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Tools and Resources
  There follows an extensive though not exhaustive collection of bioethics resources including education, research involving human participants and animals, medical and health care ethics, and applied genetics and biotechnology. The resources provide background information and various positions on a wide range of topics in the field of bioethics.  
 

Adverse Event Reporting  
  National Institutes of Health:  
   Genetic Modification Clinical Research Information System (GeMCRIS)  
Clinical Trial Monitoring  
  European Medicines Agency:  
   Guideline on Data Monitoring Committees   
  World Health Organization:  
   Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards  
Informed Consent  
  National Institutes of Health:  
   National Cancer Institute: A Guide to Understanding Informed Consent  
   Office of Biotechnology Activities: Informed Consent in Gene Transfer Research  
Models of IRB Review  
  National Institutes of Health:  
   NCI Central IRB  
  Department of Health and Human Services:  
   Alternative Models of IRB Review: Workshop Summary Report  (November 2005)  
   National Conference on Alternative IRB Models: Optimizing Human Subject Protection  (November 2006)  
Clinical Trial Design  
  National Institutes of Health:  
   Proceedings from the conference, "Considering Usual Medical Care in Clinical Trial Design: Scientific and Ethical Issues"   
Other Clinical Research Policy Resources and Information  
  National Institutes of Health:  
   Bioethics Resources on the Web  
   Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule  
   Timeline of Laws Related to Human Subjects Protections) (compiled by the Office of NIH History, NIH)  

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