Institutional Review. Federal regulations and ICH guidelines require that approval be obtained from an IRB before participation of human subjects in research studies. Before study onset, the protocol, ICF, advertisements to be used for the recruitment of study subjects, and any other written information regarding this study to be provided to the subject or the subject’s legal guardian must be approved by the IRB. Documentation of all IRB approvals and of the IRB compliance with the ICH harmonised tripartite guideline E6(R2): Good Clinical Practice will be maintained by the site and will be available for review by SIGA or its designee. All IRB approvals should be signed by the IRB chairman or designee and must identify the IRB name and address, the clinical protocol by title or protocol number or both, and the date approval or a favorable opinion was granted.
Institutional Review. Disputes as to ownership of rights related to copyrightable or patentable work created by a College District employee with College District support shall be reviewed by a review board chaired by the Vice Chancellor for Academic Success. For the purpose of this procedure:
Institutional Review. No work shall commence under this Agreement until the Department of Public Health Institutional Review Board has reviewed and approved the Study. Recipient agrees to submit the Study for ongoing Department of Public Health Institutional Review Board on at least an annual basis in accordance with all DPH procedures and policies as long as activities using Information provided by DPH are active.
