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Medical Research and Human Subjects

 

As with many well-intentioned efforts in the field of health care the legitimate concerns about protecting the rights and welfare of human subjects participating medical research have now assumed a life of their own.

Until the mid-part of the 20th century concerns regarding medical ethics basically related to therapeutics with little attention being directed to medical research.  This changed dramatically in 1946 when 20 high-ranking Nazi physicians were placed on trial in Nuremberg, Germany and charged with war crimes against humanity for performing experimental procedures on human beings without their consent.  With the publication of "The Plutonium Files" by Eileen Welsome in 1999 the citizens United States finally became aware of similar human experiments on unknowing hospital patients in the 1940s in our own country.  The Nuremberg trials verified society's need for fundamental ethical standards in the conduct of research involving human subjects.  The creation of the Nuremberg Code reflected this need.  This Code was subsequently incorporated into the Declaration of Human Rights of the United Nations.

In the United States, in 1953, the Nuremberg Code served as the impetus for the National Institutes of Health (NIH) to produce the first federal policy for the protection of human research subjects.  Efforts by the World Medical Association and the World Health Organization subsequently led to the 1960 Declaration of Helsinki which was adopted by the World Medical Society in 1964.  Its recommendations on biomedical research and the use of human subjects was updated in 1975, 1980, and 1989.

In 1966, Henry Beecher, physician-researcher from Harvard University and, in 1967, Maurice Pappworth, physician-ethicist from England issued intelligence documenting that significant abuses existed in the conduct of research involving human subjects at many of the leading medical research institutions in America and Britain.  These, and other, revelations regarding violations in the ethics of research led the United States Congress, in the 1970s, to bring pressure on the (then) Department of Health, Education and Welfare (HEW) to generate federal regulations and to create a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.  One of the results of this was the publication, by the Commission, of the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.

At the "grass roots" level these activities led to the creation of Human Subject Research Review Committees at medical facilities throughout the United States.  These Committees were originally organized for the expressed purpose of protecting the rights and welfare of patient participants in medical research projects and to make sure that informed consent existed.  These Committees, ostensibly composed of peer physicians, scientists, and consumer representatives,  have, over the years, also become progressively involved in additional areas of inquiry including:


Review of the Research Project
Quality Assessment of the Research Protocol
Determination of Investigator Integrity
Determination of Real or Potential Researcher Conflict of Interest
Disclosure of Real or Potential Conflict of Interest by Participating Parties
 

There can be no question but that the need to protect the rights and welfare of the human subject participants in medical research is paramount.  The Burton Experience has been that the role of the Institutional Human Subject Research Review Committees has changed over he past 2 decades.  While their concern has remained the welfare of the patient they have become distracted by the increased scope of their overview and their own importance.  Part of this is reflected in their change of name to: Institutional Review Board (IRB).

As IRBs involvement in assessing research protocols has become so involved that it has become, in many cases, a serious liability to the performance of the research itself.  This is particularly true when the research is inherently safe offering minimal (if any) risk to the human subject.  Those types of research requiring the more stringent overview, i.e. those involving high risk to the human subject are frequently "short-schrifted" because of valuable time wasted on other, relatively meaningless, discussions.  There are now many talented researchers, performing important scientific studies who are totally frustrated by the frivolous delays in their work created for them by IRB committees and boards.  This is a important issue.  It deserves attention.  Better review criteria and guidelines are needed.