RESOLUTION No. 466, OF 12 DECEMBER 2012


During session of the National Council of Health at its 240th General Meeting held on December 11 and 12, 2012, in the 
discharge of its official authorities and duties, conferred upon it by Law 8080 of September 19, 1990, and Law 8142 of 
December 28, 1990, and
Considering  the  respect  for  human  dignity  and  the  special  protection  to  the  members  of  the  scientific 
researches involving human beings;
Considering the development and ethical commitment, inherent to the techno-scientific development;
Considering  the  evolution  of  science  and  technology  which  unveiled  another  perception  of  life  and  its 
ways of living, with impacts not only in conception and in lengthening of the human life span, as in costumes, culture, 
human behavior upon real and virtual means available changing and innovating at a continuous and fast pace;
Considering the progress of science and technology, which may imply in current and potential benefits to the human 
being, the community in which he/she is inserted and the national and universal society, making it possible  to  
promote  well-being  and  quality  of  life,  and  promoting  the  protection  and  preservation  of  the environment 
for the current and future generations;
Considering the ethical grounds subjects raised by the progress and growth of science and technology, rooted in all 
areas of human knowledge;
Considering that all growth and progress must always respect the dignity, freedom and autonomy of the human being;
Considering  the  documents  that  form  the  pillars  of  recognition  and  affirming  dignity,  freedom  and autonomy 
of the human being, such as Nuremberg Code, from 1947, and the Universal Declaration of Human Rights, from 1948;
Considering  recent  international  documents,  a  reflection  from  the  great  scientific  and  technological 
discoveries  from  the  XX  and  XXI  centuries,  particularly  the  Helsinque  Declaration,  adopted  in  1964  and  
its versions  from  1975,  1983,  1989,  1996  and  2000;  the  International  Pact  regarding  Economical,  Social  
and Cultural  Rights,  from  1966;  the International Pact  regarding  Civil  and Political  Laws,  from  1966; the 
Universal Declaration  regarding  Human Genoma  and  Human  Rights,  from  1997;  the International  Declaration  
regarding Human  Genes  Data,  from  2003;  and  the  Universal  Declaration  regarding  Bioethics  and  Human  Rights, 
 from 2004;
Considering the Federal Constitution of the Federal Republic of Brazil, which objectives and foundations of 
sovereignty, citizenship, human dignity, labor and free enterprise social values and political pluralism and the 
objectives  of  building  a  free,  fair  and  caring  society,  to  ensure  national  development,  to  end  poverty  
and marginalization and to reduce social and regional inequalities and to promote the well being of all, without any 
type of prejudice or discrimination, are consistent with the international documents of ethics, human rights and 
development;
Considering the related and relevant Brazilian Legislation; and
Considering the Resolution no. 196/96, of the National Council of Health, from the Ministry of Health, that states 
periodic reviews to it according to the needs on techno-scientific and ethical areas.

D E C I D E S:
To approve the following guidelines and standards regulating researches involving human beings: I – PRELIMINARY 
PROVISIONS
This  Resolution  consolidates  bioethical  benchmarks  from  the  view  point  of  the  individual  and  the 
communities, such as autonomy, non maleficence, beneficence, justice and equity, among others, and it seeks to

ensure  the rights and duties  that  refer to the participants  of the research,  to the scientific  community  and the 
State.
Projects of research involving human beings must attend to this Resolution.

