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Country-Specific Instructions: Brazil

Summary

This page offers information about obtaining U.S. State Department foreign clearance for NIH research activities with Brazil.

Applying for an NIH Award with a Collaborator in Brazil

All U.S. investigators applying for an NIH award with a collaborating Brazilian institution should note that the government of Brazil performs an in-country, technical review of all foreign funded scientific awards in Brazil. This process, which involves the Brazilian Ministries of Health, Science and Technology and Foreign Affairs (ITAMARATY), is in addition to the NIH peer review process and can be lengthy.

Each Brazilian institution competing for an NIH grant is required by Brazil to have an institutional committee on ethics and research or, in exceptional cases, to have access to another Brazilian institutional committee nearby. This Committee, better known in Brazil as the Comite de Etica em Pesquisa (CEP), is the Brazilian equivalent of the U.S. Institutional Review Board (IRB). Therefore, prior to submitting the award application, the U.S. investigator should ensure that the Brazilian collaborating institution listed on the award application has an active CEP in place that is recognized by the Brazilian Ministry of Health, and that it will be able to perform the local ethical review if/when the grant is awarded. When it is unknown whether the collaborating Brazilian institution has a CEP in place, the U. S. investigator should encourage his/her collaborating partner in Brazil to inquire directly with the Brazilian National Ethics Commission (CONEP) listing of registered CEPs. When the Brazilian collaborating institution does not have its own CEP, CONEP may provide guidance about nearby CEPs that can receive submissions from other institutions. This step is crucial in expediting the Brazilian clearance if/when an award is made.

Once the application has been funded by a participating NIH Institute, Center, or Office, the Brazilian collaborator is encouraged to contact Dr. Ana Maria Tapajos, Director, Technical Analysis Division at the Brazilian Ministry of Health, International Affairs Office, to ensure that CONEP and all other pertinent Brazilian authorities have the necessary materials upon which to base their technical review. Dr. Tapajos can be reached via phone at 55 61 3315 2632, Fax 55-61-224-0014, or by e-mail. It is important to note that the Brazilian investigator will be responsible for submitting a copy of the grant application in Portuguese first to the CEP and, if necessary, to CONEP and to verify that the U.S. and Brazilian versions of the award match. All Brazilian collaborating investigators are encouraged to contact Dr. Tapajos as soon as the award is made for complete details and requirements of the technical review process performed by CONEP.

For Additional Information:

Kevin Bialy
FIC Acting International Program Officer for the Western Hemisphere Region Phone: (301) 496-6273