Table
ARTICLE 1.- Object of the law
The purpose of this law is to regulate biomedical research with human beings in health matters, in the public and private sectors.
ARTICLE 2.- Definitions
For the purposes of this law, the following definitions are established:
Autonomy: people’s ability to make decisions without influence from other people or external pressure.
Adverse event or reaction that would be attributable to the experimentation: unfavorable occurrence that:
a) results in death,
b) threatens life,
c) requires hospitalization of the participant or extension of the existing hospitalization,
d) produces persistent or significant incapacity or invalidity, or produces a congenital anomaly or birth defect.
Multicentre study: a clinical study conducted according to a single protocol in more than one place and, therefore, carried out by more than one investigator.
Vaccine development phases:
Phase I – refers to the first introduction of a trial vaccine in a human population to initially determine its safety and biological effects, including its immunogenicity. This phase may include dose and route of administration studies.
Phase II – refers to the initial trials to determine the effectiveness of the vaccine in a limited number of volunteers; this phase focuses on immunogenicity.
Phase III : aims to more fully assess safety and effectiveness in disease prevention, involving a larger number of volunteers in a generally well-controlled multicenter study.
Drug development phases:
Phase I: consists of the introduction of a drug in humans for the first time. Healthy volunteer subjects participate to assess at what levels of drug use toxicity is observed. Dose-response studies in patients are continuing to determine drug safety and, in some cases, early indications of effectiveness.
These studies aim to establish a preliminary evaluation of the safety and pharmacokinetic profile and, where possible, a pharmacodynamic profile. Except for duly substantiated exceptions, they are carried out in small groups of healthy volunteer individuals. Bioequivalence studies also belong to this phase, since these are also carried out on healthy volunteers.
Phase II – consists of controlled clinical trials, designed to demonstrate effectiveness and relative safety. It is usually performed on a limited number of closely supervised patients.
Phase III: it is carried out after establishing a reasonable probability of the drug’s effectiveness and its objective is to obtain additional information on its effectiveness for specific indications and a more precise definition of the adverse effects associated with the drug. This phase includes controlled and uncontrolled studies.
Phase IV: Trials are conducted after the national drug registration authority has approved a drug for distribution or marketing. These trials may include research designed to explore a specific pharmacological effect, establish the frequency of adverse reactions, or determine the effects of long-term administration of a drug.
Intervention: all actions of any order, related to research with human beings, that may affect in whole or in part, individually or collectively, in one way or another, the dignity and identity, integrity and well-being of people. or any of your human rights and fundamental freedoms. This type of research differs from observational studies in which there is no intervention.
Biomedical research – a type of activity designed to develop or contribute to generalizable knowledge regarding health in humans. It can be observational, epidemiological, or non-interventional or experimental, clinical or interventional. For the purposes of this law, any reference to research shall be understood as biomedical research with human beings in health matters.
Observational, epidemiological or non-interventional biomedical research: research in which no diagnostic or therapeutic intervention is carried out for experimental purposes, nor are the participating individuals subjected to conditions controlled by the researcher. For the purposes of this law, any reference to observational research shall be understood as observational, epidemiological or non-interventional biomedical research in human beings in health matters.
Experimental, clinical or interventional biomedical research: any scientific research in the area of health in which a preventive, diagnostic or therapeutic intervention is applied to human beings, in order to discover or verify the clinical, pharmacological or pharmacodynamic effects of an experimental product, a medical device or a clinical or surgical procedure; or that attempts to identify any adverse reaction to an experimental product, device, or procedure; or study the absorption, distribution, metabolism and excretion of an experimental product, in order to assess its safety and efficacy or assess the outcome of an unproven psychological intervention. For the purposes of this law, all references to clinical research shall be understood as experimental, clinical or interventional biomedical research in human beings in the area of health.
Researcher: person who exercises a recognized profession in the Costa Rican State, accredited by the CONIS to carry out biomedical research, given their scientific training. The investigator is responsible for conducting the investigation. If a team conducts the study at a center, the investigator responsible for the team will be called the principal investigator.
Contract administration organization: person or organization that signs a private contract with the sponsor, the contract research organization (CRO) and/or the investigator, to perform one or more of the tasks and functions of the investigator in the execution of the study . It must be accredited by the Conis.
Contract Research Organization : A person or organization that enters into a private contract with the sponsor, to perform one or more of the sponsor’s tasks and functions related to the study. It must be accredited by the Conis.
Participant: individual who participates in a biomedical research project, either as a direct recipient of an intervention, as a control, or as an element of observation. The individual may be a healthy person who voluntarily participates in the investigation, or a person with a condition unrelated to the ongoing investigation who participates voluntarily, or a person, usually a patient, whose condition is relevant to the use of the product under study or to answer the questions being investigated.
Sponsor: individual, company, entity or public or private organization, national or foreign, that takes responsibility for the initiation, administration, financing and publication of the results of an investigation, and that also assumes the coverage of costs and compensation.
Placebo: substance that lacks by itself therapeutic action.
Impartial Witness: A person independent of biomedical research who cannot be influenced by personnel involved in biomedical research (meaning sponsor, contract management organization, contract research organization, researcher, or officers, employees, or representatives of both), or a relative of the participant, who is present in the process of signing the informed consent.
Protocol: A document that describes the hypothesis, objective(s), design, methodology, statistical considerations, and organization of a study. It also provides the background, rationale, and rationale for the study.
ARTICLE 3.- Protection of the human being
The life, health, interest, well-being and dignity of the participants in health research, in which human beings participate, shall prevail over the interest of science, economic or commercial interests.
All health research in which human beings participate must respond to a human rights approach.
ARTICLE 4.- Principles of biomedical research
All health research in which human beings participate must be governed by the principles of respect for the dignity of persons, beneficence, non-maleficence, autonomy and distributive justice.
In addition to the above, the respective scientific ethics committee must ensure that it meets the requirements of social and scientific value, scientific validity, non-discriminatory and equitable selection of the participating populations, favorable risk-benefit ratio, independent evaluation, informed consent and respect for participants. All scientific research must respond to a human rights approach as a frame of reference.
ARTICLE 5.- Gratuity
Participation in biomedical research must always be voluntary, so participants will not be paid. Only expenses eventually incurred by a subject for her participation in the research may be reimbursed.
In the case of bioequivalence studies, in addition to the recognition of expenses, remuneration to the participant for their voluntary participation will be allowed. Said remuneration must be previously approved by the CEC, ensuring that these payments are proportional to the design of the study. The scientific ethics committee that evaluates the research must establish and execute special protection measures for the participant during recruitment and development, to protect the principle of autonomy.
ARTICLE 6.- Obligations of the State
It is the obligation of the State, in the matter of research with human beings:
a) Guarantee the rights and safety of the participants involved in the research activity.
b) Ensure compliance with the ethical standards that guide research on human beings.
c) Establish strict mechanisms for the regulation, control and monitoring of biomedical research, which ensure the protection of the participants and the correct preparation of the research.
d) Guarantee the right to research in higher education institutions.
e) Promote scientific and technical research aimed at solving the needs and health problems of the Costa Rican population.
f) Promote scientific and technical research in all the structures of the National Health System and in higher education institutions.
g) Promote the training of the staff of the National Health System in the theoretical, practical and ethical-legal principles of research.
h) Promote and encourage the execution of clinical studies, bioequivalence and others contemplated in this law, by the national pharmaceutical industry, in coordination with public institutions and when these are aimed at solving the needs and health problems of the population Costa Rican.
ARTICLE 7.- Public health research
Research in public health, of an observational type, will require the approval of the Scientific Ethics Committee, hereinafter CEC, except in the case of research that is part of the institutional work of the Ministry of Health or the Costa Rican Social Security Fund and refers to research related to with:
a) Prevention and control of endemic and epidemic diseases that require the collection of relevant data for health decisions, as in the case of outbreaks or epidemics.
b) Surveillance in public health, which incorporates the collection of data in ballots or electronic files that must be sent to the Ministry of Health to define, based on its epidemiological analysis, prevention and control actions.
c) Evaluation of social programs or evaluation of results and impact of interventions in public health.
d) Intensive pharmacovigilance of drugs and vaccines, so that actions related to their safety, warnings or marketing can be taken.
