Switch to: References

Add citations

You must login to add citations.
  1. Measuring inconsistency in research ethics committee review.Samantha Trace & Simon Erik Kolstoe - 2017 - BMC Medical Ethics 18 (1):1-10.
    Background The review of human participant research by Research Ethics Committees or Institutional Review Boards is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” where multiple committees review the same project. Committee reviews (...)
    Direct download (5 more)  
     
    Export citation  
     
    Bookmark   8 citations  
  • Rethinking risk assessment for emerging technology first-in-human trials.Anna Genske & Sabrina Engel-Glatter - 2016 - Medicine, Health Care and Philosophy 19 (1):125-139.
    Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due to the (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   3 citations