When a scientist at a University wishes to do an experiment involving human beings, he must first write a proposal describing what will be done and submit the experimental protocol to an Institutional Review B0ard (IRB). The IRB evaluates the proposal to make sure that the rights and safety of the human subjects are protected. The odious human experiments conducted by the Nazis during World War II and the Tuskegee Syphilis experiments conducted by the US Public Health Service are two examples of egregious violations of human rights that motivated the formation of IRBs.
The ethical principles that guide IRBs derive from the Belmont Report:
The three fundamental ethical principles for using any human subjects for research are:
- (1) respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent;
- (2) beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; and
- (3) justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits to potential research participants.)
The Director of the CDC, Thomas Frieden, has in his possession a document, the Director’s Update Brief novel 2009 H1N1Friday 17 JUL 2009 0815 EDT Day 90 Week of State Planning for the Fall, indicating that the case fatality rate for the new H1N1 virus for 25 – 49 year olds is 1.5% and for 50 – 64 year olds is 3.3% (page 29). These are 1918, severe pandemic numbers. Although the quoted overall case fatality rate in the US is much less than this, the same document indicates that only 6.3% of the total cases were in 25 – 49 year old range and 3.6% in the 50 – 64 age range (page 25). This was because most of the early cases in the US were children who were infected in schools and summer camps. In the fall and winter, the CDC and others expect that the virus will infect all age groups in much greater numbers. Thus, the overall case fatality rate is almost certain to increase.
The CDC provides the epidemiological data that all other government agencies, at the federal, state and local levels use for determining public health policy. Further, the general public has been told, many times, to rely on “trusted sources” like the CDC for information about the pandemic. Has the CDC provided other government agencies with the same information the Director had on July 16, 2009? We don’t know about the federal government, but there is no evidence that State governments were given this information. The public is completely unaware of the risks to middle-aged adults.
We are about to embark on a grand experiment involving hundreds of millions of Americans. The choices made by governments and individuals will have life or death consequences. Should schools stay or open or be closed? Should people begin to work at home? Should health care workers have respirators or surgical masks? In every case, the CDC has taken the position that the less protective option is the correct one. How many people in possession of the Director’s Brief from July 16, 2009 would agree that the CDC’s policies were appropriate given the available data?
Has the CDC and the Federal Government obtained informed consent from the American people for its policies?
Are the risks to the public minimised by the policies of the CDC?
Are the procedures the CDC is advising well-considered and fair to the American public?
If someone proposed an experiment that exposed otherwise healthy people to the same degree of risk that American teachers, health care workers and parents are about to be put in by keeping schools open at all costs, I think it is likely that an IRB would forbid the experiment.
They might also wonder what was going in the mind of the Principal Investigator.
What is going on in your mind, Director Frieden?