notice: The Costa Rica Vaccination Commission Secretary Roberto Arroba Tijerino testified this law governs the investigational product called covid-19 vaccines.
No. 39061-S Regulations to the Biomedical Research Regulatory Law
1º-That the health of the population is a fundamental right and a good of public interest protected by the State.
2º-That it is the responsibility of the Ministry of Health to define the policy, regulation, planning and coordination of all public and private activities related to health, including biomedical research.
3º-That on April 25, 2014, Law No. 9234 of April 22, 2014 “Regulatory Law of Biomedical Research” was published in the Official Gazette, which regulates biomedical research with human beings in health matters , in the public and private sectors.
4º-That the Law establishes the obligation of the State to create strict mechanisms for the regulation, control and follow-up of biomedical research that ensure the protection of the participants and the correct execution of the investigations.
5º-That it is of fundamental importance to guarantee the rights and safety of all human beings involved in the research activity as well as to ensure strict compliance with the ethical standards that should guide this activity.
6º-That biomedical research has been and will be very valuable to know, among others, the biological and psychological processes, the causes of diseases, methods to prevent, diagnose or cure them and production of health supplies.
7º-That the ethical and social consequences of investigations in the human being, impose special responsibilities of rigor, prudence, intellectual capacity and integrity, in the realization of said investigations.
8º-That it is necessary to provide the Law with the appropriate tools for its application, in such a way as to guarantee respect for the life, health, freedom and dignity of the people who participate in biomedical research.
9º-That the life, health, freedom, well-being and dignity of the participants in biomedical research involving human beings shall prevail over scientific interest, the production of new knowledge or economic and commercial interests.
10.-That all biomedical 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.
11.-That biomedical research is of fundamental importance for the development of new knowledge in the field of health and as part of it, in the development of better and more advanced methods aimed at promoting health, detection and timely and effective treatment. of diseases that affect human beings and especially the Costa Rican population.
12.-That in order to fulfill the responsibility to adequately encourage, regulate, regulate and supervise the research processes carried out in our country, it is necessary to have adequate regulations to guarantee both the fundamental rights of the participants and the public interest . Therefore,
They decree:
Regulation to the Regulatory Law
Biomedical Research
CHAPTER I
General disposition
Article 1-Object. The purpose of this regulation is to regulate, control and supervise the application of Law No. 9234 “Biomedical Research Regulatory Law”, in order to guarantee the life, health, interest, well-being and dignity of the people who participate in biomedical research in the public and private sectors.
Article 2- Scope of application . The provisions of this regulation are of public order, of general interest and compliance is mandatory, therefore, applicable to any individual or legal entity that is directly or indirectly related to biomedical research in the national territory.
Article 3 – Definitions and abbreviations . For the purposes of this regulation and its application, it is understood as:
a) Expanded or compassionate access: Expanded access, also known as “compassionate use”, is the use of investigational drugs outside of clinical trials. Expanded access allows patients with serious or life-threatening illnesses to access experimental or investigational drugs when they have no other medical options.
b) Anonymize: Process by which it is no longer possible to establish the link between a piece of data or a sample and its owner.
c) Audit: Independent and systematic examination of the activities and documents related to the investigation, to determine if the evaluated activities related to the investigation were carried out and if the data were registered, analyzed and correctly communicated, in accordance with the protocol, the standard operating procedures and applicable national and international regulations, as well as any other activity, document or information that the auditing body deems pertinent.
d) Informed assent: Process by which a minor, but over 12 years of age, is informed about their participation in biomedical research. The assent must be written in the appropriate and understandable language for the individual and must be accompanied by the legal informed consent of the father, mother, guardian or the person who is exercising legal custody of the minor. In case of conflict, the criteria of the minor will prevail.
e) Bioavailability: Measurement of the quantity of a pharmaceutical product contained in a pharmaceutical form that reaches the systemic circulation and the speed at which this process occurs.
f) Bioequivalence: Condition that occurs between two pharmaceutical products that are pharmaceutical equivalents and that show the same or similar bioavailability in accordance with the provisions of the applicable regulations.
g) Good Clinical Practices: A standard for the design, conduct, performance, monitoring, auditing, registration, analysis and reporting of clinical studies that provides a guarantee that the data and results reported are credible and accurate and that the data are protected. rights, integrity and confidentiality of the study subjects.
h) Good Manufacturing Practices (GMP): Set of procedures and standards aimed at guaranteeing the uniform production of batches of pharmaceutical products, equipment and biomedical material, as well as their safety and efficacy, according to national and international quality standards. (This definition is consistent with the one included in the Technical Regulation on Good Manufacturing Practices for the Pharmaceutical Industry, Pharmaceutical Products and Medicines for Human Use Executive Decree No. 35994-S, Regulation for the registration, classification, import and control of biomedical equipment and material Executive Decree No. 34482-S) CEC: Scientific Ethics Committee.
i) CEC: Scientific Ethics Committee.
j) Conis: National Health Research Council.
k) CRF: Case Report Form.
l) Informed consent: Informed consent is the process of information and understanding through which a person voluntarily expresses their desire to participate in biomedical research.
m) Medical Device: Object used to diagnose, prevent or treat diseases, which achieves its objective through physical, mechanical or thermal means. On some occasions, they may contain substances that generate the desired action.
n) Potential drug or new drug under investigation: Drug or active ingredient contained in a pharmaceutical dosage form, which has passed preclinical tests or studies and is going to be used in research or clinical trials.
o) SAE: Serious Adverse Event.
p) EMA: European Medicines Agency.
q) Amendment: A written description of changes or formal clarifications of the information recorded in a research protocol, the informed consent, the informed assent and the related documents, which generates a new version of it.
r) Research Team: Group of suitable people who carry out biomedical research, led by a principal investigator.
s) Bioequivalence Studies: These are studies with healthy volunteers to whom a pharmaceutical product is administered, in order to measure its levels in body fluids or tissues and thus evaluate its therapeutic equivalence with the reference product. Such studies are designed to measure the quality of the products. They usually have no therapeutic benefit for the participants. Because they lack therapeutic benefit, are carried out in healthy volunteers and have remuneration, they are classified as Phase I studies, as defined in article 2 of Law No. 9234 “Biomedical Research Regulatory Law”.
t) Pharmacokinetic studies: These are studies in humans in which the concentration of the active ingredient, and if applicable, of its metabolite(s) in blood, plasma, serum, or other fluids is quantified as a function of time. and biological tissues. They are used for pharmaceutical forms with active ingredients administered to exert a systemic effect.
