A624E35EC511A22EA96BE3E7265ABF72
Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title II, Chapter VI (1993)
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| 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
Health / Drug Dependence
Searching for indicator dependency:
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p.(None): with the following requirements:
p.(None): a) It will be prepared by the principal investigator, with the information indicated in the article
p.(None): 15 of this resolution.
p.(None): b) It will be reviewed by the Research Ethics Committee of the institution where the
p.(None): investigation.
p.(None): c) Indicate the names and addresses of two witnesses and their relationship with the subject of investigation.
p.(None): d) It must be signed by two witnesses and by the investigation subject or his representative
p.(None): legal, failing that. If the research subject does not know how to sign, he will print his fingerprint and his
p.(None): name will sign another person he designates.
p.(None): e) It will be prepared in duplicate, leaving a copy in the possession of the research subject or his legal representative.
p.(None): FIRST PARAGRAPH. In the case of investigations with minimal risk, the Research Ethics Committee of the
p.(None): The research institution, for justified reasons, may authorize that the Informed Consent be
p.(None): obtain without formulating in writing and
p.(None): Sheet 5 of 5
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): in the case of risk-free investigations, the investigator may be excused from obtaining it.
p.(None): SECOND PARAGRAPH. If there is any kind of dependency, ancestry or subordination of the subject of
p.(None): investigation towards the researcher that prevents him from freely granting his consent, this must be obtained
p.(None): by another member of the research team, or of the institution where the investigation will be conducted,
p.(None): completely independent of the researcher-subject relationship.
p.(None): THIRD PARAGRAPH. When it is necessary to determine the mental capacity of an individual to grant his
p.(None): consent, the principal investigator must go to a neurologist, psychiatrist or psychologist so that
p.(None): evaluate the capacity of understanding, reasoning and logic of the subject, according to the parameters
p.(None): approved by the Research Ethics Committee of the research institution.
p.(None): FOURTH PARAGRAPH. When it is presumed that the mental capacity of a subject has varied over time, the
p.(None): Informed Consent of this or, failing that, of your legal representative, must be endorsed by a professional
p.(None): (neurologist, psychiatrist, psychologist) of recognized scientific and moral capacity in the specific field, as well as
p.(None): of an observer who has no relation to the investigation, to ensure the suitability of the mechanism of
p.(None): obtaining consent, as well as its validity during the course of the investigation.
p.(None): FIFTH PARAGRAPH. When the research subject is a psychiatric patient admitted to a hospital
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Health / Drug Usage
Searching for indicator drug:
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p.(None): d) d.The research institution will render to the Research Ethics Committee and the Ministry of Health, when so
p.(None): a report is required within fifteen (15) business days following the suspension of the
p.(None): investigation, which specifies the warned effect, the measures adopted and the consequences produced.
p.(None): CHAPTER II.
p.(None): OF PHARMACOLOGICAL RESEARCH.
p.(None): ARTICLE 53. For the purposes of this regulation, pharmacological research is understood as the
p.(None): scientific activities aimed at the study of drugs and biological products for human use on
p.(None): which do not have previous experience in the country, which are not contemplated in the Pharmacological Standards in this
p.(None): Ministry and therefore, are not distributed commercially, as well as registered medications
p.(None): and approved for sale, when its use is investigated with modalities, indications, doses or routes of administration
p.(None): different from those established, including its use in combinations.
p.(None): ARTICLE 54. Investigations of medications in clinical pharmacology include
p.(None): Sheet 11 of 11
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): the sequence of studies that are carried out from when it is first administered to the human being, until it is
p.(None): They obtain data on their efficacy and therapeutic safety in large population groups. For this purpose, they are considered
p.(None): The following phases:
p.(None): to. PHASE I: It is the administration for the first time of a research drug to the healthy human being, in single doses
p.(None): or multiple, in small hospitalized groups, to establish initial pharmacological parameters in man.
p.(None): b. PHASE II: It is the administration, to the sick human being, of a research medicine, in doses
p.(None): single or multiple, in small hospitalized groups, to establish pharmacological parameters in the organism
p.(None): sick.
p.(None): c. PHASE III It is the administration, to large groups of patients, of a research drug, usually
p.(None): external, to define its therapeutic utility and identify adverse reactions, interactions and factors
p.(None): external, that can alter the pharmacological effect.
p.(None): d. PHASE IV: These are studies that are carried out after the medicine is granted, health record for sale
p.(None): and aims to generate new information on the safety of the drug during its widespread use and
p.(None): dragged on.
p.(None): ARTICLE 55. All the investigations in clinical pharmacology that are carried out must be preceded by
p.(None): complete preclinical studies that include physicochemical characteristics pharmacological activity, toxicity,
p.(None): pharmacokinetics, absorption, distribution, metabolism and excretion of the drug in different animal species;
p.(None): frequencies, routes of administration and duration of the doses studied that can serve as a basis for the safety of
p.(None): its administration in the human being; studies on mutagenesis, teratogenesis and carcinogenesis are also required.
p.(None): ARTICLE 56. The preclinical toxicology studies required for each drug will depend on it.
p.(None): in particular, of the known potential toxicology of others with similar chemical structure and of the route and time of
p.(None): administration that is intended to be used in humans.
p.(None): ARTICLE 57. The use of research drugs in humans during their assessment through Phases I
p.(None): to IV of clinical pharmacological research, it will be done with the authorization of the Research Ethics Committee, to which
p.(None): the documentation indicated in article 50 of these regulations must be submitted, in addition to the following:
p.(None): a) The basic and preclinical pharmacological information of the medicine.
p.(None): b) Information previously obtained on clinical pharmacology in cases of phases II, III and IV and evidence of
p.(None): bioavailability when required.
p.(None): ARTICLE 58. Studies of Phase I clinical pharmacology, new antineoplastic drugs and others with index
p.(None): Very reduced therapeutic, will be allowed when:
p.(None): a) They are based on preclinical studies that demonstrate the pharmacological activity of
p.(None): medication and clearly indicate the characteristics of its toxicity.
p.(None): b) They are performed only in voluntary subjects with the specific disease, confirmed by diagnostic means
p.(None): additional, that have not presented therapeutic response to any other available treatment and in whom the
p.(None): New medication could offer a therapeutic benefit.
p.(None): c) Do not incur expenses to the patient.
p.(None): ARTICLE 59. In the treatment of emergencies, in conditions that threaten the life of
p.(None): Sheet 12 of 12
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): a person when it is considered necessary to use a research drug or a known medication using
p.(None): indications, doses and routes of administration different from those established, the doctor must obtain the opinion
p.(None): favorable of the Research Ethics Committee of the research institutions and the Informed Consent of the
p.(None): subject of investigation or its legal representative, as permitted by circumstances in accordance with the following
p.(None): bases:
p.(None): a) The Research Ethics Committee will be informed of the use of the investigational drug in advance,
p.(None): if the investigator can foresee the need for its use in urgent cases, or in retrospect, if the
p.(None): use of the drug, the indication, doses or new routes of administration arose as needs not
p.(None): provided. In both cases, the Research Ethics Committee will issue an opinion in favor or against approving the
p.(None): planned use or repetition of the unforeseen use of the medication.
p.(None): b) Informed Consent will be obtained from the subject of investigation, or failing that, from
p.(None): legal representative or the closest relative in bond, except when: the condition of the subject incapacitates or
p.(None): prevent granting it, the legal representative or family member is unavailable or when you stop using the medication in
p.(None): investigation represents an absolute risk of death.
p.(None): CHAPTER III
p.(None): OF THE INVESTIGATION OF OTHER NEW RESOURCES.
p.(None): ARTICLE 60. For the purposes of this regulation, it is understood by investigation of other new resources or
p.(None): different modalities from those established, the scientific activities tending to the study of
p.(None): materials, grafts, transplants, prostheses, physical, chemical and surgical procedures,
p.(None): instruments, devices, artificial organs and other methods of prevention, diagnosis, treatment and
p.(None): rehabilitation carried out in humans or in their biological products, except pharmacological ones.
p.(None): ARTICLE 61. Any investigation referred to in this chapter must have the authorization of the Committee of
p.(None): Research Ethics. For this purpose, the research institutions must present the documentation
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Health / Health
Searching for indicator health:
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p.(None): Sheet 1 of 1
p.(None): MINISTRY OF HEALTH
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): (October 4)
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): THE MINISTER OF HEALTH
p.(None): In exercise of its legal attributions especially those conferred by Decree 2164 of 1992 and Law 10 of 1990
p.(None): CONSIDERING
p.(None): - That Article 8 of Law 10 of 1990, which organizes the National Health System and dictates other
p.(None): provisions, determines that it is up to the Ministry of Health to formulate the policies and dictate all the norms
p.(None): scientific-administrative, mandatory by the entities that make up the System,
p.(None): - That Article 2 of Decree 2164 of 1992, which restructures the Ministry of Health and determines the
p.(None): functions of its dependencies, it establishes that it will formulate the pertinent scientific and administrative norms that
p.(None): Orient the resources and actions of the System,
p.(None): RESOLVES:
p.(None): TITLE 1
p.(None): GENERAL DISPOSITION.
p.(None): ARTICLE 1. The provisions of these scientific standards are intended to establish the requirements for the
p.(None): development of the research activity in health.
p.(None): ARTICLE 2. The institutions that are going to carry out research in humans must have an Ethics Committee in
p.(None): Research, responsible for resolving all issues related to the subject.
p.(None): ARTICLE 3. The institutions, referred to in the previous article, because of their regulations and
p.(None): internal policies, will elaborate their internal procedures manual in order to support the application of these
p.(None): rules
p.(None): ARTICLE 4. Research for health includes the development of actions that contribute:
p.(None): to. To the knowledge of the biological and psychological processes in human beings.
p.(None): b. To the knowledge of the links between the causes of illness, medical practice and social structure.
p.(None): c. To the prevention and control of health problems.
p.(None): Sheet 2 of 2
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): d. To the knowledge and evaluation of the harmful effects of the environment on health.
p.(None): and. To the study of the techniques and methods that are recommended or used for the provision of health services.
p.(None): F. To the production of health supplies.
p.(None): TITLE II
p.(None): OF RESEARCH IN HUMAN BEINGS.
p.(None): CHAPTER 1.
p.(None): OF THE ETHICAL ASPECTS OF RESEARCH IN HUMAN BEINGS.
p.(None): ARTICLE 5. In any investigation in which the human being is the subject of study, the
p.(None): criterion of respect for their dignity and protection of their rights and well-being.
p.(None): ARTICLE 6. Research carried out in human beings shall be carried out according to the following criteria:
p.(None): to. It will conform to the scientific and ethical principles that justify it.
p.(None): b. It will be based on previous experimentation performed on animals, in laboratories or on other scientific facts.
p.(None): c. It will be done only when the knowledge that is intended to be produced cannot be obtained by other suitable means.
p.(None): d. The safety of the beneficiaries must prevail and clearly express the (minimum) risks, which do not
p.(None): they must, at no time, contradict article 11 of this resolution.
p.(None): and. You will have the Informed Consent and in writing of the research subject or his legal representative with the
p.(None): exceptions provided in this resolution.
p.(None): F. It must be carried out by professionals with knowledge and experience to take care of the integrity of the human being under
p.(None): the responsibility of a health entity, supervised by health authorities, provided they have
p.(None): the necessary human and material resources that guarantee the well-being of the research subject.
p.(None): g. It will be carried out when authorization is obtained: from the legal representative of the institution
p.(None): researcher and the institution where the research is carried out; Informed Consent of
p.(None): participants; and the approval of the project by the Research Ethics Committee of the institution.
p.(None): ARTICLE 7. When the experimental design of an investigation carried out in human beings includes
p.(None): several groups, random selection methods will be used to obtain an impartial allocation of participants in
p.(None): each group, and other technical standards determined for this type of research, and measures will be taken
p.(None): relevant to avoid any risk or harm to the research subjects.
p.(None): ARTICLE 8. In investigations in human beings, the privacy of the individual, subject of investigation, shall be protected.
p.(None): Identifying it only when the results require it and it authorizes it.
p.(None): Sheet 3 of 3
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 9. The probability that the subject of
p.(None): investigation suffers some damage as an immediate or late consequence of the study.
p.(None): ARTICLE 10. The group of researchers or the principal investigator shall identify the type or types of risk at which
p.(None): Research subjects will be exposed.
p.(None): ARTICLE 11. For purposes of this regulation, investigations are classified into the following categories:
p.(None): to. Risk-free research: These are studies that use research techniques and methods.
p.(None): Restrospective documentary and those in which no intervention or modification is made
p.(None): intentional of the biological, physiological, psychological or social variables of the individuals that
p.(None): participate in the study, among which are considered: review of medical records, interviews, questionnaires and
p.(None): others in which he is not identified or sensitive aspects of his behavior are treated
p.(None): b. Research with minimal risk: These are prospective studies that use data recording through
p.(None): Common procedures consisting of: physical or psychological diagnostic tests or treatments
p.(None): routine, among which are considered: weighing the subject, electrocardiograms, hearing acuity tests,
p.(None): thermographies, collection of excreta and external secretions, obtaining placenta during childbirth, collection of
p.(None): amniotic fluid when the membranes rupture, obtaining saliva, deciduous teeth and permanent teeth extracted
p.(None): by therapeutic indication, dental plaque and stones removed by non-invasive prophylactic procedures,
p.(None): hair and nail cutting without causing disfigurement, blood collection by venous puncture in adults in good condition
p.(None): health, with a maximum frequency of twice a week and a maximum volume of 450 ml in two months except during the
p.(None): pregnancy, moderate exercise in healthy volunteers, psychological tests to groups or individuals in whom
p.(None): will manipulate the subject's behavior, research with commonly used medications, wide therapeutic range and
p.(None): Registered in this Ministry or its delegated authority, using the indications, dosage and routes of administration
p.(None): established and other than the medications defined in article 55 of this resolution.
p.(None): c. Investigations with risk greater than the minimum: Are those in which the probabilities of
p.(None): affect the subject are significant, among which are considered: radiological and microwave studies,
p.(None): studies with medications and modalities defined in titles III and IV of this resolution, trials with
p.(None): new devices, studies that include surgical procedures, blood collection greater than 2% of the volume
p.(None): circulating in neonates, amniocentesis and other invasive techniques or major procedures, which
p.(None): use random methods of allocation to therapeutic schemes and those that have control with placebos, among others.
p.(None): ARTICLE 12. The principal investigator shall suspend the investigation immediately, upon warning of any risk or
p.(None): damage to the health of the subject in whom the investigation is conducted. Likewise, it will be immediately suspended for
p.(None): those research subjects that manifest it.
p.(None): ARTICLE 13. It is the responsibility of the research or sponsoring institution to provide care.
p.(None): medical to the subject that suffers any damage, if directly related to the investigation, without
p.(None): damage of the compensation that legally corresponds to him.
p.(None): ARTICLE 14. Informed Consent means the agreement in writing, whereby the subject of
p.(None): investigation or, where appropriate, your legal representative, authorizes your participation in the investigation, with full
p.(None): knowledge of the nature of the procedures, benefits and risks to be submitted, with the
p.(None): capacity of free choice and without coercion.
p.(None): Sheet 4 of 4
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 15. The Informed Consent must present the following information, which will be explained, in
p.(None): complete and clear form to the subject of investigation or, failing that, to his legal representative, in such form
p.(None): That they can understand.
p.(None): to. The justification and the objectives of the investigation.
p.(None): b. The procedures to be used and their purpose including the identification of those that are
p.(None): Experimental
p.(None): c. The inconvenience or the expected risks.
p.(None): d. The benefits that can be obtained.
p.(None): and. Alternative procedures that could be advantageous for the subject.
p.(None): F. The guarantee of receiving an answer to any question and clarification of any doubt about the
p.(None): procedures, risks, benefits and other matters related to the investigation and treatment of
p.(None): subject.
p.(None): g. The freedom to withdraw your consent at any time and stop participating in the study without it
p.(None): damages are created to continue their care and treatment.
p.(None): h. The security that the subject will not be identified and that the confidentiality of related information will be maintained
p.(None): With your privacy.
p.(None): i. The commitment to provide updated information obtained during the study, although this could affect the
p.(None): Will of the subject to continue participating.
p.(None): j. The availability of medical treatment and the compensation to which he would legally be entitled, by the
p.(None): institution responsible for the investigation, in the case of damages that directly affect it, caused by the
p.(None): investigation.
p.(None): k. In case there are additional expenses, these will be covered by the research budget or the
p.(None): institution responsible for it.
p.(None): ARTICLE 16. The Informed Consent of the taxpayer of the investigation, to be valid, must comply
p.(None): with the following requirements:
p.(None): a) It will be prepared by the principal investigator, with the information indicated in the article
p.(None): 15 of this resolution.
p.(None): b) It will be reviewed by the Research Ethics Committee of the institution where the
p.(None): investigation.
p.(None): c) Indicate the names and addresses of two witnesses and their relationship with the subject of investigation.
p.(None): d) It must be signed by two witnesses and by the investigation subject or his representative
p.(None): legal, failing that. If the research subject does not know how to sign, he will print his fingerprint and his
p.(None): name will sign another person he designates.
p.(None): e) It will be prepared in duplicate, leaving a copy in the possession of the research subject or his legal representative.
p.(None): FIRST PARAGRAPH. In the case of investigations with minimal risk, the Research Ethics Committee of the
p.(None): The research institution, for justified reasons, may authorize that the Informed Consent be
p.(None): obtain without formulating in writing and
p.(None): Sheet 5 of 5
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): in the case of risk-free investigations, the investigator may be excused from obtaining it.
p.(None): SECOND PARAGRAPH. If there is any kind of dependency, ancestry or subordination of the subject of
p.(None): investigation towards the researcher that prevents him from freely granting his consent, this must be obtained
p.(None): by another member of the research team, or of the institution where the investigation will be conducted,
p.(None): completely independent of the researcher-subject relationship.
p.(None): THIRD PARAGRAPH. When it is necessary to determine the mental capacity of an individual to grant his
p.(None): consent, the principal investigator must go to a neurologist, psychiatrist or psychologist so that
p.(None): evaluate the capacity of understanding, reasoning and logic of the subject, according to the parameters
p.(None): approved by the Research Ethics Committee of the research institution.
p.(None): FOURTH PARAGRAPH. When it is presumed that the mental capacity of a subject has varied over time, the
p.(None): Informed Consent of this or, failing that, of your legal representative, must be endorsed by a professional
p.(None): (neurologist, psychiatrist, psychologist) of recognized scientific and moral capacity in the specific field, as well as
p.(None): of an observer who has no relation to the investigation, to ensure the suitability of the mechanism of
p.(None): obtaining consent, as well as its validity during the course of the investigation.
p.(None): FIFTH PARAGRAPH. When the research subject is a psychiatric patient admitted to a hospital
p.(None): In addition to complying with the provisions of the preceding articles, it will be necessary to obtain the
p.(None): prior approval of the authority that knows about the case.
p.(None): CHAPTER II.
p.(None): OF RESEARCH IN COMMUNITIES.
p.(None): ARTICLE 17. Investigations, referring to human health, in communities, shall be admissible when the benefit
p.(None): expected for these to be reasonably insured and when previous studies conducted on a small scale
p.(None): Determine the absence of risks.
p.(None): ARTICLE 18. In investigations in communities, the principal investigator must obtain the approval of the
p.(None): health authorities and other civil authorities of the community to study, in addition to obtaining the letter of
p.(None): Informed Consent of the individuals included in the study, informing them of the information to
p.(None): referred to in articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 19. When the individuals that make up the community do not have the capacity to understand the
p.(None): implications of participating in an investigation, the Research Ethics Committee of the entity to the
p.(None): that the principal investigator belongs, or of the Entity where the investigation will be carried out, may authorize or
p.(None): not that the Informed Consent of the subjects is obtained through a reliable person with
p.(None): moral authority over the community.
p.(None): In case of not obtaining authorization from the Research Ethics Committee, the Research is not
p.(None): will perform.
p.(None): On the other hand, the participation of individuals will be entirely voluntary.
p.(None): ARTICLE 20. Experimental research in communities may only be carried out by establishments.
p.(None): that have Research Ethics Committees and the prior authorization of this Ministry to take it
p.(None): out, notwithstanding the
p.(None): Sheet 6 of 6
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): attributions that correspond to other dependencies of the State, and would have complied in any case with the studies
p.(None): prior toxicity and other tests according to the characteristics of the products and the risk involved
p.(None): For human health.
