Timothy Caulfield, professor and research director of the Health Law Institute at the University of Alberta in Canada, led a consensus workshop to develop rigorous guideline recommendations for research ethics boards. The results appear in the current issue of PLOS Biology (March 2008).
Researchers met to develop these recommendations because national and international funding initiatives have substantially increased whole-gene research activities, and media coverage of both the science and the emerging commercial offerings related to human-genome research has heightened public awareness and interest in personal genomics, says Caulfield.
Yes, these are early days in the field of human-genome research, but research ethics guidance is needed immediately, said Caulfield. With how fast this research is growing, it is necessary that we develop carefully considered consensus guidelines to ensure ethical research practices are defined for all.
Some key recommendations of the paper include the right for participants to withdraw consent (which includes the destruction of tissue samples and written information); the issues associated with participants' family members and relevant groups; and the means of obtaining clear consent from participants for possible future use of their genes.
As technology continues to advance, whole-genome research activities seem likely to increase and expand, says Caulfield. As the pace of this research intensifies, we need to continue to explore the ethical, legal and social implications of this rapidly evolving field.
The researchers note that the policy recommendations covered in the report are not the only issues that need to be considered. Commercialization, patenting, benefit sharing and the possibility of genetic discrimination are among other topics that warrant discussion in the future.
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In every subject, and with each test that we performed, our results supported the idea that PiB binds almost exclusively to beta-amyloid, which means that we can, with confidence, look to PiB to indicate the troublesome beta-amyloid deposits in brains of living patients, said the lead author Milos Ikonomovic, M.D., assistant professor of neurology and psychiatry at the University of Pittsburgh.
This patient who selflessly and generously agreed to PiB PET scanning and who gave us the gift of her brain has enabled us to compare what we detected during her life to what we confirmed after her death. The findings from our study of her brain, coupled with the further confirmation of the other 27 brains, tell us without a doubt that PiB binds to beta-amyloid and that it is a reliable indicator of the presence of Alzheimer's disease in those who are suffering its cruel effects, said Dr. Klunk.
This work is an important step forward in the development of new tools for both research and clinical care, noted Neil Buckholtz, Ph.D., chief of the Dementias of Aging Branch of the National Institute on Aging, National Institutes of Health, which supported the study. It provides additional evidence validating the use of PiB to identify beta-amyloid deposits in living individuals and advancing the potential use of PiB as an outcome measure in clinical trials of anti-beta-amyloid therapeutics.
It is estimated that up to 4.5 million people in the United States have Alzheimer's, including 50 percent of those older than age 85 and 10 percent of those over age 65. The number of those affected is expected to triple over the next 50 years.
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