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In addition, the authors present two critical action items respondents identified in deriving maximum clinical utility from innovations in NGS and genetic diagnostics, while preserving the bioethical mandates for research participation.
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The United States did not get an explicit new mandate for research, he says, and it did not get the 5-year stay it was looking for.
In the US, the FRPAA has proposed similar mandates for all research funded by the major US research funding agencies.
At the same time, national technology mandates with funds for research and development should be established and federal agencies should offer citizens majoring in engineering and science competitive, tax-free doctoral fellowships.
The Blue Cross group said Wednesday that without a Medicare mandate for such research, there might be little likelihood now that doctors or equipment makers would do it.
In order to provide a comprehensive legal mandate for genomic research, the existing pieces of legislation will require extensive review as has been done elsewhere in the United States, Europe, Asia, and Africa [ 49– 53].
For research by private researchers or research not mandated by law (e.g., a prevalence study using identifiable names linked to DNA), the rules of research would apply.
The Food and Drug Administration Modernization Act of 1997 (FDAMA) and the FDA Amendment Act of 2007 (FDAAA), respectively, established mandates for registration of interventional human research studies on the website clinicaltrials.gov (CTG) and for posting of results of completed studies.
In the absence of mandates for data sharing or publication, research funding agencies should give greater scrutiny to data sharing plans referred to in their policy documents and check their enforcement.
Incorporating feasibility studies into the research was one option that was proposed for diminishing barriers in research translation into policy and programmes, as was mandating that research proposals include systematic protocols for research transfer.
We maintain that to effect a culture change it is necessary to turn the recommendations suggested here into requirements for research, coupled with rewards for following mandated guidelines.
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