0A4F4F9BD490A749D5437F821CF06DF1
Regulatory Law of Biomedical Research No. 9234 (2014)
http://www.pgrweb.go.cr/scij/Busqueda/Normativa/Normas/nrm_texto_completo.aspx?param1=NRTC&nValor1=1&nValor2=77070&nValor3=96424&strTipM=TC
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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
Political / Illegal Activity
Searching for indicator unlawful:
(return to top)
p.001994: Correspond, communicate what is conducive to the Public Prosecutor to promote and exercise the
p.001994: relevant criminal actions.
p.001994: Article sheet
p.001994: ARTICLE 78.- Improper experimentation
p.001994: Who submits a person to research for the application of medicines, drugs,
p.001994: substances, treatments, techniques, devices or procedures, without duly informing you of the
p.001994: experimental condition of these and the risks it runs, and without express consent,
p.001994: written and documented of the victim or his legal representative and authorization of the procedure by
p.001994: part of a CEC; or who has used the victim's inability to issue a
p.001994: consent, duress, threat, deception, misinformation, manipulation or any other
p.001994: illicit means to obtain such consent, will be punished with imprisonment from three to eight
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
p.001994: Opposition to the practice of research.
p.001994: Article sheet
p.001994: ARTICLE 80.- Disability
p.001994: In addition to the corresponding prison sentence, the judicial authority must establish the
p.001994: penalty of disqualification for a period of five to ten years for investigation processes
p.001994: biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person
p.001994: that has committed the acts typified in the previous articles.
p.001994: Article sheet
p.001994: ARTICLE 81.- Influence trafficking with biomedical research
p.001994: Members of ethical committees will be sentenced to one to three years
p.001994: scientists (CEC) and officials of public or private institutions that authorize, facilitate or
...
Political / Indigenous
Searching for indicator native:
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p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
p.001994: own and characteristic disease of this or another of high prevalence.
p.001994: b) That the researcher and the sponsor commit, reliably, to respect the
p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.001994: bene fi t of other women or the product of conception at any stage of the
p.001994: Pregnancy or infant.
p.001994: Article sheet
p.001994: ARTICLE 69.- Clinical investigations with persons deprived of liberty
p.001994: Persons deprived of liberty should not be unreasonably denied the possibility of
p.001994: participate in clinical research or have access to medications, vaccines and other elements of
p.001994: research that may represent therapeutic or preventive benefit for them.
p.001994: Special attention should be given to guarantee the willingness of consent in this
p.001994: population, applying a suitably proven scientific methodology that guarantees
p.001994: reasonably that the consent of the private or the deprived of liberty is unquestionably
p.001994: voluntary.
p.001994: Article sheet
p.001994: CHAPTER X
p.001994: SANCTIONS
p.001994: ARTICLE 70.- Sanitary and administrative measures
p.001994: The Ministry of Health, the Conis or the CEC, as appropriate, should know and dictate the
p.001994: corresponding sanitary and administrative measures to avoid or amend those actions
p.001994: contrary to this law incurred by researchers, sponsors and any other interested party
p.001994: to intervene in a research project; all of the above without prejudice to civil liability,
p.001994: criminal or disciplinary that may correspond to the offender.
p.001994: Article sheet
p.001994: ARTICLE 71.- Precautionary measures
p.001994: During the processing of administrative procedures or investigations in judicial headquarters that
p.001994: question the legality of the activity of the researcher, the sponsor or the CEC, the ICO or the
p.001994: OAC and for the purpose of protecting the health and safety of the participants in an investigation, the
p.001994: competent body may impose the necessary precautionary measures.
p.001994: Investigations may be suspended temporarily or definitively, partially or totally,
p.001994: investigator or the approval of research projects in case the administrative authority or
p.001994: in judicial headquarters it is considered necessary.
p.001994: The competent body, through a well-founded resolution and prior hearing of the interested parties, must
p.001994: resolve whether it confirms, modifies or revokes the action taken. To do this, you must apply the procedure
p.001994: which establishes the Contentious-Administrative Procedural Code.
p.001994: Article sheet
p.001994: ARTICLE 72.- Infringements of the researcher or the sponsor, the ICO or the OAC
p.001994: The Conis, prior due process, may impose a fine of up to thirty percent (30%) of the
p.001994: total value of the investigation, in case the researcher or the sponsor, the ICO or the OAC incur
p.001994: in any of the following infractions:
p.001994: a) You have provided false information or omitted relevant information during the process of
p.001994: approval or execution of a research project.
p.001994: b) Start a research project without the proper approval of the CEC.
p.001994: c) Breaches or unreasonably delays compliance with the obligations set forth in this
p.001994: law.
p.001994: d) Any other breach of their obligations under the law.
p.001994: To determine the applicable sanction, the seriousness of the offense by the
p.001994: researcher, the sponsor, the ICO or the OAC or the employees, representatives or representatives of the
p.001994: company, and recidivism of the offenses against this law. The Conis will publish the list of researchers,
p.001994: the sponsors, the ICOs or the CAOs sanctioned, on the website of the Ministry of Health.
p.001994: Article sheet
p.001994: ARTICLE 73.- Infringements of the CEC
p.001994: The Conis may impose a fine on employees, representatives or representatives of a CEC
p.001994: up to three hundred times the base salary, in accordance with Law No. 7337, of May 5, 1993, and
p.001994: its reforms, a law that creates the concept of base salary for special crimes of the Criminal Code, in
p.001994: If any of them incur any of the following infractions:
p.001994: a) Breaches or unreasonably delays compliance with the obligations that this law
p.001994: grants, as well as any other obligation provided for in this law, in Law No. 5395, Law
p.001994: General de Salud, of October 30, 1973, in the code of morals or ethics of schools
p.001994: professionals to whom the researchers belong, or in the regulatory provisions of
p.001994: the aforementioned legal bodies, or any other applicable legal norm.
p.001994: b) Do not resolve or channel, in a timely manner, the complaints filed by the persons who
p.001994: They participate in the investigations, for damages suffered.
p.001994: c) Any other breach of their obligations under the law.
p.001994: To determine the applicable penalty, the seriousness of the offense, the degree of
p.001994: fault or the existence of fraud by employees, representatives or representatives of the CEC and its
p.001994: recidivism.
p.001994: Article sheet
p.001994: ARTICLE 74.- Coordination
p.001994: The Ministry of Health and Conis will determine the coordination mechanisms necessary for
p.001994: the most correct and efficient application of controls, special sanitary measures and
p.001994: sanctions provided for in this law. The proceeds of the fines set forth in this article will be distributed from the
p.001994: as follows: fifty percent (50%) to Conis and fifty percent (50%) to CEC, in
p.001994: if the breach sanctioned was from a sponsor or an investigator. In the case of
p.001994: the imposition of fines to the CEC, the product of these will correspond to the Conis.
p.001994: Article sheet
p.001994: ARTICLE 75.- Challenges
p.001994: Against the resolutions issued by the CEC, in the exercise of their powers, there will be recourse
p.001994: of appeal before the Conis. The appeal must be filed within five business days of
p.001994: the notification of the corresponding resolution.
p.001994: The resolution imposing a fine shall constitute an executive title against the offender. The Conis or the
p.001994: CEC, as appropriate, will be entitled to collect it.
p.001994: Article sheet
p.001994: ARTICLE 76.-Penalty procedure
p.001994: The sanctioning process will apply the procedure established in Law No. 6227, General Law
p.001994: of the Public Administration, of May 2, 1978.
p.001994: Article sheet
p.001994: ARTICLE 77.- Punishable facts
p.001994: If the breach of the obligations provided for in this law or its regulations result
p.001994: punishable, the Minister of Health, the Conis or the CEC, or who has knowledge of the punishable act, according to
p.001994: Correspond, communicate what is conducive to the Public Prosecutor to promote and exercise the
p.001994: relevant criminal actions.
p.001994: Article sheet
p.001994: ARTICLE 78.- Improper experimentation
p.001994: Who submits a person to research for the application of medicines, drugs,
p.001994: substances, treatments, techniques, devices or procedures, without duly informing you of the
p.001994: experimental condition of these and the risks it runs, and without express consent,
p.001994: written and documented of the victim or his legal representative and authorization of the procedure by
p.001994: part of a CEC; or who has used the victim's inability to issue a
p.001994: consent, duress, threat, deception, misinformation, manipulation or any other
p.001994: illicit means to obtain such consent, will be punished with imprisonment from three to eight
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
...
Political / migrant
Searching for indicator migrant:
(return to top)
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
p.001994: own and characteristic disease of this or another of high prevalence.
p.001994: b) That the researcher and the sponsor commit, reliably, to respect the
p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.001994: o) Establish a national registry of researchers.
p.001994: p) Keep a national registry of research and administration organizations by
p.001994: contract.
p.001994: q) Keep an updated record of the CECs and of the researchers, sponsors, OAC and ICO
p.001994: that have been sanctioned for breach of this law.
p.001994: r) Keep a record of publications and presentations in scientific activities of the
p.001994: Results of biomedical research approved in the country.
p.001994: s) Define, annually, the work plans and budgets necessary to exercise their
p.001994: functions.
p.001994: t) Ensure compliance with the ethical standards that guide biomedical research.
p.001994: Implement a biomedical research information system, accessible at all times,
p.001994: with updated databases on approved and rejected investigations,
p.001994: Registered researchers, CEC, OIC and OAC, information and guidance for potentials
p.001994: Research participants.
p.001994: u) Keep a national registry of the investigations that have been rejected and the reasons that
p.001994: They substantiated the decision.
p.001994: v) Keep a duly legalized record containing all your meetings and
p.001994: Conis agreements.
p.001994: w) Keep a record of the sanctioned investigators and the reasons that motivated the sanction.
p.001994: x) The others that the regulation of this law establishes.
p.001994: Article sheet
p.001994: ARTICLE 44.- Inspection
p.001994: The Conis will have inspection powers to the CEC, OAC, OIC, investigators or investigations
p.001994: Biomedical, when deemed necessary. For this purpose, the Conis will have the following
p.001994: functions:
p.001994: a) Carry out inspections in any field, with the purpose of verifying compliance with
p.001994: requirements established in this law.
p.001994: b) Advise ex officio or at the request of a party, in matters of its competence, to the CEC, OAC, ICO and
p.001994: researchers.
p.001994: c) Evacuate consultations regarding the competence of the CEC, OAC, ICO and researchers.
p.001994: d) Notify the parties involved of the findings in the inspections carried out.
p.001994: e) Initiate the corresponding administrative and judicial procedures in case of determining
p.001994: any breach of this law, within the deadlines established by regulation.
p.001994: f) The other functions assigned to it by regulation.
p.001994: The subjects referred to in this article must provide the information required by the Conis in the
p.001994: term that this determines, under penalty of incurring the sanctions established in this law.
p.001994: The Conis must hire and train the necessary personnel to fulfill the functions that
p.001994: Grant this item.
p.001994: Article sheet
p.001994: ARTICLE 45.- Budget
p.001994: The budget of the Conis will consist of the following resources:
p.001994: a) The amount of income from registration and registration of investigations.
p.001994: b) Legacies, grants and donations from public institutions or organizations and
p.001994: State contributions.
p.001994: c) The generated by its financial resources.
p.001994: d) The income received from accreditation, certi fi cations, registrations by
p.001994: educational activities and, in general, for the provision of the services it provides.
p.001994: e) The amount of fines generated by the application of this law.
p.001994: The Conis will be subject to compliance with the principles and the Responsibility Regime
p.001994: established in titles X and XI of Law No. 8131, Financial Administration of the Republic and
p.001994: Public Budgets, of September 18, 2001. In the rest, the Conis of the
p.001994: scope and application of that law. In the fiscalization, the Conis will be subject only to the
...
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
p.001994: own and characteristic disease of this or another of high prevalence.
p.001994: b) That the researcher and the sponsor commit, reliably, to respect the
p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
p.001994: Application of this law. They should be considered subordinate groups by reason of authority, between
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
p.001994: c) The investigation implies a minimum risk or burden for the people included in the study.
p.001994: Article sheet
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
...
p.001994: risk.
p.001994: c) That the objective of the investigation is to obtain new knowledge that results in
p.001994: bene fi t of other women or the product of conception at any stage of the
p.001994: Pregnancy or infant.
p.001994: Article sheet
p.001994: ARTICLE 69.- Clinical investigations with persons deprived of liberty
p.001994: Persons deprived of liberty should not be unreasonably denied the possibility of
p.001994: participate in clinical research or have access to medications, vaccines and other elements of
p.001994: research that may represent therapeutic or preventive benefit for them.
p.001994: Special attention should be given to guarantee the willingness of consent in this
p.001994: population, applying a suitably proven scientific methodology that guarantees
p.001994: reasonably that the consent of the private or the deprived of liberty is unquestionably
p.001994: voluntary.
p.001994: Article sheet
p.001994: CHAPTER X
p.001994: SANCTIONS
p.001994: ARTICLE 70.- Sanitary and administrative measures
p.001994: The Ministry of Health, the Conis or the CEC, as appropriate, should know and dictate the
p.001994: corresponding sanitary and administrative measures to avoid or amend those actions
p.001994: contrary to this law incurred by researchers, sponsors and any other interested party
p.001994: to intervene in a research project; all of the above without prejudice to civil liability,
p.001994: criminal or disciplinary that may correspond to the offender.
p.001994: Article sheet
p.001994: ARTICLE 71.- Precautionary measures
p.001994: During the processing of administrative procedures or investigations in judicial headquarters that
p.001994: question the legality of the activity of the researcher, the sponsor or the CEC, the ICO or the
p.001994: OAC and for the purpose of protecting the health and safety of the participants in an investigation, the
p.001994: competent body may impose the necessary precautionary measures.
p.001994: Investigations may be suspended temporarily or definitively, partially or totally,
p.001994: investigator or the approval of research projects in case the administrative authority or
p.001994: in judicial headquarters it is considered necessary.
p.001994: The competent body, through a well-founded resolution and prior hearing of the interested parties, must
p.001994: resolve whether it confirms, modifies or revokes the action taken. To do this, you must apply the procedure
p.001994: which establishes the Contentious-Administrative Procedural Code.
p.001994: Article sheet
p.001994: ARTICLE 72.- Infringements of the researcher or the sponsor, the ICO or the OAC
p.001994: The Conis, prior due process, may impose a fine of up to thirty percent (30%) of the
p.001994: total value of the investigation, in case the researcher or the sponsor, the ICO or the OAC incur
p.001994: in any of the following infractions:
p.001994: a) You have provided false information or omitted relevant information during the process of
p.001994: approval or execution of a research project.
p.001994: b) Start a research project without the proper approval of the CEC.
...
Searching for indicator political:
(return to top)
p.001994: Participants
p.001994: Article sheet
p.001994: ARTICLE 33.- Obligations of the persons participating in a biomedical investigation
p.001994: They will be obligations of the people participating in research in which beings participate
p.001994: human the following:
p.001994: a) Comply with the instructions and instructions provided.
p.001994: b) Timely inform the investigator about the adverse events they present.
p.001994: c) Inform the attending physician of their participation in a clinical investigation.
p.001994: d) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: CHAPTER V
p.001994: NATIONAL HEALTH RESEARCH COUNCIL
p.001994: ARTICLE 34.- National Health Research Council
p.001994: The National Health Research Council, hereinafter Conis, is created as an organ
p.001994: independent, multidisciplinary, ethical, technical and scientific, attached to the Ministry of Health
p.001994: with a degree of maximum deconcentration and with instrumental legal personality.
p.001994: The Conis will have the administrative structure defined by regulation and will have its own
p.001994: Internal audit in accordance with Law No. 8292, General Internal Control Law, of July 31,
p.001994: 2002, and Law No. 7428, Organic Law of the Comptroller General of the Republic, of September 7,
p.001994: 1994
p.001994: Article sheet
p.001994: ARTICLE 35.- Conis Purposes
p.001994: The purpose of the Conis will be to guarantee the quality of the investigations and their strict adherence to the
p.001994: human rights. Its members must act with absolute independence of opinion, avoiding
p.001994: in its decisions the influence of political and commercial interests.
p.001994: Article sheet
p.001994: ARTICLE 36.- Formation of the National Health Research Council
p.001994: The Conis will consist of seven proprietary members, each with their respective alternate,
p.001994: who must attend the sessions in the absence of the owner member.
p.001994: The Conis will be integrated by:
p.001994: a) The Minister of Health or the official in whom this delegate and his alternate, who will preside.
p.001994: b) The Minister of Science and Technology or the official in whom this delegate and his substitute. In
p.001994: in case the minister or the minister delegates his representation, both the holder and the substitute
p.001994: They must be research specialists. Otherwise, at least the substitute must be
p.001994: Specialist in this field.
p.001994: c) A human rights lawyer and his deputy, appointed by the College of
p.001994: Costa Rican lawyers.
p.001994: d) A representative of the Costa Rican Social Security Fund (CCSS), preferably from the
p.001994: Center for Strategic Development and Information on Health and Social Security of Social Security
p.001994: (Cendeisss) and his alternate. The Board of Directors may not designate any of the persons who
p.001994: at that time be part of its members.
p.001994: e) A representative of the National Council of Rectors (Conare) and a substitute, who must be
p.001994: bioethics specialist.
p.001994: f) A representative in property and a substitute, member of the Professional Associations of
p.001994: Physicians and surgeons; Pharmacists; Dental and Microbiologist Surgeons, appointed by the
p.001994: boards of the respective professional associations. The regulation of this law will establish
p.001994: the appointment procedure and how they will alternate each year, the charges in
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.001994: d) Independent researchers without sponsorship, provided their development and results
p.001994: Lack commercial purposes.
p.001994: e) The investigations carried out by the research programs and projects of the
p.001994: State universities.
p.001994: The foregoing shall not apply, under any circumstances, to research sponsored by
p.001994: pharmaceutical transnationals or for profit organizations.
p.001994: Article sheet
p.001994: ARTICLE 62.- Protection of files
p.001994: All information concerning research carried out in human beings must
p.001994: be recorded in the patient's file and be protected for a period of thirty years, in the
p.001994: Health institution or clinic where it was performed.
p.001994: Article sheet
p.001994: ARTICLE 63.- Use of the placebo
p.001994: The possible benefits, risks, costs and effectiveness of all biomedical research should be
p.001994: evaluated by comparison with the best existing proven intervention, except in the
p.001994: following circumstances:
p.001994: a) The use of a placebo is acceptable in studies for which there is no proven intervention or
p.001994: Existing treatment
p.001994: b) When for methodological, scientific and compelling reasons, the use of a placebo is
p.001994: necessary to determine the effectiveness and safety of an intervention that does not imply
p.001994: risk, serious adverse effects or irreversible damage for patients receiving the placebo.
p.001994: Article sheet
p.001994: CHAPTER IX
p.001994: RESEARCH WITH VULNERABLE GROUPS
p.001994: ARTICLE 64.- Minors and persons without volitional and cognitive capacity
p.001994: The clinical investigation in which a person with legal disability participates, is a person
p.001994: less or without volitional and cognitive capacity, declared judicially, can only be carried out
p.001994: when the results are expected to produce real or direct benefits to your health, or
p.001994: when comparable results cannot be obtained in older individuals or capable of granting their
p.001994: consent.
p.001994: When it is foreseeable that clinical research will not produce results in direct benefit
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
p.001994: own and characteristic disease of this or another of high prevalence.
p.001994: b) That the researcher and the sponsor commit, reliably, to respect the
p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
...
Health / Cognitive Impairment
Searching for indicator cognitive:
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p.001994: e) The investigations carried out by the research programs and projects of the
p.001994: State universities.
p.001994: The foregoing shall not apply, under any circumstances, to research sponsored by
p.001994: pharmaceutical transnationals or for profit organizations.
p.001994: Article sheet
p.001994: ARTICLE 62.- Protection of files
p.001994: All information concerning research carried out in human beings must
p.001994: be recorded in the patient's file and be protected for a period of thirty years, in the
p.001994: Health institution or clinic where it was performed.
p.001994: Article sheet
p.001994: ARTICLE 63.- Use of the placebo
p.001994: The possible benefits, risks, costs and effectiveness of all biomedical research should be
p.001994: evaluated by comparison with the best existing proven intervention, except in the
p.001994: following circumstances:
p.001994: a) The use of a placebo is acceptable in studies for which there is no proven intervention or
p.001994: Existing treatment
p.001994: b) When for methodological, scientific and compelling reasons, the use of a placebo is
p.001994: necessary to determine the effectiveness and safety of an intervention that does not imply
p.001994: risk, serious adverse effects or irreversible damage for patients receiving the placebo.
p.001994: Article sheet
p.001994: CHAPTER IX
p.001994: RESEARCH WITH VULNERABLE GROUPS
p.001994: ARTICLE 64.- Minors and persons without volitional and cognitive capacity
p.001994: The clinical investigation in which a person with legal disability participates, is a person
p.001994: less or without volitional and cognitive capacity, declared judicially, can only be carried out
p.001994: when the results are expected to produce real or direct benefits to your health, or
p.001994: when comparable results cannot be obtained in older individuals or capable of granting their
p.001994: consent.
p.001994: When it is foreseeable that clinical research will not produce results in direct benefit
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
...
Searching for indicator impairment:
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p.001994: consent.
p.001994: When it is foreseeable that clinical research will not produce results in direct benefit
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
...
Health / Drug Dependence
Searching for indicator dependence:
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p.001994: The clinical investigation in which a person with legal disability participates, is a person
p.001994: less or without volitional and cognitive capacity, declared judicially, can only be carried out
p.001994: when the results are expected to produce real or direct benefits to your health, or
p.001994: when comparable results cannot be obtained in older individuals or capable of granting their
p.001994: consent.
p.001994: When it is foreseeable that clinical research will not produce results in direct benefit
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.001994: or external pressures.
p.001994: Adverse event or reaction that would be attributable to experimentation: occurrence
p.001994: unfavorable that:
p.001994: a) results in death,
p.001994: b) life threatening,
p.001994: c) requires hospitalization of the participant or prolongation of the existing hospitalization,
p.001994: d) produces persistent or significant disability or disability, or produces a congenital anomaly
p.001994: or birth defect.
p.001994: Multicenter study: clinical study conducted according to a single protocol in more than
p.001994: a place and, therefore, made by more than one researcher.
p.001994: Phases of vaccine development:
p.001994: Phase I: refers to the first introduction of a vaccine under trial in a human population
p.001994: to initially determine its safety and its biological effects, including its immunogenicity. Is
p.001994: Phase may include dose studies and routes of administration.
p.001994: Phase II: refers to the initial trials to determine the effectiveness of the vaccine in a
p.001994: limited number of volunteers; This phase focuses on immunogenicity.
p.001994: Phase III: aims to more fully assess the safety and effectiveness in the
p.001994: disease prevention, involving a greater number of volunteers in a study
p.001994: generally multicentre properly controlled.
p.001994: Phases of drug development:
p.001994: Phase I: consists of the introduction of a drug in humans for the first time.
p.001994: Healthy voluntary subjects participate to assess at what levels of drug use observed
p.001994: toxicity. Dose-response studies are continued in patients to determine the
p.001994: medication safety and, in some cases, initial indications of its effectiveness.
p.001994: These studies are intended to establish a preliminary assessment of safety and profile.
p.001994: pharmacokinetic and, when possible, a pharmacodynamic profile. Except duly exceptions
p.001994: based, they are carried out in small groups of healthy volunteer individuals. To this phase
p.001994: the bioequivalence studies also belong, since these are also carried out in
p.001994: HealthyXvolunteers
p.001994: Phase II: consists of controlled clinical trials, designed to demonstrate effectiveness and
p.001994: relative security It is usually done in a limited number of patients closely
p.001994: supervised
p.001994: Phase III: it is done after establishing a reasonable probability of the effectiveness of the
p.001994: medication and aims to obtain additional information on its effectiveness for indications
p.001994: speci fi c and a more precise definition of the adverse effects associated with the medication. This phase
p.001994: It includes controlled and uncontrolled studies.
p.001994: Phase IV: trials are carried out after the national drug registration agency
p.001994: has approved a medication for distribution or marketing. These trials may include
p.001994: research aimed at exploring a specific pharmacological effect, establishing the frequency of
p.001994: adverse reactions or determine the effects of long-term administration of a medication.
p.001994: Intervention: all actions of any order, related to the investigation with beings
p.001994: humans, which may affect in whole or in part, individually or collectively, in one way or another, the
p.001994: dignity and identity, integrity and well-being of people or any of their rights
p.001994: Human and fundamental freedoms. This type of research differs from studies.
p.001994: observational in which there is no intervention.
p.001994: Biomedical research: a type of activity designed to develop or contribute to
p.001994: generalizable knowledge about health in human beings. It can be observational,
p.001994: epidemiological, or non-interventional or experimental, clinical or interventional. For the purposes of this
p.001994: law, any reference to research will be understood as biomedical research with human beings in
p.001994: health matter.
p.001994: Observational, epidemiological or non-interventional biomedical research: research
p.001994: in which no diagnostic or therapeutic intervention is performed for experimental purposes, nor
p.001994: subject the participating individuals to conditions controlled by the researcher. For the purposes of
p.001994: This law, any reference to observational research will be understood as biomedical research
p.001994: observational, epidemiological or non-interventional in humans in terms of health.
p.001994: Experimental, clinical or interventional biomedical research: any investigation
p.001994: scientist in the area of health in which a preventive, diagnostic or
...
