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 Biopharmaceutical Ethics
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions? mchitty@healthtech.com
Last revised November 12, 2012

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Applications:  Business of biopharmaceuticals  Molecular Medicine   Cancer genomics  Clinical trials   Genetic & genomic testing  Pharmacogenomics  Regulatory Affairs

American Journal of Bioethics, Bioethics.net http://ajobonline.com/ American Journal of Bioethics Online

Bermuda principles: Agreed upon coordinated rapid release of data into the public domain. Summary of principles agreed at the International Strategy Meeting on Human Genome Sequencing, Bermuda, 25th- 28th February 1996.  Wikipedia http://en.wikipedia.org/wiki/Bermuda_Principles 

CDC Ethics Home Page http://www.cdc.gov/od/ethics/default.htm 

clinical trials- ethics:  Bioethics Resources on the web,  Medicine and health care, Ethics and clinical trials, 2007 25 plus websites http://bioethics.od.nih.gov/ethics_clinical_trials.html  

ELSI: Ethical, Legal and Social Issues
ELSI NHGRI, National Human Genome Research Institute, NIH, US http://www.nhgri.nih.gov/ELSI/
ELSI NIEHS, National Institute of Environmental Health Sciences, NIH, US http://www.niehs.nih.gov/envgenom/elsi.htm
Ethical, legal & social issues, DOE Human Genome Project, Oak Ridge National Lab, US  http://www.ornl.gov/hgmis/elsi/elsi.html
Ethical, legal & social issues Research DOE, Human Genome Project, Oak Ridge National Lab, US http://www.ornl.gov/hgmis/research/elsi.html

genetic privacy: Genetics Privacy and Legislation, HGMIS, DOE, US   http://www.ornl.gov/TechResources/Human_Genome/elsi/legislat.html

Guidelines on Good Publication Practice, Committee on Publication Ethics, 2002 http://www.publicationethics.org.uk/cope2002/pdf2002/21330_pp48_52.pdf

informed consent:  Health & Human Services http://www.hhs.gov/ohrp/policy/consent/index.html 

Intellectual property:  Intellectual property

international and non-US bioethics organizations: Bioethics Resources on the web, US National Institutes of Health http://www.nih.gov/sigs/bioethics/international.html

International Bioethics Committee, UNESCO   http://portal.unesco.org/shs/en/ev.php-URL_ID=1879&URL_DO=DO_TOPIC&URL_SECTION=201...l 

Minorities, race and Genetics: Human Genome Project Information, DOE, US http://www.ornl.gov/TechResources/Human_Genome/elsi/minorities.html

NIH Bioethics on the web  http://www.nih.gov/sigs/bioethics/

neuroethics:  The ethics of neuroscience ... encompasses a wide array of ethical issues emerging from different branches of clinical neuroscience (neurology, psychiatry, psychopharmacology) and basic neuroscience (cognitive neuroscience, affective neuroscience).  These include ethical problems raised by advances in functional neuroimaging, brain implants and brain- machine interfaces and psychopharmacology as well as by our growing understanding of the neural bases of behavior, personality, consciousness, and states of spiritual transcendence. Neuroethics, University of Pennsylvania,  http://www.neuroethics.upenn.edu/ 

Nuffield Council on Bioethics, Nuffield Trust, Wellcome Foundation, Medical Research Council http://www.nuffieldbioethics.org/home/   Ethical issues arising from developments in medicine and biology. Current projects include donor conception, novel neurotechnologies and emerging biotechnologies such as synthetic biology and nanotechnology.

Policy and ethics, NHGRI, US  http://www.genome.gov/PolicyEthics/

Precautionary Principle, http://en.wikipedia.org/wiki/Precautionary_principle 

President's Council on Bioethics, US http://www.bioethics.gov/ Reports and background information on cloning, stem cells, genetic enhancement, patenting human life, biotechnology and public policy, sex selection. 

Bibliography
Institutional Review Board Glossary, Office Human Research Protection, HHS, US, http://www.hhs.gov/ohrp/archive/irb/irb_glossary.htm  Portions now outdated. 
Kennedy Institute of Ethics, Georgetown Univ. National Information Resource on Ethics and Human Genetics http://genethx.georgetown.edu/ 
NIH, Bioethics Resources on the Web http://www.nih.gov/sigs/bioethics/index.html 
President's Council on Bioethics, http://www.bioethics.gov/ 
Roberts, Alan, Language of Bioethics, Medical College of Georgia, 2001, 40 plus definitions http://www.mcg.edu/gpi/ethics/ph1sylbus/bioethic.htm#Capacity
What HHS can do for your family http://www.mastersinhealthcare.com/blog/2012/hhs-for-your-family/ 

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