NATIONAL HEALTH COUNCIL
RESOLUTION No. 292, OF JULY 08, 1999
The Plenary of the National Health Council at its eighty-eighth regular meeting, held on the 7th and 8th of
July 1999, in the use of its regimental powers and attributions conferred by Law 8.080, of September 19
1990, and by Law 8,142, of December 28, 1990, and CONSIDERING the need for regulation
complementary to CNS Resolution nº 196/96 (Guidelines and Regulatory Norms for Research Involving
Human Beings), attribution of CONEP according to item VIII.4.d of the same Resolution, with regard to the thematic area
“coordinated research from abroad or with foreign participation and research involving the remittance of
biological material for the outside ”(item VIII.4.c.8), RESOLVES to approve the following standard:
I - Definition: Coordinated research from abroad or with foreign participation are considered, those that involve, in the
promotion and / or execution:
a) the collaboration of foreign individuals or legal entities, whether public or private;
b) sending and / or receiving biological materials from humans;
c) sending and / or receiving data and information collected for aggregation in the results of the
search;
d) international multicenter studies.
I.1 - Respecting the conditions above, the following are not included in this thematic area:
a) research entirely carried out in the country by a foreign researcher who belongs to the
national entity technician;
b) research carried out by a multinational based in the country.
II - In all surveys, the following must be done:
II.1 - prove the Brazilian participation and identify the researcher and co-national institution
responsible;
II.2 - explain the responsibilities, rights and obligations, by agreement between the parties
involved.
III - This Resolution incorporates all the provisions contained in Resolution No. 196/96 of the Council
Of Health, on Regulatory Guidelines and Norms for Research Involving Human Beings, of which this is
complementary part of the specific thematic area.
III.1 - CNS resolutions referring to other thematic areas simultaneously contemplated in the research, must be
fulfilled, as appropriate.
IV - The costs and benefits arising from the investigation process and the results of the research must be distributed
fairly between the parties involved, and should be explained in the protocol.
V - The researcher and the national institution must pay attention to the rules and legal provisions on the shipment of
material abroad and those that protect industrial property and / or technological transfer (Law nº 9.279 of
05/14/96 that regulates rights and obligations related to industrial property, Decree nº 2.553 / 98 that regulates it
and Law 9.610 / 98 on copyright), explaining, when applicable, the agreements established, in addition to the
current legal rules on the sending of biological material abroad.
VI - During the course of the research, sponsors and researchers must communicate to the Ethics Committees
in Research - CEP, relevant information of public interest, regardless of the planned periodic reports.
VII - In preparing the protocol, special care must be taken to present the following
items:
VII.1 - Approval document issued by the Research Ethics Committee or equivalent of
institution of the country of origin, which will promote or which will also execute the project.
VII.2 - When the development of the project in the country of origin is not foreseen, the justification must be placed
in the protocol for appreciation of the CEP of the Brazilian institution.
VII.3 - Details of the financial resources involved: sources (if international and foreign and if there are
national / institutional counterpart), form and value of the researcher's remuneration and other resources
expenses with infrastructure and impact on the routine of the health service of the institution where it will take place. It should be
avoid, as far as possible, that the contribution of financial resources creates situations of discrimination between
professionals and / or between users, since these resources can lead to benefits
extraordinary for research participants and subjects.
VII.4 - Declaration by the promoter or sponsor, if any, of a commitment to comply with the terms of the resolutions of the
CNS concerning ethics in research involving human beings.
VII.5 - Declaration on the use of biological material and the data and information collected
exclusively for the purposes foreseen in the protocol, of all those who will handle the material.
VII.6 - Opinion of the researcher on the protocol, if it was impossible to participate in the design of the
project.
VIII - Within the attributions provided for in item VIII.4.c.8 of Resolution No. 196/96, it is up to CONEP, after the
approval of the institutional CEP, to appreciate the researches framed in this thematic area,
simultaneously framed in others.
VIII.1 - The omitted cases, regarding the ethical aspects of the research, will be resolved by the Commission
National Research Ethics Committee.
JOSÉ SERRA
President of the National Health Council
I ratify CNS Resolution No. 292, of July 8, 1999, under the terms of the Decree of Delegation of Competence of 12
November 1991.
JOSÉ SERRA
Minister of State for Health