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Hospitals Management

November 2012, e-Newsletter
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KnowledgeBank
Clinical Research Ethical or Unethical
Clinical Research Ethical or Unethical

Everybody believes that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects,

  • Value: enhancements of health or knowledge must be derived from the research;
  • Scientific validity: the research must be methodologically rigorous.
  • Fair subject selection: scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects.
  • Favorable risk-benefit ratio: within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks;
  • Independent review: unaffiliated individuals must review the research and approve, amend, or terminate it.
  • Informed consent: individuals should be informed about the research and provide their voluntary consent; and
  • Respect for enrolled subjects: subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored.
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Industry Updates
News
OncoSec Medical to Present at NYSSA Life Sciences and LD Micro Investor Conferences
SAN DIEGO, Nov. 27, 2012
New York Society of Security Analysts (NYSSA) Life Sciences Conference, NYSSA Conference Center, 1540 Broadway, New York, NY, November 29th at 9:30 AM ET
Presentation by: Veronica Vallejo, CPA, Vice President of Finance
Press Release
Aspireo Receives Positive Opinion from EMA for Orphan Disease Designation for Somatoprim
Tel Aviv, Israel
Monday 26 Nov, 2012
The positive opinion and recommendation has been forwarded to the European Commission for approval.
Events and Exhibition
Pharma Manufacturing
Nov 28 2012 - Nov 30 2012

Homotel Hotel
Chandigarh, India
CPhI India
 
2013 PHARMA PPM TOOLBOX
Mar 5 2013 - Mar 6 2013

Basel: Varied city of the arts
EBCG
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