1.1 (h) Human Use Subcommittee Responsibilities: The Human Use Subcommittee shall review all phases of the use of radioactive material in or on humans and make recommendations to the Full Committee regarding conditions for approval or disapproval of human use license applications and/or research protocols. When the research protocol falls within the provisions of 21 CFR 361.1, the Human Use Subcommittee serves as the Radioactive Drug Research Committee. In fulfilling its responsibilities, the subcommittee shall:
i Review the qualifications of human use license applicants with regard to State and Federal standards for training and experience;
ii Evaluate the adequacy of facilities and equipment designated for specific human use applications and establish that each individual involved in the proposed use has received the appropriate level of training in radiological health and safety;
iii Review all human use research protocols with regard to the suitability of the proposed radionuclide, the radioactive drug formulation, the dosimetry methodology and the absorbed dose to the subject, and the pharmacological dosage;
iv Ascertain whether the research protocol has received the consent of the UMDNJ Newark campus Institutional Review Board, and whether the protocol is subject to the provisions contained in 21 CFR 361.1 "Radioactive Drugs for Certain Research Uses";
v Review and take appropriate action on all reports of misadministrations
and adverse reactions following administration of radioactive
material.