t 1 i’i iii1.ifitJ i: ai i iii NiN
Law No. 20J 0-40 OF 08 DEC EMBRE 2010
S u4e ò le Dc.c: ision cte c: onforrnitú ò lo Ccns] itr tion DCC 10- i 41 to 23 rJovcrriLore 2010 le
lo Constitutional Court.
FIRST TITftE
PROVISIONS WILL GENERATE
CHAPTER 9 i FIRST
f? F I ¢ 'ïJf f. FROM THE FIELD OF APFI.IÚATION bï DLS PEOPLE
£ Jrï + I? CESES OF HEALTH RESEARCH
Article 2 I.G rr ›r: rx ° rchc + in scene or subject of
“” Me !! re or poinï keys tools to prevent and treat the rr! A! Adie or in o] 1 ‹.nu‹ ›r ir› s ‹-› ffets:
c.r) () .cgdi (very close and efficient approaches to the provision of ella sor ›tú both air care
divicJu .to the community:
c ‹› i ›lrtbr› er è better equip health profesnIes o for disease prevention purposes, Ile
health restoration and key
Article S: When the yromotor conties the moth in action with a connection see a team of
seekers, he appoints among them a principal researcher.
When the research is undertaken by several teams, these
appoint a coordinator within them.
CHAPTER II
PRINCIPLES OF RESEARCH ETHICS IN SAN-fE
Article ó Any research involving subjects carried out with respect for the following principles
- human dignity and human rights
- human vulnerability and personal integrity;
- anonymity;
- confidentiality ;
- socio-cultural beliefs and practices
- the innocent
-! cctiori beneficial research:
- research equity
- the return of the residues to the persons concerned; the rules for dissemination and use of results:
“Sharing the benefits of research.
dots elre
Article 7: The implication of human beings, as research objects, must be limited to the
possibility for them to consent freely and in all knowledge of caose.
These people have the flexibility to opt out of the research program at any time
without fear or threat.
Article 8: Clinical research and / or biomedical research cannot be carried out on a person
state of brain death only with his consent or that of his family, previously expressed in writing.
Article 9: The use of human cells for research purposes must be done in accordance with
to the texts in force.
Article 0. The use of animals for research must be done
so respect the texts in force.
TITLE II
THE FIELDS OF HEALTH RESEARCH CHAPTER ONE
APPLICATION AND CO / <POS ANTS OF HEALTH RESEARCH
Article 11: Epidemiological research, clinical research, biomedical research, research
in traditional medicine and research on health systems on different components
by this law.
Article 12 Epidemiological research is always studied with the aim of measuring the factors determining or
influencing the occurrence or persistence of a problem of a given population.
Article 13: Clinical research and biomedical research clear the diagnoses, the
organist and direct trials or experiments on humans and / or animals
en we du Cï Velcț: ° yeiтIenI Yes COnnaİSSOnCe S mÓdiCale S = ï yf urmaC eUtiCjUEzS.
Article 14: The research in traditional medicine is that which is interested in the practices of care of
health employed by individuals, groups and by a community, part of the 1st most oral traditions.
Article 15: The research on sanłé systems is that which pori on Yes di @ ositions łégislatives et
regulations relating to disease prevention and care in the matades as well as sug Yes
administrations, people and equipment contributing to it.
CHAPTER II
MODALITIES OF HEALTH RESEARCH
Article 16: Epidemiological research is concerned with the state of health of populations and its variations
in time and in space.
It can be descriptive, analytical, evaluative, experimental, prospecting, reflective and / or
Theoretical.
Article 17: Clinical research and biomedical research are with or without direct individual benefit.
They are called clinical and biomedical research with direct individual bérièz, when
is at tenóu a loúne direct file the çertonne which lends itself to it.
’. *
All other clinical and bioméôicale research, whether it concerns sick people or
no, are named without direct individual benefit.
Article 18: Research in irradition medicine aims to
validate the therapeutic properties of medicinal plants and animal and mineral extracts as well as
their uses in treatment says them cre my afleclions
‹Work effectively for the development of LC products›
traditional múder ine who have already done their therapeutic care, while at the same time
hygienic packaging and ò their good conservation, with a view to use nationally, regionally and
intefnalionole.
Article J 9 The research on health systems aims to promote decision-making
rational for the optimal management of establishments and structures of the health system.
This management aims to ensure, at a lower cost and with a better quality of service, the promotion of
health and preventive care. curative, rehabilitative and promotional to the different
system levels
TITLE ül
CONDITIONS FOR PERFORMING RESEARCH IN ITS NTE
FIRST CHAPTER
EPIDEMIOLOGICAL RESEARCH
Article 20: Any epidemiological research applied to a group of individuals to a community must
require the prior consent of its legal representatives.
