79C3C34C52B45572883A05D425EB0F82
Governing Biomedical Research on Humans
https://clinregs.niaid.nih.gov/sites/default/files/documents/mali/LawNo09-059_English%20unofficial.pdf
http://leaux.net/URLS/ConvertAPI Text Files/BE76613F4EE48B064B7016EA43C9A3E4.en.txt
Examining the file media/Synopses/BE76613F4EE48B064B7016EA43C9A3E4.html:
This file was generated: 2020-12-01 09:18:06
| 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:
(return to top)
p.(None): committee determines a period of exclusion during which the person who leads to it cannot participate in another
p.(None): research.
p.(None): Article 20: Biomedical researches can only be carried out by a competent team, in a place equipped with material and
p.(None): technical means suitable for the research and compatible with the safety requirements of the people who lead to it.
p.(None): Article 21: The fact to practice or make practice of biomedical research on a person without the consent of the person
p.(None): or his legal representatives under the conditions provided for in this Law shall be punished by:
p.(None): - One (01) to three (3) years imprisonment and a fine of 300,000 to 1,000,000 francs or one of the two penalties
p.(None): only and the prohibition, for a maximum period of five
p.(None):
p.(None): years, to exercise the professional or social activity in respect of which or in the course of which the offense was
p.(None): committed may be imposed.
p.(None): - If it has resulted in mutilation, amputation, deprivation of use of a limb or a sense, loss of the eye or other
p.(None): infirmities or sickness, the punishment will be from five to ten years of imprisonment and the prohibition on the
p.(None): pursuit of the occupational or social activity on the occasion of which the offense was committed must be pronounced.
p.(None): - In case of death the guilty shall be punished with life imprisonment and the prohibition to engage in the
p.(None): professional or social activity on the occasion of which the offense was committed must be pronounced.
p.(None): The provisions of the criminal code are applicable in relation to complicity, recidivism and mitigating circumstances.
p.(None): Article 22: Anyone undertaking research without the authorization of the Minister of Health shall be punished by five
p.(None): to ten years' imprisonment, without prejudice to the temporary or permanent closure of the research establishment.
p.(None): Article 23: The promoter whose civil liability is not guaranteed by the insurance provided for in article 8 of this law
p.(None): is punishable by imprisonment of one to six months and a fine of 300,000 to 1,000 000 francs or one of these two
p.(None): penalties only.
p.(None): The promoter who carries out or makes carried out biomedical research without having sent to the Minister for Health
p.(None): the application provided for in section 13 of this Act shall be punished by the same penalties.
p.(None): Article 24: The Minister of Health may, at any time, suspend or prohibit biomedical research in case of a public health
p.(None): risk or failure to comply with the provisions of this act. Title 5: Final provisions
p.(None): Article 25: A decree taken in Council of Ministers determines the modality of application of this law.
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
p.(None): For biomedical researches with direct individual benefit, the promoter assumes, even without fault, the compensation
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
p.(None): damage is not his/her fault or that of any stakeholder without being able to oppose the act of a third party or the
p.(None): voluntary withdrawal of the person who had initially consented to lead to the research.
p.(None): For any biomedical researches on human being, the promoter subscribes an insurance guaranteeing his civil
p.(None): responsibility as it results from this article and that of all and that of any intervener, regardless of the nature of
p.(None): the links existing between the parties and the promoter.
p.(None): The provisions of this article are of public order.
p.(None): Article 9: Biomedical research does not entitled to any direct or indirect financial compensation for the people who
p.(None): lead to it, except for the reimbursement of the exposed expenses and subject to planned special provisions.
p.(None): However, in the case of a commercial benefit of a research, refunds must be negotiated
p.(None):
p.(None): for the community under the study.
p.(None): Title 3: Modalities and procedures for biomedical research
p.(None): Article 10: Prior to carrying out a biomedical research on a person, the free, clear and express consent of the person
p.(None): must be obtained after the investigator, or the physician who represents him, has made known to him:
p.(None): - The objective of the research, its methodology and its duration;
p.(None): - Expected benefits, constraints and foreseeable risks, including in the termination of research before its expiry;
p.(None): - The opinion of an approved ethics committee.
