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Protection (Theoretical) Against Harm

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One of the most frequent questions asked by individuals who have read Lethal Decisions is, “Are there not institutional and government oversight committees that review the priorities for clinical research as well as the ethical and scientific standards that govern their conduct?” The answer is theoretically yes, but there are exceptions. Failures are many and some of them have been particularly egregious, resulting in the public apologies to those who have been wronged from US Presidents Clinton and Obama (Timeline of Ethics in Clinical Research, Ghosts of Tuskegee)

The official mission of National Institutes of Health (NIH) is, “…to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability.” NIH is composed of 27 different Institutes and Centers with individual research agendas and an annual research budget of more than $30 billion. The funds are allocated to intramural research (research conducted within and by NIH itself) and extramural research (research conducted by research organizations and individuals within academic institutions). With so much research conducted by large numbers of individuals, organizations, and academic institutions, and with such large amounts of funding devoted to clinical research, it is unfortunately relatively easy to identify specific research studies that fail to conform to the stated mission of NIH.

It is true that institutional review boards (IRBs) have been established to review, approve, and monitor clinical research involving humans but the sheer volume of new research protocols and the lack of expertise of individual IRBs to provide adequate ethical and scientific review assures that many clinical research protocols will be approved that violate ethical and scientific principles. (Are IRBs Uninformed About Informed Consents)

Since review boards are most often within the same institutions that are applying for research funds, and since they indirectly or directly benefit from the funds through overhead costs, there is an inherent conflict of interest in the approval process. The amount of money obtained from NIH for indirect (overhead) costs is significant reaching hundreds of millions of dollars for individual institutions and more than 5 billion total in 2013. The percentage of indirect costs range from 20% to as much as 103%.[1] It would be difficult to believe that this amount of money would not influence the approval process of clinical research. Added to the influence of the amount of funding is the influence of prestigious researchers and institutions.

All this is worrisome. Recently the priorities for deciding what clinical research is important and what research is duplicated or necessary have been called into question [2,3]. Further, some academics have questioned the validity of clinical research results indicating that many of the conclusions are false and cannot be replicated by other investigators [4]. Whether this is a new phenomenon related to large increases in the availability of research funds and/or the proliferation of research discoveries as a result has not been thoroughly analyzed. Regardless of the cause, increasing pressure is put on IRBs to modify the criteria for ethical standards to facilitate more rapid approval while at the same time ignoring the fact that many IRBs do not have the expertise to conduct an adequate scientific review [5]. (Institutional Review Boards, Are IRBs Uninformed About Informed Consents)

In Lethal Decisions we have identified specific instances where the scientific review and the ethical review of clinical research has failed and has resulted in exploitation of vulnerable women and children in poor countries. These have not reached a level of widespread public attention, and in spite of numerous attempts to obtain additional review by NIH, IRBs, and even the US Government Office of Human Research Protection, the insular nature of the current review process virtually excludes public scrutiny. Solutions are available, the most important of which are to avoid conflict of interest and ensure that the expertise of the IRBs is sufficient to provide credible ethical and scientific evaluation. Rather than the current institutional review board process it is likely that independent review boards, unaffiliated with the academic instruction seeking approval, will be required.

 

References

[1]    Ledford H. Indirect costs: keeping the lights on. Nature 2014; 515(7527): 326-9.

[2]    Begley CG, Buchan AM, Dirnagl U. Robust research: Institutions must do their part for reproducibility. Nature 2015; 525(7567): 25-7.

[3]   Begley CG, Ellis LM. Drug development: Raise standards for preclinical cancer research. Nature 2012; 483(7391): 531-3.

[4]    Ioannidis JP. Acknowledging and Overcoming Nonreproducibility in Basic and Preclinical Research. Jama 2017.

[5]    Faden RR, Beauchamp TL, Kass NE. Informed consent for comparative effectiveness trials. N Engl J Med 2014; 370(20): 1959-60.

Dr. Arthur Ammann's career has spanned many fields including physician, researcher, activist, advocate, philanthropist, Clinical Professor of Pediatrics and Global Health Sciences Affiliate at the University of California. Early in his 40-year medical career, Dr. Ammann discovered several new genetic immunodeficiency diseases and performed the clinical trials that resulted in FDA approval of the first pneumococcal vaccine which prevented bacterial pneumonia and meningitis. That discovery has led to the saving of millions of lives, especially of children and the elderly. In 1982, Dr. Ammann described two of the three ways that HIV is transmitted, including the first cases of transmission of AIDS from mother to infant and the first blood transfusion associated AIDS patients. 


Arthur Ammann has been featured in media outlets from Time Magazine to Frontline. He has authored over 450 scientific papers and book chapters, and authored three books. In addition to delivering national lectures and courses on ethics, immunology and HIV/AIDS, Dr. Ammann has taught in Africa, Asia, and South America. He has served with many organizations including the National Institutes of Health Advisory Committees, Congressional Testimony on AIDS and Children, AIDS Planning Committee of the Institute of Medicine of the National Academy of Sciences, and the Presidential Advisory Committee on AIDS Drug Development. Dr. Ammann has received honors and awards from more than 60 national and international organizations including the U.S. Surgeon General Award for Research, the U.S. Public Health Service Fellowship Award, the Heroes in Medicine Award by the International Association of Physicians in AIDS Care, Purpose Prize Fellow Encore Career, the Humanitarian Service Award from Wheaton College and the Outstanding Alumnus Award from New Jersey College of Medicine.


In addition to his book Lethal Decisions, Dr. Ammann is also the author of Women, HIV, and the Church - In Search of Refuge and (in)Visible. From Obscure to Valuable.


His blog Ethics in Health was established to uncover and discuss ethical concerns that are all too frequently obscured by the Academy.

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