79C3C34C52B45572883A05D425EB0F82
Law no. 2010-40 of 2010, Regarding the Ethical Code and Duties in Health Research
http://ethique-sante.org/pdf/loi-portant-code-ethique.pdf
http://leaux.net/URLS/ConvertAPI Text Files/AB728E40329491EB69B36E69052DB31C.en.txt
Examining the file media/Synopses/AB728E40329491EB69B36E69052DB31C.html:
This file was generated: 2020-12-01 09:12:23
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
Searching for indicator criminal:
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p.(None): rticle 29 óe Jo presehte law is punishable by imprisonment of six (06d months to twelve (I 2) months and a
p.(None): fine of mi) Iion (1,000,000) ò five million (5,000,000) francs or one of these two penalties
p.(None): only.
p.(None): Article 53: The fact of practicing or having practiced on a person clinical and / or biomedical research
p.(None): and research in traditional medicine authorized but having resulted in a homicide invo! on1aire por
p.(None): clumsiness, recklessness, inattention, negligence or non-observance of the rules is punished by
p.(None): imprisonment of six (06) months to two (02) years and a fine of five hundred thousand (500,000) francs to one million (1
p.(None): 000 000) of francs or one of these two penalties only.
p.(None): i!
p.(None): .
p.(None): Article S4: The llit to practice or to have practiced on a person a research cLr that eï
p.(None): biomedica! ei / or a cec nercne in traditional medicine auiorisüe evils having caused injuries
p.(None): involuntary or an ayanï eriïraïné maiaòie by default of address of precaution an incapacity
p.(None): temporary work for the tujet is Rum of imprisonment of one (0)) month to twelve (12) words and one
p.(None): omenÓe de cinçu ‹orite mille (CO 000) llanes à two hundred and fifty thousand (250,000) francs or one of
p.(None): these dest. penalties only.
p.(None): Article S5: CuicGnque cura practiced or made yrctiquer sound the consent of the subject we sound the opinion
p.(None): of the Committee clinical research and / or biomedicine and research = Research in traditional medicine having trained! s
p.(None): subject's death will be punished! this is a criminal imprisonment for five (05) years to ten () 0) years.
p.(None): If there is an inability to work for one to two (1) days, the sentence will be imprisonment for six (06) months ò
p.(None): two (02) years and an intake of five
p.(None): one hundred and one ¡soo ooo; f ‹anc› ò en mi ion q ooo oooi franc ›.
p.(None): If the temporary incapacity for work is less than twenty and one (2] days, the penalty shall be one
p.(None): imprisonment of six 06) words ò eighteen (18) months and a fine of five hundred thousand 500,000) francs ò
p.(None): one million (1,000,000] francs or one of these two sentences only.
p.(None): IlTREVI
p.(None): DlSPOS! FNALE FLONS
p.(None): Article S6 The present law which repeals all previous contrary provisions, will be executed as Boi
p.(None): of State.
p.(None): Pat le '‹esident de Ja képub1ique,
p.(None): Head of J'Etaï, Head of Gocverriement.
p.(None): ”Dr. 8ONI YAYI. -
p.(None): The Minister of State in charge of Prospectve, Development,
p.(None): Public Policy Assessment and Coordination
p.(None): of Government Action.
p.(None): The Minister of Health,
p.(None): .] ^
p.(None): ''
p.(None): Issifou TAKPARA .-
p.(None): The Keeper of the Seals, Minister of Legislation and Human Rights
p.(None): I Man,
p.(None): c ° ..: *. "*.,. 7.4) ''
p.(None): Gréqroire AKOFOD.II
...
Political / political affiliation
Searching for indicator party:
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p.(None): scientific rigor and safety of people who lend themselves to this research.
p.(None): Article 25: All clinical and / or biomedical research on humans must
p.(None): be based on the latest state of scientific knowledge and on pre-clinical experimentation
p.(None): sufficient
p.(None): provide those affected with a much higher benefit
p.(None): at the foreseeable risk incurred,
p.(None): - aim to extend scientific knowledge on human beings and
p.(None): means raised tibIes öe mointeùit.ô 6! a ”improving one's health.
p.(None): A.rtïcïe. 26 "’ F'réolablerñent ü to realization clone. Recherchec.he c) ini4 ue
p.(None): eî / or biomedical on a person, ïe free consent., éC) air and express of this1 it must be collected after
p.(None): that I researcher made him known
p.(None): - The objective of your research, its methodJogy and its cluré:
p.(None): - expected results, foreseeable constraints and risks, even in
p.(None): cases of research being stopped before its end;
p.(None): the opinion of the National Ethics Committee for Health Research (CNERS) provided for in Articles 43 and
p.(None): following of this law.
p.(None): The researcher informs the person with consent is requested of his right to refuse to participate in the
p.(None): seek or withdraw their membership at any time without incurring any threat.
p.(None): Consent is given in writing or, if not possible, certified by a third party. The latter must be completely
p.(None): independent of the researcher and the promoter.
p.(None): Article 27: Minors and adults protected by Ioi aamis in a health or social establishment do not
p.(None): may be requested for clinical and / or biomedical research as may be expected
p.(None): a direct benefit for their health and after advice from the father and / or mother, tutor or curator.
p.(None): However, they can be researched without individual benefit! direct in case these meet the
p.(None): following conditions:
p.(None): - present no foreseeable serious risk to their health
p.(None): - be useful! présentant people with the same characteristics
p.(None): age, sex and forestay;
p.(None): - cannot be done otherwise.
p.(None): Ariicle 28: When clinical and / or biomedical research is carried out on minors or
p.(None): of adults protected by law, consent must be given by:
p.(None): - holders of parental authority, for minors not
p.(None): emoncipated;
p.(None): - the legal representative, for research with direct individual benefit that poses no risk
p.(None): predictable serious, for minors or adults protected by the Ioi;
p.(None): - the guardian authorized by the family council or the guardianship judge, in other cases.
p.(None): Article 29: cliniquea clinical and / or biorüëdicôle research. Requires prior subcontracting by 3on
p.(None): ›Promoter, Ö'ùne assurance parantissônt sa
p.(None): ü / ”óÓ: r” itíeriü = üü ”: D
p.(None): “'")' '”') '” “' '\“ ”" ”” ”' '“' '”'” ”“ “” '”“)' '”'” ”'” “.” - ” ”“ ')' '' "''“ '““ ”” ””' ””
p.(None): ”'” "”' ”'“ ”“' ”” ””
...
Political / vulnerable
Searching for indicator vulnerability:
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p.(None): t 1 i’i iii1.ifitJ i: ai i iii NiN
p.(None): Law No. 20J 0-40 OF 08 DEC EMBRE 2010
p.(None): S u4e ò le Dc.c: ision cte c: onforrnitú ò lo Ccns] itr tion DCC 10- i 41 to 23 rJovcrriLore 2010 le
p.(None): lo Constitutional Court.
p.(None): FIRST TITftE
p.(None): PROVISIONS WILL GENERATE
p.(None): CHAPTER 9 i FIRST
p.(None): f? F I ¢ 'ïJf f. FROM THE FIELD OF APFI.IÚATION bï DLS PEOPLE
p.(None): £ Jrï + I? CESES OF HEALTH RESEARCH
p.(None): Article 2 I.G rr ›r: rx ° rchc + in scene or subject of
p.(None): “” Me !! re or poinï keys tools to prevent and treat the rr! A! Adie or in o] 1 ‹.nu‹ ›r ir› s ‹-› ffets:
p.(None): c.r) () .cgdi (very close and efficient approaches to the provision of ella sor ›tú both air care
p.(None): divicJu .to the community:
p.(None): c ‹› i ›lrtbr› er è better equip health profesnIes o for disease prevention purposes, Ile
p.(None): health restoration and key
p.(None): Article S: When the yromotor conties the moth in action with a connection see a team of
p.(None): seekers, he appoints among them a principal researcher.
p.(None): When the research is undertaken by several teams, these
p.(None): appoint a coordinator within them.
p.(None): CHAPTER II
p.(None): PRINCIPLES OF RESEARCH ETHICS IN SAN-fE
p.(None): Article ó Any research involving subjects carried out with respect for the following principles
p.(None): - human dignity and human rights
p.(None): - human vulnerability and personal integrity;
p.(None): - anonymity;
p.(None): - confidentiality ;
p.(None): - socio-cultural beliefs and practices
p.(None): - the innocent
p.(None): -! cctiori beneficial research:
p.(None): - research equity
p.(None): - the return of the residues to the persons concerned; the rules for dissemination and use of results:
p.(None): “Sharing the benefits of research.