p.(None):
p.(None): He or she informs the person whose consent is sought of his / her right to refuse or participate in a research or
p.(None): withdraw his / her consent at any time without incurring any liability, without detriment to the overall scientific
p.(None): quality of the results.
p.(None): In exceptional cases, where, in the interest of a sick person, the diagnosis of his illness has not been revealed to
p.(None): him, the investigator may, in the respect confidentiality and the anonymity keep certain information relating to this
p.(None): diagnosis.
p.(None): In this case, the research protocol must mention this eventuality. The information provided is summarized in a written
p.(None): document transmitted to the person whose consent is sought
p.(None): The consent is given in writing, or in case of impossibility, attests by a third party. The latter must be completely
p.(None): independent of the investigator and the promoter. The consent may also be recorded or screened.
p.(None): Article 11: In the case of biomedical research to be implemented in emergency situations which do not allow the prior
p.(None): consent of the person to be submitted to it, the protocol presented to the opinion of an approved ethics committee may
p.(None): predict that the consent of such person shall not be sought and that only of the relatives, if present, shall be
p.(None): solicited under the conditions set out above.
p.(None): The interested party will be informed as soon as possible and his / her consent will be requested for the possible
p.(None): pursuit of this research.
p.(None): Article 12: When a biomedical research is carried out on minors or on adults who are prohibited with direct individual
p.(None): benefit or without direct individual benefit, not presenting a serious foreseeable risk, consent must be given by their
p.(None): legal representatives.
p.(None):
p.(None): Article 13: Before carrying out a research on the human being, every investigator is obliged to submit the project to
p.(None): the opinion of a scientific committee and an approved ethics committee.
p.(None): The scientific committee gives its opinion on the scientific validity of the research protocol.
p.(None):
p.(None): The ethics committee gives its opinion on the conditions of validity of the research, in particular the protection of
p.(None): the participants, their information and the methods of collecting their consent, any compensations due, the general
p.(None): relevance of the project and the adequacy between the pursued objectives and the means used and the qualification of
p.(None): the investigator (s) as well. It shall communicate to the Minister in charge of health any favorable or unfavorable
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
p.(None): For biomedical researches with direct individual benefit, the promoter assumes, even without fault, the compensation
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
p.(None): damage is not his/her fault or that of any stakeholder without being able to oppose the act of a third party or the
p.(None): voluntary withdrawal of the person who had initially consented to lead to the research.
p.(None): For any biomedical researches on human being, the promoter subscribes an insurance guaranteeing his civil
p.(None): responsibility as it results from this article and that of all and that of any intervener, regardless of the nature of
p.(None): the links existing between the parties and the promoter.
p.(None): The provisions of this article are of public order.
p.(None): Article 9: Biomedical research does not entitled to any direct or indirect financial compensation for the people who
p.(None): lead to it, except for the reimbursement of the exposed expenses and subject to planned special provisions.
p.(None): However, in the case of a commercial benefit of a research, refunds must be negotiated
p.(None):
p.(None): for the community under the study.
p.(None): Title 3: Modalities and procedures for biomedical research
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.(None): - it is authorized under this act.
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
p.(None): For biomedical researches with direct individual benefit, the promoter assumes, even without fault, the compensation
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
p.(None): damage is not his/her fault or that of any stakeholder without being able to oppose the act of a third party or the
p.(None): voluntary withdrawal of the person who had initially consented to lead to the research.
p.(None): For any biomedical researches on human being, the promoter subscribes an insurance guaranteeing his civil
p.(None): responsibility as it results from this article and that of all and that of any intervener, regardless of the nature of
p.(None): the links existing between the parties and the promoter.
p.(None): The provisions of this article are of public order.
p.(None): Article 9: Biomedical research does not entitled to any direct or indirect financial compensation for the people who
p.(None): lead to it, except for the reimbursement of the exposed expenses and subject to planned special provisions.
p.(None): However, in the case of a commercial benefit of a research, refunds must be negotiated
p.(None):
p.(None): for the community under the study.
