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 
 
¶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