p.(None): dots elre
p.(None): Article 7: The implication of human beings, as research objects, must be limited to the
p.(None): possibility for them to consent freely and in all knowledge of caose.
p.(None): These people have the flexibility to opt out of the research program at any time
p.(None): without fear or threat.
p.(None): Article 8: Clinical research and / or biomedical research cannot be carried out on a person
p.(None): state of brain death only with his consent or that of his family, previously expressed in writing.
p.(None): Article 9: The use of human cells for research purposes must be done in accordance with
p.(None): to the texts in force.
p.(None): Article 0. The use of animals for research must be done
p.(None): so respect the texts in force.
p.(None): TITLE II
p.(None): THE FIELDS OF HEALTH RESEARCH CHAPTER ONE
p.(None): APPLICATION AND CO / p.(None): Article 11: Epidemiological research, clinical research, biomedical research, research
p.(None): in traditional medicine and research on health systems on different components
p.(None): by this law.
p.(None): Article 12 Epidemiological research is always studied with the aim of measuring the factors determining or
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): c ‹› i ›lrtbr› er è better equip health profesnIes o for disease prevention purposes, Ile
p.(None): health restoration and key
p.(None): Article S: When the yromotor conties the moth in action with a connection see a team of
p.(None): seekers, he appoints among them a principal researcher.
p.(None): When the research is undertaken by several teams, these
p.(None): appoint a coordinator within them.
p.(None): CHAPTER II
p.(None): PRINCIPLES OF RESEARCH ETHICS IN SAN-fE
p.(None): Article ó Any research involving subjects carried out with respect for the following principles
p.(None): - human dignity and human rights
p.(None): - human vulnerability and personal integrity;
p.(None): - anonymity;
p.(None): - confidentiality ;
p.(None): - socio-cultural beliefs and practices
p.(None): - the innocent
p.(None): -! cctiori beneficial research:
p.(None): - research equity
p.(None): - the return of the residues to the persons concerned; the rules for dissemination and use of results:
p.(None): “Sharing the benefits of research.
p.(None): dots elre
p.(None): Article 7: The implication of human beings, as research objects, must be limited to the
p.(None): possibility for them to consent freely and in all knowledge of caose.
p.(None): These people have the flexibility to opt out of the research program at any time
p.(None): without fear or threat.
p.(None): Article 8: Clinical research and / or biomedical research cannot be carried out on a person
p.(None): state of brain death only with his consent or that of his family, previously expressed in writing.
p.(None): Article 9: The use of human cells for research purposes must be done in accordance with
p.(None): to the texts in force.
p.(None): Article 0. The use of animals for research must be done
p.(None): so respect the texts in force.
p.(None): TITLE II
p.(None): THE FIELDS OF HEALTH RESEARCH CHAPTER ONE
p.(None): APPLICATION AND CO / p.(None): Article 11: Epidemiological research, clinical research, biomedical research, research
p.(None): in traditional medicine and research on health systems on different components
p.(None): by this law.
p.(None): Article 12 Epidemiological research is always studied with the aim of measuring the factors determining or
p.(None): influencing the occurrence or persistence of a problem of a given population.
p.(None): Article 13: Clinical research and biomedical research clear the diagnoses, the
p.(None): organist and direct trials or experiments on humans and / or animals
p.(None): en we du Cï Velcț: ° yeiтIenI Yes COnnaİSSOnCe S mÓdiCale S = ï yf urmaC eUtiCjUEzS.
p.(None): Article 14: The research in traditional medicine is that which is interested in the practices of care of
p.(None): health employed by individuals, groups and by a community, part of the 1st most oral traditions.
p.(None): Article 15: The research on sanłé systems is that which pori on Yes di @ ositions łégislatives et
p.(None): regulations relating to disease prevention and care in the matades as well as sug Yes
p.(None): administrations, people and equipment contributing to it.
p.(None): CHAPTER II
p.(None): MODALITIES OF HEALTH RESEARCH
p.(None): Article 16: Epidemiological research is concerned with the state of health of populations and its variations
p.(None): in time and in space.
p.(None): It can be descriptive, analytical, evaluative, experimental, prospecting, reflective and / or
p.(None): Theoretical.
...
p.(None): seek or withdraw their membership at any time without incurring any threat.
p.(None): Consent is given in writing or, if not possible, certified by a third party. The latter must be completely
p.(None): independent of the researcher and the promoter.
p.(None): Article 27: Minors and adults protected by Ioi aamis in a health or social establishment do not
p.(None): may be requested for clinical and / or biomedical research as may be expected
p.(None): a direct benefit for their health and after advice from the father and / or mother, tutor or curator.
p.(None): However, they can be researched without individual benefit! direct in case these meet the
p.(None): following conditions:
p.(None): - present no foreseeable serious risk to their health
p.(None): - be useful! présentant people with the same characteristics
p.(None): age, sex and forestay;
p.(None): - cannot be done otherwise.
p.(None): Ariicle 28: When clinical and / or biomedical research is carried out on minors or
p.(None): of adults protected by law, consent must be given by:
p.(None): - holders of parental authority, for minors not
p.(None): emoncipated;
p.(None): - the legal representative, for research with direct individual benefit that poses no risk
p.(None): predictable serious, for minors or adults protected by the Ioi;
p.(None): - the guardian authorized by the family council or the guardianship judge, in other cases.
p.(None): Article 29: cliniquea clinical and / or biorüëdicôle research. Requires prior subcontracting by 3on
p.(None): ›Promoter, Ö'ùne assurance parantissônt sa
p.(None): ü / ”óÓ: r” itíeriü = üü ”: D
p.(None): “'")' '”') '” “' '\“ ”" ”” ”' '“' '”'” ”“ “” '”“)' '”'” ”'” “.” - ” ”“ ')' '' "''“ '““ ”” ””' ””
p.(None): ”'” "”' ”'“ ”“' ”” ””
p.(None): 'Article 30: Research, or clinical or medical treatment does not give rise to any direct financial or
p.(None): indirect for people who lend themselves to it, apart from reimbursement of the costs to which they are exposed
p.(None): and subject to special arrangements made by the National Research Ethics Committee
p.(None): in health.
p.(None): Article 31. Clinical and / or biomedical research with or without direct individual benefit should not
p.(None): involve no foreseeable serious risk to the health of persons who lend themselves to it.
p.(None): It must be preceded by a medical examination of the persons concerned. performed by a designated physician
p.(None): for the principal investigator or
p.(None): the coordinator among the doctors approved by the Ô'éïhiqve National Committee for Research in
p.(None): health. The results of this examination are communicated to them through the doctor of their
p.(None): before the expression of their informed consent.
p.(None): Article 32: No one may lend himself simultaneously to several clinical or biomedical research for his benefit
p.(None): individual direct.
p.(None): Before submitting persorin to clinical and / or biomedical research, the researcher has the obligation to
p.(None): check if it is not already involved in a research in progress.
...
p.(None): ethically acceptable under the following conditions
p.(None): * when, for compelling and scientifically sound methodological reasons, it does not exist
p.(None): other ways to determine the effectiveness or safety of the new
p.(None): prophylactic, diagnostic or therapeutic method:
p.(None): * when a prophylactic, diagnostic or therapeutic ethc is being tested for a
p.(None): mild condition and that participation in the trial does not expose to additional risks of
p.(None): significant or lasting damage.
p.(None): - if the efficacy of the treatment treated in the experimental group is greater than that of the treatment
p.(None): Usually used, you are immediately included in the trial.
p.(None): Article 47 When the research proposal is initiated from outside Benin by a physical person or
p.(None): moral, it must be accompanied by the opinion of the Ethics Committee of the initiating country or of any other structure
p.(None): Taken place, before its examination by the Committee.
p.(None): TITLE V
p.(None): OFFENSES AND SANCTIONS
p.(None): Un'one with two pines only. ”-” ”” "" ""
p.(None): The same sentences are appfcaõles ïotsque I consentemont has: been
p.(None): removed before research is carried out.
p.(None): The penalty incurred when it is a legal person is a fine of five million (5,000,000) ò
p.(None): fifteen million (15,000,000) francs.
p.(None): (1,000,000) ò five million (5,000,000) = francs when the culprit is a physical person.