p.(None): Title 3: Modalities and procedures for biomedical research
p.(None): Article 10: Prior to carrying out a biomedical research on a person, the free, clear and express consent of the person
p.(None): must be obtained after the investigator, or the physician who represents him, has made known to him:
p.(None): - The objective of the research, its methodology and its duration;
p.(None): - Expected benefits, constraints and foreseeable risks, including in the termination of research before its expiry;
p.(None): - The opinion of an approved ethics committee.
p.(None):
p.(None): He or she informs the person whose consent is sought of his / her right to refuse or participate in a research or
p.(None): withdraw his / her consent at any time without incurring any liability, without detriment to the overall scientific
p.(None): quality of the results.
p.(None): In exceptional cases, where, in the interest of a sick person, the diagnosis of his illness has not been revealed to
p.(None): him, the investigator may, in the respect confidentiality and the anonymity keep certain information relating to this
p.(None): diagnosis.
p.(None): In this case, the research protocol must mention this eventuality. The information provided is summarized in a written
p.(None): document transmitted to the person whose consent is sought
p.(None): The consent is given in writing, or in case of impossibility, attests by a third party. The latter must be completely
p.(None): independent of the investigator and the promoter. The consent may also be recorded or screened.
p.(None): Article 11: In the case of biomedical research to be implemented in emergency situations which do not allow the prior
p.(None): consent of the person to be submitted to it, the protocol presented to the opinion of an approved ethics committee may
p.(None): predict that the consent of such person shall not be sought and that only of the relatives, if present, shall be
p.(None): solicited under the conditions set out above.
p.(None): The interested party will be informed as soon as possible and his / her consent will be requested for the possible
p.(None): pursuit of this research.
p.(None): Article 12: When a biomedical research is carried out on minors or on adults who are prohibited with direct individual
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.(None): responsibility as it results from this article and that of all and that of any intervener, regardless of the nature of
p.(None): the links existing between the parties and the promoter.
p.(None): The provisions of this article are of public order.
p.(None): Article 9: Biomedical research does not entitled to any direct or indirect financial compensation for the people who
p.(None): lead to it, except for the reimbursement of the exposed expenses and subject to planned special provisions.
p.(None): However, in the case of a commercial benefit of a research, refunds must be negotiated
p.(None):
p.(None): for the community under the study.
p.(None): Title 3: Modalities and procedures for biomedical research
p.(None): Article 10: Prior to carrying out a biomedical research on a person, the free, clear and express consent of the person
p.(None): must be obtained after the investigator, or the physician who represents him, has made known to him:
p.(None): - The objective of the research, its methodology and its duration;
p.(None): - Expected benefits, constraints and foreseeable risks, including in the termination of research before its expiry;
p.(None): - The opinion of an approved ethics committee.
p.(None):
p.(None): He or she informs the person whose consent is sought of his / her right to refuse or participate in a research or
p.(None): withdraw his / her consent at any time without incurring any liability, without detriment to the overall scientific
p.(None): quality of the results.
p.(None): In exceptional cases, where, in the interest of a sick person, the diagnosis of his illness has not been revealed to
p.(None): him, the investigator may, in the respect confidentiality and the anonymity keep certain information relating to this
p.(None): diagnosis.
p.(None): In this case, the research protocol must mention this eventuality. The information provided is summarized in a written
p.(None): document transmitted to the person whose consent is sought
p.(None): The consent is given in writing, or in case of impossibility, attests by a third party. The latter must be completely
p.(None): independent of the investigator and the promoter. The consent may also be recorded or screened.
p.(None): Article 11: In the case of biomedical research to be implemented in emergency situations which do not allow the prior
p.(None): consent of the person to be submitted to it, the protocol presented to the opinion of an approved ethics committee may
p.(None): predict that the consent of such person shall not be sought and that only of the relatives, if present, shall be
p.(None): solicited under the conditions set out above.
p.(None): The interested party will be informed as soon as possible and his / her consent will be requested for the possible
p.(None): pursuit of this research.