Investigations of the institutional work will be considered those that the institution must necessarily carry out to fulfill the functions assigned to it and that are within its operational plan, or in the case of emergencies.
The institutions that carry out this type of research must give a report of the final results of the study to the CONIS.
ARTICLE 8.- Competence of the Ministry of Health
The Ministry of Health, to comply with the scope of this law, will define public policies for the development of biomedical research.
CHAPTER II
INFORMED CONSENT
ARTICLE 9.- Informed consent
The participation of an individual in an investigation regulated by this law will require the express, specific, written and signed consent or with the fingerprint, of this or his legal representative, on all pages.
Informed consent is the process by which a person voluntarily confirms their desire to participate in biomedical research.
The purpose of informed consent is to protect the participants, so it cannot become a mechanism to legally protect the researcher, the sponsor, the contract administration organization and the contract research organization.
ARTICLE 10.- Minimum content of the informed consent document
The information in the informed consent document must be truthful, clear, precise and written in a way that can be understood by the participants and that is not misleading or coercive. It must contain at least:
a) Statement that the study involves research.
b) Identity of the professional responsible for the investigation and their collaborators.
c) Explanation of the objective and purpose of the investigation.
d) Source of funding for the research project.
e) Approximate number and characteristics of the people who will participate.
f) Expected duration of the person’s participation.
g) Procedures to be followed.
h) In the case of obtaining blood samples and other types of biological material, there must be the consent and the right to withdraw from the participant regarding the transfer of biological samples of human material, the tests that will be carried out, where they will be analyzed and if the results of these will be delivered or not. If you intend to keep them, you must indicate where, for how long and for what purposes.
i) Description of the risks or inconveniences that may arise with the investigation.
j) Measures to respond to eventual inconveniences or adverse events that arise.
k) Measures to ensure adequate compensation in the event that the participant suffers any damage as a result of the investigation.
l) Description of the expected benefits for the participant or for others.
m) Manifestation of the strict confidentiality of the information and the measures that will be taken to ensure it.
n) Information on the persons who will have access to the records to verify investigation procedures and data.
ñ) Measures to access relevant information for the participant, arising from the investigation or its total results.
o) Measures to maintain the confidentiality of the results of the investigation, as well as the information of the participants at the time of disclosure of the results.
p) Indicate any potential future use of the research results.
q) Indicate that, in the publications of the results of the investigation, the information of the person will remain confidential.
r) Statement that participation is voluntary and that the person can withdraw from the research at any time without losing the benefits to which the person is otherwise entitled, or being punished in any way for their withdrawal.
s) Clarification of whether any type of economic compensation will be given for food or transportation.
t) List of people you can contact if you have questions about the study and your rights. The list must contain at least the telephone number or numbers, the email address, the office address and any other data suitable for locating them.
u) The name, signature, date, time and place where the participant is summoned to deliver the copy of the document and the place where it is signed and the identification number of the participant or his legal representative, of the person who explains the informed consent and the impartial witness who signs the consent and the date it is signed.
v) The others determined by the regulations of this law and those others that in the opinion of the respective scientific ethics committees are required.
ARTICLE 11.- Additional content of informed consent in clinical research
In clinical research, in addition to what is indicated in the previous article, the informed consent must contain:
a) Treatment to be used in the research, the form and probability of assignment to each treatment.
b) Known side effects, risks and discomforts of the drugs or equipment under investigation.
c) Available alternative, preventive, diagnostic and therapeutic procedures or treatments.
d) Precautions with men and women of reproductive age and follow-up that will be given to the woman and the product, in case of becoming pregnant during participation in the research.
e) If the treatment will be continued at the end of the study.
f) Regarding the insurance policy.
g) Others determined by the regulations of this law.
ARTICLE 12.- Approval of informed consent
The informed consent and any modification to it must be approved, numbered and stamped on all its pages by the Scientific Ethics Committee, prior to its presentation to the eventual participants.
In the cases of observational research, the Scientific Ethics Committee, after an exhaustive analysis of the content and scope of the research, may waive the signing of the informed consent, when it considers that this does not affect the rights of the participants.
ARTICLE 13.- Information quality
Before any activity related to the research begins and before proceeding to sign the informed consent, the participating individual must be informed in their own language, in an appropriate and understandable language, about the nature of the research, the procedures , the risks and benefits, other therapeutic or diagnostic options, the confidentiality of the information collected and about your rights, so that you understand and make the decision to participate or not, freely, voluntarily and consciously, without coercion, coercion, threat , fraud, deception, manipulation or any other type of pressure.
The informed consent information must be truthful, clear, precise and written, in a way that is not misleading, deceptive or coercive and that can be understood by the participants. For this purpose, it must be guaranteed that the procedure for signing the informed consent has the appropriate time and conditions so that people can correctly understand the information.
ARTICLE 14.- Informed consent information
The use of information and data related to the health of individuals, for purposes not contemplated or permitted in the informed consent or in the law, is prohibited.
The person in charge of the research or clinical trials and those responsible for it may only use the information and data related to the health of the participants in accordance with the purposes expressly contemplated or permitted in the informed consent or in the law.
ARTICLE 15.- Modification of conditions
Any change in the risk-benefit ratio or in the conditions that arise during the research must be reported to the participant, so that the latter, by granting a new consent or an addendum to the principal, ratifies their permanence in the study. study or trial, or decide to withdraw from it.
ARTICLE 16.- Informed consent in people with disabilities
When people with disabilities participate in biomedical research, the information required to provide informed consent must be given in accessible conditions and formats appropriate to their needs.
ARTICLE 17.- Consent of minors
When minors participate in biomedical research, the informed consent must be signed by their legal representative or by whoever has their legal representation.
In the case of minors, but over twelve years of age, their informed consent must also be obtained; for this, they will be informed about the scope of the investigation, in a language understandable to them.
In the event that the minor refuses to assent, his or her judgment prevails over that of his or her legal representative, as long as his or her life or health does not depend on his or her participation in the research, in accordance with the provisions of Law No. º 7739, Code of Childhood and Adolescence, of January 6, 1998.
All aspects related to informed consent in minors must be assessed with the participation of the Scientific Ethics Committee, in order for the Committee to be its guarantor.
The informed assent must be approved, numbered and stamped on all its pages by the CEC, prior to its presentation to the eventual participants.
ARTICLE 18.- Consent of legally incapacitated persons (Repealed by the sole article of Law No. 9901 of September 22, 2020)
CHAPTER III
BIOLOGICAL SAMPLES OF HUMAN MATERIAL
ARTICLE 19.- Use and transfer of biological samples
The use of biological samples obtained for purposes not contemplated and approved in the informed consent, the law and other applicable regulations is prohibited.
Biological samples may only be transferred abroad, if justified according to the scientific objectives, the technical criteria of the investigation or due to the technological limitations of the country. In the case of studies with a multicenter design, where it is optimal to standardize the methodology and the reports of the laboratory tests, in accordance with the scientific objectives, the transfer of the samples to a laboratory abroad will be allowed.
In order for biological samples to leave the country, it is required that such information has been provided prior to export, in the informed consent and that the participant has consented, except in epidemiological situations that put public health at risk.
ARTICLE 20.- Right to retract for the use of biological samples of human material
The participant in biomedical research has the right to withdraw their consent regarding the possible transfer, storage, handling and use of their biological samples of human material.
ARTICLE 21.- Transfer agreements
To transfer any biological sample out of the country, a biological material transfer agreement must be signed by the legal authorities of the institutions involved, by the researcher and the sending institution, and by the researcher and the receiving institution.
ARTICLE 22.- Conservation and destruction of biological samples of human material
Biological samples of human material will be kept only as long as they are necessary for the purposes that justified their collection, unless the participant has given their explicit consent for other subsequent uses. This consent may be revoked by the participant totally or for certain purposes, at any time. When the revocation refers to any use of the sample, it will proceed to its immediate destruction and the laboratory will issue a written certificate of the destruction of the sample, except in the case of samples that have been anonymized.
