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Study design and ethical review

  • Reviewing Research - a website to help Research Ethics Committee (REC) members review research proposals and applicants consider the ethical dimensions of their research: 

http://www.reviewingresearch.com/human-challenge-studies/

  • WHO Human Challenge Trials for Vaccine Development: regulatory considerations:

http://www.who.int/biologicals/expert_committee/Human_challenge_Trials_IK_final.pdf 

  • ICH Harmonised Guideline For Good Clinical Practice: 

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf

  • AMS Microbial Challenge Studies of Human Volunteers guidelines: 

https://acmedsci.ac.uk/file-download/34726-1127728424.pdf