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None): also called research with direct finality.
p.(None): Research without direct benefit: Research supposed to bring no direct benefit to the person who leads to it. It is also
p.(None): called research without direct finality. It can increase knowledge in a biomedical field, with the possibility of
p.(None): application in the medium and long term.
p.(None): Personal identifiable information: Information about a person that allows him to be identified or re-identified by a
p.(None): combination of indirect identifiers (such as date of birth, residence or unique personal characteristics).
p.(None): Title 2: Conditions of biomedical research on humans
p.(None): Article 3: No biomedical research can be carried out on human being unless the following conditions are met:
p.(None): - the research is scientifically based and clearly described in a protocol;
p.(None): - the available pre-clinical and clinical information is sufficient to justify the conduct of the projected
p.(None): research;
p.(None): - the foreseeable risk incurred by researchers is disproportionate to the expected benefit to them or the interest
p.(None): of this research;
p.(None): - it aims to extend the scientific knowledge of human being and the means likely to improve his condition;
p.(None): - it is authorized under this act.
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
...
Social / Age
Searching for indicator age:
(return to top)
p.(None): - it is authorized under this act.
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
p.(None): For biomedical researches with direct individual benefit, the promoter assumes, even without fault, the compensation
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
p.(None): damage is not his/her fault or that of any stakeholder without being able to oppose the act of a third party or the
p.(None): voluntary withdrawal of the person who had initially consented to lead to the research.
p.(None): For any biomedical researches on human being, the promoter subscribes an insurance guaranteeing his civil
p.(None): responsibility as it results from this article and that of all and that of any intervener, regardless of the nature of
p.(None): the links existing between the parties and the promoter.
p.(None): The provisions of this article are of public order.
p.(None): Article 9: Biomedical research does not entitled to any direct or indirect financial compensation for the people who
p.(None): lead to it, except for the reimbursement of the exposed expenses and subject to planned special provisions.
p.(None): However, in the case of a commercial benefit of a research, refunds must be negotiated
...
Social / Child
Searching for indicator child:
(return to top)
p.(None): combination of indirect identifiers (such as date of birth, residence or unique personal characteristics).
p.(None): Title 2: Conditions of biomedical research on humans
p.(None): Article 3: No biomedical research can be carried out on human being unless the following conditions are met:
p.(None): - the research is scientifically based and clearly described in a protocol;
p.(None): - the available pre-clinical and clinical information is sufficient to justify the conduct of the projected
p.(None): research;
p.(None): - the foreseeable risk incurred by researchers is disproportionate to the expected benefit to them or the interest
p.(None): of this research;
p.(None): - it aims to extend the scientific knowledge of human being and the means likely to improve his condition;
p.(None): - it is authorized under this act.
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
p.(None): For biomedical researches with direct individual benefit, the promoter assumes, even without fault, the compensation
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.(None): Personal identifiable information: Information about a person that allows him to be identified or re-identified by a
p.(None): combination of indirect identifiers (such as date of birth, residence or unique personal characteristics).
p.(None): Title 2: Conditions of biomedical research on humans
p.(None): Article 3: No biomedical research can be carried out on human being unless the following conditions are met:
p.(None): - the research is scientifically based and clearly described in a protocol;
p.(None): - the available pre-clinical and clinical information is sufficient to justify the conduct of the projected
p.(None): research;
p.(None): - the foreseeable risk incurred by researchers is disproportionate to the expected benefit to them or the interest
p.(None): of this research;
p.(None): - it aims to extend the scientific knowledge of human being and the means likely to improve his condition;
p.(None): - it is authorized under this act.
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
p.(None): For biomedical researches with direct individual benefit, the promoter assumes, even without fault, the compensation
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
...
