NATIONAL HEALTH COUNCIL

RESOLUTION Nº 340, 8TH JULY 2004
The National Health Council Plenary Assembly, in its 144th Ordinary Meeting, held from the 7th to the 8th July 2004, in 
the use of its regimental competencies and granted attributions by the Law nº 8.080 of 19th September 1990 and by the 
Law nº 8.142, of 28th December 1990, and
Considering the recent technical-scientific advance and its applications on human genetic research,  requiring  
positioning  of  institutions,  researchers  and  the  Committees  for  Ethics  in Research  (CEP)  on  a  national  
basis,  thus  requiring  complementary  regulation  on  Resolution (NHC)  CNS  N°  196/96  (Guidelines  and  Regulating 
 Rules  for  Research  Involving  Human Beings) attribution of the National Commission for Ethics on Research (CONEP), 
in accordance with item VIII.4 of such Resolution;
Considering  the  subsides  received  from  the  CEPs-CONEP  system  and  the  cumulated experience on research project 
analysis on this area up to the present moment; and
Considering the need to observe the potential risks for health and the protection of human rights,  fundamental  
freedom  and  the  respect  for  human  dignity  upon  collection,  processing, usage and storage of data and human 
genetic materials,
D E C I D E S:
To approve the following Guidelines for the Ethical Analysis and the Evaluation of the Research Project on Human 
Genetic Special Thematic Area:
I – Preamble
The present Resolution incorporates all clauses stated in Resolution CNS N°196/96 of the National  Health  Council,  
concerning  Directives  and  Adjustment  Rules  on  Research  Involving Human Beings, of which it is a complementary 
part of the specific thematic area, and includes also, whichever applies,  if necessary, the dispositions of 
Resolutions CNS N°  251/97, 292/99, 303/2000 e 304/2000.
II - Terms and Definitions
II.1 – The human genetic research involves the production of genetic or proteomic data of human beings and may consist 
of different types:
a) research on basic genetic mechanisms: studies on localization, structure, function and expression of human genes and 
chromosome organization;
b) research on clinical genetics: research that consists of the descriptive study on subjects individually  and/or  on  
their  families,  aiming  at  elucidating  conditions  of  probable  genetic etiology which may involve clinical 
information analysis and genetic material tests;
c) research on populational genetics: studies on normal or pathological genetic variability on groups of individuals, 
and the relationship among these groups and a particular condition;
d) human molecular researches: researches that involve molecular assays whether or not associated to diseases; genetic 
or epigenetic studies on nucleic acids (DNA and RNA) or proteins aiming  for  novel  treatments  or  the  prevention  
of  genetic  disorders  other  pathologies  or  the identification of molecular variability;
e)  researches  on  gene  and  cellular  therapy:  introduction  of  recombinant  DNA  or  RNA molecules in human 
somatic cells in vivo (gene therapy in vivo) or human somatic cells in vitro

