Guidelines for Research Involving Recombinant DNA Molecules PDF Download
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Author: National Institutes of Health (U.S.)
Publisher:
ISBN:
Category : DNA
Languages : en
Pages : 452
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Book Description
Author: National Institutes of Health (U.S.)
Publisher:
ISBN:
Category : DNA
Languages : en
Pages : 452
Get Book Here
Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030929665X
Category : Medical
Languages : en
Pages : 78
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Book Description
Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.
Author: National Institutes of Health (U.S.)
Publisher:
ISBN:
Category : DNA
Languages : en
Pages : 452
Get Book Here
Book Description
Author: National Institutes of Health (U.S.)
Publisher:
ISBN:
Category : DNA
Languages : en
Pages : 452
Get Book Here
Book Description
Author: National Cancer Institute (U.S.). Office of Research Safety
Publisher:
ISBN:
Category : DNA
Languages : en
Pages : 260
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Book Description
Author: National Institutes of Health (U.S.)
Publisher:
ISBN:
Category : DNA
Languages : en
Pages : 606
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Book Description
Author: National Institutes of Health (U.S.)
Publisher:
ISBN:
Category : DNA
Languages : en
Pages : 152
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Book Description
Author: National Institute of Allergy and Infectious Diseases (U.S.). Office of Recombinant DNA Activities
Publisher:
ISBN:
Category : Recombinant DNA
Languages : en
Pages : 36
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Book Description
Author: National Institute of General Medical Sciences (U.S.). Office of Recombinant DNA Activities
Publisher:
ISBN:
Category : Recombinant DNA
Languages : en
Pages : 42
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Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452880
Category : Medical
Languages : en
Pages : 329
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Book Description
Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.