p.(None): Article 50: Or * the penalties provided for in article 49 above, the culprit incurs the following sanctions
p.(None): - the ban on civil, civil and family rights in accordance with the
p.(None): provisions of the penal code;
p.(None): - the prohibition for a period of two (02] years to five (05) years, to exercise the professional activity or
p.(None): social on the occasion of which or donations the exercise of which the offense was commrr ›ise:
p.(None): - confiscation of the body of the offense
p.(None): - exclusion from submission to tenders for the award of publica contracts for a period of
p.(None): five (05) years to ten (10) years.
p.(None): The penalty for a legal person is a fine of five million (5,000,000j ò
p.(None): fifteen million (15,000 "00òj of francs. It is also possible to impose the penalties provided for in the 2nd ^ 3rd and 3rd
p.(None): = e dashes
p.(None): from the previous paragraph.
p.(None): Article 51: Is punished by imprisonment of six (06) months to twelve (12) months and a fine of one million (1,000,000)
p.(None): ò five million (5,000,000) francs or one of these two sentences only
p.(None): - QL4concon has practiced or has practiced clinical and / or biomedical research and research in
p.(None): traditional medicine in violation of the respect for confidentiality provided for in article ó of this law:
p.(None): - anyone who has practiced or has practiced clinical and / or biomedical research and research in
p.(None): traditional medicine without having obtained the prior notice provided for in articles 26, 41 and 42 of this law;
p.(None): - anyone who practiced or had to practice, forced to practice or
p.(None): : ArtiCïe ’$ 2: I.e romoteur Carib la‹ espón'sObiIité c1vi.le is not guaranteed for the insurance provided 1
p.(None): rticle 29 óe Jo presehte law is punishable by imprisonment of six (06d months to twelve (I 2) months and a
p.(None): fine of mi) Iion (1,000,000) ò five million (5,000,000) francs or one of these two penalties
p.(None): only.
...
Health / Physically Ill
Searching for indicator sick:
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p.(None): Article 11: Epidemiological research, clinical research, biomedical research, research
p.(None): in traditional medicine and research on health systems on different components
p.(None): by this law.
p.(None): Article 12 Epidemiological research is always studied with the aim of measuring the factors determining or
p.(None): influencing the occurrence or persistence of a problem of a given population.
p.(None): Article 13: Clinical research and biomedical research clear the diagnoses, the
p.(None): organist and direct trials or experiments on humans and / or animals
p.(None): en we du Cï Velcț: ° yeiтIenI Yes COnnaİSSOnCe S mÓdiCale S = ï yf urmaC eUtiCjUEzS.
p.(None): Article 14: The research in traditional medicine is that which is interested in the practices of care of
p.(None): health employed by individuals, groups and by a community, part of the 1st most oral traditions.
p.(None): Article 15: The research on sanłé systems is that which pori on Yes di @ ositions łégislatives et
p.(None): regulations relating to disease prevention and care in the matades as well as sug Yes
p.(None): administrations, people and equipment contributing to it.
p.(None): CHAPTER II
p.(None): MODALITIES OF HEALTH RESEARCH
p.(None): Article 16: Epidemiological research is concerned with the state of health of populations and its variations
p.(None): in time and in space.
p.(None): It can be descriptive, analytical, evaluative, experimental, prospecting, reflective and / or
p.(None): Theoretical.
p.(None): Article 17: Clinical research and biomedical research are with or without direct individual benefit.
p.(None): They are called clinical and biomedical research with direct individual bérièz, when
p.(None): is at tenóu a loúne direct file the çertonne which lends itself to it.
p.(None): ’. *
p.(None): All other clinical and bioméôicale research, whether it concerns sick people or
p.(None): no, are named without direct individual benefit.
p.(None): Article 18: Research in irradition medicine aims to
p.(None): validate the therapeutic properties of medicinal plants and animal and mineral extracts as well as
p.(None): their uses in treatment says them cre my afleclions
p.(None): ‹Work effectively for the development of LC products›
p.(None): traditional múder ine who have already done their therapeutic care, while at the same time
p.(None): hygienic packaging and ò their good conservation, with a view to use nationally, regionally and
p.(None): intefnalionole.
p.(None): Article J 9 The research on health systems aims to promote decision-making
p.(None): rational for the optimal management of establishments and structures of the health system.
p.(None): This management aims to ensure, at a lower cost and with a better quality of service, the promotion of
p.(None): health and preventive care. curative, rehabilitative and promotional to the different
p.(None): system levels
p.(None): TITLE ül
p.(None): CONDITIONS FOR PERFORMING RESEARCH IN ITS NTE
p.(None): FIRST CHAPTER
p.(None): EPIDEMIOLOGICAL RESEARCH
p.(None): Article 20: Any epidemiological research applied to a group of individuals to a community must
p.(None): require the prior consent of its legal representatives.
p.(None): When a group of individuals or a community to be studied must be represented by
p.(None): as an authorized person, the researcher must ensure the authenticity of his mandate.
p.(None): Article 21: The informed consent on an individual basis of persons participating in any research
p.(None): epidemiological is mandatory.
p.(None): Lr '. consent is said to be enlightened when the person sought omits the purpose and nature of the
...
Social / Child
Searching for indicator child:
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p.(None): individual direct.
p.(None): Before submitting persorin to clinical and / or biomedical research, the researcher has the obligation to
p.(None): check if it is not already involved in a research in progress.
p.(None): For each researches its direct individual benefit. ! th protocol submitted to the opinion of the National Committee
p.(None): of ethics for health research determines a period of excitement during which your person
p.(None): who lends itself to it cannot participate in another research for its therapeutic = direct aim. The duration of
p.(None): this period varies depending on the nature of the research.
p.(None): Article 33. Clinical and / or biomedical research for direct individual benefit must be carried out
p.(None): a place equipped with material and technical resources suitable for research and compatible with Res imperatives of
p.(None): safety of people who lend themselves to it. The research site thus defined must be flown by the Minister
p.(None): in charge of health, according to the opinion of the National Ethics Committee for Health Research.
p.(None): Article 34: Any clinical and / or biomedical research Cjvec or without direct individual benefit on the
p.(None): pregnant women, parturients and nursing mothers must meet the following conditions
p.(None): - be devoid of any foreseeable serious risk to the health of the mother
p.(None): and / or the child;
p.(None): - to be ”useful õ the knowledge and phenomena of pregnancy, the”
p.(None): acceuühe eril “u de: i’ lalter ente “” ”
p.(None): Article 35: 'use for therapeutic purposes of organs, tissues or cells of onimal origin which
p.(None): are neither medicinal devices, nor intended for "generic or celiac therapies, is not
p.(None): possible that donations within the framework of clinical and / or biomedical research subject to the provisions of this law.
p.(None): Article 36. By way of derogation from the provisions öe io presents Ioi, clinical research and / or
p.(None): Diomedical concerning the therapeutic use of such organs, tissues or cells in humans cannot
p.(None): be implemented only after authorization by the Minister for Health, assent of the
p.(None): National Ethics Committee for Health Research.
p.(None): The authorization may be subject to specific conditions relating to the
p.(None): long-term monitoring of patients.
p.(None): Article 37 Good practices ›relating to harvesting, storage, processing,
p.(None): transport and use of orpanes, tissues and cells of animals, bound together by the
p.(None): ministers in exchange for health and high school, on the proposal of the National Ethics Committee for the
p.(None): health research.
p.(None): Article 38. Joint decrees $ devit minrelre $ in charge of health and elevation fix
p.(None): - the practical dv = cap relating to selection, production and breeding of animals;
p.(None): - the health conditions $ to which the animals from which the orpanes, tissues and
p.(None): cells used;
p.(None): the rules of identification of cew animals, orpanes, tissues and cells allow ant to assess the TFOÇability of
p.(None): products obtained.
...
