APPROVAL OF NIH RESEARCH PROJECT TITLED "RETROVIRUS

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