Searching for indicator influence:
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p.001994: HOME | PGR SINALEVI | POWER | HACIENDA | IDH COURT | LEGAL DICTIONARY | HELP | SITE MAP
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p.001994: Search: Regulations >> Law 9234 >> Date 04/22/2014 >> Full text Internet
p.001994: Search Articles << Articles >> Standard Sheet
p.001994: Regulations Remember that Control F is an option that allows you to search the entire text
p.001994: Pronouncements
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p.001994: Year: 50 results
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p.001994: Search in: Document file
p.001994: Search Biomedical Research Regulatory Law
p.001994: No. 9234
p.001994: Advanced Search Menu
p.001994: THE LEGISLATIVE ASSEMBLY
p.001994: Text complete
p.001994: Standard sheet
p.001994: OF THE REPUBLIC OF COSTA RICA
p.001994: Regulations affected
p.001994: Concordances
p.001994: DECREE:
p.001994: Regulations
p.001994: Descriptors
p.001994: text-align: center '> REGULATORY LAW OF BIOMEDICAL RESEARCH
p.001994: PGR pronouncements
p.001994: Constitutional actions and resolutions
p.001994: Related case law
p.001994: CHAPTER I
p.001994: Jurisp of the Treasury
p.001994: GENERAL DISPOSITION
p.001994: Options:
p.001994: ARTICLE 1.- Object of the law
p.001994: save
p.001994: The purpose of this law is to regulate biomedical research with human beings in
p.001994: Print health matters, in the public and private sectors.
p.001994: Article sheet
p.001994: ARTICLE 2.- Definitions
p.001994: For the purposes of this law, the following definitions are established:
p.001994: Autonomy: ability of people to make decisions without the influence of other people
p.001994: or external pressures.
p.001994: Adverse event or reaction that would be attributable to experimentation: occurrence
p.001994: unfavorable that:
p.001994: a) results in death,
p.001994: b) life threatening,
p.001994: c) requires hospitalization of the participant or prolongation of the existing hospitalization,
p.001994: d) produces persistent or significant disability or disability, or produces a congenital anomaly
p.001994: or birth defect.
p.001994: Multicenter study: clinical study conducted according to a single protocol in more than
p.001994: a place and, therefore, made by more than one researcher.
p.001994: Phases of vaccine development:
p.001994: Phase I: refers to the first introduction of a vaccine under trial in a human population
p.001994: to initially determine its safety and its biological effects, including its immunogenicity. Is
p.001994: Phase may include dose studies and routes of administration.
p.001994: Phase II: refers to the initial trials to determine the effectiveness of the vaccine in a
p.001994: limited number of volunteers; This phase focuses on immunogenicity.
p.001994: Phase III: aims to more fully assess the safety and effectiveness in the
p.001994: disease prevention, involving a greater number of volunteers in a study
p.001994: generally multicentre properly controlled.
p.001994: Phases of drug development:
...
p.001994: Participants
p.001994: Article sheet
p.001994: ARTICLE 33.- Obligations of the persons participating in a biomedical investigation
p.001994: They will be obligations of the people participating in research in which beings participate
p.001994: human the following:
p.001994: a) Comply with the instructions and instructions provided.
p.001994: b) Timely inform the investigator about the adverse events they present.
p.001994: c) Inform the attending physician of their participation in a clinical investigation.
p.001994: d) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: CHAPTER V
p.001994: NATIONAL HEALTH RESEARCH COUNCIL
p.001994: ARTICLE 34.- National Health Research Council
p.001994: The National Health Research Council, hereinafter Conis, is created as an organ
p.001994: independent, multidisciplinary, ethical, technical and scientific, attached to the Ministry of Health
p.001994: with a degree of maximum deconcentration and with instrumental legal personality.
p.001994: The Conis will have the administrative structure defined by regulation and will have its own
p.001994: Internal audit in accordance with Law No. 8292, General Internal Control Law, of July 31,
p.001994: 2002, and Law No. 7428, Organic Law of the Comptroller General of the Republic, of September 7,
p.001994: 1994
p.001994: Article sheet
p.001994: ARTICLE 35.- Conis Purposes
p.001994: The purpose of the Conis will be to guarantee the quality of the investigations and their strict adherence to the
p.001994: human rights. Its members must act with absolute independence of opinion, avoiding
p.001994: in its decisions the influence of political and commercial interests.
p.001994: Article sheet
p.001994: ARTICLE 36.- Formation of the National Health Research Council
p.001994: The Conis will consist of seven proprietary members, each with their respective alternate,
p.001994: who must attend the sessions in the absence of the owner member.
p.001994: The Conis will be integrated by:
p.001994: a) The Minister of Health or the official in whom this delegate and his alternate, who will preside.
p.001994: b) The Minister of Science and Technology or the official in whom this delegate and his substitute. In
p.001994: in case the minister or the minister delegates his representation, both the holder and the substitute
p.001994: They must be research specialists. Otherwise, at least the substitute must be
p.001994: Specialist in this field.
p.001994: c) A human rights lawyer and his deputy, appointed by the College of
p.001994: Costa Rican lawyers.
p.001994: d) A representative of the Costa Rican Social Security Fund (CCSS), preferably from the
p.001994: Center for Strategic Development and Information on Health and Social Security of Social Security
p.001994: (Cendeisss) and his alternate. The Board of Directors may not designate any of the persons who
p.001994: at that time be part of its members.
p.001994: e) A representative of the National Council of Rectors (Conare) and a substitute, who must be
p.001994: bioethics specialist.
p.001994: f) A representative in property and a substitute, member of the Professional Associations of
p.001994: Physicians and surgeons; Pharmacists; Dental and Microbiologist Surgeons, appointed by the
p.001994: boards of the respective professional associations. The regulation of this law will establish
p.001994: the appointment procedure and how they will alternate each year, the charges in
...
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
p.001994: Opposition to the practice of research.
p.001994: Article sheet
p.001994: ARTICLE 80.- Disability
p.001994: In addition to the corresponding prison sentence, the judicial authority must establish the
p.001994: penalty of disqualification for a period of five to ten years for investigation processes
p.001994: biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person
p.001994: that has committed the acts typified in the previous articles.
p.001994: Article sheet
p.001994: ARTICLE 81.- Influence trafficking with biomedical research
p.001994: Members of ethical committees will be sentenced to one to three years
p.001994: scientists (CEC) and officials of public or private institutions that authorize, facilitate or
p.001994: hire biomedical research in which they participate or have interests
p.001994: economic companies in which they, their spouses or partners, or their relatives by
p.001994: consanguinity or affinity until the third grade inclusive, be part of their boards of directors,
p.001994: Participate directly or by interposite natural or legal person in your share capital, or work
p.001994: as researchers
p.001994: Article sheet
p.001994: ARTICLE 82.- Gifts and coercion
p.001994: A prison sentence of three to five years will be imposed on the member of a scientific ethics committee
p.001994: that accepts any kind of gifts from people or companies that carry out research
p.001994: biomedical, without prejudice to other sanctions and responsibilities that proceed in accordance with the
p.001994: legal system.
p.001994: Article sheet
p.001994: ARTICLE 83.- Offering of gifts and coercion
p.001994: A person who offers gifts or exercises will be imposed three to five years in prison
p.001994: coercion to the members of a CEC to obtain favorable results in the authorization or any
p.001994: stage of the investigation, without prejudice to other sanctions and responsibilities arising from
p.001994: compliance with the legal system.
p.001994: Article sheet
p.001994: ARTICLE 84.- Improper use of privileged information
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Searching for indicator substance:
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p.001994: accredited by the Conis to carry out biomedical research, given its scientific training. The
p.001994: Researcher is responsible for conducting the investigation. If it is a team that performs the
p.001994: study in a center, the investigator responsible for the team will be called principal investigator.
p.001994: Contract management organization: person or organization that signs a
p.001994: private contract with the sponsor, the contract research organization (ICO) and / or the
p.001994: researcher, to perform one or more of the tasks and functions of the researcher in the execution of the
p.001994: study. Must be accredited by Conis.
p.001994: Contract research organization: person or organization that signs a contract
p.001994: private with the sponsor, to perform one or more of the work and functions of the sponsor
p.001994: related to the study. Must be accredited by Conis.
p.001994: Participant: individual who participates in a biomedical research project, either as
p.001994: direct receiver of an intervention, as a control, or as an element of observation. The individual
p.001994: it can be a healthy person who voluntarily participates in the investigation, or a person with a
p.001994: condition unrelated to the ongoing research that participates voluntarily, or a
p.001994: person, usually a patient, whose condition is relevant to the use of the product studied or
p.001994: to answer the questions that are being investigated.
p.001994: Sponsor: individual, company, entity or public or private organization, national or
p.001994: foreigner, who takes responsibility for startup, administration, financing and publication
p.001994: of the results of an investigation, and which also assumes the coverage of costs and compensation.
p.001994: Placebo: substance that itself lacks therapeutic action.
p.001994: Impartial witness: a person independent of biomedical research that cannot be
p.001994: in fl uenced by personnel involved in biomedical research (understood as such the sponsor,
p.001994: the contract management organization, the contract research organization, the
p.001994: investigator or officials, employees or representatives of both), or a family member of the
p.001994: participant, who is present in the process of signing the informed consent.
p.001994: Protocol: document that describes the hypothesis, the objective or the objectives, the design, the
p.001994: methodology, statistical considerations and organization of a study. Also, provides
p.001994: the background, the basics and the justification of the study.
p.001994: Article sheet
p.001994: ARTICLE 3.- Protection of the human being
p.001994: The life, health, interest, well-being and dignity of the participants in an investigation in
p.001994: health, in which human beings participate, will prevail over the interest of science, of interests
p.001994: Economic or commercial.
p.001994: All health research involving human beings must respond to an approach of
p.001994: human rights.
p.001994: Article sheet
p.001994: ARTICLE 4.- Principles of biomedical research
p.001994: All health research involving human beings must be governed by the
p.001994: principles of respect for people's dignity, bene fi ciency, non-maleficence, autonomy and justice
p.001994: Distributive
...
Health / Healthy People
Searching for indicator volunteers:
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p.001994: Jurisp of the Treasury
p.001994: GENERAL DISPOSITION
p.001994: Options:
p.001994: ARTICLE 1.- Object of the law
p.001994: save
p.001994: The purpose of this law is to regulate biomedical research with human beings in
p.001994: Print health matters, in the public and private sectors.
p.001994: Article sheet
p.001994: ARTICLE 2.- Definitions
p.001994: For the purposes of this law, the following definitions are established:
p.001994: Autonomy: ability of people to make decisions without the influence of other people
p.001994: or external pressures.
p.001994: Adverse event or reaction that would be attributable to experimentation: occurrence
p.001994: unfavorable that:
p.001994: a) results in death,
p.001994: b) life threatening,
p.001994: c) requires hospitalization of the participant or prolongation of the existing hospitalization,
p.001994: d) produces persistent or significant disability or disability, or produces a congenital anomaly
p.001994: or birth defect.
p.001994: Multicenter study: clinical study conducted according to a single protocol in more than
p.001994: a place and, therefore, made by more than one researcher.
p.001994: Phases of vaccine development:
p.001994: Phase I: refers to the first introduction of a vaccine under trial in a human population
p.001994: to initially determine its safety and its biological effects, including its immunogenicity. Is
p.001994: Phase may include dose studies and routes of administration.
p.001994: Phase II: refers to the initial trials to determine the effectiveness of the vaccine in a
p.001994: limited number of volunteers; This phase focuses on immunogenicity.
p.001994: Phase III: aims to more fully assess the safety and effectiveness in the
p.001994: disease prevention, involving a greater number of volunteers in a study
p.001994: generally multicentre properly controlled.
p.001994: Phases of drug development:
p.001994: Phase I: consists of the introduction of a drug in humans for the first time.
p.001994: Healthy voluntary subjects participate to assess at what levels of drug use observed
p.001994: toxicity. Dose-response studies are continued in patients to determine the
p.001994: medication safety and, in some cases, initial indications of its effectiveness.
p.001994: These studies are intended to establish a preliminary assessment of safety and profile.
p.001994: pharmacokinetic and, when possible, a pharmacodynamic profile. Except duly exceptions
p.001994: based, they are carried out in small groups of healthy volunteer individuals. To this phase
p.001994: the bioequivalence studies also belong, since these are also carried out in
p.001994: HealthyXvolunteers
p.001994: Phase II: consists of controlled clinical trials, designed to demonstrate effectiveness and
p.001994: relative security It is usually done in a limited number of patients closely
p.001994: supervised
p.001994: Phase III: it is done after establishing a reasonable probability of the effectiveness of the
p.001994: medication and aims to obtain additional information on its effectiveness for indications
p.001994: speci fi c and a more precise definition of the adverse effects associated with the medication. This phase
p.001994: It includes controlled and uncontrolled studies.
p.001994: Phase IV: trials are carried out after the national drug registration agency
p.001994: has approved a medication for distribution or marketing. These trials may include
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.001994: required to provide informed consent must be given in accessible conditions and formats
p.001994: and appropriate to your needs.
p.001994: Article sheet
p.001994: ARTICLE 17.- Consent of minors
p.001994: When minors participate in a biomedical research, the consent
p.001994: Informed must be signed by your legal representative or by whoever has your legal representation.
p.001994: In the case of minors, but over twelve years old, you must also
p.001994: count on your informed consent; To do this, they will be informed about the scope of the
p.001994: research, in a language understandable to them.
p.001994: In the event that the minor refuses to agree, his or her criteria prevails over that of
p.001994: your legal representative, as long as your life or your health does not depend on your participation in the
p.001994: research, in accordance with the provisions of Law No. 7739, Childhood and Adolescence Code,
p.001994: of January 6, 1998.
p.001994: All aspects related to informed consent in minors
p.001994: must be valued with the participation of the Scientific Ethical Committee, so that the Committee is
p.001994: guarantor of this.
p.001994: The informed assent must be approved, folded and sealed in all its pages by the
p.001994: CEC, prior to submission to potential participants.
p.001994: Article sheet
p.001994: ARTICLE 18.- Consent of legally disabled persons
p.001994: In the case of biomedical research involving people declared as
p.001994: unable, through a judicial process, informed consent must be signed by your
p.001994: legal representative.
p.001994: Article sheet
p.001994: CHAPTER III
p.001994: BIOLOGICAL SAMPLES OF HUMAN MATERIAL
p.001994: ARTICLE 19.- Use and transfer of biological samples
p.001994: The use of biological samples obtained for purposes not covered and prohibited is prohibited.
p.001994: approved in the informed consent, the law and other applicable regulations.
p.001994: Biological samples may only be transferred abroad, if justified in accordance with the
p.001994: scientific objectives, the technical criteria of the research or the technological limitations of the
p.001994: country. In the case of studies with multicenter design, where it is optimal to standardize the
p.001994: methodology and laboratory test reports, in accordance with the scientific objectives, are
p.001994: It will allow the transfer of samples to a laboratory abroad.
p.001994: In order for biological samples to leave the country, it is required that such information be
p.001994: supplied prior to export, in informed consent and that the participant has
p.001994: consented, except epidemiological situations that put public health at risk.
p.001994: Article sheet
p.001994: ARTICLE 20.- Right to retract for the use of biological samples of material
p.001994: human
p.001994: The participant in a biomedical research assists the right to retract their
p.001994: consent on the possible transfer, storage, handling and use of your biological samples of
p.001994: human material
...
Searching for indicator disability:
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p.001994: Regulations Remember that Control F is an option that allows you to search the entire text
p.001994: Pronouncements
p.001994: Constitutional Affairs Go to the end of the document
p.001994: Year: 50 results
p.001994: - You are in the latest version of the standard-
p.001994: Search in: Document file
p.001994: Search Biomedical Research Regulatory Law
p.001994: No. 9234
p.001994: Advanced Search Menu
p.001994: THE LEGISLATIVE ASSEMBLY
p.001994: Text complete
p.001994: Standard sheet
p.001994: OF THE REPUBLIC OF COSTA RICA
p.001994: Regulations affected
p.001994: Concordances
p.001994: DECREE:
p.001994: Regulations
p.001994: Descriptors
p.001994: text-align: center '> REGULATORY LAW OF BIOMEDICAL RESEARCH
p.001994: PGR pronouncements
p.001994: Constitutional actions and resolutions
p.001994: Related case law
p.001994: CHAPTER I
p.001994: Jurisp of the Treasury
p.001994: GENERAL DISPOSITION
p.001994: Options:
p.001994: ARTICLE 1.- Object of the law
p.001994: save
p.001994: The purpose of this law is to regulate biomedical research with human beings in
p.001994: Print health matters, in the public and private sectors.
p.001994: Article sheet
p.001994: ARTICLE 2.- Definitions
p.001994: For the purposes of this law, the following definitions are established:
p.001994: Autonomy: ability of people to make decisions without the influence of other people
p.001994: or external pressures.
p.001994: Adverse event or reaction that would be attributable to experimentation: occurrence
p.001994: unfavorable that:
p.001994: a) results in death,
p.001994: b) life threatening,
p.001994: c) requires hospitalization of the participant or prolongation of the existing hospitalization,
p.001994: d) produces persistent or significant disability or disability, or produces a congenital anomaly
p.001994: or birth defect.
p.001994: Multicenter study: clinical study conducted according to a single protocol in more than
p.001994: a place and, therefore, made by more than one researcher.
p.001994: Phases of vaccine development:
p.001994: Phase I: refers to the first introduction of a vaccine under trial in a human population
p.001994: to initially determine its safety and its biological effects, including its immunogenicity. Is
p.001994: Phase may include dose studies and routes of administration.
p.001994: Phase II: refers to the initial trials to determine the effectiveness of the vaccine in a
p.001994: limited number of volunteers; This phase focuses on immunogenicity.
p.001994: Phase III: aims to more fully assess the safety and effectiveness in the
p.001994: disease prevention, involving a greater number of volunteers in a study
p.001994: generally multicentre properly controlled.
p.001994: Phases of drug development:
p.001994: Phase I: consists of the introduction of a drug in humans for the first time.
p.001994: Healthy voluntary subjects participate to assess at what levels of drug use observed
p.001994: toxicity. Dose-response studies are continued in patients to determine the
p.001994: medication safety and, in some cases, initial indications of its effectiveness.
p.001994: These studies are intended to establish a preliminary assessment of safety and profile.
p.001994: pharmacokinetic and, when possible, a pharmacodynamic profile. Except duly exceptions
...
p.001994: pharmaceutical transnationals or for profit organizations.
p.001994: Article sheet
p.001994: ARTICLE 62.- Protection of files
p.001994: All information concerning research carried out in human beings must
p.001994: be recorded in the patient's file and be protected for a period of thirty years, in the
p.001994: Health institution or clinic where it was performed.
p.001994: Article sheet
p.001994: ARTICLE 63.- Use of the placebo
p.001994: The possible benefits, risks, costs and effectiveness of all biomedical research should be
p.001994: evaluated by comparison with the best existing proven intervention, except in the
p.001994: following circumstances:
p.001994: a) The use of a placebo is acceptable in studies for which there is no proven intervention or
p.001994: Existing treatment
p.001994: b) When for methodological, scientific and compelling reasons, the use of a placebo is
p.001994: necessary to determine the effectiveness and safety of an intervention that does not imply
p.001994: risk, serious adverse effects or irreversible damage for patients receiving the placebo.
p.001994: Article sheet
p.001994: CHAPTER IX
p.001994: RESEARCH WITH VULNERABLE GROUPS
p.001994: ARTICLE 64.- Minors and persons without volitional and cognitive capacity
p.001994: The clinical investigation in which a person with legal disability participates, is a person
p.001994: less or without volitional and cognitive capacity, declared judicially, can only be carried out
p.001994: when the results are expected to produce real or direct benefits to your health, or
p.001994: when comparable results cannot be obtained in older individuals or capable of granting their
p.001994: consent.
p.001994: When it is foreseeable that clinical research will not produce results in direct benefit
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
...
p.001994: illicit means to obtain such consent, will be punished with imprisonment from three to eight
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
p.001994: Opposition to the practice of research.
p.001994: Article sheet
p.001994: ARTICLE 80.- Disability
p.001994: In addition to the corresponding prison sentence, the judicial authority must establish the
p.001994: penalty of disqualification for a period of five to ten years for investigation processes
p.001994: biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person
p.001994: that has committed the acts typified in the previous articles.
p.001994: Article sheet
p.001994: ARTICLE 81.- Influence trafficking with biomedical research
p.001994: Members of ethical committees will be sentenced to one to three years
p.001994: scientists (CEC) and officials of public or private institutions that authorize, facilitate or
p.001994: hire biomedical research in which they participate or have interests
p.001994: economic companies in which they, their spouses or partners, or their relatives by
p.001994: consanguinity or affinity until the third grade inclusive, be part of their boards of directors,
p.001994: Participate directly or by interposite natural or legal person in your share capital, or work
p.001994: as researchers
p.001994: Article sheet
p.001994: ARTICLE 82.- Gifts and coercion
p.001994: A prison sentence of three to five years will be imposed on the member of a scientific ethics committee
p.001994: that accepts any kind of gifts from people or companies that carry out research
p.001994: biomedical, without prejudice to other sanctions and responsibilities that proceed in accordance with the
p.001994: legal system.
p.001994: Article sheet
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.001994: consent, duress, threat, deception, misinformation, manipulation or any other
p.001994: illicit means to obtain such consent, will be punished with imprisonment from three to eight
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
p.001994: Opposition to the practice of research.
p.001994: Article sheet
p.001994: ARTICLE 80.- Disability
p.001994: In addition to the corresponding prison sentence, the judicial authority must establish the
p.001994: penalty of disqualification for a period of five to ten years for investigation processes
p.001994: biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person
p.001994: that has committed the acts typified in the previous articles.
p.001994: Article sheet
p.001994: ARTICLE 81.- Influence trafficking with biomedical research
p.001994: Members of ethical committees will be sentenced to one to three years
p.001994: scientists (CEC) and officials of public or private institutions that authorize, facilitate or
p.001994: hire biomedical research in which they participate or have interests
p.001994: economic companies in which they, their spouses or partners, or their relatives by
p.001994: consanguinity or affinity until the third grade inclusive, be part of their boards of directors,
p.001994: Participate directly or by interposite natural or legal person in your share capital, or work
p.001994: as researchers
p.001994: Article sheet
p.001994: ARTICLE 82.- Gifts and coercion
p.001994: A prison sentence of three to five years will be imposed on the member of a scientific ethics committee
p.001994: that accepts any kind of gifts from people or companies that carry out research
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.001994: researcher, to perform one or more of the tasks and functions of the researcher in the execution of the
p.001994: study. Must be accredited by Conis.
p.001994: Contract research organization: person or organization that signs a contract
p.001994: private with the sponsor, to perform one or more of the work and functions of the sponsor
p.001994: related to the study. Must be accredited by Conis.
p.001994: Participant: individual who participates in a biomedical research project, either as
p.001994: direct receiver of an intervention, as a control, or as an element of observation. The individual
p.001994: it can be a healthy person who voluntarily participates in the investigation, or a person with a
p.001994: condition unrelated to the ongoing research that participates voluntarily, or a
p.001994: person, usually a patient, whose condition is relevant to the use of the product studied or
p.001994: to answer the questions that are being investigated.
p.001994: Sponsor: individual, company, entity or public or private organization, national or
p.001994: foreigner, who takes responsibility for startup, administration, financing and publication
p.001994: of the results of an investigation, and which also assumes the coverage of costs and compensation.
p.001994: Placebo: substance that itself lacks therapeutic action.
p.001994: Impartial witness: a person independent of biomedical research that cannot be
p.001994: in fl uenced by personnel involved in biomedical research (understood as such the sponsor,
p.001994: the contract management organization, the contract research organization, the
p.001994: investigator or officials, employees or representatives of both), or a family member of the
p.001994: participant, who is present in the process of signing the informed consent.
p.001994: Protocol: document that describes the hypothesis, the objective or the objectives, the design, the
p.001994: methodology, statistical considerations and organization of a study. Also, provides
p.001994: the background, the basics and the justification of the study.
p.001994: Article sheet
p.001994: ARTICLE 3.- Protection of the human being
p.001994: The life, health, interest, well-being and dignity of the participants in an investigation in
p.001994: health, in which human beings participate, will prevail over the interest of science, of interests
p.001994: Economic or commercial.
p.001994: All health research involving human beings must respond to an approach of
p.001994: human rights.
p.001994: Article sheet
p.001994: ARTICLE 4.- Principles of biomedical research
p.001994: All health research involving human beings must be governed by the
p.001994: principles of respect for people's dignity, bene fi ciency, non-maleficence, autonomy and justice
p.001994: Distributive
p.001994: In addition to the above, the respective scientific ethical committee must ensure that it complies with the
p.001994: requirements of social and scientific value, scientific validity, non-discriminatory and equitable selection of
p.001994: Participating populations, favorable risk-benefit ratio, independent evaluation, consent
p.001994: Human rights as a frame of reference.
p.001994: Article sheet
p.001994: ARTICLE 5.- Gratuity
...
p.001994: personal data or confidential documents related to the investigation, will be subject to
p.001994: duty of confidentiality.
p.001994: The obligation of confidentiality does not apply when any of the following conditions exist,
p.001994: which must be consigned and accepted by the participant in the consent
p.001994: informed:
p.001994: a) When required by the scientific ethical committee that approved the research.
p.001994: b) When required by the National Health Research Council, in order to comply with the
p.001994: requirements of an inspection and surveillance of an investigation.
p.001994: c) When the monitor or the auditor of the investigation requires verifying the data contained in the
p.001994: clinical records of the participants of an investigation, for purposes of an audit or
p.001994: follow-up by the sponsor or competent regulatory authority.
p.001994: d) When requested by a competent judicial authority.
p.001994: e) When a medical emergency occurs to the participant.
p.001994: f) When the doctor responsible for clinical care requires to know such information to
p.001994: Treatment effects of your patient.
p.001994: Article sheet
p.001994: ARTICLE 26.- Transfer of data
p.001994: The transfer of personal data to third parties outside an investigation where they participate
p.001994: Human beings will require the express and written consent of the participant.
p.001994: If the data obtained from the participant could reveal personal information of their
p.001994: family members, the transfer to third parties will require the express and written consent of all interested parties.
p.001994: Article sheet
p.001994: ARTICLE 27.- Right to information
p.001994: Participants in an investigation are entitled:
p.001994: a) To access, personally or through their legal representative, the results of their
p.001994: analysis, when these have not been subjected to dissociation or anonymization processes, if the
p.001994: Study design allows.
p.001994: b) To be informed about the advances, of the unexpected adverse events that occur
p.001994: present and of the general results of the investigation.
p.001994: c) That the ethnic, cultural and social characteristics of the community or group are respected
p.001994: population to which they belong.
p.001994: d) That all verbal and written information be provided through an understandable lexicon and in
p.001994: The language of the participants.
p.001994: e) To be informed of discovered diseases that are not part of the process of
p.001994: investigation.
p.001994: f) To access and obtain a copy of your personal file, which must include all the
p.001994: information regarding the research or clinical trial.
p.001994: Article sheet
p.001994: ARTICLE 28.- Right to enjoy the benefits that result from the investigation
p.001994: Participants in a clinical investigation will have the right to enjoy for free,
p.001994: they require it, of the preventive, therapeutic and diagnostic treatments generated by the study, if
p.001994: it has been shown that these are beneficial to health, as long as the prescription of these
...