Social / Mothers
Searching for indicator mothers:
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p.(None): health. The results of this examination are communicated to them through the doctor of their
p.(None): before the expression of their informed consent.
p.(None): Article 32: No one may lend himself simultaneously to several clinical or biomedical research for his benefit
p.(None): individual direct.
p.(None): Before submitting persorin to clinical and / or biomedical research, the researcher has the obligation to
p.(None): check if it is not already involved in a research in progress.
p.(None): For each researches its direct individual benefit. ! th protocol submitted to the opinion of the National Committee
p.(None): of ethics for health research determines a period of excitement during which your person
p.(None): who lends itself to it cannot participate in another research for its therapeutic = direct aim. The duration of
p.(None): this period varies depending on the nature of the research.
p.(None): Article 33. Clinical and / or biomedical research for direct individual benefit must be carried out
p.(None): a place equipped with material and technical resources suitable for research and compatible with Res imperatives of
p.(None): safety of people who lend themselves to it. The research site thus defined must be flown by the Minister
p.(None): in charge of health, according to the opinion of the National Ethics Committee for Health Research.
p.(None): Article 34: Any clinical and / or biomedical research Cjvec or without direct individual benefit on the
p.(None): pregnant women, parturients and nursing mothers must meet the following conditions
p.(None): - be devoid of any foreseeable serious risk to the health of the mother
p.(None): and / or the child;
p.(None): - to be ”useful õ the knowledge and phenomena of pregnancy, the”
p.(None): acceuühe eril “u de: i’ lalter ente “” ”
p.(None): Article 35: 'use for therapeutic purposes of organs, tissues or cells of onimal origin which
p.(None): are neither medicinal devices, nor intended for "generic or celiac therapies, is not
p.(None): possible that donations within the framework of clinical and / or biomedical research subject to the provisions of this law.
p.(None): Article 36. By way of derogation from the provisions öe io presents Ioi, clinical research and / or
p.(None): Diomedical concerning the therapeutic use of such organs, tissues or cells in humans cannot
p.(None): be implemented only after authorization by the Minister for Health, assent of the
p.(None): National Ethics Committee for Health Research.
p.(None): The authorization may be subject to specific conditions relating to the
p.(None): long-term monitoring of patients.
p.(None): Article 37 Good practices ›relating to harvesting, storage, processing,
p.(None): transport and use of orpanes, tissues and cells of animals, bound together by the
p.(None): ministers in exchange for health and high school, on the proposal of the National Ethics Committee for the
p.(None): health research.
p.(None): Article 38. Joint decrees $ devit minrelre $ in charge of health and elevation fix
p.(None): - the practical dv = cap relating to selection, production and breeding of animals;
p.(None): - the health conditions $ to which the animals from which the orpanes, tissues and
p.(None): cells used;
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.(None): “” Me !! re or poinï keys tools to prevent and treat the rr! A! Adie or in o] 1 ‹.nu‹ ›r ir› s ‹-› ffets:
p.(None): c.r) () .cgdi (very close and efficient approaches to the provision of ella sor ›tú both air care
p.(None): divicJu .to the community:
p.(None): c ‹› i ›lrtbr› er è better equip health profesnIes o for disease prevention purposes, Ile
p.(None): health restoration and key
p.(None): Article S: When the yromotor conties the moth in action with a connection see a team of
p.(None): seekers, he appoints among them a principal researcher.
p.(None): When the research is undertaken by several teams, these
p.(None): appoint a coordinator within them.
p.(None): CHAPTER II
p.(None): PRINCIPLES OF RESEARCH ETHICS IN SAN-fE
p.(None): Article ó Any research involving subjects carried out with respect for the following principles
p.(None): - human dignity and human rights
p.(None): - human vulnerability and personal integrity;
p.(None): - anonymity;
p.(None): - confidentiality ;
p.(None): - socio-cultural beliefs and practices
p.(None): - the innocent
p.(None): -! cctiori beneficial research:
p.(None): - research equity
p.(None): - the return of the residues to the persons concerned; the rules for dissemination and use of results:
p.(None): “Sharing the benefits of research.
p.(None): dots elre
p.(None): Article 7: The implication of human beings, as research objects, must be limited to the
p.(None): possibility for them to consent freely and in all knowledge of caose.
p.(None): These people have the flexibility to opt out of the research program at any time
p.(None): without fear or threat.
p.(None): Article 8: Clinical research and / or biomedical research cannot be carried out on a person
p.(None): state of brain death only with his consent or that of his family, previously expressed in writing.
p.(None): Article 9: The use of human cells for research purposes must be done in accordance with
p.(None): to the texts in force.
p.(None): Article 0. The use of animals for research must be done
p.(None): so respect the texts in force.
p.(None): TITLE II
p.(None): THE FIELDS OF HEALTH RESEARCH CHAPTER ONE
p.(None): APPLICATION AND CO / p.(None): Article 11: Epidemiological research, clinical research, biomedical research, research
p.(None): in traditional medicine and research on health systems on different components
p.(None): by this law.
p.(None): Article 12 Epidemiological research is always studied with the aim of measuring the factors determining or
p.(None): influencing the occurrence or persistence of a problem of a given population.
p.(None): Article 13: Clinical research and biomedical research clear the diagnoses, the
p.(None): organist and direct trials or experiments on humans and / or animals
p.(None): en we du Cï Velcț: ° yeiтIenI Yes COnnaİSSOnCe S mÓdiCale S = ï yf urmaC eUtiCjUEzS.
p.(None): Article 14: The research in traditional medicine is that which is interested in the practices of care of
p.(None): health employed by individuals, groups and by a community, part of the 1st most oral traditions.
p.(None): Article 15: The research on sanłé systems is that which pori on Yes di @ ositions łégislatives et
p.(None): regulations relating to disease prevention and care in the matades as well as sug Yes
p.(None): administrations, people and equipment contributing to it.
p.(None): CHAPTER II
p.(None): MODALITIES OF HEALTH RESEARCH
...
p.(None): a doctor with at least five (05) years of experience in the field concerned;
p.(None): under material and technical conditions adapted to the study and compatible with the imperatives of
p.(None): scientific rigor and safety of people who lend themselves to this research.
p.(None): Article 25: All clinical and / or biomedical research on humans must
p.(None): be based on the latest state of scientific knowledge and on pre-clinical experimentation
p.(None): sufficient
p.(None): provide those affected with a much higher benefit
p.(None): at the foreseeable risk incurred,
p.(None): - aim to extend scientific knowledge on human beings and
p.(None): means raised tibIes öe mointeùit.ô 6! a ”improving one's health.
p.(None): A.rtïcïe. 26 "’ F'réolablerñent ü to realization clone. Recherchec.he c) ini4 ue
p.(None): eî / or biomedical on a person, ïe free consent., éC) air and express of this1 it must be collected after
p.(None): that I researcher made him known
p.(None): - The objective of your research, its methodJogy and its cluré:
p.(None): - expected results, foreseeable constraints and risks, even in
p.(None): cases of research being stopped before its end;
p.(None): the opinion of the National Ethics Committee for Health Research (CNERS) provided for in Articles 43 and
p.(None): following of this law.
p.(None): The researcher informs the person with consent is requested of his right to refuse to participate in the
p.(None): seek or withdraw their membership at any time without incurring any threat.
p.(None): Consent is given in writing or, if not possible, certified by a third party. The latter must be completely
p.(None): independent of the researcher and the promoter.
p.(None): Article 27: Minors and adults protected by Ioi aamis in a health or social establishment do not
p.(None): may be requested for clinical and / or biomedical research as may be expected
p.(None): a direct benefit for their health and after advice from the father and / or mother, tutor or curator.
p.(None): However, they can be researched without individual benefit! direct in case these meet the
p.(None): following conditions:
p.(None): - present no foreseeable serious risk to their health
p.(None): - be useful! présentant people with the same characteristics
p.(None): age, sex and forestay;
p.(None): - cannot be done otherwise.
p.(None): Ariicle 28: When clinical and / or biomedical research is carried out on minors or
p.(None): of adults protected by law, consent must be given by:
p.(None): - holders of parental authority, for minors not
p.(None): emoncipated;
p.(None): - the legal representative, for research with direct individual benefit that poses no risk
p.(None): predictable serious, for minors or adults protected by the Ioi;
p.(None): - the guardian authorized by the family council or the guardianship judge, in other cases.
p.(None): Article 29: cliniquea clinical and / or biorüëdicôle research. Requires prior subcontracting by 3on
p.(None): ›Promoter, Ö'ùne assurance parantissônt sa
p.(None): ü / ”óÓ: r” itíeriü = üü ”: D
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): health. The results of this examination are communicated to them through the doctor of their
p.(None): before the expression of their informed consent.
p.(None): Article 32: No one may lend himself simultaneously to several clinical or biomedical research for his benefit
p.(None): individual direct.
p.(None): Before submitting persorin to clinical and / or biomedical research, the researcher has the obligation to
p.(None): check if it is not already involved in a research in progress.
p.(None): For each researches its direct individual benefit. ! th protocol submitted to the opinion of the National Committee
p.(None): of ethics for health research determines a period of excitement during which your person
p.(None): who lends itself to it cannot participate in another research for its therapeutic = direct aim. The duration of
p.(None): this period varies depending on the nature of the research.
