Ethics of human research.

I am by no means a card-carrying ethicist and when I received the formal request to speak at this meeting on the subject of ethics of human research I initially thought I would ask Drs. Hawes and Rattner exactly what they wanted me to cover, realizing that such a broad topic could be the subject of book chapters, entire conferences, and more. I did not pursue that thought but, given the limited time and perhaps my limited ability to engage you, I decided to focus on a few questions in this broad category which might be especially pertinent to a group such as this, devoted as you are to probing the depths–perhaps I should say scaling the heights–of innovation in the biotechnology of therapeutic intervention as it relates to the management of disorders that plague the human condition. My purpose is to raise questions more than to articulate rules, to express concerns rather than confirm precepts. I will speak of definitions, review some historical points about ethics, and discuss some principles that need to be developed as the field of NOTES goes forward. Why does this topic appear on a program such as this? Why in a clearly technology-driven conference should we delve into philosophy and social science, you might well ask? Well, for one, there is clearly current public concern about many areas of human research—from the uproar and guilt over the Tuskegee experiments on venereal disease among black males, cloning, stem cell research, and genetic manipulation. There is also anxiety over legal liability questions, university–industry relationships, conflicts of interest, intellectual property as well as the application of regulations—whether governmental, such as HIPAA or institutional, such as Institutional Review Boards. There is even an editorial in the June 2007 issue of Surgical Endoscopy whose authors state that the pursuit of NOTES and NOTES research could be regarded as unethical. It is therefore very important and timely for us to consider ethics in human research in the context of the introduction of new technology and new procedures in medical and surgical practice. To my surprise on preparing for this talk, while I was able to find a significant literature on topics in areas such as stem cell research and genetic manipulation, I could find practically nothing related to endoscopic minimal access intervention. If lawyers, nurses, chemists, anthropologists, and many others are discussing ethics in the context of what they do—why should not we? First, some definitions. Ethics— we can take Aristotle’s definition: the prevalent tone of sentiment of a people or community, or Webster’s definition: rules or standards governing the conduct of a person or the members of a profession. Consider, however, the more specific definition of medical ethics as found in Stedman’s Medical Dictionary, ‘‘the principles of correct professional conduct with regards to the rights of the physician himself, his patients, and his fellow practitioners. Modern attempts to articulate principles of medical ethical conduct all convey the laudable values of truthfulness, benefiting others, gaining respect of colleagues, reassurance and safety for patients as well as protection of practitioners from litigation and censure by legal and regulatory entities Presented at the 2nd International Conference on Natural Translumenal Endoscopic Surgery (NOTES), July 14, 2007, Boston, Massachusetts.