p.(None): ARTICLE 21. In all community research, research designs must offer the measures
p.(None): protection practices of individuals and ensure the obtaining of valid results in accordance with the
p.(None): established guidelines for the development of these models.
p.(None): ARTICLE 22. In any community investigation, the ethical considerations applicable to research
p.(None): in humans, they must be extrapolated to the communal context in the pertinent aspects.
p.(None): CHAPTER III
p.(None): OF INVESTIGATIONS IN MINORS OR DISABLED.
p.(None): ARTICLE 23. In addition to the general provisions of ethics that must be complied with in all research in human beings,
p.(None): that which is carried out in minors or physically and mentally disabled, must fully satisfy all
p.(None): the requirements set out in this chapter.
p.(None): ARTICLE 24. When it is intended to conduct investigations in minors, it must be ensured that
p.(None): similar studies have previously been done in adults and immature animals;
p.(None): except in the case of studies of conditions that are characteristic of the neonatal stage or conditions
p.(None): specific of certain ages.
p.(None): ARTICLE 25. To carry out investigations in minors or in physically and mentally disabled persons, in
p.(None): In any case, obtain, in addition to the Informed Consent of those exercising parental authority or
p.(None): legal representation of the minor or the person concerned, certification of a neurologist, psychiatrist or
p.(None): psychologist, about the capacity of understanding, reasoning and logic of the subject.
p.(None): ARTICLE 26. When the mental capacity and the psychological state of the minor or disabled person allow it,
p.(None): you must also obtain your acceptance to be the subject of investigation after explaining what
p.(None): pretend to do The Research Ethics Committee of the respective health entity must ensure the
p.(None): Compliance with these requirements.
p.(None): ARTICLE 27. Investigations classified with risk and with probabilities of direct benefit for the
p.(None): minor or disabled, will be admissible when:
p.(None): a) The risk is justified by the importance of the benefit that the minor or the disabled will receive.
p.(None): b) The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None): ARTICLE 28. Investigations classified as risk and without direct benefit to the minor or the
p.(None): disabled, will be admissible according to the following considerations:
p.(None): FIRST PARAGRAPH. WHEN THE RISK IS MINIMUM
p.(None): a) The intervention or procedure must represent for the minor or the disabled a reasonable experience and
p.(None): comparable to those inherent in your current medical, psychological, social or educational situation.
p.(None): Sheet 7 of 7
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
p.(None): possible for the embryo, fetus or newborn in your case.
p.(None): The Informed Consent of the spouse or partner may only be waived in case of disability or impossibility
p.(None): reliable or manifest to provide it; because the partner does not take care of the woman or, well, when
p.(None): there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None): ARTICLE 31. Research carried out on pregnant women must be preceded by studies.
p.(None): performed on non-pregnant women who demonstrate safety, except for specific studies that require
p.(None): such condition.
p.(None): ARTICLE 32. Research without therapeutic benefit in pregnant women whose objective is to obtain
p.(None): generalizable knowledge about pregnancy should not represent a risk greater than the minimum for women, the
p.(None): embryo or fetus
p.(None): ARTICLE 33. Investigations in pregnant women that involve an intervention or
p.(None): experimental procedure not related to pregnancy, but with therapeutic benefit for women, such as
p.(None): it would be in cases of toxemia gravidarum, diabetes, hypertension and neoplasms, among others, should not expose to
p.(None): embryo or fetus at a greater than minimum risk, except when the use of the intervention or procedure is
p.(None): Sheet 8 of 8
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): justify to save the woman's life.
p.(None): ARTICLE 34. Research in pregnant women, with therapeutic benefit related to pregnancy, is
p.(None): will allow when:
p.(None): a) Aim to improve the health of the pregnant woman with a minimal risk to the embryo or the fetus.
p.(None): b) Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None): ARTICLE 35. During the execution of investigations in pregnant women:
p.(None): a) Investigators will not have the authority to decide on the time, method or procedure used
p.(None): to terminate the pregnancy, nor participation in decisions about the viability of the fetus.
p.(None): b) It is strictly forbidden to grant stimuli, monetary or otherwise, to terminate the pregnancy,
p.(None): for the interest of the investigation or for other reasons.
p.(None): ARTICLE 36. Informed Consent for investigations during labor shall be obtained in agreement.
p.(None): with what is stipulated in articles 14, 15 and 16 of this regulation, before it is initiated and indicating
p.(None): expressly that it can be withdrawn at any time during labor.
p.(None): ARTICLE 37. Research on women during the puerperium will be allowed when they do not interfere with the health of the
p.(None): mother or with the newborn.
p.(None): ARTICLE 38. Research on women during breastfeeding will be authorized when there is no risk to
p.(None): the infant or when the mother decides not to breastfeed; your food is secured by another method and you get the
p.(None): Informed Consent in accordance with the provisions of articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 39. Fetuses will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the pregnant woman.
p.(None): ARTICLE 40. Newborns will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the mother.
p.(None): ARTICLE 41. Newborns shall not be subject to investigation, except when it is intended to:
p.(None): increase its probability of survival until the feasibility phase; the procedures do not cause the
p.(None): cessation of vital functions, or when, without adding any risk, generalized knowledge is sought
p.(None): important that cannot be obtained otherwise.
p.(None): ARTICLE 42. Live births may be subject to investigation if the provisions on
p.(None): investigation in minors, indicated in this resolution.
p.(None): ARTICLE 43. Investigations with embryos, deaths, fetuses, dead births, macerated fecal matter, cells,
p.(None): tissues and organs extracted from them, will be made in accordance with the provisions of this regulation.
p.(None): ARTICLE 44. Research on artificial fertilization shall only be admissible when applied to the solution of
p.(None): sterility problems that cannot be solved in any other way, respecting the moral point of view,
p.(None): cultural and social of the couple.
p.(None): CHAPTER V.
p.(None): Sheet 9 of 9
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): OF THE INVESTIGATIONS IN SUBORDINATED GROUPS.
p.(None): ARTICLE 45. Subordinated groups are understood as the following: students, workers of the
p.(None): laboratories and hospitals, employees and members of the armed forces, interns in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which the Consent
p.(None): Informed may be influenced by some authority.
p.(None): ARTICLE 46. When investigations are conducted in subordinate groups, in the Ethics Committee in
p.(None): Research, one or more members of the study population, capable of representing the values must participate
p.(None): moral, cultural and social group in question and monitor:
p.(None): a) That the participation, the rejection of the subjects to intervene or withdrawal of their consent during the study, does not
p.(None): affect their school, employment, military situation or related to the judicial process to which they were subject and the
p.(None): conditions of compliance with the judgment of the case.
p.(None): b) That the results of the investigation are not used to the detriment of the participating individuals.
p.(None): c) That the research institution and the sponsors are responsible for the medical treatment of the damages
p.(None): caused and, where appropriate, the compensation that legally corresponds for the harmful consequences of
p.(None): the investigation.
p.(None): CHAPTER VI
p.(None): OF THE RESEARCH IN ORGANS, FABRICS AND THEIR DERIVATIVES, PRODUCTS AND CADAVERES OF HUMAN BEINGS.
p.(None): ARTICLE 47. The investigation referred to in this chapter includes that which includes the use of organs,
p.(None): tissues and their derivatives, products and corpses of human beings, as well as the set of activities
p.(None): relative to its obtaining, conservation, use, preparation and final destination.
p.(None): ARTICLE 48. This investigation must observe in addition to due respect to the human corpse, the
p.(None): applicable provisions of these regulations and other regulations related to the disposition of organs, tissues and
p.(None): corpses of human beings.
p.(None): TITLE III
p.(None): OF THE INVESTIGATIONS OF NEW PROFILACTIC, DIAGNOSTIC, THERAPEUTIC AND REHABILITATION RESOURCES.
p.(None): CHAPTER I. GENERAL PROVISIONS.
p.(None): ARTICLE 49. When research is conducted on human beings, on new prophylactic resources, of
p.(None): diagnostic, therapeutic and rehabilitation, or it is intended to modify those already known, should be observed
p.(None): as applicable, the provisions of the preceding articles and satisfy the provisions of this title.
p.(None): ARTICLE 50. The Research Ethics Committee of the health entity shall be responsible for studying and
p.(None): Approve research projects and request the following documents:
p.(None): a) Research project that must contain an objective and complete analysis of the
p.(None): Sheet 10 of 10
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): risks involved, compared to the risks of established diagnostic and treatment methods
p.(None): and the expectation of living conditions with and without the proposed procedure or treatment and others
p.(None): Information relevant to a research proposal.
p.(None): b) Letter from the legal representative of the research and executing institution, when appropriate, authorizing the
p.(None): Conduct of the investigation.
p.(None): c) Description of available resources, including areas, equipment, and auxiliary laboratory services
p.(None): which will be used for research development.
p.(None): d) Description of the resources available for the management of medical emergencies.
p.(None): e) Researchers' resume that includes their academic preparation, experience and production
p.(None): scientific in the area of the proposed research.
p.(None): f) The requirements indicated in articles 57 and 61 of this resolution, as the case may be.
p.(None): ARTICLE 51. When there is sponsorship or other forms of remuneration, the measures shall be established.
p.(None): necessary to prevent these from causing conflicts of interest to the researcher in the protection of the rights of
p.(None): subjects of investigation, although they have given their consent in the preservation of the truth of the results and in
p.(None): The allocation of resources.
p.(None): ARTICLE 52. In the development of the investigations contemplated in this title, the
p.(None): following obligations:
p.(None): a) The principal investigator will inform the Research Ethics Committee of the research institution or
p.(None): the executing institution, of any probable adverse effect or directly related to the
p.(None): investigation.
p.(None): b) The director of the research institution shall notify the Research Ethics Committee, when required,
p.(None): of the presence of any adverse effect, within a maximum period of 15 business days following its presentation.
p.(None): c) The Research Ethics Committee shall suspend or cancel the investigation in the presence of any
p.(None): adverse effect that is an ethical or technical impediment to continue the study.
p.(None): d) d.The research institution will render to the Research Ethics Committee and the Ministry of Health, when so
p.(None): a report is required within fifteen (15) business days following the suspension of the
p.(None): investigation, which specifies the warned effect, the measures adopted and the consequences produced.
p.(None): CHAPTER II.
p.(None): OF PHARMACOLOGICAL RESEARCH.
p.(None): ARTICLE 53. For the purposes of this regulation, pharmacological research is understood as the
p.(None): scientific activities aimed at the study of drugs and biological products for human use on
p.(None): which do not have previous experience in the country, which are not contemplated in the Pharmacological Standards in this
p.(None): Ministry and therefore, are not distributed commercially, as well as registered medications
p.(None): and approved for sale, when its use is investigated with modalities, indications, doses or routes of administration
p.(None): different from those established, including its use in combinations.
p.(None): ARTICLE 54. Investigations of medications in clinical pharmacology include
p.(None): Sheet 11 of 11
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): the sequence of studies that are carried out from when it is first administered to the human being, until it is
p.(None): They obtain data on their efficacy and therapeutic safety in large population groups. For this purpose, they are considered
p.(None): The following phases:
p.(None): to. PHASE I: It is the administration for the first time of a research drug to the healthy human being, in single doses
p.(None): or multiple, in small hospitalized groups, to establish initial pharmacological parameters in man.
p.(None): b. PHASE II: It is the administration, to the sick human being, of a research medicine, in doses
p.(None): single or multiple, in small hospitalized groups, to establish pharmacological parameters in the organism
p.(None): sick.
p.(None): c. PHASE III It is the administration, to large groups of patients, of a research drug, usually
p.(None): external, to define its therapeutic utility and identify adverse reactions, interactions and factors
p.(None): external, that can alter the pharmacological effect.
p.(None): d. PHASE IV: These are studies that are carried out after the medicine is granted, health record for sale
p.(None): and aims to generate new information on the safety of the drug during its widespread use and
p.(None): dragged on.
p.(None): ARTICLE 55. All the investigations in clinical pharmacology that are carried out must be preceded by
p.(None): complete preclinical studies that include physicochemical characteristics pharmacological activity, toxicity,
p.(None): pharmacokinetics, absorption, distribution, metabolism and excretion of the drug in different animal species;
p.(None): frequencies, routes of administration and duration of the doses studied that can serve as a basis for the safety of
p.(None): its administration in the human being; studies on mutagenesis, teratogenesis and carcinogenesis are also required.
p.(None): ARTICLE 56. The preclinical toxicology studies required for each drug will depend on it.
p.(None): in particular, of the known potential toxicology of others with similar chemical structure and of the route and time of
p.(None): administration that is intended to be used in humans.
p.(None): ARTICLE 57. The use of research drugs in humans during their assessment through Phases I
p.(None): to IV of clinical pharmacological research, it will be done with the authorization of the Research Ethics Committee, to which
p.(None): the documentation indicated in article 50 of these regulations must be submitted, in addition to the following:
p.(None): a) The basic and preclinical pharmacological information of the medicine.
p.(None): b) Information previously obtained on clinical pharmacology in cases of phases II, III and IV and evidence of
p.(None): bioavailability when required.
p.(None): ARTICLE 58. Studies of Phase I clinical pharmacology, new antineoplastic drugs and others with index
p.(None): Very reduced therapeutic, will be allowed when:
p.(None): a) They are based on preclinical studies that demonstrate the pharmacological activity of
p.(None): medication and clearly indicate the characteristics of its toxicity.
p.(None): b) They are performed only in voluntary subjects with the specific disease, confirmed by diagnostic means
p.(None): additional, that have not presented therapeutic response to any other available treatment and in whom the
p.(None): New medication could offer a therapeutic benefit.
p.(None): c) Do not incur expenses to the patient.
p.(None): ARTICLE 59. In the treatment of emergencies, in conditions that threaten the life of
p.(None): Sheet 12 of 12
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): a person when it is considered necessary to use a research drug or a known medication using
p.(None): indications, doses and routes of administration different from those established, the doctor must obtain the opinion
p.(None): favorable of the Research Ethics Committee of the research institutions and the Informed Consent of the
p.(None): subject of investigation or its legal representative, as permitted by circumstances in accordance with the following
p.(None): bases:
p.(None): a) The Research Ethics Committee will be informed of the use of the investigational drug in advance,
p.(None): if the investigator can foresee the need for its use in urgent cases, or in retrospect, if the
p.(None): use of the drug, the indication, doses or new routes of administration arose as needs not
p.(None): provided. In both cases, the Research Ethics Committee will issue an opinion in favor or against approving the
p.(None): planned use or repetition of the unforeseen use of the medication.
p.(None): b) Informed Consent will be obtained from the subject of investigation, or failing that, from
p.(None): legal representative or the closest relative in bond, except when: the condition of the subject incapacitates or
...
p.(None): ARTICLE 60. For the purposes of this regulation, it is understood by investigation of other new resources or
p.(None): different modalities from those established, the scientific activities tending to the study of
p.(None): materials, grafts, transplants, prostheses, physical, chemical and surgical procedures,
p.(None): instruments, devices, artificial organs and other methods of prevention, diagnosis, treatment and
p.(None): rehabilitation carried out in humans or in their biological products, except pharmacological ones.
p.(None): ARTICLE 61. Any investigation referred to in this chapter must have the authorization of the Committee of
p.(None): Research Ethics. For this purpose, the research institutions must present the documentation
p.(None): which is indicated in article 50 of this resolution, in addition to the following:
p.(None): a) The scientific foundations, information on previous experimentation carried out in animals or in the laboratory.
p.(None): b) Previous clinical research studies when there are any.
p.(None): ARTICLE 62. All research on grafts and transplants must observe, in addition to the
p.(None): applicable provisions of this regulation, what is stipulated in terms of sanitary control of the provision of
p.(None): organs, tissues and bodies of human beings.
p.(None): TITLE IV.
p.(None): OF THE BIOSECURITY OF THE INVESTIGATIONS.
p.(None): CHAPTER I.
p.(None): OF THE RESEARCH WITH PATHOGEN MICROORGANISMS OR MATERIALBIOLOGICO THAT CAN CONTAIN THEM.
p.(None): ARTICLE 63. The research institutions in which research is carried out with pathogenic microorganisms or
p.(None): Biological material that may contain them should:
p.(None): Sheet 13 of 13
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): a) Have the facilities and laboratory equipment in accordance with the technical standards, which for this purpose
p.(None): Issue this Ministry, to ensure the safe handling of such germs.
p.(None): b) Develop a manual of procedures for microbiology laboratories and make it available to staff
p.(None): Professional, technical, service and maintenance.
p.(None): c) Train personnel on the handling, transport, use, decontamination and disposal of waste.
p.(None): d) Determine the need for medical surveillance of personnel involved in investigations and in their
p.(None): case, implement it.
p.(None): e) Establish a safety supervision and monitoring program in microbiology laboratories.
p.(None): f) Have an updated bibliography and an archive on equipment safety, system availability
p.(None): of containment, rules and regulations, risks involved and other related aspects.
p.(None): g) Comply with the other provisions determined by this Ministry.
p.(None): ARTICLE 64. In the research institutions mentioned in the previous article, the laboratories of
p.(None): Microbiology will comply with the requirements established by the technical standards issued by this Ministry and
p.(None): They will classify into three types like this:
p.(None): a) Basic microbiology laboratory.
p.(None): b) Microbiological safety laboratory.
p.(None): c) Laboratory of maximum microbiological safety.
p.(None): ARTICLE 65. The manual of procedures referred to in letter b of article 63
p.(None): of this regulation, will describe the following aspects:
p.(None): a) Laboratory practices.
p.(None): b) Personal security of employees.
p.(None): c) Management and maintenance of facilities and equipment.
p.(None): d) Urgent situations.
p.(None): e) Entry and transit restrictions.
p.(None): f) Reception and transportation of biological materials.
p.(None): g) Waste disposal.
p.(None): h) Decontamination.
p.(None): i) The others deemed necessary to achieve microbiological safety.
p.(None): ARTICLE 66. The principal investigator in agreement with the Hospital Ethics Committee, or the Ethics Committee in
p.(None): Research, and the legal representative of the research institution, will determine according to the
p.(None): existing technical standards, the type of laboratory in which the investigations will be conducted
p.(None): proposals; as well as the
p.(None): Sheet 14 of 14
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): respective procedures taking into account the degree of risk of infection presented by the
p.(None): microorganisms to use.
p.(None): ARTICLE 67. To evaluate the degree of risk referred to in the previous article, this Ministry will issue the norm.
p.(None): corresponding technique and will classify the microorganisms into four groups, according to the following criteria:
p.(None): a) RISK GROUP I: Microorganisms that represent little risk for the individual and for the community.
p.(None): b) RISK GROUP II: Microorganisms that represent moderate risk for the individual and limited for the community.
p.(None): c) RISK GROUP III: Microorganisms that represent high risk for the individual and low for the
p.(None): community.
p.(None): d) RISK GROUP IV: Microorganisms that represent high risk for the individual and for the community.
p.(None): ARTICLE 68. Microorganisms classified in risk groups I and II must be managed in
p.(None): Basic microbiology laboratories, using safety cabinets when deemed necessary.
p.(None): ARTICLE 69. Microorganisms classified in risk group III must be managed in laboratories of
p.(None): microbiological safety
p.(None): ARTICLE 70. Microorganisms that are classified in risk group IV shall be handled in laboratories of
p.(None): maximum microbiological safety, under the authorization and control of the corresponding health authorities.
p.(None): ARTICLE 71. During the development of the investigations referred to in this chapter, the
p.(None): Principal investigator will be responsible:
p.(None): a) Determine the real and potential risks of the proposed investigations and, if approved by
p.(None): part of the Committees of the research institution, make them known to the other researchers that make up the
p.(None): group and technical and auxiliary personnel involved in the investigation.
p.(None): b) Determine the appropriate level of physical containment, select microbiological practices
p.(None): suitable and design procedures to deal with possible accidents during the investigation and instruct the
p.(None): Participating staff on these aspects.
p.(None): c) Ensure that the participating personnel comply with the requirements of medical prophylaxis, vaccines or tests
p.(None): serological
p.(None): d) Supervise that the transport of infectious materials is done quickly, in accordance with the regulations
p.(None): techniques issued by this Ministry.
p.(None): e) Inform the Biosafety Commission about the occurrence of illness among the personnel participating in the
p.(None): research that could be attributed to transcutaneous inoculation, ingestion or inhalation of materials
p.(None): infectious, as well as accidents that cause contamination that may affect personnel or the environment.
p.(None): f) Report to the Biosafety Commission the difficulties or failures in the implementation of the procedures for
p.(None): safety, correct work errors that could cause the release of infectious material and ensure
p.(None): integrity of physical containment measures.