and transferring of these cells to an organism (gene therapy ex vivo) and researches with human stem cells with genetic 
modifications; e
f)  research  on  behavioral  genetics:  study  aiming  at  establishing  possible  relationships between genetic 
characteristics and human behavior.
II.2 – All procedures related to human genetics that have not been fully accepted in the scientific  literature  will  
be  considered  as  research  and,  therefore,  must  comply  with  the guidelines set forth in this Resolution. It 
includes genetic procedures on assisted reproduction not yet regulated by the Federal Medicine Council.
III – Ethical Aspects
The  main  purpose  of  researches  on  genetics  shall  be  related  to  scientific  knowledge accumulation that 
promotes suffering relief and improves the health of individuals and humanity.
III.1  –  The  genetic  research  produces  a  special  data  category  by  containing  medical, scientific  and  
personal  information  and  thus,  the  knowledge  impact  shall  be  evaluated  on  the individual, family and the 
group to which he belongs.
III.2 – Data protection means shall be anticipated in order to avoid the stigmatization and discrimination of 
individuals, families or groups’.
III.3  –  Researches  involving  predictive  tests  must  be  preceded  by  clarification,  before material collecting, 
with respect to the meaning and possible usage of expected results.
III.4 – It shall be offered to research subjects the option to choose whether or not they want to be informed of the 
results of their medical exams.
III.5 – Research projects must contain a proposal for genetic advice, whenever the case.
III.6 – It is the research subjects’ liability to authorize or not data storage and collection of materials within the 
scope of the research, after being informed about the procedures defined in the Resolution concerning storage of 
biological materials.
III.7 – Every individual has access to his/her genetic data, as well as the right to retrieve them from banks where 
they are stored.
III.8  –  In  order  to  have  individual  genetic  data  irreversibly  dissociated  from  any identifiable individual, 
justification must be provided for such procedure so as to be evaluated by CEP and CONEP.
III.9 - In the event of genetic data dissociation approval by CEP and CONEP, the research subject must be informed of 
advantages and disadvantages of such dissociation and a specific Term of Consent for this finality signed.
III.10 –The item V.7 of Resolution CNS N°196/96 must be observed including a possible patent registration.
III.11 – The resulting genetic data of a research associated to  an identifiable individual shall not be divulged nor 
become accessible to a third party, particularly to employers, insurance companies  and  educational  institutions.  In 
 addition  to  that,  such  resulting  data  shall  not  be provided  for  crossing  with  other  stored  data  for  
judicial  purposes  or  other  finality,  unless otherwise duly authorized by the  research subject.


III.12 – Human genetic data collected on researches with a predefined purpose shall only be used for a different 
purpose if duly authorized by the donor or his/her legal representative. It is also required a new research protocol 
duly approved by the Committee for Ethics in Research and, if necessary, by CONEP. In the event of not obtaining the 
TCLE, a formal justification shall be presented to CEP evaluation.
III.13 – In the case of human genetic data exchange among institutions, there shall be an agreement among themselves 
towards mutual cooperation and equal data access.
III.14 – Human genetic data shall not be stored by individuals, requiring the participation of a responsible 
institution that ensures adequate protection.
III.15  –  The  benefits  of  human  genetic  data  utilization  collected  within  the  research scope, including 
populational genetic studies, shall be shared among the involved communities, on an international or national basis.
III.16 – Researches for genome modification shall only be carried out with somatic cells. IV- Research Protocol:
IV.1 – Researches on the area of human genetics shall be submitted to CEP evaluation as complete protocols and, if 
necessary, submitted also to CONEP, in accordance with chapter VI of  Resolution  CNS  No   196/96,  not  being  
accepted  as  amendments,  addends  or  sub-study  of another area’s protocol. It shall also include:
a)   research justification;
b)   how genes, DNA and RNA segments or gene products in study are correlated with a possible condition of the research 
subject;
c)   clear  explanation  of  exams  and  tests  that  will  be  carried  out  and  the  indication  of genes, DNA and 
RNA segments or gene products that will be studied;
d)   justification  for  choice  and  size  of  the  sample,  particularly  when  it  regards  a vulnerable population 
or group and distinct cultures (for example, indigenous group);
e)   recruitment means of both the research subjects and controls, when necessary;
f)   careful  analysis  of  potential  and  current  risks  and  benefits  for  the  individual,  the group and future 
generations, when necessary;
g)   information regarding the use, storage or other destinations of biological material;
h)   measures   and   cares   for   assuring   the   privacy   and   avoiding   stigmatization   and discrimination of 
the research subject, the family and the group in any way;
i)    explanation of preexistent agreement related to the property of generated information as well as the industrial 
property, when necessary;
j)    description of the genetic advice planning and clinical surveillance, when indicated, including  the  names  and  
contacts  of  the  responsible  professionals,  approach  type according  to  expected  situations,  consequences  to  
subjects  and  foreseen  conducts. The responsible professionals for the  genetic  advices and  clinical surveillance 
must comply with the professional formation and certificates required by the professional councils and specialty 
societies;

l)   a justification for the transport of biological material and/or data to other institutions, national  or  foreign, 
 with  clear  indication  of  material  and/or  data  types  as  well  as  the

listing of exams and tests to be carried out. It is also required to clarify the reasons why the exams or tests can not 
be performed in Brazil, if this is the case; and
m)  in international cooperation projects the opportunities for technology transfer should be described.