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
p.001994: own and characteristic disease of this or another of high prevalence.
p.001994: b) That the researcher and the sponsor commit, reliably, to respect the
p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.001994: email, the address of the office and any other suitable data to locate them.
p.001994: u) The name, signature, date, time and place where the participant is summoned to deliver the
p.001994: copy of the document and the place where you subscribe and the identification number of the participant or his
p.001994: legal representative, of the person who explains the informed consent and of the impartial witness
p.001994: who signs the consent and the date on which it is signed.
p.001994: v) The others determined by the regulations of this law and those others that in the opinion of the committees
p.001994: Ethical respective scientists are required.
p.001994: Article sheet
p.001994: ARTICLE 11.- Additional content of informed consent in investigations
p.001994: clinics
p.001994: In clinical research, in addition to what is indicated in the previous article, consent
p.001994: informed must contain:
p.001994: a) Treatment to be used in the investigation, the form and probability of assignment to
p.001994: each treatment
p.001994: b) Known side effects, risks and discomforts of medications or equipment in
p.001994: investigation.
p.001994: c) Alternative, preventive, diagnostic and therapeutic procedures or treatments
p.001994: available.
p.001994: d) Precautions with men and women of reproductive age and follow-up that will be given to the
p.001994: woman and the product, if she had become pregnant during participation in the
p.001994: investigation.
p.001994: e) If the treatment will continue at the end of the study.
p.001994: f) Regarding the insurance policy.
p.001994: g) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: ARTICLE 12.- Approval of informed consent
p.001994: Informed consent and any modification thereto must be approved, foliated and
p.001994: sealed in all its pages by the Scientific Ethical Committee, prior to its presentation to the eventual
p.001994: participants.
p.001994: In the cases of observational investigations, the Scientific Ethical Committee, after analysis
p.001994: exhaustive of the content and scope of the investigation, may exempt from the signature of consent
p.001994: informed, when it considers that this does not affect the rights of the participants.
p.001994: Article sheet
p.001994: ARTICLE 13.- Quality of the information
p.001994: Before any activity related to the investigation is initiated and before it is initiated
p.001994: proceed to sign the informed consent, the participating individual must be informed in his
p.001994: own language, in an appropriate and understandable language, about the nature of research, the
p.001994: procedures, risks and bene fi ts, other therapeutic or diagnostic options, confidentiality
p.001994: of the information collected and about your rights, so that you understand and make the decision to
...
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
p.001994: Application of this law. They should be considered subordinate groups by reason of authority, between
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
p.001994: c) The investigation implies a minimum risk or burden for the people included in the study.
p.001994: Article sheet
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
p.001994: a) That comparable results cannot be obtained in non-pregnant or in-period women
p.001994: breastfeeding
p.001994: b) That the research involves a minimum risk to their health, from the product of the
p.001994: conception at any stage of pregnancy or infant, or that the benefit exceeds the
p.001994: risk.
p.001994: c) That the objective of the investigation is to obtain new knowledge that results in
p.001994: bene fi t of other women or the product of conception at any stage of the
p.001994: Pregnancy or infant.
p.001994: Article sheet
p.001994: ARTICLE 69.- Clinical investigations with persons deprived of liberty
p.001994: Persons deprived of liberty should not be unreasonably denied the possibility of
p.001994: participate in clinical research or have access to medications, vaccines and other elements of
p.001994: research that may represent therapeutic or preventive benefit for them.
p.001994: Special attention should be given to guarantee the willingness of consent in this
p.001994: population, applying a suitably proven scientific methodology that guarantees
p.001994: reasonably that the consent of the private or the deprived of liberty is unquestionably
p.001994: voluntary.
p.001994: Article sheet
p.001994: CHAPTER X
p.001994: SANCTIONS
...
Health / Terminally Ill
Searching for indicator terminal:
(return to top)
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
p.001994: own and characteristic disease of this or another of high prevalence.
p.001994: b) That the researcher and the sponsor commit, reliably, to respect the
...
Health / breastfeeding
Searching for indicator breastfeeding:
(return to top)
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
p.001994: Application of this law. They should be considered subordinate groups by reason of authority, between
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
p.001994: c) The investigation implies a minimum risk or burden for the people included in the study.
p.001994: Article sheet
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
p.001994: a) That comparable results cannot be obtained in non-pregnant or in-period women
p.001994: breastfeeding
p.001994: b) That the research involves a minimum risk to their health, from the product of the
p.001994: conception at any stage of pregnancy or infant, or that the benefit exceeds the
p.001994: risk.
p.001994: c) That the objective of the investigation is to obtain new knowledge that results in
p.001994: bene fi t of other women or the product of conception at any stage of the
p.001994: Pregnancy or infant.
p.001994: Article sheet
p.001994: ARTICLE 69.- Clinical investigations with persons deprived of liberty
p.001994: Persons deprived of liberty should not be unreasonably denied the possibility of
p.001994: participate in clinical research or have access to medications, vaccines and other elements of
p.001994: research that may represent therapeutic or preventive benefit for them.
p.001994: Special attention should be given to guarantee the willingness of consent in this
p.001994: population, applying a suitably proven scientific methodology that guarantees
p.001994: reasonably that the consent of the private or the deprived of liberty is unquestionably
p.001994: voluntary.
p.001994: Article sheet
p.001994: CHAPTER X
p.001994: SANCTIONS
p.001994: ARTICLE 70.- Sanitary and administrative measures
p.001994: The Ministry of Health, the Conis or the CEC, as appropriate, should know and dictate the
...
Health / hospitalized patients
Searching for indicator hospitalized:
(return to top)
p.001994: When it is foreseeable that clinical research will not produce results in direct benefit
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
...
Health / ill
Searching for indicator ill:
(return to top)
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.001994: written in a way that can be understood by the participants and that does not lead to error or coercion.
p.001994: It must contain at least:
p.001994: a) Statement that the study involves research.
p.001994: b) Identity of the professional responsible for the research and its collaborators.
p.001994: c) Explanation of the objective and purpose of the investigation.
p.001994: d) Source of funding for the research project.
p.001994: e) Approximate number and characteristics of the people who will participate.
p.001994: f) Expected duration of the person's participation.
p.001994: g) Procedures to be followed.
p.001994: h) In case of obtaining blood samples and other biological material, there must be
p.001994: consent and the right to retract the participant on the transfer of samples
p.001994: biological material, the tests that will be performed, where they will be analyzed and if
p.001994: will deliver or not the results of these. In case you want to save them you must indicate
p.001994: where, for how long and for what purposes.
p.001994: i) Description of the risks or inconveniences that may arise with the investigation.
p.001994: j) Measures to respond to any inconvenience or adverse events that may arise.
p.001994: k) Measures to ensure adequate compensation in case the participant suffers
p.001994: Some damage as a result of the investigation.
p.001994: l) Description of the expected benefits for the participant or for others.
p.001994: m) Demonstration of the strict confidentiality of the information and the measures to be taken
p.001994: to ensure it.
p.001994: n) Information on the people who will have access to the records to verify
p.001994: Procedures and research data.
p.001994: ñ) Measures to access the relevant information for the participant, arising from the
p.001994: research or the total results of this.
p.001994: o) Measures to maintain the confidentiality of the results of the investigation, as well as the
p.001994: information of the participants at the time of the dissemination of the results.
p.001994: p) Indicate any potential future use of the research results.
p.001994: q) Indicate that, in the publications of the research results, the information of the
p.001994: person will remain confidential.
p.001994: r) Statement that participation is voluntary and that the person may withdraw from the
p.001994: research at any time without losing the bene fi ts to which the person of all
p.001994: Forms you have the right, nor to be punished in any way for your withdrawal.
p.001994: s) Clarification of whether there will be any kind of financial compensation for food
p.001994: or transportation
p.001994: t) List of people who can contact if you have questions about the study and
p.001994: Your rights. The list must contain at least the telephone number (s), the address of
p.001994: email, the address of the office and any other suitable data to locate them.
p.001994: u) The name, signature, date, time and place where the participant is summoned to deliver the
p.001994: copy of the document and the place where you subscribe and the identification number of the participant or his
p.001994: legal representative, of the person who explains the informed consent and of the impartial witness
p.001994: who signs the consent and the date on which it is signed.
p.001994: v) The others determined by the regulations of this law and those others that in the opinion of the committees
p.001994: Ethical respective scientists are required.
...
p.001994: place and conditions of conservation, the objectives of this conservation, the future uses of
p.001994: samples and the possibility of transfer of the samples to third parties.
p.001994: The donation and use of human biological samples in an investigation may not
p.001994: Remuneration or other compensation to the participant; it is also prohibited
p.001994: the sale of biological samples that have been obtained for a biomedical investigation.
p.001994: Article sheet
p.001994: CHAPTER IV
p.001994: RIGHTS AND OBLIGATIONS OF PARTICIPANTS
p.001994: ARTICLE 24.- Right to withdraw
p.001994: Participants in an investigation will have, without the need to give explanations, the right to
p.001994: Give up your participation at any time. In those cases in which the abrupt withdrawal
p.001994: means a risk to the health of the participant, the mechanisms that
p.001994: Minimize the risk situation.
p.001994: Such resignation will not cause any damage or inconvenience to the participants,
p.001994: for your right to health or in the exercise of any other of your rights.
p.001994: Article sheet
p.001994: ARTICLE 25.- Right to confidentiality
p.001994: The use of data related to the health of persons for purposes other than
p.001994: those for whom consent was given.
p.001994: Participants in an investigation will have the right to be saved
p.001994: confidentiality about your identity, personal information and your health, as well as about the treatments or
p.001994: the results of the analyzes or procedures to which they were submitted and other personal data,
p.001994: except when the law requires otherwise.
p.001994: People or entities that have access to confidential data of the participants must
p.001994: take all necessary measures to ensure that privacy will not be affected, the
p.001994: confidentiality, integrity and dignity of the participants. To this end, anyone who in
p.001994: the exercise of their functions, in an investigation where human beings participate, have access to
p.001994: personal data or confidential documents related to the investigation, will be subject to
p.001994: duty of confidentiality.
p.001994: The obligation of confidentiality does not apply when any of the following conditions exist,
p.001994: which must be consigned and accepted by the participant in the consent
p.001994: informed:
p.001994: a) When required by the scientific ethical committee that approved the research.
p.001994: b) When required by the National Health Research Council, in order to comply with the
p.001994: requirements of an inspection and surveillance of an investigation.
p.001994: c) When the monitor or the auditor of the investigation requires verifying the data contained in the
p.001994: clinical records of the participants of an investigation, for purposes of an audit or
p.001994: follow-up by the sponsor or competent regulatory authority.
p.001994: d) When requested by a competent judicial authority.
p.001994: e) When a medical emergency occurs to the participant.
p.001994: f) When the doctor responsible for clinical care requires to know such information to
p.001994: Treatment effects of your patient.
p.001994: Article sheet
p.001994: ARTICLE 26.- Transfer of data
p.001994: The transfer of personal data to third parties outside an investigation where they participate
p.001994: Human beings will require the express and written consent of the participant.
p.001994: If the data obtained from the participant could reveal personal information of their
p.001994: family members, the transfer to third parties will require the express and written consent of all interested parties.
p.001994: Article sheet
p.001994: ARTICLE 27.- Right to information
p.001994: Participants in an investigation are entitled:
p.001994: a) To access, personally or through their legal representative, the results of their
p.001994: analysis, when these have not been subjected to dissociation or anonymization processes, if the
p.001994: Study design allows.
p.001994: b) To be informed about the advances, of the unexpected adverse events that occur
p.001994: present and of the general results of the investigation.
p.001994: c) That the ethnic, cultural and social characteristics of the community or group are respected
p.001994: population to which they belong.
p.001994: d) That all verbal and written information be provided through an understandable lexicon and in
p.001994: The language of the participants.
p.001994: e) To be informed of discovered diseases that are not part of the process of
p.001994: investigation.
p.001994: f) To access and obtain a copy of your personal file, which must include all the
p.001994: information regarding the research or clinical trial.
p.001994: Article sheet
p.001994: ARTICLE 28.- Right to enjoy the benefits that result from the investigation
p.001994: Participants in a clinical investigation will have the right to enjoy for free,
p.001994: they require it, of the preventive, therapeutic and diagnostic treatments generated by the study, if
p.001994: it has been shown that these are beneficial to health, as long as the prescription of these
p.001994: methods or treatments are endorsed by the professionals responsible for the treatment and monitoring
p.001994: of the patient, and in accordance with what is expressed in this law.
p.001994: Article sheet
p.001994: ARTICLE 29.- Right to health care
p.001994: No participant in a biomedical research will lose their right to receive care in
p.001994: health that you would be entitled to receive before, during or after your participation in an investigation.
p.001994: Article sheet
p.001994: ARTICLE 30.- Right to compensation for damages
p.001994: People who have suffered damage to health, as a result of their participation in a
p.001994: investigation, they will receive the corresponding compensation as provided in this law and their
p.001994: regulation.
p.001994: Article sheet
p.001994: ARTICLE 31.- Protection policy for the participants
p.001994: The clinical investigation must be covered by a civil liability policy that protects
p.001994: the participants of the damages and losses derived from the investigation, during the period that lasts,
p.001994: since the beginning of the investigation and for at least two years, after the end of the
p.001994: Participation of the participant in the investigation. Policies must be issued in coherence with the
p.001994: principle of proportionality and dignity of human life, and must be enforceable in the country.
p.001994: The ethical scientific committees must assess the policy that is presented and define its term of validity
p.001994: starting from the minimum established in this law.
p.001994: The Ministry of Health will regulate the process that guarantees the access of the participants to the
p.001994: benefits offered by the assurance of health research.
p.001994: Article sheet
p.001994: ARTICLE 32.- Information to people who participate in biomedical research
p.001994: In the informed consent given to the potential participant, it must be delivered
p.001994: proof or copy of the policy, indicating the number, the issuing entity, the term of
p.001994: protection, the conditions that the policy will have and the procedure to access it by the
p.001994: Participants
p.001994: Article sheet
p.001994: ARTICLE 33.- Obligations of the persons participating in a biomedical investigation
p.001994: They will be obligations of the people participating in research in which beings participate
p.001994: human the following:
p.001994: a) Comply with the instructions and instructions provided.
p.001994: b) Timely inform the investigator about the adverse events they present.
p.001994: c) Inform the attending physician of their participation in a clinical investigation.
p.001994: d) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: CHAPTER V
p.001994: NATIONAL HEALTH RESEARCH COUNCIL
p.001994: ARTICLE 34.- National Health Research Council
p.001994: The National Health Research Council, hereinafter Conis, is created as an organ
p.001994: independent, multidisciplinary, ethical, technical and scientific, attached to the Ministry of Health
p.001994: with a degree of maximum deconcentration and with instrumental legal personality.
p.001994: The Conis will have the administrative structure defined by regulation and will have its own
p.001994: Internal audit in accordance with Law No. 8292, General Internal Control Law, of July 31,
p.001994: 2002, and Law No. 7428, Organic Law of the Comptroller General of the Republic, of September 7,
p.001994: 1994
p.001994: Article sheet
p.001994: ARTICLE 35.- Conis Purposes
p.001994: The purpose of the Conis will be to guarantee the quality of the investigations and their strict adherence to the
p.001994: human rights. Its members must act with absolute independence of opinion, avoiding
p.001994: in its decisions the influence of political and commercial interests.
p.001994: Article sheet
...
p.001994: and) When you designate an organization to conduct an investigation (organization of
p.001994: administration by contract), you must sign a contract in which the
p.001994: obligations and responsibilities assumed by said organization.
p.001994: z) Comply with the provisions of the Ministry of Health, the Conis and the CEC regarding their
p.001994: competition.
p.001994: a) Forward, to the CEC that approved the investigation and to the Conis, a copy of the publications and / or
p.001994: Certification of participation in scientific activities of the research results.
p.001994: Article sheet
p.001994: ARTICLE 52.- Publication of results of biomedical research
p.001994: It is the obligation of the researcher to publish or present, in any congress or scientific activity, the
p.001994: Results of the biomedical research carried out. By publishing the results of
p.001994: Biomedical research, researchers must respect the accuracy of the data and results
p.001994: obtained, and disclose both positive and negative results, include the information
p.001994: corresponding to the sources of research funding and the sponsoring entities, and
p.001994: indicate the institution or health institutions where the research was carried out. Likewise
p.001994: In the publications, respect for the right of confidentiality of the
p.001994: participants.
p.001994: The Conis may dispense with the publication of the results of biomedical research,
p.001994: when it comes to results with few contributions.
p.001994: Article sheet
p.001994: ARTICLE 53.- Obligations of the sponsor
p.001994: The sponsor's obligations are:
p.001994: a) Ensure and document that electronic data systems meet the requirements of
p.001994: integrity, accuracy, reliability and consistency in the proposed execution and that maintain a
p.001994: security system that prevents unauthorized access of data.
p.001994: b) Select appropriately the researcher, his team and the entity in which
p.001994: will conduct the investigation
p.001994: c) Supervise the conduct of investigations and implement a system of
p.001994: quality standards
p.001994: d) Ensure sufficient funding, adequate material resources and equipment to the researcher and to
p.001994: the entity that will carry out the investigation, by signing contracts that contain
p.001994: these conditions.
p.001994: e) Define and obtain an agreement with the investigator to conduct the compliance investigation
p.001994: with good clinical practices, national regulatory requirements and the protocol
p.001994: approved by the CEC.
p.001994: f) Verify that the sponsoring research has been approved by the respective accredited CEC
p.001994: in the country.
p.001994: g) Provide adequate and permanent training on scientific and ethical methodologies of the
p.001994: Research the researcher and his team.
p.001994: h) Verify that the investigator reports to the CEC those cases in which he found
p.001994: Deviations to the approved protocol.
p.001994: i) Cover the costs of the treatment of the participants who suffered an injury such as
p.001994: Research consequence.
p.001994: j) Compensate those participants who suffered injuries or heirs in case of death,
p.001994: as a direct consequence of clinical research and related to the
p.001994: This procedures, as long as these are not inherent risks of the medications
p.001994: and / or standard procedures; To do this, you must have a valid insurance policy that
p.001994: cover from the beginning of the investigation and up to a minimum of two years after the end of the
p.001994: Participation of the participant in the investigation. Guarantee legal coverage and a policy of
p.001994: civil liability in favor of the researcher and his team, in order to deal with
...
p.001994: transferred. Likewise, you must transfer to the CEC any modification to this agreement, in a
p.001994: maximum period of eight business days.
p.001994: c) All those that the sponsor or researcher has transferred through the contract or
p.001994: contractual document signed between them.
p.001994: d) Respond, jointly and severally with the sponsor or investigator, to possible damages or
p.001994: damages caused by the tasks or functions that have been transferred.
p.001994: Article sheet
p.001994: CHAPTER VIII
p.001994: RESEARCH WITH HUMAN BEINGS
p.001994: ARTICLE 55.- Approvals and authorizations
p.001994: All research, before its start, must have the written approval of a CEC
p.001994: duly accredited and, in case it is to be carried out in a public or private health center,
p.001994: It must also have the authorization of the corresponding authority or authorities. None
p.001994: authority, public or private, may authorize an investigation without the approval of the respective CEC.
p.001994: In the case of investigations that require the importation of medicines, equipment,
p.001994: devices and supplies, related to approved investigations, approvals and
p.001994: authorizations indicated in the previous paragraph will be indispensable requirements for their
p.001994: Import to the researcher.
p.001994: Article sheet
p.001994: ARTICLE 56.- Control and monitoring of investigations
p.001994: In all cases, the conduct of the investigation must conform to the content of the
p.001994: project to which the authorization had been granted.
p.001994: The health authorities shall, at all times, have inspection powers over the
p.001994: research, being able to have access to the individual medical records of the participants of the
p.001994: investigation, for which they must keep, in any case, their confidentiality.
p.001994: The health authorities, the Conis or the CEC can cautiously suspend the
p.001994: Authorized investigation in cases where the requirements established
p.001994: this law or when they have indications that the health, integrity and safety of the participants is in
p.001994: danger, having to protect their rights at all times. These measures will proceed in the
p.001994: initial act of the administrative process and must be dictated as a preliminary act, in order to
p.001994: guarantee the rights and security of the participants, and due process. They must also
p.001994: notify all interested parties, including the authorities of the health center where
p.001994: I was conducting the investigation.
p.001994: Article sheet
p.001994: ARTICLE 57.- Inapplicability of positive silence
p.001994: It will not be applicable to the approval, fiscalization, control and monitoring processes of
p.001994: Biomedical research projects, in any of its modalities, the fi gure of silence
p.001994: positive regulated in article 330 of Law No. 6227, General Law of Public Administration, of 2
p.001994: May 1978.
p.001994: Article sheet
p.001994: ARTICLE 58.- Contract
p.001994: Any biomedical research that has external sponsorship to the public or private entity,
p.001994: Where such activity is carried out, you must have a contract by which the rights are regulated and
p.001994: the obligations of both the sponsor and the researcher to carry out the investigation. East
p.001994: contract must indicate the agreed payment for conducting the investigation and include a clause through the
p.001994: which the sponsor is responsible for short and long term adverse events, which are
...
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
p.001994: a) That comparable results cannot be obtained in non-pregnant or in-period women
p.001994: breastfeeding
p.001994: b) That the research involves a minimum risk to their health, from the product of the
p.001994: conception at any stage of pregnancy or infant, or that the benefit exceeds the
p.001994: risk.
p.001994: c) That the objective of the investigation is to obtain new knowledge that results in
p.001994: bene fi t of other women or the product of conception at any stage of the
p.001994: Pregnancy or infant.
p.001994: Article sheet
p.001994: ARTICLE 69.- Clinical investigations with persons deprived of liberty
p.001994: Persons deprived of liberty should not be unreasonably denied the possibility of
p.001994: participate in clinical research or have access to medications, vaccines and other elements of
p.001994: research that may represent therapeutic or preventive benefit for them.
p.001994: Special attention should be given to guarantee the willingness of consent in this
p.001994: population, applying a suitably proven scientific methodology that guarantees
p.001994: reasonably that the consent of the private or the deprived of liberty is unquestionably
p.001994: voluntary.
p.001994: Article sheet
p.001994: CHAPTER X
p.001994: SANCTIONS
p.001994: ARTICLE 70.- Sanitary and administrative measures
p.001994: The Ministry of Health, the Conis or the CEC, as appropriate, should know and dictate the
p.001994: corresponding sanitary and administrative measures to avoid or amend those actions
p.001994: contrary to this law incurred by researchers, sponsors and any other interested party
p.001994: to intervene in a research project; all of the above without prejudice to civil liability,
p.001994: criminal or disciplinary that may correspond to the offender.
p.001994: Article sheet
p.001994: ARTICLE 71.- Precautionary measures
p.001994: During the processing of administrative procedures or investigations in judicial headquarters that
p.001994: question the legality of the activity of the researcher, the sponsor or the CEC, the ICO or the
p.001994: OAC and for the purpose of protecting the health and safety of the participants in an investigation, the
p.001994: competent body may impose the necessary precautionary measures.
p.001994: Investigations may be suspended temporarily or definitively, partially or totally,
...