II – TERMS AND DEFINITIONS
This Resolution adopts the following definitions:
II.1 – research findings – facts or information met by the investigator along the study and considered as relevant to 
the participants or communities involved;
II.2 – informed consent agreement – an agreement of the research participant, child, teenager or legally unable,  free  
of  vice  (simulation,  fraud  or  error),  dependence,  subordination  or  intimidation.  Such  research participants 
must be clarified about the nature of research, its objectives, methods, expected benefits, potential risks and the 
discomfort that it might occur by reason of said investigation, according to their comprehension and respecting their 
singularities;
II.3 – assistance to the research participant:
II.3.1 – immediate assistance – considered as an emergency and with no cost of any kind to the research participant, in 
situations that he/she may need it; and
II.3.2 – full assistance – that provided to attend complications and damages caused directly or indirectly by the 
research;
II.4 – research benefits – immediate or posterior, direct or indirect profit, attained by the participant and/or 
his/her community caused by his/her participation in the research;
II.5  –  informed  consent  form  –  an  agreement  from  the  research  participant  and/or  from  his/her  legal 
representative,  free  of  vice  (simulation,  fraud  or  error),  dependence,  subordination  or  intimidation  
following  a complete  and  detailed  explanation  of  the  nature  of  the  research,  its  objectives,  methods,  
expected  benefits, potential risks and discomfort that might occur by reason of said investigation;
II.6 – damage related to or caused by the research – immediate or posterior, direct or indirect offense, to the 
individual or community, caused by the research;
II.7  –  compensation  –  material  coverage  for  compensating  damages  caused  by  the  research  to  its 
participants;
II.8 – research applicant institution – public or private organization, legitimated and qualified, to which the leading 
researcher is linked to;
II.9  –  research  co-participating  institution  –  public  or  private  organization,  legitimated  and  qualified,  
in which some of the stages or steps of the research are developed;
II.10 – research participant – the individual who accepts to be studied on a voluntary and informed basis or  under  
the  clarification  and  authorization  of  his/her  legal  representatives.  The  participation  must  be  free  of 
charge, except Phase I or Bioequivalence clinical researches;
II.11 – sponsor – public or private individual or legal entity that supports the research, throughout financial shares, 
infrastructure, human resources or institutional support;
II.12 – research – a formal and systematic process which aims at the production, at the advancement of knowledge and/or 
at obtaining answers to problems by using a scientific methodology;
II.13  –  research  in  human  reproduction  –  researches  engaged  with  the  functions  of  the  reproductive 
system,  procreation  and  factors  that  affect  the  reproductive  health  of  humans,  considering  as  “research 
participants” all those who were affected by its procedures;
II.14 – research involving human beings – researches involving, individually or collectively and directly or 
indirectly, human beings as a whole or part thereof, including handling of his/her data, information or biological 
materials;
II.15 –investigator  – a member of the research team, co-responsible for the integrity  and welfare of all participants 
of the research;

II.16 – leading researcher – a person in charge of the coordination of the research and co-responsible for the 
integrity and welfare of all participants of the research;
II.17 – research protocol – a set of documents describing the research regarding its fundamental aspects and the 
information related to the research participants, the researcher’s qualification and all responsible bodies;
II.18  –  previous  material  compensation  –  material  compensation  dedicated  exclusively  for  expenses related to 
transportation and meal for the research participant and his/her companion(s), and if necessary, prior to his/her 
participation in the research;
II.19 – final report – the one presented after the closure of the research, totaling its results;
II.20 – partial report – the one presented during the research showing relevant facts and partial results of its 
development;
II.21   –   indemnification   –   material   compensation   dedicated   exclusively   for   expenses   related   to 
transportation and meal for the research participant and his/her companion(s), whenever necessary;
II.22 – research risks – possible damage to the human being physical, psychic, moral, intellectual, social, cultural or 
spiritual dimension, caused by and from any research;
II.23 – Informed Consent Form (ICF) – a document specifying the research participant and/or his/her legal 
representative's  consent  statement,  in  the  form  of  a  written  consent,  and  it  must  contain  all  necessary 
information,  in  a  clear  and  objective  language,  so  the  participant  and/or  his  legal  representative  
clearly understand about the research to which he/she is willing to participate;
II.24 – Consent Term – a document prepared for minors or legally incapable for their easy understanding allowing them, 
after being clearly informed about the research, to state their will to participate in the research without prejudice 
to the consent of their legal representatives; and
II.25 – vulnerability – the condition of individuals or groups that, for any reason whatsoever, have their 
self-judgment  capability reduced  or  disabled,  or by  any  means  they  are prevented to resist  to the  opposition, 
especially when it comes to the informed consent form.

III – ETHICAL ASPECTS OF RESEARCHES INVOLVING HUMAN BEINGS
The researches involving human beings must attend to the relevant ethical and scientific grounds.
III.1 – Ethics of research involve:
a)   respect  the  research  participant’s  dignity  and  autonomy,  recognizing  his/her  vulnerability,  ensuring 
his/her will to contribute and remain, or not, in the research, by means of express, free and informed statement;
b)   balance known and potential, individual or collective, risks and benefits committing to the maximum of benefits 
and to the minimum of risks and damages;
c)   ensure that known damages will be avoided; and
d)   social relevance of investigation, ensuring the equated weighting of interests involved with no loss to the sense 
of its social-humanitarian purpose.
III.2 – In any area of knowledge involving human beings, the researches shall comply with the following demands:
a)   shall be appropriate to the scientific values that justifies it and with concrete possibilities of responding to 
uncertainties;
b)   shall be founded in scientific grounds, previous testing and/or appropriate assumptions to the specific area of 
investigation;
c)   shall be performed only when the expected knowledge cannot be obtained through other means;
d)   always seek for the expected benefits to prevail regarding risks and/or foreseeable discomforts;
e)   use the appropriate methodology to answer the studied subjects specifying if a qualitative, quantitative or 
quali-quantitative investigation;