p.(None): Article 33. Clinical and / or biomedical research for direct individual benefit must be carried out
p.(None): a place equipped with material and technical resources suitable for research and compatible with Res imperatives of
p.(None): safety of people who lend themselves to it. The research site thus defined must be flown by the Minister
p.(None): in charge of health, according to the opinion of the National Ethics Committee for Health Research.
p.(None): Article 34: Any clinical and / or biomedical research Cjvec or without direct individual benefit on the
p.(None): pregnant women, parturients and nursing mothers must meet the following conditions
p.(None): - be devoid of any foreseeable serious risk to the health of the mother
p.(None): and / or the child;
p.(None): - to be ”useful õ the knowledge and phenomena of pregnancy, the”
p.(None): acceuühe eril “u de: i’ lalter ente “” ”
p.(None): Article 35: 'use for therapeutic purposes of organs, tissues or cells of onimal origin which
p.(None): are neither medicinal devices, nor intended for "generic or celiac therapies, is not
p.(None): possible that donations within the framework of clinical and / or biomedical research subject to the provisions of this law.
p.(None): Article 36. By way of derogation from the provisions öe io presents Ioi, clinical research and / or
p.(None): Diomedical concerning the therapeutic use of such organs, tissues or cells in humans cannot
p.(None): be implemented only after authorization by the Minister for Health, assent of the
p.(None): National Ethics Committee for Health Research.
p.(None): The authorization may be subject to specific conditions relating to the
p.(None): long-term monitoring of patients.
p.(None): Article 37 Good practices ›relating to harvesting, storage, processing,
p.(None): transport and use of orpanes, tissues and cells of animals, bound together by the
p.(None): ministers in exchange for health and high school, on the proposal of the National Ethics Committee for the
p.(None): health research.
p.(None): Article 38. Joint decrees $ devit minrelre $ in charge of health and elevation fix
p.(None): - the practical dv = cap relating to selection, production and breeding of animals;
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): it is impossible to locate people participating in any
p.(None): search for which your files will be examined:
p.(None): there is a risk of bias in the results of certain researches or in persons participating in a
p.(None): research is likely to modify ”leuts behaviors.
p.(None): CHAPTER II
p.(None): RESEARCHCNNI4UEETBOVE0CALE
p.(None): Article 24: Clinical and biomedical research must be carried out:
p.(None): - under the direction of a researcher who, if he is not a mechanic, must be assisted
p.(None): a doctor with at least five (05) years of experience in the field concerned;
p.(None): under material and technical conditions adapted to the study and compatible with the imperatives of
p.(None): scientific rigor and safety of people who lend themselves to this research.
p.(None): Article 25: All clinical and / or biomedical research on humans must
p.(None): be based on the latest state of scientific knowledge and on pre-clinical experimentation
p.(None): sufficient
p.(None): provide those affected with a much higher benefit
p.(None): at the foreseeable risk incurred,
p.(None): - aim to extend scientific knowledge on human beings and
p.(None): means raised tibIes öe mointeùit.ô 6! a ”improving one's health.
p.(None): A.rtïcïe. 26 "’ F'réolablerñent ü to realization clone. Recherchec.he c) ini4 ue
p.(None): eî / or biomedical on a person, ïe free consent., éC) air and express of this1 it must be collected after
p.(None): that I researcher made him known
p.(None): - The objective of your research, its methodJogy and its cluré:
p.(None): - expected results, foreseeable constraints and risks, even in
p.(None): cases of research being stopped before its end;
p.(None): the opinion of the National Ethics Committee for Health Research (CNERS) provided for in Articles 43 and
p.(None): following of this law.
p.(None): The researcher informs the person with consent is requested of his right to refuse to participate in the
p.(None): seek or withdraw their membership at any time without incurring any threat.
p.(None): Consent is given in writing or, if not possible, certified by a third party. The latter must be completely
p.(None): independent of the researcher and the promoter.
p.(None): Article 27: Minors and adults protected by Ioi aamis in a health or social establishment do not
p.(None): may be requested for clinical and / or biomedical research as may be expected
p.(None): a direct benefit for their health and after advice from the father and / or mother, tutor or curator.
p.(None): However, they can be researched without individual benefit! direct in case these meet the
p.(None): following conditions:
p.(None): - present no foreseeable serious risk to their health
p.(None): - be useful! présentant people with the same characteristics
p.(None): age, sex and forestay;
p.(None): - cannot be done otherwise.
p.(None): Ariicle 28: When clinical and / or biomedical research is carried out on minors or
p.(None): of adults protected by law, consent must be given by:
p.(None): - holders of parental authority, for minors not
p.(None): emoncipated;
...
p.(None): ›Promoter, Ö'ùne assurance parantissônt sa
p.(None): ü / ”óÓ: r” itíeriü = üü ”: D
p.(None): “'")' '”') '” “' '\“ ”" ”” ”' '“' '”'” ”“ “” '”“)' '”'” ”'” “.” - ” ”“ ')' '' "''“ '““ ”” ””' ””
p.(None): ”'” "”' ”'“ ”“' ”” ””
p.(None): 'Article 30: Research, or clinical or medical treatment does not give rise to any direct financial or
p.(None): indirect for people who lend themselves to it, apart from reimbursement of the costs to which they are exposed
p.(None): and subject to special arrangements made by the National Research Ethics Committee
p.(None): in health.
p.(None): Article 31. Clinical and / or biomedical research with or without direct individual benefit should not
p.(None): involve no foreseeable serious risk to the health of persons who lend themselves to it.
p.(None): It must be preceded by a medical examination of the persons concerned. performed by a designated physician
p.(None): for the principal investigator or
p.(None): the coordinator among the doctors approved by the Ô'éïhiqve National Committee for Research in
p.(None): health. The results of this examination are communicated to them through the doctor of their
p.(None): before the expression of their informed consent.
p.(None): Article 32: No one may lend himself simultaneously to several clinical or biomedical research for his benefit
p.(None): individual direct.
p.(None): Before submitting persorin to clinical and / or biomedical research, the researcher has the obligation to
p.(None): check if it is not already involved in a research in progress.
p.(None): For each researches its direct individual benefit. ! th protocol submitted to the opinion of the National Committee
p.(None): of ethics for health research determines a period of excitement during which your person
p.(None): who lends itself to it cannot participate in another research for its therapeutic = direct aim. The duration of
p.(None): this period varies depending on the nature of the research.
p.(None): Article 33. Clinical and / or biomedical research for direct individual benefit must be carried out
p.(None): a place equipped with material and technical resources suitable for research and compatible with Res imperatives of
p.(None): safety of people who lend themselves to it. The research site thus defined must be flown by the Minister
p.(None): in charge of health, according to the opinion of the National Ethics Committee for Health Research.
p.(None): Article 34: Any clinical and / or biomedical research Cjvec or without direct individual benefit on the
p.(None): pregnant women, parturients and nursing mothers must meet the following conditions
p.(None): - be devoid of any foreseeable serious risk to the health of the mother
p.(None): and / or the child;
p.(None): - to be ”useful õ the knowledge and phenomena of pregnancy, the”
p.(None): acceuühe eril “u de: i’ lalter ente “” ”
p.(None): Article 35: 'use for therapeutic purposes of organs, tissues or cells of onimal origin which
p.(None): are neither medicinal devices, nor intended for "generic or celiac therapies, is not
p.(None): possible that donations within the framework of clinical and / or biomedical research subject to the provisions of this law.
p.(None): Article 36. By way of derogation from the provisions öe io presents Ioi, clinical research and / or
p.(None): Diomedical concerning the therapeutic use of such organs, tissues or cells in humans cannot
p.(None): be implemented only after authorization by the Minister for Health, assent of the
p.(None): National Ethics Committee for Health Research.
p.(None): The authorization may be subject to specific conditions relating to the
p.(None): long-term monitoring of patients.
p.(None): Article 37 Good practices ›relating to harvesting, storage, processing,
p.(None): transport and use of orpanes, tissues and cells of animals, bound together by the
...
p.(None): determines to 'omposition. 1es attributions and Yes modalities of functioning of the Committee.
