By: Varun Sethi, MD, PhD
Technology and Medical Ethics
AMA Tackles Ethics of Telemedicine
A report by the Council on Ethical and Judicial Affairs (CEJA) was recently supported at a reference committee hearing but failed to get approval from the American Medical Association (AMA) House of Delegates. This report recommended that physicians providing clinical services via telemedicine must uphold the standards of professionalism as expected in in-person examinations, and be cognizant of the limitations of relevant technologies.
Some of the concerns were about parts of the recommendations dealing with informed consent. A delegate of the American College of Radiology (ACR), Todd M. Hertzberg MD, explained that there were scenarios in context of teleradiology and telepathology where in the process of informed consent was not in place and/or was less specific. A delegate from Texas, Arlo F. Weltge, MD, PhD, MPH, agreed that telemedicine is emerging as being clearly important, but expressed concern about a current case where in the Texas Medical Board was being sued for an interpretation. Weltge explained that the interpretation of the AMA code on telemedicine ethics could imply that, “anybody can set up a remote station and prescribe medications and, if you will, become an internet pill-mill.”
Other delegates supported the code and emphasized that Telemedicine is the future, and the future is here! Nonetheless, there is a strong need for ethical guidelines and these are needed as a priority. (Sarah Wickline Wallen, MedPage Today)
Biomedical Research Funding
Study claims $28 billion a year spent on irreproducible biomedical research
Economists report that the exorbitant amount of $28 billion is spent each year on irreproducible preclinical research in the United States. By reviewing literature for over two dozen studies, economists estimated that about 53% of preclinical studies have errors and are thus not reproducible. The source of these ‘errors’ varied from problems with reagents and reference materials (36%), problems with study design (28%), errors in data analysis and reporting (25%), and laboratory protocols (11%). With an estimated 56 billion dollars spent by NIH and US public and private funders, ~ 50% of this total (i.e. 28 billion dollars) was used for ‘irreproducible research’.
While the NIH has issued new criteria to strengthen the reproducibility of funded research, the authors of this report suggest that irreproducible research is not necessarily a ‘waste’. They emphasize that investment should be increased, with a relatively small part dedicated for improving the reproducibility rate of research. Other strategies include improving training researchers in the realms of study design, and stressing the use of validated reagents only etc. Microbiologist Ferric Fang is concerned about the possibility to extrapolate findings from a few studies. Calling this report ridiculous and unhelpful, Fang stressed that an irreproducible result does not imply that the original result was incorrect. (ScienceInsider)
Research and Collaboration Policy
Funders must encourage scientists to share
Following the precedent established by the Human Genome Project, researchers and scientists agree that it is important to share large data sets (e.g. genomics, epidemiology, population level health), in order to realize the full potential and maximize benefits of that data. A recent survey reported that both the providers as well as those who use the shared data, are frustrated with the data-access process. Access protocols are very specific and tailored to different studies, augmenting the administrative burden.
An expert advisory group has published recommendations to aid researchers. They suggest that data access plans must be incorporated into the grant application process. Funders should be encouraged to standardize the process, allowing for flexibility of individual study characteristics; access procedures should be transparent, straightforward and allow for an independent appeal process to settle disputes. Participants in studies can also be protected better if data access provisions are planned at the onset, e.g. permission to share de-identified data could be incorporated in the consent form. To encourage scientists to contribute to data sharing, rewards could also be used as a motivation, the group suggested.
To protect the providers of data, it is also important to allow for justifiable restrictions for hard earned data sets. The group stressed the need for a clear explanation of the conditions imposed. Significant breaches of data/ material transfer agreements should also be treated seriously so as to act as a deterrent to such practice. In an era of international and collaborative science, scientists need to be encouraged to volunteer to share data and must also be made to feel protected. (Martin Bobrow, Nature Column: World View)
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