Searching for indicator fetuses:
(return to top)
p.(None): Law No. 09-059 / of December 28th , 2009 Governing biomedical research on humans
p.(None):
p.(None): The National Assembly deliberated and adopted at the meeting of December 15th, 2009; The President of the Republic
p.(None): promulgates the following law:
p.(None): Title 1: General provisions
p.(None): Chapter 1: The Purpose of the Scope
p.(None): Article 1: This law governs biomedical research on human being.
p.(None): The provisions of this Act apply to researches on living persons, embryos and fetuses, biological material of human
p.(None): origin, identifiable personal information, corps, embryos or fetuses resulting from pregnancies or spontaneous abortion
p.(None): and stillbirths.
p.(None): Chapter 2: Definitions
p.(None): Article 2: For the purposes of this Law, we mean by:
p.(None): Research committee: A center approved by the Minister in charge of health for one or more types of biomedical research.
p.(None): Institutional Ethics Committee: Ethics committee planned in the organic texts of a national research institution.
p.(None): National Ethics Committee: A committee set up at the national level to investigate biomedical research files on the
p.(None): ethical level, on its own initiative, at the request of the President of the Republic, the Prime Minister, a member of
p.(None): the Government , presidents of institutions or presidents of foundations and NGOs recognized as public utility and
p.(None): research investigators.
p.(None): Research Coordinator: A physical person in charge of coordinating the actions of investigators working on the same
p.(None): project and in different centers.
p.(None): Research institution: Any specialized body with moral personality whose mission is to promote and conduct biomedical
p.(None): research.
p.(None): Research investigator: An individual who is responsible for directing and overseeing the implementation of the research
p.(None): project of the promoter that is authorized under the Malian law. A lead investigator is required per research project.
p.(None): Promoter: A physical or moral person, institution or organization that initiates and finances a research project on
p.(None): human being.
p.(None):
p.(None): Biomedical research: Any clinical, biological or surgical experiment organized and practiced on the human being with a
p.(None): view to the development of biological or medical knowledge.
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.(None): Title 2: Conditions of biomedical research on humans
p.(None): Article 3: No biomedical research can be carried out on human being unless the following conditions are met:
p.(None): - the research is scientifically based and clearly described in a protocol;
p.(None): - the available pre-clinical and clinical information is sufficient to justify the conduct of the projected
p.(None): research;
p.(None): - the foreseeable risk incurred by researchers is disproportionate to the expected benefit to them or the interest
p.(None): of this research;
p.(None): - it aims to extend the scientific knowledge of human being and the means likely to improve his condition;
p.(None): - it is authorized under this act.
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
p.(None): For biomedical researches with direct individual benefit, the promoter assumes, even without fault, the compensation
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
p.(None): damage is not his/her fault or that of any stakeholder without being able to oppose the act of a third party or the
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): called research without direct finality. It can increase knowledge in a biomedical field, with the possibility of
p.(None): application in the medium and long term.
p.(None): Personal identifiable information: Information about a person that allows him to be identified or re-identified by a
p.(None): combination of indirect identifiers (such as date of birth, residence or unique personal characteristics).
p.(None): Title 2: Conditions of biomedical research on humans
p.(None): Article 3: No biomedical research can be carried out on human being unless the following conditions are met:
p.(None): - the research is scientifically based and clearly described in a protocol;
p.(None): - the available pre-clinical and clinical information is sufficient to justify the conduct of the projected
p.(None): research;
p.(None): - the foreseeable risk incurred by researchers is disproportionate to the expected benefit to them or the interest
p.(None): of this research;
p.(None): - it aims to extend the scientific knowledge of human being and the means likely to improve his condition;
p.(None): - it is authorized under this act.
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): application in the medium and long term.
p.(None): Personal identifiable information: Information about a person that allows him to be identified or re-identified by a
p.(None): combination of indirect identifiers (such as date of birth, residence or unique personal characteristics).
p.(None): Title 2: Conditions of biomedical research on humans
p.(None): Article 3: No biomedical research can be carried out on human being unless the following conditions are met:
p.(None): - the research is scientifically based and clearly described in a protocol;
p.(None): - the available pre-clinical and clinical information is sufficient to justify the conduct of the projected
p.(None): research;
p.(None): - the foreseeable risk incurred by researchers is disproportionate to the expected benefit to them or the interest
p.(None): of this research;
p.(None): - it aims to extend the scientific knowledge of human being and the means likely to improve his condition;
p.(None): - it is authorized under this act.
