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Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework.
Am J Bioeth. 2015; 15(12):25-9.AJ

Abstract

CRISPR germline editing therapies (CGETs) hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny at each stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing.

Authors+Show Affiliations

a Stanford University.a Stanford University.a Stanford University.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26632357

Citation

Evitt, Niklaus H., et al. "Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework." The American Journal of Bioethics : AJOB, vol. 15, no. 12, 2015, pp. 25-9.
Evitt NH, Mascharak S, Altman RB. Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework. Am J Bioeth. 2015;15(12):25-9.
Evitt, N. H., Mascharak, S., & Altman, R. B. (2015). Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework. The American Journal of Bioethics : AJOB, 15(12), 25-9. https://doi.org/10.1080/15265161.2015.1104160
Evitt NH, Mascharak S, Altman RB. Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework. Am J Bioeth. 2015;15(12):25-9. PubMed PMID: 26632357.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework. AU - Evitt,Niklaus H, AU - Mascharak,Shamik, AU - Altman,Russ B, PY - 2015/12/4/entrez PY - 2015/12/4/pubmed PY - 2016/9/7/medline KW - CRISPR-Cas KW - clinical ethics KW - gene editing KW - gene therapy KW - genetic disease KW - germline modification SP - 25 EP - 9 JF - The American journal of bioethics : AJOB JO - Am J Bioeth VL - 15 IS - 12 N2 - CRISPR germline editing therapies (CGETs) hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny at each stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing. SN - 1536-0075 UR - https://www.unboundmedicine.com/medline/citation/26632357/Human_Germline_CRISPR_Cas_Modification:_Toward_a_Regulatory_Framework_ L2 - http://www.tandfonline.com/doi/full/10.1080/15265161.2015.1104160 DB - PRIME DP - Unbound Medicine ER -