburn Assistant Directors Editor Joanne Lynn, M.D. Linda Starke Alan Meisel, J.D. Alan J. Weisbard, J.D. Support Staff Professional Staff Florence Chertok Mary Ann Baily, Ph.D. Gretchen Erhardt Dan Brock, Ph.D. Ruth Morris Allen Buchanan, Ph.D. Clara Pittman Andrew Burness, M.B.A. Kevin Powers Kathryn Kelly, M.S.W. Nancy Watson Susan Morgan Marian Osterweis, Ph.D. Renie Schapiro, M.P.H. President’s Commission Daniel Wikler, Ph.D. Commonwealth Fellows and Student Interns Research Assistants Susan Formaker (1982) Michelle Leguay Kenneth Kim (1982) Katherine Locke Eddie Lockard (1982) Ruby J. Sherrod Stephen Massey (1982) Jeffrey Stryker Ruth Oratz (1981) Lisa Rovin (1982) Special Consultants William Thompson (1981) Caroline Kaufmann, Ph.D. Mindy Werner (1982) Louis Morris, Ph.D. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Suite 555, 2000 K Street, N.W., Washington, DC 20006 (202) 653-8051 October 21, 1982 The President The White House Washington, D.C. 20500 Dear Mr. President: On behalf of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, I am pleased to transmit our Report on Making Health Care Decisions. This is one of several subjects that Public Law 95- 622 directs the Commission to study and regarding which we are to report to the President, the Congress, and relevant departments of government. In mandating a study of “the ethical and legal implications of the requirements for informed consent,” the Congress assigned us a subject that is at the heart of current concerns about the relationship between patients and health care professionals. Although our studies have shown that the public and the educators of health professionals are greatly interested in this topic, it is not one that has been primarily a matter of Federal concern. The Commission does not recommend the adoption of specific regulations on this subject by Federal departments and agencies. Indeed, while recognizing the important role that the law has played in this area, the Commission does not look to the law as the primary means of bringing about needed changes in attitudes and practices. Rather, the Commission sees “informed consent” as an ethical obligation that involves a process of shared decisionmaking based upon the mutual respect and participation of patients and health professionals. Only through improved communication can we establish a firm footing for the trust that patients place in those who provide their health care. There are, nonetheless, several areas in which the Federal government can play a leading role. For example, it can ensure that the hospitals it operates and the professionals it employs take the steps recommended for all health care providers in this Report. Moreover, it can lend support--especially through the Department of Health and Human Services--to initiatives to develop, evaluate, and disseminate methods of improving the interpersonal side of health care, in line with the efforts that have advanced its scientific side. The Commission believes that this Report should be of interest to members of the public and of the health care professions, as well as to officials of the Federal government. We are pleased to have had an opportunity to assist in improving understanding of this important topic. Respectfully, Morris B. Abram Chairman President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Suite 555, 2000 K Street, N.W., Washington, DC 20006 (202) 653-8051 October 21, 1982 The Honorable George Bush President United States Senate Washington, D.C. 20510 Dear Mr. President: On behalf of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, I am pleased to transmit our Report on Making Health Care Decisions. This is one of several subjects that Public Law 95- 622 directs the Commission to study and regarding which we are to report to the President, the Congress, and relevant departments of government. In mandating a study of “the ethical and legal implications of the requirements for informed consent,” the Congress assigned us a subject that is at the heart of current concerns about the relationship between patients and health care professionals. Although our studies have shown that the public and the educators of health professionals are greatly interested in this topic, it is not one that has been primarily a matter of Federal concern. The Commission does not recommend the adoption of specific regulations on this subject by Federal departments and agencies. Indeed, while recognizing the important role that the law has played in this area, the Commission does not look to the law as the primary means of bringing about needed changes in attitudes and practices. Rather, the Commission sees “informed consent” as an ethical obligation that involves a process of shared decisionmaking based upon the mutual respect and participation of patients and health professionals. Only through improved communication can we establish a firm footing for the trust that patients place in those who provide their health care. There are, nonetheless, several areas in which the Federal government can play a leading role. For example, it can ensure that the hospitals it operates and the professionals it employs take the steps recommended for all health care providers in this Report. Moreover, it can lend support--especially through the Department of Health and Human Services--to initiatives to develop, evaluate, and disseminate methods of improving the interpersonal side of health care, in line with the efforts that have advanced its scientific side. The Commission believes that this Report should be of interest to members of the public and of the health care professions, as well as to officials of the Federal government. We are pleased to have had an opportunity to assist in improving understanding of this important topic. Respectfully, Morris B. Abram Chairman President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Suite 555, 2000 K Street, N.W., Washington, DC 20006 (202) 653-8051 October 21, 1982 The Honorable Thomas P. O’Neill, Jr. Speaker U.S. House of Representatives Washington, D.C. 20515 Dear Mr. Speaker: On behalf of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, I am pleased to transmit our Report on Making Health Care Decisions. This is one of several subjects that Public Law 95-622 directs the Commission to study and regarding which we are to report to the President, the Congress, and relevant departments of government. In mandating a study of “the ethical and legal implications of the requirements for informed consent,” the Congress assigned us a subject that is at the heart of current concerns about the relationship between patients and health care professionals. Although our studies have shown that the public and the educators of health professionals are greatly interested in this topic, it is not one that has been primarily a matter of Federal concern. The Commission does not recommend the adoption of specific regulations on this subject by Federal departments and agencies. Indeed, while recognizing the important role that the law has played in this area, the Commission does not look to the law as the primary means of bringing about needed changes in attitudes and practices. Rather, the Commission sees “informed consent” as an ethical obligation that involves a process of shared decisionmaking based upon the mutual respect and participation of patients and health professionals. Only through improved communication can we establish a firm footing for the trust that patients place in those who provide their health care. There are, nonetheless, several areas in which the Federal government can play a leading role. For example, it can ensure that the hospitals it operates and the professionals it employs take the steps recommended for all health care providers in this Report. Moreover, it can lend support--especially through the Department of Health and Human Services--to initiatives to develop, evaluate, and disseminate methods of improving the interpersonal side of health care, in line with the efforts that have advanced its scientific side. The Commission believes that this Report should be of interest to members of the public and of the health care professions, as well as to officials of the Federal government.