Social / Age
Searching for indicator age:
(return to top)
p.001994: or transportation
p.001994: t) List of people who can contact if you have questions about the study and
p.001994: Your rights. The list must contain at least the telephone number (s), the address of
p.001994: email, the address of the office and any other suitable data to locate them.
p.001994: u) The name, signature, date, time and place where the participant is summoned to deliver the
p.001994: copy of the document and the place where you subscribe and the identification number of the participant or his
p.001994: legal representative, of the person who explains the informed consent and of the impartial witness
p.001994: who signs the consent and the date on which it is signed.
p.001994: v) The others determined by the regulations of this law and those others that in the opinion of the committees
p.001994: Ethical respective scientists are required.
p.001994: Article sheet
p.001994: ARTICLE 11.- Additional content of informed consent in investigations
p.001994: clinics
p.001994: In clinical research, in addition to what is indicated in the previous article, consent
p.001994: informed must contain:
p.001994: a) Treatment to be used in the investigation, the form and probability of assignment to
p.001994: each treatment
p.001994: b) Known side effects, risks and discomforts of medications or equipment in
p.001994: investigation.
p.001994: c) Alternative, preventive, diagnostic and therapeutic procedures or treatments
p.001994: available.
p.001994: d) Precautions with men and women of reproductive age and follow-up that will be given to the
p.001994: woman and the product, if she had become pregnant during participation in the
p.001994: investigation.
p.001994: e) If the treatment will continue at the end of the study.
p.001994: f) Regarding the insurance policy.
p.001994: g) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: ARTICLE 12.- Approval of informed consent
p.001994: Informed consent and any modification thereto must be approved, foliated and
p.001994: sealed in all its pages by the Scientific Ethical Committee, prior to its presentation to the eventual
p.001994: participants.
p.001994: In the cases of observational investigations, the Scientific Ethical Committee, after analysis
p.001994: exhaustive of the content and scope of the investigation, may exempt from the signature of consent
p.001994: informed, when it considers that this does not affect the rights of the participants.
p.001994: Article sheet
p.001994: ARTICLE 13.- Quality of the information
p.001994: Before any activity related to the investigation is initiated and before it is initiated
p.001994: proceed to sign the informed consent, the participating individual must be informed in his
p.001994: own language, in an appropriate and understandable language, about the nature of research, the
p.001994: procedures, risks and bene fi ts, other therapeutic or diagnostic options, confidentiality
p.001994: of the information collected and about your rights, so that you understand and make the decision to
...
p.001994: Existing treatment
p.001994: b) When for methodological, scientific and compelling reasons, the use of a placebo is
p.001994: necessary to determine the effectiveness and safety of an intervention that does not imply
p.001994: risk, serious adverse effects or irreversible damage for patients receiving the placebo.
p.001994: Article sheet
p.001994: CHAPTER IX
p.001994: RESEARCH WITH VULNERABLE GROUPS
p.001994: ARTICLE 64.- Minors and persons without volitional and cognitive capacity
p.001994: The clinical investigation in which a person with legal disability participates, is a person
p.001994: less or without volitional and cognitive capacity, declared judicially, can only be carried out
p.001994: when the results are expected to produce real or direct benefits to your health, or
p.001994: when comparable results cannot be obtained in older individuals or capable of granting their
p.001994: consent.
p.001994: When it is foreseeable that clinical research will not produce results in direct benefit
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
...
Social / Child
Searching for indicator children:
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p.001994: Completion of each investigation.
p.001994: n) To send quarterly and annual reports of its management before the Conis, which include the
p.001994: investigations approved, rejected, suspended, canceled and finalized, amendments to
p.001994: active investigations, inspections carried out and the list of active investigations.
p.001994: ñ) Offer training to its members, so that they receive regular training and
p.001994: continuing education in relation to bioethics and biomedical research.
p.001994: o) Guarantee researchers the possibility of presenting the objections they consider
p.001994: necessary in relation to the agreements of the CEC.
p.001994: p) To inform the Conis and the competent institutional authorities of the
p.001994: irregularities or breaches of this law.
p.001994: q) Evacuate immediately the inquiries of the participants of an investigation when
p.001994: request information about your rights, and process, as soon as possible, complaints
p.001994: that these present in relation to the investigation or to the proceeding of an investigator or his
p.001994: human team.
p.001994: r) Comply with the provisions of the Ministry of Health and the Conis regarding their competence.
p.001994: s) The amounts to be paid to the CEC for the review process of the research projects
p.001994: submitted for review, possible approval and for the supervision, renewal and inspection of
p.001994: The approved projects will be those determined by the CEC after the cost analysis
p.001994: corresponding and in accordance with the regulations of this law.
p.001994: t) Keep a record of the publications or presentations made of the results of
p.001994: investigations approved by the committee.
p.001994: u) Notify the National Children's Board when they are approved or renewed
p.001994: investigations of minors, for what it may concern.
p.001994: v) The others established by the regulations of this law.
p.001994: Article sheet
p.001994: ARTICLE 49.- Incompatibilities
p.001994: They may not be part of the CEC:
p.001994: a) The members of the boards of directors of public institutions or private companies
p.001994: promoters of biomedical research, when they participate directly or by interposite person
p.001994: of the capital stock of private companies of this nature or their spouse, partner
p.001994: or some of their relatives by consanguinity or affinity until the third grade inclusive.
p.001994: b) The officials of the entity, public or private, in which the committee is established, in which
p.001994: they or their spouse, or partner, or any of their relatives by consanguinity or
p.001994: affinity until the third grade even occupy leadership or management positions that imply
p.001994: competence to decide on the authorization of biomedical research projects.
p.001994: When one of the members of a CEC has links that imply a risk of conflict of
p.001994: interest, in accordance with the provisions of article 38 of Law No. 8422, Law against Corruption
p.001994: and the Illicit Enrichment in the Public Function, of October 6, 2004, and its reforms, and others
p.001994: regulations of the legal system, you must refrain from participating in the administrative process, the
p.001994: approval, control and monitoring of that specific investigation.
p.001994: Article sheet
p.001994: ARTICLE 50.- Budget and resources
p.001994: The entities that constitute a CEC must provide them with human and material resources
p.001994: necessary to fulfill its functions and obligations.
p.001994: Article sheet
p.001994: CHAPTER VII
p.001994: OBLIGATIONS OF THE INVESTIGATOR,
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.001994: part of a CEC; or who has used the victim's inability to issue a
p.001994: consent, duress, threat, deception, misinformation, manipulation or any other
p.001994: illicit means to obtain such consent, will be punished with imprisonment from three to eight
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
p.001994: Opposition to the practice of research.
p.001994: Article sheet
p.001994: ARTICLE 80.- Disability
p.001994: In addition to the corresponding prison sentence, the judicial authority must establish the
p.001994: penalty of disqualification for a period of five to ten years for investigation processes
p.001994: biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person
p.001994: that has committed the acts typified in the previous articles.
p.001994: Article sheet
p.001994: ARTICLE 81.- Influence trafficking with biomedical research
p.001994: Members of ethical committees will be sentenced to one to three years
p.001994: scientists (CEC) and officials of public or private institutions that authorize, facilitate or
p.001994: hire biomedical research in which they participate or have interests
p.001994: economic companies in which they, their spouses or partners, or their relatives by
p.001994: consanguinity or affinity until the third grade inclusive, be part of their boards of directors,
p.001994: Participate directly or by interposite natural or legal person in your share capital, or work
p.001994: as researchers
p.001994: Article sheet
p.001994: ARTICLE 82.- Gifts and coercion
p.001994: A prison sentence of three to five years will be imposed on the member of a scientific ethics committee
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.001994: clinical records of the participants of an investigation, for purposes of an audit or
p.001994: follow-up by the sponsor or competent regulatory authority.
p.001994: d) When requested by a competent judicial authority.
p.001994: e) When a medical emergency occurs to the participant.
p.001994: f) When the doctor responsible for clinical care requires to know such information to
p.001994: Treatment effects of your patient.
p.001994: Article sheet
p.001994: ARTICLE 26.- Transfer of data
p.001994: The transfer of personal data to third parties outside an investigation where they participate
p.001994: Human beings will require the express and written consent of the participant.
p.001994: If the data obtained from the participant could reveal personal information of their
p.001994: family members, the transfer to third parties will require the express and written consent of all interested parties.
p.001994: Article sheet
p.001994: ARTICLE 27.- Right to information
p.001994: Participants in an investigation are entitled:
p.001994: a) To access, personally or through their legal representative, the results of their
p.001994: analysis, when these have not been subjected to dissociation or anonymization processes, if the
p.001994: Study design allows.
p.001994: b) To be informed about the advances, of the unexpected adverse events that occur
p.001994: present and of the general results of the investigation.
p.001994: c) That the ethnic, cultural and social characteristics of the community or group are respected
p.001994: population to which they belong.
p.001994: d) That all verbal and written information be provided through an understandable lexicon and in
p.001994: The language of the participants.
p.001994: e) To be informed of discovered diseases that are not part of the process of
p.001994: investigation.
p.001994: f) To access and obtain a copy of your personal file, which must include all the
p.001994: information regarding the research or clinical trial.
p.001994: Article sheet
p.001994: ARTICLE 28.- Right to enjoy the benefits that result from the investigation
p.001994: Participants in a clinical investigation will have the right to enjoy for free,
p.001994: they require it, of the preventive, therapeutic and diagnostic treatments generated by the study, if
p.001994: it has been shown that these are beneficial to health, as long as the prescription of these
p.001994: methods or treatments are endorsed by the professionals responsible for the treatment and monitoring
p.001994: of the patient, and in accordance with what is expressed in this law.
p.001994: Article sheet
p.001994: ARTICLE 29.- Right to health care
p.001994: No participant in a biomedical research will lose their right to receive care in
p.001994: health that you would be entitled to receive before, during or after your participation in an investigation.
p.001994: Article sheet
p.001994: ARTICLE 30.- Right to compensation for damages
p.001994: People who have suffered damage to health, as a result of their participation in a
p.001994: investigation, they will receive the corresponding compensation as provided in this law and their
p.001994: regulation.
p.001994: Article sheet
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
p.001994: Application of this law. They should be considered subordinate groups by reason of authority, between
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
p.001994: c) The investigation implies a minimum risk or burden for the people included in the study.
p.001994: Article sheet
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
p.001994: a) That comparable results cannot be obtained in non-pregnant or in-period women
p.001994: breastfeeding
p.001994: b) That the research involves a minimum risk to their health, from the product of the
p.001994: conception at any stage of pregnancy or infant, or that the benefit exceeds the
p.001994: risk.
p.001994: c) That the objective of the investigation is to obtain new knowledge that results in
p.001994: bene fi t of other women or the product of conception at any stage of the
p.001994: Pregnancy or infant.
p.001994: Article sheet
p.001994: ARTICLE 69.- Clinical investigations with persons deprived of liberty
p.001994: Persons deprived of liberty should not be unreasonably denied the possibility of
p.001994: participate in clinical research or have access to medications, vaccines and other elements of
p.001994: research that may represent therapeutic or preventive benefit for them.
p.001994: Special attention should be given to guarantee the willingness of consent in this
p.001994: population, applying a suitably proven scientific methodology that guarantees
p.001994: reasonably that the consent of the private or the deprived of liberty is unquestionably
p.001994: voluntary.
p.001994: Article sheet
p.001994: CHAPTER X
p.001994: SANCTIONS
p.001994: ARTICLE 70.- Sanitary and administrative measures
p.001994: The Ministry of Health, the Conis or the CEC, as appropriate, should know and dictate the
p.001994: corresponding sanitary and administrative measures to avoid or amend those actions
p.001994: contrary to this law incurred by researchers, sponsors and any other interested party
p.001994: to intervene in a research project; all of the above without prejudice to civil liability,
p.001994: criminal or disciplinary that may correspond to the offender.
p.001994: Article sheet
p.001994: ARTICLE 71.- Precautionary measures
p.001994: During the processing of administrative procedures or investigations in judicial headquarters that
p.001994: question the legality of the activity of the researcher, the sponsor or the CEC, the ICO or the
p.001994: OAC and for the purpose of protecting the health and safety of the participants in an investigation, the
p.001994: competent body may impose the necessary precautionary measures.
p.001994: Investigations may be suspended temporarily or definitively, partially or totally,
p.001994: investigator or the approval of research projects in case the administrative authority or
p.001994: in judicial headquarters it is considered necessary.
p.001994: The competent body, through a well-founded resolution and prior hearing of the interested parties, must
p.001994: resolve whether it confirms, modifies or revokes the action taken. To do this, you must apply the procedure
p.001994: which establishes the Contentious-Administrative Procedural Code.
p.001994: Article sheet
...
Searching for indicator prison:
(return to top)
p.001994: Article sheet
p.001994: ARTICLE 78.- Improper experimentation
p.001994: Who submits a person to research for the application of medicines, drugs,
p.001994: substances, treatments, techniques, devices or procedures, without duly informing you of the
p.001994: experimental condition of these and the risks it runs, and without express consent,
p.001994: written and documented of the victim or his legal representative and authorization of the procedure by
p.001994: part of a CEC; or who has used the victim's inability to issue a
p.001994: consent, duress, threat, deception, misinformation, manipulation or any other
p.001994: illicit means to obtain such consent, will be punished with imprisonment from three to eight
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
p.001994: Opposition to the practice of research.
p.001994: Article sheet
p.001994: ARTICLE 80.- Disability
p.001994: In addition to the corresponding prison sentence, the judicial authority must establish the
p.001994: penalty of disqualification for a period of five to ten years for investigation processes
p.001994: biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person
p.001994: that has committed the acts typified in the previous articles.
p.001994: Article sheet
p.001994: ARTICLE 81.- Influence trafficking with biomedical research
p.001994: Members of ethical committees will be sentenced to one to three years
p.001994: scientists (CEC) and officials of public or private institutions that authorize, facilitate or
p.001994: hire biomedical research in which they participate or have interests
p.001994: economic companies in which they, their spouses or partners, or their relatives by
p.001994: consanguinity or affinity until the third grade inclusive, be part of their boards of directors,
p.001994: Participate directly or by interposite natural or legal person in your share capital, or work
p.001994: as researchers
p.001994: Article sheet
p.001994: ARTICLE 82.- Gifts and coercion
p.001994: A prison sentence of three to five years will be imposed on the member of a scientific ethics committee
p.001994: that accepts any kind of gifts from people or companies that carry out research
p.001994: biomedical, without prejudice to other sanctions and responsibilities that proceed in accordance with the
p.001994: legal system.
p.001994: Article sheet
p.001994: ARTICLE 83.- Offering of gifts and coercion
p.001994: A person who offers gifts or exercises will be imposed three to five years in prison
p.001994: coercion to the members of a CEC to obtain favorable results in the authorization or any
p.001994: stage of the investigation, without prejudice to other sanctions and responsibilities arising from
p.001994: compliance with the legal system.
p.001994: Article sheet
p.001994: ARTICLE 84.- Improper use of privileged information
p.001994: Anyone using his position in the public service or in the private sector uses protocols or
p.001994: medical or social records of patients or users, to locate, recruit or contact participants
p.001994: for the biomedical research that meant economic benefit to him, his spouse or partner, or
p.001994: to his relatives by consanguinity or affinity until the second grade inclusive, will be sanctioned with
p.001994: prison sentence of one to three years, without prejudice to other penalties and responsibilities that may apply
p.001994: in accordance with the legal system.
p.001994: Article sheet
p.001994: CHAPTER XI
p.001994: FINAL PROVISIONS
p.001994: ARTICLE 85.- Violation of privacy
p.001994: The person who discloses or publishes will be punished with a penalty of two to four years in prison,
p.001994: by any means, private information about the participants in a clinical experiment, without the
p.001994: prior consent of these.
p.001994: Article sheet
p.001994: ARTICLE 86.- Regulation
p.001994: The Executive Power shall regulate this law within a period of six months; without
p.001994: However, the lack of regulation will not prevent its application.
p.001994: Article sheet
p.001994: ARTICLE 87.- Derogatory
p.001994: Articles 25, 26, 64, 65, 66, 67 and 68 all of Law No. 5395, General Law of
p.001994: Health, October 30, 1973.
p.001994: Article sheet
p.001994: TRANSITORY I.-
p.001994: CECs of public or private entities are authorized, which, in effect, are hereby
p.001994: law they are operating, to continue doing it and start the approval of clinical investigations
p.001994: in strict compliance with the provisions of this law. However, within six months
p.001994: counted from the constitution and installation of the Conis, such CEC are obliged to
p.001994: be accredited before the Conis adapting to the requirements demanded in the present law for its
p.001994: functioning. After this six month period expires, the CEC that have not requested the respective
p.001994: accreditation, they will automatically lose their authorization to operate.
p.001994: Article sheet
p.001994: TRANSITORY II.-
p.001994: The Ministry of Health is authorized to allocate human, fi nancial and financial resources.
p.001994: any other type, that are required for the operation of the Conis until it has not
p.001994: the funds necessary to operate and fully comply with the functions assigned to it
p.001994: in this law Within the period of six months from the effective date of this law, the Ministry of
p.001994: Health will formulate the corresponding budget that contemplates the content for the allocation of
...
Social / Infant
Searching for indicator infant:
(return to top)
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
p.001994: c) The investigation implies a minimum risk or burden for the people included in the study.
p.001994: Article sheet
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
p.001994: a) That comparable results cannot be obtained in non-pregnant or in-period women
p.001994: breastfeeding
p.001994: b) That the research involves a minimum risk to their health, from the product of the
p.001994: conception at any stage of pregnancy or infant, or that the benefit exceeds the
p.001994: risk.
p.001994: c) That the objective of the investigation is to obtain new knowledge that results in
p.001994: bene fi t of other women or the product of conception at any stage of the
p.001994: Pregnancy or infant.
p.001994: Article sheet
p.001994: ARTICLE 69.- Clinical investigations with persons deprived of liberty
p.001994: Persons deprived of liberty should not be unreasonably denied the possibility of
p.001994: participate in clinical research or have access to medications, vaccines and other elements of
p.001994: research that may represent therapeutic or preventive benefit for them.
p.001994: Special attention should be given to guarantee the willingness of consent in this
p.001994: population, applying a suitably proven scientific methodology that guarantees
p.001994: reasonably that the consent of the private or the deprived of liberty is unquestionably
p.001994: voluntary.
p.001994: Article sheet
p.001994: CHAPTER X
p.001994: SANCTIONS
p.001994: ARTICLE 70.- Sanitary and administrative measures
p.001994: The Ministry of Health, the Conis or the CEC, as appropriate, should know and dictate the
p.001994: corresponding sanitary and administrative measures to avoid or amend those actions
p.001994: contrary to this law incurred by researchers, sponsors and any other interested party
p.001994: to intervene in a research project; all of the above without prejudice to civil liability,
p.001994: criminal or disciplinary that may correspond to the offender.
p.001994: Article sheet
p.001994: ARTICLE 71.- Precautionary measures
p.001994: During the processing of administrative procedures or investigations in judicial headquarters that
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.001994: investigation.
p.001994: c) Alternative, preventive, diagnostic and therapeutic procedures or treatments
p.001994: available.
p.001994: d) Precautions with men and women of reproductive age and follow-up that will be given to the
p.001994: woman and the product, if she had become pregnant during participation in the
p.001994: investigation.
p.001994: e) If the treatment will continue at the end of the study.
p.001994: f) Regarding the insurance policy.
p.001994: g) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: ARTICLE 12.- Approval of informed consent
p.001994: Informed consent and any modification thereto must be approved, foliated and
p.001994: sealed in all its pages by the Scientific Ethical Committee, prior to its presentation to the eventual
p.001994: participants.
p.001994: In the cases of observational investigations, the Scientific Ethical Committee, after analysis
p.001994: exhaustive of the content and scope of the investigation, may exempt from the signature of consent
p.001994: informed, when it considers that this does not affect the rights of the participants.
p.001994: Article sheet
p.001994: ARTICLE 13.- Quality of the information
p.001994: Before any activity related to the investigation is initiated and before it is initiated
p.001994: proceed to sign the informed consent, the participating individual must be informed in his
p.001994: own language, in an appropriate and understandable language, about the nature of research, the
p.001994: procedures, risks and bene fi ts, other therapeutic or diagnostic options, confidentiality
p.001994: of the information collected and about your rights, so that you understand and make the decision to
p.001994: participate or not, freely, voluntarily and consciously, without coercion, coercion, threat, fraud,
p.001994: deception, manipulation or any other type of pressure.
p.001994: The informed consent information must be truthful, clear, accurate and written, so
p.001994: that does not lead to error, deceit or coercion and that can be understood by the participants. For this one
p.001994: In effect, it must be ensured that the procedure for signing informed consent counts
p.001994: with the appropriate time and conditions so that people can understand correctly
p.001994: information.
p.001994: Article sheet
p.001994: ARTICLE 14.- Information of the informed consent
p.001994: The use of information and data relating to people's health is prohibited, with
p.001994: purposes not contemplated or allowed in the informed consent or in the law.
p.001994: The person in charge of the research or clinical trials and those responsible for it may only
p.001994: use the information and data related to the health of the participants in accordance with
p.001994: Article sheet
p.001994: ARTICLE 15.- Modification of conditions
p.001994: Any modification in the risk-benefit ratio or in the conditions that arise
p.001994: During the investigation, the participant must be informed, so that he or she is
p.001994: by granting a new consent or an addendum to the principal, ratify your
p.001994: stay in the study or trial, or decide to withdraw from it.
p.001994: Article sheet
p.001994: ARTICLE 16.- Informed consent in persons with disabilities
p.001994: When people with disabilities participate in a biomedical research, the information
p.001994: required to provide informed consent must be given in accessible conditions and formats
p.001994: and appropriate to your needs.
p.001994: Article sheet
p.001994: ARTICLE 17.- Consent of minors
p.001994: When minors participate in a biomedical research, the consent
p.001994: Informed must be signed by your legal representative or by whoever has your legal representation.
p.001994: In the case of minors, but over twelve years old, you must also
p.001994: count on your informed consent; To do this, they will be informed about the scope of the
p.001994: research, in a language understandable to them.
p.001994: In the event that the minor refuses to agree, his or her criteria prevails over that of
p.001994: your legal representative, as long as your life or your health does not depend on your participation in the
p.001994: research, in accordance with the provisions of Law No. 7739, Childhood and Adolescence Code,
p.001994: of January 6, 1998.
p.001994: All aspects related to informed consent in minors
p.001994: must be valued with the participation of the Scientific Ethical Committee, so that the Committee is
p.001994: guarantor of this.
p.001994: The informed assent must be approved, folded and sealed in all its pages by the
p.001994: CEC, prior to submission to potential participants.
p.001994: Article sheet
p.001994: ARTICLE 18.- Consent of legally disabled persons
p.001994: In the case of biomedical research involving people declared as
p.001994: unable, through a judicial process, informed consent must be signed by your
p.001994: legal representative.
p.001994: Article sheet
p.001994: CHAPTER III
p.001994: BIOLOGICAL SAMPLES OF HUMAN MATERIAL
p.001994: ARTICLE 19.- Use and transfer of biological samples
p.001994: The use of biological samples obtained for purposes not covered and prohibited is prohibited.
p.001994: approved in the informed consent, the law and other applicable regulations.
p.001994: Biological samples may only be transferred abroad, if justified in accordance with the
p.001994: scientific objectives, the technical criteria of the research or the technological limitations of the
...
p.001994: e) When a medical emergency occurs to the participant.
p.001994: f) When the doctor responsible for clinical care requires to know such information to
p.001994: Treatment effects of your patient.
p.001994: Article sheet
p.001994: ARTICLE 26.- Transfer of data
p.001994: The transfer of personal data to third parties outside an investigation where they participate
p.001994: Human beings will require the express and written consent of the participant.
p.001994: If the data obtained from the participant could reveal personal information of their
p.001994: family members, the transfer to third parties will require the express and written consent of all interested parties.
p.001994: Article sheet
p.001994: ARTICLE 27.- Right to information
p.001994: Participants in an investigation are entitled:
p.001994: a) To access, personally or through their legal representative, the results of their
p.001994: analysis, when these have not been subjected to dissociation or anonymization processes, if the
p.001994: Study design allows.
p.001994: b) To be informed about the advances, of the unexpected adverse events that occur
p.001994: present and of the general results of the investigation.
p.001994: c) That the ethnic, cultural and social characteristics of the community or group are respected
p.001994: population to which they belong.
p.001994: d) That all verbal and written information be provided through an understandable lexicon and in
p.001994: The language of the participants.
p.001994: e) To be informed of discovered diseases that are not part of the process of
p.001994: investigation.
p.001994: f) To access and obtain a copy of your personal file, which must include all the
p.001994: information regarding the research or clinical trial.
p.001994: Article sheet
p.001994: ARTICLE 28.- Right to enjoy the benefits that result from the investigation
p.001994: Participants in a clinical investigation will have the right to enjoy for free,
p.001994: they require it, of the preventive, therapeutic and diagnostic treatments generated by the study, if
p.001994: it has been shown that these are beneficial to health, as long as the prescription of these
p.001994: methods or treatments are endorsed by the professionals responsible for the treatment and monitoring
p.001994: of the patient, and in accordance with what is expressed in this law.
p.001994: Article sheet
p.001994: ARTICLE 29.- Right to health care
p.001994: No participant in a biomedical research will lose their right to receive care in
p.001994: health that you would be entitled to receive before, during or after your participation in an investigation.
p.001994: Article sheet
p.001994: ARTICLE 30.- Right to compensation for damages
p.001994: People who have suffered damage to health, as a result of their participation in a
p.001994: investigation, they will receive the corresponding compensation as provided in this law and their
p.001994: regulation.
p.001994: Article sheet
p.001994: ARTICLE 31.- Protection policy for the participants
p.001994: The clinical investigation must be covered by a civil liability policy that protects
p.001994: the participants of the damages and losses derived from the investigation, during the period that lasts,
...