p.(None): Article 45: The Comiłé is placed under the supervision of the Minister in charge of
p.(None): CHAPTER II
p.(None): OF THE IMPLEMENTATION OF THE CONTROL
p.(None): Article 4b: Examination of any epidemiological research protocol requiring the presence of doin witness troops
p.(None): ›Ensure that
p.(None): s ”
p.(None): - the benefits, yes risks, contiaintes and effectiveness of the new method are èwiu-c * far
p.(None): comparison with the best òiagnostic, ihći-op = ulic or preventive methods in use;
p.(None): - the control group receives a placebo only when there is no proven treatment for the targeted disease
p.(None): ; however, even if there is a proven treatment, placebo-controlled trials may be
p.(None): ethically acceptable under the following conditions
p.(None): * when, for compelling and scientifically sound methodological reasons, it does not exist
p.(None): other ways to determine the effectiveness or safety of the new
p.(None): prophylactic, diagnostic or therapeutic method:
p.(None): * when a prophylactic, diagnostic or therapeutic ethc is being tested for a
p.(None): mild condition and that participation in the trial does not expose to additional risks of
p.(None): significant or lasting damage.
p.(None): - if the efficacy of the treatment treated in the experimental group is greater than that of the treatment
p.(None): Usually used, you are immediately included in the trial.
p.(None): Article 47 When the research proposal is initiated from outside Benin by a physical person or
p.(None): moral, it must be accompanied by the opinion of the Ethics Committee of the initiating country or of any other structure
p.(None): Taken place, before its examination by the Committee.
p.(None): TITLE V
p.(None): OFFENSES AND SANCTIONS
p.(None): Un'one with two pines only. ”-” ”” "" ""
p.(None): The same sentences are appfcaõles ïotsque I consentemont has: been
p.(None): removed before research is carried out.
p.(None): The penalty incurred when it is a legal person is a fine of five million (5,000,000) ò
p.(None): fifteen million (15,000,000) francs.
p.(None): (1,000,000) ò five million (5,000,000) = francs when the culprit is a physical person.
p.(None): Article 50: Or * the penalties provided for in article 49 above, the culprit incurs the following sanctions
p.(None): - the ban on civil, civil and family rights in accordance with the
p.(None): provisions of the penal code;
p.(None): - the prohibition for a period of two (02] years to five (05) years, to exercise the professional activity or
p.(None): social on the occasion of which or donations the exercise of which the offense was commrr ›ise:
p.(None): - confiscation of the body of the offense
p.(None): - exclusion from submission to tenders for the award of publica contracts for a period of
p.(None): five (05) years to ten (10) years.
p.(None): The penalty for a legal person is a fine of five million (5,000,000j ò
p.(None): fifteen million (15,000 "00òj of francs. It is also possible to impose the penalties provided for in the 2nd ^ 3rd and 3rd
p.(None): = e dashes
p.(None): from the previous paragraph.
p.(None): Article 51: Is punished by imprisonment of six (06) months to twelve (12) months and a fine of one million (1,000,000)
p.(None): ò five million (5,000,000) francs or one of these two sentences only
...
p.(None): - anyone who practiced or had to practice, forced to practice or
p.(None): : ArtiCïe ’$ 2: I.e romoteur Carib la‹ espón'sObiIité c1vi.le is not guaranteed for the insurance provided 1
p.(None): rticle 29 óe Jo presehte law is punishable by imprisonment of six (06d months to twelve (I 2) months and a
p.(None): fine of mi) Iion (1,000,000) ò five million (5,000,000) francs or one of these two penalties
p.(None): only.
p.(None): Article 53: The fact of practicing or having practiced on a person clinical and / or biomedical research
p.(None): and research in traditional medicine authorized but having resulted in a homicide invo! on1aire por
p.(None): clumsiness, recklessness, inattention, negligence or non-observance of the rules is punished by
p.(None): imprisonment of six (06) months to two (02) years and a fine of five hundred thousand (500,000) francs to one million (1
p.(None): 000 000) of francs or one of these two penalties only.
p.(None): i!
p.(None): .
p.(None): Article S4: The llit to practice or to have practiced on a person a research cLr that eï
p.(None): biomedica! ei / or a cec nercne in traditional medicine auiorisüe evils having caused injuries
p.(None): involuntary or an ayanï eriïraïné maiaòie by default of address of precaution an incapacity
p.(None): temporary work for the tujet is Rum of imprisonment of one (0)) month to twelve (12) words and one
p.(None): omenÓe de cinçu ‹orite mille (CO 000) llanes à two hundred and fifty thousand (250,000) francs or one of
p.(None): these dest. penalties only.
p.(None): Article S5: CuicGnque cura practiced or made yrctiquer sound the consent of the subject we sound the opinion
p.(None): of the Committee clinical research and / or biomedicine and research = Research in traditional medicine having trained! s
p.(None): subject's death will be punished! this is a criminal imprisonment for five (05) years to ten () 0) years.
p.(None): If there is an inability to work for one to two (1) days, the sentence will be imprisonment for six (06) months ò
p.(None): two (02) years and an intake of five
p.(None): one hundred and one ¡soo ooo; f ‹anc› ò en mi ion q ooo oooi franc ›.
p.(None): If the temporary incapacity for work is less than twenty and one (2] days, the penalty shall be one
p.(None): imprisonment of six 06) words ò eighteen (18) months and a fine of five hundred thousand 500,000) francs ò
p.(None): one million (1,000,000] francs or one of these two sentences only.
p.(None): IlTREVI
p.(None): DlSPOS! FNALE FLONS
p.(None): Article S6 The present law which repeals all previous contrary provisions, will be executed as Boi
p.(None): of State.
p.(None): Pat le '‹esident de Ja képub1ique,
p.(None): Head of J'Etaï, Head of Gocverriement.
p.(None): ”Dr. 8ONI YAYI. -
p.(None): The Minister of State in charge of Prospectve, Development,
p.(None): Public Policy Assessment and Coordination
p.(None): of Government Action.
p.(None): The Minister of Health,
p.(None): .] ^
p.(None): ''
p.(None): Issifou TAKPARA .-
p.(None): The Keeper of the Seals, Minister of Legislation and Human Rights
p.(None): I Man,
p.(None): c ° ..: *. "*.,. 7.4) ''
p.(None): Gréqroire AKOFOD.II
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.(None): ò five million (5,000,000) francs or one of these two sentences only
p.(None): - QL4concon has practiced or has practiced clinical and / or biomedical research and research in
p.(None): traditional medicine in violation of the respect for confidentiality provided for in article ó of this law:
p.(None): - anyone who has practiced or has practiced clinical and / or biomedical research and research in
p.(None): traditional medicine without having obtained the prior notice provided for in articles 26, 41 and 42 of this law;
p.(None): - anyone who practiced or had to practice, forced to practice or
p.(None): : ArtiCïe ’$ 2: I.e romoteur Carib la‹ espón'sObiIité c1vi.le is not guaranteed for the insurance provided 1
p.(None): rticle 29 óe Jo presehte law is punishable by imprisonment of six (06d months to twelve (I 2) months and a
p.(None): fine of mi) Iion (1,000,000) ò five million (5,000,000) francs or one of these two penalties
p.(None): only.
p.(None): Article 53: The fact of practicing or having practiced on a person clinical and / or biomedical research
p.(None): and research in traditional medicine authorized but having resulted in a homicide invo! on1aire por
p.(None): clumsiness, recklessness, inattention, negligence or non-observance of the rules is punished by
p.(None): imprisonment of six (06) months to two (02) years and a fine of five hundred thousand (500,000) francs to one million (1
p.(None): 000 000) of francs or one of these two penalties only.
p.(None): i!
p.(None): .
p.(None): Article S4: The llit to practice or to have practiced on a person a research cLr that eï
p.(None): biomedica! ei / or a cec nercne in traditional medicine auiorisüe evils having caused injuries
p.(None): involuntary or an ayanï eriïraïné maiaòie by default of address of precaution an incapacity
p.(None): temporary work for the tujet is Rum of imprisonment of one (0)) month to twelve (12) words and one
p.(None): omenÓe de cinçu ‹orite mille (CO 000) llanes à two hundred and fifty thousand (250,000) francs or one of
p.(None): these dest. penalties only.
p.(None): Article S5: CuicGnque cura practiced or made yrctiquer sound the consent of the subject we sound the opinion
p.(None): of the Committee clinical research and / or biomedicine and research = Research in traditional medicine having trained! s
p.(None): subject's death will be punished! this is a criminal imprisonment for five (05) years to ten () 0) years.
p.(None): If there is an inability to work for one to two (1) days, the sentence will be imprisonment for six (06) months ò
p.(None): two (02) years and an intake of five
p.(None): one hundred and one ¡soo ooo; f ‹anc› ò en mi ion q ooo oooi franc ›.
p.(None): If the temporary incapacity for work is less than twenty and one (2] days, the penalty shall be one
p.(None): imprisonment of six 06) words ò eighteen (18) months and a fine of five hundred thousand 500,000) francs ò
p.(None): one million (1,000,000] francs or one of these two sentences only.