f)    if there is a need to allocate the research participants randomly into experimental and control groups, ensure 
beforehand that it is not possible to establish the advantages of a procedure over another, by reviewing literature, 
observation methods or methods that do not involve human beings;
g)   obtain   a   deliberate   consent   statement   from   the   research   participant   and/or   his/her   legal 
representative,  including  on  cases  where,  due  to  their  nature,  the  researches  imply  in  posteriori consent;
h)   count  on human resources and materials  necessary to ensure the research participant’s wellbeing, and the 
investigator(s) must have appropriate professional capability to develop his/her function in the proposed project;
i)    provide procedures ensuring confidentiality and privacy, image protection and avoiding stigmatization of the 
research participants, and to guarantee the non-use of information to the detriment of people and/or  communities,  
including  in  terms  of  self-esteem,  prestige  and/or  economic  and  financial aspects;
j)    to be preferably developed on individuals with full autonomy. Individuals or vulnerable groups shall not 
participate  in  the  research  when  the  expected  information  may  be  obtained  with  participants  fully capable, 
unless the research may bring benefits to the individuals or vulnerable groups.
k)   always  respect  cultural, social,  moral, religious  and  ethical  values,  as well  as  habits and practices, 
when involving communities in researches;
l)    ensure, wherever possible, that researches within communities become beneficial to their effects and continue 
after their conclusion. When there is a real benefit to motivate or stimulate changes of habits or behaviors for the 
sake of the community, the research protocol shall include, wherever possible, willingness to communicate such 
advantage to the people and/or community;
m)  communicate the competent authorities, as well as to the bodies legitimized by the Social Control, the results 
and/or findings of the research, every time they can contribute to improving living conditions of the community, 
preserving, however, the image and ensuring that the research participants will not be stigmatized;
n)   ensure the benefits resulting from the project to the research participants, whether in terms of social return, 
access to procedures, products or research agents;
o)   ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according 
to the case, while needed, including those in tracking researches;
p)   present evidence  of  commitments  and advantages  to the research participants  and  Brazil  resulting from the 
performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and 
national institution responsible for the research in Brazil must be identified. The  studies  sponsored  abroad  must  
also  respond,  when  applicable,  to  the  needs  of  transferring knowledge  and  technology  to  the  Brazilian  
team  and,  in  case  of  developing  new  drugs,  their registration in Brazil are mandatory, if safety and 
effectiveness are proven;
q)   use the material and data obtained from the research solely for the purposes identified in its protocol or 
according to the participant’s consent statement;
r)   consider  evaluating  risks  and  benefits  and  eventual  interferences  regarding  fertility,  pregnancy, embryo 
or fetus, childbirth, puerperium, lactation and newborn in researches carried out in pregnant women or those in the 
childbearing age;
s)   consider that the researches carried out in pregnant women must be performed before those carried out  in  women  
after  their  gestational  period,  except  for  researches  to  which  pregnancy  is  the  main purpose;
t)    women who declare themselves with no risk of pregnancy, whether by sexual relation or by no means of 
reproduction, guarantee the right to participate on es without the compulsory use of contraceptives; and

u)   discontinue    research    only    after    analysis    of    reasons    for    such    discontinuation    by    
the CEP/CONEP/CNS/MS  System  approving  such  study,  unless  in  cases  of  justified  urgency  to  the benefit of 
their participants.
III.3 – The researches using experimental methodologies in the biomedical area, involving human beings, besides that 
recommended in item III.2, shall:
a)   be  founded  on  previous  experimentation  carried  out  in  labs  using  animals  or  other  experimental models 
and scientific evidence, when appropriate;
b)   when  using  placebo,  such  use  shall  be  fully  justified  as  to  its  non  maleficence  and  methodology 
requirements,  where  the  benefits,  risks,  difficulties  and  effectiveness  of  a  new  therapeutic  method shall 
be tested, comparing it to the best current prophylactic, diagnostic and therapeutic methods. It is not included the 
use of placebo or any other treatment to studies where there are no proven methods of prophylaxis, diagnosis or 
treatment;
c)   use the biological material and data obtained from the study solely to that  intended purpose in the protocol, or 
according to the consent granted by the research participant; and
d)   guarantee to all participants, at the end of the study and for unlimited time, free access to the best 
prophylactic, diagnostic and therapeutic methods that have proven their efficiency;
d.1) the access will also be guaranteed in the interval between the end of the individual’s participation and the  end 
of  the study,  in which  case this guarantee could  be granted by means of  an extension  study, according to a duly 
justified analysis from the doctor assisting the research participant.