u) Pharmacodynamic studies: These are studies carried out in human beings to measure the temporal evolution of a specific pharmacological effect (whether or not it is a therapeutic activity of the product) of a certain active principle and, if applicable, of its active metabolites that have close relation to the administered dose.
v) Therapeutic equivalent: Pharmaceutical equivalents or pharmaceutical alternatives that after the administration of the same molar dose, their effects with respect to safety and efficacy, are essentially the same, when they are administered to patients by the same route and according to the specified conditions. in the lettering.
w) Adverse event: Any unfavorable medical occurrence in a patient or subject of a clinical investigation to whom a pharmaceutical product is administered and that does not necessarily have a causal relationship with this treatment.
x) Clinically significant adverse event: Any occurrence, event or harmful reaction whose nature, severity or consequences are considered important or relevant from the medical point of view for the health and well-being of the research study participant. Clinical significance requires consideration of different factors, including intensity, time course, seriousness of the outcome, and the presence or absence of sequelae.
y) Unexpected adverse event: Any event, event or unintended harmful reaction whose nature, severity or consequences are not known or could not have been anticipated with the information already described on the research product or the study protocol.
z) Vulnerable groups: Those whose willingness to participate as volunteers in biomedical research may be unduly influenced by the unjustified expectation of benefits related to participation, a retaliatory response by people of superior hierarchy in case of refusal to participate, lack of capacity to give informed consent, lack of alternative means of obtaining medical care, or other high-cost necessities. Examples include members of groups with hierarchical structures, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory staff, pharmaceutical industry employees, members of the police and security forces. , and persons detained or deprived of liberty. In addition,
aa) IATA: International Air Transport Association.
bb) IDE: Investigational Device Exemption.
cc) IND: Investigation New Drug.
dd) Law: Law No. 9234 “Biomedical Research Regulatory Law”.
ee) Medication: Any natural, synthetic or semi-synthetic substance or products and any mixture of these substances or products used for the diagnosis, prevention or treatment and relief of diseases or abnormal physical states, or their symptoms. and for the establishment or modification of organic functions in people.
ff) MICITT: Ministry of Science, Technology and Telecommunications.
gg) OAC: Site Management Organization.
hh) OIC: Contract Research Organization.
ii) PANI: National Children’s Board.
jj) Research Product: Registered or unregistered product of health interest that is being tested or used as a reference or comparator in biomedical research. Pharmaceutical products, biomedical equipment and materials, food and dietary or nutritional supplements, diagnostic tests, natural products, cosmetics and hygiene products are included in this definition.
kk) RIS/CIOMS: International safety reports according to the International Council of Organizations in Medical Sciences.
ll) Research site: Place where the research activities are carried out or where samples of biological material or research products are stored, guarded or dispensed, which must have the corresponding sanitary authorization according to their category of establishment.
mm) Traceability or traceability: Ability to reproduce the history of movements and locations of a batch of a product under investigation through a documentary monitoring system.
nn) Vulnerability: Substantial inability to protect one’s interests and rights, due to impediments such as lack of capacity to give informed consent, lack of alternative means of obtaining medical care or other high-cost needs, or being a subordinate member of a hierarchical group.
Article 4º- Applicable regulations. All biomedical research where human beings participate must guarantee, respect and comply with Human Rights. The National Health Research Council (CONIS), the Scientific Ethics Committees (CEC), the researchers, the technical team related to the research, the sponsors, the Contract Administration Organizations (OAC), the Contract Research Organizations ( OIC) and the support staff of these entities, must fulfill their functions and obligations in strict accordance with the Universal Declaration of Human Rights, the Inter-American Convention on Human Rights, the International Covenant on Civil and Political Rights, the Convention on the Rights of Persons with Disabilities,
Article 5 – Of biomedical research with stem cells, human genome and proteome . Biomedical research related to human stem cells, genome or proteome must comply with the purpose and purpose of Law No. 9234, namely the direct or indirect improvement of people’s health and respect human dignity. In particular, research on the human genome must be limited by respect for the fundamental rights of those involved with a rigorous evaluation of the risks and benefits involved and must be carried out in compliance with the Universal Declaration on the Human Genome and Human Rights of the UNESCO.
Article 6 – Of the obligations of the State and public or private institutions or entities .
1. From the Ministry of Health:
a) Establish the biomedical research policy, priorities and plans considering the epidemiological profile and the analysis of the health situation. The Directorate of Scientific and Technological Development in Health will review the priorities each year, with the participation of the sectors involved and must be socialized to the entire population and incorporated into the National Plan for Science and Technology in Health.
b) Coordinate the formation of CONIS and promote the creation of CECs in institutions that carry out biomedical research, as established in Article 34 et seq. of Law No. 9234.
c) Create the National System of Information on Science and Technology in Health, which will be established in close coordination between CONIS and the Directorate of Scientific and Technological Development in Health. It will have information related to the registry of biomedical research carried out in the country, institutions that carry out health research, human resources for research, budget and sources of financing for biomedical research, infrastructure for research, production and dissemination of knowledge, among others. This information must be continually updated and publicly accessible.
d) Promote and strengthen the training of the human resources of the National Health System in ethical and scientific aspects of biomedical research, for which it must prepare annual training programs.
e) Promote in public or private academic institutions that carry out biomedical research, the incorporation of content on scientific research and bioethics in the curriculum of the careers they offer.
f) Monitor compliance with this Regulation together with CONIS and the Directorate of Scientific and Technological Development in Health.
g) Form the CEC of the Ministry of Health.
2. Public, private, national or foreign institutions or entities that carry out biomedical research:
a) Every public or private institution or entity that conducts biomedical research must establish an institutional regulation that governs its biomedical research, in accordance with the provisions of Law No. 9234 and these Regulations.
b) Every public or private institution or entity that conducts biomedical research will allocate a budget that guarantees full compliance with its annual research program.
c) Without prejudice to what is established in point b, any public or private institution or entity that conducts biomedical research may manage to obtain external funds for the development of new research.
d) The public or private institution or entity that conducts biomedical research may form a CEC, in accordance with the provisions of Law No. 9234 and these regulations.
e) Any public or private institution or entity that conducts biomedical research may define an incentive program for researchers that favor the performance of biomedical research.
Article 7º- Observational public health research . Observational-type public health research will be governed by the provisions of article 7 of Law No. 9234. Researchers who conduct research that does not require approval by a CEC must register their studies in the CONIS, and must comply with the following requirements :
a) Send to CONIS a research profile that contains at least administrative information, responsible institution and participating institutions, sponsors, name of the researchers, address and contact information of the researchers, institution to which the researchers belong, qualifications and experience of the principal investigator in research, start and end date of the research, cost and source of funds. They must also submit the following technical information to the CONIS: title of the research, justification, relevant demographic and epidemiological data of the place of study, objectives, place where the research will be carried out, and methodology.
b) The institutions that carry out this type of research must submit a report on the final results of the study to CONIS, within a period not exceeding two months after the end of the research. In the case of multicenter studies, the period is extended to 6 months. The above terms may be extended at the request of the researcher for the same period and only once, with the approval of the CONIS.
c) The CONIS may request additional information on the investigation if it deems it necessary.