In the event that the biological samples of human material are preserved, the participant will be informed of the place and the conditions of conservation, objectives, future uses, transfer to third parties and conditions to be able to request their destruction, according to the rules that apply for destruction. of biological samples, except in the case of samples that have been anonymised.
ARTICLE 23.- Donation or assignment of biological samples of human material
To donate or assign a biological sample of human material to third parties, specific informed consent must be obtained for any of these purposes. In this, the place and conditions of conservation, the objectives of this conservation, the future uses of the samples and the possibility of transferring the samples to third parties must be made clear.
The donation and use of human biological samples in research may not be remunerated or any other type of compensation provided to the participant; Likewise, the sale of biological samples that have been obtained for biomedical research is prohibited.
CHAPTER IV
RIGHTS AND OBLIGATIONS OF THE PARTICIPANTS
ARTICLE 24.- Right to withdraw
Participants in an investigation will have, without giving explanations, the right to withdraw their participation at any time. In those cases in which the abrupt withdrawal means a risk to the participant’s health, mechanisms must be established to minimize the risk situation.
This waiver will not cause any harm or inconvenience to the participants, for their right to health or in the exercise of any other of their rights.
ARTICLE 25.- Right to confidentiality
The use of data relating to the health of individuals for purposes other than those for which consent was given is prohibited.
The people participating in an investigation shall have the right to confidentiality regarding their identity, personal information and their health, as well as the treatments or the results of the analyzes or procedures to which they were subjected and other personal data, except when the law demand the opposite.
The persons or entities that have access to the confidential data of the participants must adopt all the necessary measures to ensure that the privacy, confidentiality, integrity and dignity of the participants will not be affected. To this end, any person who, in the exercise of their functions, in an investigation involving human beings, has access to personal data or confidential documents related to the investigation, will be subject to the duty of confidentiality.
The obligation of confidentiality does not apply when any of the following conditions are met, which must be recorded and accepted by the participant in the informed consent:
a) When required by the scientific ethics committee that approved the research.
b) When required by the National Health Research Council, in order to meet the requirements of an inspection and surveillance of an investigation.
c) When the research monitor or auditor needs to verify data contained in the clinical records of the research participants, for purposes of an audit or follow-up by the sponsor or competent regulatory authority.
d) When requested by a competent judicial authority.
e) When a medical emergency occurs to the participant.
f) When the doctor responsible for clinical care needs to know said information for purposes of treating his patient.
ARTICLE 26.- Transfer of data
The transfer of personal data to third parties unrelated to research involving human beings will require the express and written consent of the participant.
If the data obtained from the participant could reveal personal information of their relatives, the transfer to third parties will require the express and written consent of all interested parties.
ARTICLE 27.- Right to information
Research participants have the right:
a) To access, personally or through their legal representative, the results of their analyses, when these have not been subjected to dissociation or anonymization processes, if the design of the study allows it.
b) To be informed about the progress, unexpected adverse events that occur and the general results of the investigation.
c) To respect the ethnic, cultural and social characteristics of the community or population group to which they belong.
d) That all the verbal and written information is given through an understandable lexicon and in the language of the participants.
e) To be informed of the diseases discovered that are not part of the investigation process.
f) To access and obtain a copy of their personal file, which must contain all the information regarding the research or clinical trial.
ARTICLE 28.- Right to enjoy the benefits resulting from the investigation
Participants in a clinical investigation will have the right to enjoy free of charge, as long as they require it, the preventive, therapeutic and diagnostic treatments generated by the study, if it has been shown that these are beneficial for health, as long as the prescription of these methods or treatments is endorsed by the professionals responsible for the treatment and follow-up of the patient, and in accordance with what is expressed in this law.
ARTICLE 29.- Right to health care
No participant in biomedical research will lose his right to receive the health care that he would be entitled to receive before, during or after his participation in research.
ARTICLE 30.- Right to compensation for damages
People who have suffered damage to health as a result of their participation in an investigation will receive the corresponding compensation according to the provisions of this law and its regulations.
ARTICLE 31.- Protection policy for participants
The clinical investigation must be covered by a civil liability policy that protects the participants from damages derived from the investigation, during the period that it lasts, from the beginning of the investigation and for at least two years after the end of the investigation. terminate the participant’s participation in the research. The policies must be issued in accordance with the principle of proportionality and dignity of human life, and must be enforceable in the country. The scientific ethics committees must assess the policy that is presented and define its term of validity based on the minimum established in this law.
The Ministry of Health will regulate the process that guarantees the access of the participants to the benefits offered by the assurance of health research.
ARTICLE 32.- Information to people who participate in biomedical research
In the informed consent given to the possible participant, proof or a copy of the policy must be provided, indicating the number, the entity that issues it, the term of protection, the conditions that the policy will have and the procedure. to access it by the participants.
ARTICLE 33.- Obligations of the people participating in biomedical research
The obligations of the people participating in research involving human beings will be the following:
a) Comply with the indications and instructions given to them.
b) Timely inform the investigator about the adverse events that occur.
c) Inform the treating physician of their participation in a clinical investigation.
d) Others determined by the regulations of this law.
CHAPTER V
NATIONAL HEALTH RESEARCH COUNCIL
ARTICLE 34.- National Health Research Council
The National Health Research Council, hereinafter CONIS, is created as an independent, multidisciplinary body of an ethical, technical and scientific nature, attached to the Ministry of Health with a maximum degree of deconcentration and with instrumental legal personality.
The CONIS will have the administrative structure defined by regulation and will have its own internal audit in accordance with Law No. 8292, General Law of Internal Control, of July 31, 2002, and Law No. 7428, Law Organic Statement of the Office of the Comptroller General of the Republic, dated September 7, 1994.
ARTICLE 35.- Purposes of the Conis
The purpose of the CONIS is to guarantee the quality of the investigations and their strict adherence to human rights. Its members must act with absolute independence of criteria, avoiding the influence of political and commercial interests in their decisions.
ARTICLE 36.- Formation of the National Health Research Council
The CONIS will be made up of seven proprietary members, each with their respective alternate, who must attend the sessions in the absence of the proprietary member.
The Conis will be made up of:
a) The Minister of Health or the official to whom he delegates and his alternate, who will preside.
b) The Minister of Science and Technology or the official delegated by him and his substitute. In the event that the minister delegates her representation, both the holder and the substitute must be research specialists. Otherwise, at least the substitute must be a specialist in this field.
c) A lawyer specializing in human rights and his substitute, appointed by the Costa Rican Bar Association.
d) A representative of the Costa Rican Social Security Fund (CCSS), preferably from the Center for Strategic Development and Information on Health and Social Security of Social Security (Cendeisss) and his alternate. The Board of Directors may not designate any of the persons who are part of its members at that time.
e) A representative of the National Council of Rectors (Conare) and an alternate, who must be a specialist in bioethics.
f) A representative in property and an alternate, member of the Professional Colleges of Physicians and Surgeons; Pharmacists; Dental Surgeons and Microbiologists, appointed by the boards of directors of the respective professional associations. The regulations of this law will establish the appointment procedure and the way in which the positions in property and the substitution between the four professional associations will be alternated each year, so that the positions are rotated.
g) A proprietary member and an alternate representing the community, who will be appointed for this purpose by the Ombudsman’s Office. The procedure for the election of the person representing the community will be determined by the Ombudsman’s Office.
The members of the CONIS will hold office for a period of five years and may be re-elected. The community representative will be appointed for a maximum term of three years and may not be re-elected. The members of the CONIS may be dismissed from their positions for the reasons indicated in the regulations of this law.
The members of the Conis may not be appointed simultaneously in the Conis or in any other scientific ethics committee (CEC).