IV – PROCESS OF INFORMED CONSENT FORM
Due  respect to human dignity  requires that  every research be carried out  after  subjects,  individuals  or groups,  
or  their  legal  representatives  have  given  the  respective  informed  consent  form  expressing  their agreement 
to participate in the research.
The Process of the Informed Consent Form refers to all steps the guests need to observe to participate in a research 
and to be able to manifest themselves as autonomous, conscientious, free and informed.
IV.1 – The first step of the Process of the Informed Consent Form refers to clarify the guests about their 
participation   in   the   research,   where   the   investigator   or   person   delegated   by   him/her   or   under 
  his/her responsibility should:
a)   look  for  the  right  moment,  condition  or  place  to  carry  out  the  clarification  taking  into  account  
the guests’ peculiarities and privacy to participate in the research;
b)   provide clear and accessible information using the most appropriate strategies referred to the culture, age, 
socio-economic conditions and autonomy of the subjects participating in the research; and
c)   grant the appropriate time so that the subjects participating in the research could think and consult, if 
necessary, their family or other people to help them take an informed consent decision.
IV.2 – Once the first step of clarification is completed, the investigator or  person delegated by him/her shall  
submit  the  Informed  Consent  Form  to  the  guest  participating  in  the  research,  or  to  his/her  legal 
representative, to be read and understood before the concession of the consent statement.
IV.3 – The Informed Consent must contain:
a)   justification, objectives and procedures that will be used in the research detailing the methods applied, 
notifying the possibility of their inclusion into control or experimental group, when applicable;
b)   explanation of potential discomforts and risks resulting from participating in the research, besides the benefits  
expected  from  such  participation  and  presenting  measures  and  cautions  to  avoid  and/or lower effects and 
adverse conditions that may cause damage, taking into account characteristics and context of the research participant;
c)   clarification  regarding  monitoring  and  assistance  that  the  research  participants  are  entitled  to, 
including the benefits and monitoring following the closure and/or interruption of the research;

d)   granting  of  total  freedom  to  the  research  participant  to  refuse  to  participate  or  to  remove  his/her 
consent at any stage of the research, with no penalty;
e)   granting  of  maintaining  confidentiality  and  privacy  of  all  research  participants  during  all  stages  of 
research;
f)    granting the research participant a copy of the Informed Consent Form;
g)   explanation of the reimbursement guarantee and how will the expenses of the research participants be covered and 
thereof;
h)   explanation  of  the  indemnification  guarantee  in  the  case  of  eventual  damages  caused  by  the research.
IV.4  –  The  Informed  Consent  Form  used  in  researches  adopting  experimental  methodologies  in  the biomedical 
area, involving human beings, besides that expected on item IV.3 above, must contain, necessarily, the following:
a)   explanation, where appropriate, of the existing alternative treatment methods;
b)   clarification  ,  where  appropriate,  regarding  the  possibility  of  including  the  participant  into  a  
control group or placebo, clearly explaining the significance of that possibility; and
c)   do not demand from the research participant, under any justification, a waiver of indemnification for damages. The 
Informed Consent Form shall not include any liability disclaim nor imply waiver by the research participant of his/her 
legal rights, including the right to procure indemnification for potential damages.
IV.5 – The Informed Consent Form should also:
a)   contain  a  statement  of  the  leading  researcher  expressing  the  compliance  with  the  requirements 
specified on items IV.3 and, where applicable, IV.4;
b)   be adapted to the ethical rules and to the local culture, by the leading researcher, on researches with foreign 
cooperation elaborated abroad, with clear and accessible language to all and particularly to the participants of the 
research, taking special care for easy reading and understanding;
c)   be approved by CEP to which the project was presented and by CONEP, when applicable; and
d)   be elaborated in 2 copies and with all pages initialed and signed at the end by the guest invited to participate 
in the research, or by his/her legal representative, as well as by the leading researcher or those delegated by 
him/her, and with all signed pages on the same sheet. Both copies shall state the address  and  contact  number  or  
other  of  those  responsible  for  the  research,  of  the  local  CEP  and CONEP, when applicable.
IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the 
following shall be complied with as well:
a)   researches  involving  children  and  adolescents,  individuals  mentally  disturbed  or  ill  and  those  who 
have  their  capacity  to  consent  substantially  reduced,  shall  include  in  the  protocol  unquestionable 
justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of 
informed consent statement by means of their legal representatives and the research participant, to the fullest extent 
of his/her capacity, is guaranteed the right to information;
b)   freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are  
exposed  to  specific  conditioning  or  authority  influence,  featuring  situations  restricting  their autonomy,  
specially  students,  members  of  the  armed  forces,  employees,  prisoners  rehabilitation, shelters,  nursing  
homes or religious  associations  interns and  alike,  in addition  to be free to decide whether or not to participate 
in the research, with no retaliation of any kind;
c)   researches   with   individuals   diagnosed   with   encephalic   death   may   comply   with   the   following 
requirements:
c.1) documentary evidence of encephalic death;