CHAPTER II
of informed consent
Article 8 – On informed consent .
a) In all biomedical research in which human beings participate, except that indicated in articles 7 and 12 of Law No. 9234, the researcher must obtain informed, individual, voluntary, express, specific, written and signed consent or with the fingerprint of the participant or their legal representative on all sheets, and of an impartial witness on the final sheet. In the case of the legal representative; A copy of the documentation must be included where the right to legal representation is registered.
b) The CECs may request that additional information be included in the Informed Consent, in addition to that established in articles 10 and 11 of Law No. 9234.
c) Researchers must guarantee respect for the dignity and autonomy of people; Each individual must be given the space they require to make the queries they deem pertinent and thus be able to make decisions related to their participation in the research.
d) Prior to signing the informed consent, the researcher or the person designated by him, who must be part of the research team, will transmit the information orally and in writing, appropriate to the level of understanding of the individual, in his own language and ensure that the research participant has adequately understood the information (see annex 1), so that they have complete autonomy to make the decision to participate or not, freely, voluntarily and consciously, without coercion, duress, threat, fraud, deception, manipulation or any other type of pressure.
e) Informed consent must be obtained before starting any research procedure, it must be in writing and signed by the participant; the original document is kept by the researcher and a true and exact copy must be given to the participant. The researcher will be responsible for the confidential handling of the document that will be included in the file of each research participant.
f) The process of signing the informed consent must be carried out in the presence of an impartial witness of legal age, who could be a family member, selected by the participant or their legal representative, without any connection with the research team, the researchers, the sponsors, OACs or ICOs. The witness must be a person with sufficient capacity to understand the scope of her actions, they will not have access to the confidential information of the participant, nor will they be present when it is analyzed.
g) In all pages of the informed consent document, the participant or their legal representative, as appropriate, must use the signature registered in the identification document, which must be verified by the researcher. A copy of this identification document will be attached to the copy of the informed consent that remains in the participant’s file.
h) In the case of minors, the legal representative will participate in the information process, making sure of their understanding as well as the freely expressed will of the minor’s participation or not. The best interests of the minor and her rights to confidentiality and privacy must be guaranteed.
i) In the case of minors, but over twelve years of age, the researcher must obtain the informed assent of the participant individually, voluntarily and expressly, which must be accompanied by the informed consent signed by the legal representative. The assent must be written in appropriate and understandable language. To record her assent, the minor must write her name on the document.
j) When research is carried out in special cultural groups such as ethnic groups or religions, the researcher must respect the rules established by these groups. The informed consent information must be provided in the language of your culture, in case you do not understand Spanish.
k) When the research is carried out in a captive population such as educational centers, health establishments, social adaptation centers, among others, the researcher must respect the provisions established by the institution and obtain the corresponding written permission to carry out the research, without prejudice of obtaining the individual informed consent mentioned above.
Article 9 – Informed consent for people with disabilities .
a) In all research in which people with visual disabilities participate, the researcher must give the information and informed consent in accessible and appropriate formats in common agreement with the participant, such as oral reading, braille system or others. These formats must be approved by the respective CEC.
b) In all research in which people with hearing disabilities participate, the researcher must give the information and informed consent in accessible and appropriate formats in common agreement with the participant, such as written formats, Costa Rican Sign Language (LESCO) or others. These formats must be approved by the respective CEC.
CHAPTER III
Biological samples of human material
Article 10.- Of the minimum requirements of the laboratories that participate in clinical research .
a) Have a current Sanitary Operating Permit.
b) Have all the facilities and equipment necessary to conduct the study.
c) Have internal operating manuals, specifying their internal processes for the handling, processing, storage, elimination and disposal, land, sea and air transfer of biological samples, as well as the maintenance of their equipment.
d) Have trained personnel to fulfill the responsibilities assigned therein, including documented training in Good Clinical Practices, renewed at least every three years with a program endorsed by the Conis.
e) Have physical spaces with restricted access control to store all documentation/specific supplies of the investigation, duly identified.
f) Have duly identified the laboratory equipment used specifically for research and give it proper maintenance.
Article 11.- Of the handling of biological samples . All types of biological samples of human material must be processed and stored in centers authorized for such purposes, such as clinical, research or other laboratories, which must have a sanitary operating permit granted by the Ministry of Health.
The samples of human material that require to be anonymized may not have personal information of the participant that can identify them, they must be registered by means of a non-binding code with the participant, assigned in the investigation.
The handling of biological samples in each laboratory must be in accordance with the provisions of its internal operating manuals and may only be carried out by personnel trained for such purposes.
Article 12.- Land, sea or air transport of biological material .
a) All transport of biological and infectious material must comply with the UN3373 Regulation, following all the guidelines of category A for biological material and category B for infectious material and the regulations established for these purposes by the Ministry of Health.
b) Laboratory personnel in charge of transporting biological material must have a current IATA Certification.
c) The laboratories will be responsible for verifying that the transport agency complies with the requirements established by the United Nations Committee of Experts for the transport of samples, and any other binding national or international standard.
d) The laboratories that participate in clinical research are responsible for giving the sample all the necessary handling and packaging so that it reaches its final destination in good conditions.
CHAPTER IV
Of the rights and obligations of the participants
Article 13.- Of the guarantees of the participants . People who have suffered damage to health as a result of their participation in clinical research and who are related to its procedures, or their heirs in the event of death, will receive the corresponding compensation according to the provisions of Law No. 9234 and in the policy constituted for this purpose.
