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NIH requires San Diego CFAR International Pilot grants to have both international and domestic (UC San Diego or other CFAR member institution) approval or exemption. Ethics approvals often take several weeks to obtain.
NIH requires international ethics approval or exemption of any study that involves human subjects and their specimens or data. If ethics approval is needed, you must submit your study to an ethics committee or Institutional Review Board (IRB) in your country. The committee or IRB must have an active U.S. Federalwide Assurance (FWA).
The sooner you obtain ethics approval or exemption in your country, the sooner your International Pilot grant can be funded. Please email a copy of the approval notice to the International Core. We will take care of translations if necessary.
Brazil and India each require national ethics approvals for studies in those countries that involve human subjects. For Brazil, the agency is CONEP, and for India, it is ICMR. The NIH will not authorize funding for your Pilot grant until you obtain these approvals. Email a copy of the approval notice to the International Core. We will take care of translations if necessary.
If international ethics approvals are needed, then similar approval also will be needed from your San Diego CFAR collaborator's institution.
Collaborators who are based at UC San Diego should contact the International Core before applying for ethics approval. We are fortunate to be able to collaborate with the Regulatory Team at the UC San Diego Antiviral Research Center.
Collaborators based at other SD CFAR member institutions should follow their own institution's ethics procedures. Email a copy of the approval notice to the International Core.
Studies are considered active for one year from the date of NIH approval. Occasionally an ethics approval will expire during the active period of a study, and we will ask for a copy of the ethics renewal. If you receive a supplemental award, we will request copies of the amended ethics approval and the renewal notice. Please email the international renewal notices to the International Core.