c.2)  a  written  consent  from  family  members  and/or  legal  representative  or  documentary  evidence  of 
individual’s will to participate in researches;
c.3) respect to human dignity;
c.4) no additional economic-financial burden to the family;
c.5) no prejudice to other patients awaiting hospitalization or treatment; and
c.6) likely to acquire new, relevant scientific knowledge which cannot be so acquired any other way;
d) the existence of an official government communication channel to clarify doubts to all those involved in the 
research projects, as well as for those cases of encephalic death diagnosis; and
e)  in  group  culture  communities  recognizing  the  leader’s  authority  or  the  collectiveness  upon  the 
individual,  the  authorization  for  the  research  should  respect  such  feature,  without  the  prejudice  of 
individual consent, when possible and desirable. The authorization for the research should be granted in advance by 
government bodies when the Brazilian Legislation rules upon their competence, like it is the case  of  the  National  
Indian  Foundation  (FUNAI),  where  indigenous  communities  are  under  their  own responsibility.
IV.7 – The research depending on restriction to information to the research participants, such restriction shall be 
fully explained and justified by the leading researcher and submitted to the CEP/CONEP. Data collected from the 
research participants may not be used for any other purposes other than those specified in the protocol and/or informed 
consent statement.
IV.8 – In cases where unfeasible to obtain the Informed Consent Form or that its obtaining may imply to substantial  
risks  to  the  privacy  and  confidentiality  of  the  research  participant’s  data  or  to  the  bonds  of  trust 
between investigator and investigated, the dismissal of such Statement Form must be rightly requested by the 
investigator to the CEP/CONEP System, for evaluation, without prejudice to the subsequent clarification process.

V - RISKS AND BENEFITS
Every research with human beings is considered to involve risks of different types. The bigger and more evident  the  
risks,  the  bigger  should  be  the  care  offered  by  CEP/CONEP  to  minimize  them  and  protect  the research  
participants.  Possibilities  for  immediate  or  further  damages  must  be  analyzed  at  an  individual  and 
collective  level.  The  analysis  of  risks  is  an  indispensable  part  to  the  ethical  analysis  which  generates 
 the monitoring plan that shall be offered by the CEP/CONEP System in each specific case.
V.1 – Researches involving human beings will be admissible when:
a) the risk is justified by the expected benefit; and
b) in case of experimental researches referred to health, the benefit is bigger, or, at least, equal to the already 
established options for prevention, diagnosis and treatment.
V.2  –  Researches  with  solely  indirect  benefits  to  their  participants  are  admissible  as  long  as  their 
physical, psychological, moral, intellectual, social, cultural and spiritual dimensions are considered.
V.3 – The leading researcher must immediately communicate to the CEP/CONEP System any significant risk or damage the 
research participant may suffer, stated or not in the Informed Consent Form and evaluate as an emergency the need to 
adjust or suspend the study.
V.4  –  In  the  health  area  researches,  the  researcher  shall  evaluate  the  need  to  adjust  or  suspend  the 
ongoing study as soon as the significant superiority of an intervention over other comparative(s) are recognized, 
aiming at offering all subjects the benefits of the best regimen.
V.5 – The CEP/CONEP System shall be informed of any relevant fact that may change the regular course of  the  studies  
approved  by  it  and,  specifically,  in  those  researches  related  to  health,  to  be  informed  of  the adverse 
effects and the significant superiority of a research upon other or other comparatives.
V.6 – The investigator, the sponsor and the institutions and/or organizations involved in different stages of the  
researches  shall  provide  immediate  assistance,  in  terms  of  item  II.3,  as  well  as to  be  responsible  for  
the complete assistance to all subjects when referred to complications and damages caused by such research.

V.7 – Every research subject who come to suffer any damages whatsoever in the future, whether or not indicated in the 
consent statement and resulting from his/her participation shall be entitled to indemnification on the part of the 
investigator, sponsor and institutions involved in the different stages of the research.

VI – RESEARCH PROTOCOL
The protocol to be submitted to ethical review will only be subject to examination if accompanied with all 
documentation required by the CEP/CONEP System, considering the nature and specificities of each research. Plataforma  
BRASIL  is  the  official  system  for  launching  researches  for  the  CEP/CONEP  System  analysis  and monitoring.

