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Viewing cable 06BRASILIA887, APPROVAL OF NIH RESEARCH PROJECT ENTITLED "NICHD INTL

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Reference ID Created Released Classification Origin
06BRASILIA887 2006-05-08 17:20 2011-07-11 00:00 UNCLASSIFIED Embassy Brasilia
VZCZCXYZ0006
RR RUEHWEB

DE RUEHBR #0887/01 1281720
ZNR UUUUU ZZH
R 081720Z MAY 06
FM AMEMBASSY BRASILIA
TO SECSTATE WASHDC 5310
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