benefits of stem cell research on spinal cord injuries at a neuroscience conference at the Massachusetts Institute of Technology in Cambridge. (Wikimedia Commons/Mike Lin)
The Reeve Foundation invests its research dollars in six areas: neuroprotection, regeneration (axon growth, remyelination, inhibition), cell transplantation (including stem cells), rehabilitation, secondary complications, and therapy delivery and clinical trials. At more than $30 million, therapy delivery is the most heavily funded area, accounting for about 27 percent of the total. Cell transplantation (including stem cell research) receives less than 10 percent of the total funding. Therapy delivery includes epidural stimulation, which, in groundbreaking progress between 2009 and 2013, allowed four young men, at least two years post-injury, to recover movement in their legs, hips, ankles, and toes and improve their overall health and sense of well-being.
By the conclusion of the study, all four men were able to bear weight independently. Park Lu, a California spinal cord injury scientist, was lead author of a 2012 paper that reported a modest but meaningful advance in growth above and below a complete lesion in spinal cord–injured animals, using stem cells as a bridge. Lu is an exceptionally motivated researcher. His focus was redirected into the field after he suffered a spinal cord injury in an automobile accident. Both these studies were funded in part by the Reeve Foundation. The legacy of Christopher and Dana Reeve survives in the research and outreach of the foundation that bears their names.
Wylene Rholetter
Auburn University
See Also: Advocacy; Clinical Trials, U.S.: Spinal Cord Injury; Spinal Cord Injury.
Further Readings
Christopher & Dana Reeve Foundation. http://www.christopherreeve.org (Accessed May 2014).
“The Good Fight.” New Scientist, v.177/2386 (2003).
Winter, Judy. “Honoring Special Needs Excellence.” Breakthrough Parenting for Children With Special Needs: Raising the Bar of Expectations. Hoboken, NJ: Wiley & Sons, 2006.
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Clinical Trials, Ethics of
Clinical trials are of the utmost importance in the development and continued monitoring of new drugs entering the market, to ensure their safety and efficacy in improving human health. Although extensive experimentation in the lab and in animal models of human disease takes place prior to clinical trials, trials on human patients are a necessity to determine whether the new approach will work well in humans, and often in what group of people and in what combination with other drugs (if any). Because the treatments being administered to volunteer patients are for the first time being tested in humans, various mechanisms must be in place to protect those volunteers as much as possible. Failure to do so can lead to abuse and unfair maltreatment of patients, which is why strict regulations are in place for clinical trials to ensure ethical treatment of volunteer patients.
For clinical trials to be ethical, there must be informed consent, internal review board (IRB) review, and compliance with regulations based on influential historical events that are now used as guidelines, having been developed in response to problems or concerns in practice. An example of these regulations is the Code of Federal Regulations, Title 45 Volume 46 (45 C.F.R. 46, issued by the U.S. Department of Health and Human Services, which governs federally funded research in the United States). The historical events that led to the original establishment of ethical regulations in clinical trials are in part documented and based upon well-respected, influential documents known as the Nuremberg Code, the Helsinki Report, and the Belmont Report. The seven main principles of ethical clinical research that today guide the conduct of ethical clinical research and trials are based on these documents.
The Nuremberg Code
The Nuremberg Code was created after World War II, following the Nuremberg Trials, with the goal of protecting human rights and patients in clinical research. During World War II, extensive human experimentation was conducted by the Nazis (National Socialists) in Germany. These experimentations were exposed during the Nuremberg Trials of 1947 and resulted in a code of ethics, which set “standards to which physicians must conform when carrying out experiments on human subjects.” The code of ethics was called for, taking into account that several of the accused in the “Doctors’ Trials” presented arguments that their medical experimentations differed little from those conducted by others in the United States and elsewhere, prior to World War II.
One such example brought up by the trial defendants was the Stateville Penitentiary malaria experiments that took place in Illinois in the United States. The nominated medical adviser to the Nuremberg Trials, Andrew Ivy, had firsthand knowledge of these experiments. The defendants furthermore argued that there was no law differentiating between what is and is not allowed, and therefore they had committed no legal crime. Based on this, six main points defining what is and is not legitimate medical research were presented to the Counsel for War Crimes by Leo Alexander. The results of the trial itself reiterated these points and included the addition of four more points in the verdict in a section titled “Permissible Medical Experimentation.”
Key roles in the analysis of the ideas and shaping of medical research ethics, born from the trials, were played by American neuropsychiatrist Leo Alexander, German psychiatrist Werner Leibbrand, and American physiologist/medical historian Andrew Ivy. Ivy is recorded as stating during the trials that there is “no justification in killing five people in order to save the lives of five hundred” and citing the Hippocratic moral maxim in that “what refers to the Hippocratic oath is that he must have respect for life and the human rights of his experimental patient.” Together, the 10 points became the basis of the 10 principles of the Nuremberg Code, although no specific findings from the trials were included.
The principles called for informed consent, absence of coercion, well-thought-out and planned scientific experimentation, and benefits to the participants in the clinical research. In general, it was argued that the ethics of human experimentation should be in conformation with the ethics of the medical profession and the Hippocratic oath, but that more was necessary to protect human subjects participating in clinical research, hence bringing forth the Nuremberg Code of ethics.
The 10 principles of the Nuremberg Code were adapted and expanded upon in the Declaration of Helsinki. While the Nuremberg Code protects the human rights of clinical research subjects, the Declaration of Helsinki focuses on the obligations of the physicians to the participants. Probably the most important of these is that participation by the human subject in experimentation must be by voluntary consent (changed in the Declaration of Helsinki to also include consent by the legal guardian when the subject is legally incapacitated). The Nuremberg Code was pivotal in changing what constitutes good and ethical conduct of clinical research.
The Helsinki Report
Also known as the Declaration of Helsinki, the Helsinki Report is a cornerstone document on the ethics of human clinical research, developed by the World Medical Association (WMA) in 1964, with seven revisions, the latest and only official version of which can be found at the WMA’s website (http://www.wma.net/en/20activities/10ethics/10helsinki/index.html).