p.(None): Sheet 15 of 15
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 72. The Research Ethics Committee of the research institution must make periodic visits
p.(None): to assess compliance with the measures and recommend modifications to laboratory practices,
p.(None): including the temporary or permanent suspension of investigations that represent an uncontrolled risk of
p.(None): infection or contamination for laboratory workers, the community or the environment.
p.(None): CHAPTER II.
p.(None): OF THE RESEARCH THAT INVOLVES CONSTRUCTION AND MANAGEMENT OF RECOMBINANT NUCLEIC DECIDES.
p.(None): ARTICLE 73. For the purposes of this regulation, recombinant nucleic acids shall be understood as new
p.(None): combinations of genetic material obtained outside a living cell, through the insertion of segments
p.(None): natural or synthetic deoxyribonucleic acid in a virus, bacterial plasmid or other molecules
p.(None): of deoxyribonucleic acid that serve as a vector system to allow incorporation into a host cell,
p.(None): in which they are not found naturally, but in which they will be able to replicate. Equally
p.(None): deoxyribonucleic acid molecules resulting from such replication are included.
p.(None): ARTICLE 74. Investigations with recombinant nucleic acids shall be designed in such a way.
p.(None): so that the maximum level of biological containment is achieved, selecting the host systems and
p.(None): suitable vectors, which decrease the probability of dissemination of recombinant molecules outside the
p.(None): laboratory, taking into account the origin of the genetic material and the technical standards issued by this Ministry.
p.(None): ARTICLE 75. The principal investigator in agreement with: his hierarchical superior, the Research Ethics Committee,
...
p.(None): they will carry out the experiments referred to in this chapter, taking into account the genetic material that is intended
p.(None): replicate
p.(None): ARTICLE 76. Authorization of this Ministry is required to initiate the following types of
p.(None): experimentation:
p.(None): a) Formation of recombinant deoxyribonucleic acid derived from microorganisms
p.(None): pathogens that are classified in risk groups III and IV referred to in article 71 of this
p.(None): resolution, as well as the formation of recombinant genetic material derived from cells that are
p.(None): infected by such agents, regardless of the host and vector system used.
p.(None): b) Intentional construction of recombinant nucleic acids to induce the biosynthesis of potent toxins for
p.(None): vertebrates
p.(None): c) Intentional release to the environment of any microorganism that carries nucleic acids
p.(None): recombinant
p.(None): d) Transfer of antibiotic resistance of microorganisms that do not acquire it in nature, if such
p.(None): Transfer could adversely affect the use of the antibiotic in human medicine.
p.(None): e) Experiment with microorganisms or recombinant nucleic acids in cultures larger than ten (10) liters due
p.(None): because their physical and biological containment is more difficult unless the recombinant molecules have
p.(None): rigorously characterized and demonstrated the absence of dangerous genes in them. Those are excluded
p.(None): industrial and agricultural processes not directly and specifically related to activities
p.(None): established in article 1 of this resolution.
p.(None): Sheet 16 of 16
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): CHAPTER III
p.(None): OF THE RESEARCH WITH RADIOACTIVE ISOTOPES AND DEVICES AND GENERATORS OF IONIZING AND ELECTROMAGNETIC RADIATIONS.
p.(None): ARTICLE 77. Medical research that involves the use in humans of radioactive isotopes and
p.(None): Ionizing and electromagnetic radiation generating devices must be carried out in accordance
p.(None): with the laws, regulations and norms on radiological safety, that govern in the national territory.
p.(None): ARTICLE 78. In the institutions where these investigations are carried out, the Biosafety Commission shall ensure that
p.(None): for each study, the person responsible for the
p.(None): radiological and physical safety of these institutions, for the fulfillment of the requirements and
p.(None): obligations, as responsible for radiological safety.
p.(None): ARTICLE 79. The responsible person referred to in the previous article shall:
p.(None): a) Have the training, qualification and certification legally required for said function.
p.(None): b) Prepare a manual of procedures in accordance with the laws, regulations and regulations in force and with the
p.(None): characteristics of the installation or equipment, which must be available to all personnel, in which
p.(None): Describe: the identification and control of radiation sources, controlled and monitored areas, monitoring
p.(None): Dosimetric staff, emergency plan, waste management plan and training
p.(None): personnel involved in procedures and radiological safety.
p.(None): c) Define, implement and monitor compliance with radiological and physical safety measures.
p.(None): d) Inform the personnel involved in the investigation about these standards and train them on
p.(None): Work procedures and the characteristics of the laboratory and equipment.
...
p.(None): unduly exposed to ionizing radiation. Legally established Equivalent Dose limits
p.(None): they should be considered as upper limits and not design or control. Protection measures against
p.(None): ionizing radiation should be optimized, so that the number of people exposed and the Equivalent Dose received
p.(None): by the investigator or the patient undergoing the investigation, be as low as reasonably possible,
p.(None): taking into account the socio-economic factors of the environment in which it works.
p.(None): ARTICLE 81. In the examination or treatment that is part of a medical research program and that
p.(None): entails a net benefit for the patient, the justification of the procedure will be done with them
p.(None): Justification criteria for a routine medical exposure. However, given the character
p.(None): experimental, said justification will be subject to a thorough scrutiny individually, discarding
p.(None): other diagnostic or therapeutic methods that can be evaluated comparatively.
p.(None): ARTICLE 82. The deliberate irradiation of personnel during procedures for research purposes
p.(None): that does not pursue a direct benefit to irradiated persons, will be carried out only by persons adequately
p.(None): qualified and trained, and with the respective permission of the institution where the
p.(None): irradiation, under the advice of the National Entity responsible for radiological protection in harmony with the standards
p.(None): current surveillance and radiological control.
p.(None): Sheet 17 of 17
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 83. Occupationally exposed personnel must be over 18 years of age, and limits will be taken into account
p.(None): of occupational exposure determined by the authorized national entity, with special consideration in the case of
p.(None): Women of childbearing age and pregnant.
p.(None): PARAGRAPH. Pregnant or breastfeeding women should not work in places of high risk of
p.(None): incorporation of radioactive materials.
p.(None): ARTICLE 84. The persons, included in the procedure, must be informed about the risk of irradiation to which
p.(None): submit, so that their participation is under their free will and with knowledge of cause. It is necessary the
p.(None): Informed Consent of family members or legal guardian when the subject of the investigation does not
p.(None): Be in a position to decide on your acceptance.
p.(None): ARTICLE 85. These investigations must be subject to individual evaluation, followed by a plan of procedures and a
p.(None): final protocol approved by the competent authority in the field, to analyze them thoroughly from
p.(None): the point of view of radiation protection and the condition of true volunteers of people who do not
p.(None): they will receive a net benefit from the procedure, since no special dose limits can be set in these
p.(None): cases.
p.(None): ARTICLE 86. The use of ionizing radiation for research in pregnant women and forbidden is prohibited.
p.(None): minors, and is restricted to specific studies prior to research in women of age
p.(None): reproductive
p.(None): PARAGRAPH. In the previous cases, reconsideration may be made in the case of procedures
p.(None): Therapeutics in pathological processes considered special by their prognosis or by their characteristics,
p.(None): with the prior written authorization of the person involved, or the relative, or legally responsible person.
p.(None): TITLE V.
p.(None): BIOMEDICAL RESEARCH WITH ANIMALS.
p.(None): ARTICLE 87. In any investigation in which the animals are subject to study, they must be kept in
p.(None): Account, in addition to the provisions determined in Law 84 of 1989, the following:
p.(None): a) Whenever appropriate, methods such as mathematical models, simulation in
p.(None): In vitro computer and biological systems.
p.(None): b) Animal testing should only be done after studying its importance to human health or
p.(None): animal and for the advancement of biological knowledge.
p.(None): c) The animals selected for experimentation must be of an appropriate species and quality, and
p.(None): use the minimum number required to obtain scientifically valid results.
p.(None): d) Only legally acquired animals will be used and kept in proper condition and that
p.(None): comply with current sanitary regulations.
p.(None): e) Researchers and other staff should never stop treating animals as sentient beings and should
p.(None): consider proper care and use as an ethical imperative and avoid or minimize discomfort, anguish and
p.(None): pain.
p.(None): f) Researchers should presume, which procedures that would cause pain in humans also cause pain in
p.(None): other vertebrate species, even when it is still missing
p.(None): Sheet 18 of 18
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): Much to know about the perception of pain in animals.
p.(None): g) Any procedure that may cause animals more than pain or momentary anguish or
p.(None): minimum, should be performed with sedation, analgesia or appropriate anesthesia and in accordance with veterinary practice
p.(None): accepted. No surgical or painful procedures should be performed on non-anesthetized animals,
p.(None): paralyzed by chemical agents.
p.(None): Euthanasia of the animals will be carried out with appropriate anesthetics, approved by the veterinary association.
p.(None): h) When it is required to depart from the provisions of the preceding paragraph, the decision should not be taken only by
p.(None): the researcher directly involved, but must be taken by the Ethics Committee, established by law 84 of
p.(None): 1989. These exceptions should not be made solely for demonstration or teaching purposes.
p.(None): i) At the end of the experiment, or when appropriate during the experiment, animals that may suffer chronic pain or
p.(None): severe, anguish, discomfort or disability that cannot be mitigated, must be sacrificed without pain.
p.(None): j) Animals maintained for biomedical purposes must be kept in the best conditions of life, of
p.(None): be possible under the supervision of veterinarians with experience in laboratory animals. In any case it is due
p.(None): have veterinary care when required.
p.(None): k) The director of the institute, department or unit where animals are used is responsible for ensuring
p.(None): that researchers and other staff have appropriate qualification or experience to perform
p.(None): Animal procedures You must provide adequate in-service training opportunities that include the
p.(None): Concern for a humane and appropriate treatment for the animals under their care.
p.(None): ARTICLE 88. The use of animals in research, teaching and testing is accepted only when
p.(None): promises to contribute to the understanding and advancement of knowledge of the fundamental principles
p.(None): biological or the development of better means for the protection of health and well-being of both man and
p.(None): of the animal
p.(None): ARTICLE 89. Animals must be used, in case the researcher has discarded other
...
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Health / Mentally Disabled
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p.(None): that have Research Ethics Committees and the prior authorization of this Ministry to take it
p.(None): out, notwithstanding the
p.(None): Sheet 6 of 6
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): attributions that correspond to other dependencies of the State, and would have complied in any case with the studies
p.(None): prior toxicity and other tests according to the characteristics of the products and the risk involved
p.(None): For human health.
p.(None): ARTICLE 21. In all community research, research designs must offer the measures
p.(None): protection practices of individuals and ensure the obtaining of valid results in accordance with the
p.(None): established guidelines for the development of these models.
p.(None): ARTICLE 22. In any community investigation, the ethical considerations applicable to research
p.(None): in humans, they must be extrapolated to the communal context in the pertinent aspects.
p.(None): CHAPTER III
p.(None): OF INVESTIGATIONS IN MINORS OR DISABLED.
p.(None): ARTICLE 23. In addition to the general provisions of ethics that must be complied with in all research in human beings,
p.(None): that which is carried out in minors or physically and mentally disabled, must fully satisfy all
p.(None): the requirements set out in this chapter.
p.(None): ARTICLE 24. When it is intended to conduct investigations in minors, it must be ensured that
p.(None): similar studies have previously been done in adults and immature animals;
p.(None): except in the case of studies of conditions that are characteristic of the neonatal stage or conditions
p.(None): specific of certain ages.
p.(None): ARTICLE 25. To carry out investigations in minors or in physically and mentally disabled persons, in
p.(None): In any case, obtain, in addition to the Informed Consent of those exercising parental authority or
p.(None): legal representation of the minor or the person concerned, certification of a neurologist, psychiatrist or
p.(None): psychologist, about the capacity of understanding, reasoning and logic of the subject.
p.(None): ARTICLE 26. When the mental capacity and the psychological state of the minor or disabled person allow it,
p.(None): you must also obtain your acceptance to be the subject of investigation after explaining what
p.(None): pretend to do The Research Ethics Committee of the respective health entity must ensure the
p.(None): Compliance with these requirements.
p.(None): ARTICLE 27. Investigations classified with risk and with probabilities of direct benefit for the
p.(None): minor or disabled, will be admissible when:
...
p.(None): FIRST PARAGRAPH. WHEN THE RISK IS MINIMUM
p.(None): a) The intervention or procedure must represent for the minor or the disabled a reasonable experience and
p.(None): comparable to those inherent in your current medical, psychological, social or educational situation.
p.(None): Sheet 7 of 7
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
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Searching for indicator disabled:
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p.(None): moral authority over the community.
p.(None): In case of not obtaining authorization from the Research Ethics Committee, the Research is not
p.(None): will perform.
p.(None): On the other hand, the participation of individuals will be entirely voluntary.
p.(None): ARTICLE 20. Experimental research in communities may only be carried out by establishments.
p.(None): that have Research Ethics Committees and the prior authorization of this Ministry to take it
p.(None): out, notwithstanding the
p.(None): Sheet 6 of 6
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): attributions that correspond to other dependencies of the State, and would have complied in any case with the studies
p.(None): prior toxicity and other tests according to the characteristics of the products and the risk involved
p.(None): For human health.
p.(None): ARTICLE 21. In all community research, research designs must offer the measures
p.(None): protection practices of individuals and ensure the obtaining of valid results in accordance with the
p.(None): established guidelines for the development of these models.
p.(None): ARTICLE 22. In any community investigation, the ethical considerations applicable to research
p.(None): in humans, they must be extrapolated to the communal context in the pertinent aspects.
p.(None): CHAPTER III
p.(None): OF INVESTIGATIONS IN MINORS OR DISABLED.
p.(None): ARTICLE 23. In addition to the general provisions of ethics that must be complied with in all research in human beings,
p.(None): that which is carried out in minors or physically and mentally disabled, must fully satisfy all
p.(None): the requirements set out in this chapter.
p.(None): ARTICLE 24. When it is intended to conduct investigations in minors, it must be ensured that
p.(None): similar studies have previously been done in adults and immature animals;
p.(None): except in the case of studies of conditions that are characteristic of the neonatal stage or conditions
p.(None): specific of certain ages.
p.(None): ARTICLE 25. To carry out investigations in minors or in physically and mentally disabled persons, in
p.(None): In any case, obtain, in addition to the Informed Consent of those exercising parental authority or
p.(None): legal representation of the minor or the person concerned, certification of a neurologist, psychiatrist or
p.(None): psychologist, about the capacity of understanding, reasoning and logic of the subject.
p.(None): ARTICLE 26. When the mental capacity and the psychological state of the minor or disabled person allow it,
p.(None): you must also obtain your acceptance to be the subject of investigation after explaining what
p.(None): pretend to do The Research Ethics Committee of the respective health entity must ensure the
p.(None): Compliance with these requirements.
p.(None): ARTICLE 27. Investigations classified with risk and with probabilities of direct benefit for the
p.(None): minor or disabled, will be admissible when:
p.(None): a) The risk is justified by the importance of the benefit that the minor or the disabled will receive.
p.(None): b) The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None): ARTICLE 28. Investigations classified as risk and without direct benefit to the minor or the
p.(None): disabled, will be admissible according to the following considerations:
p.(None): FIRST PARAGRAPH. WHEN THE RISK IS MINIMUM
p.(None): a) The intervention or procedure must represent for the minor or the disabled a reasonable experience and
p.(None): comparable to those inherent in your current medical, psychological, social or educational situation.
p.(None): Sheet 7 of 7
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
p.(None): possible for the embryo, fetus or newborn in your case.
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p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
p.(None): possible for the embryo, fetus or newborn in your case.
p.(None): The Informed Consent of the spouse or partner may only be waived in case of disability or impossibility
p.(None): reliable or manifest to provide it; because the partner does not take care of the woman or, well, when
p.(None): there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None): ARTICLE 31. Research carried out on pregnant women must be preceded by studies.
p.(None): performed on non-pregnant women who demonstrate safety, except for specific studies that require
p.(None): such condition.
p.(None): ARTICLE 32. Research without therapeutic benefit in pregnant women whose objective is to obtain
p.(None): generalizable knowledge about pregnancy should not represent a risk greater than the minimum for women, the
p.(None): embryo or fetus
p.(None): ARTICLE 33. Investigations in pregnant women that involve an intervention or
p.(None): experimental procedure not related to pregnancy, but with therapeutic benefit for women, such as
...
p.(None): comply with current sanitary regulations.
p.(None): e) Researchers and other staff should never stop treating animals as sentient beings and should
p.(None): consider proper care and use as an ethical imperative and avoid or minimize discomfort, anguish and
p.(None): pain.
p.(None): f) Researchers should presume, which procedures that would cause pain in humans also cause pain in
p.(None): other vertebrate species, even when it is still missing
p.(None): Sheet 18 of 18
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): Much to know about the perception of pain in animals.
p.(None): g) Any procedure that may cause animals more than pain or momentary anguish or
p.(None): minimum, should be performed with sedation, analgesia or appropriate anesthesia and in accordance with veterinary practice
p.(None): accepted. No surgical or painful procedures should be performed on non-anesthetized animals,
p.(None): paralyzed by chemical agents.
p.(None): Euthanasia of the animals will be carried out with appropriate anesthetics, approved by the veterinary association.
p.(None): h) When it is required to depart from the provisions of the preceding paragraph, the decision should not be taken only by
p.(None): the researcher directly involved, but must be taken by the Ethics Committee, established by law 84 of
p.(None): 1989. These exceptions should not be made solely for demonstration or teaching purposes.
p.(None): i) At the end of the experiment, or when appropriate during the experiment, animals that may suffer chronic pain or
p.(None): severe, anguish, discomfort or disability that cannot be mitigated, must be sacrificed without pain.
p.(None): j) Animals maintained for biomedical purposes must be kept in the best conditions of life, of
p.(None): be possible under the supervision of veterinarians with experience in laboratory animals. In any case it is due
p.(None): have veterinary care when required.
p.(None): k) The director of the institute, department or unit where animals are used is responsible for ensuring
p.(None): that researchers and other staff have appropriate qualification or experience to perform
p.(None): Animal procedures You must provide adequate in-service training opportunities that include the
p.(None): Concern for a humane and appropriate treatment for the animals under their care.
p.(None): ARTICLE 88. The use of animals in research, teaching and testing is accepted only when
p.(None): promises to contribute to the understanding and advancement of knowledge of the fundamental principles
p.(None): biological or the development of better means for the protection of health and well-being of both man and
p.(None): of the animal
p.(None): ARTICLE 89. Animals must be used, in case the researcher has discarded other
p.(None): alternatives, to this end the Russell Burch principle "3R", replacement, reduction and refinement is followed.
p.(None): ARTICLE 90. Bioterios must agree with the species, body conformation, habits,
p.(None): Postural preferences and locomotive characteristics of animals, to provide comfort, except when
p.(None): Experimental variables justify other situations.
p.(None): ARTICLE 91. The bioterios of production or chronic maintenance will be supervised by the professional personnel
p.(None): qualified and competent in the field and should allow growth, maturation, reproduction and behavior
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p.(None): a person when it is considered necessary to use a research drug or a known medication using
p.(None): indications, doses and routes of administration different from those established, the doctor must obtain the opinion
p.(None): favorable of the Research Ethics Committee of the research institutions and the Informed Consent of the
p.(None): subject of investigation or its legal representative, as permitted by circumstances in accordance with the following
p.(None): bases:
p.(None): a) The Research Ethics Committee will be informed of the use of the investigational drug in advance,
p.(None): if the investigator can foresee the need for its use in urgent cases, or in retrospect, if the
p.(None): use of the drug, the indication, doses or new routes of administration arose as needs not
p.(None): provided. In both cases, the Research Ethics Committee will issue an opinion in favor or against approving the
p.(None): planned use or repetition of the unforeseen use of the medication.
p.(None): b) Informed Consent will be obtained from the subject of investigation, or failing that, from
p.(None): legal representative or the closest relative in bond, except when: the condition of the subject incapacitates or
p.(None): prevent granting it, the legal representative or family member is unavailable or when you stop using the medication in
p.(None): investigation represents an absolute risk of death.
p.(None): CHAPTER III
p.(None): OF THE INVESTIGATION OF OTHER NEW RESOURCES.
p.(None): ARTICLE 60. For the purposes of this regulation, it is understood by investigation of other new resources or
p.(None): different modalities from those established, the scientific activities tending to the study of
p.(None): materials, grafts, transplants, prostheses, physical, chemical and surgical procedures,
p.(None): instruments, devices, artificial organs and other methods of prevention, diagnosis, treatment and
p.(None): rehabilitation carried out in humans or in their biological products, except pharmacological ones.
