For a link directly to the NIH site, and the full document text, click the title above.
SUMMARY: The National Institutes of Health (NIH) is requesting public comment on draft guidelines entitled "National Institutes of Health Guidelines for Human Stem Cell Research" (Guidelines).
The purpose of these draft Guidelines is to implement Executive Order 13505, issued on March 9, 2009, as it pertains to extramural NIH-funded research, to establish policy and procedures under which NIH will fund research in this area, and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH procedures, consistent with Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH research involving human stem cells.
These draft Guidelines would allow funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose. Funding will continue to be allowed for human stem cell research using adult stem cells and induced pluripotent stem cells. Specifically, these Guidelines describe the conditions and informed consent procedures that would have been required during the derivation of human embryonic stem cells for research using these cells to be funded by the NIH. NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed under these Guidelines.
Showing posts with label NIH. Show all posts
Showing posts with label NIH. Show all posts
Thursday, May 21, 2009
Sunday, May 11, 2008
Clinical Competence or Electronic Medical Records?
It may seem unfair to ask: "do you favor clinical competence over electronic medical records"? But today, the United States doesn't have enough dollars to pay for health care for its entire population. Use of billions of dollars of scarce resources to pay for electronic medical records systems will divert money from training competent clinicians in evidence-based medicine and may have a detrimental effect on health care.
Pysician, nurse, and nurse practitioner training programs stress the mantra: show us the evidence for the diagnosis you make and the treatment you prescribe. Unfortunately, health systems administrators, insurers, politicians and others who control the flow of health care dollars are not required to show solid evidence supporting their rush to electronic medical records. The information technology industry claims superiority for its products. Politicians, bureaucrats and administrators wax enthusiastic about their chance to spend billions of dollars on technology which does not yet demonstrate patient health outcome superiority as compared to traditional paper records and systems. The issue isn't whether a computer generates a pretty report for a mid-level administrator; it is whether the patient lives or dies or suffers severe medically unnecessary complications or pain.
Citing two studies of handheld electronic medical record systems, a 2006 Canadian abstract did not find conclusive evidence of a net benefit from the use of the handheld medical record system. It did report an increase in the number of wrong or redundant diagnoses (http://www.biomedcentral.com/1472-6947/6/26/abstract downloaded 5/11/2008).
Crosson and others reported the effects of electronic medical records on diabetes care in an NIH funded study (http://www.annfammed.org/cgi/content/full/5/3/209 downloaded 5.11.2008). Statistical analyses demonstrated no evidence of an improvement in ultimate outcome. Surprisingly ". . . . patients with diabetes in practices that did not have an EMR were significantly more likely to have received care that met the guidelines for processes of care, treatment, and intermediate outcomes".
There is literature claiming that electronic medical records systems show a good return on investment (http://www.medicalnewstoday.com/articles/76786.php downloaded 5/11/2008). Where are comparable studies demonstrating that the money spent for such expensive systems show a net benefit to patient outcomes. Where is the answer to the mantra: show us the evidence?
Pysician, nurse, and nurse practitioner training programs stress the mantra: show us the evidence for the diagnosis you make and the treatment you prescribe. Unfortunately, health systems administrators, insurers, politicians and others who control the flow of health care dollars are not required to show solid evidence supporting their rush to electronic medical records. The information technology industry claims superiority for its products. Politicians, bureaucrats and administrators wax enthusiastic about their chance to spend billions of dollars on technology which does not yet demonstrate patient health outcome superiority as compared to traditional paper records and systems. The issue isn't whether a computer generates a pretty report for a mid-level administrator; it is whether the patient lives or dies or suffers severe medically unnecessary complications or pain.
Citing two studies of handheld electronic medical record systems, a 2006 Canadian abstract did not find conclusive evidence of a net benefit from the use of the handheld medical record system. It did report an increase in the number of wrong or redundant diagnoses (http://www.biomedcentral.com/1472-6947/6/26/abstract downloaded 5/11/2008).
Crosson and others reported the effects of electronic medical records on diabetes care in an NIH funded study (http://www.annfammed.org/cgi/content/full/5/3/209 downloaded 5.11.2008). Statistical analyses demonstrated no evidence of an improvement in ultimate outcome. Surprisingly ". . . . patients with diabetes in practices that did not have an EMR were significantly more likely to have received care that met the guidelines for processes of care, treatment, and intermediate outcomes".
There is literature claiming that electronic medical records systems show a good return on investment (http://www.medicalnewstoday.com/articles/76786.php downloaded 5/11/2008). Where are comparable studies demonstrating that the money spent for such expensive systems show a net benefit to patient outcomes. Where is the answer to the mantra: show us the evidence?
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