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
p.(None): For biomedical researches with direct individual benefit, the promoter assumes, even without fault, the compensation
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
p.(None): damage is not his/her fault or that of any stakeholder without being able to oppose the act of a third party or the
p.(None): voluntary withdrawal of the person who had initially consented to lead to the research.
p.(None): For any biomedical researches on human being, the promoter subscribes an insurance guaranteeing his civil
p.(None): responsibility as it results from this article and that of all and that of any intervener, regardless of the nature of
p.(None): the links existing between the parties and the promoter.
p.(None): The provisions of this article are of public order.
p.(None): Article 9: Biomedical research does not entitled to any direct or indirect financial compensation for the people who
p.(None): lead to it, except for the reimbursement of the exposed expenses and subject to planned special provisions.
p.(None): However, in the case of a commercial benefit of a research, refunds must be negotiated
p.(None):
p.(None): for the community under the study.
p.(None): Title 3: Modalities and procedures for biomedical research
p.(None): Article 10: Prior to carrying out a biomedical research on a person, the free, clear and express consent of the person
p.(None): must be obtained after the investigator, or the physician who represents him, has made known to him:
p.(None): - The objective of the research, its methodology and its duration;
p.(None): - Expected benefits, constraints and foreseeable risks, including in the termination of research before its expiry;
p.(None): - The opinion of an approved ethics committee.
p.(None):
p.(None): He or she informs the person whose consent is sought of his / her right to refuse or participate in a research or
p.(None): withdraw his / her consent at any time without incurring any liability, without detriment to the overall scientific
p.(None): quality of the results.
p.(None): In exceptional cases, where, in the interest of a sick person, the diagnosis of his illness has not been revealed to
p.(None): him, the investigator may, in the respect confidentiality and the anonymity keep certain information relating to this
p.(None): diagnosis.
p.(None): In this case, the research protocol must mention this eventuality. The information provided is summarized in a written
p.(None): document transmitted to the person whose consent is sought
p.(None): The consent is given in writing, or in case of impossibility, attests by a third party. The latter must be completely
p.(None): independent of the investigator and the promoter. The consent may also be recorded or screened.
p.(None): Article 11: In the case of biomedical research to be implemented in emergency situations which do not allow the prior
p.(None): consent of the person to be submitted to it, the protocol presented to the opinion of an approved ethics committee may
p.(None): predict that the consent of such person shall not be sought and that only of the relatives, if present, shall be
p.(None): solicited under the conditions set out above.
p.(None): The interested party will be informed as soon as possible and his / her consent will be requested for the possible
p.(None): pursuit of this research.
p.(None): Article 12: When a biomedical research is carried out on minors or on adults who are prohibited with direct individual
p.(None): benefit or without direct individual benefit, not presenting a serious foreseeable risk, consent must be given by their
p.(None): legal representatives.
p.(None):
p.(None): Article 13: Before carrying out a research on the human being, every investigator is obliged to submit the project to
p.(None): the opinion of a scientific committee and an approved ethics committee.
p.(None): The scientific committee gives its opinion on the scientific validity of the research protocol.
p.(None):
p.(None): The ethics committee gives its opinion on the conditions of validity of the research, in particular the protection of
p.(None): the participants, their information and the methods of collecting their consent, any compensations due, the general
p.(None): relevance of the project and the adequacy between the pursued objectives and the means used and the qualification of
p.(None): the investigator (s) as well. It shall communicate to the Minister in charge of health any favorable or unfavorable
p.(None): opinion given to a research project according to the level of research and the national interest.
p.(None): Prior to its implementation, the sponsor or main investigator shall send to the Minister of Health an application
p.(None): describing the essential data of the research, accompanied by the opinion of the committee or committees consulted.
p.(None): This opinion does not relieve him of his responsibility.
p.(None): When the research is to be carried out in one or more public or private establishments, the sponsor or main
p.(None): investigator shall inform the director(s) of those institutions before the research is carried out.