VII – CEP/CONEP SYSTEM
It  is  integrated  by  the  National  Commission  of  Ethics  in  Research  –  CONEP/CNS/MS  of  the  National Council 
of Health and by the Committees of Ethic in Research – CEP – composing a system using mechanisms, tools  and  proper  
instruments  of  inter-relationship,  cooperatively,  aiming  especially  the  protection  of  Brazil’s research 
participants, in a coordinated and decentralized manner by means of an accreditation process.
VII.1 – Researches involving human beings shall be submitted to the CEP/CONEP System evaluation, which  by  analyzing  
and  deciding,  it  becomes  the  co-responsible  for  guaranteeing  protection  to  all  research participants.
VII.2  –  The  CEP  are  interdisciplinary  and  independent  groups  of  a  public  function  and  advisory, 
deliberate, and educational nature, established to protect the interests of all research participants in their 
integrity and dignity and to contribute to the research development according to ethical standards:
VII.2.1 – institutions and/or organizations performing researches involving human beings shall establish one  or  more  
Committees  of  Ethic  in  Researches  –  CEP,  according  to  their  own  needs,  and  meeting  the normative 
criteria; and
VII.2.2 – in case of a non existing CEP in the applicant institution or in case of an investigator with no 
institutional affiliation, it shall be CONEP’s responsibility to indicate a CEP to perform the analysis of the research 
among those presenting the best conditions for monitoring such research.
VII.3 – CONEP is a collegiate body that is advisory, deliberative, legislative, educational and independent in nature 
and is linked to the National Council of Health/MS.
VII.4 – The ethical review of projects involving human beings shall be associated to its scientific analysis.
VII.5  –  Members  of  CEP/CONEP  System  shall  be  fully  independent  to  make  any  decision  they  deem 
appropriate in the discharge of their duties, safeguarding the confidentiality of the information received. Hence, they 
 shall  not  be  subject  to  any  pressure  whatsoever  on  the  part  of  higher-ranked  personnel  or  third  
parties interested  in  a  certain  research.  They  should  avoid  taking  decisions  when  involved  in  the  
research  under analysis.
VII.6 – Members of CEP and CONEP may not receive any compensation for the discharge of their duties, and   may   only   
receive   reimbursement   of   expenses   related   to   transportation,   lodging   and   meal.   It   is recommended, 
however, that during the regular working hours at CEP, or at CONEP, they are dismissed from their  other  obligations  
in  the  institutions  and/or  organizations  to  which  they  render  services  given  the  public relevance of the 
function.

VIII – COMMITTEES OF ETHIC IN RESEARCH (CEP) DUTIES:
VIII.1 – evaluate protocols of research involving human beings, with priority given to subjects related to public  
relevance  and  strategic  interests  for  the Unified  Health  System  (SUS)  priorities’  agenda,  based  on  the 
epidemiological indicators providing a duly justified opinion, always guided, among others, by the impersonality,

transparency,  reasonability,  proportionality  and  efficiency  principles  within  deadlines  laid  down  by  
operational standards, avoiding redundancies that may result in slowing down the analysis;
VIII.2 – perform an advisory and educational role in matters related to ethics; and
VIII.3 – elaborate its Bylaws.

IX – NATIONAL COMISSION OF ETHICS IN RESEARCHES (CONEP) DUTIES:
IX.1 – examine all ethical aspects of researches involving human beings, as well as to adapt and update all applicable 
rules, for which purpose they may refer to the society whenever they judge necessary;
IX.2  –  promote  popular  participation  in  initiatives  of  Social  Control  in  Researches  with  Human  Beings, 
besides establishing institutional CEP and other bodies, whenever such creation may imply in the strengthening of 
protecting the research participants in Brazil;
IX.3 – register and supervise the operation and cancel the registry of any other CEP that may form the CEP/CONEP 
System;
IX.4  -  evaluate  protocols  of  research  involving  human  beings,  providing  a  duly  justified  opinion,  always 
guided, among others, by the impersonality, transparency, reasonability, proportionality and efficiency principles 
within deadlines laid down by operational standards, avoiding redundancies that may result in slowing down the 
analysis;
1.   human genetics, when the project may involve:
1.1 shipments of human genetics overseas or any other human biological material for obtaining genetic material, except 
in those cases where there is cooperation with the Brazilian Government;
1.2 storage of biological material or human genetic data abroad and within the country, when part of an agreement with 
foreign institutions or with commercial institutions;
1.3 changes in the genetic structure of human cells for in vivo use;
1.4 researches in genetics of human reproduction (reprogenetics);
1.5 researches of genetics in behavior; and
1.6 researches in which irreversible dissociation of research participant’s data is expected;
2.   human reproduction: researches interested in the functioning of the reproductive system, procreation and  factors  
affecting  the  human  reproductive  health,  shall  consider  as  “research  participant’s”  all those who are 
affected by the procedures thereof. It will be up to CONEP to analyze the project when it involves:
2.1 – assisted reproduction;
2.2 – gametes, pre-embryos, embryos and fetus manipulation; and
2.3 – fetal medicine, when involving invasive procedures;
3.   therapy equipments and devices, new or not registered in the country;
4.   new invasive therapy procedures;
5.   studies with indigenous populations;
6.   research  projects  involving  genetically  modified  organisms  (GMOs),  embryonic  stem  cells  and organisms  
representing  high  collective  risk,  including  organisms  related  to  them,  in  areas  of: experimentation, 
construction, growing, manipulation, transportation, transfer, import, export, storage, release into the environment 
and disposal;
7.   setting up and functioning protocols of biobanks for research purposes;
8.   researches  with  coordination  and/or  sponsorship  originated  outside  Brazil,  except  those  with  the 
Brazilian Government co-sponsorship; and
9.   projects  that,  at  the  discretion  of  CEP  and  duly  justified,  were  judged  as  worthy  of  analysis  by 
CONEP;

