Rembrandt "The Corpse"

An Economist commentary entitled “To He that Hath” reviews a study published in the journal Nature called “Conform and Be Funded” that discusses who does and does not get funded by NIH. It raises an issue of fairness in funding. But does it also raise an ethical issue?

The National Institutes of Health (NIH) is the world’s largest research institution with a current annual budget of $40 billion per year. Between 2002 and 2011 NIH funded approximately 460,000 grants for over $200 billion and in the process contributed to the discovery of new diseases, new treatments and new means of preventing some of the most lethal and devastating diseases known to mankind.  Why then raise any questions?

In spite of the success of clinical research, with such large sums of money available, it is important to provide close scrutiny as to who receives the money and what kinds of research are conducted. With so many grants provided to thousands of research investigators it is also difficult to provide the proper oversight to ensure that all research conforms to the highest principles of science and ethics. One danger is that the authority to approve research grants is placed in the hands of a relatively small number of individuals who with time, favor a particular type of research, or overlook scientific and ethical principles in the research that is being proposed.

Broadly speaking, research priorities are determined by NIH study sections consisting of scientists who are selected for their expertise and experience. However the analysis by Ioannidis and Nicholson suggests that high impact researchers (researchers whose research is widely quoted) who are not part of the study sections, receive less NIH funding. They postulate that this may mean that either study sections favor research performed by their existing members or that they recruit members who have research interests similar to themselves. If this were true then there is a clear conflict of interest. While their study results are controversial they deserve consideration.

However, there may be other reasons for basis and if true, would be quite disturbing given the extraordinary large amount of funding that is entrusted to NIH each year and one that would raise some ethical concerns. It is possible that high-impact scientists have more stringent scientific and ethical criteria for the conduct of research studies, as well as specific opinions on what research is of highest priority for the benefit of mankind. Their opinions may conflict with study section member’s opinions. Since the views of these scientists are publicly known it would be easy to exclude those who might dissent , allowing less qualified studies to be approved.

We became suspicious that this might be a possibility following the publication of an article evaluating an experimental antibody preparation obtained from HIV-infected individuals to determine whether it could reduce HIV transmission from HIV infected mothers to their infants. The problem was that a similar study had been discontinued in the United States years earlier. Further studies could not be conducted in the US because of scientific and ethical concerns by many scientists. In spite of objections from these highly credible scientists, who were not on the study sections and did not have the opportunity to review the research protocol, the study went forward in Africa enrolling vulnerable HIV-infected women and their infants. Based on this study and others, it is clear that there are problems in the research approval process at the NIH. ( See previous post: “Who will protect vulnerable populations from research exploitation?“)

If certain scientists are excluded from study sections and from review of clinical research protocols how extensive is the problem? With the levels of research funding at risk in an unstable US economy NIH needs to demonstrate that they are capable of using existing funding responsibly by establishing sound criteria for priorities given to research as well as credible review of the quality of the science and ethics involved in conducting the research.

References

Conform and Be Funded  NATURE Volume 492, Dec 6, 2013

Who will protect vulnerable populations from research exploitation? ethicsinhealth.org, December 2011