p.(None): The promoter shall inform the Minister of Health of any effect that may have contributed to the occurrence of a death,
p.(None): caused hospitalization or resulted in lasting organic or functional consequence and likely to be due to research. He
p.(None): shall also inform him of any premature termination of the investigation, indicating the reason of the termination.
p.(None): Article 14: Subject to any ethical or legal obligation to reveal confidential information, members of committees,
p.(None): people called upon to collaborate in their work and agents of the state who own them should keep secret the information
p.(None): they may be knowledgeable about because of their duties and that lead to it or ongoing or objects or experimented
p.(None): methods. People who are not independent of the sponsor and the investigator cannot valuably participate in a
p.(None): deliberation of the examined research.
p.(None): Researchers must maintain the confidentiality of the personal information regarding participants to the research, under
p.(None): reserve to any ethical or legal obligation to reveal confidential information.
p.(None):
p.(None): Article 15: Biomedical researches without direct individual benefit must not involve any serious and predictable risk
p.(None): to the health of the people who lead to it. They must be preceded by a medical examination of the people concerned. The
p.(None): results of this diagnosis are communicated to them through the main investigator.
p.(None): Article 16: In the case of a research without direct individual benefit to the people who lead to it, the promoter pays
p.(None): to these people an indemnity in compensation for the constraints underwent. The total amount of compensation that a
p.(None): person may receive in the same year taken for its application.
p.(None): Article 17: Health inspectors, the Pharmaceutical and Medicines Directorate and the members of the approved ethics
p.(None): committee shall be responsible for ensuring compliance with the provisions of this law and the regulations adopted for
p.(None): its application.
p.(None): Article 18: The information relating to the search shall be recorded in registers, processed and stored in such a way
p.(None): as to the presentation of complete and accurate reports on research and its interpretation as well as its checking.
p.(None): These information must be available at the body that conducted the research and at the researcher.
p.(None): Title 4: Prohibitions and penalties
p.(None): Article 19: No one can simultaneously lead to several biomedical researches which could harm his health or the results
p.(None): of the research.
p.(None): For each research, the protocol submitted for the advisory opinion of the scientific committee and the approved ethics
p.(None): committee determines a period of exclusion during which the person who leads to it cannot participate in another
p.(None): research.
p.(None): Article 20: Biomedical researches can only be carried out by a competent team, in a place equipped with material and
p.(None): technical means suitable for the research and compatible with the safety requirements of the people who lead to it.
p.(None): Article 21: The fact to practice or make practice of biomedical research on a person without the consent of the person
p.(None): or his legal representatives under the conditions provided for in this Law shall be punished by:
p.(None): - One (01) to three (3) years imprisonment and a fine of 300,000 to 1,000,000 francs or one of the two penalties
p.(None): only and the prohibition, for a maximum period of five
p.(None):
p.(None): years, to exercise the professional or social activity in respect of which or in the course of which the offense was
p.(None): committed may be imposed.
p.(None): - If it has resulted in mutilation, amputation, deprivation of use of a limb or a sense, loss of the eye or other
p.(None): infirmities or sickness, the punishment will be from five to ten years of imprisonment and the prohibition on the
p.(None): pursuit of the occupational or social activity on the occasion of which the offense was committed must be pronounced.
p.(None): - In case of death the guilty shall be punished with life imprisonment and the prohibition to engage in the
p.(None): professional or social activity on the occasion of which the offense was committed must be pronounced.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): - the available pre-clinical and clinical information is sufficient to justify the conduct of the projected
p.(None): research;
p.(None): - the foreseeable risk incurred by researchers is disproportionate to the expected benefit to them or the interest
p.(None): of this research;
p.(None): - it aims to extend the scientific knowledge of human being and the means likely to improve his condition;
p.(None): - it is authorized under this act.
p.(None):
p.(None): Article 4: Biomedical researches may only be carried out:
p.(None):
p.(None): - Under the direction and supervision of an investigator with appropriate training and experience;
p.(None): - In material and technical conditions adapted to the study and compatible with the requirements of scientific
p.(None): rigor and safety of the people who lead to this research.