p.(None): ARTICLE 61. Any investigation referred to in this chapter must have the authorization of the Committee of
p.(None): Research Ethics. For this purpose, the research institutions must present the documentation
p.(None): which is indicated in article 50 of this resolution, in addition to the following:
p.(None): a) The scientific foundations, information on previous experimentation carried out in animals or in the laboratory.
p.(None): b) Previous clinical research studies when there are any.
p.(None): ARTICLE 62. All research on grafts and transplants must observe, in addition to the
p.(None): applicable provisions of this regulation, what is stipulated in terms of sanitary control of the provision of
p.(None): organs, tissues and bodies of human beings.
p.(None): TITLE IV.
p.(None): OF THE BIOSECURITY OF THE INVESTIGATIONS.
p.(None): CHAPTER I.
p.(None): OF THE RESEARCH WITH PATHOGEN MICROORGANISMS OR MATERIALBIOLOGICO THAT CAN CONTAIN THEM.
p.(None): ARTICLE 63. The research institutions in which research is carried out with pathogenic microorganisms or
...
p.(None): qualified and trained, and with the respective permission of the institution where the
p.(None): irradiation, under the advice of the National Entity responsible for radiological protection in harmony with the standards
p.(None): current surveillance and radiological control.
p.(None): Sheet 17 of 17
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 83. Occupationally exposed personnel must be over 18 years of age, and limits will be taken into account
p.(None): of occupational exposure determined by the authorized national entity, with special consideration in the case of
p.(None): Women of childbearing age and pregnant.
p.(None): PARAGRAPH. Pregnant or breastfeeding women should not work in places of high risk of
p.(None): incorporation of radioactive materials.
p.(None): ARTICLE 84. The persons, included in the procedure, must be informed about the risk of irradiation to which
p.(None): submit, so that their participation is under their free will and with knowledge of cause. It is necessary the
p.(None): Informed Consent of family members or legal guardian when the subject of the investigation does not
p.(None): Be in a position to decide on your acceptance.
p.(None): ARTICLE 85. These investigations must be subject to individual evaluation, followed by a plan of procedures and a
p.(None): final protocol approved by the competent authority in the field, to analyze them thoroughly from
p.(None): the point of view of radiation protection and the condition of true volunteers of people who do not
p.(None): they will receive a net benefit from the procedure, since no special dose limits can be set in these
p.(None): cases.
p.(None): ARTICLE 86. The use of ionizing radiation for research in pregnant women and forbidden is prohibited.
p.(None): minors, and is restricted to specific studies prior to research in women of age
p.(None): reproductive
p.(None): PARAGRAPH. In the previous cases, reconsideration may be made in the case of procedures
p.(None): Therapeutics in pathological processes considered special by their prognosis or by their characteristics,
p.(None): with the prior written authorization of the person involved, or the relative, or legally responsible person.
p.(None): TITLE V.
p.(None): BIOMEDICAL RESEARCH WITH ANIMALS.
p.(None): ARTICLE 87. In any investigation in which the animals are subject to study, they must be kept in
p.(None): Account, in addition to the provisions determined in Law 84 of 1989, the following:
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Health / Physically Disabled
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p.(None): provisions, determines that it is up to the Ministry of Health to formulate the policies and dictate all the norms
p.(None): scientific-administrative, mandatory by the entities that make up the System,
p.(None): - That Article 2 of Decree 2164 of 1992, which restructures the Ministry of Health and determines the
p.(None): functions of its dependencies, it establishes that it will formulate the pertinent scientific and administrative norms that
p.(None): Orient the resources and actions of the System,
p.(None): RESOLVES:
p.(None): TITLE 1
p.(None): GENERAL DISPOSITION.
p.(None): ARTICLE 1. The provisions of these scientific standards are intended to establish the requirements for the
p.(None): development of the research activity in health.
p.(None): ARTICLE 2. The institutions that are going to carry out research in humans must have an Ethics Committee in
p.(None): Research, responsible for resolving all issues related to the subject.
p.(None): ARTICLE 3. The institutions, referred to in the previous article, because of their regulations and
p.(None): internal policies, will elaborate their internal procedures manual in order to support the application of these
p.(None): rules
p.(None): ARTICLE 4. Research for health includes the development of actions that contribute:
p.(None): to. To the knowledge of the biological and psychological processes in human beings.
p.(None): b. To the knowledge of the links between the causes of illness, medical practice and social structure.
p.(None): c. To the prevention and control of health problems.
p.(None): Sheet 2 of 2
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): d. To the knowledge and evaluation of the harmful effects of the environment on health.
p.(None): and. To the study of the techniques and methods that are recommended or used for the provision of health services.
p.(None): F. To the production of health supplies.
p.(None): TITLE II
p.(None): OF RESEARCH IN HUMAN BEINGS.
p.(None): CHAPTER 1.
p.(None): OF THE ETHICAL ASPECTS OF RESEARCH IN HUMAN BEINGS.
p.(None): ARTICLE 5. In any investigation in which the human being is the subject of study, the
p.(None): criterion of respect for their dignity and protection of their rights and well-being.
p.(None): ARTICLE 6. Research carried out in human beings shall be carried out according to the following criteria:
p.(None): to. It will conform to the scientific and ethical principles that justify it.
p.(None): b. It will be based on previous experimentation performed on animals, in laboratories or on other scientific facts.
p.(None): c. It will be done only when the knowledge that is intended to be produced cannot be obtained by other suitable means.
p.(None): d. The safety of the beneficiaries must prevail and clearly express the (minimum) risks, which do not
p.(None): they must, at no time, contradict article 11 of this resolution.
...
p.(None): minor or disabled, will be admissible when:
p.(None): a) The risk is justified by the importance of the benefit that the minor or the disabled will receive.
p.(None): b) The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None): ARTICLE 28. Investigations classified as risk and without direct benefit to the minor or the
p.(None): disabled, will be admissible according to the following considerations:
p.(None): FIRST PARAGRAPH. WHEN THE RISK IS MINIMUM
p.(None): a) The intervention or procedure must represent for the minor or the disabled a reasonable experience and
p.(None): comparable to those inherent in your current medical, psychological, social or educational situation.
p.(None): Sheet 7 of 7
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
...
p.(None): ARTICLE 68. Microorganisms classified in risk groups I and II must be managed in
p.(None): Basic microbiology laboratories, using safety cabinets when deemed necessary.
p.(None): ARTICLE 69. Microorganisms classified in risk group III must be managed in laboratories of
p.(None): microbiological safety
p.(None): ARTICLE 70. Microorganisms that are classified in risk group IV shall be handled in laboratories of
p.(None): maximum microbiological safety, under the authorization and control of the corresponding health authorities.
p.(None): ARTICLE 71. During the development of the investigations referred to in this chapter, the
p.(None): Principal investigator will be responsible:
p.(None): a) Determine the real and potential risks of the proposed investigations and, if approved by
p.(None): part of the Committees of the research institution, make them known to the other researchers that make up the
p.(None): group and technical and auxiliary personnel involved in the investigation.
p.(None): b) Determine the appropriate level of physical containment, select microbiological practices
p.(None): suitable and design procedures to deal with possible accidents during the investigation and instruct the
p.(None): Participating staff on these aspects.
p.(None): c) Ensure that the participating personnel comply with the requirements of medical prophylaxis, vaccines or tests
p.(None): serological
p.(None): d) Supervise that the transport of infectious materials is done quickly, in accordance with the regulations
p.(None): techniques issued by this Ministry.
p.(None): e) Inform the Biosafety Commission about the occurrence of illness among the personnel participating in the
p.(None): research that could be attributed to transcutaneous inoculation, ingestion or inhalation of materials
p.(None): infectious, as well as accidents that cause contamination that may affect personnel or the environment.
p.(None): f) Report to the Biosafety Commission the difficulties or failures in the implementation of the procedures for
p.(None): safety, correct work errors that could cause the release of infectious material and ensure
p.(None): integrity of physical containment measures.
p.(None): Sheet 15 of 15
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 72. The Research Ethics Committee of the research institution must make periodic visits
p.(None): to assess compliance with the measures and recommend modifications to laboratory practices,
p.(None): including the temporary or permanent suspension of investigations that represent an uncontrolled risk of
p.(None): infection or contamination for laboratory workers, the community or the environment.
p.(None): CHAPTER II.
p.(None): OF THE RESEARCH THAT INVOLVES CONSTRUCTION AND MANAGEMENT OF RECOMBINANT NUCLEIC DECIDES.
p.(None): ARTICLE 73. For the purposes of this regulation, recombinant nucleic acids shall be understood as new
p.(None): combinations of genetic material obtained outside a living cell, through the insertion of segments
p.(None): natural or synthetic deoxyribonucleic acid in a virus, bacterial plasmid or other molecules
p.(None): of deoxyribonucleic acid that serve as a vector system to allow incorporation into a host cell,
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p.(None): On the other hand, the participation of individuals will be entirely voluntary.
p.(None): ARTICLE 20. Experimental research in communities may only be carried out by establishments.
p.(None): that have Research Ethics Committees and the prior authorization of this Ministry to take it
p.(None): out, notwithstanding the
p.(None): Sheet 6 of 6
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): attributions that correspond to other dependencies of the State, and would have complied in any case with the studies
p.(None): prior toxicity and other tests according to the characteristics of the products and the risk involved
p.(None): For human health.
p.(None): ARTICLE 21. In all community research, research designs must offer the measures
p.(None): protection practices of individuals and ensure the obtaining of valid results in accordance with the
p.(None): established guidelines for the development of these models.
p.(None): ARTICLE 22. In any community investigation, the ethical considerations applicable to research
p.(None): in humans, they must be extrapolated to the communal context in the pertinent aspects.
p.(None): CHAPTER III
p.(None): OF INVESTIGATIONS IN MINORS OR DISABLED.
p.(None): ARTICLE 23. In addition to the general provisions of ethics that must be complied with in all research in human beings,
p.(None): that which is carried out in minors or physically and mentally disabled, must fully satisfy all
p.(None): the requirements set out in this chapter.
p.(None): ARTICLE 24. When it is intended to conduct investigations in minors, it must be ensured that
p.(None): similar studies have previously been done in adults and immature animals;
p.(None): except in the case of studies of conditions that are characteristic of the neonatal stage or conditions
p.(None): specific of certain ages.
p.(None): ARTICLE 25. To carry out investigations in minors or in physically and mentally disabled persons, in
p.(None): In any case, obtain, in addition to the Informed Consent of those exercising parental authority or
p.(None): legal representation of the minor or the person concerned, certification of a neurologist, psychiatrist or
p.(None): psychologist, about the capacity of understanding, reasoning and logic of the subject.
p.(None): ARTICLE 26. When the mental capacity and the psychological state of the minor or disabled person allow it,
p.(None): you must also obtain your acceptance to be the subject of investigation after explaining what
p.(None): pretend to do The Research Ethics Committee of the respective health entity must ensure the
p.(None): Compliance with these requirements.
p.(None): ARTICLE 27. Investigations classified with risk and with probabilities of direct benefit for the
p.(None): minor or disabled, will be admissible when:
...
p.(None): disabled, will be admissible according to the following considerations:
p.(None): FIRST PARAGRAPH. WHEN THE RISK IS MINIMUM
p.(None): a) The intervention or procedure must represent for the minor or the disabled a reasonable experience and
p.(None): comparable to those inherent in your current medical, psychological, social or educational situation.
p.(None): Sheet 7 of 7
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.(None): investigation, which specifies the warned effect, the measures adopted and the consequences produced.
p.(None): CHAPTER II.
p.(None): OF PHARMACOLOGICAL RESEARCH.
p.(None): ARTICLE 53. For the purposes of this regulation, pharmacological research is understood as the
p.(None): scientific activities aimed at the study of drugs and biological products for human use on
p.(None): which do not have previous experience in the country, which are not contemplated in the Pharmacological Standards in this
p.(None): Ministry and therefore, are not distributed commercially, as well as registered medications
p.(None): and approved for sale, when its use is investigated with modalities, indications, doses or routes of administration
p.(None): different from those established, including its use in combinations.
p.(None): ARTICLE 54. Investigations of medications in clinical pharmacology include
p.(None): Sheet 11 of 11
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): the sequence of studies that are carried out from when it is first administered to the human being, until it is
p.(None): They obtain data on their efficacy and therapeutic safety in large population groups. For this purpose, they are considered
p.(None): The following phases:
p.(None): to. PHASE I: It is the administration for the first time of a research drug to the healthy human being, in single doses
p.(None): or multiple, in small hospitalized groups, to establish initial pharmacological parameters in man.
p.(None): b. PHASE II: It is the administration, to the sick human being, of a research medicine, in doses
p.(None): single or multiple, in small hospitalized groups, to establish pharmacological parameters in the organism
p.(None): sick.
p.(None): c. PHASE III It is the administration, to large groups of patients, of a research drug, usually
p.(None): external, to define its therapeutic utility and identify adverse reactions, interactions and factors
p.(None): external, that can alter the pharmacological effect.
p.(None): d. PHASE IV: These are studies that are carried out after the medicine is granted, health record for sale
p.(None): and aims to generate new information on the safety of the drug during its widespread use and
p.(None): dragged on.
p.(None): ARTICLE 55. All the investigations in clinical pharmacology that are carried out must be preceded by
p.(None): complete preclinical studies that include physicochemical characteristics pharmacological activity, toxicity,
p.(None): pharmacokinetics, absorption, distribution, metabolism and excretion of the drug in different animal species;
p.(None): frequencies, routes of administration and duration of the doses studied that can serve as a basis for the safety of
p.(None): its administration in the human being; studies on mutagenesis, teratogenesis and carcinogenesis are also required.
p.(None): ARTICLE 56. The preclinical toxicology studies required for each drug will depend on it.
p.(None): in particular, of the known potential toxicology of others with similar chemical structure and of the route and time of
p.(None): administration that is intended to be used in humans.
p.(None): ARTICLE 57. The use of research drugs in humans during their assessment through Phases I
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
p.(None): possible for the embryo, fetus or newborn in your case.
p.(None): The Informed Consent of the spouse or partner may only be waived in case of disability or impossibility
p.(None): reliable or manifest to provide it; because the partner does not take care of the woman or, well, when
p.(None): there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None): ARTICLE 31. Research carried out on pregnant women must be preceded by studies.
p.(None): performed on non-pregnant women who demonstrate safety, except for specific studies that require
p.(None): such condition.
p.(None): ARTICLE 32. Research without therapeutic benefit in pregnant women whose objective is to obtain
p.(None): generalizable knowledge about pregnancy should not represent a risk greater than the minimum for women, the
p.(None): embryo or fetus
p.(None): ARTICLE 33. Investigations in pregnant women that involve an intervention or
p.(None): experimental procedure not related to pregnancy, but with therapeutic benefit for women, such as
p.(None): it would be in cases of toxemia gravidarum, diabetes, hypertension and neoplasms, among others, should not expose to
p.(None): embryo or fetus at a greater than minimum risk, except when the use of the intervention or procedure is
p.(None): Sheet 8 of 8
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): justify to save the woman's life.
p.(None): ARTICLE 34. Research in pregnant women, with therapeutic benefit related to pregnancy, is
p.(None): will allow when:
p.(None): a) Aim to improve the health of the pregnant woman with a minimal risk to the embryo or the fetus.
p.(None): b) Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None): ARTICLE 35. During the execution of investigations in pregnant women:
p.(None): a) Investigators will not have the authority to decide on the time, method or procedure used
p.(None): to terminate the pregnancy, nor participation in decisions about the viability of the fetus.
p.(None): b) It is strictly forbidden to grant stimuli, monetary or otherwise, to terminate the pregnancy,
p.(None): for the interest of the investigation or for other reasons.
p.(None): ARTICLE 36. Informed Consent for investigations during labor shall be obtained in agreement.
p.(None): with what is stipulated in articles 14, 15 and 16 of this regulation, before it is initiated and indicating
p.(None): expressly that it can be withdrawn at any time during labor.
p.(None): ARTICLE 37. Research on women during the puerperium will be allowed when they do not interfere with the health of the
p.(None): mother or with the newborn.
p.(None): ARTICLE 38. Research on women during breastfeeding will be authorized when there is no risk to
p.(None): the infant or when the mother decides not to breastfeed; your food is secured by another method and you get the
p.(None): Informed Consent in accordance with the provisions of articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 39. Fetuses will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the pregnant woman.
p.(None): ARTICLE 40. Newborns will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the mother.
p.(None): ARTICLE 41. Newborns shall not be subject to investigation, except when it is intended to:
p.(None): increase its probability of survival until the feasibility phase; the procedures do not cause the
p.(None): cessation of vital functions, or when, without adding any risk, generalized knowledge is sought
p.(None): important that cannot be obtained otherwise.
p.(None): ARTICLE 42. Live births may be subject to investigation if the provisions on
p.(None): investigation in minors, indicated in this resolution.
p.(None): ARTICLE 43. Investigations with embryos, deaths, fetuses, dead births, macerated fecal matter, cells,
p.(None): tissues and organs extracted from them, will be made in accordance with the provisions of this regulation.
p.(None): ARTICLE 44. Research on artificial fertilization shall only be admissible when applied to the solution of
p.(None): sterility problems that cannot be solved in any other way, respecting the moral point of view,
p.(None): cultural and social of the couple.
p.(None): CHAPTER V.
p.(None): Sheet 9 of 9
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): OF THE INVESTIGATIONS IN SUBORDINATED GROUPS.
p.(None): ARTICLE 45. Subordinated groups are understood as the following: students, workers of the
...
p.(None): ARTICLE 81. In the examination or treatment that is part of a medical research program and that
p.(None): entails a net benefit for the patient, the justification of the procedure will be done with them
p.(None): Justification criteria for a routine medical exposure. However, given the character
p.(None): experimental, said justification will be subject to a thorough scrutiny individually, discarding
p.(None): other diagnostic or therapeutic methods that can be evaluated comparatively.
p.(None): ARTICLE 82. The deliberate irradiation of personnel during procedures for research purposes
p.(None): that does not pursue a direct benefit to irradiated persons, will be carried out only by persons adequately
p.(None): qualified and trained, and with the respective permission of the institution where the
p.(None): irradiation, under the advice of the National Entity responsible for radiological protection in harmony with the standards
p.(None): current surveillance and radiological control.
p.(None): Sheet 17 of 17
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 83. Occupationally exposed personnel must be over 18 years of age, and limits will be taken into account
p.(None): of occupational exposure determined by the authorized national entity, with special consideration in the case of
p.(None): Women of childbearing age and pregnant.
p.(None): PARAGRAPH. Pregnant or breastfeeding women should not work in places of high risk of
p.(None): incorporation of radioactive materials.
p.(None): ARTICLE 84. The persons, included in the procedure, must be informed about the risk of irradiation to which
p.(None): submit, so that their participation is under their free will and with knowledge of cause. It is necessary the
p.(None): Informed Consent of family members or legal guardian when the subject of the investigation does not
p.(None): Be in a position to decide on your acceptance.
p.(None): ARTICLE 85. These investigations must be subject to individual evaluation, followed by a plan of procedures and a
p.(None): final protocol approved by the competent authority in the field, to analyze them thoroughly from
p.(None): the point of view of radiation protection and the condition of true volunteers of people who do not
p.(None): they will receive a net benefit from the procedure, since no special dose limits can be set in these
p.(None): cases.
p.(None): ARTICLE 86. The use of ionizing radiation for research in pregnant women and forbidden is prohibited.
p.(None): minors, and is restricted to specific studies prior to research in women of age
p.(None): reproductive
p.(None): PARAGRAPH. In the previous cases, reconsideration may be made in the case of procedures
p.(None): Therapeutics in pathological processes considered special by their prognosis or by their characteristics,
p.(None): with the prior written authorization of the person involved, or the relative, or legally responsible person.
p.(None): TITLE V.
p.(None): BIOMEDICAL RESEARCH WITH ANIMALS.
p.(None): ARTICLE 87. In any investigation in which the animals are subject to study, they must be kept in
p.(None): Account, in addition to the provisions determined in Law 84 of 1989, the following:
p.(None): a) Whenever appropriate, methods such as mathematical models, simulation in
p.(None): In vitro computer and biological systems.
p.(None): b) Animal testing should only be done after studying its importance to human health or
p.(None): animal and for the advancement of biological knowledge.
p.(None): c) The animals selected for experimentation must be of an appropriate species and quality, and
p.(None): use the minimum number required to obtain scientifically valid results.
p.(None): d) Only legally acquired animals will be used and kept in proper condition and that
p.(None): comply with current sanitary regulations.
p.(None): e) Researchers and other staff should never stop treating animals as sentient beings and should
p.(None): consider proper care and use as an ethical imperative and avoid or minimize discomfort, anguish and
p.(None): pain.