Article 14.- Of the protection policy for the participants . To guarantee the access of the participants and their heirs to the right to compensation for damages:
a) The sponsor of all biomedical research must have an insurance policy with a validity period that covers from the beginning of the research and for a minimum of two years after the end of the research. Completion will be deemed completed on the date of delivery of the final report of the investigation or study to the CEC.
b) For the purposes of the participants, the policy will cover them from the beginning of their participation, which will be considered verified, for each participant, with the signing of the Informed Consent, and for three years, after the participant’s participation in the investigation.
c) The CEC will supervise that the term of temporary legal coverage of the civil liability policy is a minimum of two years.
d) The sponsor must guarantee legal coverage and a civil liability policy in favor of the researcher and his human team, in order to face possible claims for injuries or damages attributable to clinical research, as long as it is not due to negligence. , malpractice or protocol violations, in which case the responsibility rests with the investigator.
e) The Principal Investigator must guarantee a civil liability policy in order to deal with possible claims for injuries or damages attributable to clinical research in the cases of the previous paragraph.
f) All civil liability policies must be valid and enforceable in Costa Rica. In order for the policies to comply with the legal requirement of being enforceable in the country, in accordance with the constitutional principle of prompt and due justice, the OACs, OICs, sponsors or principal investigators must guarantee that their insurers have branches or service centers in the country in such a way that the absence of operation centers in the national territory does not make the exercise of the rights associated with the policies null and void, which, while still valid and enforceable, could become ineffective.
Article 15.- Of the guarantees of the participants or their heirs . To guarantee the access of the participants or their heirs to the right to compensation for damages:
a) In the initial submission, the main researcher must provide a written explanation to the CEC on what are the mechanisms and procedures that will be used to guarantee that the participants understand, enjoy and are able to exercise the rights that assist them in accordance with what is established in articles 30, 31 and 53 subsection j) of Law No. 9234.
b) The informed consent document will contain a clear, detailed and circumstantial explanation, through which the participants or right holders can access the benefits, in accordance with the procedures of the respective insurance company. In the informed consent given to each participant, proof or a copy of the policy must be given, 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. to it by the participants.
c) In the event of an event or adverse reaction that would be attributable to the experimentation, the insurers will have a maximum period of thirty days, from receipt of the complete documentation, to deliver the resources to the beneficiaries. The foregoing without prejudice to advances that can be delivered in shorter terms to meet immediate expenses.
d) In case of non-compliance with the previous term as well as any other non-compliance, discrepancy, non-conformity or anomaly in the offer, formalization or execution of the policies, the CONIS will issue a report to the General Superintendence of Insurance for the respective investigation, in order to that establishes the corresponding administrative and pecuniary sanctions.
Article 16.- Of the procedure for processing claims for breach of access to insurance benefits in health research . People who allege having suffered an injury, damage or loss as a result of their participation in a clinical investigation and that are related to its procedures, or their heirs in case of death, who allege controversy with the fulfillment of the insurance benefits , must comply with the provisions of articles 4 and 84 of Law No. 8956 “Regulatory Law of Insurance Contracts” of June 17, 2011.
Article 17.- Of the obligations of the people participating in a biomedical investigation . In addition to what is established in article 33 of Law No. 9234, the following are the obligation of the participants in biomedical research:
a) If the participant requires medical attention independent of the study, they must inform the treating physician of their participation in a clinical investigation in order not to put their health at risk. In the cases of children or people with disabilities, it will be the responsibility of their parents or legal representatives to provide this information.
b) If the participant requires medical care independent of the study, they must inform the researcher of the treatment they are receiving, in order not to jeopardize their health or the results of the study.
c) You must provide truthful and timely information about your previous illnesses and pre-existing clinical conditions.
CHAPTER V
From the National Health Research Council
Article 18.- Of the functions of the CONIS . Additional functions of the Conis will be:
a) Promote the development of biomedical research to improve national public health.
b) Preserve and safeguard the files of the projects and matters submitted to their knowledge and all documentation that supports their actions, in accordance with the procedures and conditions established by these regulations, under the archival principles and rules that govern the confidentiality of this documentation.
c) Authorize the digitization of the research files and those of the participants, when so required by the researchers, the OICs, the OACs or the CECs.
d) Supervise the independence of the CEC with the principal investigator, sponsor, or any other influence.
e) Carry out inspections of the CECs at least once a year.
f) Regulate and supervise with special emphasis the investigations that include the use of placebo.
Article 19.- On the formation of the National Health Research Council . The Council will be composed of:
a) The Minister of Health or his representative, who will preside over it.
b) The Minister of Science, Technology and Telecommunications or his representative.
c) A Lawyer specializing in human rights, who will be appointed by the Board of Directors of the Costa Rican Bar Association.
d) A representative of the Costa Rican Social Security Fund (CCSS), who will be appointed by the Board of Directors, preferably belonging to the Social Security Center for Strategic Development and Information on Health and Social Security (Cendeisss).
e) A proprietary representative and member of the College of Physicians and Surgeons; Pharmacists; Dental Surgeons and Microbiologists appointed by the boards of directors of the respective colleges. The order of alternation in the appointment of the representatives of the professional associations will be as follows: First year: College of Physicians and Surgeons of Costa Rica; second year College of Pharmacists of Costa Rica; third year College of Dental Surgeons of Costa Rica and fourth year College of Microbiologists and Clinical Chemists of Costa Rica.
f) A representative of the National Council of Rectors, who must be a specialist in bioethics.
g) A representative of the community, who will be appointed by the Ombudsman’s Office. This representative will be appointed for a term of three years and may not be re-elected.
Article 20.- Causes of removal and revocation of appointment . The following will be causes for removal of the members of the CONIS:
a) Unexcused absences. Whoever, without just cause, does not attend three or more of the regular sessions, either consecutively or alternately, during a calendar year, will be removed from his or her position.
Absences must be justified 24 hours in advance to the Presidency of the CONIS with the reasons that motivate them. In urgent cases, they may be motivated during the 3 business days following the holding of the respective session.
b) Breach of Functions:
i. When violations of the legally assumed duties are incurred by infringing, consenting, or facilitating to third parties infractions of the legal provisions, regulations, agreements of the Conis, CEC or bioethical principles that govern biomedical research.
ii. When the duty of secrecy is violated by disclosing information or communicating to third parties matters that the Conis has declared as confidential or as “sensitive information”, temporarily or permanently, or that have not been firmly resolved and previously communicated to the interested parties.
iii. When any type of abuse is incurred in the exercise of the position, in persecution, harassment, defamation, discredit or discrimination against other members of the CONIS, officials, collaborators, members or staff of the CEC, as well as those managed .
IV. When any other breach of the duties imposed by the legality block or the bioethical principles that govern biomedical research is incurred.
c) Conflict of interest:
i. When the CONIS is not informed in a timely manner of any conflict of interest, pre-existing or that arises subsequently, both for the knowledge of a specific case and for the exercise of general functions as a member of the CONIS. In case of not opportunely inhibiting, the CONIS must dictate a formal resolution of separation from the position, guaranteeing the Due Process and Right of Defense.
ii. In the event of being disqualified or recused, in a timely manner for a specific case, the condition of member will not be lost, and the member must refrain from participating or directly or indirectly influencing the matters in which the conflict of interest is declared.
