VZCZCXYZ0009
PP RUEHWEB

DE RUEHBR #1623 2211844
ZNR UUUUU ZZH
P 091844Z AUG 06
FM AMEMBASSY BRASILIA
TO SECSTATE WASHDC PRIORITY 6292

UNCLAS BRASILIA 001623 
 
SIPDIS 
 
SIPDIS 
 
STATE PASS TO DHHS/NIH/FIC FOR KEVIN BIALY 
 
E.O. 12958: N/A 
TAGS: TBIO KSCA OSCI BR
SUBJECT: APPROVAL OF NIH RESEARCH PROJECT TITLED "RETROVIRUS 
EPIDEMIOLOGY DONOR-STUDY II" 
 
REFS: A) STATE 59955, B) BRASILIA 1081 
 
¶1. On August 4, 2006, Embassy received from the Brazilian Ministry 
of Foreign Affairs, Division of Science and Technology, (DCTEC/MFA) 
an official notification (number 043, dated August 2, 2006) 
approving the research project proposal entitled "Retrovirus 
Epidemiology Donor-Study II", (number HB 047175).  Informal 
translation of the approval notice follows: 
 
Begin text: 
 
"This is to inform that after consultation to the appropriate 
federal organs, the project titled "Retrovirus Epidemiology 
Donor-Study II", to be developed by Dr. Anna Barbara 
Carneiro-Proetti, from Fundacao Centro de Hematologia de Minas 
Gerais - HEMOMINAS;  Dr. Thelma Therezinha Goncalvez, from Fundacao 
Pro-Sangue/Hemocentro de Sao Paulo;  Dr. Divaldo de Almeida Sampaio, 
of Hospital das Clinicas da Universidade Federal de Pernambuco - 
HEMOPE and Dr. Ester Cerdeira Sabino, from Fundacao da Faculdade de 
Medicina de Sao Paulo, financially supported by the National 
Institutes of Health (NIH), was approved by the Brazilian 
Government.  This research will not use human subjects in its first 
phase, and is therefore exempt from CEP - CONEP's evaluation. 
 
Following the Ministry of Health's request, I am passing on such 
text with few remarks: 
 
2)"According to the Ministry of Health's routine, copy of the 
protocol received was forwarded to the Brazilian researchers in 
order to have them attesting the accuracy of the document, in 
comparison to what should have been developed in the Brazilian 
territory.  In response to that the researchers informed the 
following: 
 
This is a preparatory phase, in which human subjects will not be 
involved.  After the end of this phase (Phase 1), a new request will 
be sent to the Brazilian Government for approval of the second phase 
of the project (Phase 2). 
At this moment the clinical protocols should be defined, and 
submitted to CONEP's approval.  Phase-2 will only be initiated after 
total approval of the appropriate organs." 
 
3)I emphasize that for the collection and transfer of data and/or 
biological material abroad, procedures should conform to current 
legislation. 
 
Cordially, 
(signature) 
Everton Frask Lucero 
Head of the Division of Science and Technology" 
 
End of text of translation. 
 
¶2.  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. 
 
SOBEL