...
Health / healthy volunteers
Searching for indicator healthy volunteers:
(return to top)
p.(None): ARTICLE 11. For purposes of this regulation, investigations are classified into the following categories:
p.(None): to. Risk-free research: These are studies that use research techniques and methods.
p.(None): Restrospective documentary and those in which no intervention or modification is made
p.(None): intentional of the biological, physiological, psychological or social variables of the individuals that
p.(None): participate in the study, among which are considered: review of medical records, interviews, questionnaires and
p.(None): others in which he is not identified or sensitive aspects of his behavior are treated
p.(None): b. Research with minimal risk: These are prospective studies that use data recording through
p.(None): Common procedures consisting of: physical or psychological diagnostic tests or treatments
p.(None): routine, among which are considered: weighing the subject, electrocardiograms, hearing acuity tests,
p.(None): thermographies, collection of excreta and external secretions, obtaining placenta during childbirth, collection of
p.(None): amniotic fluid when the membranes rupture, obtaining saliva, deciduous teeth and permanent teeth extracted
p.(None): by therapeutic indication, dental plaque and stones removed by non-invasive prophylactic procedures,
p.(None): hair and nail cutting without causing disfigurement, blood collection by venous puncture in adults in good condition
p.(None): health, with a maximum frequency of twice a week and a maximum volume of 450 ml in two months except during the
p.(None): pregnancy, moderate exercise in healthy volunteers, psychological tests to groups or individuals in whom
p.(None): will manipulate the subject's behavior, research with commonly used medications, wide therapeutic range and
p.(None): Registered in this Ministry or its delegated authority, using the indications, dosage and routes of administration
p.(None): established and other than the medications defined in article 55 of this resolution.
p.(None): c. Investigations with risk greater than the minimum: Are those in which the probabilities of
p.(None): affect the subject are significant, among which are considered: radiological and microwave studies,
p.(None): studies with medications and modalities defined in titles III and IV of this resolution, trials with
p.(None): new devices, studies that include surgical procedures, blood collection greater than 2% of the volume
p.(None): circulating in neonates, amniocentesis and other invasive techniques or major procedures, which
p.(None): use random methods of allocation to therapeutic schemes and those that have control with placebos, among others.
p.(None): ARTICLE 12. The principal investigator shall suspend the investigation immediately, upon warning of any risk or
p.(None): damage to the health of the subject in whom the investigation is conducted. Likewise, it will be immediately suspended for
p.(None): those research subjects that manifest it.
p.(None): ARTICLE 13. It is the responsibility of the research or sponsoring institution to provide care.
p.(None): medical to the subject that suffers any damage, if directly related to the investigation, without
...
Health / hospitalized patients
Searching for indicator hospitalized:
(return to top)
p.(None): a report is required within fifteen (15) business days following the suspension of the
p.(None): investigation, which specifies the warned effect, the measures adopted and the consequences produced.
p.(None): CHAPTER II.
p.(None): OF PHARMACOLOGICAL RESEARCH.
p.(None): ARTICLE 53. For the purposes of this regulation, pharmacological research is understood as the
p.(None): scientific activities aimed at the study of drugs and biological products for human use on
p.(None): which do not have previous experience in the country, which are not contemplated in the Pharmacological Standards in this
p.(None): Ministry and therefore, are not distributed commercially, as well as registered medications
p.(None): and approved for sale, when its use is investigated with modalities, indications, doses or routes of administration
p.(None): different from those established, including its use in combinations.
p.(None): ARTICLE 54. Investigations of medications in clinical pharmacology include
p.(None): Sheet 11 of 11
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): the sequence of studies that are carried out from when it is first administered to the human being, until it is
p.(None): They obtain data on their efficacy and therapeutic safety in large population groups. For this purpose, they are considered
p.(None): The following phases:
p.(None): to. PHASE I: It is the administration for the first time of a research drug to the healthy human being, in single doses
p.(None): or multiple, in small hospitalized groups, to establish initial pharmacological parameters in man.
p.(None): b. PHASE II: It is the administration, to the sick human being, of a research medicine, in doses
p.(None): single or multiple, in small hospitalized groups, to establish pharmacological parameters in the organism
p.(None): sick.
p.(None): c. PHASE III It is the administration, to large groups of patients, of a research drug, usually
p.(None): external, to define its therapeutic utility and identify adverse reactions, interactions and factors
p.(None): external, that can alter the pharmacological effect.
p.(None): d. PHASE IV: These are studies that are carried out after the medicine is granted, health record for sale
p.(None): and aims to generate new information on the safety of the drug during its widespread use and
p.(None): dragged on.
p.(None): ARTICLE 55. All the investigations in clinical pharmacology that are carried out must be preceded by
p.(None): complete preclinical studies that include physicochemical characteristics pharmacological activity, toxicity,
p.(None): pharmacokinetics, absorption, distribution, metabolism and excretion of the drug in different animal species;
p.(None): frequencies, routes of administration and duration of the doses studied that can serve as a basis for the safety of
p.(None): its administration in the human being; studies on mutagenesis, teratogenesis and carcinogenesis are also required.
p.(None): ARTICLE 56. The preclinical toxicology studies required for each drug will depend on it.
p.(None): in particular, of the known potential toxicology of others with similar chemical structure and of the route and time of
p.(None): administration that is intended to be used in humans.
p.(None): ARTICLE 57. The use of research drugs in humans during their assessment through Phases I
...
Health / volunteers
Searching for indicator volunteers:
(return to top)
p.(None): ARTICLE 83. Occupationally exposed personnel must be over 18 years of age, and limits will be taken into account
p.(None): of occupational exposure determined by the authorized national entity, with special consideration in the case of
p.(None): Women of childbearing age and pregnant.
p.(None): PARAGRAPH. Pregnant or breastfeeding women should not work in places of high risk of
p.(None): incorporation of radioactive materials.
p.(None): ARTICLE 84. The persons, included in the procedure, must be informed about the risk of irradiation to which
p.(None): submit, so that their participation is under their free will and with knowledge of cause. It is necessary the
p.(None): Informed Consent of family members or legal guardian when the subject of the investigation does not
p.(None): Be in a position to decide on your acceptance.
p.(None): ARTICLE 85. These investigations must be subject to individual evaluation, followed by a plan of procedures and a
p.(None): final protocol approved by the competent authority in the field, to analyze them thoroughly from
p.(None): the point of view of radiation protection and the condition of true volunteers of people who do not
p.(None): they will receive a net benefit from the procedure, since no special dose limits can be set in these
p.(None): cases.
p.(None): ARTICLE 86. The use of ionizing radiation for research in pregnant women and forbidden is prohibited.
p.(None): minors, and is restricted to specific studies prior to research in women of age
p.(None): reproductive
p.(None): PARAGRAPH. In the previous cases, reconsideration may be made in the case of procedures
p.(None): Therapeutics in pathological processes considered special by their prognosis or by their characteristics,
p.(None): with the prior written authorization of the person involved, or the relative, or legally responsible person.
p.(None): TITLE V.
p.(None): BIOMEDICAL RESEARCH WITH ANIMALS.
p.(None): ARTICLE 87. In any investigation in which the animals are subject to study, they must be kept in
p.(None): Account, in addition to the provisions determined in Law 84 of 1989, the following:
p.(None): a) Whenever appropriate, methods such as mathematical models, simulation in
p.(None): In vitro computer and biological systems.
p.(None): b) Animal testing should only be done after studying its importance to human health or
p.(None): animal and for the advancement of biological knowledge.
p.(None): c) The animals selected for experimentation must be of an appropriate species and quality, and
p.(None): use the minimum number required to obtain scientifically valid results.
p.(None): d) Only legally acquired animals will be used and kept in proper condition and that
p.(None): comply with current sanitary regulations.
...
Social / Age
Searching for indicator age:
(return to top)
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
p.(None): possible for the embryo, fetus or newborn in your case.
p.(None): The Informed Consent of the spouse or partner may only be waived in case of disability or impossibility
p.(None): reliable or manifest to provide it; because the partner does not take care of the woman or, well, when
p.(None): there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
...
p.(None): ionizing radiation should be optimized, so that the number of people exposed and the Equivalent Dose received
p.(None): by the investigator or the patient undergoing the investigation, be as low as reasonably possible,
p.(None): taking into account the socio-economic factors of the environment in which it works.
p.(None): ARTICLE 81. In the examination or treatment that is part of a medical research program and that
p.(None): entails a net benefit for the patient, the justification of the procedure will be done with them
p.(None): Justification criteria for a routine medical exposure. However, given the character
p.(None): experimental, said justification will be subject to a thorough scrutiny individually, discarding
p.(None): other diagnostic or therapeutic methods that can be evaluated comparatively.
p.(None): ARTICLE 82. The deliberate irradiation of personnel during procedures for research purposes
p.(None): that does not pursue a direct benefit to irradiated persons, will be carried out only by persons adequately
p.(None): qualified and trained, and with the respective permission of the institution where the
p.(None): irradiation, under the advice of the National Entity responsible for radiological protection in harmony with the standards
p.(None): current surveillance and radiological control.
p.(None): Sheet 17 of 17
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 83. Occupationally exposed personnel must be over 18 years of age, and limits will be taken into account
p.(None): of occupational exposure determined by the authorized national entity, with special consideration in the case of
p.(None): Women of childbearing age and pregnant.
p.(None): PARAGRAPH. Pregnant or breastfeeding women should not work in places of high risk of
p.(None): incorporation of radioactive materials.
p.(None): ARTICLE 84. The persons, included in the procedure, must be informed about the risk of irradiation to which
p.(None): submit, so that their participation is under their free will and with knowledge of cause. It is necessary the
p.(None): Informed Consent of family members or legal guardian when the subject of the investigation does not
p.(None): Be in a position to decide on your acceptance.
p.(None): ARTICLE 85. These investigations must be subject to individual evaluation, followed by a plan of procedures and a
p.(None): final protocol approved by the competent authority in the field, to analyze them thoroughly from
p.(None): the point of view of radiation protection and the condition of true volunteers of people who do not
p.(None): they will receive a net benefit from the procedure, since no special dose limits can be set in these
p.(None): cases.
p.(None): ARTICLE 86. The use of ionizing radiation for research in pregnant women and forbidden is prohibited.
p.(None): minors, and is restricted to specific studies prior to research in women of age
p.(None): reproductive
p.(None): PARAGRAPH. In the previous cases, reconsideration may be made in the case of procedures
p.(None): Therapeutics in pathological processes considered special by their prognosis or by their characteristics,
p.(None): with the prior written authorization of the person involved, or the relative, or legally responsible person.
p.(None): TITLE V.
p.(None): BIOMEDICAL RESEARCH WITH ANIMALS.
p.(None): ARTICLE 87. In any investigation in which the animals are subject to study, they must be kept in
p.(None): Account, in addition to the provisions determined in Law 84 of 1989, the following:
p.(None): a) Whenever appropriate, methods such as mathematical models, simulation in
p.(None): In vitro computer and biological systems.
p.(None): b) Animal testing should only be done after studying its importance to human health or
p.(None): animal and for the advancement of biological knowledge.
p.(None): c) The animals selected for experimentation must be of an appropriate species and quality, and
p.(None): use the minimum number required to obtain scientifically valid results.
p.(None): d) Only legally acquired animals will be used and kept in proper condition and that
p.(None): comply with current sanitary regulations.
p.(None): e) Researchers and other staff should never stop treating animals as sentient beings and should
p.(None): consider proper care and use as an ethical imperative and avoid or minimize discomfort, anguish and
p.(None): pain.
p.(None): f) Researchers should presume, which procedures that would cause pain in humans also cause pain in
p.(None): other vertebrate species, even when it is still missing
p.(None): Sheet 18 of 18
p.(None): RESOLUTION NUMBER 8430 OF 1993
...
Social / Child
Searching for indicator child:
(return to top)
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
...
Searching for indicator children:
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p.(None): disabled, will be admissible according to the following considerations:
p.(None): FIRST PARAGRAPH. WHEN THE RISK IS MINIMUM
p.(None): a) The intervention or procedure must represent for the minor or the disabled a reasonable experience and
p.(None): comparable to those inherent in your current medical, psychological, social or educational situation.
p.(None): Sheet 7 of 7
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
...
Social / Educational
Searching for indicator educational:
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p.(None): pretend to do The Research Ethics Committee of the respective health entity must ensure the
p.(None): Compliance with these requirements.
p.(None): ARTICLE 27. Investigations classified with risk and with probabilities of direct benefit for the
p.(None): minor or disabled, will be admissible when:
p.(None): a) The risk is justified by the importance of the benefit that the minor or the disabled will receive.
p.(None): b) The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None): ARTICLE 28. Investigations classified as risk and without direct benefit to the minor or the
p.(None): disabled, will be admissible according to the following considerations:
p.(None): FIRST PARAGRAPH. WHEN THE RISK IS MINIMUM
p.(None): a) The intervention or procedure must represent for the minor or the disabled a reasonable experience and
p.(None): comparable to those inherent in your current medical, psychological, social or educational situation.
p.(None): Sheet 7 of 7
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
p.(None): possible for the embryo, fetus or newborn in your case.
p.(None): The Informed Consent of the spouse or partner may only be waived in case of disability or impossibility
p.(None): reliable or manifest to provide it; because the partner does not take care of the woman or, well, when
p.(None): there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None): ARTICLE 31. Research carried out on pregnant women must be preceded by studies.
p.(None): performed on non-pregnant women who demonstrate safety, except for specific studies that require
p.(None): such condition.
p.(None): ARTICLE 32. Research without therapeutic benefit in pregnant women whose objective is to obtain
p.(None): generalizable knowledge about pregnancy should not represent a risk greater than the minimum for women, the
p.(None): embryo or fetus
p.(None): ARTICLE 33. Investigations in pregnant women that involve an intervention or
p.(None): experimental procedure not related to pregnancy, but with therapeutic benefit for women, such as
p.(None): it would be in cases of toxemia gravidarum, diabetes, hypertension and neoplasms, among others, should not expose to
p.(None): embryo or fetus at a greater than minimum risk, except when the use of the intervention or procedure is
p.(None): Sheet 8 of 8
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): justify to save the woman's life.
p.(None): ARTICLE 34. Research in pregnant women, with therapeutic benefit related to pregnancy, is
p.(None): will allow when:
p.(None): a) Aim to improve the health of the pregnant woman with a minimal risk to the embryo or the fetus.
p.(None): b) Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None): ARTICLE 35. During the execution of investigations in pregnant women:
p.(None): a) Investigators will not have the authority to decide on the time, method or procedure used
p.(None): to terminate the pregnancy, nor participation in decisions about the viability of the fetus.
p.(None): b) It is strictly forbidden to grant stimuli, monetary or otherwise, to terminate the pregnancy,
p.(None): for the interest of the investigation or for other reasons.
p.(None): ARTICLE 36. Informed Consent for investigations during labor shall be obtained in agreement.
p.(None): with what is stipulated in articles 14, 15 and 16 of this regulation, before it is initiated and indicating
p.(None): expressly that it can be withdrawn at any time during labor.
p.(None): ARTICLE 37. Research on women during the puerperium will be allowed when they do not interfere with the health of the
p.(None): mother or with the newborn.
p.(None): ARTICLE 38. Research on women during breastfeeding will be authorized when there is no risk to
p.(None): the infant or when the mother decides not to breastfeed; your food is secured by another method and you get the
p.(None): Informed Consent in accordance with the provisions of articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 39. Fetuses will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the pregnant woman.
p.(None): ARTICLE 40. Newborns will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the mother.
...
Searching for indicator fetuses:
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p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
p.(None): possible for the embryo, fetus or newborn in your case.
p.(None): The Informed Consent of the spouse or partner may only be waived in case of disability or impossibility
p.(None): reliable or manifest to provide it; because the partner does not take care of the woman or, well, when
p.(None): there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None): ARTICLE 31. Research carried out on pregnant women must be preceded by studies.
p.(None): performed on non-pregnant women who demonstrate safety, except for specific studies that require
p.(None): such condition.
p.(None): ARTICLE 32. Research without therapeutic benefit in pregnant women whose objective is to obtain
...
p.(None): a) Investigators will not have the authority to decide on the time, method or procedure used
p.(None): to terminate the pregnancy, nor participation in decisions about the viability of the fetus.
p.(None): b) It is strictly forbidden to grant stimuli, monetary or otherwise, to terminate the pregnancy,
p.(None): for the interest of the investigation or for other reasons.
p.(None): ARTICLE 36. Informed Consent for investigations during labor shall be obtained in agreement.
p.(None): with what is stipulated in articles 14, 15 and 16 of this regulation, before it is initiated and indicating
p.(None): expressly that it can be withdrawn at any time during labor.
p.(None): ARTICLE 37. Research on women during the puerperium will be allowed when they do not interfere with the health of the
p.(None): mother or with the newborn.
p.(None): ARTICLE 38. Research on women during breastfeeding will be authorized when there is no risk to
p.(None): the infant or when the mother decides not to breastfeed; your food is secured by another method and you get the
p.(None): Informed Consent in accordance with the provisions of articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 39. Fetuses will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the pregnant woman.
p.(None): ARTICLE 40. Newborns will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the mother.
p.(None): ARTICLE 41. Newborns shall not be subject to investigation, except when it is intended to:
p.(None): increase its probability of survival until the feasibility phase; the procedures do not cause the
p.(None): cessation of vital functions, or when, without adding any risk, generalized knowledge is sought
p.(None): important that cannot be obtained otherwise.
p.(None): ARTICLE 42. Live births may be subject to investigation if the provisions on
p.(None): investigation in minors, indicated in this resolution.
p.(None): ARTICLE 43. Investigations with embryos, deaths, fetuses, dead births, macerated fecal matter, cells,
p.(None): tissues and organs extracted from them, will be made in accordance with the provisions of this regulation.
p.(None): ARTICLE 44. Research on artificial fertilization shall only be admissible when applied to the solution of
p.(None): sterility problems that cannot be solved in any other way, respecting the moral point of view,
p.(None): cultural and social of the couple.
p.(None): CHAPTER V.
p.(None): Sheet 9 of 9
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): OF THE INVESTIGATIONS IN SUBORDINATED GROUPS.
p.(None): ARTICLE 45. Subordinated groups are understood as the following: students, workers of the
p.(None): laboratories and hospitals, employees and members of the armed forces, interns in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which the Consent
p.(None): Informed may be influenced by some authority.
p.(None): ARTICLE 46. When investigations are conducted in subordinate groups, in the Ethics Committee in
p.(None): Research, one or more members of the study population, capable of representing the values must participate
p.(None): moral, cultural and social group in question and monitor:
...
Searching for indicator neonates:
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p.(None): thermographies, collection of excreta and external secretions, obtaining placenta during childbirth, collection of
p.(None): amniotic fluid when the membranes rupture, obtaining saliva, deciduous teeth and permanent teeth extracted
p.(None): by therapeutic indication, dental plaque and stones removed by non-invasive prophylactic procedures,
p.(None): hair and nail cutting without causing disfigurement, blood collection by venous puncture in adults in good condition
p.(None): health, with a maximum frequency of twice a week and a maximum volume of 450 ml in two months except during the
p.(None): pregnancy, moderate exercise in healthy volunteers, psychological tests to groups or individuals in whom
p.(None): will manipulate the subject's behavior, research with commonly used medications, wide therapeutic range and
p.(None): Registered in this Ministry or its delegated authority, using the indications, dosage and routes of administration
p.(None): established and other than the medications defined in article 55 of this resolution.
p.(None): c. Investigations with risk greater than the minimum: Are those in which the probabilities of
p.(None): affect the subject are significant, among which are considered: radiological and microwave studies,
p.(None): studies with medications and modalities defined in titles III and IV of this resolution, trials with
p.(None): new devices, studies that include surgical procedures, blood collection greater than 2% of the volume
p.(None): circulating in neonates, amniocentesis and other invasive techniques or major procedures, which
p.(None): use random methods of allocation to therapeutic schemes and those that have control with placebos, among others.
p.(None): ARTICLE 12. The principal investigator shall suspend the investigation immediately, upon warning of any risk or
p.(None): damage to the health of the subject in whom the investigation is conducted. Likewise, it will be immediately suspended for
p.(None): those research subjects that manifest it.
p.(None): ARTICLE 13. It is the responsibility of the research or sponsoring institution to provide care.
p.(None): medical to the subject that suffers any damage, if directly related to the investigation, without
p.(None): damage of the compensation that legally corresponds to him.
p.(None): ARTICLE 14. Informed Consent means the agreement in writing, whereby the subject of
p.(None): investigation or, where appropriate, your legal representative, authorizes your participation in the investigation, with full
p.(None): knowledge of the nature of the procedures, benefits and risks to be submitted, with the
p.(None): capacity of free choice and without coercion.
p.(None): Sheet 4 of 4
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 15. The Informed Consent must present the following information, which will be explained, in
...