ARTICLE 37.- Allowances
The members of the CONIS will be remunerated through allowances per session, the amount of which will be equal to eighty percent (80%) of the allowances paid to the members of the Board of Directors of the Costa Rican Social Security Fund for each session. The number of paid monthly sessions may not exceed ten sessions per month, between ordinary and extraordinary sessions.
The CONIS will meet ordinarily once a week and, extraordinarily, when necessary, by summons made by its president or by no less than two of its members.
No member of the CONIS may directly or indirectly receive any remuneration or material recognition from sponsors, researchers, contract management organizations or contract research organizations. The members of the CONIS who incur in this offense will be dismissed from their positions.
ARTICLE 38.- Academic and professional requirements to integrate the Conis
The members of the CONIS, holders and alternates must be professionals in the fields of human rights, bioethics, clinical research, epidemiology, public health or health services.
To occupy a position in the Conis it is required at least:
a) Possess a university degree with at least a bachelor’s degree and be attached to the respective college.
b) Have recognized and proven honorability.
These requirements do not apply to subparagraph g), as well as to the case of who occupies the position of minister, indicated in article 36 of this law.
ARTICLE 39.- Revocation of appointment
The National Health Research Council, by simple agreement, may request the corresponding body or institution to revoke the appointment of any of its members due to unjustified absences, breach of their duties within the CONIS or conflict of interest.
ARTICLE 40.- Ad hoc members and special commissions
The CONIS may incorporate, temporarily and to the extent it deems necessary, consultants or experts, who will not have the right to vote. It may also form subcommittees or working groups for the technical analysis of projects or specific topics. The people who make up the National Health Research Council may not simultaneously form part of any other scientific ethics committee in the country. The CONIS is hereby authorized to pay, charged to the institutional budget, the consultants or experts that it requires to hire to meet the objectives of this law.
ARTICLE 41.- Confidentiality agreement and declaration of conflict of interest
The members of the CONIS and all the staff must sign, before starting work, a confidentiality agreement, make a declaration of activities and conflict of interest, and must refrain from taking part in the deliberations and voting in which they have an interest. direct, indirect or relative in the matter examined; to do so, they must disclose any conflict of interest that may affect their objectivity.
ARTICLE 42.- Quorum
The quorum will be integrated with the presence of the majority of the members. The agreements will be made with the concurring vote of the majority of those present. When there is a tie, the president will decide with his quality vote. The resignation or cessation of one of the members will not imply the disintegration of the body, as long as the quorum required to meet is maintained.
ARTICLE 43.- Functions of the CONIS
The functions of the Conis will be:
a) Regulate and supervise and monitor biomedical research and guarantee the life, health, interest, well-being and dignity of people.
b) Accredit, register and supervise the operation of CECs, both public and private, contract management organizations (OAC) and contract research organizations (OIC).
c) Accredit researchers who carry out biomedical research.
d) Resolve, within a period not to exceed three months, the conflicts between the investigators and the CECs.
e) Hear and promptly resolve complaints or claims against investigators, OICs, OACs, CECs or the entities on which they depend.
f) Supervise and inspect any OAC, OIC, CEC, investigator or research project to verify compliance with the established standards.
g) Suspend, for reasons of proven urgency, or cancel at any time, the approval of a research project, if it is determined that the freedom, dignity, privacy, health or well-being of the participants is in danger. .
h) Suspend, temporarily or permanently, the accreditation of a CEC or researcher, if it is determined that they are not complying with the provisions of this law.
i) Promote and encourage training in bioethics in research, at the national level in general, and in particular for CECs, sponsors and researchers.
j) Inform, in writing, the health authorities of the health regions of the Ministry of Health, about the research approved and about to be carried out in their jurisdiction.
k) Manage the budget assigned in this law.
l) Submit an annual functions report to the institutions represented in the CONIS.
m) Verify that the CECs have adequate and sufficient financial resources for their operation. The CONIS may require the entities that constitute the CECs to provide them with adequate and sufficient human and material resources for their proper functioning.
n) Keep a national record of all biomedical research carried out in private and public centers in the country, verifying that the CECs must send it when approving an investigation and before it begins, which will be publicly accessible.
ñ) Keep a national registry of health entities or establishments that carry out biomedical research.
o) Establish a national registry of researchers.
p) Maintain a national registry of contract research and administration organizations.
q) Keep an up-to-date record of the CECs and of the researchers, sponsors, OACs and OICs that have been sanctioned for non-compliance with this law.
r) Keep a record of publications and presentations in scientific activities of the results of biomedical research approved in the country.
s) Define, annually, the work plans and budgets necessary to perform their duties.
t) Ensure compliance with the ethical standards that guide biomedical research. Implement a biomedical research information system, accessible at all times, with updated databases on approved and rejected research, registered researchers, CEC, OIC and OAC, information and guidance for potential research participants.
u) Keep a national registry of the investigations that have been rejected and the reasons that supported the decision.
v) Keep a duly legalized minute book containing all its meetings and the agreements of the Conis.
w) Keep a record of sanctioned researchers and the reasons for the sanction.
x) The others that the regulations of this law establish.
ARTICLE 44.- Inspection
The CONIS will have the power to inspect the CEC, OAC, OIC, researchers or biomedical research, when it deems it necessary. For such purposes, the Conis will have the following functions:
a) Carry out inspections in any area, in order to verify that the requirements established in this law are met.
b) Advise ex officio or at the request of a party, in matters within its competence, to the CEC, OAC, OIC and investigators.
c) Evacuate queries regarding its competence from the CEC, OAC, OIC and investigators.
d) Notify the parties involved of the findings of the inspections carried out.
e) Initiate the corresponding administrative and judicial procedures in case of determining any breach of this law, within the terms established by regulation.
f) The other functions attributed to it by regulation.
The subjects referred to in this article must provide the information required by the CONIS within the term determined by it, under penalty of incurring the sanctions established in this law.
The CONIS must hire and train the necessary personnel to fulfill the functions granted by this article.
ARTICLE 45.- Budget
The Conis budget will be made up of the following resources:
a) The amount of income for registration and registration of research.
b) Legacies, subsidies and donations from public institutions or organizations and contributions from the State.
c) What is generated by its financial resources.
d) Income received for accreditation, certifications, registration for educational activities and, in general, for the provision of services provided.
e) The amount of the fines generated by the application of this law.
The CONIS will be subject to compliance with the principles and the Responsibility Regime established in titles X and XI of Law No. 8131, Financial Administration of the Republic and Public Budgets, of September 18, 2001. In the rest, exempts the CONIS from the scope and application of that law. In the control, the CONIS will be subject only to the provisions of the Comptroller General of the Republic.
CHAPTER VI
SCIENTIFIC ETHICS COMMITTEES
ARTICLE 46.- Scientific Ethics Committees
Any public or private entity in whose facilities biomedical research is carried out may set up a scientific ethics committee, hereinafter CEC, regardless of criteria, trained in research bioethics and which must be duly accredited by the CONIS.
The Ministry of Health will form a CEC that will be in charge of approving Phase I clinical trials, as well as the approval of research by researchers and/or independent public or private entities that do not have a CEC.
Those independent researchers and/or public or private entities that do not have a CEC may also submit the research project to any CEC duly accredited by the CONIS.
The public or private entities that create a CEC have the obligation to ensure sufficient independence of criteria and operation, as well as all the resources for the fulfillment of its obligations.
ARTICLE 47.- Integration
The CECs must be multidisciplinary in their composition and their members must have recognized honorability, at least one scientific expert with experience in research and one person who represents the interests of the community, appointed through mechanisms that seek the widest possible consultation and participation, in accordance with the respective regulations. They must have a minimum of five members and will be governed by the rules established in this law and its internal regulations.
Both members and support staff of the CEC must sign a confidentiality agreement and declaration of conflict of interest.
