TABLE 37.

Regulatory agencies and committees with jurisdiction over human challenge studies^a

United States	Indication for review	United Kingdom	Indication for review
FDA, Office of Vaccines Research and Review	A human challenge study is proposed, with or without a vaccine.	MHRA	A vaccine is included in the human challenge study.
IRB	A human challenge study is proposed, with or without a vaccine.	IRB	A human challenge study is proposed, with or without a vaccine.
Institutional Biosafety Committee	The challenge strain or vaccine is considered to be a GMO, and the institution where the research is conducted receives U.S. government funding.	Advisory Committee on Releases to the Environment of the Department for Environment, Food and Rural Affairs	The challenge strain or vaccine is considered to be a GMO.
U.S. Vaccines and Related Biological Products Advisory Committee to the FDA	The proposed study using a challenge model is a vaccine efficacy trial, particularly if proposed to be a pivotal efficacy trial to support vaccine licensure.

^aFDA, U.S. Food and Drug Administration; IRB, institutional review board; GMO, genetically modified organism; MHRA, Medicines and Healthcare products Regulatory Agency.