Social / Incarcerated
Searching for indicator restricted:
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p.(None): PARAGRAPH. Pregnant or breastfeeding women should not work in places of high risk of
p.(None): incorporation of radioactive materials.
p.(None): ARTICLE 84. The persons, included in the procedure, must be informed about the risk of irradiation to which
p.(None): submit, so that their participation is under their free will and with knowledge of cause. It is necessary the
p.(None): Informed Consent of family members or legal guardian when the subject of the investigation does not
p.(None): Be in a position to decide on your acceptance.
p.(None): ARTICLE 85. These investigations must be subject to individual evaluation, followed by a plan of procedures and a
p.(None): final protocol approved by the competent authority in the field, to analyze them thoroughly from
p.(None): the point of view of radiation protection and the condition of true volunteers of people who do not
p.(None): they will receive a net benefit from the procedure, since no special dose limits can be set in these
p.(None): cases.
p.(None): ARTICLE 86. The use of ionizing radiation for research in pregnant women and forbidden is prohibited.
p.(None): minors, and is restricted to specific studies prior to research in women of age
p.(None): reproductive
p.(None): PARAGRAPH. In the previous cases, reconsideration may be made in the case of procedures
p.(None): Therapeutics in pathological processes considered special by their prognosis or by their characteristics,
p.(None): with the prior written authorization of the person involved, or the relative, or legally responsible person.
p.(None): TITLE V.
p.(None): BIOMEDICAL RESEARCH WITH ANIMALS.
p.(None): ARTICLE 87. In any investigation in which the animals are subject to study, they must be kept in
p.(None): Account, in addition to the provisions determined in Law 84 of 1989, the following:
p.(None): a) Whenever appropriate, methods such as mathematical models, simulation in
p.(None): In vitro computer and biological systems.
p.(None): b) Animal testing should only be done after studying its importance to human health or
p.(None): animal and for the advancement of biological knowledge.
p.(None): c) The animals selected for experimentation must be of an appropriate species and quality, and
p.(None): use the minimum number required to obtain scientifically valid results.
p.(None): d) Only legally acquired animals will be used and kept in proper condition and that
p.(None): comply with current sanitary regulations.
p.(None): e) Researchers and other staff should never stop treating animals as sentient beings and should
p.(None): consider proper care and use as an ethical imperative and avoid or minimize discomfort, anguish and
p.(None): pain.
p.(None): f) Researchers should presume, which procedures that would cause pain in humans also cause pain in
p.(None): other vertebrate species, even when it is still missing
p.(None): Sheet 18 of 18
...
Social / Infant
Searching for indicator infant:
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p.(None): b) Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None): ARTICLE 35. During the execution of investigations in pregnant women:
p.(None): a) Investigators will not have the authority to decide on the time, method or procedure used
p.(None): to terminate the pregnancy, nor participation in decisions about the viability of the fetus.
p.(None): b) It is strictly forbidden to grant stimuli, monetary or otherwise, to terminate the pregnancy,
p.(None): for the interest of the investigation or for other reasons.
p.(None): ARTICLE 36. Informed Consent for investigations during labor shall be obtained in agreement.
p.(None): with what is stipulated in articles 14, 15 and 16 of this regulation, before it is initiated and indicating
p.(None): expressly that it can be withdrawn at any time during labor.
p.(None): ARTICLE 37. Research on women during the puerperium will be allowed when they do not interfere with the health of the
p.(None): mother or with the newborn.
p.(None): ARTICLE 38. Research on women during breastfeeding will be authorized when there is no risk to
p.(None): the infant or when the mother decides not to breastfeed; your food is secured by another method and you get the
p.(None): Informed Consent in accordance with the provisions of articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 39. Fetuses will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the pregnant woman.
p.(None): ARTICLE 40. Newborns will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the mother.
p.(None): ARTICLE 41. Newborns shall not be subject to investigation, except when it is intended to:
p.(None): increase its probability of survival until the feasibility phase; the procedures do not cause the
p.(None): cessation of vital functions, or when, without adding any risk, generalized knowledge is sought
p.(None): important that cannot be obtained otherwise.
p.(None): ARTICLE 42. Live births may be subject to investigation if the provisions on
p.(None): investigation in minors, indicated in this resolution.
p.(None): ARTICLE 43. Investigations with embryos, deaths, fetuses, dead births, macerated fecal matter, cells,
p.(None): tissues and organs extracted from them, will be made in accordance with the provisions of this regulation.
p.(None): ARTICLE 44. Research on artificial fertilization shall only be admissible when applied to the solution of
p.(None): sterility problems that cannot be solved in any other way, respecting the moral point of view,
...
Social / Marital Status
Searching for indicator single:
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p.(None): a report is required within fifteen (15) business days following the suspension of the
p.(None): investigation, which specifies the warned effect, the measures adopted and the consequences produced.
p.(None): CHAPTER II.
p.(None): OF PHARMACOLOGICAL RESEARCH.
p.(None): ARTICLE 53. For the purposes of this regulation, pharmacological research is understood as the
p.(None): scientific activities aimed at the study of drugs and biological products for human use on
p.(None): which do not have previous experience in the country, which are not contemplated in the Pharmacological Standards in this
p.(None): Ministry and therefore, are not distributed commercially, as well as registered medications
p.(None): and approved for sale, when its use is investigated with modalities, indications, doses or routes of administration
p.(None): different from those established, including its use in combinations.
p.(None): ARTICLE 54. Investigations of medications in clinical pharmacology include
p.(None): Sheet 11 of 11
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): the sequence of studies that are carried out from when it is first administered to the human being, until it is
p.(None): They obtain data on their efficacy and therapeutic safety in large population groups. For this purpose, they are considered
p.(None): The following phases:
p.(None): to. PHASE I: It is the administration for the first time of a research drug to the healthy human being, in single doses
p.(None): or multiple, in small hospitalized groups, to establish initial pharmacological parameters in man.
p.(None): b. PHASE II: It is the administration, to the sick human being, of a research medicine, in doses
p.(None): single or multiple, in small hospitalized groups, to establish pharmacological parameters in the organism
p.(None): sick.
p.(None): c. PHASE III It is the administration, to large groups of patients, of a research drug, usually
p.(None): external, to define its therapeutic utility and identify adverse reactions, interactions and factors
p.(None): external, that can alter the pharmacological effect.
p.(None): d. PHASE IV: These are studies that are carried out after the medicine is granted, health record for sale
p.(None): and aims to generate new information on the safety of the drug during its widespread use and
p.(None): dragged on.
p.(None): ARTICLE 55. All the investigations in clinical pharmacology that are carried out must be preceded by
p.(None): complete preclinical studies that include physicochemical characteristics pharmacological activity, toxicity,
p.(None): pharmacokinetics, absorption, distribution, metabolism and excretion of the drug in different animal species;
p.(None): frequencies, routes of administration and duration of the doses studied that can serve as a basis for the safety of
p.(None): its administration in the human being; studies on mutagenesis, teratogenesis and carcinogenesis are also required.
p.(None): ARTICLE 56. The preclinical toxicology studies required for each drug will depend on it.
p.(None): in particular, of the known potential toxicology of others with similar chemical structure and of the route and time of
p.(None): administration that is intended to be used in humans.
...
Social / Social
Searching for indicator social:
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p.(None): provisions, determines that it is up to the Ministry of Health to formulate the policies and dictate all the norms
p.(None): scientific-administrative, mandatory by the entities that make up the System,
p.(None): - That Article 2 of Decree 2164 of 1992, which restructures the Ministry of Health and determines the
p.(None): functions of its dependencies, it establishes that it will formulate the pertinent scientific and administrative norms that
p.(None): Orient the resources and actions of the System,
p.(None): RESOLVES:
p.(None): TITLE 1
p.(None): GENERAL DISPOSITION.
p.(None): ARTICLE 1. The provisions of these scientific standards are intended to establish the requirements for the
p.(None): development of the research activity in health.
p.(None): ARTICLE 2. The institutions that are going to carry out research in humans must have an Ethics Committee in
p.(None): Research, responsible for resolving all issues related to the subject.
p.(None): ARTICLE 3. The institutions, referred to in the previous article, because of their regulations and
p.(None): internal policies, will elaborate their internal procedures manual in order to support the application of these
p.(None): rules
p.(None): ARTICLE 4. Research for health includes the development of actions that contribute:
p.(None): to. To the knowledge of the biological and psychological processes in human beings.
p.(None): b. To the knowledge of the links between the causes of illness, medical practice and social structure.
p.(None): c. To the prevention and control of health problems.
p.(None): Sheet 2 of 2
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): d. To the knowledge and evaluation of the harmful effects of the environment on health.
p.(None): and. To the study of the techniques and methods that are recommended or used for the provision of health services.
p.(None): F. To the production of health supplies.
p.(None): TITLE II
p.(None): OF RESEARCH IN HUMAN BEINGS.
p.(None): CHAPTER 1.
p.(None): OF THE ETHICAL ASPECTS OF RESEARCH IN HUMAN BEINGS.
p.(None): ARTICLE 5. In any investigation in which the human being is the subject of study, the
p.(None): criterion of respect for their dignity and protection of their rights and well-being.
p.(None): ARTICLE 6. Research carried out in human beings shall be carried out according to the following criteria:
p.(None): to. It will conform to the scientific and ethical principles that justify it.
p.(None): b. It will be based on previous experimentation performed on animals, in laboratories or on other scientific facts.
p.(None): c. It will be done only when the knowledge that is intended to be produced cannot be obtained by other suitable means.
p.(None): d. The safety of the beneficiaries must prevail and clearly express the (minimum) risks, which do not
p.(None): they must, at no time, contradict article 11 of this resolution.
...
p.(None): ARTICLE 7. When the experimental design of an investigation carried out in human beings includes
p.(None): several groups, random selection methods will be used to obtain an impartial allocation of participants in
p.(None): each group, and other technical standards determined for this type of research, and measures will be taken
p.(None): relevant to avoid any risk or harm to the research subjects.
p.(None): ARTICLE 8. In investigations in human beings, the privacy of the individual, subject of investigation, shall be protected.
p.(None): Identifying it only when the results require it and it authorizes it.
p.(None): Sheet 3 of 3
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 9. The probability that the subject of
p.(None): investigation suffers some damage as an immediate or late consequence of the study.
p.(None): ARTICLE 10. The group of researchers or the principal investigator shall identify the type or types of risk at which
p.(None): Research subjects will be exposed.
p.(None): ARTICLE 11. For purposes of this regulation, investigations are classified into the following categories:
p.(None): to. Risk-free research: These are studies that use research techniques and methods.
p.(None): Restrospective documentary and those in which no intervention or modification is made
p.(None): intentional of the biological, physiological, psychological or social variables of the individuals that
p.(None): participate in the study, among which are considered: review of medical records, interviews, questionnaires and
p.(None): others in which he is not identified or sensitive aspects of his behavior are treated
p.(None): b. Research with minimal risk: These are prospective studies that use data recording through
p.(None): Common procedures consisting of: physical or psychological diagnostic tests or treatments
p.(None): routine, among which are considered: weighing the subject, electrocardiograms, hearing acuity tests,
p.(None): thermographies, collection of excreta and external secretions, obtaining placenta during childbirth, collection of
p.(None): amniotic fluid when the membranes rupture, obtaining saliva, deciduous teeth and permanent teeth extracted
p.(None): by therapeutic indication, dental plaque and stones removed by non-invasive prophylactic procedures,
p.(None): hair and nail cutting without causing disfigurement, blood collection by venous puncture in adults in good condition
p.(None): health, with a maximum frequency of twice a week and a maximum volume of 450 ml in two months except during the
p.(None): pregnancy, moderate exercise in healthy volunteers, psychological tests to groups or individuals in whom
p.(None): will manipulate the subject's behavior, research with commonly used medications, wide therapeutic range and
p.(None): Registered in this Ministry or its delegated authority, using the indications, dosage and routes of administration
...
p.(None): you must also obtain your acceptance to be the subject of investigation after explaining what
p.(None): pretend to do The Research Ethics Committee of the respective health entity must ensure the
p.(None): Compliance with these requirements.
p.(None): ARTICLE 27. Investigations classified with risk and with probabilities of direct benefit for the
p.(None): minor or disabled, will be admissible when:
p.(None): a) The risk is justified by the importance of the benefit that the minor or the disabled will receive.
p.(None): b) The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None): ARTICLE 28. Investigations classified as risk and without direct benefit to the minor or the
p.(None): disabled, will be admissible according to the following considerations:
p.(None): FIRST PARAGRAPH. WHEN THE RISK IS MINIMUM
p.(None): a) The intervention or procedure must represent for the minor or the disabled a reasonable experience and
p.(None): comparable to those inherent in your current medical, psychological, social or educational situation.
p.(None): Sheet 7 of 7
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
...
p.(None): Informed Consent in accordance with the provisions of articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 39. Fetuses will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the pregnant woman.
p.(None): ARTICLE 40. Newborns will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the mother.
p.(None): ARTICLE 41. Newborns shall not be subject to investigation, except when it is intended to:
p.(None): increase its probability of survival until the feasibility phase; the procedures do not cause the
p.(None): cessation of vital functions, or when, without adding any risk, generalized knowledge is sought
p.(None): important that cannot be obtained otherwise.
p.(None): ARTICLE 42. Live births may be subject to investigation if the provisions on
p.(None): investigation in minors, indicated in this resolution.
p.(None): ARTICLE 43. Investigations with embryos, deaths, fetuses, dead births, macerated fecal matter, cells,
p.(None): tissues and organs extracted from them, will be made in accordance with the provisions of this regulation.
p.(None): ARTICLE 44. Research on artificial fertilization shall only be admissible when applied to the solution of
p.(None): sterility problems that cannot be solved in any other way, respecting the moral point of view,
p.(None): cultural and social of the couple.
p.(None): CHAPTER V.
p.(None): Sheet 9 of 9
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): OF THE INVESTIGATIONS IN SUBORDINATED GROUPS.
p.(None): ARTICLE 45. Subordinated groups are understood as the following: students, workers of the
p.(None): laboratories and hospitals, employees and members of the armed forces, interns in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which the Consent
p.(None): Informed may be influenced by some authority.
p.(None): ARTICLE 46. When investigations are conducted in subordinate groups, in the Ethics Committee in
p.(None): Research, one or more members of the study population, capable of representing the values must participate
p.(None): moral, cultural and social group in question and monitor:
p.(None): a) That the participation, the rejection of the subjects to intervene or withdrawal of their consent during the study, does not
p.(None): affect their school, employment, military situation or related to the judicial process to which they were subject and the
p.(None): conditions of compliance with the judgment of the case.
p.(None): b) That the results of the investigation are not used to the detriment of the participating individuals.
p.(None): c) That the research institution and the sponsors are responsible for the medical treatment of the damages
p.(None): caused and, where appropriate, the compensation that legally corresponds for the harmful consequences of
p.(None): the investigation.
p.(None): CHAPTER VI
p.(None): OF THE RESEARCH IN ORGANS, FABRICS AND THEIR DERIVATIVES, PRODUCTS AND CADAVERES OF HUMAN BEINGS.
p.(None): ARTICLE 47. The investigation referred to in this chapter includes that which includes the use of organs,
p.(None): tissues and their derivatives, products and corpses of human beings, as well as the set of activities
p.(None): relative to its obtaining, conservation, use, preparation and final destination.
p.(None): ARTICLE 48. This investigation must observe in addition to due respect to the human corpse, the
p.(None): applicable provisions of these regulations and other regulations related to the disposition of organs, tissues and
p.(None): corpses of human beings.
p.(None): TITLE III
p.(None): OF THE INVESTIGATIONS OF NEW PROFILACTIC, DIAGNOSTIC, THERAPEUTIC AND REHABILITATION RESOURCES.
p.(None): CHAPTER I. GENERAL PROVISIONS.
p.(None): ARTICLE 49. When research is conducted on human beings, on new prophylactic resources, of
...
Social / Soldier
Searching for indicator military:
(return to top)
p.(None): cultural and social of the couple.
p.(None): CHAPTER V.
p.(None): Sheet 9 of 9
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): OF THE INVESTIGATIONS IN SUBORDINATED GROUPS.
p.(None): ARTICLE 45. Subordinated groups are understood as the following: students, workers of the
p.(None): laboratories and hospitals, employees and members of the armed forces, interns in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which the Consent
p.(None): Informed may be influenced by some authority.
p.(None): ARTICLE 46. When investigations are conducted in subordinate groups, in the Ethics Committee in
p.(None): Research, one or more members of the study population, capable of representing the values must participate
p.(None): moral, cultural and social group in question and monitor:
p.(None): a) That the participation, the rejection of the subjects to intervene or withdrawal of their consent during the study, does not
p.(None): affect their school, employment, military situation or related to the judicial process to which they were subject and the
p.(None): conditions of compliance with the judgment of the case.
p.(None): b) That the results of the investigation are not used to the detriment of the participating individuals.
p.(None): c) That the research institution and the sponsors are responsible for the medical treatment of the damages
p.(None): caused and, where appropriate, the compensation that legally corresponds for the harmful consequences of
p.(None): the investigation.
p.(None): CHAPTER VI
p.(None): OF THE RESEARCH IN ORGANS, FABRICS AND THEIR DERIVATIVES, PRODUCTS AND CADAVERES OF HUMAN BEINGS.
p.(None): ARTICLE 47. The investigation referred to in this chapter includes that which includes the use of organs,
p.(None): tissues and their derivatives, products and corpses of human beings, as well as the set of activities
p.(None): relative to its obtaining, conservation, use, preparation and final destination.
p.(None): ARTICLE 48. This investigation must observe in addition to due respect to the human corpse, the
p.(None): applicable provisions of these regulations and other regulations related to the disposition of organs, tissues and
p.(None): corpses of human beings.
p.(None): TITLE III
p.(None): OF THE INVESTIGATIONS OF NEW PROFILACTIC, DIAGNOSTIC, THERAPEUTIC AND REHABILITATION RESOURCES.
p.(None): CHAPTER I. GENERAL PROVISIONS.
p.(None): ARTICLE 49. When research is conducted on human beings, on new prophylactic resources, of
p.(None): diagnostic, therapeutic and rehabilitation, or it is intended to modify those already known, should be observed
p.(None): as applicable, the provisions of the preceding articles and satisfy the provisions of this title.
...