ARTICLE 48.- Functions and obligations of scientific ethics committees (CEC)
The functions and obligations of the CECs are:
a) Ensure that life, health, interest, well-being and human dignity are strictly respected in biomedical research and that the requirements and criteria of scientific rigor are met, as well as the ethical standards that regulate the matter, among others. them, the process of informed consent, the suitability and experience of the researchers, and the requirements established in this law.
b) Protect the rights, safety, freedom, dignity and well-being of subjects participating in biomedical research.
c) Take into consideration the principle of justice, so that the benefits and inconveniences of the investigation are distributed equitably among all groups and social classes.
d) Dictate its internal operating regulations, which must be approved by the CONIS as an accreditation requirement.
e) Know, approve or reject the research projects in which human beings participate, within the periods established in its internal regulations.
f) Provide the information to update the National Registry of Biomedical Research at the time of approving an investigation and before it begins.
g) Know, approve or reject the requests for renewal of biomedical research projects, within the periods established in the regulations of this law.
h) Know, approve or reject the amendments to the original protocol, to the informed consent and to the informed assent.
i) Suspend or cancel, at any time, the execution of a research project, if it is determined that the health or well-being of the participants may be in danger.
j) Keep a duly legalized minute book containing all of its meetings and a file of each of the projects submitted for review.
k) Monitor the execution of the projects through the reports periodically submitted by the main researcher and carry out, at least once a year, an audit of each institution and research center. You should also know the study completion report.
l) Review, record and communicate to the CONIS all serious or unexpected adverse events and the most relevant situations that occur during the development of the investigation that are reported to the CEC.
m) Preserve and safeguard the files of the projects submitted to its knowledge and all the documentation that supports its actions for a period of fifteen years after the completion of each investigation.
n) Submit quarterly and annual reports on their management before the CONIS, which include approved, rejected, suspended, canceled and completed investigations, amendments to active investigations, inspections carried out and the list of active investigations.
ñ) Offer training to its members, so that they periodically receive training and continuing education in relation to bioethics and biomedical research.
o) Guarantee researchers the possibility of presenting the objections they consider necessary in relation to the agreements of the CEC.
p) Inform the CONIS and the competent institutional authorities of irregularities or breaches of this law.
q) Immediately evacuate the queries of the participants of an investigation when they request information about their rights, and process, as soon as possible, the complaints that they present in relation to the investigation or with the conduct of an investigator or your human team.
r) Abide by the provisions of the Ministry of Health and the CONIS in matters of their competence.
s) The amounts to be paid to the CEC for the review process of the research projects submitted for review, possible approval and for the supervision, renewal and inspection of the approved projects, will be those determined by the CEC after the corresponding cost analysis. and in accordance with the regulations of this law.
t) Keep a record of the publications or presentations made of the results of the investigations approved by the committee.
u) Notify the National Children’s Board when investigations on minors are approved or renewed, for what corresponds.
v) Others established by the regulations of this law.
ARTICLE 49.- Incompatibilities
They may not be part of the CEC:
a) The members of the boards of directors of public institutions or private companies that promote biomedical research, when they participate directly or through an intermediary in the share capital of such private companies or their spouse, partner or some of their relatives by blood or affinity up to the third degree inclusive.
b) The officials of the entity, public or private, in which the committee is established, in which they or their spouse, or partner, or any of their relatives by consanguinity or affinity up to the third degree inclusive, occupy positions of leadership or management that imply the competence to decide on the authorization of biomedical research projects.
When one of the members of a CEC has links that imply a risk of conflict of interest, in accordance with the provisions of article 38 of Law No. 8422, Law against Corruption and Illicit Enrichment in Public Function, of 6 of October 2004, and its reforms, and other regulations of the legal system, must refrain from participating in the administrative process, approval, control and monitoring of that specific investigation.
ARTICLE 50.- Budget and resources
The entities that constitute a CEC must provide them with the necessary human and material resources to fulfill their functions and obligations.
CHAPTER VII
RESEARCHER OBLIGATIONS,
SPONSORS, ORGANIZATIONS
OF ADMINISTRATION BY CONTRACT
AND RESEARCH ORGANIZATIONS
BY CONTRACT
ARTICLE 51.- Obligations of the researcher
The obligations of the researcher responsible for the execution of biomedical research are:
a) Strictly respect life, health and human dignity and meet the requirements and criteria of scientific rigor, as well as the ethical standards that regulate the matter and the requirements established in this law.
b) Keep updated on bioethical aspects and good clinical practices.
c) Guarantee that carrying out biomedical research implies, in all cases, that the care, procedures and routine treatments required by the participants take precedence over the development of the research.
d) Have academic education, training and experience to assume responsibility for the appropriate conduct of biomedical research.
e) Have a sufficient number of qualified personnel and adequate facilities to carry out biomedical research.
f) Ensure that the members who are part of the research team have the appropriate qualification and experience for the proposed research within the exercise of their profession, in accordance with the provisions of Law No. 5395, General Health Law, of 30 of October 1973. In the case of students who carry out undergraduate, graduate and postgraduate studies, the respective CEC may exempt them from this requirement to the extent that it does not imply a risk for the participants.
g) Submit the research protocol to the CEC duly accredited and, before starting any activity related to the research, have the respective approval.
h) Be completely familiar with the research protocol and informed consent and, in the case of clinical trials, with the investigator’s brochure and with the drug, equipment or material under investigation.
i) Comply with the provisions of the research protocol approved by the CEC.
j) Guarantee that informed consent is obtained correctly and in a timely manner by the participant or their legal representative, when the corresponding CEC has not exempted them from said requirement.
k) Take control of drugs, equipment or materials in clinical trials.
l ) Guarantee that the reported data of biomedical research are accurate, legible, complete and within the required time.
m) Ensure that people for whom the investigation is of special risk are excluded from it.
n) Submit to the respective CEC, for review, all the amendments that occur to the protocol before the changes can be implemented, provided that this does not imply a risk for the participants.
ñ) Send the international safety reports to the respective CEC, in the case of multicenter research or studies.
o) Inform the CEC, within a maximum period of twenty-four hours, of all serious adverse events or unexpected problems occurring in the biomedical research under their charge.
p) Submit reports to the CEC about the progress of the investigation, through quarterly and annual reports.
q) Offer advice to the participants of an investigation, throughout its development, about their rights.
r) Guarantee, through adequate control, that the potential benefits for the health of the participants outweigh the risks.
s) Immediately inform the participants and the CEC, in case of early termination of the investigation, a detailed explanation of this suspension. In the case of clinical trials, ensure appropriate treatment and follow-up for each of the participants.
t) Safeguard in a file all the documentation of each investigation, for a period of fifteen years after the conclusion of the investigation.
u) Submit a copy of the final report and the final results of the investigation, according to the requirements of the CEC that approved it.
v) Make available to the participants the information that is considered relevant to their health.
w) Comply with the ethical, scientific and administrative obligations imposed by the sponsor of the research, the CEC, the CONIS or any regulatory entity, with the interest of verifying the protection of the rights of the research participants, cxmmnl;idfrq34a15
x) Declare any possible conflict of interest before and during the investigation.
y) When designating an organization to conduct an investigation (contract management organization), you must sign a contract that establishes the obligations and responsibilities assumed by said organization.
z) Abide by the provisions of the Ministry of Health, the CONIS and the CEC in matters of their competence.
aa) Submit, to the CEC that approved the research and to the CONIS, a copy of the publications and/or certification of participation in scientific activities of the results of the research.
ARTICLE 52.- Publication of results of biomedical research
It is the obligation of the researcher to publish or present, in a congress or scientific activity, the results of the biomedical research carried out. When publishing the results of biomedical research, researchers must respect the accuracy of the data and results obtained, and disclose both positive and negative results, include the information corresponding to the sources of funding for the research and the sponsoring entities, and indicate the health institution or institutions where the research was conducted. In the same way, in the publications, respect for the right of confidentiality of the participants will be kept.
The CONIS may waive the publication of the results of biomedical research, in the case of results with few contributions.
