Belmont Revisited: Ethical Principles for Research with Human Subjects
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《新英格兰医药杂志》
On July 12, 1974 — one month before he resigned in response to the Watergate scandal — President Richard Nixon signed the National Research Act, which Congress had passed in response to another scandal that was also linked to a place name: Tuskegee. This law created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged with various investigative and deliberative duties, including a statutory responsibility "to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects."
Several months and 15 meetings into their deliberations, the members of the commission and a few advisors retreated to Belmont House (an 18th-century estate in rural Maryland maintained by the Smithsonian Institution as a conference center) for a long weekend to identify "basic ethical principles" for research involving human subjects. The final product of this gathering was published after three years — and considerable additional discussion — as "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research," which was first published in the Federal Register on April 18, 1979. The report was purposefully brief, and its three basic ethical principles and concomitant applications can be stated with almost mathematical precision: "respect for persons" relates to "informed consent," "beneficence" relates to "assessment of risk and benefits," and "justice" relates to "selection of subjects." Bioethicists generally agree that this report was and is a foundational document in the national and international development of research ethics.
The essays in this book, Belmont Revisited, arose from a 1999 conference held to commemorate the 20th anniversary of "The Belmont Report." Although this book was published six years after the conference, the time seems to have been well spent. The editors — who were associated with a more recent federal bioethics panel, the National Bioethics Advisory Commission — have done an exemplary job of organizing 15 essays into an unusually cohesive whole. The essays are augmented with several elements that enhance the value of the book: insightful introductory and concluding pieces that help frame the various contributions, a detailed subject index (which is missing from many edited collections of essays), and "The Belmont Report" reprinted in the appendix.
Most of the essays in Belmont Revisited discuss the various perceived strengths and weaknesses of "The Belmont Report." These pieces are generally thought provoking, but some of the language verges on the philosophically arcane. Historians like me have a reputation for impatience with philosophers, but I suspect that many readers would share my occasional difficulty with discussions that include terms such as casuistry, commensuration, and consequentialist. My chief disappointment with this book is that no historians are included among the contributors. A few pieces are historically oriented, but they are written by participants who reflect on a past they personally experienced. This is a valuable genre, but it is not quite history.
I put on my historian hat for a half hour and did a little research with the use of a newspaper database. I searched for the phrase "Belmont Report" in the New York Times, the Washington Post, and the Wall Street Journal and found only the 2002 obituary in the New York Times for the chair of the National Commission, Kenneth Ryan. I found no information when I searched for "Belmont principles." I then did a combined search with the words "respect" (or "autonomy"), "beneficence," and "justice." I found only three articles related to bioethics that contained all these words — and none made reference to "Belmont." When I searched for articles that included the word "human" and variations of the words "experiment" and "ethics," the database produced more than 1000 hits. Since 1979, it seems that the press has been giving considerable coverage to the ethical aspects of research with human subjects, but, as compared with discussions among bioethicists, it seems less clear that "The Belmont Report" or its principles have entered the realm of public discourse.
I would need to wear my historian hat for much longer than a half hour (and I would need to take it off and scratch my head several times) to fully explicate this preliminary research. However, it strikes me as a worthy project for someone. Perhaps "Belmont" should be revisited — again.
Jon M. Harkness, Ph.D.
University of Minnesota
Minneapolis, MN 55455
harkn008@umn.edu(Edited by James F. Childr)
Several months and 15 meetings into their deliberations, the members of the commission and a few advisors retreated to Belmont House (an 18th-century estate in rural Maryland maintained by the Smithsonian Institution as a conference center) for a long weekend to identify "basic ethical principles" for research involving human subjects. The final product of this gathering was published after three years — and considerable additional discussion — as "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research," which was first published in the Federal Register on April 18, 1979. The report was purposefully brief, and its three basic ethical principles and concomitant applications can be stated with almost mathematical precision: "respect for persons" relates to "informed consent," "beneficence" relates to "assessment of risk and benefits," and "justice" relates to "selection of subjects." Bioethicists generally agree that this report was and is a foundational document in the national and international development of research ethics.
The essays in this book, Belmont Revisited, arose from a 1999 conference held to commemorate the 20th anniversary of "The Belmont Report." Although this book was published six years after the conference, the time seems to have been well spent. The editors — who were associated with a more recent federal bioethics panel, the National Bioethics Advisory Commission — have done an exemplary job of organizing 15 essays into an unusually cohesive whole. The essays are augmented with several elements that enhance the value of the book: insightful introductory and concluding pieces that help frame the various contributions, a detailed subject index (which is missing from many edited collections of essays), and "The Belmont Report" reprinted in the appendix.
Most of the essays in Belmont Revisited discuss the various perceived strengths and weaknesses of "The Belmont Report." These pieces are generally thought provoking, but some of the language verges on the philosophically arcane. Historians like me have a reputation for impatience with philosophers, but I suspect that many readers would share my occasional difficulty with discussions that include terms such as casuistry, commensuration, and consequentialist. My chief disappointment with this book is that no historians are included among the contributors. A few pieces are historically oriented, but they are written by participants who reflect on a past they personally experienced. This is a valuable genre, but it is not quite history.
I put on my historian hat for a half hour and did a little research with the use of a newspaper database. I searched for the phrase "Belmont Report" in the New York Times, the Washington Post, and the Wall Street Journal and found only the 2002 obituary in the New York Times for the chair of the National Commission, Kenneth Ryan. I found no information when I searched for "Belmont principles." I then did a combined search with the words "respect" (or "autonomy"), "beneficence," and "justice." I found only three articles related to bioethics that contained all these words — and none made reference to "Belmont." When I searched for articles that included the word "human" and variations of the words "experiment" and "ethics," the database produced more than 1000 hits. Since 1979, it seems that the press has been giving considerable coverage to the ethical aspects of research with human subjects, but, as compared with discussions among bioethicists, it seems less clear that "The Belmont Report" or its principles have entered the realm of public discourse.
I would need to wear my historian hat for much longer than a half hour (and I would need to take it off and scratch my head several times) to fully explicate this preliminary research. However, it strikes me as a worthy project for someone. Perhaps "Belmont" should be revisited — again.
Jon M. Harkness, Ph.D.
University of Minnesota
Minneapolis, MN 55455
harkn008@umn.edu(Edited by James F. Childr)