V - Freely Given and Informed Consent Term – TCLE
V.1 – The TCLE must be elaborated according to the rule in chapter IV  of Resolution CNS N° 196/96, with special 
emphasis on the following items:
a) clear explanation of exams and tests that will be performed, the indication of genes, DNA and RNA segments or gene 
product that will be studied and their correlation with a possible condition of the research subject;
b) guarantee of secrecy, privacy and, when necessary, anonymity;
c) the genetic advice planning and clinical surveillance, with the indication of the responsible people, without cost 
to the research subjects;
d)  kind  and  degree  of  access  to  results  by  the  subject,  with  the  option  to acknowledge or not this 
information;
e) in the case of material storage, the information should be included in the TCLE, explaining the possibility of 
utilization in a new  research  project.  It must state that the subject  will  be  contacted  for  further  
authorization  for  the  use  of  the  material  in  future projects and, when impossible to do so, the fact shall be 
justified to the CEP. In addition to that, it is also required to explain that the material will only be used upon 
approval of a new project by CEP and CONEP (when necessary);
f) information on protection measures of individual data, exam and test results as well as the clinical report will 
only be accessed by the involved researchers and not by third parties (insurance companies, employers, hierarchical 
supervisors, etc);
g) information on protection measures against any kind of individual or collective discrimination and/or 
stigmatization; and
h)  in  investigations  of  families,  it  is  required  to  obtain  the  Freely  Given  and Informed Consent Term of 
each individual of the study.

VI – Operational:
VI.1. It is CEP’s duty, based on chapter VII of the resolution CNS N° 196/96, to analyze research projects, assuming 
co-responsibility as far as ethical aspects are concerned.
VI.2. It is CEP’s duty to promptly return to the researcher a protocol that does not contain all the relevant 
information (chapter VI – Resolution CNS Nº 196/96, as well as chapters III and IV of the present Resolution).
VI.3. It is CONEP’s duty the final approval on human genetic researches that include:
a)  the  dispatch  abroad  of  genetic  material  or  any  human  biological  material  aiming  at obtaining genetic 
material;
b)  the  storage  of  biological  material  or  human  genetic  data,  abroad  or  in  this  country, when in 
partnership with foreign or commercial institutions;
c) alterations of the genetic structure of human cells for in vivo utilization;

d) researches on the area of human-reproduction genetics (repro-genetics);
e) researches on behavioral genetics; and
f) researches that anticipate irreversible dissociation of research subject and data.
VI.4 – In the cases mentioned in VI.3 above, CEP must examine protocol, elaborate the fundamented  report  and  send  
both  to  CONEP  with  the  complete  documentation  according  to Resolution  CNS  N°  196/96,  items  VII.13.a  and  
b  and  VIII.4.c.1.  The  researcher  shall  be informed that he must await the report issued by CONEP so as to start 
up the project execution.
VI.5 –  It is delegated to CEP the final approval of human genetic projects that are not included  in  item  VI.3  
above.  In  this  case,  CEP  must  send  to  CONEP  the  front  page  and  the fundamented report, whether it has been 
approved or not.
VI.6  –  Dispatch  of  material  abroad  must  obey  the  normative  and  legal  rules  of  the country.


HUMBERTO COSTA
President of the National Health Council


I ratify the Resolution CNS nº 340, of 8th July 2004, in the terms of the Competency Delegation Decree of 12th November 
1991.

HUMBERTO COSTA
Minister of Health