ARTICLE 53.- Obligations of the sponsor
The sponsor’s obligations are:
a) Ensure and document that the electronic data systems meet the requirements of integrity, accuracy, reliability and consistency in the proposed execution and that they maintain a security system that prevents unauthorized data access.
b) Properly select the investigator, his human team and the entity in which the investigation will be carried out.
c) Supervise the conduct of investigations and implement a system of quality standards.
d) Ensure sufficient financing, adequate material resources and equipment for the researcher and the entity that will carry out the research, through the signing of contracts that contain said conditions.
e) Define and obtain an agreement with the investigator to conduct the investigation in accordance with good clinical practices, national regulatory requirements and the protocol approved by the CEC.
f) Verify that the research it sponsors has been approved by the respective CEC accredited in the country.
g) Offer adequate and permanent training on scientific and ethical research methodologies to the researcher and his human team.
h) Verify that the investigator reports to the CEC those cases in which he found deviations from the approved protocol.
i) Cover the costs of the treatment of the participants who suffered an injury as a result of the investigation.
**i)**Compensate those participants who suffered injuries or heirs in case of death, as a direct consequence of the clinical investigation and that are related to its procedures, as long as these are not inherent risks of medications and/or standard procedures; To do this, you must have a valid insurance policy that covers from the beginning of the research and up to a minimum of two years after the participant’s participation in the research has ended. Guarantee legal coverage and a civil liability policy in favor of the researcher and his human team, in order to deal with possible claims for injuries or damages attributable to clinical research, as long as it is not due to negligence, incompetence or violations of the protocol,
k) Provide the participant, free of charge and after the conclusion of a clinical investigation, the drug, device or procedure that has been the subject of investigation, unless:
i . The medication, device or procedure ceases to be effective for the participant or is not required, which must be established by the treating physician through a duly founded resolution, which will become part of the file and will be communicated to the CEC within three business days after its issuance.
ii. The development of said drug, device or procedure is discontinued.
iii. The investigator certifies that it is not essential to preserve the health of the participant and there are therapeutic alternatives.
IV. The patient does not give the informed consent required for the continuation of treatment.
l) Notify the investigator, the CEC and the CONIS about the reasons that justify the suspension of a biomedical investigation.
m) Guarantee the researcher, the CEC and the participants that the suspension of a biomedical research will not affect the latter.
n) Certify that in biomedical research, the research products (including active comparator and placebo, if applicable), are manufactured in accordance with good manufacturing practices, that storage conditions are indicated, that packaging prevents contamination or deterioration during transport and storage, coding and labeling in Spanish and comply with the requirements established by regulation.
ñ) Ensure the timely delivery of the products under investigation, keep records of the shipment, reception, disposition, return and destruction of these products.
o) Document the financial aspects of the research in an agreement between the sponsor and the researcher.
p) The sponsor may transfer any or all of its research-related tasks and functions to a contract research organization (CRO), but will retain ultimate responsibility for the quality and integrity of the research data.
q) Any task and function related to the investigation, which is transferred and assumed by an OIC, must be specified in writing. All the obligations described here, which are made to the sponsor in this law, also apply to the OIC to the extent that it has assumed the tasks and functions of the sponsor.
r) Abide by the provisions of the Ministry of Health, the CONIS and the CEC in matters of their competence.
s) Custody in a file all the documentation of each investigation, for a period of fifteen years after the conclusion of the investigation.
t) Submit a copy of the final report and the final results of the investigation to the CEC and the CONIS, which must publish them in the digital registry that it will create for that purpose.
u) Make available to the participants the information that is considered relevant to their health.
v) Comply with the ethical, scientific and administrative obligations imposed by the CEC, the CONIS or by any regulatory entity, with the interest of verifying the protection of the dignity and rights of the research participants, in accordance with the Current legislation and international ethical guidelines for experimental clinical research.
w) Declare any possible conflict of interest before and during the investigation.
x) When designating an organization to carry out an investigation (contract management organization, OAC), you must sign a contract that establishes the obligations and responsibilities assumed by said organization.
y) Submit, to the CEC that approved the research and to the CONIS, a copy of the publications and/or certification of participation in scientific activities of the results of the research.
ARTICLE 54.- Obligations of the contract management organization and the contract research organization
The obligations of the contract management organization (hereinafter OAC) and the contract research organization (hereinafter OIC) will be the following:
a) Submit to the CEC quarterly and annual reports on its management.
b) Submit to the CEC, for its registration, the agreement document signed with the sponsor of the research or with the researcher, in order to know the tasks and functions that have been transferred. Likewise, you must transfer to the CEC any modification to this agreement, within a maximum period of eight business days.
c) All that the sponsor or researcher has transferred through the contract or contractual document signed between them.
d) Respond, jointly with the sponsor or researcher, to possible damages or losses caused by the tasks or functions that have been transferred.
CHAPTER VIII
RESEARCH WITH HUMAN BEINGS
ARTICLE 55.- Approvals and authorizations
All research, before it begins, must have the written approval of a duly accredited CEC and, if it is to be carried out in a public or private health center, it must also have the authorization of the authority or authorities. corresponding. No authority, public or private, may authorize an investigation without the approval of the respective CEC.
In the case of research that requires the importation of medicines, equipment, devices and supplies related to approved research, the approvals and authorizations indicated in the previous paragraph will be essential requirements for their importation to the researcher.
ARTICLE 56.- Control and monitoring of investigations
In all cases, the conduct of the research must be adjusted to the content of the project to which the authorization had been granted.
The health authorities will have, at all times, inspection powers over the investigation, being able to have access to the individual medical records of the research participants, for which they must keep, in any case, their confidential nature.
The health authorities, the CONIS or the CEC may provisionally suspend the authorized research in cases in which the requirements established by this law have not been observed or when they have indications that the health, integrity and safety of the participants is in danger, must at all times protect the rights of these. Said measures will proceed in the initial act of the administrative process and must be issued as a preliminary act, in order to guarantee the rights and safety of the participants, and due process. Likewise, they must notify all interested parties, including the authorities of the health center where the investigation was being carried out.
ARTICLE 57.- Inapplicability of positive silence
The figure of positive silence regulated in article 330 of Law No. 6227, General Law of Public Administration, will not be applicable to the processes of approval, inspection, control and monitoring of biomedical research projects, in any of its modalities. , dated May 2, 1978.
ARTICLE 58.- Contract
All biomedical research that has external sponsorship to the public or private entity, where such activity is carried out, must have a contract that regulates the rights and obligations of both the sponsor and the researcher who carries out the research. This contract must indicate the agreed payment for carrying out the research and include a clause whereby the sponsor is responsible for short-term and long-term adverse events resulting from the research. The absence of such clause does not relieve the sponsor of its responsibility. Said contract must be signed by the representative of the sponsor, the principal investigator and the representative of the public or private entity, and must be signed prior to the start of the research.
ARTICLE 59.- Prohibition to the hierarchs of public and private institutions
Hierarchs and officials of public or private institutions are prohibited from authorizing the development of biomedical research or, for the same purpose, transferring resources of any kind from the entities under their charge, if said research does not have the prior approval of a CEC. The respective authorities of the hospitals of the Costa Rican Social Security Fund, where an experimental clinical investigation is intended to be carried out, may deny the facilitation of the resources referred to in this article, if in their opinion the transfer of any type of resource could affect patient care and the medical assistance service in charge of that institution.
ARTICLE 60.- Canon
For the purposes of registering a biomedical research project, the main researcher must pay the CONIS an amount equivalent to three percent (3%) of the total research budget. For these purposes, the investigator, the sponsor, the OAC or the OIC must submit a copy of the contract signed with him to the CEC and it will be the obligation of the CEC to send a copy of this document to the CONIS, in accordance with the provisions of this law. This amount must be paid to CONIS at the time of requesting the registration of the approved project.
The funds corresponding to the fees mentioned in this article will be used to finance the following activities:
a) The proper functioning of the Conis.
b) Training for CONIS members and their staff on research, regulation and related issues.
c) Promote interest in biomedical research, either directly or by collaborating with projects or programs organized by health authorities or the scientific community made up of the public sector.
d) Collaborate and encourage activities to improve research processes and dissemination of bioethics, and the rights of users of health services and participants in research projects.
e) Finance projects of interest to public health defined by the Ministry of Health.