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
p.001994: own and characteristic disease of this or another of high prevalence.
p.001994: b) That the researcher and the sponsor commit, reliably, to respect the
p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
p.001994: Application of this law. They should be considered subordinate groups by reason of authority, between
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
...
Social / Marital Status
Searching for indicator single:
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p.001994: Search in: Document file
p.001994: Search Biomedical Research Regulatory Law
p.001994: No. 9234
p.001994: Advanced Search Menu
p.001994: THE LEGISLATIVE ASSEMBLY
p.001994: Text complete
p.001994: Standard sheet
p.001994: OF THE REPUBLIC OF COSTA RICA
p.001994: Regulations affected
p.001994: Concordances
p.001994: DECREE:
p.001994: Regulations
p.001994: Descriptors
p.001994: text-align: center '> REGULATORY LAW OF BIOMEDICAL RESEARCH
p.001994: PGR pronouncements
p.001994: Constitutional actions and resolutions
p.001994: Related case law
p.001994: CHAPTER I
p.001994: Jurisp of the Treasury
p.001994: GENERAL DISPOSITION
p.001994: Options:
p.001994: ARTICLE 1.- Object of the law
p.001994: save
p.001994: The purpose of this law is to regulate biomedical research with human beings in
p.001994: Print health matters, in the public and private sectors.
p.001994: Article sheet
p.001994: ARTICLE 2.- Definitions
p.001994: For the purposes of this law, the following definitions are established:
p.001994: Autonomy: ability of people to make decisions without the influence of other people
p.001994: or external pressures.
p.001994: Adverse event or reaction that would be attributable to experimentation: occurrence
p.001994: unfavorable that:
p.001994: a) results in death,
p.001994: b) life threatening,
p.001994: c) requires hospitalization of the participant or prolongation of the existing hospitalization,
p.001994: d) produces persistent or significant disability or disability, or produces a congenital anomaly
p.001994: or birth defect.
p.001994: Multicenter study: clinical study conducted according to a single protocol in more than
p.001994: a place and, therefore, made by more than one researcher.
p.001994: Phases of vaccine development:
p.001994: Phase I: refers to the first introduction of a vaccine under trial in a human population
p.001994: to initially determine its safety and its biological effects, including its immunogenicity. Is
p.001994: Phase may include dose studies and routes of administration.
p.001994: Phase II: refers to the initial trials to determine the effectiveness of the vaccine in a
p.001994: limited number of volunteers; This phase focuses on immunogenicity.
p.001994: Phase III: aims to more fully assess the safety and effectiveness in the
p.001994: disease prevention, involving a greater number of volunteers in a study
p.001994: generally multicentre properly controlled.
p.001994: Phases of drug development:
p.001994: Phase I: consists of the introduction of a drug in humans for the first time.
p.001994: Healthy voluntary subjects participate to assess at what levels of drug use observed
p.001994: toxicity. Dose-response studies are continued in patients to determine the
p.001994: medication safety and, in some cases, initial indications of its effectiveness.
p.001994: These studies are intended to establish a preliminary assessment of safety and profile.
p.001994: pharmacokinetic and, when possible, a pharmacodynamic profile. Except duly exceptions
p.001994: based, they are carried out in small groups of healthy volunteer individuals. To this phase
p.001994: the bioequivalence studies also belong, since these are also carried out in
...
Social / Police Officer
Searching for indicator police:
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p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
p.001994: Application of this law. They should be considered subordinate groups by reason of authority, between
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
p.001994: c) The investigation implies a minimum risk or burden for the people included in the study.
p.001994: Article sheet
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
p.001994: a) That comparable results cannot be obtained in non-pregnant or in-period women
p.001994: breastfeeding
p.001994: b) That the research involves a minimum risk to their health, from the product of the
p.001994: conception at any stage of pregnancy or infant, or that the benefit exceeds the
p.001994: risk.
p.001994: c) That the objective of the investigation is to obtain new knowledge that results in
...
Social / Property Ownership
Searching for indicator home:
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p.001994: HOME | PGR SINALEVI | POWER | HACIENDA | IDH COURT | LEGAL DICTIONARY | HELP | SITE MAP
p.001994: JUDICIAL PJ
p.001994: Search: Regulations >> Law 9234 >> Date 04/22/2014 >> Full text Internet
p.001994: Search Articles << Articles >> Standard Sheet
p.001994: Regulations Remember that Control F is an option that allows you to search the entire text
p.001994: Pronouncements
p.001994: Constitutional Affairs Go to the end of the document
p.001994: Year: 50 results
p.001994: - You are in the latest version of the standard-
p.001994: Search in: Document file
p.001994: Search Biomedical Research Regulatory Law
p.001994: No. 9234
p.001994: Advanced Search Menu
p.001994: THE LEGISLATIVE ASSEMBLY
p.001994: Text complete
p.001994: Standard sheet
p.001994: OF THE REPUBLIC OF COSTA RICA
p.001994: Regulations affected
p.001994: Concordances
p.001994: DECREE:
p.001994: Regulations
p.001994: Descriptors
p.001994: text-align: center '> REGULATORY LAW OF BIOMEDICAL RESEARCH
p.001994: PGR pronouncements
p.001994: Constitutional actions and resolutions
p.001994: Related case law
p.001994: CHAPTER I
p.001994: Jurisp of the Treasury
p.001994: GENERAL DISPOSITION
p.001994: Options:
p.001994: ARTICLE 1.- Object of the law
p.001994: save
p.001994: The purpose of this law is to regulate biomedical research with human beings in
p.001994: Print health matters, in the public and private sectors.
p.001994: Article sheet
p.001994: ARTICLE 2.- Definitions
p.001994: For the purposes of this law, the following definitions are established:
p.001994: Autonomy: ability of people to make decisions without the influence of other people
p.001994: or external pressures.
p.001994: Adverse event or reaction that would be attributable to experimentation: occurrence
p.001994: unfavorable that:
p.001994: a) results in death,
...
Searching for indicator property:
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p.001994: The purpose of the Conis will be to guarantee the quality of the investigations and their strict adherence to the
p.001994: human rights. Its members must act with absolute independence of opinion, avoiding
p.001994: in its decisions the influence of political and commercial interests.
p.001994: Article sheet
p.001994: ARTICLE 36.- Formation of the National Health Research Council
p.001994: The Conis will consist of seven proprietary members, each with their respective alternate,
p.001994: who must attend the sessions in the absence of the owner member.
p.001994: The Conis will be integrated by:
p.001994: a) The Minister of Health or the official in whom this delegate and his alternate, who will preside.
p.001994: b) The Minister of Science and Technology or the official in whom this delegate and his substitute. In
p.001994: in case the minister or the minister delegates his representation, both the holder and the substitute
p.001994: They must be research specialists. Otherwise, at least the substitute must be
p.001994: Specialist in this field.
p.001994: c) A human rights lawyer and his deputy, appointed by the College of
p.001994: Costa Rican lawyers.
p.001994: d) A representative of the Costa Rican Social Security Fund (CCSS), preferably from the
p.001994: Center for Strategic Development and Information on Health and Social Security of Social Security
p.001994: (Cendeisss) and his alternate. The Board of Directors may not designate any of the persons who
p.001994: at that time be part of its members.
p.001994: e) A representative of the National Council of Rectors (Conare) and a substitute, who must be
p.001994: bioethics specialist.
p.001994: f) A representative in property and a substitute, member of the Professional Associations of
p.001994: Physicians and surgeons; Pharmacists; Dental and Microbiologist Surgeons, appointed by the
p.001994: boards of the respective professional associations. The regulation of this law will establish
p.001994: the appointment procedure and how they will alternate each year, the charges in
p.001994: ownership and substitution between the four professional colleges, so that the
p.001994: posts.
p.001994: g) A proprietary member and a substitute representing the community, which for that purpose
p.001994: will be appointed by the Ombudsman's Office. The procedure for choosing the
p.001994: representative of the community will be determined by the Ombudsman's Office.
p.001994: The members of the Conis will last in their positions a period of five years and may be
p.001994: re-elected The community representative will be appointed for a maximum period of three years and not
p.001994: may be re-elected The members of the Conis may be dismissed from their positions for the reasons
p.001994: they indicate in the regulation of this law.
p.001994: The members of the Conis may not be named simultaneously in the Conis or in
p.001994: any other scientific ethical committee (CEC).
p.001994: Article sheet
p.001994: ARTICLE 37.- Diets
p.001994: The members of the Conis will be remunerated by per diets per session, whose amount will be
p.001994: to eighty percent (80%) of the allowances paid to the members of the Board of Directors of the Fund
p.001994: Costa Rican Social Security for each session. The number of sessions paid monthly
p.001994: may not exceed ten sessions per month, between ordinary and extraordinary sessions.
p.001994: The Conis will ordinarily meet once a week and, extraordinarily, whenever
p.001994: necessary, by call made by its president or by not less than two of its members.
...
Social / Threat of Stigma
Searching for indicator threat:
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p.001994: f) Regarding the insurance policy.
p.001994: g) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: ARTICLE 12.- Approval of informed consent
p.001994: Informed consent and any modification thereto must be approved, foliated and
p.001994: sealed in all its pages by the Scientific Ethical Committee, prior to its presentation to the eventual
p.001994: participants.
p.001994: In the cases of observational investigations, the Scientific Ethical Committee, after analysis
p.001994: exhaustive of the content and scope of the investigation, may exempt from the signature of consent
p.001994: informed, when it considers that this does not affect the rights of the participants.
p.001994: Article sheet
p.001994: ARTICLE 13.- Quality of the information
p.001994: Before any activity related to the investigation is initiated and before it is initiated
p.001994: proceed to sign the informed consent, the participating individual must be informed in his
p.001994: own language, in an appropriate and understandable language, about the nature of research, the
p.001994: procedures, risks and bene fi ts, other therapeutic or diagnostic options, confidentiality
p.001994: of the information collected and about your rights, so that you understand and make the decision to
p.001994: participate or not, freely, voluntarily and consciously, without coercion, coercion, threat, fraud,
p.001994: deception, manipulation or any other type of pressure.
p.001994: The informed consent information must be truthful, clear, accurate and written, so
p.001994: that does not lead to error, deceit or coercion and that can be understood by the participants. For this one
p.001994: In effect, it must be ensured that the procedure for signing informed consent counts
p.001994: with the appropriate time and conditions so that people can understand correctly
p.001994: information.
p.001994: Article sheet
p.001994: ARTICLE 14.- Information of the informed consent
p.001994: The use of information and data relating to people's health is prohibited, with
p.001994: purposes not contemplated or allowed in the informed consent or in the law.
p.001994: The person in charge of the research or clinical trials and those responsible for it may only
p.001994: use the information and data related to the health of the participants in accordance with
p.001994: Article sheet
p.001994: ARTICLE 15.- Modification of conditions
p.001994: Any modification in the risk-benefit ratio or in the conditions that arise
p.001994: During the investigation, the participant must be informed, so that he or she is
p.001994: by granting a new consent or an addendum to the principal, ratify your
p.001994: stay in the study or trial, or decide to withdraw from it.
p.001994: Article sheet
p.001994: ARTICLE 16.- Informed consent in persons with disabilities
...
p.001994: of appeal before the Conis. The appeal must be filed within five business days of
p.001994: the notification of the corresponding resolution.
p.001994: The resolution imposing a fine shall constitute an executive title against the offender. The Conis or the
p.001994: CEC, as appropriate, will be entitled to collect it.
p.001994: Article sheet
p.001994: ARTICLE 76.-Penalty procedure
p.001994: The sanctioning process will apply the procedure established in Law No. 6227, General Law
p.001994: of the Public Administration, of May 2, 1978.
p.001994: Article sheet
p.001994: ARTICLE 77.- Punishable facts
p.001994: If the breach of the obligations provided for in this law or its regulations result
p.001994: punishable, the Minister of Health, the Conis or the CEC, or who has knowledge of the punishable act, according to
p.001994: Correspond, communicate what is conducive to the Public Prosecutor to promote and exercise the
p.001994: relevant criminal actions.
p.001994: Article sheet
p.001994: ARTICLE 78.- Improper experimentation
p.001994: Who submits a person to research for the application of medicines, drugs,
p.001994: substances, treatments, techniques, devices or procedures, without duly informing you of the
p.001994: experimental condition of these and the risks it runs, and without express consent,
p.001994: written and documented of the victim or his legal representative and authorization of the procedure by
p.001994: part of a CEC; or who has used the victim's inability to issue a
p.001994: consent, duress, threat, deception, misinformation, manipulation or any other
p.001994: illicit means to obtain such consent, will be punished with imprisonment from three to eight
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
p.001994: Opposition to the practice of research.
p.001994: Article sheet
p.001994: ARTICLE 80.- Disability
p.001994: In addition to the corresponding prison sentence, the judicial authority must establish the
p.001994: penalty of disqualification for a period of five to ten years for investigation processes
p.001994: biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person
p.001994: that has committed the acts typified in the previous articles.
p.001994: Article sheet
p.001994: ARTICLE 81.- Influence trafficking with biomedical research
p.001994: Members of ethical committees will be sentenced to one to three years
...
Social / Victim of Abuse
Searching for indicator victim:
(return to top)
p.001994: if the breach sanctioned was from a sponsor or an investigator. In the case of
p.001994: the imposition of fines to the CEC, the product of these will correspond to the Conis.
p.001994: Article sheet
p.001994: ARTICLE 75.- Challenges
p.001994: Against the resolutions issued by the CEC, in the exercise of their powers, there will be recourse
p.001994: of appeal before the Conis. The appeal must be filed within five business days of
p.001994: the notification of the corresponding resolution.
p.001994: The resolution imposing a fine shall constitute an executive title against the offender. The Conis or the
p.001994: CEC, as appropriate, will be entitled to collect it.
p.001994: Article sheet
p.001994: ARTICLE 76.-Penalty procedure
p.001994: The sanctioning process will apply the procedure established in Law No. 6227, General Law
p.001994: of the Public Administration, of May 2, 1978.
p.001994: Article sheet
p.001994: ARTICLE 77.- Punishable facts
p.001994: If the breach of the obligations provided for in this law or its regulations result
p.001994: punishable, the Minister of Health, the Conis or the CEC, or who has knowledge of the punishable act, according to
p.001994: Correspond, communicate what is conducive to the Public Prosecutor to promote and exercise the
p.001994: relevant criminal actions.
p.001994: Article sheet
p.001994: ARTICLE 78.- Improper experimentation
p.001994: Who submits a person to research for the application of medicines, drugs,
p.001994: substances, treatments, techniques, devices or procedures, without duly informing you of the
p.001994: experimental condition of these and the risks it runs, and without express consent,
p.001994: written and documented of the victim or his legal representative and authorization of the procedure by
p.001994: part of a CEC; or who has used the victim's inability to issue a
p.001994: consent, duress, threat, deception, misinformation, manipulation or any other
p.001994: illicit means to obtain such consent, will be punished with imprisonment from three to eight
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
...
Social / Women
Searching for indicator women:
(return to top)
p.001994: s) Clarification of whether there will be any kind of financial compensation for food
p.001994: or transportation
p.001994: t) List of people who can contact if you have questions about the study and
p.001994: Your rights. The list must contain at least the telephone number (s), the address of
p.001994: email, the address of the office and any other suitable data to locate them.
p.001994: u) The name, signature, date, time and place where the participant is summoned to deliver the
p.001994: copy of the document and the place where you subscribe and the identification number of the participant or his
p.001994: legal representative, of the person who explains the informed consent and of the impartial witness
p.001994: who signs the consent and the date on which it is signed.
p.001994: v) The others determined by the regulations of this law and those others that in the opinion of the committees
p.001994: Ethical respective scientists are required.
p.001994: Article sheet
p.001994: ARTICLE 11.- Additional content of informed consent in investigations
p.001994: clinics
p.001994: In clinical research, in addition to what is indicated in the previous article, consent
p.001994: informed must contain:
p.001994: a) Treatment to be used in the investigation, the form and probability of assignment to
p.001994: each treatment
p.001994: b) Known side effects, risks and discomforts of medications or equipment in
p.001994: investigation.
p.001994: c) Alternative, preventive, diagnostic and therapeutic procedures or treatments
p.001994: available.
p.001994: d) Precautions with men and women of reproductive age and follow-up that will be given to the
p.001994: woman and the product, if she had become pregnant during participation in the
p.001994: investigation.
p.001994: e) If the treatment will continue at the end of the study.
p.001994: f) Regarding the insurance policy.
p.001994: g) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: ARTICLE 12.- Approval of informed consent
p.001994: Informed consent and any modification thereto must be approved, foliated and
p.001994: sealed in all its pages by the Scientific Ethical Committee, prior to its presentation to the eventual
p.001994: participants.
p.001994: In the cases of observational investigations, the Scientific Ethical Committee, after analysis
p.001994: exhaustive of the content and scope of the investigation, may exempt from the signature of consent
p.001994: informed, when it considers that this does not affect the rights of the participants.
p.001994: Article sheet
p.001994: ARTICLE 13.- Quality of the information
p.001994: Before any activity related to the investigation is initiated and before it is initiated
p.001994: proceed to sign the informed consent, the participating individual must be informed in his
p.001994: own language, in an appropriate and understandable language, about the nature of research, the
p.001994: procedures, risks and bene fi ts, other therapeutic or diagnostic options, confidentiality
...
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
p.001994: Application of this law. They should be considered subordinate groups by reason of authority, between
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
p.001994: c) The investigation implies a minimum risk or burden for the people included in the study.
p.001994: Article sheet
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
p.001994: a) That comparable results cannot be obtained in non-pregnant or in-period women
p.001994: breastfeeding
p.001994: b) That the research involves a minimum risk to their health, from the product of the
p.001994: conception at any stage of pregnancy or infant, or that the benefit exceeds the
p.001994: risk.
p.001994: c) That the objective of the investigation is to obtain new knowledge that results in
p.001994: bene fi t of other women or the product of conception at any stage of the
p.001994: Pregnancy or infant.
p.001994: Article sheet
p.001994: ARTICLE 69.- Clinical investigations with persons deprived of liberty
p.001994: Persons deprived of liberty should not be unreasonably denied the possibility of
p.001994: participate in clinical research or have access to medications, vaccines and other elements of
p.001994: research that may represent therapeutic or preventive benefit for them.
p.001994: Special attention should be given to guarantee the willingness of consent in this
p.001994: population, applying a suitably proven scientific methodology that guarantees
p.001994: reasonably that the consent of the private or the deprived of liberty is unquestionably
p.001994: voluntary.
p.001994: Article sheet
p.001994: CHAPTER X
p.001994: SANCTIONS
p.001994: ARTICLE 70.- Sanitary and administrative measures
p.001994: The Ministry of Health, the Conis or the CEC, as appropriate, should know and dictate the
p.001994: corresponding sanitary and administrative measures to avoid or amend those actions
p.001994: contrary to this law incurred by researchers, sponsors and any other interested party
p.001994: to intervene in a research project; all of the above without prejudice to civil liability,
p.001994: criminal or disciplinary that may correspond to the offender.
p.001994: Article sheet
p.001994: ARTICLE 71.- Precautionary measures
...
p.001994: part of a CEC; or who has used the victim's inability to issue a
p.001994: consent, duress, threat, deception, misinformation, manipulation or any other
p.001994: illicit means to obtain such consent, will be punished with imprisonment from three to eight
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
p.001994: Opposition to the practice of research.
p.001994: Article sheet
p.001994: ARTICLE 80.- Disability
p.001994: In addition to the corresponding prison sentence, the judicial authority must establish the
p.001994: penalty of disqualification for a period of five to ten years for investigation processes
p.001994: biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person
p.001994: that has committed the acts typified in the previous articles.
p.001994: Article sheet
p.001994: ARTICLE 81.- Influence trafficking with biomedical research
p.001994: Members of ethical committees will be sentenced to one to three years
p.001994: scientists (CEC) and officials of public or private institutions that authorize, facilitate or
p.001994: hire biomedical research in which they participate or have interests
p.001994: economic companies in which they, their spouses or partners, or their relatives by
p.001994: consanguinity or affinity until the third grade inclusive, be part of their boards of directors,
p.001994: Participate directly or by interposite natural or legal person in your share capital, or work
p.001994: as researchers
p.001994: Article sheet
p.001994: ARTICLE 82.- Gifts and coercion
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.001994: The person in charge of the research or clinical trials and those responsible for it may only
p.001994: use the information and data related to the health of the participants in accordance with
p.001994: Article sheet
p.001994: ARTICLE 15.- Modification of conditions
p.001994: Any modification in the risk-benefit ratio or in the conditions that arise
p.001994: During the investigation, the participant must be informed, so that he or she is
p.001994: by granting a new consent or an addendum to the principal, ratify your
p.001994: stay in the study or trial, or decide to withdraw from it.
p.001994: Article sheet
p.001994: ARTICLE 16.- Informed consent in persons with disabilities
p.001994: When people with disabilities participate in a biomedical research, the information
p.001994: required to provide informed consent must be given in accessible conditions and formats
p.001994: and appropriate to your needs.
p.001994: Article sheet
p.001994: ARTICLE 17.- Consent of minors
p.001994: When minors participate in a biomedical research, the consent
p.001994: Informed must be signed by your legal representative or by whoever has your legal representation.
p.001994: In the case of minors, but over twelve years old, you must also
p.001994: count on your informed consent; To do this, they will be informed about the scope of the
p.001994: research, in a language understandable to them.
p.001994: In the event that the minor refuses to agree, his or her criteria prevails over that of
p.001994: your legal representative, as long as your life or your health does not depend on your participation in the
p.001994: research, in accordance with the provisions of Law No. 7739, Childhood and Adolescence Code,
p.001994: of January 6, 1998.
p.001994: All aspects related to informed consent in minors
p.001994: must be valued with the participation of the Scientific Ethical Committee, so that the Committee is
p.001994: guarantor of this.
p.001994: The informed assent must be approved, folded and sealed in all its pages by the
p.001994: CEC, prior to submission to potential participants.
p.001994: Article sheet
p.001994: ARTICLE 18.- Consent of legally disabled persons
p.001994: In the case of biomedical research involving people declared as
p.001994: unable, through a judicial process, informed consent must be signed by your
p.001994: legal representative.
p.001994: Article sheet
p.001994: CHAPTER III
p.001994: BIOLOGICAL SAMPLES OF HUMAN MATERIAL
p.001994: ARTICLE 19.- Use and transfer of biological samples
p.001994: The use of biological samples obtained for purposes not covered and prohibited is prohibited.
p.001994: approved in the informed consent, the law and other applicable regulations.
p.001994: Biological samples may only be transferred abroad, if justified in accordance with the
p.001994: scientific objectives, the technical criteria of the research or the technological limitations of the
p.001994: country. In the case of studies with multicenter design, where it is optimal to standardize the
...