The CONIS, by simple agreement, may request the corresponding body or institution, the revocation of the appointment of any of its members for the same causes of removal indicated above, or any other that derives from the Right to Protection of Health, Dignity Human Rights and the Right to Life or for reasons of public interest, a resolution that will be duly motivated.
Article 21.- Of the audit of the Conis . According to article 34 of Law No. 9234, the CONIS will have its own internal audit, on which it will report directly.
Article 22.- Of the diets . The owner member of the CONIS or the substitute in his absence, will receive the corresponding diet when he complies with at least 75% permanence in the session, whether ordinary or extraordinary. Public officials who participate in the sessions during working hours will not receive the allowances.
For this purpose, the Executive Secretariat of the CONIS must keep a record with the time of entry, exit and signature of the member.
Article 23.- Of external consultants and special commissions . The CONIS may seek temporary advice and to the extent it deems necessary, through consultants or experts. It may also form subcommittees or working groups for the technical analysis of projects or specific topics. The CONIS is authorized to cancel, charged to the institutional budget, the expert consultants that it needs to hire to meet the objectives of Law No. 9234. This decision must be motivated and the consultants hired must make a formal declaration of conflict of interest, activities and confidentiality, prior to starting their work, and submit a final report on activities at the end of their duties.
Article 24.- Of the Budget . The CONIS, through the Executive Technical Secretariat, must establish the administrative legal procedure for the collection and accreditation of the funds provided for in article 45 of Law No. 9234 to finance the operation of the CONIS.
Article 25.- CEC accreditation . The CECs will be authorized to operate by the CONIS, in accordance with the provisions of subparagraph b) of article 43 of Law No. 9234, for which they must present the following requirements:
a) Have a current Sanitary Operating Permit.
b) The members that make up the CEC must comply with the requirements established in article 47 of Law No. 9234, in addition to providing the updated curriculum vitae of all the members that will make up the CEC.
c) Infrastructure that complies with the appropriate sanitary physical conditions, for meetings and administrative management.
d) Appropriate infrastructure for the conservation of files that guarantees the privacy and confidentiality of the information.
e) Adequate and sufficient administrative staff for the anticipated workload of the CEC, at a minimum a director (who must be a member of the CEC) and an administrative assistant or secretary.
f) Sufficient and appropriate computer equipment and programs for its operation and compliance with the electronic information requirements requested by the CONIS.
g) Internal work regulations.
h) Manual of internal work procedures.
i) Audit policy and procedures.
j) Minutes book to be legalized by the CONIS.
k) Signed commitment of all members to comply with Law No. 9234 and these regulations.
l) Signed commitment of the members to keep confidentiality.
m) Documented training in Good Clinical Practices, renewed at least every three years with a program endorsed by the Conis.
n) Signed commitment to comply with Good Clinical Practices.
o) Signed commitment to declare any conflict of interest, in accordance with the provisions of article 49 of Law No. 9234.
The CONIS will have a term of thirty calendar days counted from the presentation of the request in full form for its resolution. The CONIS will issue an accreditation certificate valid for three years. The CEC will have the obligation to process the renewal of its accreditation, before its expiration, being able to present its renewal request to the CONIS, one month before expiration.
Article 26.- Authorization for researchers . The CECs will be authorized to operate by the CONIS, in accordance with the provisions of subparagraph b) of article 43 of Law No. 9234, for which they must present the following requirements:
1. Principal investigators:
a) Profession according to the type of research.
b) Incorporation into the respective professional association.
c) In the case of foreign researchers, they must have a temporary professional practice permit issued by the respective professional association.
d) Membership card of the respective College and valid identity document.
e) At least five years of professional practice certified by the respective college, for interventional clinical trials.
f) At least two years of professional practice certified by the respective college, for observational or epidemiological studies.
g) The provisions of subsections d), and e), do not apply to university students who have a biomedical study as a graduation requirement. In addition, students must have a tutor who meets the requirement for interventional, observational or epidemiological studies, as appropriate.
h) Participation in at least two interventional investigations to serve as principal investigator in an interventional investigation, this requirement does not apply to epidemiological or observational investigations.
i) Documented training in Good Clinical Practices, renewed at least every three years with a program endorsed by the Conis.
j) Signed commitment to comply with the provisions of Law No. 9234, the regulations and Good Clinical Practices.
k) Declaration of conflicts of interest.
l) Signed commitment to keep confidentiality.
m) Signed commitment to report all serious adverse events or events of significant clinical importance to the CEC, within a period not exceeding 24 hours after they become known, as well as non-serious adverse events. Related on a monthly basis and unrelated non-serious adverse events in the quarterly report.
n) The professional associations in each branch will be in charge of validating the professional qualifications requested in these regulations in the case of foreign researchers.
2. Secondary investigators or sub-investigators:
a) Profession according to the type of research.
b) Incorporation into the respective professional association and current membership card. This requirement does not apply to university graduation projects.
c) Valid identity document.
d) Documented training in Good Clinical Practices, renewed at least every three years with a program endorsed by the Conis.
e) Signed commitment to declare any conflict of interest.
f) Signed commitment of the members to maintain confidentiality.
g) Signed commitment to comply with the provisions of Law No. 9234, the regulations and Good Clinical Practices.
The CONIS will issue an accreditation certificate valid for three years. The main and secondary researchers will have the obligation to process the renewal of their accreditation, before its expiration, being able to present their renewal request to the CONIS, at most one month before the expiration.
Article 27.- Of the authorization of the OAC . The OACs will be authorized by the CONIS for which they must meet the following requirements:
a) Have a current Sanitary Operating Permit.
b) Legal identification number.
c) Internal regulations.
d) Manual of internal work procedures.
e) Administrative structure.
f) Description of physical infrastructure, human resources and computer resources.
g) Documented training of OAC staff in Good Clinical Practices, renewed at least every three years with a program endorsed by the CONIS as applicable.
h) Signed commitment to comply with the provisions of Law No. 9234, the regulations and Good Clinical Practices.
i) Signed commitment of the staff to declare any conflict of interest.
j) Signed commitment of the personnel to maintain confidentiality.
The CONIS will have a period of thirty calendar days counted from the presentation of the accreditation request in full for its resolution. The CONIS will issue an accreditation certificate valid for three years. The OACs will have the obligation to process the renewal of their accreditation, before its expiration, being able to present their renewal application to the CONIS, one month before the expiration.