p.(None): IlTREVI
p.(None): DlSPOS! FNALE FLONS
p.(None): Article S6 The present law which repeals all previous contrary provisions, will be executed as Boi
p.(None): of State.
p.(None): Pat le '‹esident de Ja képub1ique,
p.(None): Head of J'Etaï, Head of Gocverriement.
p.(None): ”Dr. 8ONI YAYI. -
p.(None): The Minister of State in charge of Prospectve, Development,
p.(None): Public Policy Assessment and Coordination
p.(None): of Government Action.
p.(None): The Minister of Health,
p.(None): .] ^
p.(None): ''
p.(None): Issifou TAKPARA .-
p.(None): The Keeper of the Seals, Minister of Legislation and Human Rights
p.(None): I Man,
p.(None): c ° ..: *. "*.,. 7.4) ''
p.(None): Gréqroire AKOFOD.II
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): acceuühe eril “u de: i’ lalter ente “” ”
p.(None): Article 35: 'use for therapeutic purposes of organs, tissues or cells of onimal origin which
p.(None): are neither medicinal devices, nor intended for "generic or celiac therapies, is not
p.(None): possible that donations within the framework of clinical and / or biomedical research subject to the provisions of this law.
p.(None): Article 36. By way of derogation from the provisions öe io presents Ioi, clinical research and / or
p.(None): Diomedical concerning the therapeutic use of such organs, tissues or cells in humans cannot
p.(None): be implemented only after authorization by the Minister for Health, assent of the
p.(None): National Ethics Committee for Health Research.
p.(None): The authorization may be subject to specific conditions relating to the
p.(None): long-term monitoring of patients.
p.(None): Article 37 Good practices ›relating to harvesting, storage, processing,
p.(None): transport and use of orpanes, tissues and cells of animals, bound together by the
p.(None): ministers in exchange for health and high school, on the proposal of the National Ethics Committee for the
p.(None): health research.
p.(None): Article 38. Joint decrees $ devit minrelre $ in charge of health and elevation fix
p.(None): - the practical dv = cap relating to selection, production and breeding of animals;
p.(None): - the health conditions $ to which the animals from which the orpanes, tissues and
p.(None): cells used;
p.(None): the rules of identification of cew animals, orpanes, tissues and cells allow ant to assess the TFOÇability of
p.(None): products obtained.
p.(None): Article 39: In the event of clinical and / or biomedical research ò to implement donations of emergency situations which do not
p.(None): not allow the prior consent of the person who will be subject to it to be obtained, the protocol
p.(None): presented to ò I‘avi $ from the National Ethics Committee for Health Research may provide that the consent of
p.(None): this person will not be sought and that feul bera sought, that of $ members of so Camille donations Yes conditions
p.(None): provided for in Article 26 of this law. The interested in zero informed, as soon as possible, and his con $ enîemenJïui
p.(None): will be requested for ÓvenJuelle's further research.
p.(None): CHAPI-ARE III
p.(None): RESEARCH IN MED ”ECILIA ïRADìTJONNEŁLE
p.(None): 40 Ła research in medicine tr.a..ditionne.1ïe.
p.(None): must be
p.(None): donations of material conditions $ and techniques adapted to research and compatible with
p.(None): imperative of scientific response and safety of people who lend themselves to this research.
p.(None): Article 41: All research in traditional medicine on the eye
p.(None): humoin must
p.(None): - be based on an ethnomedical study:
p.(None): - settle on! c confirmation by the doctor of the diagnosis and the therapeutic result;
p.(None): - provide the persons concerned with a benefit far greater than the foreseeable risk incurred
p.(None): - aim to extend scientific knowledge of the human being and the means likely to maintain or
p.(None): to improve their state of health:
p.(None): - require the prior approval of the Nationa County! of ethics for health research.
p.(None): CHAPTER IV
p.(None): FROM RESEARCHER LESSYSTEVESDESANTE
p.(None): Article 42: All research on health systems must require:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): cases of research being stopped before its end;
p.(None): the opinion of the National Ethics Committee for Health Research (CNERS) provided for in Articles 43 and
p.(None): following of this law.
p.(None): The researcher informs the person with consent is requested of his right to refuse to participate in the
p.(None): seek or withdraw their membership at any time without incurring any threat.
p.(None): Consent is given in writing or, if not possible, certified by a third party. The latter must be completely
p.(None): independent of the researcher and the promoter.
p.(None): Article 27: Minors and adults protected by Ioi aamis in a health or social establishment do not
p.(None): may be requested for clinical and / or biomedical research as may be expected
p.(None): a direct benefit for their health and after advice from the father and / or mother, tutor or curator.
p.(None): However, they can be researched without individual benefit! direct in case these meet the
p.(None): following conditions:
p.(None): - present no foreseeable serious risk to their health
p.(None): - be useful! présentant people with the same characteristics
p.(None): age, sex and forestay;
p.(None): - cannot be done otherwise.
p.(None): Ariicle 28: When clinical and / or biomedical research is carried out on minors or
p.(None): of adults protected by law, consent must be given by:
p.(None): - holders of parental authority, for minors not
p.(None): emoncipated;
p.(None): - the legal representative, for research with direct individual benefit that poses no risk
p.(None): predictable serious, for minors or adults protected by the Ioi;
p.(None): - the guardian authorized by the family council or the guardianship judge, in other cases.
p.(None): Article 29: cliniquea clinical and / or biorüëdicôle research. Requires prior subcontracting by 3on
p.(None): ›Promoter, Ö'ùne assurance parantissônt sa
p.(None): ü / ”óÓ: r” itíeriü = üü ”: D
p.(None): “'")' '”') '” “' '\“ ”" ”” ”' '“' '”'” ”“ “” '”“)' '”'” ”'” “.” - ” ”“ ')' '' "''“ '““ ”” ””' ””
p.(None): ”'” "”' ”'“ ”“' ”” ””
p.(None): 'Article 30: Research, or clinical or medical treatment does not give rise to any direct financial or
p.(None): indirect for people who lend themselves to it, apart from reimbursement of the costs to which they are exposed
p.(None): and subject to special arrangements made by the National Research Ethics Committee
p.(None): in health.
p.(None): Article 31. Clinical and / or biomedical research with or without direct individual benefit should not
p.(None): involve no foreseeable serious risk to the health of persons who lend themselves to it.
p.(None): It must be preceded by a medical examination of the persons concerned. performed by a designated physician
p.(None): for the principal investigator or
p.(None): the coordinator among the doctors approved by the Ô'éïhiqve National Committee for Research in
p.(None): health. The results of this examination are communicated to them through the doctor of their
p.(None): before the expression of their informed consent.
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.(None): to improve their state of health:
p.(None): - require the prior approval of the Nationa County! of ethics for health research.
p.(None): CHAPTER IV
p.(None): FROM RESEARCHER LESSYSTEVESDESANTE
p.(None): Article 42: All research on health systems must require:
p.(None): - the active participation of health professionals and managers of the healthcare system;
p.(None): - the agreement and participation of the individuals, troops and communities concerned:
p.(None): - the prúoloble agreement of the National Ethics Committee for Research in $ anłé.
p.(None): TITLE IV
p.(None): HEALTH RESEARCH MONITORING
p.(None): FIRST CHAPTER
p.(None): OF THE CONIROLE BODY
p.(None): Article 43: The National Ethics Committee for Health Research (CNERS) is hereinafter called: “ïe
p.(None): 6omite * ’.
p.(None): .The Committee is I organize; from coяł ‹ôie de to research in .sontë en
p.(None): R% p.Ÿ, bl.¡.9ÿ, e.ô?, Ğ - * '^' n. , ..,. ./ ’.. ^ .. ... - ..:
p.(None): Arłíč) e "4: Un” @ ëcтeÎ fś en co: nseiI des miD1streз, ”SUf‘ proposìłiOn of the Minister in charge of Health,
p.(None): determines to 'omposition. 1es attributions and Yes modalities of functioning of the Committee.