Social / education
Searching for indicator education:
(return to top)
p.001994: Human rights as a frame of reference.
p.001994: Article sheet
p.001994: ARTICLE 5.- Gratuity
p.001994: Participation in a biomedical research should always be voluntary, so you do not
p.001994: will reward the participants. Only expenses incurred by an event may be reimbursed.
p.001994: subject for their participation in the investigation.
p.001994: In the case of bioequivalence studies, in addition to the recognition of expenses, it will be allowed
p.001994: the remuneration to the participant for their voluntary participation. Said remuneration must be
p.001994: previously approved by the CEC, making sure that these payments are proportional to the
p.001994: study design. The scientific ethical committee that evaluates the research must establish and execute
p.001994: special protection measures for the participant during recruitment and development, to protect the
p.001994: principle of autonomy.
p.001994: Article sheet
p.001994: ARTICLE 6.- Obligations of the State
p.001994: It is the obligation of the State, in terms of research with human beings:
p.001994: a) Guarantee the rights and security of the participants involved in the activity
p.001994: researcher
p.001994: b) Ensure compliance with ethical standards that guide research in beings
p.001994: humans.
p.001994: c) Establish strict mechanisms for regulation, control and monitoring of research
p.001994: biomedical, to ensure the protection of the participants and the correct preparation of
p.001994: the investigations.
p.001994: d) Guarantee the right to research in higher education institutions.
p.001994: e) Promote scientific and technical research aimed at solving the needs and
p.001994: health problems of the Costa Rican population.
p.001994: f) Promote scientific and technical research in all the structures of the National System of
p.001994: Health and higher education institutions.
p.001994: g) Promote the training of the personnel of the National Health System in the theoretical principles,
p.001994: Practical and ethical-legal research.
p.001994: h) Promote and encourage the execution of clinical studies, bioequivalence and others contemplated
p.001994: in this law, by the national pharmaceutical industry, in coordination with the institutions
p.001994: public and when these are aimed at solving the health needs and problems of the
p.001994: Costa Rican population
p.001994: Article sheet
p.001994: ARTICLE 7.- Public health research
p.001994: Public health research, observational, will require the approval of the Ethics Committee
p.001994: Scientist, hereinafter CEC, except in the case of investigations of the institutional work of the
p.001994: Ministry of Health or the Costa Rican Social Security Fund and referred to investigations
p.001994: related to:
p.001994: a) Prevention and control of endemic and epidemic diseases that require collection of
p.001994: relevant data for health decisions, such as outbreaks or epidemics.
p.001994: b) Public health surveillance, which incorporates data collection in ballots or files
p.001994: electronic that must be sent to the Ministry of Health to define, based on its analysis
p.001994: epidemiological, prevention and control actions.
p.001994: c) Evaluation of social programs or evaluation of results and impact of interventions
p.001994: in public health.
p.001994: d) Pharmacovigilance intensive medication and vaccines, so that they can be taken
p.001994: actions related to security, warnings or commercialization of these.
p.001994: Investigations of the institutional work will be considered those that the institution
p.001994: must necessarily perform to fulfill the functions assigned to it and that are found
...
p.001994: g) Know, approve or reject requests for renewal of research projects
p.001994: biomedical, within the periods established in the regulations of this law.
p.001994: h) Know, approve or reject the amendments to the original protocol, informed consent and
p.001994: to informed assent.
p.001994: i) Suspend or cancel, at any time, the execution of a project of
p.001994: investigation, if it is determined that the health or well-being of the
p.001994: participants.
p.001994: j) Keep a duly legalized book of records in which all your meetings and a
p.001994: file of each of the projects presented to them for review.
p.001994: k) Follow up on the execution of the projects through the reports submitted
p.001994: periodically the principal investigator and perform, at least once a year, an audit to
p.001994: Each institution and research center. You should also know the finalization report of the
p.001994: study.
p.001994: l) Review, record and communicate to the Conis all serious or unexpected adverse events and
p.001994: most relevant situations that occur during the development of the investigation that are reported
p.001994: to the CEC.
p.001994: m) Preserve and guard the archives of the projects submitted to their knowledge and all the
p.001994: documentation that supports your actions for a period of fifteen years after the
p.001994: Completion of each investigation.
p.001994: n) To send quarterly and annual reports of its management before the Conis, which include the
p.001994: investigations approved, rejected, suspended, canceled and finalized, amendments to
p.001994: active investigations, inspections carried out and the list of active investigations.
p.001994: ñ) Offer training to its members, so that they receive regular training and
p.001994: continuing education in relation to bioethics and biomedical research.
p.001994: o) Guarantee researchers the possibility of presenting the objections they consider
p.001994: necessary in relation to the agreements of the CEC.
p.001994: p) To inform the Conis and the competent institutional authorities of the
p.001994: irregularities or breaches of this law.
p.001994: q) Evacuate immediately the inquiries of the participants of an investigation when
p.001994: request information about your rights, and process, as soon as possible, complaints
p.001994: that these present in relation to the investigation or to the proceeding of an investigator or his
p.001994: human team.
p.001994: r) Comply with the provisions of the Ministry of Health and the Conis regarding their competence.
p.001994: s) The amounts to be paid to the CEC for the review process of the research projects
p.001994: submitted for review, possible approval and for the supervision, renewal and inspection of
p.001994: The approved projects will be those determined by the CEC after the cost analysis
p.001994: corresponding and in accordance with the regulations of this law.
p.001994: t) Keep a record of the publications or presentations made of the results of
p.001994: investigations approved by the committee.
p.001994: u) Notify the National Children's Board when they are approved or renewed
p.001994: investigations of minors, for what it may concern.
p.001994: v) The others established by the regulations of this law.
p.001994: Article sheet
p.001994: ARTICLE 49.- Incompatibilities
p.001994: They may not be part of the CEC:
p.001994: a) The members of the boards of directors of public institutions or private companies
p.001994: promoters of biomedical research, when they participate directly or by interposite person
p.001994: of the capital stock of private companies of this nature or their spouse, partner
...
p.001994: For the purposes of registering a biomedical research project, the principal investigator
p.001994: you must cancel a sum equivalent to three percent (3%) of the total budget of the
p.001994: investigation. For these purposes, the researcher, the sponsor, the OAC or the ICO must present
p.001994: before the CEC a copy of the contract signed with him and it will be the obligation of the CEC to send a copy of this
p.001994: document to the Conis, in accordance with the provisions of this law. This amount must be paid at
p.001994: Conis at the time of requesting the registration of the approved project.
p.001994: The funds corresponding to the fees mentioned in this article will be destined to
p.001994: finance the following activities:
p.001994: a) The proper functioning of the Conis.
p.001994: b) Training of Conis members and their staff in research, regulation and
p.001994: subjects related to the subject.
p.001994: c) Promote interest in biomedical research, either directly or in collaboration
p.001994: with projects or programs organized by the health authorities or the scientific community
p.001994: integrated by the public sector.
p.001994: d) Collaborate and encourage activities to improve the research and dissemination processes of
p.001994: bioethics, and the rights of users of health services and participants in
p.001994: e) Finance projects of interest to public health defined by the Ministry of Health.
p.001994: Article sheet
p.001994: ARTICLE 61.- Exemption
p.001994: The following are exempt from the cancellation of the fee stipulated in the previous article
p.001994: research:
p.001994: a) Those that are classified as of public interest by the Executive Power.
p.001994: b) Those that are considered a health priority by the Ministry of Health.
p.001994: c) Those that are investigations carried out by students of higher education, with the
p.001994: purpose of obtaining an undergraduate, graduate, postgraduate or similar degree.
p.001994: d) Independent researchers without sponsorship, provided their development and results
p.001994: Lack commercial purposes.
p.001994: e) The investigations carried out by the research programs and projects of the
p.001994: State universities.
p.001994: The foregoing shall not apply, under any circumstances, to research sponsored by
p.001994: pharmaceutical transnationals or for profit organizations.
p.001994: Article sheet
p.001994: ARTICLE 62.- Protection of files
p.001994: All information concerning research carried out in human beings must
p.001994: be recorded in the patient's file and be protected for a period of thirty years, in the
p.001994: Health institution or clinic where it was performed.
p.001994: Article sheet
p.001994: ARTICLE 63.- Use of the placebo
p.001994: The possible benefits, risks, costs and effectiveness of all biomedical research should be
p.001994: evaluated by comparison with the best existing proven intervention, except in the
p.001994: following circumstances:
p.001994: a) The use of a placebo is acceptable in studies for which there is no proven intervention or
p.001994: Existing treatment
p.001994: b) When for methodological, scientific and compelling reasons, the use of a placebo is
p.001994: necessary to determine the effectiveness and safety of an intervention that does not imply
p.001994: risk, serious adverse effects or irreversible damage for patients receiving the placebo.
p.001994: Article sheet
p.001994: CHAPTER IX
...
Social / employees
Searching for indicator employees:
(return to top)
p.001994: private contract with the sponsor, the contract research organization (ICO) and / or the
p.001994: researcher, to perform one or more of the tasks and functions of the researcher in the execution of the
p.001994: study. Must be accredited by Conis.
p.001994: Contract research organization: person or organization that signs a contract
p.001994: private with the sponsor, to perform one or more of the work and functions of the sponsor
p.001994: related to the study. Must be accredited by Conis.
p.001994: Participant: individual who participates in a biomedical research project, either as
p.001994: direct receiver of an intervention, as a control, or as an element of observation. The individual
p.001994: it can be a healthy person who voluntarily participates in the investigation, or a person with a
p.001994: condition unrelated to the ongoing research that participates voluntarily, or a
p.001994: person, usually a patient, whose condition is relevant to the use of the product studied or
p.001994: to answer the questions that are being investigated.
p.001994: Sponsor: individual, company, entity or public or private organization, national or
p.001994: foreigner, who takes responsibility for startup, administration, financing and publication
p.001994: of the results of an investigation, and which also assumes the coverage of costs and compensation.
p.001994: Placebo: substance that itself lacks therapeutic action.
p.001994: Impartial witness: a person independent of biomedical research that cannot be
p.001994: in fl uenced by personnel involved in biomedical research (understood as such the sponsor,
p.001994: the contract management organization, the contract research organization, the
p.001994: investigator or officials, employees or representatives of both), or a family member of the
p.001994: participant, who is present in the process of signing the informed consent.
p.001994: Protocol: document that describes the hypothesis, the objective or the objectives, the design, the
p.001994: methodology, statistical considerations and organization of a study. Also, provides
p.001994: the background, the basics and the justification of the study.
p.001994: Article sheet
p.001994: ARTICLE 3.- Protection of the human being
p.001994: The life, health, interest, well-being and dignity of the participants in an investigation in
p.001994: health, in which human beings participate, will prevail over the interest of science, of interests
p.001994: Economic or commercial.
p.001994: All health research involving human beings must respond to an approach of
p.001994: human rights.
p.001994: Article sheet
p.001994: ARTICLE 4.- Principles of biomedical research
p.001994: All health research involving human beings must be governed by the
p.001994: principles of respect for people's dignity, bene fi ciency, non-maleficence, autonomy and justice
p.001994: Distributive
p.001994: In addition to the above, the respective scientific ethical committee must ensure that it complies with the
p.001994: requirements of social and scientific value, scientific validity, non-discriminatory and equitable selection of
p.001994: Participating populations, favorable risk-benefit ratio, independent evaluation, consent
p.001994: Human rights as a frame of reference.
p.001994: Article sheet
...
p.001994: question the legality of the activity of the researcher, the sponsor or the CEC, the ICO or the
p.001994: OAC and for the purpose of protecting the health and safety of the participants in an investigation, the
p.001994: competent body may impose the necessary precautionary measures.
p.001994: Investigations may be suspended temporarily or definitively, partially or totally,
p.001994: investigator or the approval of research projects in case the administrative authority or
p.001994: in judicial headquarters it is considered necessary.
p.001994: The competent body, through a well-founded resolution and prior hearing of the interested parties, must
p.001994: resolve whether it confirms, modifies or revokes the action taken. To do this, you must apply the procedure
p.001994: which establishes the Contentious-Administrative Procedural Code.
p.001994: Article sheet
p.001994: ARTICLE 72.- Infringements of the researcher or the sponsor, the ICO or the OAC
p.001994: The Conis, prior due process, may impose a fine of up to thirty percent (30%) of the
p.001994: total value of the investigation, in case the researcher or the sponsor, the ICO or the OAC incur
p.001994: in any of the following infractions:
p.001994: a) You have provided false information or omitted relevant information during the process of
p.001994: approval or execution of a research project.
p.001994: b) Start a research project without the proper approval of the CEC.
p.001994: c) Breaches or unreasonably delays compliance with the obligations set forth in this
p.001994: law.
p.001994: d) Any other breach of their obligations under the law.
p.001994: To determine the applicable sanction, the seriousness of the offense by the
p.001994: researcher, the sponsor, the ICO or the OAC or the employees, representatives or representatives of the
p.001994: company, and recidivism of the offenses against this law. The Conis will publish the list of researchers,
p.001994: the sponsors, the ICOs or the CAOs sanctioned, on the website of the Ministry of Health.
p.001994: Article sheet
p.001994: ARTICLE 73.- Infringements of the CEC
p.001994: The Conis may impose a fine on employees, representatives or representatives of a CEC
p.001994: up to three hundred times the base salary, in accordance with Law No. 7337, of May 5, 1993, and
p.001994: its reforms, a law that creates the concept of base salary for special crimes of the Criminal Code, in
p.001994: If any of them incur any of the following infractions:
p.001994: a) Breaches or unreasonably delays compliance with the obligations that this law
p.001994: grants, as well as any other obligation provided for in this law, in Law No. 5395, Law
p.001994: General de Salud, of October 30, 1973, in the code of morals or ethics of schools
p.001994: professionals to whom the researchers belong, or in the regulatory provisions of
p.001994: the aforementioned legal bodies, or any other applicable legal norm.
p.001994: b) Do not resolve or channel, in a timely manner, the complaints filed by the persons who
p.001994: They participate in the investigations, for damages suffered.
p.001994: c) Any other breach of their obligations under the law.
p.001994: To determine the applicable penalty, the seriousness of the offense, the degree of
p.001994: fault or the existence of fraud by employees, representatives or representatives of the CEC and its
p.001994: recidivism.
p.001994: Article sheet
p.001994: ARTICLE 74.- Coordination
p.001994: The Ministry of Health and Conis will determine the coordination mechanisms necessary for
p.001994: the most correct and efficient application of controls, special sanitary measures and
p.001994: sanctions provided for in this law. The proceeds of the fines set forth in this article will be distributed from the
p.001994: as follows: fifty percent (50%) to Conis and fifty percent (50%) to CEC, in
p.001994: if the breach sanctioned was from a sponsor or an investigator. In the case of
p.001994: the imposition of fines to the CEC, the product of these will correspond to the Conis.
p.001994: Article sheet
p.001994: ARTICLE 75.- Challenges
p.001994: Against the resolutions issued by the CEC, in the exercise of their powers, there will be recourse
p.001994: of appeal before the Conis. The appeal must be filed within five business days of
p.001994: the notification of the corresponding resolution.
p.001994: The resolution imposing a fine shall constitute an executive title against the offender. The Conis or the
p.001994: CEC, as appropriate, will be entitled to collect it.
p.001994: Article sheet
p.001994: ARTICLE 76.-Penalty procedure
p.001994: The sanctioning process will apply the procedure established in Law No. 6227, General Law
p.001994: of the Public Administration, of May 2, 1978.
p.001994: Article sheet
p.001994: ARTICLE 77.- Punishable facts
p.001994: If the breach of the obligations provided for in this law or its regulations result
p.001994: punishable, the Minister of Health, the Conis or the CEC, or who has knowledge of the punishable act, according to
p.001994: Correspond, communicate what is conducive to the Public Prosecutor to promote and exercise the
p.001994: relevant criminal actions.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.001994: ñ) Measures to access the relevant information for the participant, arising from the
p.001994: research or the total results of this.
p.001994: o) Measures to maintain the confidentiality of the results of the investigation, as well as the
p.001994: information of the participants at the time of the dissemination of the results.
p.001994: p) Indicate any potential future use of the research results.
p.001994: q) Indicate that, in the publications of the research results, the information of the
p.001994: person will remain confidential.
p.001994: r) Statement that participation is voluntary and that the person may withdraw from the
p.001994: research at any time without losing the bene fi ts to which the person of all
p.001994: Forms you have the right, nor to be punished in any way for your withdrawal.
p.001994: s) Clarification of whether there will be any kind of financial compensation for food
p.001994: or transportation
p.001994: t) List of people who can contact if you have questions about the study and
p.001994: Your rights. The list must contain at least the telephone number (s), the address of
p.001994: email, the address of the office and any other suitable data to locate them.
p.001994: u) The name, signature, date, time and place where the participant is summoned to deliver the
p.001994: copy of the document and the place where you subscribe and the identification number of the participant or his
p.001994: legal representative, of the person who explains the informed consent and of the impartial witness
p.001994: who signs the consent and the date on which it is signed.
p.001994: v) The others determined by the regulations of this law and those others that in the opinion of the committees
p.001994: Ethical respective scientists are required.
p.001994: Article sheet
p.001994: ARTICLE 11.- Additional content of informed consent in investigations
p.001994: clinics
p.001994: In clinical research, in addition to what is indicated in the previous article, consent
p.001994: informed must contain:
p.001994: a) Treatment to be used in the investigation, the form and probability of assignment to
p.001994: each treatment
p.001994: b) Known side effects, risks and discomforts of medications or equipment in
p.001994: investigation.
p.001994: c) Alternative, preventive, diagnostic and therapeutic procedures or treatments
p.001994: available.
p.001994: d) Precautions with men and women of reproductive age and follow-up that will be given to the
p.001994: woman and the product, if she had become pregnant during participation in the
p.001994: investigation.
p.001994: e) If the treatment will continue at the end of the study.
p.001994: f) Regarding the insurance policy.
p.001994: g) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: ARTICLE 12.- Approval of informed consent
p.001994: Informed consent and any modification thereto must be approved, foliated and
p.001994: sealed in all its pages by the Scientific Ethical Committee, prior to its presentation to the eventual
p.001994: participants.
p.001994: In the cases of observational investigations, the Scientific Ethical Committee, after analysis
...
p.001994: protection, the conditions that the policy will have and the procedure to access it by the
p.001994: Participants
p.001994: Article sheet
p.001994: ARTICLE 33.- Obligations of the persons participating in a biomedical investigation
p.001994: They will be obligations of the people participating in research in which beings participate
p.001994: human the following:
p.001994: a) Comply with the instructions and instructions provided.
p.001994: b) Timely inform the investigator about the adverse events they present.
p.001994: c) Inform the attending physician of their participation in a clinical investigation.
p.001994: d) The others determined by the regulations of this law.
p.001994: Article sheet
p.001994: CHAPTER V
p.001994: NATIONAL HEALTH RESEARCH COUNCIL
p.001994: ARTICLE 34.- National Health Research Council
p.001994: The National Health Research Council, hereinafter Conis, is created as an organ
p.001994: independent, multidisciplinary, ethical, technical and scientific, attached to the Ministry of Health
p.001994: with a degree of maximum deconcentration and with instrumental legal personality.
p.001994: The Conis will have the administrative structure defined by regulation and will have its own
p.001994: Internal audit in accordance with Law No. 8292, General Internal Control Law, of July 31,
p.001994: 2002, and Law No. 7428, Organic Law of the Comptroller General of the Republic, of September 7,
p.001994: 1994
p.001994: Article sheet
p.001994: ARTICLE 35.- Conis Purposes
p.001994: The purpose of the Conis will be to guarantee the quality of the investigations and their strict adherence to the
p.001994: human rights. Its members must act with absolute independence of opinion, avoiding
p.001994: in its decisions the influence of political and commercial interests.
p.001994: Article sheet
p.001994: ARTICLE 36.- Formation of the National Health Research Council
p.001994: The Conis will consist of seven proprietary members, each with their respective alternate,
p.001994: who must attend the sessions in the absence of the owner member.
p.001994: The Conis will be integrated by:
p.001994: a) The Minister of Health or the official in whom this delegate and his alternate, who will preside.
p.001994: b) The Minister of Science and Technology or the official in whom this delegate and his substitute. In
p.001994: in case the minister or the minister delegates his representation, both the holder and the substitute
p.001994: They must be research specialists. Otherwise, at least the substitute must be
p.001994: Specialist in this field.
p.001994: c) A human rights lawyer and his deputy, appointed by the College of
p.001994: Costa Rican lawyers.
p.001994: d) A representative of the Costa Rican Social Security Fund (CCSS), preferably from the
p.001994: Center for Strategic Development and Information on Health and Social Security of Social Security
p.001994: (Cendeisss) and his alternate. The Board of Directors may not designate any of the persons who
p.001994: at that time be part of its members.
p.001994: e) A representative of the National Council of Rectors (Conare) and a substitute, who must be
p.001994: bioethics specialist.
p.001994: f) A representative in property and a substitute, member of the Professional Associations of
p.001994: Physicians and surgeons; Pharmacists; Dental and Microbiologist Surgeons, appointed by the
...
p.001994: Biomedical research projects, in any of its modalities, the fi gure of silence
p.001994: positive regulated in article 330 of Law No. 6227, General Law of Public Administration, of 2
p.001994: May 1978.
p.001994: Article sheet
p.001994: ARTICLE 58.- Contract
p.001994: Any biomedical research that has external sponsorship to the public or private entity,
p.001994: Where such activity is carried out, you must have a contract by which the rights are regulated and
p.001994: the obligations of both the sponsor and the researcher to carry out the investigation. East
p.001994: contract must indicate the agreed payment for conducting the investigation and include a clause through the
p.001994: which the sponsor is responsible for short and long term adverse events, which are
p.001994: product of this. The absence of such clause does not exempt the sponsor from its responsibility. Saying
p.001994: contract must be signed by the sponsor's representative, the principal investigator and the
p.001994: representative of the public or private entity, and must subscribe before the beginning of the
p.001994: investigation.
p.001994: Article sheet
p.001994: ARTICLE 59.- Prohibition to the hierarchs of public and private institutions
p.001994: The hierarchs and officials of public or private institutions are prohibited from authorizing
p.001994: development of biomedical research or with the same purpose, assign resources of any type of
p.001994: entities under your charge, if such investigations do not have the prior approval of a CEC. The
p.001994: respective authorities of the hospitals of the Costa Rican Social Security Fund, where
p.001994: intends to conduct an experimental clinical investigation, may deny the facilitation of resources
p.001994: to which this article refers, if in your opinion the transfer of any kind of resource could affect the
p.001994: patient care and the medical assistance service in charge of that institution.
p.001994: Article sheet
p.001994: ARTICLE 60.- Canon
p.001994: For the purposes of registering a biomedical research project, the principal investigator
p.001994: you must cancel a sum equivalent to three percent (3%) of the total budget of the
p.001994: investigation. For these purposes, the researcher, the sponsor, the OAC or the ICO must present
p.001994: before the CEC a copy of the contract signed with him and it will be the obligation of the CEC to send a copy of this
p.001994: document to the Conis, in accordance with the provisions of this law. This amount must be paid at
p.001994: Conis at the time of requesting the registration of the approved project.
p.001994: The funds corresponding to the fees mentioned in this article will be destined to
p.001994: finance the following activities:
p.001994: a) The proper functioning of the Conis.
p.001994: b) Training of Conis members and their staff in research, regulation and
p.001994: subjects related to the subject.
p.001994: c) Promote interest in biomedical research, either directly or in collaboration
p.001994: with projects or programs organized by the health authorities or the scientific community
p.001994: integrated by the public sector.
p.001994: d) Collaborate and encourage activities to improve the research and dissemination processes of
p.001994: bioethics, and the rights of users of health services and participants in
p.001994: e) Finance projects of interest to public health defined by the Ministry of Health.
p.001994: Article sheet
p.001994: ARTICLE 61.- Exemption
p.001994: The following are exempt from the cancellation of the fee stipulated in the previous article
p.001994: research:
p.001994: a) Those that are classified as of public interest by the Executive Power.
...
