Identifier
Created
Classification
Origin
07BRASILIA226
2007-02-09 15:01:00
UNCLASSIFIED
Embassy Brasilia
Cable title:  

APPROVAL OF NIH RESEARCH PROJECT ENTITLED "LONG TERM IMPACT

Tags:  TBIO KSCA OSCI BR 
pdf how-to read a cable
VZCZCXYZ0003
PP RUEHWEB

DE RUEHBR #0226/01 0401501
ZNR UUUUU ZZH
P 091501Z FEB 07
FM AMEMBASSY BRASILIA
TO SECSTATE WASHDC PRIORITY 8052
UNCLAS BRASILIA 000226 

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 "LONG TERM IMPACT
AND INTERVENTION FOR DIARRHEA IN BRAZIL"

REFS: A) 05 STATE 113144, B) 05 BRASILIA 1719

UNCLAS BRASILIA 000226

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 "LONG TERM IMPACT
AND INTERVENTION FOR DIARRHEA IN BRAZIL"

REFS: A) 05 STATE 113144, B) 05 BRASILIA 1719


1. On January 15, 2007, Embassy received from the Brazilian Ministry
of Foreign Affairs, Division of Science and Technology, (DCTEC/MFA)
an official notification (number 003, dated January 15, 2007)
approving the research project proposal entitled "Long Term Impact
and Intervention for Diarrhea in Brazil," (contract number
AI026512-16),under the direction of Dr. Aldo Angelo Moreira Lima.
Informal translation of the approval notice follows:


2. Begin text:

"Dear Counselor,

This is to inform that after consultations with the appropriate
federal agencies, the project titled "Long-term Impact and
Intervention for Diarrhea in Brazil," to be developed by Dr. Aldo
Angelo Moreira Lima, from Federal University of Ceara (UFC),and
financially supported by the National Institutes of Health (NIH),
was approved by the Brazilian Government, with the following
provisos:

The National Commission on Research Ethics (CONEP),drawing its
authority from CNS Resolution 196/96, through Opinion no. 760/2006,
expresses its approval of the proposed research project with the
recommendation to address the below-mentioned issues before the
project starts, which should be monitored by the Research Ethics
Committee (CEP) and reported to CONEP.

1) Page 39 of the project states that the oral use of arginine,
alanyl-glutamine and glycine is experimental and there is no way to
predict all possible present and future risks associated with this
research. On this issue, the Free and Informed Consent Agreement
must better explain the reimbursement for possible expenses in the
research, as well as the coverage for possible damages caused to
research individuals and it must be made clear who will be
responsible for covering against these damages and where the
volunteer will find help in an emergency. The responsibility of the
researcher for any damage shall also be clarified. The mere
mentioning of the right to legal claim is not enough.

2) We are waiting for the approval document issued by the Research
Ethics Committee of the University of Virginia (United States) in
accordance with item VII.1 of Resolution 292/99. We point out that
page 45 of the project states that the protocol and the Consent
Agreement and any subsequent change will be revised and approved by
both ethics committees (a local one at UFC and another at the
University of Virginia).

3) Page 45 of the protocol should clarify the references to
resolutions and/or a statement should be attached saying that in the
case of needing to interrupt the study, this will follow the
provisions under items III.3 "z" ("cease the study only after
assessing the reasons for discontinuity by the CEP which approved
it") and VII.13 "f" ("The research ceased without explanation
accepted by the CEP which approved it is considered unethical") of
CNS Resolution 196/96 and item III.2"e" of CNS Resolution 251/97
(explanation submitted to CEP). We point out that the interruption
of the study should be bound to a bilateral decision between NIAID
and UFC and acceptable only for reasons of protecting its
volunteers.

4) Inclusion and exclusion criteria are defined. In the inclusion
criteria, however, there is no reference to 2,000 family members who
are to be the donors of genetic material.

5) As to the Free and Informed Consent Agreement (Termo de
Consentimento Livre e Esclarecido - TCLE),two TCLEs have been
presented (one for the research with micronutrients and another for
genetic research),as part of the participants will perform only the
procedures relative to the (family) genetic evaluations and others
will perform both genetic procedures and the clinic part of the
research with micronutrients. These two TCLEs, however, released on
April 8, 2005, predate the version initially presented (November 23,
2005) and precede the date of CONEP Opinion 352/2006 (dated April
20, 2006). It is understood that the TCLE versions must be dated
later than the CONEP Opinion date.

6) In the TCLE specific for micronutrients research, the sentence
which considers free medical assistance and free supplies in test as
benefits must be excluded. This fact might be considered an
infringement of autonomy, as it may be considered a possible
inducement to the subject of the research and infringe its autonomy,
as it does not really constitute a benefit to the subjects, because
access to treatment should be guaranteed to all. This sentence might
be placed for example under an item titled "costs".

7) In the TCLE specific for genetic research, no reference to
prescribing the medicine under study should be included, which is
mentioned in some items."


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.

SOBEL