Article 28.- Of the authorization of the OIC . The OIC will be authorized by the CONIS, for which they must meet the following requirements:
a) Have a current Sanitary Operating Permit.
b) Legal identification number.
c) Internal regulations.
d) Manual of internal work procedures.
e) Administrative structure.
f) Description of physical infrastructure, human resources and computer resources.
g) Documented training in Good Clinical Practices, renewed at least every three years with a program endorsed by the Conis.
h) Signed commitment to comply with the provisions of Law No. 9234, these regulations and Good Clinical Practices.
i) Signed commitment of the staff to declare any conflict of interest.
j) Signed commitment of the personnel to maintain confidentiality.
The CONIS will have a period of thirty calendar days counted from the presentation of the accreditation request in full for its resolution. The CONIS will issue an accreditation certificate valid for three years. The OICs will have the obligation to process the renewal of their accreditation, before its expiration, and may present their renewal request to the CONIS, one month before expiration.
Research sites or establishments where clinical research activities are carried out or where experimental products or drugs are stored, guarded or dispensed to be used in research must have a Sanitary Operating Permit from the Ministry of Health.
Article 29.- Notifications to the National Children’s Board . The National Children’s Board will define, within a period of sixty calendar days, from the publication of these regulations, the body responsible for receiving notifications of approved or renewed research in which minors participate, for what corresponds, according to what is established in article 48 subsection u) of Law No. 9234. Until such an instance is defined, notifications will be addressed to the Executive Presidency of PANI.
CHAPTER VI
Of the Scientific Ethics Committees
Article 30.- Of the Integration of the Scientific Ethics Committees . The Scientific Ethics Committees will be made up of seven proprietary members, each with their respective alternate, who in the absence of the owner will attend the sessions, without prejudice to the fact that they may attend jointly with the owner in order to better follow up on what is discussed in the meeting. within said collegiate body. This integration will be as follows:
a) A professional person with experience in health research.
b) A legal professional with knowledge of human rights.
c) Three professionals in Health Sciences.
d) A professional person in Social Sciences.
e) A person representative of the community, who will be appointed by the Organizations that develop activities related to health issues, who will be appointed in an assembly in which the representatives formally registered with the public or private entity, in whose establishment they are carried out, will participate. biomedical research by non-governmental organizations that develop activities related to health issues. This representative and his alternate will be elected every five years and may be re-elected for more than one term.
The president will be appointed from among the members of the Scientific Ethics Committees, by an absolute majority of them, and will remain in office for one year, and may be re-elected.
Likewise, they may attend the sessions of the Scientific Ethics Committee advisors on specific topics related to biomedical research, invited to the sessions of the Scientific Ethics Committees, who will have the right to speak only.
Public or private entities in whose establishments biomedical research is carried out, will register non-governmental organizations that develop activities related to health issues.
The requirements for the registration of these organizations will be:
Register with the public or private institution in whose establishment biomedical research is carried out, by signing and submitting the registration form called “REGISTRATION FORM FOR NON-GOVERNMENTAL ORGANIZATIONS THAT DEVELOP ACTIVITIES LINKED TO HEALTH ISSUES”, annexed to this decree. This form must be signed by the legal representative of the NGO, and attach a simple copy of your identity card.
a) Provide a letter with the name and qualities of the people who make up the organization, as well as the position within it.
b) Current legal status. This will be verified by the competent authorities of each public or private entity, in whose establishment biomedical research is carried out.
c) Present the Annual Work Plan, in which the general lines of action of the organization are established.
The public or private entities in whose establishment biomedical research is carried out, will have a period of ten calendar days, counted from the day following the receipt of the registration request for its resolution.
Said entities must verify the information presented by the interested party and will prevent, once and in writing, that they complete the omitted requirements, or that they clarify or correct the information. The prevention indicated suspends the term of resolution and will grant the interested party three business days, counted from the business day following the receipt of said prevention to complete or clarify; After these, the calculation of the remaining term foreseen to resolve will continue.
The non-registration of the NGO will prevent its participation in the Assembly.
Article 31.- Publication of the meeting call and procedure to carry out the meeting . For the appointment of the representative referred to in subparagraph e) of the previous article, the public or private entity in whose establishment biomedical research is carried out will publish a notice in a newspaper of national circulation, without prejudice to other additional mechanisms that are decided to be used, to convene The assembly to the representatives of non-governmental organizations that develop activities related to health issues, formally registered with the public or private entity.
Said publication will be made one month in advance and will indicate the deadline for the representatives of the Non-Governmental Organizations that develop activities related to health issues, to present to the public or private entity in whose establishments biomedical research is carried out, the requests of registration and the requirements indicated in article thirty-two of this decree. It will also indicate the date, time and place where the meeting will be held. To comply with the procedure, the following must be done:
a) It is up to the public or private entity in whose establishments biomedical research is carried out to coordinate what is necessary for the assembly to take place and its representatives must be present during the assembly and until its conclusion.
b) The quorum for the assembly to take place will be the simple majority of the non-governmental organizations that carry out activities related to health issues formally registered with the public or private entities in whose establishments biomedical research is carried out. For this purpose, the representatives of public or private entities will proceed to verify it, through the registration of non-governmental organizations that carry out activities related to registered health issues. When there is no quorum, one hour after the appointed time, the assembly will begin with the representatives present. Attendees must sign the respective minutes and those who arrive fifteen will not be able to do so or participate.minutes after the meeting started. Only the participants, the representatives of the public or private entity in whose establishments biomedical research is carried out, may be in such a venue. The participants will proceed to the election of the person representing the NGO that develops activities related to health issues. Said election will be carried out by consensus, failing that by simple majority, for which candidates will be nominated among the participants, the vote will be secret and for transparency purposes, the assembly will elect two participants to be next to the coordinator of the assembly at the time of withdrawing the ballots from the ballot box, as well as to verify the count and the correct writing of the name of the candidate for whom they vote.
c) During the assembly, a person will be designated who will be in charge of drawing up the minutes of the process. This in order to record that the Assembly was held in accordance with the legal system, which must be signed by the person representing the public or private entity in whose establishments biomedical research is carried out, as well as by the participants in the assembly. .
d) A copy of the minutes will be sent to the responsible authority of the public or private entity in whose establishments biomedical research is carried out, so that it can convene a session of the Scientific Ethics Committee and the representative of the organizations that develop activities related to biomedical research. Health. It will also be emailed to organizations.”
Article 32.- Functioning of the Scientific Ethics Committees . The members of the Scientific Ethics Committees will last in their positions for five years, and may be re-elected for equal periods. However, his appointment may be revoked by the responsible authority of the public or private entity in whose establishments biomedical research is carried out before the expiration of the term for which he was appointed, for which the responsible authority will notify the CONIS.