IX.5  –  strengthen  the  participation  of  CEPs  through  a  continuous  process  of  training,  qualification  and 
accreditation;
IX.6  –  coordinate  the  CEPs  accreditation  process,  appointing  them  responsibilities  originally  from CONEP, 
according to their skill levels;
IX.7 – analyze and monitor, directly and indirectly, within the standards deadline, the research protocols that  may  
involve  needs  for  a  higher  protection  related  to  their  research  participants,  specially  the  risks thereof. 
Within such scope, it shall always be considered as first priority and, or in association, the national interests  in  
the  scientific  and  technological  development,  as  the  basis  for  determining  the  relevance  and opportunity 
for performing such researches;
IX.8  –  analyze and monitor,  directly  and indirectly,  research  protocols  with  conflict  of  interests that make 
the fair local analysis difficult and not viable;
IX.9 – rightly analyze any CEP/CONEP System protocol, whenever appropriate; and
IX.10  –  analyze,  urgently  and  with  special  processing,  research  protocols  with  relevant  public  interest 
such as those that contribute to the public health, justice and reduction of social inequalities and technological 
premises, upon request of the Ministry of Health or other organization of Public Administration, or even at the 
discretion of CONEP/CNS Plenary.

X – ETHICAL ANALYSYS PROCEDURES
X.1 – CEPs ETHICAL ANALYSIS DUTIES:
1.   it  is  CEP’s  responsibility  to  issue,  after  analysis,  a  duly  reasoned  opinion  in  which  the collegiate 
 decision  is  presented  in  a  clear,  objective  and  detailed  manner,  respecting  the deadline laid down in the 
operating standard;
2.   forward  CONEP’s  duties  protocols  after  an  informed  analysis,  according  to  the  current operating 
standards taking special care of all documentation that must follow such forwarding, including  the  detailed  proof  
of  expenses  and  the  financing  resources  necessary  for  the research;
3.   CEP shall also be responsible for:
a)   keeping  the  confidential  custody  of  all  data  obtained  while  on  duty  and  filing  the  complete 
protocol;
b)   monitoring  the  project’s  development  through  biannual  reports  from  investigators  and  other monitoring 
strategies, according to the risk inherent to the research;
c)   CEP shall keep the project, protocol and corresponding reports filed for a five-year period after the closure of 
the study, and such filing may be digitally processed.
d)   receiving complaints of abuse and notifications about adverse facts that might alter the study’s regular course, 
deciding on the continuation, modification or discontinuation of the research, requesting, if applicable, the change of 
the Statement Consent;
e)   requiring the opening of a research to the institution’s and/or organization’s board, or to the public competent 
bodies,  if known any case of complaints of irregularities  in the researches involving human beings and, if proved the 
existence of such complaints, communicate the fact to CONEP and, where applicable, to other authorities; and
f)    maintain   a   regular   and   ongoing   communication   with   CONEP,   through   its   Executive Secretariat.
X.2 – PROCEDURE OF CONEP’s ETHICAL ANALYSIS:
1. it is CONEP’s responsibility to issue a duly reasoned opinion, respecting the deadline to be laid down in the 
Operating Standard, with a clear, objective and detailed analysis of all elements and documents of the project;

