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The following blog was posted by Jennifer Rhodes, a partner at Ice Miller LLP.

In our fourth in a series of life science distinguished speakers luncheons we were privileged to have Dr. Eric Meslin Ph.D., Director IU Center for Bioethics, Associate Dean (Bioethics), IU School of Medicine, Professor of Medicine, Medical and Molecular Genetics, and Philosophy.  The topic was “What In The World does Ethics Have To Do With Health Research.”  Dr. Meslin’s point was not just to talk about the world but the people who are working in it, on it, for it and with it.

Dr. Meslin started out by telling the group that there is much more research going on in the world involving a collaboration of researchers from different countries and cultures, but the problem then becomes, who is reviewing the research and what ethical guidelines apply.  There is also a lot more money than ever before.  Studies show that between 1998 and 2003, global expenditures on health research have quadrupled, to about $125 billion.  By 2000, 70% of all clinical trials were funded by the private sector.  It's not simply the federal government or the pharmaceutical industry, but there are also public and private players, including large philanthropic players.

And yet the shift in the epidemiology of diseases is happening in economically developing countries just like it's happening here.  People who live in developing countries are not just dying of malaria, TB or HIV.  They die of heart disease, cancer and diabetes just as people in developed countries such as the U.S. do.  He pointed out that drugs are still too expensive, despite the efforts of many in the healthcare industry that donate drugs and have humanitarian aid programs.  And still, the Global Forum on Health Research coined the phrase the “10/90 Gap” which means that of all of the dollars spent on research in the world only 10% is going to diseases that affect 90% of the world's population.

This begs the question which was Dr. Meslin’s topic of discussion, what in the world does ethics have to do with health research?  And the answer is: all studies involving human subjects must receive prior science and ethics review.  He went on to state that despite the increased investment in research and development and international philanthropy, there is still a demonstrable inequity in access to benefits of research.  Which led to his next big question, are there universal ethical principles that apply irrespective of country or culture?  Bioethics has been working on this question for quite some time.  There are 17 articles in the universal declaration on bioethics and human rights.  But what do you do when they conflict?  Which one takes precedence over the other?  And what is really meant by each of them?

Collaborative research not exclusively, but especially between economically developed and developing countries requires some common set of ethics guidelines or procedures.  Not feeling that there was a single set of ethical principles, Dr. Meslin and his international colleagues have written a memorandum of understanding that is the first of its kind to describe the common principles that will be followed in their research and guide those relationships and activities.  The guidelines address the following issues: Who may be asked for informed consent?  What procedures will be in place to prevent exploitation?  When is it acceptable to use a placebo?  Where else is it acceptable to conduct studies that can feasibly be carried out in one’s home country?  Why is research conducted on some groups and not others? And how should any benefits be distributed?

Despite the significance of the guidelines, Dr. Meslin emphasized that there was still work to be done in order to make this document live and work.  Simply stated, they had to figure out what its limitations were, and this is what they realized, not only do cultural differences have a real impact on how people think about ethical issues in different countries, but economically developing countries are not necessarily ethically developing countries. He made the point that we should not be thinking that just because a country's GDP is lower than ours, that the people who are in that country are any less concerned about ethics, are any less concerned about how to carry out ethically relevant research and ethically consistent research.  The question of ethics in healthcare research is an ongoing one and will always be.