Searching for indicator armed forces:
(return to top)
p.(None): ARTICLE 40. Newborns will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the mother.
p.(None): ARTICLE 41. Newborns shall not be subject to investigation, except when it is intended to:
p.(None): increase its probability of survival until the feasibility phase; the procedures do not cause the
p.(None): cessation of vital functions, or when, without adding any risk, generalized knowledge is sought
p.(None): important that cannot be obtained otherwise.
p.(None): ARTICLE 42. Live births may be subject to investigation if the provisions on
p.(None): investigation in minors, indicated in this resolution.
p.(None): ARTICLE 43. Investigations with embryos, deaths, fetuses, dead births, macerated fecal matter, cells,
p.(None): tissues and organs extracted from them, will be made in accordance with the provisions of this regulation.
p.(None): ARTICLE 44. Research on artificial fertilization shall only be admissible when applied to the solution of
p.(None): sterility problems that cannot be solved in any other way, respecting the moral point of view,
p.(None): cultural and social of the couple.
p.(None): CHAPTER V.
p.(None): Sheet 9 of 9
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): OF THE INVESTIGATIONS IN SUBORDINATED GROUPS.
p.(None): ARTICLE 45. Subordinated groups are understood as the following: students, workers of the
p.(None): laboratories and hospitals, employees and members of the armed forces, interns in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which the Consent
p.(None): Informed may be influenced by some authority.
p.(None): ARTICLE 46. When investigations are conducted in subordinate groups, in the Ethics Committee in
p.(None): Research, one or more members of the study population, capable of representing the values must participate
p.(None): moral, cultural and social group in question and monitor:
p.(None): a) That the participation, the rejection of the subjects to intervene or withdrawal of their consent during the study, does not
p.(None): affect their school, employment, military situation or related to the judicial process to which they were subject and the
p.(None): conditions of compliance with the judgment of the case.
p.(None): b) That the results of the investigation are not used to the detriment of the participating individuals.
p.(None): c) That the research institution and the sponsors are responsible for the medical treatment of the damages
p.(None): caused and, where appropriate, the compensation that legally corresponds for the harmful consequences of
p.(None): the investigation.
p.(None): CHAPTER VI
p.(None): OF THE RESEARCH IN ORGANS, FABRICS AND THEIR DERIVATIVES, PRODUCTS AND CADAVERES OF HUMAN BEINGS.
p.(None): ARTICLE 47. The investigation referred to in this chapter includes that which includes the use of organs,
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
p.(None): possible for the embryo, fetus or newborn in your case.
p.(None): The Informed Consent of the spouse or partner may only be waived in case of disability or impossibility
p.(None): reliable or manifest to provide it; because the partner does not take care of the woman or, well, when
p.(None): there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None): ARTICLE 31. Research carried out on pregnant women must be preceded by studies.
p.(None): performed on non-pregnant women who demonstrate safety, except for specific studies that require
p.(None): such condition.
p.(None): ARTICLE 32. Research without therapeutic benefit in pregnant women whose objective is to obtain
p.(None): generalizable knowledge about pregnancy should not represent a risk greater than the minimum for women, the
p.(None): embryo or fetus
p.(None): ARTICLE 33. Investigations in pregnant women that involve an intervention or
p.(None): experimental procedure not related to pregnancy, but with therapeutic benefit for women, such as
p.(None): it would be in cases of toxemia gravidarum, diabetes, hypertension and neoplasms, among others, should not expose to
p.(None): embryo or fetus at a greater than minimum risk, except when the use of the intervention or procedure is
p.(None): Sheet 8 of 8
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): justify to save the woman's life.
p.(None): ARTICLE 34. Research in pregnant women, with therapeutic benefit related to pregnancy, is
p.(None): will allow when:
p.(None): a) Aim to improve the health of the pregnant woman with a minimal risk to the embryo or the fetus.
p.(None): b) Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None): ARTICLE 35. During the execution of investigations in pregnant women:
p.(None): a) Investigators will not have the authority to decide on the time, method or procedure used
p.(None): to terminate the pregnancy, nor participation in decisions about the viability of the fetus.
p.(None): b) It is strictly forbidden to grant stimuli, monetary or otherwise, to terminate the pregnancy,
p.(None): for the interest of the investigation or for other reasons.
p.(None): ARTICLE 36. Informed Consent for investigations during labor shall be obtained in agreement.
p.(None): with what is stipulated in articles 14, 15 and 16 of this regulation, before it is initiated and indicating
p.(None): expressly that it can be withdrawn at any time during labor.
p.(None): ARTICLE 37. Research on women during the puerperium will be allowed when they do not interfere with the health of the
p.(None): mother or with the newborn.
p.(None): ARTICLE 38. Research on women during breastfeeding will be authorized when there is no risk to
p.(None): the infant or when the mother decides not to breastfeed; your food is secured by another method and you get the
p.(None): Informed Consent in accordance with the provisions of articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 39. Fetuses will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the pregnant woman.
p.(None): ARTICLE 40. Newborns will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the mother.
p.(None): ARTICLE 41. Newborns shall not be subject to investigation, except when it is intended to:
p.(None): increase its probability of survival until the feasibility phase; the procedures do not cause the
p.(None): cessation of vital functions, or when, without adding any risk, generalized knowledge is sought
p.(None): important that cannot be obtained otherwise.
p.(None): ARTICLE 42. Live births may be subject to investigation if the provisions on
p.(None): investigation in minors, indicated in this resolution.
p.(None): ARTICLE 43. Investigations with embryos, deaths, fetuses, dead births, macerated fecal matter, cells,
p.(None): tissues and organs extracted from them, will be made in accordance with the provisions of this regulation.
p.(None): ARTICLE 44. Research on artificial fertilization shall only be admissible when applied to the solution of
...
p.(None): by the investigator or the patient undergoing the investigation, be as low as reasonably possible,
p.(None): taking into account the socio-economic factors of the environment in which it works.
p.(None): ARTICLE 81. In the examination or treatment that is part of a medical research program and that
p.(None): entails a net benefit for the patient, the justification of the procedure will be done with them
p.(None): Justification criteria for a routine medical exposure. However, given the character
p.(None): experimental, said justification will be subject to a thorough scrutiny individually, discarding
p.(None): other diagnostic or therapeutic methods that can be evaluated comparatively.
p.(None): ARTICLE 82. The deliberate irradiation of personnel during procedures for research purposes
p.(None): that does not pursue a direct benefit to irradiated persons, will be carried out only by persons adequately
p.(None): qualified and trained, and with the respective permission of the institution where the
p.(None): irradiation, under the advice of the National Entity responsible for radiological protection in harmony with the standards
p.(None): current surveillance and radiological control.
p.(None): Sheet 17 of 17
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 83. Occupationally exposed personnel must be over 18 years of age, and limits will be taken into account
p.(None): of occupational exposure determined by the authorized national entity, with special consideration in the case of
p.(None): Women of childbearing age and pregnant.
p.(None): PARAGRAPH. Pregnant or breastfeeding women should not work in places of high risk of
p.(None): incorporation of radioactive materials.
p.(None): ARTICLE 84. The persons, included in the procedure, must be informed about the risk of irradiation to which
p.(None): submit, so that their participation is under their free will and with knowledge of cause. It is necessary the
p.(None): Informed Consent of family members or legal guardian when the subject of the investigation does not
p.(None): Be in a position to decide on your acceptance.
p.(None): ARTICLE 85. These investigations must be subject to individual evaluation, followed by a plan of procedures and a
p.(None): final protocol approved by the competent authority in the field, to analyze them thoroughly from
p.(None): the point of view of radiation protection and the condition of true volunteers of people who do not
p.(None): they will receive a net benefit from the procedure, since no special dose limits can be set in these
p.(None): cases.
p.(None): ARTICLE 86. The use of ionizing radiation for research in pregnant women and forbidden is prohibited.
p.(None): minors, and is restricted to specific studies prior to research in women of age
p.(None): reproductive
p.(None): PARAGRAPH. In the previous cases, reconsideration may be made in the case of procedures
p.(None): Therapeutics in pathological processes considered special by their prognosis or by their characteristics,
p.(None): with the prior written authorization of the person involved, or the relative, or legally responsible person.
p.(None): TITLE V.
p.(None): BIOMEDICAL RESEARCH WITH ANIMALS.
p.(None): ARTICLE 87. In any investigation in which the animals are subject to study, they must be kept in
p.(None): Account, in addition to the provisions determined in Law 84 of 1989, the following:
p.(None): a) Whenever appropriate, methods such as mathematical models, simulation in
p.(None): In vitro computer and biological systems.
p.(None): b) Animal testing should only be done after studying its importance to human health or
p.(None): animal and for the advancement of biological knowledge.
p.(None): c) The animals selected for experimentation must be of an appropriate species and quality, and
p.(None): use the minimum number required to obtain scientifically valid results.
p.(None): d) Only legally acquired animals will be used and kept in proper condition and that
p.(None): comply with current sanitary regulations.
p.(None): e) Researchers and other staff should never stop treating animals as sentient beings and should
p.(None): consider proper care and use as an ethical imperative and avoid or minimize discomfort, anguish and
p.(None): pain.
p.(None): f) Researchers should presume, which procedures that would cause pain in humans also cause pain in
p.(None): other vertebrate species, even when it is still missing
p.(None): Sheet 18 of 18
p.(None): RESOLUTION NUMBER 8430 OF 1993
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): established guidelines for the development of these models.
p.(None): ARTICLE 22. In any community investigation, the ethical considerations applicable to research
p.(None): in humans, they must be extrapolated to the communal context in the pertinent aspects.
p.(None): CHAPTER III
p.(None): OF INVESTIGATIONS IN MINORS OR DISABLED.
p.(None): ARTICLE 23. In addition to the general provisions of ethics that must be complied with in all research in human beings,
p.(None): that which is carried out in minors or physically and mentally disabled, must fully satisfy all
p.(None): the requirements set out in this chapter.
p.(None): ARTICLE 24. When it is intended to conduct investigations in minors, it must be ensured that
p.(None): similar studies have previously been done in adults and immature animals;
p.(None): except in the case of studies of conditions that are characteristic of the neonatal stage or conditions
p.(None): specific of certain ages.
p.(None): ARTICLE 25. To carry out investigations in minors or in physically and mentally disabled persons, in
p.(None): In any case, obtain, in addition to the Informed Consent of those exercising parental authority or
p.(None): legal representation of the minor or the person concerned, certification of a neurologist, psychiatrist or
p.(None): psychologist, about the capacity of understanding, reasoning and logic of the subject.
p.(None): ARTICLE 26. When the mental capacity and the psychological state of the minor or disabled person allow it,
p.(None): you must also obtain your acceptance to be the subject of investigation after explaining what
p.(None): pretend to do The Research Ethics Committee of the respective health entity must ensure the
p.(None): Compliance with these requirements.
p.(None): ARTICLE 27. Investigations classified with risk and with probabilities of direct benefit for the
p.(None): minor or disabled, will be admissible when:
p.(None): a) The risk is justified by the importance of the benefit that the minor or the disabled will receive.
p.(None): b) The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None): ARTICLE 28. Investigations classified as risk and without direct benefit to the minor or the
p.(None): disabled, will be admissible according to the following considerations:
p.(None): FIRST PARAGRAPH. WHEN THE RISK IS MINIMUM
p.(None): a) The intervention or procedure must represent for the minor or the disabled a reasonable experience and
p.(None): comparable to those inherent in your current medical, psychological, social or educational situation.
p.(None): Sheet 7 of 7
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): b) The intervention or procedure should have a high probability of obtaining positive results or knowledge
p.(None): generalizable about the condition or illness of the minor or the disabled that are of great importance for
p.(None): Understand the disorder or to achieve improvement in other subjects.
p.(None): SECOND PARAGRAPH. WHEN THE RISK IS GREATER TO THE MINIMUM
p.(None): a) The investigation should have a high probability of attending, preventing or alleviating a serious problem that
p.(None): affect the health and well-being of children or the physically or mentally disabled.
p.(None): b) The Research Ethics Committee of the research institution will establish strict supervision
p.(None): to determine if the magnitude of the anticipated risks increases or others arise and will suspend the investigation in
p.(None): the moment when the risk could affect the biological, psychological or social well-being of the child or
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): disabled.
p.(None): CHAPTER IV
p.(None): OF RESEARCH IN WOMEN IN FERTIL AGE, PREGNANT, DURING LABOR, PUERPERIO, BREASTFEEDING AND RECENT
p.(None): BORN; OF THE USE OF EMBRYOS, OBITOS AND FETOS AND OF ARTIFICIAL FERTILIZATION.
p.(None): ARTICLE 29. In the investigations classified as of risk greater than the minimum, that are carried out in women in
p.(None): Old age, they must meet the following requirements:
p.(None): a) Certify that women are not pregnant prior to acceptance as research subjects.
p.(None): b) Decrease as much as possible the chances of pregnancy during the development of the investigation.
p.(None): ARTICLE 30. To carry out investigations in pregnant women, during labor, postpartum and
p.(None): lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for the
p.(None): artificial fertilization, it is required to obtain the Informed Consent of the woman and her spouse or
p.(None): partner in accordance with the provisions of articles 15 and 16 of this regulation, prior information of the risks
p.(None): possible for the embryo, fetus or newborn in your case.
p.(None): The Informed Consent of the spouse or partner may only be waived in case of disability or impossibility
p.(None): reliable or manifest to provide it; because the partner does not take care of the woman or, well, when
p.(None): there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None): ARTICLE 31. Research carried out on pregnant women must be preceded by studies.
p.(None): performed on non-pregnant women who demonstrate safety, except for specific studies that require
p.(None): such condition.
p.(None): ARTICLE 32. Research without therapeutic benefit in pregnant women whose objective is to obtain
p.(None): generalizable knowledge about pregnancy should not represent a risk greater than the minimum for women, the
p.(None): embryo or fetus
p.(None): ARTICLE 33. Investigations in pregnant women that involve an intervention or
p.(None): experimental procedure not related to pregnancy, but with therapeutic benefit for women, such as
p.(None): it would be in cases of toxemia gravidarum, diabetes, hypertension and neoplasms, among others, should not expose to
p.(None): embryo or fetus at a greater than minimum risk, except when the use of the intervention or procedure is
p.(None): Sheet 8 of 8
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): justify to save the woman's life.
p.(None): ARTICLE 34. Research in pregnant women, with therapeutic benefit related to pregnancy, is
p.(None): will allow when:
p.(None): a) Aim to improve the health of the pregnant woman with a minimal risk to the embryo or the fetus.
p.(None): b) Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None): ARTICLE 35. During the execution of investigations in pregnant women:
p.(None): a) Investigators will not have the authority to decide on the time, method or procedure used
p.(None): to terminate the pregnancy, nor participation in decisions about the viability of the fetus.
p.(None): b) It is strictly forbidden to grant stimuli, monetary or otherwise, to terminate the pregnancy,
p.(None): for the interest of the investigation or for other reasons.
p.(None): ARTICLE 36. Informed Consent for investigations during labor shall be obtained in agreement.
p.(None): with what is stipulated in articles 14, 15 and 16 of this regulation, before it is initiated and indicating
p.(None): expressly that it can be withdrawn at any time during labor.
p.(None): ARTICLE 37. Research on women during the puerperium will be allowed when they do not interfere with the health of the
p.(None): mother or with the newborn.
p.(None): ARTICLE 38. Research on women during breastfeeding will be authorized when there is no risk to
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): to IV of clinical pharmacological research, it will be done with the authorization of the Research Ethics Committee, to which
p.(None): the documentation indicated in article 50 of these regulations must be submitted, in addition to the following:
p.(None): a) The basic and preclinical pharmacological information of the medicine.
p.(None): b) Information previously obtained on clinical pharmacology in cases of phases II, III and IV and evidence of
p.(None): bioavailability when required.
p.(None): ARTICLE 58. Studies of Phase I clinical pharmacology, new antineoplastic drugs and others with index
p.(None): Very reduced therapeutic, will be allowed when:
p.(None): a) They are based on preclinical studies that demonstrate the pharmacological activity of
p.(None): medication and clearly indicate the characteristics of its toxicity.
p.(None): b) They are performed only in voluntary subjects with the specific disease, confirmed by diagnostic means
p.(None): additional, that have not presented therapeutic response to any other available treatment and in whom the
p.(None): New medication could offer a therapeutic benefit.
p.(None): c) Do not incur expenses to the patient.
p.(None): ARTICLE 59. In the treatment of emergencies, in conditions that threaten the life of
p.(None): Sheet 12 of 12
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): a person when it is considered necessary to use a research drug or a known medication using
p.(None): indications, doses and routes of administration different from those established, the doctor must obtain the opinion
p.(None): favorable of the Research Ethics Committee of the research institutions and the Informed Consent of the
p.(None): subject of investigation or its legal representative, as permitted by circumstances in accordance with the following
p.(None): bases:
p.(None): a) The Research Ethics Committee will be informed of the use of the investigational drug in advance,
p.(None): if the investigator can foresee the need for its use in urgent cases, or in retrospect, if the
p.(None): use of the drug, the indication, doses or new routes of administration arose as needs not
p.(None): provided. In both cases, the Research Ethics Committee will issue an opinion in favor or against approving the
p.(None): planned use or repetition of the unforeseen use of the medication.
p.(None): b) Informed Consent will be obtained from the subject of investigation, or failing that, from
p.(None): legal representative or the closest relative in bond, except when: the condition of the subject incapacitates or
p.(None): prevent granting it, the legal representative or family member is unavailable or when you stop using the medication in
p.(None): investigation represents an absolute risk of death.
p.(None): CHAPTER III
p.(None): OF THE INVESTIGATION OF OTHER NEW RESOURCES.
p.(None): ARTICLE 60. For the purposes of this regulation, it is understood by investigation of other new resources or
p.(None): different modalities from those established, the scientific activities tending to the study of
p.(None): materials, grafts, transplants, prostheses, physical, chemical and surgical procedures,
p.(None): instruments, devices, artificial organs and other methods of prevention, diagnosis, treatment and
p.(None): rehabilitation carried out in humans or in their biological products, except pharmacological ones.
p.(None): ARTICLE 61. Any investigation referred to in this chapter must have the authorization of the Committee of
p.(None): Research Ethics. For this purpose, the research institutions must present the documentation
p.(None): which is indicated in article 50 of this resolution, in addition to the following:
p.(None): a) The scientific foundations, information on previous experimentation carried out in animals or in the laboratory.
p.(None): b) Previous clinical research studies when there are any.
...
Social / property
Searching for indicator property:
(return to top)
p.(None): Experimental variables justify other situations.
p.(None): ARTICLE 91. The bioterios of production or chronic maintenance will be supervised by the professional personnel
p.(None): qualified and competent in the field and should allow growth, maturation, reproduction and behavior
p.(None): normal of animals, in accordance with the standards that the institution itself issues.
p.(None): ARTICLE 92. The director of the institution where animal research is conducted, shall establish and monitor the
p.(None): compliance with safety measures for the care and management of animals, as well as prophylaxis measures and
p.(None): vaccination necessary for the protection of occupationally exposed personnel.
p.(None): ARTICLE 93. The director of the institution where animal research is carried out, must monitor, order or
p.(None): execute, the following security measures are taken into account, as appropriate:
p.(None): Sheet 19 of 19
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): a) Isolation.
p.(None): b) The quarantine.
p.(None): c) Personal observation.
p.(None): d) Vaccination of people.
p.(None): e) The vaccination of animals, as soon as it refers to human health.
p.(None): f) The destruction or control of insects and other fauna, transmitting and harmful, as long as it refers to human health.
p.(None): g) The suspension of work or services.
p.(None): h) The assurance and destruction of objects or products or substances.
p.(None): i) Eviction of houses, buildings, establishments and in general from any property.
p.(None): j) The prohibition of the use of certain species, and
p.(None): k) The others of a sanitary nature determined by this Ministry or competent entity of its level, which may prevent
p.(None): are caused or continue to cause risks or damage to health.
p.(None): ARTICLE 94. This resolution is effective as of the date of its publication.
p.(None): PUBLISH AND COMPLY
...
Economic / Economic/Poverty
Searching for indicator economic:
(return to top)
p.(None): radiological and physical safety of these institutions, for the fulfillment of the requirements and
p.(None): obligations, as responsible for radiological safety.
p.(None): ARTICLE 79. The responsible person referred to in the previous article shall:
p.(None): a) Have the training, qualification and certification legally required for said function.
p.(None): b) Prepare a manual of procedures in accordance with the laws, regulations and regulations in force and with the
p.(None): characteristics of the installation or equipment, which must be available to all personnel, in which
p.(None): Describe: the identification and control of radiation sources, controlled and monitored areas, monitoring
p.(None): Dosimetric staff, emergency plan, waste management plan and training
p.(None): personnel involved in procedures and radiological safety.
p.(None): c) Define, implement and monitor compliance with radiological and physical safety measures.
p.(None): d) Inform the personnel involved in the investigation about these standards and train them on
p.(None): Work procedures and the characteristics of the laboratory and equipment.
p.(None): ARTICLE 80. Given that each exposure involves a risk, it is strictly prohibited.
p.(None): unduly exposed to ionizing radiation. Legally established Equivalent Dose limits
p.(None): they should be considered as upper limits and not design or control. Protection measures against
p.(None): ionizing radiation should be optimized, so that the number of people exposed and the Equivalent Dose received
p.(None): by the investigator or the patient undergoing the investigation, be as low as reasonably possible,
p.(None): taking into account the socio-economic factors of the environment in which it works.
p.(None): ARTICLE 81. In the examination or treatment that is part of a medical research program and that
p.(None): entails a net benefit for the patient, the justification of the procedure will be done with them
p.(None): Justification criteria for a routine medical exposure. However, given the character
p.(None): experimental, said justification will be subject to a thorough scrutiny individually, discarding
p.(None): other diagnostic or therapeutic methods that can be evaluated comparatively.
p.(None): ARTICLE 82. The deliberate irradiation of personnel during procedures for research purposes
p.(None): that does not pursue a direct benefit to irradiated persons, will be carried out only by persons adequately
p.(None): qualified and trained, and with the respective permission of the institution where the
p.(None): irradiation, under the advice of the National Entity responsible for radiological protection in harmony with the standards
p.(None): current surveillance and radiological control.
p.(None): Sheet 17 of 17
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 83. Occupationally exposed personnel must be over 18 years of age, and limits will be taken into account
p.(None): of occupational exposure determined by the authorized national entity, with special consideration in the case of
p.(None): Women of childbearing age and pregnant.