ARTICLE 61.- Exemption
The following investigations are exempt from the cancellation of the canon stipulated in the previous article:
a) Those that are classified as of public interest by the Executive Power.
b) Those that are considered a health priority by the Ministry of Health.
c) Those that are investigations carried out by higher education students, in order to obtain an undergraduate, graduate, postgraduate or similar degree.
d) Independent researchers without sponsorship, provided that their development and results are not for commercial purposes.
e) The investigations carried out by the research programs and projects of state universities.
The foregoing shall not apply, under any circumstances, to research sponsored by pharmaceutical transnationals or for-profit organizations.
ARTICLE 62.- Protection of records
All information concerning research carried out on human beings must be recorded in the patient’s file and protected for a period of thirty years, in the health institution or clinic where it was carried out.
ARTICLE 63.- Use of placebo
The potential benefits, risks, costs, and efficacy of all biomedical research should be evaluated by comparing it with the best existing proven intervention, except in the following circumstances:
a) The use of a placebo is acceptable in studies for which there is no proven intervention or existing treatment.
b) When for methodological, scientific and compelling reasons, the use of a placebo is necessary to determine the efficacy and safety of an intervention that does not imply a risk, serious adverse effects or irreversible damage for the patients who receive the placebo.
CHAPTER IX
INVESTIGATIONS WITH VULNERABLE GROUPS
ARTICLE 64.- Minors and people without volitional and cognitive capacity
Clinical research in which a person with legal incapacity participates, be it a minor or a person without volitional and cognitive capacity, declared judicially, may only be carried out when it is expected that the results may produce real or direct benefits for their health, or when they are not may obtain comparable results in individuals who are older or capable of giving consent.
When it is foreseeable that the clinical research will not produce results of direct benefit to the health of these participants, the research may be authorized exceptionally, if the following conditions are met:
a ) That the research aims to contribute to the understanding of the disease or to a beneficial result for other people of the same age or with the same disease or condition.
b) That the research entails a minimum risk and burden for the participant.
ARTICLE 65.- Persons highly dependent on health care
Clinical investigations must be evaluated with special care when carried out with particularly vulnerable human beings, at the discretion of the CEC, due to their high dependence on health care and/or their limited capacity to understand the information provided and freely express their willingness to participate, or both circumstances. Biomedical research will require additional protection conditions and procedures, when carried out on:
a) Persons with disabilities who are highly dependent on care and attention.
b) People with moderate or severe cognitive impairment.
c) Serious psychiatric patients, whether hospitalized or not.
d) People in emergency health situations.
e) Critically ill patients with intensive care.
f) Patients with terminal illnesses.
These investigations must meet at least the following conditions:
1) They may not be contrary to the best interests of the patient.
2) Will seek therapeutic benefit with a reasonable possibility of superiority over standard treatment.
3) They may not have a greater risk than that of the patient’s conditions and alternative treatment methods.
4) The informed consent process will be implemented in the most reasonable way possible to meet your requirements, including the participation of family members and the authorized representative.
5) In cases in which the patient is not the one who gives consent, they will be informed as soon as possible and may withdraw from the research without any consequences for their due care and attention.
6) Any other that defines the regulation to this law.
ARTICLE 66.- Emigrant autochthonous communities and particularly vulnerable groups
Clinical research in vulnerable groups may only be carried out to the extent that the following circumstances are proven:
a) That the research is carried out with the aim of treating and benefiting the community in some specific ailment and characteristic of this or in another of high prevalence.
b) That the researcher and the sponsor commit, irrefutably, to respect the value system, worldview and culture of the community that will participate in the study, and to adapt the design and procedures of the study to the customs of each native community .
c) That the consent of each participant belonging to a native community is preceded by information provided in the native language of their culture, in case they do not understand Spanish and that, in any of these cases, the researcher guarantees the understanding of the information and freedom of the decision made by him or the participant.
d) That the investigation has the approval of a CEC that met with the presence of a representative of the community, elected by the same community, and with the authorization of the CONIS.
ARTICLE 67.- Subordinate groups
The investigations in which human beings participate, that are carried out on people or groups that are under the authority of the researchers or that of a third party, or in certain situations of dependency that may violate or affect their autonomy, and that do not suppose a benefit directly for the participants in the research, require special attention for the application of this law. Subordinate groups by reason of authority should be considered, among others, students, residents and/or attendees of medicine or other health sciences, persons deprived of their liberty and police and security officials. These investigations can only be carried out when the following conditions are met:
a) The research is carried out with the purpose of achieving a benefit for the subordinate group under study.
b) The research cannot be carried out in non-subordinate population groups.
c) The research poses minimal risk or burden to the people included in the study.
ARTICLE 68.- Clinical research with pregnant or lactating women
Pregnant or lactating women should not participate in clinical research, except if the following conditions are met simultaneously:
a) That comparable results cannot be obtained in non-pregnant or lactating women.
b) That the research involves a minimal risk to their health, to the product of conception at any stage of pregnancy or to the infant, or that the benefit outweighs the risk.
c) That the objective of the research is to obtain new knowledge that will benefit other women or the product of conception in any of the stages of pregnancy or breastfeeding.
ARTICLE 69.- Clinical investigations with persons deprived of liberty
Persons deprived of their liberty must not be unjustifiably denied the opportunity to participate in clinical research or to have access to medicines, vaccines and other research elements that may represent therapeutic or preventive benefit for them.
Special attention must be paid to guaranteeing the voluntary nature of consent in this population, applying a properly proven scientific methodology that reasonably guarantees that the consent of the person deprived of liberty is unquestionably voluntary.
CHAPTER X
SANCTIONS
ARTICLE 70.- Sanitary and administrative measures
The Ministry of Health, the CONIS or the CEC, as appropriate, must know and dictate the corresponding sanitary and administrative measures to avoid or amend those actions contrary to this law incurred by researchers, sponsors and any other interested party involved in a investigation project; all of the above without prejudice to the civil, criminal or disciplinary liability that may correspond to the offender.
ARTICLE 71.- Precautionary measures
During the processing of administrative procedures or investigations in court that question the legality of the activity of the investigator, the sponsor or the CEC, the OIC or the OAC and for the purpose of safeguarding the health and safety of the participants in an investigation , the competent body may impose the necessary precautionary measures.
The investigations, the investigator or the approval of research projects may be temporarily or permanently, partially or totally suspended in the event that the administrative authority or the judicial authority considers it necessary.
The competent body, through a well-founded resolution and after hearing the interested parties, must resolve whether to confirm, modify or revoke the measure adopted. To do this, you must apply the procedure established by the Contentious-Administrative Procedure Code.
ARTICLE 72.- Violations of the investigator or the sponsor, the OIC or the OAC
The CONIS, after due process, may impose a fine of up to thirty percent (30%) of the total value of the investigation, in the event that the investigator or the sponsor, the OIC or the OAC incurs in any of the following infractions:
a) Has provided false information or has omitted relevant information during the process of approval or execution of a research project.
b) Initiate a research project without the proper approval of the CEC.
c) Failure to comply with or unjustifiably delay the fulfillment of the obligations set forth in this law.
d) Any other breach of the obligations that correspond to them according to the law.
To determine the applicable sanction, the seriousness of the offense by the investigator, the sponsor, the OIC or the OAC or the employees, representatives or representatives of the company, and the recurrence of offenses against this law will be taken into account. The CONIS will publish the list of sanctioned investigators, sponsors, OICs or OACs on the website of the Ministry of Health.
ARTICLE 73.- Infringements of the CEC
The CONIS may impose on the employees, representatives or representatives of a CEC, a fine of up to three hundred times the base salary, in accordance with Law No. 7337, of May 5, 1993, and its reforms, a law that creates the Concept of base salary for special crimes of the Penal Code, in case any of them incurs in any of the following infractions:
a) Failure to comply with or unjustifiably delay the fulfillment of the obligations that this law grants, as well as any other obligation provided for in this law, in Law No. 5395, General Health Law, of October 30, 1973, in the code of morals or ethics of the professional associations to which the researchers belong, or in the regulatory provisions of the aforementioned legal bodies, or any other applicable legal norm.
b) Does not resolve or channel, in a timely manner, the complaints filed by the people participating in the investigations, for damages suffered.
c) Any other breach of the obligations that correspond to them according to the law.