p.(None):
p.(None):
p.(None): Article 5: Researches without direct individual benefit to pregnant women or who breast feed are admitted only if
p.(None): there is a balance of advantages and prejudices favorable to the woman and her embryo, her fetus or her child.
p.(None):
p.(None): Article 6: People deprived of liberty may only be solicited for biomedical research if they are expected to have a
p.(None): direct and major benefit for their health.
p.(None): Article 7: Minors, adults under guardianship, people staying in a health or social institution and patients in
p.(None): emergency situations may be solicited for biomedical research only if they can benefit individually or collectively.
p.(None): However, researches without direct individual benefit are allowed if the following three conditions are met:
p.(None): - Presenting no predictable serious risks on their health;
p.(None): - Be useful to people with the same age, illness or disability characteristics;
p.(None): - Results that cannot be achieved otherwise.
p.(None):
p.(None): Article 8: In the case of biomedical researches without direct individual benefit, the promoter assumes, even without
p.(None): fault, the compensation for the harmful consequences of the research for the person who leads to it, without being able
p.(None): to oppose the act of a third party or the voluntary withdrawal of the person who had initially consented to lead to the
p.(None): research.
p.(None): For biomedical researches with direct individual benefit, the promoter assumes, even without fault, the compensation
p.(None): for the harmful consequences of the search for the person who leads to it, except evidence of his discharge that the
p.(None): damage is not his/her fault or that of any stakeholder without being able to oppose the act of a third party or the
p.(None): voluntary withdrawal of the person who had initially consented to lead to the research.
p.(None): For any biomedical researches on human being, the promoter subscribes an insurance guaranteeing his civil
p.(None): responsibility as it results from this article and that of all and that of any intervener, regardless of the nature of
p.(None): the links existing between the parties and the promoter.
...
p.(None): - Expected benefits, constraints and foreseeable risks, including in the termination of research before its expiry;
p.(None): - The opinion of an approved ethics committee.
p.(None):
p.(None): He or she informs the person whose consent is sought of his / her right to refuse or participate in a research or
p.(None): withdraw his / her consent at any time without incurring any liability, without detriment to the overall scientific
p.(None): quality of the results.
p.(None): In exceptional cases, where, in the interest of a sick person, the diagnosis of his illness has not been revealed to
p.(None): him, the investigator may, in the respect confidentiality and the anonymity keep certain information relating to this
p.(None): diagnosis.
p.(None): In this case, the research protocol must mention this eventuality. The information provided is summarized in a written
p.(None): document transmitted to the person whose consent is sought
p.(None): The consent is given in writing, or in case of impossibility, attests by a third party. The latter must be completely
p.(None): independent of the investigator and the promoter. The consent may also be recorded or screened.
p.(None): Article 11: In the case of biomedical research to be implemented in emergency situations which do not allow the prior
p.(None): consent of the person to be submitted to it, the protocol presented to the opinion of an approved ethics committee may
p.(None): predict that the consent of such person shall not be sought and that only of the relatives, if present, shall be
p.(None): solicited under the conditions set out above.
p.(None): The interested party will be informed as soon as possible and his / her consent will be requested for the possible
p.(None): pursuit of this research.
p.(None): Article 12: When a biomedical research is carried out on minors or on adults who are prohibited with direct individual
p.(None): benefit or without direct individual benefit, not presenting a serious foreseeable risk, consent must be given by their
p.(None): legal representatives.
p.(None):
p.(None): Article 13: Before carrying out a research on the human being, every investigator is obliged to submit the project to
p.(None): the opinion of a scientific committee and an approved ethics committee.
p.(None): The scientific committee gives its opinion on the scientific validity of the research protocol.
p.(None):
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| child | Child |
| criminal | criminal |
| disability | Mentally Disabled |
| embryo | embryo |
| emergency | Public Emergency |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| illness | Physically Disabled |
| liberty | Incarcerated |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| pregnant | Pregnant |
| sick | Physically Ill |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| fetus | ['fetuses'] |
| fetuses | ['fetus'] |
Trigger Words
consent
ethics
harm
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input