As tissue samples and DNA are shared more widely than ever, scientists and federal agencies are looking closer their responsibilities towards research subjects. Last Thursday, a National Institutes of Health (NIH) advisory committee has rejected a request to use 47 lines in research on human embryonic stem cells funded by the federal, saying donors had given too many rights. Moreover, researchers of a new DNA-based project's Hospital Boston Children planning to tell families about relevant findings to their own DNA. This information is traditionally not shared because it is easier to anonymize samples and not to worry about the findings are relevant for patients.
The NIH decision stems from an ongoing review triggered by the new guidelines from the Obama administration that were announced last spring. Among other things, the NIH requires that embryos that were brought to new cell lines were created by in vitro fertilization and no longer needed, and that couples gave informed consent for their use in research. So far, 67 new lines have been approved and 101 are under consideration, with 234 more in the pipeline.
The sort that lines the NIH-funded investigators can work and do not make the cut falls to a committee of ethicists and researchers. There is "a lot of work," says Landis history, director of the National Institute of Neurological Disorders and Stroke and the head of the NIH Stem Cell Task Force.
At a meeting last week of the Advisory Committee to the Director of NIH, Jeffrey Botkin, an ethicist at the University of Utah and the committee chairman, said that 47 of the 53 lines recently considered were deemed ineligible for federal funding. All were provided by the reproduction Genetics Institute (RGI) in Chicago, Illinois that specializes in helping couples who carry genes for rare diseases create healthy embryos can then be implanted. Indeed, 42 lines performed genetic defects, a trait that the NIH Director Francis Collins noted would have made interesting to study.
But the group Botkin blocked all 47 because "donors seem to be asked to give up the right to sue" in the form of informed consent, they signed. This clause constitutes a "language exculpatory" in which subjects have given up substantial rights, and NIH does not allow it in the stem cell lines. Botkin said RGI could return to the embryo donors and seek fresh consent. But in an article USA Today , a scientist at the clinic said it would be impossible for lines that date as far back as 03.
The Gene Partnership Project Hospital Boston children takes a different approach. The project will look at how genes and environment interact to drive the disease in children is different from its predecessors, said Kenneth Mandl, a physician and biomedical informaticist, and one of the project leaders childhood. "We took the decision not to go with a standard, lightweight consent" form that often comes with the gift DNA sample, he said. In these cases, the data is stripped of identifiers; if researchers find a gene that increases the risk of schizophrenia by 3%, for example, they do not have to worry about the possible impact on participants.
The Gene Partnership Project will weigh all kinds of questions, says Mandl. A committee is now considering the conclusions of which could be "relevant" to patients and therefore should be shared. The back and forth works in both directions: While researchers working on the samples will not know who they belong to, those running the project will confer with participants regularly to collect more data on their health, request samples additional or request their participation in the investigations. With most of biobanks, Mandl said, "If someone comes with a diagnosis of asthma, but four years later develops heart disease ... this person will be labeled with a diagnosis of asthma, but not heart disease. " However, he said, the record of each participant in the Boston effort will continue to evolve.
The project so far has collected hundreds of samples. At the end of the year, he hopes to be adding more than 800 samples per month.
0 Komentar