To determine the applicable sanction, the seriousness of the offense, the degree of fault or the existence of fraud on the part of the employees, representatives or representatives of the CEC and their recidivism will be taken into account.
ARTICLE 74.- Coordination
The Ministry of Health and the CONIS will determine the necessary coordination mechanisms for the most correct and efficient application of the controls, the special sanitary measures and the sanctions provided for in this law. The product of the fines established in this article will be distributed as follows: fifty percent (50%) to the CONIS and fifty percent (50%) to the CEC, in the event that the non-compliance sanctioned was a sponsor or of an investigator. In the case of the imposition of fines to the CEC, the product of these will correspond to the Conis.
ARTICLE 75.- Challenges
Against the resolutions issued by the CEC, in the exercise of their powers, there will be an appeal before the CONIS. The appeal must be filed within five business days following the notification of the corresponding resolution.
The resolution that imposes a fine will constitute an enforceable title against the offender. The Conis or the CEC, as appropriate, will be entitled to collect it.
ARTICLE 76.- Penalty procedure
The sanctioning process will apply the procedure established in Law No. 6227, General Law of Public Administration, of May 2, 1978.
ARTICLE 77.- Punishable acts
If the failure to comply with the obligations set forth in this law or its regulations result in punishable acts, the Minister of Health, the CONIS or the CEC, or whoever has knowledge of the punishable act, as appropriate, will notify the Public Ministry of the matter so that it promotes and exercises relevant criminal actions.
ARTICLE 78.- Undue experimentation
Whoever subjects a person to research for the application of medicines, drugs, substances, treatments, techniques, devices or procedures, without duly informing him of the experimental condition of these and the risks he runs, and without express consent, written and documented from the victim or his legal representative and authorization of the procedure by a CEC; or whoever has used the impossibility of the victim to give consent, coercion, threat, deception, disinformation, manipulation or any other illicit means to obtain said consent, will be punished with a prison sentence of three to eight years.
Anyone who promotes or conducts biomedical scientific research without the informed consent validly granted by the participants or their legal representative, unless the respective CEC has exempted compliance with such a requirement in accordance with this law, or has used coercion. , threat, deception, disinformation, manipulation, or any other illicit means to obtain said consent, will be sentenced to imprisonment from three to eight years.
ARTICLE 79.- Serious undue experimentation
The prison sentence will be from five to ten years, when the behaviors described in the previous article are carried out by public officials or in the case of investigators who are repeat offenders in the sanctioned behavior or when they are committed to the detriment of minors, pregnant women , elderly and disabled people or who for any reason cannot express their opposition to the practice of research.
ARTICLE 80.- Disqualification
In addition to the corresponding prison sentence, the judicial authority must establish the sanction of disqualification for a period of five to ten years for biomedical research processes or for the exercise of their profession, or both, according to the assessment of the facts, to the person who has committed the acts typified in the previous articles.
ARTICLE 81.- Influence peddling with biomedical research
A prison sentence of one to three years will be imposed on members of scientific ethics committees (CEC) and officials of public or private institutions that authorize, facilitate or contract the performance of biomedical research in which companies participate or have economic interests. in which they, their spouses or partners, or their relatives by consanguinity or affinity up to the third degree inclusive, form part of their boards of directors, participate directly or through an intermediary natural or legal person in their share capital, or work as researchers.
ARTICLE 82.- Gifts and coercion
A prison sentence of three to five years will be imposed on the member of a scientific ethics committee who accepts any type of donations from people or companies that carry out biomedical research, without prejudice to other sanctions and responsibilities that proceed in accordance with the legal system. .
ARTICLE 83.- Offering of gifts and coercion
A sentence of three to five years in prison will be imposed on the person who offers gifts or exercises coercion to the members of a CEC to obtain favorable results in the authorization or any stage of the investigation, without prejudice to other sanctions and responsibilities that proceed in accordance with the legal system.
ARTICLE 84.- Improper use of privileged information
Whoever, using his position in the public function or in the private sector, uses protocols or medical or social records of patients or users, to locate, recruit or contact participants for biomedical research that means economic benefit to him, his spouse or partner, or his relatives by consanguinity or affinity up to the second degree inclusive, shall be sanctioned with a prison sentence of one to three years, without prejudice to other sanctions and responsibilities that proceed in accordance with the legal system.
CHAPTER XI
FINAL PROVISIONS
ARTICLE 85.- Violation of privacy
The person who discloses or publishes, by any means, private information about the participants in a clinical experiment, without their prior consent, will be punished with a sentence of two to four years in prison.
ARTICLE 86.- Regulation
The Executive Branch will regulate this law within a period of six months; however, the lack of regulation will not prevent its application.
ARTICLE 87.- Repeals
Articles 25, 26, 64, 65, 66, 67 and 68 all of Law No. 5395, General Health Law, of October 30, 1973 are repealed.
TRANSITORY I.-
CECs of public or private entities that are operating at the time this law is in force are hereby authorized to continue doing so and initiate the approval of clinical investigations in strict compliance with the provisions of this law. However, within a period of six months counted from the constitution and installation of the Conis, such CECs are obliged to accredit themselves before the Conis, adapting to the requirements demanded in this law for their operation. After this period of six months, the CECs that have not requested the respective accreditation will automatically lose their authorization to operate.
TRANSITORY II.-
The Ministry of Health is authorized to allocate human, financial and any other resources required for the operation of the CONIS until it has the necessary funds to operate and fully comply with the functions assigned to it. in this law. Within a period of six months counted from the effective date of this law, the Ministry of Health will formulate the corresponding budget that contemplates the content for the allocation of the places necessary for the formation, strengthening and operation of the Conis powers, as well as the provision of resources to finance the infrastructure and equipment required for the effective and efficient operation of said body. The Ministry of Health will send the corresponding plan of expenses to the Ministry of Finance,
TRANSITORY III.-
Within forty-five days following the integration and entry into operation of the Conis, this body will submit its first operating budget to the Comptroller General of the Republic for approval. Likewise, it is authorized to include in this first budget the items that allow the retroactive payment of the per diems to the members of the Conis for the sessions they have attended and have been held since its installation and until the date of approval by the Comptroller General of the Republic. of that budget. This authorization also governs the retroactive payment of administrative expenses incurred during the same period.
TRANSITORY IV.-
If at the end of sixty business days, counted from the publication of this law or, as the case may be, from the day that the term of the appointment in the CONIS expires of the institutions obliged to do so, that have not done so, automatically Members who have not been appointed will be represented by:
a) The Minister of Health.
b) The Minister of Science and Technology.
c) The president of the Costa Rican Social Security Fund.
d) The president of Conare.
e) The president of the Costa Rican Bar Association.
f) A prosecutor from any of the professional associations of Physicians and Surgeons, Pharmacy, Dental Surgeons or Microbiology, at the election of the Ministry of Health, and by a representative of the community appointed by the head of the Ministry of Health.
g) A representative of the citizenry, appointed by the head of the Ministry of Health.
The members appointed in this way will be in their positions until the respective holder and his alternate are appointed in the manner provided in this law or the respective regulations. The members of the CONIS, mentioned in the previous paragraph, are obliged to inform and accredit the name of their respective alternate, who must meet the requirements established in this law, in the first session attended.
TRANSITORY V.-
As long as the CONIS does not have its own internal audit, it may be audited by the internal audit of the Ministry of Health, in accordance with Law No. 8292, General Law of Internal Control, of July 31, 2002 and Law No. º 7428, Organic Law of the Comptroller General of the Republic, of September 7, 1994.
It governs from its publication.
Given in the Presidency of the Republic, San José, on the twenty-second day of the month of April of the year two thousand and fourteen.