When a group of individuals or a community to be studied must be represented by
as an authorized person, the researcher must ensure the authenticity of his mandate.
Article 21: The informed consent on an individual basis of persons participating in any research
epidemiological is mandatory.
Lr '. consent is said to be enlightened when the person sought omits the purpose and nature of the
research, the obligations involved in his payment, as well as the risks and benefits that
can unravel it.
Refusal of individual participation in such research must be
! ibre and respected.
Article 22: When groups of individuals are formed for the purposes of epidemiological and
if it is not possible to identify their representative, the researcher must obtain informed consent
and free from any of the people called to participate in this research.
Article 23: Informed consent is not required in the event that
it is impossible to locate people participating in any
search for which your files will be examined:
there is a risk of bias in the results of certain researches or in persons participating in a
research is likely to modify ”leuts behaviors.
CHAPTER II
RESEARCHCNNI4UEETBOVE0CALE
Article 24: Clinical and biomedical research must be carried out:
- under the direction of a researcher who, if he is not a mechanic, must be assisted
a doctor with at least five (05) years of experience in the field concerned;
under material and technical conditions adapted to the study and compatible with the imperatives of
scientific rigor and safety of people who lend themselves to this research.
Article 25: All clinical and / or biomedical research on humans must
be based on the latest state of scientific knowledge and on pre-clinical experimentation
sufficient
provide those affected with a much higher benefit
at the foreseeable risk incurred,
- aim to extend scientific knowledge on human beings and
means raised tibIes öe mointeùit.ô 6! a ”improving one's health.
A.rtïcïe. 26 "’ F'réolablerñent ü to realization clone. Recherchec.he c) ini4 ue
eî / or biomedical on a person, ïe free consent., éC) air and express of this1 it must be collected after
that I researcher made him known
- The objective of your research, its methodJogy and its cluré:
- expected results, foreseeable constraints and risks, even in
cases of research being stopped before its end;
the opinion of the National Ethics Committee for Health Research (CNERS) provided for in Articles 43 and
following of this law.
The researcher informs the person with consent is requested of his right to refuse to participate in the
seek or withdraw their membership at any time without incurring any threat.
Consent is given in writing or, if not possible, certified by a third party. The latter must be completely
independent of the researcher and the promoter.
Article 27: Minors and adults protected by Ioi aamis in a health or social establishment do not
may be requested for clinical and / or biomedical research as may be expected
a direct benefit for their health and after advice from the father and / or mother, tutor or curator.
However, they can be researched without individual benefit! direct in case these meet the
following conditions:
- present no foreseeable serious risk to their health
- be useful! présentant people with the same characteristics
age, sex and forestay;
- cannot be done otherwise.
Ariicle 28: When clinical and / or biomedical research is carried out on minors or
of adults protected by law, consent must be given by:
- holders of parental authority, for minors not
emoncipated;
- the legal representative, for research with direct individual benefit that poses no risk
predictable serious, for minors or adults protected by the Ioi;
- the guardian authorized by the family council or the guardianship judge, in other cases.
Article 29: cliniquea clinical and / or biorüëdicôle research. Requires prior subcontracting by 3on
›Promoter, Ö'ùne assurance parantissônt sa
ü / ”óÓ: r” itíeriü = üü ”: D
“'")' '”') '” “' '\“ ”" ”” ”' '“' '”'” ”“ “” '”“)' '”'” ”'” “.” - ” ”“ ')' '' "''“ '““ ”” ””' ””
”'” "”' ”'“ ”“' ”” ””
'Article 30: Research, or clinical or medical treatment does not give rise to any direct financial or
indirect for people who lend themselves to it, apart from reimbursement of the costs to which they are exposed
and subject to special arrangements made by the National Research Ethics Committee
in health.
Article 31. Clinical and / or biomedical research with or without direct individual benefit should not
involve no foreseeable serious risk to the health of persons who lend themselves to it.
It must be preceded by a medical examination of the persons concerned. performed by a designated physician
for the principal investigator or
the coordinator among the doctors approved by the Ô'éïhiqve National Committee for Research in
health. The results of this examination are communicated to them through the doctor of their
before the expression of their informed consent.
Article 32: No one may lend himself simultaneously to several clinical or biomedical research for his benefit
individual direct.
Before submitting persorin to clinical and / or biomedical research, the researcher has the obligation to
check if it is not already involved in a research in progress.
For each researches its direct individual benefit. ! th protocol submitted to the opinion of the National Committee
of ethics for health research determines a period of excitement during which your person
who lends itself to it cannot participate in another research for its therapeutic = direct aim. The duration of
this period varies depending on the nature of the research.