2. CONEP shall also be responsible for the direct or indirect monitoring of all research protocols within its duties; 
and
3. the provisions about the Procedures of CEP’s Ethical Analysis are applied to CONEP in cases where it operates as 
CEP.
X.3 – COMMON PROVISIONS TO CEP AND CONEP:
1. members of CEP/CONEP shall exempt themselves from the case’s analysis and discussion, as well as from 
decision-making, when involved in the research;
2.  CEPs  and  CONEP  may  count  on  ad  hoc  consultants,  people  belonging  to  or  not,  an 
institution/organization, with the purpose of providing technical support;
3. a research lacking its protocol shall not be analyzed;
4.  any  approved  research  that  becomes  discontinued  by  the  leading  researcher,  without  an acceptable  
justification  satisfactory  to  the  CEP  or  CONEP,  approving  such  research  shall  be considered an unethical 
investigation;
5. CEP’s review shall be completed upon its classification under one of the following categories:
a) approved;
b) outstanding: when CEP considers the correction of the presented protocol as necessary, and requests  specific  
review,  change  or  relevant  information,  which  shall  be  performed  within  the deadline laid down in operating 
standard; and
c) not approved;
6. CEP may request, if judged as convenient and appropriate while performing the ethical review, information,  
documents  and  others  needed  for  the  well  understanding  of  the  issues,  and discontinue the procedure until 
confirming the receipt of said elements;
7. should the decision be not approved, it shall be CEP and/or CONEP’s responsibility to appeal, within 30 days, 
whenever a new fact is presented to substantiate the need for a reevaluation;
8.  CEPs  and  CONEP  shall  determine  the  research  protocol  filing  in  cases  where  the  leading researcher did 
not meet the requests addressed to him/her within the stated deadline. They shall also consider the withdrawn protocol 
when requested by the leading researcher;
9.  once  the  project  is  approved,  CEP,  or  CONEP  in  situations  acting  as  a  CEP  or  under  the operation of 
 its original duties,  it  becomes the co-responsible for that referred to the research’s ethical aspects; and
10. shall be considered as authorized for implementation those projects approved by CEP, or by CONEP when in situations 
acting originally as a CEP or under the operation of its duties.

XI – LEADING RESEARCHER
XI.1  –  The  researcher  has  a  non  transferable,  indeclinable  responsibility  which  includes  the  following 
ethical and legal aspects:
XI.2 – The investigator is required to:
a)   submit  the  duly  guided  protocol  to  CEP  and  CONEP,  awaiting  for  the  ethical  approval decision before 
starting the research;
b)   elaborate the Informed Consent Form;
c)   develop project as designed;
d)   prepare and submit interim and final reports;
e)   submit all data requested at any time by CEP or CONEP;
f)    keep  under  his/her  custody  and  responsibility  for  5  years,  records  of  all  research  data, physical or 
digital, after the closure of such research;
g)   forward  all  results  for  publication,  including  the  respective  acknowledgments  concerning associate 
investigators and technical staff participating in the project; and

h)   submit to the relevant CEO or CONEP reasonable, acceptable explanation for discontinuation of a project or non 
publication of any results.

XII – OTHER PROVISIONS
XII.1  –  Every  area  of  research  and  each  research  modality,  in  addition  to  abide  by  the  provisions 
contained in this Resolution, shall comply with all branch requirements and specific regulations.
XII.2 – Research promotion agencies and editorial staff of scientific journals shall require documentary evidence of 
project’s approval by the CEP/CONEP System.
XII.3 – By virtue of the contextual nature of all considerations contained herein, this Resolution will be subject to 
regular reviews to meet the requirements of the technical-scientific and ethical areas.

XIII – RESOLUTIONS AND SPECIFIC RULES
XIII.1  –  The  assessment  procedures  of  research  protocols,  as  well  as  the  specific  aspects  of registry,  
like  concession,  renewal  or  cancellation  and,  also  accreditation  of  Ethical  Committees  in Research shall be 
regulated by Resolution from the National Council of Health.
XIII.2 – The accreditation process of Ethical Committees in Research that form the CEP/CONEP System shall be treated by 
a Resolution from CNS.
XIII.3   –   Ethical   research   specificities   in   social   and   human   science   and   others   adopting 
methodologies   from   those   areas   shall   be   addressed   in   complementary   resolution,   given   their 
particularities.
XIII.4 – Ethical research specificities with strategic interest for SUS shall be addressed in specific complementary 
Resolution.
XIII.5  –  Procedural  and  administrative  aspects  of  CEP/CONEP  System  shall  be  treated  in Operating Standard 
from CNS.
XIII.6 – Risk typification and gradation in different research methodologies shall be defined by the National Council 
of Health own rule.

XIV – FINAL PROVISIONS
Resolutions CNS no. 196/96, 303/2000 and 404/2008 are hereby repealed. This Resolution shall come into force upon 
publication.



ALEXANDRE ROCHA SANTOS PADILHA
President of the National Council of Health


I approve the Resolution CNS no. 466 of December 12, 2012, pursuant to the terms of the Decree of Delegation of 
Authority dated November 12, 1991.


ALEXANDRE ROCHA SANTOS PADILHA
Ministry of State for Health



Published in DOU nº 12 – Thursday, June 13, 2013 – Section 1 – Page 59]