Dr Tom Kerns
North Seattle Community College

 

Jenner On Trial

Tom Kerns

 

 

 

 

Chapter 3

 

Edward Jenner comes alive

Or rather, I have given the impression of bringing him back to life, for purposes of a case study. I have chosen to dramatically bring Jenner and his work back to life right at the point when he would have had to present his proposed research to an ERC for approval. I have done this by means of a modest theatrical performance which entails a bit of costuming and a good bit of audience involvement. In the course of this presentation, audiences, or classes, or even memberships of real, working ERCs, are asked to imagine that they have been constituted as an ERC, that they are located in London in April of 1796, that their ERC is affiliated with the Royal Society, and that Dr Jenner has filed application materials with them, requesting their approval of his proposed cowpox inoculation experiment. I then explain, in more or less detail (depending on the audience) what guidelines they should use in their ethical review of Jenner's protocol. I introduce them to the WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (approved and promulgated by WHO in 1993), and ask them to use these Guidelines as their primary ethical standard. I ask them to also use their plain good sense in discussing and reviewing his proposed experiments.

At this point, after some questions and discussion, and after reminding the audience that they now have the character, the charge, and the responsibilities of an ERC, with power to approve or disapprove this proposed research, and after thanking them for their generosity in offering to serve on this committee, I introduce them to Dr Edward Jenner.

Here, Dr Jenner (i.e., Dr Kerns in costume) rises from his chair and (in an approximation of an 18th century physician's dress, and with a modest British accent) addresses the committee. He thanks them again for their time, he reminds them of the grievousness of the scourge of smallpox by recalling some features of the disease and showing them some photographs of sufferers, and he reminds them of the seriousness of their deliberations today. He reminds them that many thousands of millions of lives will be affected by the decisions they make today. He then reviews with them his application forms for ethical review, materials which have been included in the next section of this book.

For the remainder of their time together, then, Dr Jenner presents his background research and observations, articulates his theory that deliberate infection with the cowpox will protect persons against ever contracting the smallpox, and he proposes the experiment he wishes to perform in order to test his theory. The committee is then free to ask him questions, to probe for details about informed consent, about potential harms and benefits, about comparisons with the current standards of treatment, and so on. (The committee is also free to sometimes turn to the other empty chair in front of the room and address questions to Dr Kerns, at which point I temporarily step out of character, respond to the question as Dr Kerns, and then return to being Jenner.)

Toward the end of their deliberations, the committee must then vote to either approve, approve with conditions, or disapprove Jenner's proposed experiments.

Regardless of what the final vote of the committee turns out to be in these deliberations, when committee members ask their questions of Jenner and Kerns, they invariably raise many of the key ethical quandaries that beset all of those who sit on today's ERCs in real life. They raise questions about vulnerable subjects, and whether they are being taken advantage of, questions about how to weigh the risks inherent in doing the research against the risks inherent in not doing the research, questions about how to assess benefits (particularly in vaccine trials where all the subjects are healthy), questions about how much preliminary research is adequate, and questions about how best to insure the protection of all the volunteering subjects. The audience/committees also soon become aware that many of the issues they raise in relation to Jenner's research are the same issues that will also need to be raised with proposed HIV vaccine trials, as well as with proposed malaria, tuberculosis, and other vaccine trials.

Jenner's imagined application materials are included in the next chapter, and are done onto a modern 1990s ERC application form. It thus includes questions about virtually all the matters which most of today's ERCs need to consider before they can do an ethical review of a proposed protocol. His application materials also include a proposed consent form for the principal investigator to sign and for each consenting subject to read and sign.

As you study the following application materials, you might try to imagine that you are a member of an ERC in London in 1796, and that you are being asked to pass judgment on, i.e. (to approve or disapprove) the ethical worth of Jenner's proposed experiment. In doing this, you will be placing yourself at the very center of one of the original moments in biomedical research. As Rothman explains:

Human experimentation made its first significant impact on medical knowledge in the eighteenth century, primarily through the work of the English physician Edward Jenner...and his research on a vaccination against smallpox.

Perhaps what we learn here with the earliest vaccination experiments can also be instructive in our understanding of present day vaccination experiments, particularly those for HIV vaccines.

There were, of course, no ERCs in Jenner's time, since these bodies have come into existence only in the latter half of the 20th century, but many of the values embodied in today's ethical guidelines for human subjects research are values that were just as prevalent in Jenner's time in England as they are today - even if they were not as clearly articulated then as now. Because of this, an ethical review of Jenner's proposal will also be helpful in clarifying some of the issues that face today's ERCs when they are asked to do an ethical review of any of today's proposed vaccine trials.

Dr Jenner's formal application materials for ethical review would probably have looked something like those in the next chapter.

 

Jenner homepage and Table of Contents
preface | Introduction | chp 1 | chp 2 | chp 3 | chp 4
cchp 5 | chp 6 | chp 7 | chp 8 | App I | App II
Ethical Issues in HIV Vaccine Trials