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