Article 33. Clinical and / or biomedical research for direct individual benefit must be carried out
a place equipped with material and technical resources suitable for research and compatible with Res imperatives of
safety of people who lend themselves to it. The research site thus defined must be flown by the Minister
in charge of health, according to the opinion of the National Ethics Committee for Health Research.
Article 34: Any clinical and / or biomedical research Cjvec or without direct individual benefit on the
pregnant women, parturients and nursing mothers must meet the following conditions
- be devoid of any foreseeable serious risk to the health of the mother
and / or the child;
- to be ”useful õ the knowledge and phenomena of pregnancy, the”
acceuühe eril “u de: i’ lalter ente “” ”
Article 35: 'use for therapeutic purposes of organs, tissues or cells of onimal origin which
are neither medicinal devices, nor intended for "generic or celiac therapies, is not
possible that donations within the framework of clinical and / or biomedical research subject to the provisions of this law.
Article 36. By way of derogation from the provisions öe io presents Ioi, clinical research and / or
Diomedical concerning the therapeutic use of such organs, tissues or cells in humans cannot
be implemented only after authorization by the Minister for Health, assent of the
National Ethics Committee for Health Research.
The authorization may be subject to specific conditions relating to the
long-term monitoring of patients.
Article 37 Good practices ›relating to harvesting, storage, processing,
transport and use of orpanes, tissues and cells of animals, bound together by the
ministers in exchange for health and high school, on the proposal of the National Ethics Committee for the
health research.
Article 38. Joint decrees $ devit minrelre $ in charge of health and elevation fix
- the practical dv = cap relating to selection, production and breeding of animals;
- the health conditions $ to which the animals from which the orpanes, tissues and
cells used;
the rules of identification of cew animals, orpanes, tissues and cells allow ant to assess the TFOÇability of
products obtained.
Article 39: In the event of clinical and / or biomedical research ò to implement donations of emergency situations which do not
not allow the prior consent of the person who will be subject to it to be obtained, the protocol
presented to ò I‘avi $ from the National Ethics Committee for Health Research may provide that the consent of
this person will not be sought and that feul bera sought, that of $ members of so Camille donations Yes conditions
provided for in Article 26 of this law. The interested in zero informed, as soon as possible, and his con $ enîemenJïui
will be requested for ÓvenJuelle's further research.
CHAPI-ARE III
RESEARCH IN MED ”ECILIA ïRADìTJONNEŁLE
40 Ła research in medicine tr.a..ditionne.1ïe.
must be
donations of material conditions $ and techniques adapted to research and compatible with
imperative of scientific response and safety of people who lend themselves to this research.
Article 41: All research in traditional medicine on the eye
humoin must
- be based on an ethnomedical study:
- settle on! c confirmation by the doctor of the diagnosis and the therapeutic result;
- provide the persons concerned with a benefit far greater than the foreseeable risk incurred
- aim to extend scientific knowledge of the human being and the means likely to maintain or
to improve their state of health:
- require the prior approval of the Nationa County! of ethics for health research.
CHAPTER IV
FROM RESEARCHER LESSYSTEVESDESANTE
Article 42: All research on health systems must require:
- the active participation of health professionals and managers of the healthcare system;
- the agreement and participation of the individuals, troops and communities concerned:
- the prúoloble agreement of the National Ethics Committee for Research in $ anłé.
TITLE IV
HEALTH RESEARCH MONITORING
FIRST CHAPTER
OF THE CONIROLE BODY
Article 43: The National Ethics Committee for Health Research (CNERS) is hereinafter called: “ïe
6omite * ’.
.The Committee is I organize; from coяł ‹ôie de to research in .sontë en
R% p.Ÿ, bl.¡.9ÿ, e.ô?, Ğ - * '^' n. , ..,. ./ ’.. ^ .. ... - ..:
Arłíč) e "4: Un” @ ëcтeÎ fś en co: nseiI des miD1streз, ”SUf‘ proposìłiOn of the Minister in charge of Health,
determines to 'omposition. 1es attributions and Yes modalities of functioning of the Committee.
Article 45: The Comiłé is placed under the supervision of the Minister in charge of
CHAPTER II
OF THE IMPLEMENTATION OF THE CONTROL
Article 4b: Examination of any epidemiological research protocol requiring the presence of doin witness troops
›Ensure that
s ”
- the benefits, yes risks, contiaintes and effectiveness of the new method are èwiu-c * far
comparison with the best òiagnostic, ihći-op = ulic or preventive methods in use;
- the control group receives a placebo only when there is no proven treatment for the targeted disease
; however, even if there is a proven treatment, placebo-controlled trials may be
ethically acceptable under the following conditions
* when, for compelling and scientifically sound methodological reasons, it does not exist
other ways to determine the effectiveness or safety of the new
prophylactic, diagnostic or therapeutic method:
* when a prophylactic, diagnostic or therapeutic ethc is being tested for a
mild condition and that participation in the trial does not expose to additional risks of
significant or lasting damage.
