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Decree-Law No. 26/2007
of July 30
Several studies on human beings are carried out in the country, without the approval of an Ethics Committee for this purpose.
National, permanent, that disciplines their performance, making research interests compatible and respect
by the human condition.
Efforts have been made to create ad hoc Ethics Committees, whose scope of action is very limited.
Considering that research with human beings is necessary to clarify epidemiological aspects,
therapeutic and prophylactic diagnoses of various diseases that affect humanity in general and our
populations, in particular, it is necessary to set up an Ethics Committee for health research,
permanent and independent of all political, institutional, professional and economic influences.
c) A representative of the Medical Association;
d) A representative of the Bar Association;
e) A representative of the NGO Platform;
f) A representative of a religious institution;
g) A representative from the University of Cape Verde.
2. The representatives of the bodies and institutions referred to in paragraph 1 of this article are appointed by the
competent bodies or entities.
3. CNEPS members are appointed by order of the Government member responsible for health, published in the
Official Bulletin.
4. The President of CNEPS is elected, from among its members, under the terms provided for in the respective regulations
internal.
5. The CNEPS Secretariat is provided by the Directorate
General of Health.
Like this,
In the use of the option conferred by subparagraph a), paragraph 2, of article 203 of the Constitution, the Government decrees the following:
Article 1
Object
The National Research Ethics Committee for Health, CNEPS for short, is created.
Article 2
Nature
CNEPS is an autonomous and independent, multisectoral and multidisciplinary entity, which ensures safeguarding
dignity, rights, security and well-being of all potential research participants
to health.
Article 3
Scope of application
1. The present diploma applies to services and public and private bodies that intervene in the area of
Cheers.
2. The provision of the previous number covers the personnel
perform functions in the respective services and bodies.
Article 4
Composition
1. CNEPS has the following composition:
a) A representative of the Ministry of Health;
b) A representative of the National Human Rights Commission;
Article 5
Mandate
1. The mandate of CNEPS members lasts for 2 years, renewable for an equal period.
2. Membership in the CNEPS does not confer any
the perception of any remuneration.
Article 6
Assignments
CNEPS is responsible for:
a) To guarantee the safeguarding of dignity, rights, security, well-being and all aspects of the
integrated care of the subjects object of research;
b) Undertake an independent, competent and diligent examination of the ethical aspects of research protocols in human beings
humans;
c) Monitor the process of conducting the research, taking into account the legislation on the matter in force
in the country;
d) Approve its internal regulations.
Article 7
Powers of the President
1. The CNEPS President is responsible for:
a) Chairing Committee meetings;
b) Convene the Committee's meetings and prepare the respective agenda;
c) Dispatch the Committee's affairs and appoint the rapporteurs;
d) Guide and coordinate the Committee's secretariat.
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Article 8
Operation
1. The CNEPS meets ordinarily once a month and, extraordinarily, whenever called by its President,
on its own initiative or at the request of 4 of its members.
2. CNEPS approves its internal regulations at its first meeting, convened by the Director-General for Health.
3. CNEPS members may consult with experts in certain areas, whenever they deem necessary.
4. CNEPS decisions can only be taken at meetings where at least four of its members are present.
5. All members present at the meeting must participate in the decision-making process, with no abstentions.
However, declarations of unsuccessful votes must be made.
6. CNEPS decisions are taken by consensus, and in the absence of this, the decision must be taken by a majority of members
present, with the President having the casting vote.
7. The minutes of the meetings must be approved and signed by all members present,
disagreeing with the content of the same, to state the respective declarations of overdue vote.
Article 9
Research processes
1. The research processes submitted to CNEPS are
instructed with the following documents, in three copies:
a) Research protocol;
b) Informed consent form;
c) Curriculum vitae of the responsible researcher.
2. The processes referred to in number 1, must be sent to CNEPS, accompanied by a letter signed and dated by the
applicant, containing the list of documents submitted, the specification of the research title and the indication of the
address, through which the CNEPS must notify its opinion.
3. CNEPS may request other documents that it understands
necessary for the analysis of the process.
4. Research processes, organized in accordance with the provisions of paragraph 1, must be submitted with a
at least 15 days prior to the date of the next CNEPS meeting, either directly or by mail
registered with the Directorate-General for Health.
Article 10
Incompatibilities
1. CNEPS members who are interested in the research must not participate in the respective process
deliberative.
2. The provisions of paragraph 1, must be communicated before the process under analysis and must be included in the minutes of the meeting.
Article 11
Deliberation
1. Resolutions must be notified in writing to the Ministry of Health and the researchers who submitted the
research protocol, within two weeks, counting from the date of the meeting in which they were taken.
2. The notification referred to in paragraph 1, must be made
clearly and contain the following elements:
a) The exact title of the problem to be examined;
b) The specific identification of the examined documents, including the consent forms;
c) The detailed description of the resolution;
d) Any CNEPS guidelines;
e) The signature of the CNEPS president or other authorized member;
f) Date of the opinion issued by CNEPS.
3. In the case of a conditional deliberation, the CNEPS must:
a) Notify the requirements, with appropriate suggestions for reviewing the problem, as well as the procedures for a new
examination of the study;
b) Ask the researcher to confirm the acceptance of the CNEPS requirements, as well as a communication, in the case of
a modification of the protocol, either in relation to the conditions of participation of individuals in the study or in
with regard to the consent forms, the methodology.
5. In the case of an unfavorable opinion, the CNEPS
it must substantiate the respective resolution.
6. Human study should only be started
after its approval by CNEPS.
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Article 12
Implementation
This law enters into force on the day following its publication.
Seen and approved by the Council of Ministers.
José Maria Pereira Neves - Basílio Mosso Ramos - Cristina Duarte - José Manuel Andrade
Enacted on 25 July 2007.
Publish yourself.
The President of the Republic, PEDRO VERONA RO- DRIGUES PIRES
Countersigned on July 26, 2007.
The Prime Minister, José Maria Pereira Neves
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