APPROVAL OF NIH RESEARCH PROJECT ENTITLED "NICHD INTL

UNCLAS BRASILIA 000887 SIPDIS SIPDIS STATE PASS TO DHHS/NIH/FIC FOR KBIALY WHA/BSC E.O. 12958: N/A TAGS: TBIO KSCA OSCI BR SUBJECT: APPROVAL OF NIH RESEARCH PROJECT ENTITLED "NICHD INTL PEDIATRIC AND PERINATAL HIV STUDIES NETWORK COORDINATING CENTER" REFS: A) 05 STATE 175816, B) 05 BRASILIA 3290 ¶1. On May 4, 2006, Embassy received from the Brazilian Ministry of Foreign Affairs, Division of Science and Technology, (DCTEC/MFA) an official notification (number 022, dated April 27, 2006) approving the research project proposal entitled "The National Institute of Child Health and Human Development (NICHD) International Pediatric and Perinatal HIV Studies Network Coordinating Center (A Randomized Open Trial of Three Hepatitis Vaccination Schema in HIV-Positive Youth)," (number HD33345-09),under the direction of: Dr. Ricardo Hugo S. Oliveira, Dr. Esau Custodio Joao Filho, Dr. Jorge Andrade Pinto, Dr. Geraldo Duarte and Dr. Marisa Mussi-Pinhata, and Dr. Marinella Della Negra. Informal translation of the approval notice follows: ¶2. Begin text: "Dear Counselor, I hereby inform you that after consultation with relevant federal agencies, the project "A Randomized Open Label Trial of Three Hepatitis Vaccination Schema in HIV-Positive Youth", to be developed by Dr. Ricardo Oliveira of Instituto de Puericultura e Pediatria Martagao; Dr. Esau Custodio Joao Filho of Hospital dos Servidores do Estado do Rio de Janeiro; Dr. Jorge Andrade Pinto of Universidade Federal de Minas Gerais; Dr. Geraldo Duarte and Dr. Marisa Mussi-Pinhata of Hospital das Clinicas de Ribeirao Preto - USP; Dr. Marinella Della Negra of Instituto de Infectologia Emilio Ribas, with the financial support of "National Institutes of Health" (NIH), was approved by the Brazilian government, according to the following CONEP recommendations: "When proceeding with the review of the research Project in question, in reply to a request for revision of CONEP opinion n 1882/2005, which was not approved, the researcher submitted the following clarification: a) She informed that the amendments to the original protocol were necessary because this is an international multicenter study to be adapted to local conditions in Brazil. b) She supplied details about the randomization methodology and hypotheses to the study based on relevant bibliography already submitted. c) She pointed out that the indication of vaccines in the study already exists in Brazil and in the U.S. d) She informed the laboratories in Brazil and budget data (NIH sponsorship). e) She guaranteed that, according to exclusion criteria, professionals participating in other studies will not be included. However, concerning pregnancy care, it is requested that the Free and Informed Consent Agreement include the information that in case the teenager becomes pregnant, mother and baby care shall be ensured, if necessary. (item III, "u" of reply CNS 196/96). In view of the explanation, the National Commission for Ethics in Research - CONEP, by virtue of the authority established in CNS Resolution 196/96, expresses its approval of the proposed research Project including the recommendation mentioned above, which should be monitored by the Research Ethics Committee (Comite de Etica em Pesquisa/CEP) before the research project starts. Status: Protocol approved with recommendation. Note: According to the protocol, the study will be carried out in the Bahamas and the United States. In Brazil, the following research centers will participate in the study alongside with Instituto de Infectologia Emilio Ribas: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo, Hospital dos Servidores Publicos do Rio de Janeiro, Universidade Federal do Rio de Janeiro and Universidade Federal de Minas Gerais. Any changes to this information must be communicated to CONEP. Research centers which do not have Research Ethics Committees (CEPs) must ask CONEP to indicate a CEP to analyze the Project in question." ¶2. Since this is a multicenter project, this Protocol is subject to new CNS Resolution n: 346/2005. ¶3. The Ministry of Science and Technology determined that for the collection and transfer of data and/or biological material abroad, Brazilian researchers must request authorization from the National Council for Scientific and Technological Development (CNPq),in accordance with the legislation in force Best regards, Cordially, Everton Frask Lucero (Signature) Deputy Head of the Division of Science and Technology" End of text. ¶3. The Embassy sees no adverse foreign policy implications with respect to this research project. We reiterate the importance of complying with Brazilian law on the export of data and biological material and medical research involving human beings. CHICOLA