HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Robert M. Sade Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Sade, R. M. Search for Related Content PubMed PubMed Citation Articles by Sade, R. M. Related Collections Esophagus - cancer

Ann Thorac Surg 2003;75:325-328
© 2003 The Society of Thoracic Surgeons

---

Ethics in cardiothoracic surgery

Publication of unethical research studies: the importance of informed consent

^a Institute of Human Values in Health Care, Medical University of South Carolina, Charleston, South Carolina, USA

* Address reprint requests to Dr Sade, Department of Surgery, 96 Jonathan Lucas St, Suite 409, PO Box 250612, Charleston, SC 29425, USA.
e-mail: sader@musc.edu

The first 300 words of the full text of this article appear below.

Scientific research on human beings has been reported since the 18th century, when prisoners at Newgate were pardoned if they agreed to undergo variola vaccination (1721), and Edward Jenner began a series of cowpox vaccinations in children (1776) [1]. No ethical guidelines existed, however, until Thomas Percival wrote, in 1803: "... [I]t is for the public good... that new remedies and new methods of chirurgical treatment should be devised [emphasis Percival’s] ... And no such trials should be instituted without a previous consultation of the physicians or surgeons according to the nature of the case" [2]. Percival did not mention protecting the interests of human subjects. It was not until the 19th century that William Beaumont, writing about his classic experiments on Alexis St. Martin, expressed the view that research should be carried out only on subjects who voluntarily consented [3].

One of the earliest official guidelines for human research that required informed consent was promulgated in 1931: "Innovative therapy should be carried out only after the subject has unambiguously consented to the procedure in the light of relevant information provided in advance" [4]. It is an irony of the history of medical research that this statement was part of a broad, forward-looking research policy—the Reichgesundheitsrat Circular—developed in Germany. For it was the atrocious German human experimentation of the Nazi era that led to the Nuremberg Doctors’ Trial of 1946 and the resulting Nuremberg Code, the first international research guidelines. The Code consisted of 10 succinct principles. To emphasize the importance—indeed, the primacy—of consent, the very first line of the Code states, "The voluntary consent of the human subject is absolutely essential."

Recognizing the need for more detailed guidelines for medical research, the World Medical Association developed and approved such a document at its General Assembly . . . [Full Text of this Article]

This article has been cited by other articles:

				M. I. Block, L. M. Khitin, and R. M. Sade Ethical process in human research published in thoracic surgery journals. Ann. Thorac. Surg., July 1, 2006; 82(1): 6 - 11. [Abstract] [Full Text] [PDF]

				C. V. Fernandez Publication of ethically suspect research: should it occur? Int. J. Qual. Health Care, October 1, 2005; 17(5): 377 - 378. [Full Text] [PDF]

				K. Vahakangas Ethical aspects of molecular epidemiology of cancer Carcinogenesis, April 1, 2004; 25(4): 465 - 471. [Abstract] [Full Text] [PDF]