Article 33.- Of the cessation of the members of the CEC . The members of the CEC will be dismissed from their positions if they have been sanctioned for incurring in any of the causes described in Law No. 9234, for violating or consenting to violations of the Law or these regulations, serious breach of their obligations, sudden incompatibility or prosecution for intentional crime, permanent inability to perform their duties, for missing three consecutive or alternate ordinary sessions without just cause, for incurring a conflict of interest or for any of the causes established in national legislation.
Article 34.- External consultants and special commissions . The CEC may seek temporary advice and to the extent it deems necessary, through consultants or experts. It may also form subcommittees or working groups for the technical analysis of projects or specific topics. This decision must be motivated and the contractors must make a formal declaration of conflict of interest, activities and confidentiality and submit a final report on activities.
Article 35.- Of the Secretary . The Scientific Ethics Committees will appoint a secretary from among their members and they will remain in office for one year, and may be re-elected.
Article 36.- Quorum . The quorum for sessions will be four of its members. Resolutions will be taken by absolute majority. In case of a tie, the president will have the casting vote.
Article 37.- Functions of the President . The functions of the person exercising the presidency will be the following:
a) Chair the sessions.
b) Ensure compliance with the functions of the Committee.
c) Summon ordinary and extraordinary sessions and draw up the agenda.
d) Execute the agreements of the Committee
Article 38.- Functions of the secretary . The functions of the person who exercises the secretariat will be the following:
a) Prepare the minutes of the sessions.
b) Communicate the agreements.
c) Keep the files up to date and numbered in chronological order.
Article 39.- Of the sessions . The Scientific Ethics Committees will hold sessions once a week and whenever necessary, for which the person holding the presidency will convene 24 hours in advance.
Article 40.- Headquarters . The Scientific Ethics Committees will have their headquarters in the facilities of the public or private entity where biomedical research is carried out.
Article 41.- Of the records . The Committees will keep a book with the minutes of the sessions, where their resolutions will be recorded. The minutes will be signed by the president and the secretary. The members of the Committees whose vote is contrary to the agreement reached, must include in the minutes the reasons that justify it.
Article 42.- On the approval of projects . The Committees must issue a statement on the approval or disapproval or renewal of the biomedical research projects that are presented to them, within a calendar month, counted from the business day following the presentation of the request.
Article 43.- About resources . The resolutions issued by the Committees may be appealed before the CONIS, in the terms set forth in article 75 of the Biomedical Research Regulatory Law.
CHAPTER VII
From research with human beings
Article 44.- Submission, approvals and authorizations of experimental, clinical or interventional biomedical research . Prior to the start of any experimental, clinical or interventional research, the institution or researcher must submit to the CEC of their choice a submission package that will consist of the following documentation:
a) Written request letter from the researcher to review the study for possible approval.
b) Study protocol in its original language and its official translation into Spanish with date and version.
c) Researcher’s monograph or manual in its original language and its official translation in Spanish, with date and version.
d) Informed consent, in Spanish, in simple and understandable language, with date and version.
e) Informed assent, in Spanish, in simple and understandable language, with date and version, if applicable.
f) Case Report Form in English or Spanish (CRF).
g) Diaries, questionnaires or other materials for the participant in Spanish.
h) IND for vaccines and medicines or IDE for devices or their equivalents (except in situations of qualified exception at the discretion of the CONIS or in cases of investigations of Costa Rican authorship), as appropriate, or a copy of the approval letter from the FDA, EMA or another recognized national or international agency.
i) For medical devices, include the Classification of the device according to the FDA, EMA or other nationally or internationally recognized agency.
j) Registration certificates of the drug or device, if they are already registered with the Ministry of Health.
k) List of countries and centers where the study is conducted (in the case of multicenter studies) and the number of expected participants per center.
l) Copy of the contract between the researcher and the sponsor or, failing that, the sponsor’s representative.
m) Study budget.
n) Certification of protocol approval by an accredited CEC in the sponsor’s country of origin if there are participating centers in that country (only for multicenter studies).
o) Total number of participants expected in Costa Rica and in each study site in Costa Rica (in case of multicenter studies).
p) Description of the site, facilities and details for this study, including the laboratories where the analyzes will be performed.
q) History of submitting the study to one or more other CECs in Costa Rica; outcome of the review (pass, fail).
r) For studies with vaccines and drugs or medical devices, proof that they were manufactured in compliance with good manufacturing practices. Studies with sterile medical devices must also include certification of sterility.
s) For studies with vaccines and medications, it must include a copy of the label in Spanish according to the following: indicate that they are research products, study reference code, pharmaceutical form, route of administration, lot number, number of units, date expiration date, dosage if applicable, storage conditions, identification of the participant and any other information necessary for the participant.
t) The justification for including people belonging to vulnerable populations as participants (if applicable) and a description of the special measures to minimize the risk and inconvenience for these participants.
u) The rules or criteria according to which the participants can be withdrawn from the study.
v) The methods of registering and reporting adverse events or reactions and the measures to deal with these complications.
w) For research in pregnant women, if applicable, the procedures to monitor the outcome of the pregnancy, with special attention to the health of the woman and the child.
x) The procedures and responsible persons proposed to obtain informed consent.
y) The measures to inform the participants about the results of the study.
z) Curriculum vitae of all the members of the research team, with a photocopy of identity document, current professional card or certificate of current membership of the professional association, proof of Good Clinical Practices course with less than three years of seniority endorsed by the Conis .
aa) Copy of the accreditation of investigators and sub-investigators.
bb) Commitment of all members of the research team to comply with Law No. 9234, the Standards of Good Clinical Practices and the entire legal system related to biomedical research.
cc) Declaration of conflicts of interest of all members of the research team.
dd) Valid authorization and accreditation certificate, if applicable, of the research site, laboratories and other research facilities.
ee) Plans for treatment of injuries and compensation procedure for disability or death.
ff) Commitment of the principal investigator to report serious adverse events (SAEs), unexpected or clinically significant ones, to the corresponding CEC, within 24 hours after learning of them, and timely follow-up of the events. Likewise, to report to the CEC on a monthly basis related non-serious adverse events and in the quarterly report, unrelated non-serious adverse events.
gg) Commitment of the principal investigator to report serious adverse events (SAR), unexpected or clinically significant due to the use of medications, equipment or medical devices that are registered with the Ministry of Health.
hh) Commitment of the principal investigator to present the periodic and final reports as established in article 51 subsection p) of Law No. 9234.
ii) Commitment of the principal investigator to send the CEC a monthly summary of the International Safety Reports (RIS/CIOMS).
jj) Sponsor’s commitment to cover treatment costs for study-related injuries.
kk) Commitment of the sponsor to provide insurance for legal and financial coverage to the researcher and his work team for claims arising from the study and that do not refer to negligence or malpractice. Include a copy of the policy.