General/Other / Dependent
Searching for indicator dependent:
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p.001994: Article sheet
p.001994: CHAPTER IX
p.001994: RESEARCH WITH VULNERABLE GROUPS
p.001994: ARTICLE 64.- Minors and persons without volitional and cognitive capacity
p.001994: The clinical investigation in which a person with legal disability participates, is a person
p.001994: less or without volitional and cognitive capacity, declared judicially, can only be carried out
p.001994: when the results are expected to produce real or direct benefits to your health, or
p.001994: when comparable results cannot be obtained in older individuals or capable of granting their
p.001994: consent.
p.001994: When it is foreseeable that clinical research will not produce results in direct benefit
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
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General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.001994: HOME | PGR SINALEVI | POWER | HACIENDA | IDH COURT | LEGAL DICTIONARY | HELP | SITE MAP
p.001994: JUDICIAL PJ
p.001994: Search: Regulations >> Law 9234 >> Date 04/22/2014 >> Full text Internet
p.001994: Search Articles << Articles >> Standard Sheet
p.001994: Regulations Remember that Control F is an option that allows you to search the entire text
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p.001994: Advanced Search Menu
p.001994: THE LEGISLATIVE ASSEMBLY
p.001994: Text complete
p.001994: Standard sheet
p.001994: OF THE REPUBLIC OF COSTA RICA
p.001994: Regulations affected
p.001994: Concordances
p.001994: DECREE:
p.001994: Regulations
p.001994: Descriptors
p.001994: text-align: center '> REGULATORY LAW OF BIOMEDICAL RESEARCH
p.001994: PGR pronouncements
p.001994: Constitutional actions and resolutions
p.001994: Related case law
p.001994: CHAPTER I
p.001994: Jurisp of the Treasury
p.001994: GENERAL DISPOSITION
p.001994: Options:
p.001994: ARTICLE 1.- Object of the law
p.001994: save
p.001994: The purpose of this law is to regulate biomedical research with human beings in
p.001994: Print health matters, in the public and private sectors.
p.001994: Article sheet
p.001994: ARTICLE 2.- Definitions
p.001994: For the purposes of this law, the following definitions are established:
p.001994: Autonomy: ability of people to make decisions without the influence of other people
p.001994: or external pressures.
p.001994: Adverse event or reaction that would be attributable to experimentation: occurrence
p.001994: unfavorable that:
p.001994: a) results in death,
p.001994: b) life threatening,
p.001994: c) requires hospitalization of the participant or prolongation of the existing hospitalization,
p.001994: d) produces persistent or significant disability or disability, or produces a congenital anomaly
p.001994: or birth defect.
p.001994: Multicenter study: clinical study conducted according to a single protocol in more than
p.001994: a place and, therefore, made by more than one researcher.
p.001994: Phases of vaccine development:
p.001994: Phase I: refers to the first introduction of a vaccine under trial in a human population
p.001994: to initially determine its safety and its biological effects, including its immunogenicity. Is
p.001994: Phase may include dose studies and routes of administration.
p.001994: Phase II: refers to the initial trials to determine the effectiveness of the vaccine in a
p.001994: limited number of volunteers; This phase focuses on immunogenicity.
p.001994: Phase III: aims to more fully assess the safety and effectiveness in the
p.001994: disease prevention, involving a greater number of volunteers in a study
p.001994: generally multicentre properly controlled.
p.001994: Phases of drug development:
...
p.001994: Placebo: substance that itself lacks therapeutic action.
p.001994: Impartial witness: a person independent of biomedical research that cannot be
p.001994: in fl uenced by personnel involved in biomedical research (understood as such the sponsor,
p.001994: the contract management organization, the contract research organization, the
p.001994: investigator or officials, employees or representatives of both), or a family member of the
p.001994: participant, who is present in the process of signing the informed consent.
p.001994: Protocol: document that describes the hypothesis, the objective or the objectives, the design, the
p.001994: methodology, statistical considerations and organization of a study. Also, provides
p.001994: the background, the basics and the justification of the study.
p.001994: Article sheet
p.001994: ARTICLE 3.- Protection of the human being
p.001994: The life, health, interest, well-being and dignity of the participants in an investigation in
p.001994: health, in which human beings participate, will prevail over the interest of science, of interests
p.001994: Economic or commercial.
p.001994: All health research involving human beings must respond to an approach of
p.001994: human rights.
p.001994: Article sheet
p.001994: ARTICLE 4.- Principles of biomedical research
p.001994: All health research involving human beings must be governed by the
p.001994: principles of respect for people's dignity, bene fi ciency, non-maleficence, autonomy and justice
p.001994: Distributive
p.001994: In addition to the above, the respective scientific ethical committee must ensure that it complies with the
p.001994: requirements of social and scientific value, scientific validity, non-discriminatory and equitable selection of
p.001994: Participating populations, favorable risk-benefit ratio, independent evaluation, consent
p.001994: Human rights as a frame of reference.
p.001994: Article sheet
p.001994: ARTICLE 5.- Gratuity
p.001994: Participation in a biomedical research should always be voluntary, so you do not
p.001994: will reward the participants. Only expenses incurred by an event may be reimbursed.
p.001994: subject for their participation in the investigation.
p.001994: In the case of bioequivalence studies, in addition to the recognition of expenses, it will be allowed
p.001994: the remuneration to the participant for their voluntary participation. Said remuneration must be
p.001994: previously approved by the CEC, making sure that these payments are proportional to the
p.001994: study design. The scientific ethical committee that evaluates the research must establish and execute
p.001994: special protection measures for the participant during recruitment and development, to protect the
p.001994: principle of autonomy.
p.001994: Article sheet
p.001994: ARTICLE 6.- Obligations of the State
p.001994: It is the obligation of the State, in terms of research with human beings:
p.001994: a) Guarantee the rights and security of the participants involved in the activity
p.001994: researcher
p.001994: b) Ensure compliance with ethical standards that guide research in beings
p.001994: humans.
p.001994: c) Establish strict mechanisms for regulation, control and monitoring of research
p.001994: biomedical, to ensure the protection of the participants and the correct preparation of
p.001994: the investigations.
p.001994: d) Guarantee the right to research in higher education institutions.
p.001994: e) Promote scientific and technical research aimed at solving the needs and
p.001994: health problems of the Costa Rican population.
p.001994: f) Promote scientific and technical research in all the structures of the National System of
p.001994: Health and higher education institutions.
p.001994: g) Promote the training of the personnel of the National Health System in the theoretical principles,
p.001994: Practical and ethical-legal research.
p.001994: h) Promote and encourage the execution of clinical studies, bioequivalence and others contemplated
p.001994: in this law, by the national pharmaceutical industry, in coordination with the institutions
p.001994: public and when these are aimed at solving the health needs and problems of the
p.001994: Costa Rican population
p.001994: Article sheet
p.001994: ARTICLE 7.- Public health research
p.001994: Public health research, observational, will require the approval of the Ethics Committee
...
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
p.001994: own and characteristic disease of this or another of high prevalence.
p.001994: b) That the researcher and the sponsor commit, reliably, to respect the
p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
p.001994: Application of this law. They should be considered subordinate groups by reason of authority, between
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
p.001994: c) The investigation implies a minimum risk or burden for the people included in the study.
p.001994: Article sheet
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
p.001994: a) That comparable results cannot be obtained in non-pregnant or in-period women
p.001994: breastfeeding
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.001994: Practical and ethical-legal research.
p.001994: h) Promote and encourage the execution of clinical studies, bioequivalence and others contemplated
p.001994: in this law, by the national pharmaceutical industry, in coordination with the institutions
p.001994: public and when these are aimed at solving the health needs and problems of the
p.001994: Costa Rican population
p.001994: Article sheet
p.001994: ARTICLE 7.- Public health research
p.001994: Public health research, observational, will require the approval of the Ethics Committee
p.001994: Scientist, hereinafter CEC, except in the case of investigations of the institutional work of the
p.001994: Ministry of Health or the Costa Rican Social Security Fund and referred to investigations
p.001994: related to:
p.001994: a) Prevention and control of endemic and epidemic diseases that require collection of
p.001994: relevant data for health decisions, such as outbreaks or epidemics.
p.001994: b) Public health surveillance, which incorporates data collection in ballots or files
p.001994: electronic that must be sent to the Ministry of Health to define, based on its analysis
p.001994: epidemiological, prevention and control actions.
p.001994: c) Evaluation of social programs or evaluation of results and impact of interventions
p.001994: in public health.
p.001994: d) Pharmacovigilance intensive medication and vaccines, so that they can be taken
p.001994: actions related to security, warnings or commercialization of these.
p.001994: Investigations of the institutional work will be considered those that the institution
p.001994: must necessarily perform to fulfill the functions assigned to it and that are found
p.001994: within your operational plan, or in case of emergency.
p.001994: Institutions that carry out this type of research must provide a report of the
p.001994: Final results of the study to Conis.
p.001994: Article sheet
p.001994: ARTICLE 8.- Competence of the Ministry of Health
p.001994: The Ministry of Health, in order to comply with the scope of this law, shall define the policies
p.001994: public for the development of biomedical research.
p.001994: Article sheet
p.001994: CHAPTER II
p.001994: INFORMED CONSENT
p.001994: ARTICLE 9.- Informed consent
p.001994: The participation of an individual in an investigation regulated by this law will require the
p.001994: express, specific, written and signed consent or with the fingerprint of this or its
p.001994: legal representative, on all sheets.
p.001994: Informed consent is the process by which a person confirms,
p.001994: voluntarily, your desire to participate in a biomedical research.
p.001994: The objective of informed consent is to protect the participants, so they cannot
p.001994: become a mechanism to legally protect the researcher, the sponsor, the organization
p.001994: contract management and contract research organization.
p.001994: Article sheet
p.001994: ARTICLE 10.- Minimum content of the informed consent document
p.001994: The information in the informed consent document must be truthful, clear, accurate and
...
p.001994: the results of the analyzes or procedures to which they were submitted and other personal data,
p.001994: except when the law requires otherwise.
p.001994: People or entities that have access to confidential data of the participants must
p.001994: take all necessary measures to ensure that privacy will not be affected, the
p.001994: confidentiality, integrity and dignity of the participants. To this end, anyone who in
p.001994: the exercise of their functions, in an investigation where human beings participate, have access to
p.001994: personal data or confidential documents related to the investigation, will be subject to
p.001994: duty of confidentiality.
p.001994: The obligation of confidentiality does not apply when any of the following conditions exist,
p.001994: which must be consigned and accepted by the participant in the consent
p.001994: informed:
p.001994: a) When required by the scientific ethical committee that approved the research.
p.001994: b) When required by the National Health Research Council, in order to comply with the
p.001994: requirements of an inspection and surveillance of an investigation.
p.001994: c) When the monitor or the auditor of the investigation requires verifying the data contained in the
p.001994: clinical records of the participants of an investigation, for purposes of an audit or
p.001994: follow-up by the sponsor or competent regulatory authority.
p.001994: d) When requested by a competent judicial authority.
p.001994: e) When a medical emergency occurs to the participant.
p.001994: f) When the doctor responsible for clinical care requires to know such information to
p.001994: Treatment effects of your patient.
p.001994: Article sheet
p.001994: ARTICLE 26.- Transfer of data
p.001994: The transfer of personal data to third parties outside an investigation where they participate
p.001994: Human beings will require the express and written consent of the participant.
p.001994: If the data obtained from the participant could reveal personal information of their
p.001994: family members, the transfer to third parties will require the express and written consent of all interested parties.
p.001994: Article sheet
p.001994: ARTICLE 27.- Right to information
p.001994: Participants in an investigation are entitled:
p.001994: a) To access, personally or through their legal representative, the results of their
p.001994: analysis, when these have not been subjected to dissociation or anonymization processes, if the
p.001994: Study design allows.
p.001994: b) To be informed about the advances, of the unexpected adverse events that occur
p.001994: present and of the general results of the investigation.
p.001994: c) That the ethnic, cultural and social characteristics of the community or group are respected
p.001994: population to which they belong.
p.001994: d) That all verbal and written information be provided through an understandable lexicon and in
p.001994: The language of the participants.
p.001994: e) To be informed of discovered diseases that are not part of the process of
...
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
p.001994: particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on
p.001994: health care and / or your limited ability to understand the information provided and express
p.001994: freely your willingness to participate, or both circumstances. Biomedical research
p.001994: they will require additional protection conditions and procedures, when they are carried out on:
p.001994: a) People with disabilities highly dependent on care and attention.
p.001994: b) People with moderate or severe cognitive impairment.
p.001994: c) Serious psychiatric patients, whether or not they are hospitalized.
p.001994: d) People in health emergency situations.
p.001994: e) Critically ill patients with intensive care.
p.001994: f) Patients with terminal diseases.
p.001994: These investigations must meet at least the following conditions:
p.001994: 1) They may not be contrary to the best interests of the patient.
p.001994: 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the
p.001994: standard treatment
p.001994: 3) They may not have a greater risk than the patient's own conditions and methods
p.001994: Treatment alternatives
p.001994: 4) The informed consent process will be implemented to the most reasonable way
p.001994: possible to meet their requirements, including the participation of family members and
p.001994: Authorized representative.
p.001994: 5) In cases where the patient is not the one who gives consent, he will be informed
p.001994: as soon as possible and you can withdraw from the investigation without any consequence for your
p.001994: due attention and care.
p.001994: 6) Any other that defines the regulation to this law.
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.001994: those for whom consent was given.
p.001994: Participants in an investigation will have the right to be saved
p.001994: confidentiality about your identity, personal information and your health, as well as about the treatments or
p.001994: the results of the analyzes or procedures to which they were submitted and other personal data,
p.001994: except when the law requires otherwise.
p.001994: People or entities that have access to confidential data of the participants must
p.001994: take all necessary measures to ensure that privacy will not be affected, the
p.001994: confidentiality, integrity and dignity of the participants. To this end, anyone who in
p.001994: the exercise of their functions, in an investigation where human beings participate, have access to
p.001994: personal data or confidential documents related to the investigation, will be subject to
p.001994: duty of confidentiality.
p.001994: The obligation of confidentiality does not apply when any of the following conditions exist,
p.001994: which must be consigned and accepted by the participant in the consent
p.001994: informed:
p.001994: a) When required by the scientific ethical committee that approved the research.
p.001994: b) When required by the National Health Research Council, in order to comply with the
p.001994: requirements of an inspection and surveillance of an investigation.
p.001994: c) When the monitor or the auditor of the investigation requires verifying the data contained in the
p.001994: clinical records of the participants of an investigation, for purposes of an audit or
p.001994: follow-up by the sponsor or competent regulatory authority.
p.001994: d) When requested by a competent judicial authority.
p.001994: e) When a medical emergency occurs to the participant.
p.001994: f) When the doctor responsible for clinical care requires to know such information to
p.001994: Treatment effects of your patient.
p.001994: Article sheet
p.001994: ARTICLE 26.- Transfer of data
p.001994: The transfer of personal data to third parties outside an investigation where they participate
p.001994: Human beings will require the express and written consent of the participant.
p.001994: If the data obtained from the participant could reveal personal information of their
p.001994: family members, the transfer to third parties will require the express and written consent of all interested parties.
p.001994: Article sheet
p.001994: ARTICLE 27.- Right to information
p.001994: Participants in an investigation are entitled:
p.001994: a) To access, personally or through their legal representative, the results of their
p.001994: analysis, when these have not been subjected to dissociation or anonymization processes, if the
p.001994: Study design allows.
p.001994: b) To be informed about the advances, of the unexpected adverse events that occur
p.001994: present and of the general results of the investigation.
p.001994: c) That the ethnic, cultural and social characteristics of the community or group are respected
p.001994: population to which they belong.
p.001994: d) That all verbal and written information be provided through an understandable lexicon and in
...
p.001994: contract administration, OAC), must sign a contract that establishes the
p.001994: obligations and responsibilities assumed by said organization.
p.001994: y) Forward, to the CEC that approved the investigation and to the Conis, a copy of the publications and / or
p.001994: Certification of participation in scientific activities of the research results.
p.001994: Article sheet
p.001994: ARTICLE 54.- Obligations of the administration organization by contract and of the
p.001994: contract research organization
p.001994: They will be obligations of the contract management organization (hereinafter OAC) and of the
p.001994: contract research organization (hereinafter ICO), the following:
p.001994: a) Send quarterly and annual reports of its management to the CEC.
p.001994: b) Submit to the CEC, for registration, the agreement document signed with the sponsor of the
p.001994: research or with the researcher, in order to know the tasks and functions that have been
p.001994: transferred. Likewise, you must transfer to the CEC any modification to this agreement, in a
p.001994: maximum period of eight business days.
p.001994: c) All those that the sponsor or researcher has transferred through the contract or
p.001994: contractual document signed between them.
p.001994: d) Respond, jointly and severally with the sponsor or investigator, to possible damages or
p.001994: damages caused by the tasks or functions that have been transferred.
p.001994: Article sheet
p.001994: CHAPTER VIII
p.001994: RESEARCH WITH HUMAN BEINGS
p.001994: ARTICLE 55.- Approvals and authorizations
p.001994: All research, before its start, must have the written approval of a CEC
p.001994: duly accredited and, in case it is to be carried out in a public or private health center,
p.001994: It must also have the authorization of the corresponding authority or authorities. None
p.001994: authority, public or private, may authorize an investigation without the approval of the respective CEC.
p.001994: In the case of investigations that require the importation of medicines, equipment,
p.001994: devices and supplies, related to approved investigations, approvals and
p.001994: authorizations indicated in the previous paragraph will be indispensable requirements for their
p.001994: Import to the researcher.
p.001994: Article sheet
p.001994: ARTICLE 56.- Control and monitoring of investigations
p.001994: In all cases, the conduct of the investigation must conform to the content of the
p.001994: project to which the authorization had been granted.
p.001994: The health authorities shall, at all times, have inspection powers over the
p.001994: research, being able to have access to the individual medical records of the participants of the
p.001994: investigation, for which they must keep, in any case, their confidentiality.
p.001994: The health authorities, the Conis or the CEC can cautiously suspend the
p.001994: Authorized investigation in cases where the requirements established
p.001994: this law or when they have indications that the health, integrity and safety of the participants is in
p.001994: danger, having to protect their rights at all times. These measures will proceed in the
p.001994: initial act of the administrative process and must be dictated as a preliminary act, in order to
p.001994: guarantee the rights and security of the participants, and due process. They must also
p.001994: notify all interested parties, including the authorities of the health center where
p.001994: I was conducting the investigation.
p.001994: Article sheet
p.001994: ARTICLE 57.- Inapplicability of positive silence
...
p.001994: Article sheet
p.001994: ARTICLE 66.- Native migrant and collective communities particularly
p.001994: vulnerable
p.001994: Clinical research in vulnerable groups can only be carried out to the extent that
p.001994: accredit the following circumstances:
p.001994: a) That the investigation is carried out with the objective of treating and benefiting the community in some
p.001994: own and characteristic disease of this or another of high prevalence.
p.001994: b) That the researcher and the sponsor commit, reliably, to respect the
p.001994: value system, worldview and culture of the community that will participate in the study, and to
p.001994: adapt the study design and procedures to the customs of each community
p.001994: original.
p.001994: c) That the consent of each participant belonging to an original community be
p.001994: preceded by information provided in the original language of their culture, in case of
p.001994: that does not understand Spanish and that, in any of these cases, the researcher guarantees the
p.001994: understanding of the information and freedom of the decision made by him or the participant.
p.001994: d) That the investigation has the approval of a CEC that met with the presence of a
p.001994: community representative, elected by the same community, and with the authorization of the Conis.
p.001994: Article sheet
p.001994: ARTICLE 67.- Subordinate groups
p.001994: Research involving human beings, which are carried out on people or
p.001994: groups that are under the authority of researchers or that of a third party, or in certain
p.001994: dependency situations that may violate or affect their autonomy, and that do not involve a
p.001994: Direct bene fi t for research participants, they require special attention for the
p.001994: Application of this law. They should be considered subordinate groups by reason of authority, between
p.001994: others, students, residents and / or concurrent of medicine or other health sciences, people
p.001994: deprived of their liberty and police and security officials. These investigations can only
p.001994: be performed when the following conditions are met:
p.001994: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group
p.001994: under study.
p.001994: b) The investigation cannot be carried out in non-subordinate population groups.
p.001994: c) The investigation implies a minimum risk or burden for the people included in the study.
p.001994: Article sheet
p.001994: ARTICLE 68.- Clinical investigations with pregnant women or in period of
p.001994: lactation
p.001994: Pregnant or breastfeeding women should not participate in an investigation
p.001994: clinical, unless the following conditions are met simultaneously:
p.001994: a) That comparable results cannot be obtained in non-pregnant or in-period women
p.001994: breastfeeding
p.001994: b) That the research involves a minimum risk to their health, from the product of the
p.001994: conception at any stage of pregnancy or infant, or that the benefit exceeds the
...
p.001994: Special attention should be given to guarantee the willingness of consent in this
p.001994: population, applying a suitably proven scientific methodology that guarantees
p.001994: reasonably that the consent of the private or the deprived of liberty is unquestionably
p.001994: voluntary.
p.001994: Article sheet
p.001994: CHAPTER X
p.001994: SANCTIONS
p.001994: ARTICLE 70.- Sanitary and administrative measures
p.001994: The Ministry of Health, the Conis or the CEC, as appropriate, should know and dictate the
p.001994: corresponding sanitary and administrative measures to avoid or amend those actions
p.001994: contrary to this law incurred by researchers, sponsors and any other interested party
p.001994: to intervene in a research project; all of the above without prejudice to civil liability,
p.001994: criminal or disciplinary that may correspond to the offender.
p.001994: Article sheet
p.001994: ARTICLE 71.- Precautionary measures
p.001994: During the processing of administrative procedures or investigations in judicial headquarters that
p.001994: question the legality of the activity of the researcher, the sponsor or the CEC, the ICO or the
p.001994: OAC and for the purpose of protecting the health and safety of the participants in an investigation, the
p.001994: competent body may impose the necessary precautionary measures.
p.001994: Investigations may be suspended temporarily or definitively, partially or totally,
p.001994: investigator or the approval of research projects in case the administrative authority or
p.001994: in judicial headquarters it is considered necessary.
p.001994: The competent body, through a well-founded resolution and prior hearing of the interested parties, must
p.001994: resolve whether it confirms, modifies or revokes the action taken. To do this, you must apply the procedure
p.001994: which establishes the Contentious-Administrative Procedural Code.
p.001994: Article sheet
p.001994: ARTICLE 72.- Infringements of the researcher or the sponsor, the ICO or the OAC
p.001994: The Conis, prior due process, may impose a fine of up to thirty percent (30%) of the
p.001994: total value of the investigation, in case the researcher or the sponsor, the ICO or the OAC incur
p.001994: in any of the following infractions:
p.001994: a) You have provided false information or omitted relevant information during the process of
p.001994: approval or execution of a research project.
p.001994: b) Start a research project without the proper approval of the CEC.
p.001994: c) Breaches or unreasonably delays compliance with the obligations set forth in this
p.001994: law.
p.001994: d) Any other breach of their obligations under the law.
p.001994: To determine the applicable sanction, the seriousness of the offense by the
p.001994: researcher, the sponsor, the ICO or the OAC or the employees, representatives or representatives of the
p.001994: company, and recidivism of the offenses against this law. The Conis will publish the list of researchers,
p.001994: the sponsors, the ICOs or the CAOs sanctioned, on the website of the Ministry of Health.
p.001994: Article sheet
p.001994: ARTICLE 73.- Infringements of the CEC
p.001994: The Conis may impose a fine on employees, representatives or representatives of a CEC
...
p.001994: years.
p.001994: Who promotes or conducts biomedical scientific research without having the
p.001994: Informed consent validly granted by the participants or their legal representative, except
p.001994: that the respective CEC has exempted from compliance with such requirement in accordance with this
p.001994: law, or has used coercion, threat, deception, misinformation, manipulation, or
p.001994: any other unlawful means to obtain such consent, a prison sentence of
p.001994: Three to eight years.
p.001994: Article sheet
p.001994: ARTICLE 79.- Severe undue experimentation
p.001994: The prison sentence will be five to ten years, when the behaviors described in the article
p.001994: above are carried out by public officials or are repeat investigators in the
p.001994: sanctioned conduct or when committed to the detriment of minors, women in a state of
p.001994: pregnancy, the elderly and people who are incapable or who for any reason cannot express their
p.001994: Opposition to the practice of research.
p.001994: Article sheet
p.001994: ARTICLE 80.- Disability
p.001994: In addition to the corresponding prison sentence, the judicial authority must establish the
p.001994: penalty of disqualification for a period of five to ten years for investigation processes
p.001994: biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person
p.001994: that has committed the acts typified in the previous articles.
p.001994: Article sheet
p.001994: ARTICLE 81.- Influence trafficking with biomedical research
p.001994: Members of ethical committees will be sentenced to one to three years
p.001994: scientists (CEC) and officials of public or private institutions that authorize, facilitate or
p.001994: hire biomedical research in which they participate or have interests
p.001994: economic companies in which they, their spouses or partners, or their relatives by
p.001994: consanguinity or affinity until the third grade inclusive, be part of their boards of directors,
p.001994: Participate directly or by interposite natural or legal person in your share capital, or work
p.001994: as researchers
p.001994: Article sheet
p.001994: ARTICLE 82.- Gifts and coercion
p.001994: A prison sentence of three to five years will be imposed on the member of a scientific ethics committee
p.001994: that accepts any kind of gifts from people or companies that carry out research
p.001994: biomedical, without prejudice to other sanctions and responsibilities that proceed in accordance with the
p.001994: legal system.
p.001994: Article sheet
p.001994: ARTICLE 83.- Offering of gifts and coercion
p.001994: A person who offers gifts or exercises will be imposed three to five years in prison
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.001994: Researcher: person who exercises a profession recognized in the Costa Rican State,
p.001994: accredited by the Conis to carry out biomedical research, given its scientific training. The
p.001994: Researcher is responsible for conducting the investigation. If it is a team that performs the
p.001994: study in a center, the investigator responsible for the team will be called principal investigator.
p.001994: Contract management organization: person or organization that signs a
p.001994: private contract with the sponsor, the contract research organization (ICO) and / or the
p.001994: researcher, to perform one or more of the tasks and functions of the researcher in the execution of the
p.001994: study. Must be accredited by Conis.
p.001994: Contract research organization: person or organization that signs a contract
p.001994: private with the sponsor, to perform one or more of the work and functions of the sponsor
p.001994: related to the study. Must be accredited by Conis.
p.001994: Participant: individual who participates in a biomedical research project, either as
p.001994: direct receiver of an intervention, as a control, or as an element of observation. The individual
p.001994: it can be a healthy person who voluntarily participates in the investigation, or a person with a
p.001994: condition unrelated to the ongoing research that participates voluntarily, or a
p.001994: person, usually a patient, whose condition is relevant to the use of the product studied or
p.001994: to answer the questions that are being investigated.
p.001994: Sponsor: individual, company, entity or public or private organization, national or
p.001994: foreigner, who takes responsibility for startup, administration, financing and publication
p.001994: of the results of an investigation, and which also assumes the coverage of costs and compensation.
p.001994: Placebo: substance that itself lacks therapeutic action.
p.001994: Impartial witness: a person independent of biomedical research that cannot be
p.001994: in fl uenced by personnel involved in biomedical research (understood as such the sponsor,
p.001994: the contract management organization, the contract research organization, the
p.001994: investigator or officials, employees or representatives of both), or a family member of the
p.001994: participant, who is present in the process of signing the informed consent.
p.001994: Protocol: document that describes the hypothesis, the objective or the objectives, the design, the
p.001994: methodology, statistical considerations and organization of a study. Also, provides
p.001994: the background, the basics and the justification of the study.
p.001994: Article sheet
p.001994: ARTICLE 3.- Protection of the human being
p.001994: The life, health, interest, well-being and dignity of the participants in an investigation in
p.001994: health, in which human beings participate, will prevail over the interest of science, of interests
p.001994: Economic or commercial.
p.001994: All health research involving human beings must respond to an approach of
p.001994: human rights.