...
General/Other / Manipulable
Searching for indicator manipulate:
(return to top)
p.(None): Restrospective documentary and those in which no intervention or modification is made
p.(None): intentional of the biological, physiological, psychological or social variables of the individuals that
p.(None): participate in the study, among which are considered: review of medical records, interviews, questionnaires and
p.(None): others in which he is not identified or sensitive aspects of his behavior are treated
p.(None): b. Research with minimal risk: These are prospective studies that use data recording through
p.(None): Common procedures consisting of: physical or psychological diagnostic tests or treatments
p.(None): routine, among which are considered: weighing the subject, electrocardiograms, hearing acuity tests,
p.(None): thermographies, collection of excreta and external secretions, obtaining placenta during childbirth, collection of
p.(None): amniotic fluid when the membranes rupture, obtaining saliva, deciduous teeth and permanent teeth extracted
p.(None): by therapeutic indication, dental plaque and stones removed by non-invasive prophylactic procedures,
p.(None): hair and nail cutting without causing disfigurement, blood collection by venous puncture in adults in good condition
p.(None): health, with a maximum frequency of twice a week and a maximum volume of 450 ml in two months except during the
p.(None): pregnancy, moderate exercise in healthy volunteers, psychological tests to groups or individuals in whom
p.(None): will manipulate the subject's behavior, research with commonly used medications, wide therapeutic range and
p.(None): Registered in this Ministry or its delegated authority, using the indications, dosage and routes of administration
p.(None): established and other than the medications defined in article 55 of this resolution.
p.(None): c. Investigations with risk greater than the minimum: Are those in which the probabilities of
p.(None): affect the subject are significant, among which are considered: radiological and microwave studies,
p.(None): studies with medications and modalities defined in titles III and IV of this resolution, trials with
p.(None): new devices, studies that include surgical procedures, blood collection greater than 2% of the volume
p.(None): circulating in neonates, amniocentesis and other invasive techniques or major procedures, which
p.(None): use random methods of allocation to therapeutic schemes and those that have control with placebos, among others.
p.(None): ARTICLE 12. The principal investigator shall suspend the investigation immediately, upon warning of any risk or
p.(None): damage to the health of the subject in whom the investigation is conducted. Likewise, it will be immediately suspended for
p.(None): those research subjects that manifest it.
p.(None): ARTICLE 13. It is the responsibility of the research or sponsoring institution to provide care.
p.(None): medical to the subject that suffers any damage, if directly related to the investigation, without
p.(None): damage of the compensation that legally corresponds to him.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): rigorously characterized and demonstrated the absence of dangerous genes in them. Those are excluded
p.(None): industrial and agricultural processes not directly and specifically related to activities
p.(None): established in article 1 of this resolution.
p.(None): Sheet 16 of 16
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): CHAPTER III
p.(None): OF THE RESEARCH WITH RADIOACTIVE ISOTOPES AND DEVICES AND GENERATORS OF IONIZING AND ELECTROMAGNETIC RADIATIONS.
p.(None): ARTICLE 77. Medical research that involves the use in humans of radioactive isotopes and
p.(None): Ionizing and electromagnetic radiation generating devices must be carried out in accordance
p.(None): with the laws, regulations and norms on radiological safety, that govern in the national territory.
p.(None): ARTICLE 78. In the institutions where these investigations are carried out, the Biosafety Commission shall ensure that
p.(None): for each study, the person responsible for the
p.(None): radiological and physical safety of these institutions, for the fulfillment of the requirements and
p.(None): obligations, as responsible for radiological safety.
p.(None): ARTICLE 79. The responsible person referred to in the previous article shall:
p.(None): a) Have the training, qualification and certification legally required for said function.
p.(None): b) Prepare a manual of procedures in accordance with the laws, regulations and regulations in force and with the
p.(None): characteristics of the installation or equipment, which must be available to all personnel, in which
p.(None): Describe: the identification and control of radiation sources, controlled and monitored areas, monitoring
p.(None): Dosimetric staff, emergency plan, waste management plan and training
p.(None): personnel involved in procedures and radiological safety.
p.(None): c) Define, implement and monitor compliance with radiological and physical safety measures.
p.(None): d) Inform the personnel involved in the investigation about these standards and train them on
p.(None): Work procedures and the characteristics of the laboratory and equipment.
p.(None): ARTICLE 80. Given that each exposure involves a risk, it is strictly prohibited.
p.(None): unduly exposed to ionizing radiation. Legally established Equivalent Dose limits
p.(None): they should be considered as upper limits and not design or control. Protection measures against
p.(None): ionizing radiation should be optimized, so that the number of people exposed and the Equivalent Dose received
p.(None): by the investigator or the patient undergoing the investigation, be as low as reasonably possible,
p.(None): taking into account the socio-economic factors of the environment in which it works.
p.(None): ARTICLE 81. In the examination or treatment that is part of a medical research program and that
p.(None): entails a net benefit for the patient, the justification of the procedure will be done with them
p.(None): Justification criteria for a routine medical exposure. However, given the character
p.(None): experimental, said justification will be subject to a thorough scrutiny individually, discarding
p.(None): other diagnostic or therapeutic methods that can be evaluated comparatively.
p.(None): ARTICLE 82. The deliberate irradiation of personnel during procedures for research purposes
p.(None): that does not pursue a direct benefit to irradiated persons, will be carried out only by persons adequately
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): intentional of the biological, physiological, psychological or social variables of the individuals that
p.(None): participate in the study, among which are considered: review of medical records, interviews, questionnaires and
p.(None): others in which he is not identified or sensitive aspects of his behavior are treated
p.(None): b. Research with minimal risk: These are prospective studies that use data recording through
p.(None): Common procedures consisting of: physical or psychological diagnostic tests or treatments
p.(None): routine, among which are considered: weighing the subject, electrocardiograms, hearing acuity tests,
p.(None): thermographies, collection of excreta and external secretions, obtaining placenta during childbirth, collection of
p.(None): amniotic fluid when the membranes rupture, obtaining saliva, deciduous teeth and permanent teeth extracted
p.(None): by therapeutic indication, dental plaque and stones removed by non-invasive prophylactic procedures,
p.(None): hair and nail cutting without causing disfigurement, blood collection by venous puncture in adults in good condition
p.(None): health, with a maximum frequency of twice a week and a maximum volume of 450 ml in two months except during the
p.(None): pregnancy, moderate exercise in healthy volunteers, psychological tests to groups or individuals in whom
p.(None): will manipulate the subject's behavior, research with commonly used medications, wide therapeutic range and
p.(None): Registered in this Ministry or its delegated authority, using the indications, dosage and routes of administration
p.(None): established and other than the medications defined in article 55 of this resolution.
p.(None): c. Investigations with risk greater than the minimum: Are those in which the probabilities of
p.(None): affect the subject are significant, among which are considered: radiological and microwave studies,
p.(None): studies with medications and modalities defined in titles III and IV of this resolution, trials with
p.(None): new devices, studies that include surgical procedures, blood collection greater than 2% of the volume
p.(None): circulating in neonates, amniocentesis and other invasive techniques or major procedures, which
p.(None): use random methods of allocation to therapeutic schemes and those that have control with placebos, among others.
p.(None): ARTICLE 12. The principal investigator shall suspend the investigation immediately, upon warning of any risk or
p.(None): damage to the health of the subject in whom the investigation is conducted. Likewise, it will be immediately suspended for
p.(None): those research subjects that manifest it.
p.(None): ARTICLE 13. It is the responsibility of the research or sponsoring institution to provide care.
p.(None): medical to the subject that suffers any damage, if directly related to the investigation, without
p.(None): damage of the compensation that legally corresponds to him.
p.(None): ARTICLE 14. Informed Consent means the agreement in writing, whereby the subject of
p.(None): investigation or, where appropriate, your legal representative, authorizes your participation in the investigation, with full
...
p.(None): by another member of the research team, or of the institution where the investigation will be conducted,
p.(None): completely independent of the researcher-subject relationship.
p.(None): THIRD PARAGRAPH. When it is necessary to determine the mental capacity of an individual to grant his
p.(None): consent, the principal investigator must go to a neurologist, psychiatrist or psychologist so that
p.(None): evaluate the capacity of understanding, reasoning and logic of the subject, according to the parameters
p.(None): approved by the Research Ethics Committee of the research institution.
p.(None): FOURTH PARAGRAPH. When it is presumed that the mental capacity of a subject has varied over time, the
p.(None): Informed Consent of this or, failing that, of your legal representative, must be endorsed by a professional
p.(None): (neurologist, psychiatrist, psychologist) of recognized scientific and moral capacity in the specific field, as well as
p.(None): of an observer who has no relation to the investigation, to ensure the suitability of the mechanism of
p.(None): obtaining consent, as well as its validity during the course of the investigation.
p.(None): FIFTH PARAGRAPH. When the research subject is a psychiatric patient admitted to a hospital
p.(None): In addition to complying with the provisions of the preceding articles, it will be necessary to obtain the
p.(None): prior approval of the authority that knows about the case.
p.(None): CHAPTER II.
p.(None): OF RESEARCH IN COMMUNITIES.
p.(None): ARTICLE 17. Investigations, referring to human health, in communities, shall be admissible when the benefit
p.(None): expected for these to be reasonably insured and when previous studies conducted on a small scale
p.(None): Determine the absence of risks.
p.(None): ARTICLE 18. In investigations in communities, the principal investigator must obtain the approval of the
p.(None): health authorities and other civil authorities of the community to study, in addition to obtaining the letter of
p.(None): Informed Consent of the individuals included in the study, informing them of the information to
p.(None): referred to in articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 19. When the individuals that make up the community do not have the capacity to understand the
p.(None): implications of participating in an investigation, the Research Ethics Committee of the entity to the
p.(None): that the principal investigator belongs, or of the Entity where the investigation will be carried out, may authorize or
p.(None): not that the Informed Consent of the subjects is obtained through a reliable person with
p.(None): moral authority over the community.
p.(None): In case of not obtaining authorization from the Research Ethics Committee, the Research is not
p.(None): will perform.
p.(None): On the other hand, the participation of individuals will be entirely voluntary.
p.(None): ARTICLE 20. Experimental research in communities may only be carried out by establishments.
p.(None): that have Research Ethics Committees and the prior authorization of this Ministry to take it
p.(None): out, notwithstanding the
p.(None): Sheet 6 of 6
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): attributions that correspond to other dependencies of the State, and would have complied in any case with the studies
p.(None): prior toxicity and other tests according to the characteristics of the products and the risk involved
p.(None): For human health.
p.(None): ARTICLE 21. In all community research, research designs must offer the measures
p.(None): protection practices of individuals and ensure the obtaining of valid results in accordance with the
p.(None): established guidelines for the development of these models.
p.(None): ARTICLE 22. In any community investigation, the ethical considerations applicable to research
p.(None): in humans, they must be extrapolated to the communal context in the pertinent aspects.
p.(None): CHAPTER III
p.(None): OF INVESTIGATIONS IN MINORS OR DISABLED.
p.(None): ARTICLE 23. In addition to the general provisions of ethics that must be complied with in all research in human beings,
p.(None): that which is carried out in minors or physically and mentally disabled, must fully satisfy all
p.(None): the requirements set out in this chapter.
p.(None): ARTICLE 24. When it is intended to conduct investigations in minors, it must be ensured that
p.(None): similar studies have previously been done in adults and immature animals;
p.(None): except in the case of studies of conditions that are characteristic of the neonatal stage or conditions
p.(None): specific of certain ages.
p.(None): ARTICLE 25. To carry out investigations in minors or in physically and mentally disabled persons, in
p.(None): In any case, obtain, in addition to the Informed Consent of those exercising parental authority or
p.(None): legal representation of the minor or the person concerned, certification of a neurologist, psychiatrist or
p.(None): psychologist, about the capacity of understanding, reasoning and logic of the subject.
p.(None): ARTICLE 26. When the mental capacity and the psychological state of the minor or disabled person allow it,
p.(None): you must also obtain your acceptance to be the subject of investigation after explaining what
p.(None): pretend to do The Research Ethics Committee of the respective health entity must ensure the
p.(None): Compliance with these requirements.
p.(None): ARTICLE 27. Investigations classified with risk and with probabilities of direct benefit for the
p.(None): minor or disabled, will be admissible when:
p.(None): a) The risk is justified by the importance of the benefit that the minor or the disabled will receive.
p.(None): b) The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None): ARTICLE 28. Investigations classified as risk and without direct benefit to the minor or the
...
p.(None): it would be in cases of toxemia gravidarum, diabetes, hypertension and neoplasms, among others, should not expose to
p.(None): embryo or fetus at a greater than minimum risk, except when the use of the intervention or procedure is
p.(None): Sheet 8 of 8
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): justify to save the woman's life.
p.(None): ARTICLE 34. Research in pregnant women, with therapeutic benefit related to pregnancy, is
p.(None): will allow when:
p.(None): a) Aim to improve the health of the pregnant woman with a minimal risk to the embryo or the fetus.
p.(None): b) Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None): ARTICLE 35. During the execution of investigations in pregnant women:
p.(None): a) Investigators will not have the authority to decide on the time, method or procedure used
p.(None): to terminate the pregnancy, nor participation in decisions about the viability of the fetus.
p.(None): b) It is strictly forbidden to grant stimuli, monetary or otherwise, to terminate the pregnancy,
p.(None): for the interest of the investigation or for other reasons.
p.(None): ARTICLE 36. Informed Consent for investigations during labor shall be obtained in agreement.
p.(None): with what is stipulated in articles 14, 15 and 16 of this regulation, before it is initiated and indicating
p.(None): expressly that it can be withdrawn at any time during labor.
p.(None): ARTICLE 37. Research on women during the puerperium will be allowed when they do not interfere with the health of the
p.(None): mother or with the newborn.
p.(None): ARTICLE 38. Research on women during breastfeeding will be authorized when there is no risk to
p.(None): the infant or when the mother decides not to breastfeed; your food is secured by another method and you get the
p.(None): Informed Consent in accordance with the provisions of articles 14, 15 and 16 of this resolution.
p.(None): ARTICLE 39. Fetuses will be subject to investigation only if the techniques and means used
p.(None): They provide maximum security for them and the pregnant woman.
...
p.(None): cessation of vital functions, or when, without adding any risk, generalized knowledge is sought
p.(None): important that cannot be obtained otherwise.
p.(None): ARTICLE 42. Live births may be subject to investigation if the provisions on
p.(None): investigation in minors, indicated in this resolution.
p.(None): ARTICLE 43. Investigations with embryos, deaths, fetuses, dead births, macerated fecal matter, cells,
p.(None): tissues and organs extracted from them, will be made in accordance with the provisions of this regulation.
p.(None): ARTICLE 44. Research on artificial fertilization shall only be admissible when applied to the solution of
p.(None): sterility problems that cannot be solved in any other way, respecting the moral point of view,
p.(None): cultural and social of the couple.
p.(None): CHAPTER V.
p.(None): Sheet 9 of 9
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): OF THE INVESTIGATIONS IN SUBORDINATED GROUPS.
p.(None): ARTICLE 45. Subordinated groups are understood as the following: students, workers of the
p.(None): laboratories and hospitals, employees and members of the armed forces, interns in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which the Consent
p.(None): Informed may be influenced by some authority.
p.(None): ARTICLE 46. When investigations are conducted in subordinate groups, in the Ethics Committee in
p.(None): Research, one or more members of the study population, capable of representing the values must participate
p.(None): moral, cultural and social group in question and monitor:
p.(None): a) That the participation, the rejection of the subjects to intervene or withdrawal of their consent during the study, does not
p.(None): affect their school, employment, military situation or related to the judicial process to which they were subject and the
p.(None): conditions of compliance with the judgment of the case.
p.(None): b) That the results of the investigation are not used to the detriment of the participating individuals.
p.(None): c) That the research institution and the sponsors are responsible for the medical treatment of the damages
p.(None): caused and, where appropriate, the compensation that legally corresponds for the harmful consequences of
p.(None): the investigation.
p.(None): CHAPTER VI
p.(None): OF THE RESEARCH IN ORGANS, FABRICS AND THEIR DERIVATIVES, PRODUCTS AND CADAVERES OF HUMAN BEINGS.
p.(None): ARTICLE 47. The investigation referred to in this chapter includes that which includes the use of organs,
p.(None): tissues and their derivatives, products and corpses of human beings, as well as the set of activities
p.(None): relative to its obtaining, conservation, use, preparation and final destination.
p.(None): ARTICLE 48. This investigation must observe in addition to due respect to the human corpse, the
...
p.(None): current surveillance and radiological control.
p.(None): Sheet 17 of 17
p.(None): RESOLUTION NUMBER 8430 OF 1993
p.(None): By which the scientific, technical and administrative standards for health research are established.
p.(None): ARTICLE 83. Occupationally exposed personnel must be over 18 years of age, and limits will be taken into account
p.(None): of occupational exposure determined by the authorized national entity, with special consideration in the case of
p.(None): Women of childbearing age and pregnant.
p.(None): PARAGRAPH. Pregnant or breastfeeding women should not work in places of high risk of
p.(None): incorporation of radioactive materials.
p.(None): ARTICLE 84. The persons, included in the procedure, must be informed about the risk of irradiation to which
p.(None): submit, so that their participation is under their free will and with knowledge of cause. It is necessary the
p.(None): Informed Consent of family members or legal guardian when the subject of the investigation does not
p.(None): Be in a position to decide on your acceptance.
p.(None): ARTICLE 85. These investigations must be subject to individual evaluation, followed by a plan of procedures and a
p.(None): final protocol approved by the competent authority in the field, to analyze them thoroughly from
p.(None): the point of view of radiation protection and the condition of true volunteers of people who do not
p.(None): they will receive a net benefit from the procedure, since no special dose limits can be set in these
p.(None): cases.
p.(None): ARTICLE 86. The use of ionizing radiation for research in pregnant women and forbidden is prohibited.
p.(None): minors, and is restricted to specific studies prior to research in women of age
p.(None): reproductive
p.(None): PARAGRAPH. In the previous cases, reconsideration may be made in the case of procedures
p.(None): Therapeutics in pathological processes considered special by their prognosis or by their characteristics,
p.(None): with the prior written authorization of the person involved, or the relative, or legally responsible person.
p.(None): TITLE V.
p.(None): BIOMEDICAL RESEARCH WITH ANIMALS.
p.(None): ARTICLE 87. In any investigation in which the animals are subject to study, they must be kept in
p.(None): Account, in addition to the provisions determined in Law 84 of 1989, the following:
p.(None): a) Whenever appropriate, methods such as mathematical models, simulation in
p.(None): In vitro computer and biological systems.
p.(None): b) Animal testing should only be done after studying its importance to human health or
p.(None): animal and for the advancement of biological knowledge.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| armed forces | Soldier |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| dependency | Drug Dependence |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| economic | Economic/Poverty |
| educational | Educational |
| embryo | embryo |
| emergency | Public Emergency |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| health | Health |
| healthy volunteers | healthy volunteers |
| hospitalized | hospitalized patients |
| illness | Physically Disabled |
| infant | Infant |
| manipulate | Manipulable |
| mentally | Mentally Disabled |
| military | Soldier |
| minor | Youth/Minors |
| neonates | Fetus/Neonate |
| opinion | philosophical differences/differences of opinion |
| physically | Physically Disabled |
| pregnant | Pregnant |
| property | property |
| restricted | Incarcerated |
| sick | Physically Ill |
| single | Marital Status |
| social | Social |
| volunteers | volunteers |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| armed forces | ['military'] |
| child | ['children'] |
| children | ['child'] |
| disability | ['mentally', 'disabled'] |
| disabled | ['mentally', 'disability'] |
| fetus | ['fetuses', 'neonates'] |
| fetuses | ['fetus', 'neonates'] |
| illness | ['physically'] |
| mentally | ['disabled', 'disability'] |
| military | ['armedXforces'] |
| neonates | ['fetus', 'fetuses'] |
| physically | ['illness'] |
Trigger Words
capacity
coercion
consent
cultural
ethics
harm
protection
risk
sensitive
Applicable Type / Vulnerability / Indicator Overlay for this Input