p.(None): Article 45: The Comiłé is placed under the supervision of the Minister in charge of
p.(None): CHAPTER II
p.(None): OF THE IMPLEMENTATION OF THE CONTROL
p.(None): Article 4b: Examination of any epidemiological research protocol requiring the presence of doin witness troops
p.(None): ›Ensure that
p.(None): s ”
p.(None): - the benefits, yes risks, contiaintes and effectiveness of the new method are èwiu-c * far
p.(None): comparison with the best òiagnostic, ihći-op = ulic or preventive methods in use;
p.(None): - the control group receives a placebo only when there is no proven treatment for the targeted disease
p.(None): ; however, even if there is a proven treatment, placebo-controlled trials may be
p.(None): ethically acceptable under the following conditions
p.(None): * when, for compelling and scientifically sound methodological reasons, it does not exist
p.(None): other ways to determine the effectiveness or safety of the new
p.(None): prophylactic, diagnostic or therapeutic method:
p.(None): * when a prophylactic, diagnostic or therapeutic ethc is being tested for a
p.(None): mild condition and that participation in the trial does not expose to additional risks of
p.(None): significant or lasting damage.
p.(None): - if the efficacy of the treatment treated in the experimental group is greater than that of the treatment
p.(None): Usually used, you are immediately included in the trial.
p.(None): Article 47 When the research proposal is initiated from outside Benin by a physical person or
p.(None): moral, it must be accompanied by the opinion of the Ethics Committee of the initiating country or of any other structure
p.(None): Taken place, before its examination by the Committee.
p.(None): TITLE V
p.(None): OFFENSES AND SANCTIONS
p.(None): Un'one with two pines only. ”-” ”” "" ""
p.(None): The same sentences are appfcaõles ïotsque I consentemont has: been
p.(None): removed before research is carried out.
p.(None): The penalty incurred when it is a legal person is a fine of five million (5,000,000) ò
p.(None): fifteen million (15,000,000) francs.
...
Searching for indicator placebo:
(return to top)
p.(None): CHAPTER IV
p.(None): FROM RESEARCHER LESSYSTEVESDESANTE
p.(None): Article 42: All research on health systems must require:
p.(None): - the active participation of health professionals and managers of the healthcare system;
p.(None): - the agreement and participation of the individuals, troops and communities concerned:
p.(None): - the prúoloble agreement of the National Ethics Committee for Research in $ anłé.
p.(None): TITLE IV
p.(None): HEALTH RESEARCH MONITORING
p.(None): FIRST CHAPTER
p.(None): OF THE CONIROLE BODY
p.(None): Article 43: The National Ethics Committee for Health Research (CNERS) is hereinafter called: “ïe
p.(None): 6omite * ’.
p.(None): .The Committee is I organize; from coяł ‹ôie de to research in .sontë en
p.(None): R% p.Ÿ, bl.¡.9ÿ, e.ô?, Ğ - * '^' n. , ..,. ./ ’.. ^ .. ... - ..:
p.(None): Arłíč) e "4: Un” @ ëcтeÎ fś en co: nseiI des miD1streз, ”SUf‘ proposìłiOn of the Minister in charge of Health,
p.(None): determines to 'omposition. 1es attributions and Yes modalities of functioning of the Committee.
p.(None): Article 45: The Comiłé is placed under the supervision of the Minister in charge of
p.(None): CHAPTER II
p.(None): OF THE IMPLEMENTATION OF THE CONTROL
p.(None): Article 4b: Examination of any epidemiological research protocol requiring the presence of doin witness troops
p.(None): ›Ensure that
p.(None): s ”
p.(None): - the benefits, yes risks, contiaintes and effectiveness of the new method are èwiu-c * far
p.(None): comparison with the best òiagnostic, ihći-op = ulic or preventive methods in use;
p.(None): - the control group receives a placebo only when there is no proven treatment for the targeted disease
p.(None): ; however, even if there is a proven treatment, placebo-controlled trials may be
p.(None): ethically acceptable under the following conditions
p.(None): * when, for compelling and scientifically sound methodological reasons, it does not exist
p.(None): other ways to determine the effectiveness or safety of the new
p.(None): prophylactic, diagnostic or therapeutic method:
p.(None): * when a prophylactic, diagnostic or therapeutic ethc is being tested for a
p.(None): mild condition and that participation in the trial does not expose to additional risks of
p.(None): significant or lasting damage.
p.(None): - if the efficacy of the treatment treated in the experimental group is greater than that of the treatment
p.(None): Usually used, you are immediately included in the trial.
p.(None): Article 47 When the research proposal is initiated from outside Benin by a physical person or
p.(None): moral, it must be accompanied by the opinion of the Ethics Committee of the initiating country or of any other structure
p.(None): Taken place, before its examination by the Committee.
p.(None): TITLE V
p.(None): OFFENSES AND SANCTIONS
p.(None): Un'one with two pines only. ”-” ”” "" ""
p.(None): The same sentences are appfcaõles ïotsque I consentemont has: been
p.(None): removed before research is carried out.
p.(None): The penalty incurred when it is a legal person is a fine of five million (5,000,000) ò
p.(None): fifteen million (15,000,000) francs.
p.(None): (1,000,000) ò five million (5,000,000) = francs when the culprit is a physical person.
p.(None): Article 50: Or * the penalties provided for in article 49 above, the culprit incurs the following sanctions
p.(None): - the ban on civil, civil and family rights in accordance with the
p.(None): provisions of the penal code;
...
Orphaned Trigger Words
p.(None): hygienic packaging and ò their good conservation, with a view to use nationally, regionally and
p.(None): intefnalionole.
p.(None): Article J 9 The research on health systems aims to promote decision-making
p.(None): rational for the optimal management of establishments and structures of the health system.
p.(None): This management aims to ensure, at a lower cost and with a better quality of service, the promotion of
p.(None): health and preventive care. curative, rehabilitative and promotional to the different
p.(None): system levels
p.(None): TITLE ül
p.(None): CONDITIONS FOR PERFORMING RESEARCH IN ITS NTE
p.(None): FIRST CHAPTER
p.(None): EPIDEMIOLOGICAL RESEARCH
p.(None): Article 20: Any epidemiological research applied to a group of individuals to a community must
p.(None): require the prior consent of its legal representatives.
p.(None): When a group of individuals or a community to be studied must be represented by
p.(None): as an authorized person, the researcher must ensure the authenticity of his mandate.
p.(None): Article 21: The informed consent on an individual basis of persons participating in any research
p.(None): epidemiological is mandatory.
p.(None): Lr '. consent is said to be enlightened when the person sought omits the purpose and nature of the
p.(None): research, the obligations involved in his payment, as well as the risks and benefits that
p.(None): can unravel it.
p.(None): Refusal of individual participation in such research must be
p.(None): ! ibre and respected.
p.(None): Article 22: When groups of individuals are formed for the purposes of epidemiological and
p.(None): if it is not possible to identify their representative, the researcher must obtain informed consent
p.(None): and free from any of the people called to participate in this research.
p.(None): Article 23: Informed consent is not required in the event that
p.(None): it is impossible to locate people participating in any
p.(None): search for which your files will be examined:
p.(None): there is a risk of bias in the results of certain researches or in persons participating in a
p.(None): research is likely to modify ”leuts behaviors.
p.(None): CHAPTER II
p.(None): RESEARCHCNNI4UEETBOVE0CALE
p.(None): Article 24: Clinical and biomedical research must be carried out:
p.(None): - under the direction of a researcher who, if he is not a mechanic, must be assisted
p.(None): a doctor with at least five (05) years of experience in the field concerned;
p.(None): under material and technical conditions adapted to the study and compatible with the imperatives of
p.(None): scientific rigor and safety of people who lend themselves to this research.
p.(None): Article 25: All clinical and / or biomedical research on humans must
p.(None): be based on the latest state of scientific knowledge and on pre-clinical experimentation
p.(None): sufficient
p.(None): provide those affected with a much higher benefit
p.(None): at the foreseeable risk incurred,
p.(None): - aim to extend scientific knowledge on human beings and
p.(None): means raised tibIes öe mointeùit.ô 6! a ”improving one's health.
p.(None): A.rtïcïe. 26 "’ F'réolablerñent ü to realization clone. Recherchec.he c) ini4 ue
p.(None): eî / or biomedical on a person, ïe free consent., éC) air and express of this1 it must be collected after
p.(None): that I researcher made him known
p.(None): - The objective of your research, its methodJogy and its cluré:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| child | Child |
| control group | participants in a control group |
| criminal | criminal |
| emergency | Public Emergency |
| family | Motherhood/Family |
| incapacity | Incapacitated |
| mothers | Mothers |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| placebo | participants in a control group |
| sick | Physically Ill |
| threat | Threat of Stigma |
| vulnerability | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| control group | ['placebo'] |
| placebo | ['controlXgroup'] |
Trigger Words
consent
cultural
ethics
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input