p.001994: Article sheet
p.001994: ARTICLE 4.- Principles of biomedical research
p.001994: All health research involving human beings must be governed by the
p.001994: principles of respect for people's dignity, bene fi ciency, non-maleficence, autonomy and justice
p.001994: Distributive
...
p.001994: Participation of the participant in the investigation. Guarantee legal coverage and a policy of
p.001994: civil liability in favor of the researcher and his team, in order to deal with
p.001994: possible claims for injuries or damages attributable to clinical research, as long as no
p.001994: it is due to negligence, inaccuracy or violations of the protocol, in which case the responsibility
p.001994: It is up to the researcher.
p.001994: k) Provide the participant, free of charge and after the conclusion of an investigation
p.001994: clinic, the medication, device or procedure that has been the subject of investigation, except
p.001994: what:
p.001994: i. The medication, device or procedure is no longer effective for the participant or not
p.001994: require, which must be established by the attending physician by resolution
p.001994: duly founded, which will become part of the file and will be communicated to the
p.001994: CEC within three business days after issuance.
p.001994: ii. The development of said medication, device or procedure is suspended.
p.001994: iii. The researcher certifies that it is not essential to preserve the participant's health
p.001994: and there are therapeutic alternatives.
p.001994: iv. The patient does not grant the informed consent required for the continuation of the
p.001994: treatment.
p.001994: l) Notify the investigator, the CEC and the Conis about the reasons that justify the suspension of
p.001994: Biomedical research
p.001994: m) Guarantee the researcher, the CEC and the participants that the suspension of an investigation
p.001994: Biomedical will not affect the latter.
p.001994: n) Certify that in biomedical research the products under investigation (including
p.001994: active comparator and placebo if applicable), be manufactured according to the good ones
p.001994: manufacturing practices, storage conditions indicated, packaging
p.001994: prevent contamination or deterioration during transport and storage, coding
p.001994: and labeling in Spanish and comply with the requirements established by regulation.
p.001994: ñ) Ensure timely delivery of the products under investigation, keep records of the shipment,
p.001994: the reception, disposal, return and destruction of these products.
p.001994: o) Document the financial aspects of the investigation in an agreement between the sponsor and
p.001994: the investigator.
p.001994: p) The sponsor may transfer any or all of its tasks and functions related to the
p.001994: research to a contract research organization (ICO), but will maintain the
p.001994: final responsibility for the quality and integrity of the research data.
p.001994: q) Any task and function related to the investigation, which is transferred and assumed by
p.001994: An ICO must be specified in writing. All obligations described here, which are made
p.001994: to the sponsor in this law, they also apply to the ICO as far as it has assumed the
p.001994: tasks and functions of the sponsor.
p.001994: r) Comply with the provisions of the Ministry of Health, the Conis and the CEC regarding their
p.001994: competition.
p.001994: s) Keep in a file all the documentation of each investigation, for a period of
p.001994: Fifteen years after the conclusion of the investigation.
p.001994: t) Send a copy of the final report and the final results of the investigation to the CEC and the Conis,
p.001994: which must publish them in the digital register that will be created for this purpose.
p.001994: u) Make available to participants the information deemed relevant for the
p.001994: health of these.
p.001994: v) Comply with the ethical, scientific and administrative obligations imposed by the CEC,
...
p.001994: with projects or programs organized by the health authorities or the scientific community
p.001994: integrated by the public sector.
p.001994: d) Collaborate and encourage activities to improve the research and dissemination processes of
p.001994: bioethics, and the rights of users of health services and participants in
p.001994: e) Finance projects of interest to public health defined by the Ministry of Health.
p.001994: Article sheet
p.001994: ARTICLE 61.- Exemption
p.001994: The following are exempt from the cancellation of the fee stipulated in the previous article
p.001994: research:
p.001994: a) Those that are classified as of public interest by the Executive Power.
p.001994: b) Those that are considered a health priority by the Ministry of Health.
p.001994: c) Those that are investigations carried out by students of higher education, with the
p.001994: purpose of obtaining an undergraduate, graduate, postgraduate or similar degree.
p.001994: d) Independent researchers without sponsorship, provided their development and results
p.001994: Lack commercial purposes.
p.001994: e) The investigations carried out by the research programs and projects of the
p.001994: State universities.
p.001994: The foregoing shall not apply, under any circumstances, to research sponsored by
p.001994: pharmaceutical transnationals or for profit organizations.
p.001994: Article sheet
p.001994: ARTICLE 62.- Protection of files
p.001994: All information concerning research carried out in human beings must
p.001994: be recorded in the patient's file and be protected for a period of thirty years, in the
p.001994: Health institution or clinic where it was performed.
p.001994: Article sheet
p.001994: ARTICLE 63.- Use of the placebo
p.001994: The possible benefits, risks, costs and effectiveness of all biomedical research should be
p.001994: evaluated by comparison with the best existing proven intervention, except in the
p.001994: following circumstances:
p.001994: a) The use of a placebo is acceptable in studies for which there is no proven intervention or
p.001994: Existing treatment
p.001994: b) When for methodological, scientific and compelling reasons, the use of a placebo is
p.001994: necessary to determine the effectiveness and safety of an intervention that does not imply
p.001994: risk, serious adverse effects or irreversible damage for patients receiving the placebo.
p.001994: Article sheet
p.001994: CHAPTER IX
p.001994: RESEARCH WITH VULNERABLE GROUPS
p.001994: ARTICLE 64.- Minors and persons without volitional and cognitive capacity
p.001994: The clinical investigation in which a person with legal disability participates, is a person
p.001994: less or without volitional and cognitive capacity, declared judicially, can only be carried out
p.001994: when the results are expected to produce real or direct benefits to your health, or
p.001994: when comparable results cannot be obtained in older individuals or capable of granting their
p.001994: consent.
p.001994: When it is foreseeable that clinical research will not produce results in direct benefit
p.001994: for the health of these participants, the research may be authorized in an exceptional way, if
p.001994: the following conditions will concur:
p.001994: a) That the research aims to contribute to the understanding of the disease or to a
p.001994: beneficial outcome for other people of the same age or with the same disease or
p.001994: condition.
p.001994: b) That the investigation entails a minimum risk and burden for the participant.
p.001994: Article sheet
p.001994: ARTICLE 65.- People highly dependent on health care
p.001994: Clinical investigations should be evaluated with special care when carried out with
...
Orphaned Trigger Words
p.001994: scientific objectives, the technical criteria of the research or the technological limitations of the
p.001994: country. In the case of studies with multicenter design, where it is optimal to standardize the
p.001994: methodology and laboratory test reports, in accordance with the scientific objectives, are
p.001994: It will allow the transfer of samples to a laboratory abroad.
p.001994: In order for biological samples to leave the country, it is required that such information be
p.001994: supplied prior to export, in informed consent and that the participant has
p.001994: consented, except epidemiological situations that put public health at risk.
p.001994: Article sheet
p.001994: ARTICLE 20.- Right to retract for the use of biological samples of material
p.001994: human
p.001994: The participant in a biomedical research assists the right to retract their
p.001994: consent on the possible transfer, storage, handling and use of your biological samples of
p.001994: human material
p.001994: Article sheet
p.001994: ARTICLE 21.- Transfer agreements
p.001994: To transfer any biological sample outside the country, you must have an agreement to
p.001994: transfer of biological material, signed by the legal authorities of the institutions
p.001994: involved, by the researcher and the sending institution, and by the researcher and the institution that
p.001994: receives.
p.001994: Article sheet
p.001994: ARTICLE 22.- Conservation and destruction of biological samples of material
p.001994: human
p.001994: Biological samples of human material will be preserved only as long as they are
p.001994: necessary for the purposes that justified their collection, unless the participant has granted their
p.001994: explicit consent for other later uses. This consent may be revoked by the
p.001994: participant totally or for certain purposes, at any time. When the revocation is
p.001994: referring to any use of the sample, it will proceed to the immediate destruction of this and the laboratory
p.001994: extend a written certificate of the destruction of the sample, except in the case of samples that have
p.001994: been anonymized
p.001994: In case the biological samples of human material are preserved, the participant
p.001994: will be informed of the place and of the conservation conditions, objectives, future uses, assignment to
p.001994: third parties and conditions to request their destruction, according to the rules that apply to the
p.001994: destruction of biological samples, except in the case of samples that have been anonymized.
p.001994: Article sheet
p.001994: ARTICLE 23.- Donation or transfer of biological samples of human material
p.001994: To donate or transfer a biological sample of human material to third parties, you must have
p.001994: specific informed consent for any of those purposes. In this, the
p.001994: place and conditions of conservation, the objectives of this conservation, the future uses of
p.001994: samples and the possibility of transfer of the samples to third parties.
p.001994: The donation and use of human biological samples in an investigation may not
p.001994: Remuneration or other compensation to the participant; it is also prohibited
p.001994: the sale of biological samples that have been obtained for a biomedical investigation.
p.001994: Article sheet
p.001994: CHAPTER IV
p.001994: RIGHTS AND OBLIGATIONS OF PARTICIPANTS
p.001994: ARTICLE 24.- Right to withdraw
p.001994: Participants in an investigation will have, without the need to give explanations, the right to
p.001994: Give up your participation at any time. In those cases in which the abrupt withdrawal
...
p.001994: refrain from taking part in deliberations and voting in which they have a direct interest,
p.001994: indirect or familiar in the matter examined; for this, they must reveal any conflict of interest that
p.001994: It can affect your objectivity.
p.001994: Article sheet
p.001994: ARTICLE 42.- Quorum
p.001994: The quorum will be integrated with the presence of the majority of the members. The agreements will be taken
p.001994: with the concurrent vote of the majority of those present. When there is a tie, the president
p.001994: Will resolve with your vote of quality. The resignation or termination of one of the members shall not imply
p.001994: disintegration of the organ, as long as the quorum required to meet remains.
p.001994: Article sheet
p.001994: ARTICLE 43.- Functions of the Conis
p.001994: They will be functions of the Conis:
p.001994: a) Regulate and supervise and monitor biomedical research and guarantee life,
p.001994: health, interest, well-being and dignity of people.
p.001994: b) Accredit, register and supervise the operation of CECs, both public and private, a
p.001994: contract management organizations (OAC) and research organizations
p.001994: by contract (ICO).
p.001994: c) Accredit researchers who carry out biomedical research.
p.001994: d) Resolve, within a period not exceeding three months, the conflicts between researchers and
p.001994: the CEC.
p.001994: e) Know and timely resolve complaints or claims against investigators,
p.001994: ICO, OACs, CECs or the entities on which they depend.
p.001994: f) Supervise and inspect any OAC, OIC, CEC, researcher or research project
p.001994: to verify compliance with established standards.
p.001994: g) Suspend, for reasons of proven urgency, or cancel at any time, the
p.001994: approval of a research project, if it is determined that freedom is endangered, the
p.001994: dignity, privacy, health or welfare of the participants.
p.001994: h) Suspend, temporarily or permanently, the accreditation of a CEC or researcher, if
p.001994: determines that it is not complying with the provisions of this law.
p.001994: i) Promote and promote training in research bioethics, at the national level in
p.001994: general, and in particular to CECs, to sponsors and researchers.
p.001994: j) Inform, in writing, the health authorities of the health regions of the Ministry of
p.001994: Health, about the investigations approved and that are to be carried out in your jurisdiction.
p.001994: k) Manage the budget allocated in this law.
p.001994: l) Present an annual report of functions to the institutions represented in the Conis.
p.001994: m) Verify that CECs have adequate and sufficient financial resources for their
p.001994: functioning. The Conis may require the entities that constitute the CEC that provide them with
p.001994: adequate and sufficient human and material resources for its proper functioning.
p.001994: n) Keep a national registry of all biomedical research carried out in the
p.001994: private and public centers in the country verifying that the CEC must send at the time of
p.001994: Approve an investigation and before it begins, which will be publicly accessible.
p.001994: ñ) Keep a national registry of the health entities or establishments that you carry out
p.001994: biomedical research
p.001994: o) Establish a national registry of researchers.
p.001994: p) Keep a national registry of research and administration organizations by
p.001994: contract.
p.001994: q) Keep an updated record of the CECs and of the researchers, sponsors, OAC and ICO
p.001994: that have been sanctioned for breach of this law.
p.001994: r) Keep a record of publications and presentations in scientific activities of the
p.001994: Results of biomedical research approved in the country.
...
p.001994: The Ministry of Health will form a CEC that will be in charge of the approval of the tests
p.001994: Phase I clinical, as well as research approval of researchers and / or entities
p.001994: independent, public or private, that do not have a CEC.
p.001994: Those independent investigators and / or public or private entities that do not have a CEC,
p.001994: They may also submit the research project to any CEC duly accredited by the
p.001994: Conis.
p.001994: Public or private entities that create a CEC are required to assure you
p.001994: sufficient independence of criteria and operation, as well as all resources for compliance
p.001994: of your obligations.
p.001994: Article sheet
p.001994: ARTICLE 47.- Integration
p.001994: The CEC must be multidisciplinary in its composition and its members must have
p.001994: recognized honorability, at least one scientific expert with research experience and a
p.001994: person representing the interests of the community, appointed through mechanisms that
p.001994: seek the widest possible consultation and participation, in accordance with the respective regulations.
p.001994: They must have a minimum of five members and will be governed by the rules established in this law
p.001994: and its internal regulations.
p.001994: Both CEC members and support staff must sign an agreement to
p.001994: Confidentiality and declaration of conflict of interest.
p.001994: Article sheet
p.001994: ARTICLE 48.- Functions and obligations of the scientific ethical committees (CEC)
p.001994: The functions and obligations of the CEC are:
p.001994: a) Ensure that biomedical research strictly respects life, health, and
p.001994: interest, well-being and human dignity and rigorous requirements and criteria are met
p.001994: scientifically, as well as the ethical norms that regulate the subject, among them, the process of
p.001994: Informed consent, suitability and experience of researchers, and requirements
p.001994: established in this law.
p.001994: b) Protect the rights, security, freedom, dignity and well-being of the subjects that
p.001994: They participate in a biomedical research.
p.001994: c) Take into consideration the principle of justice, so that the benefits and
p.001994: Disadvantages of research are distributed equally among all groups
p.001994: social classes.
p.001994: d) Dictate its internal operating regulations, which must be approved by Conis as
p.001994: accreditation requirement
p.001994: e) Know, approve or reject research projects in which beings participate
p.001994: human, within the deadlines established in its internal regulations.
p.001994: f) Provide information to update the National Registry of Biomedical Research at
p.001994: time to approve an investigation and before it begins.
p.001994: g) Know, approve or reject requests for renewal of research projects
p.001994: biomedical, within the periods established in the regulations of this law.
p.001994: h) Know, approve or reject the amendments to the original protocol, informed consent and
p.001994: to informed assent.
p.001994: i) Suspend or cancel, at any time, the execution of a project of
p.001994: investigation, if it is determined that the health or well-being of the
p.001994: participants.
p.001994: j) Keep a duly legalized book of records in which all your meetings and a
p.001994: file of each of the projects presented to them for review.
p.001994: k) Follow up on the execution of the projects through the reports submitted
p.001994: periodically the principal investigator and perform, at least once a year, an audit to
p.001994: Each institution and research center. You should also know the finalization report of the
p.001994: study.
p.001994: l) Review, record and communicate to the Conis all serious or unexpected adverse events and
p.001994: most relevant situations that occur during the development of the investigation that are reported
p.001994: to the CEC.
p.001994: m) Preserve and guard the archives of the projects submitted to their knowledge and all the
...
p.001994: Article sheet
p.001994: ARTICLE 50.- Budget and resources
p.001994: The entities that constitute a CEC must provide them with human and material resources
p.001994: necessary to fulfill its functions and obligations.
p.001994: Article sheet
p.001994: CHAPTER VII
p.001994: OBLIGATIONS OF THE INVESTIGATOR,
p.001994: SPONSORS, ORGANIZATIONS
p.001994: OF ADMINISTRATION BY CONTRACT
p.001994: AND RESEARCH ORGANIZATIONS
p.001994: BY CONTRACT
p.001994: ARTICLE 51.- Obligations of the researcher
p.001994: The obligations of the researcher responsible for the execution of biomedical research are:
p.001994: a) Strictly respect life, health and human dignity and meet the requirements and
p.001994: criteria of scientific rigor, as well as the ethical norms that regulate the subject and
p.001994: requirements established in this law.
p.001994: b) Stay updated on bioethical aspects and good clinical practices.
p.001994: c) Ensure that the conduct of biomedical research implies, in all cases, that
p.001994: routine care, procedures and treatments that participants require are put before the
p.001994: investigation Development.
p.001994: d) Have academic training, training and experience to take responsibility
p.001994: of the proper conduct of biomedical research.
p.001994: e) Have a sufficient number of qualified personnel and adequate facilities to carry
p.001994: conducted biomedical research
p.001994: f) Ensure that the members that are part of the research team have the qualification and
p.001994: adequate experience for the proposed research within the exercise of your profession, in
p.001994: concordance with the provisions of Law No. 5395, General Health Law, of October 30,
p.001994: 1973. In the case of students carrying out undergraduate, graduate and postgraduate studies, the CEC
p.001994: respective may exempt them from this requirement to the extent that this does not imply a risk to
p.001994: participants.
p.001994: g) Present the investigation protocol before the duly accredited CEC and, before initiating
p.001994: any activity related to the investigation, have the respective approval.
p.001994: h) Be completely familiar with the investigation and consent protocol
p.001994: informed and, in case of clinical trials, with the investigator's brochure and with the medication,
p.001994: research equipment or material.
p.001994: i) Comply with the provisions of the research protocol approved by the CEC.
p.001994: j) Ensure the obtaining of informed consent in a correct and timely manner by
p.001994: of the participant or his legal representative, when the corresponding CEC has not exempted him
p.001994: of said requirement.
p.001994: k) Keep track of medications, equipment or materials in clinical trials.
p.001994: l) Ensure that the reported data of the biomedical research are accurate, legible, are
p.001994: complete and in the required time.
p.001994: m) Ensure that the persons for whom the special risk research journal is
p.001994: excluded from this.
p.001994: n) To send to the respective CEC, for its revision, all the amendments that occur to the
p.001994: protocol before the changes can be implemented, provided that this does not imply a
p.001994: risk for participants.
p.001994: ñ) Send the international security reports to the respective CEC, in case of investigations
p.001994: or multicenter studies.
p.001994: o) Inform the CEC, within a maximum period of twenty-four hours, of all adverse events
p.001994: serious or unexpected problems occurred in the biomedical research under your charge.
p.001994: p) Send reports to the CEC about the progress of the investigation, through reports
p.001994: quarterly and yearly.
p.001994: q) Offer advice to research participants during the entire development of
p.001994: This, about your rights.
p.001994: r) Ensure, through adequate control, that the potential health benefits of
p.001994: Participants outweigh the risks.
p.001994: s) Inform the participants and the CEC immediately, in case of early termination of the
p.001994: investigation, a detailed explanation of this suspension. In case of clinical trials,
p.001994: ensure appropriate treatment and follow-up for each of the participants.
p.001994: t) Keep in a file all the documentation of each investigation, for a period of fifteen
p.001994: years after the conclusion of the investigation.
p.001994: u) Send a copy of the final report and the final results of the investigation, according to the
p.001994: CEC requirements that approved it.
p.001994: v) Make available to participants the information deemed relevant for the
p.001994: health of these.
p.001994: w) Comply with the ethical, scientific and administrative obligations imposed on it by the
p.001994: research sponsor, the CEC, the Conis or any regulatory entity, with the interest of
p.001994: verify the protection of the rights of the participants in the investigation, in accordance with the
p.001994: current legislation.
p.001994: x) Declare any possible conflict of interest before and during the investigation.
p.001994: and) When you designate an organization to conduct an investigation (organization of
p.001994: administration by contract), you must sign a contract in which the
p.001994: obligations and responsibilities assumed by said organization.
p.001994: z) Comply with the provisions of the Ministry of Health, the Conis and the CEC regarding their
p.001994: competition.
p.001994: a) Forward, to the CEC that approved the investigation and to the Conis, a copy of the publications and / or
p.001994: Certification of participation in scientific activities of the research results.
p.001994: Article sheet
p.001994: ARTICLE 52.- Publication of results of biomedical research
p.001994: It is the obligation of the researcher to publish or present, in any congress or scientific activity, the
p.001994: Results of the biomedical research carried out. By publishing the results of
p.001994: Biomedical research, researchers must respect the accuracy of the data and results
p.001994: obtained, and disclose both positive and negative results, include the information
p.001994: corresponding to the sources of research funding and the sponsoring entities, and
p.001994: indicate the institution or health institutions where the research was carried out. Likewise
p.001994: In the publications, respect for the right of confidentiality of the
p.001994: participants.
p.001994: The Conis may dispense with the publication of the results of biomedical research,
p.001994: when it comes to results with few contributions.
p.001994: Article sheet
p.001994: ARTICLE 53.- Obligations of the sponsor
p.001994: The sponsor's obligations are:
p.001994: a) Ensure and document that electronic data systems meet the requirements of
...
p.001994: prevent contamination or deterioration during transport and storage, coding
p.001994: and labeling in Spanish and comply with the requirements established by regulation.
p.001994: ñ) Ensure timely delivery of the products under investigation, keep records of the shipment,
p.001994: the reception, disposal, return and destruction of these products.
p.001994: o) Document the financial aspects of the investigation in an agreement between the sponsor and
p.001994: the investigator.
p.001994: p) The sponsor may transfer any or all of its tasks and functions related to the
p.001994: research to a contract research organization (ICO), but will maintain the
p.001994: final responsibility for the quality and integrity of the research data.
p.001994: q) Any task and function related to the investigation, which is transferred and assumed by
p.001994: An ICO must be specified in writing. All obligations described here, which are made
p.001994: to the sponsor in this law, they also apply to the ICO as far as it has assumed the
p.001994: tasks and functions of the sponsor.
p.001994: r) Comply with the provisions of the Ministry of Health, the Conis and the CEC regarding their
p.001994: competition.
p.001994: s) Keep in a file all the documentation of each investigation, for a period of
p.001994: Fifteen years after the conclusion of the investigation.
p.001994: t) Send a copy of the final report and the final results of the investigation to the CEC and the Conis,
p.001994: which must publish them in the digital register that will be created for this purpose.
p.001994: u) Make available to participants the information deemed relevant for the
p.001994: health of these.
p.001994: v) Comply with the ethical, scientific and administrative obligations imposed by the CEC,
p.001994: the Conis or by any regulatory entity, with the interest of verifying the protection of dignity and
p.001994: of the rights of the participants in the investigation, in accordance with current legislation and
p.001994: International ethical guidelines for experimental clinical research.
p.001994: w) Declare any possible conflict of interest before and during the conduct of the
p.001994: investigation.
p.001994: x) When you designate an organization to conduct an investigation (organization of
p.001994: contract administration, OAC), must sign a contract that establishes the
p.001994: obligations and responsibilities assumed by said organization.
p.001994: y) Forward, to the CEC that approved the investigation and to the Conis, a copy of the publications and / or
p.001994: Certification of participation in scientific activities of the research results.
p.001994: Article sheet
p.001994: ARTICLE 54.- Obligations of the administration organization by contract and of the
p.001994: contract research organization
p.001994: They will be obligations of the contract management organization (hereinafter OAC) and of the
p.001994: contract research organization (hereinafter ICO), the following:
p.001994: a) Send quarterly and annual reports of its management to the CEC.
p.001994: b) Submit to the CEC, for registration, the agreement document signed with the sponsor of the
p.001994: research or with the researcher, in order to know the tasks and functions that have been
p.001994: transferred. Likewise, you must transfer to the CEC any modification to this agreement, in a
p.001994: maximum period of eight business days.
p.001994: c) All those that the sponsor or researcher has transferred through the contract or
p.001994: contractual document signed between them.
p.001994: d) Respond, jointly and severally with the sponsor or investigator, to possible damages or
p.001994: damages caused by the tasks or functions that have been transferred.
p.001994: Article sheet
p.001994: CHAPTER VIII
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| breastfeeding | breastfeeding |
| children | Child |
| cognitive | Cognitive Impairment |
| criminal | criminal |
| dependence | Drug Dependence |
| dependent | Dependent |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| elderly | Elderly |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| family | Motherhood/Family |
| home | Property Ownership |
| hospitalized | hospitalized patients |
| ill | ill |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| infant | Infant |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| migrant | migrant |
| minor | Youth/Minors |
| native | Indigenous |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| placebo | participants in a control group |
| police | Police Officer |
| political | political affiliation |
| pregnant | Pregnant |
| prison | Incarcerated |
| property | Property Ownership |
| single | Marital Status |
| substance | Drug Usage |
| terminal | Terminally Ill |
| threat | Threat of Stigma |
| unlawful | Illegal Activity |
| victim | Victim of Abuse |
| volunteers | Healthy People |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| cognitive | ['impairment'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| drug | ['influence', 'substance'] |
| home | ['property'] |
| impairment | ['cognitive'] |
| influence | ['drug', 'substance'] |
| liberty | ['prison'] |
| party | ['political'] |
| political | ['party'] |
| prison | ['liberty'] |
| property | ['home'] |
| substance | ['drug', 'influence'] |
Trigger Words
capacity
coercion
consent
cultural
ethics
justice
protect
protection
risk
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input