- if the efficacy of the treatment treated in the experimental group is greater than that of the treatment
Usually used, you are immediately included in the trial.
Article 47 When the research proposal is initiated from outside Benin by a physical person or
moral, it must be accompanied by the opinion of the Ethics Committee of the initiating country or of any other structure
Taken place, before its examination by the Committee.
TITLE V
OFFENSES AND SANCTIONS
Un'one with two pines only. ”-” ”” "" ""
The same sentences are appfcaõles ïotsque I consentemont has: been
removed before research is carried out.
The penalty incurred when it is a legal person is a fine of five million (5,000,000) ò
fifteen million (15,000,000) francs.
(1,000,000) ò five million (5,000,000) = francs when the culprit is a physical person.
Article 50: Or * the penalties provided for in article 49 above, the culprit incurs the following sanctions
- the ban on civil, civil and family rights in accordance with the
provisions of the penal code;
- the prohibition for a period of two (02] years to five (05) years, to exercise the professional activity or
social on the occasion of which or donations the exercise of which the offense was commrr ›ise:
- confiscation of the body of the offense
- exclusion from submission to tenders for the award of publica contracts for a period of
five (05) years to ten (10) years.
The penalty for a legal person is a fine of five million (5,000,000j ò
fifteen million (15,000 "00òj of francs. It is also possible to impose the penalties provided for in the 2nd ^ 3rd and 3rd
= e dashes
from the previous paragraph.
Article 51: Is punished by imprisonment of six (06) months to twelve (12) months and a fine of one million (1,000,000)
ò five million (5,000,000) francs or one of these two sentences only
- QL4concon has practiced or has practiced clinical and / or biomedical research and research in
traditional medicine in violation of the respect for confidentiality provided for in article ó of this law:
- anyone who has practiced or has practiced clinical and / or biomedical research and research in
traditional medicine without having obtained the prior notice provided for in articles 26, 41 and 42 of this law;
- anyone who practiced or had to practice, forced to practice or
: ArtiCïe ’$ 2: I.e romoteur Carib la‹ espón'sObiIité c1vi.le is not guaranteed for the insurance provided 1
rticle 29 óe Jo presehte law is punishable by imprisonment of six (06d months to twelve (I 2) months and a
fine of mi) Iion (1,000,000) ò five million (5,000,000) francs or one of these two penalties
only.
Article 53: The fact of practicing or having practiced on a person clinical and / or biomedical research
and research in traditional medicine authorized but having resulted in a homicide invo! on1aire por
clumsiness, recklessness, inattention, negligence or non-observance of the rules is punished by
imprisonment of six (06) months to two (02) years and a fine of five hundred thousand (500,000) francs to one million (1
000 000) of francs or one of these two penalties only.
i!
.
Article S4: The llit to practice or to have practiced on a person a research cLr that eï
biomedica! ei / or a cec nercne in traditional medicine auiorisüe evils having caused injuries
involuntary or an ayanï eriïraïné maiaòie by default of address of precaution an incapacity
temporary work for the tujet is Rum of imprisonment of one (0)) month to twelve (12) words and one
omenÓe de cinçu ‹orite mille (CO 000) llanes à two hundred and fifty thousand (250,000) francs or one of
these dest. penalties only.
Article S5: CuicGnque cura practiced or made yrctiquer sound the consent of the subject we sound the opinion
of the Committee clinical research and / or biomedicine and research = Research in traditional medicine having trained! s
subject's death will be punished! this is a criminal imprisonment for five (05) years to ten () 0) years.
If there is an inability to work for one to two (1) days, the sentence will be imprisonment for six (06) months ò
two (02) years and an intake of five
one hundred and one ¡soo ooo; f ‹anc› ò en mi ion q ooo oooi franc ›.
If the temporary incapacity for work is less than twenty and one (2] days, the penalty shall be one
imprisonment of six 06) words ò eighteen (18) months and a fine of five hundred thousand 500,000) francs ò
one million (1,000,000] francs or one of these two sentences only.
IlTREVI
DlSPOS! FNALE FLONS
Article S6 The present law which repeals all previous contrary provisions, will be executed as Boi
of State.
Pat le '‹esident de Ja képub1ique,
Head of J'Etaï, Head of Gocverriement.
”Dr. 8ONI YAYI. -
The Minister of State in charge of Prospectve, Development,
Public Policy Assessment and Coordination
of Government Action.
The Minister of Health,
.] ^
''
Issifou TAKPARA .-
The Keeper of the Seals, Minister of Legislation and Human Rights
I Man,
c ° ..: *. "*.,. 7.4) ''
Gréqroire AKOFOD.II
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