ll) Commitment of the sponsor to compensate/indemnify the participants for injuries related to the research study, with a copy of the current policy for at least two years after the end of the study.
mm) Commitment of the sponsor to provide free treatment with the study drug, if it has been shown to be beneficial to their health, as established in articles 28 and 53 of Law No. 9234.
nn) Commitment of the sponsor to report the final results to the CEC, whether favorable or unfavorable.
oo) Commitment of the sponsor to participate to the researcher in the publication of the results and explain what role the researcher will play in the publication.
pp) Explanation of how you will recruit participants, including any materials you intend to use.
qq) Explanation of how medical emergencies and serious adverse events will be handled, which centers the participant should go to, and the procedure to follow.
rr) Register of authorized signatures in the documentation of the research study and description of functions of the research team.
ss) Explanation describing the procedures for participants to exercise the rights detailed in article 27 of Law No. 9234.
tt) Non-notarial sworn statement indicating whether an OIC or OAC will participate in the course of the investigation, with their respective accreditations by the CONIS.
Article 45.- Of the content of the experimental, clinical or interventional biomedical research protocol . The study protocol must contain the following aspects:
a) Title of the study.
b) Name and address of the sponsor.
c) Summary of the study.
d) Study phase.
e) Justification of the study.
f) Objectives, hypotheses and questions to be answered.
g) Summary of the results of all previous studies on the subject, published or not, preclinical and clinical.
h) Detailed description of the study design.
i) Number of participants necessary to achieve the objectives and statistical determination.
j) Inclusion and exclusion criteria.
k) Description of all interventions and procedures.
l) Other therapies permitted or prohibited.
m) Laboratory analysis, images and others.
n) Plans for the statistical analysis of the data.
o) Plans for security monitoring and whether there is a Security Data Review Board.
p) Risks and expected adverse effects.
q) For medical devices, the possible risks of misuse or alternative uses of the device must be included, if applicable.
r) Plan for the reporting and management of adverse events.
s) Benefits for the individual participant.
t) Benefits for the population.
u) Time needed to develop the study (total and per participant).
v) Provisions to protect the privacy and confidentiality of the data, plan for the use of codes and opening of the blind, if applicable.
w) Determine the future use of biological samples and participant data.
x) Rights to publish the results.
y) List of bibliographical references.
Additionally, it should be explained how the following will be done (what, who, how, when will it be done):
i. Recruitment of participants.
ii. Obtaining informed consent.
iii. Obtaining informed consent (if applicable).
IV. Management of adverse events, unexpected cases and emergencies.
v. Administration of alternative therapy, if there was therapeutic failure and if applicable.
saw. Continuation of therapy at the end of the study.
vii. Management of pregnancy and its product in case of pregnancy during the study.
viii. Communication of new information to participants if it could affect their decision to remain in the study.
ix. Communication to the participants of information of interest about the results of the study.
In the case of research that requires the importation of vaccines, medications, equipment, devices, and supplies related to approved research, CEC and CONIS approval must be obtained.
Article 46.- Submission, approvals and authorizations of observational or epidemiological biomedical research . Prior to the start of any observational or epidemiological investigation, the institution or investigator must submit to the CEC of their choice a submission package that will consist of the following documentation:
a) Written request letter from the researcher to review the study for possible approval.
b) Study protocol in Spanish with date and version.
c) Informed consent, in Spanish, in simple and understandable language, with date and version, if applicable. In cases where informed consent will not be used, a letter justifying its non-use will be submitted.
d) Informed assent, in Spanish, in simple and understandable language, with date and version, if applicable.
e) Diaries, questionnaires or other materials for the participant in Spanish.
f) Submit a list of countries and centers where the study is conducted and number of participants, this when they are multicenter studies.
g) Copy of the contract between the sponsor, the investigator, if applicable, OAC and OIC.
h) Study budget.
i) Certification of approval of the protocol by an accredited CEC in the country of origin of the sponsor, if applicable.
j) Total number of participants, total in Costa Rica and in each study site (in case of multicenter studies).
k) Description of the site, facilities and details for this study.
l) Submission of the study to one or more other CECs in Costa Rica; outcome of the review (pass, fail, details).
m) Present the justification for including people belonging to vulnerable populations as participants (if applicable) and a description of the special measures to minimize the risk and inconvenience for these participants.
n) Present the norms or criteria according to which the participants can be withdrawn from the study.
o) Present the methods for registering and reporting adverse events or reactions and the measures to deal with these complications.
p) For research on pregnant women, if applicable, present the procedures to monitor the product of the pregnancy, with special attention to the health of the woman and the child.
q) Present the procedures and responsible persons proposed to obtain informed consent.
r) Present the procedure to inform the participants about the results of the study.
s) Submit the protocol to ensure the confidentiality of data collection and records, including storage systems.
t) Present the Curriculum vitae of all the members of the research team, accompanied by a photocopy of the identity document, the current professional license or current temporary professional practice in the case of foreigners, from the respective professional association, proof of the Good Clinical Practices course with less than three years old and endorsed by the Conis.
u) Copy of the accreditation of investigators and sub-investigators.
v) Commitment of all members of the research team to comply with Law No. 9234, these regulations, the Standards of Good Clinical Practices, and the legal system related to biomedical research.
w) Declaration of conflicts of interest of all members of the research team.
x) Valid authorization and accreditation certificate, if applicable, of the research site, laboratories, regencies, and other research facilities.
y) Commitment of the principal investigator to submit periodic and final reports as established.
z) Commitment of the sponsor to report the final results to the CEC, be they positive or negative.
aa) Commitment of the sponsor to involve the researcher in the publication of the results and explain what role the researcher will play in the publication.
bb) Explanation of how you will recruit participants, including any materials you intend to use.
cc) Letter of authorized signatures in the documentation of the study and functions of the research team.
Article 47.- Of the content of the observational or epidemiological biomedical research protocol . The study protocol must contain the following points:
a) Title of the study.
b) Name and address of the sponsor.
c) Summary of the study.
d) Justification of the study.
e) Objectives, hypotheses and questions to be answered.
f) Summary of the results of all previous studies on the subject, published or not.
g) Detailed description of the study design.
h) Number of participants necessary to achieve the objectives and statistical determination.
i) Inclusion and exclusion criteria.
j) Laboratory analysis, images, psychological tests and others.
k) Plans for the statistical analysis of the data.
l) Benefits for the individual participant.
m) Benefits for the population.
n) Time needed to develop the total study and per participant.
o) Provisions to protect the privacy, confidentiality and storage of the data, detail of the anonymization of the data of the participants.
p) Determine the future use of biological samples and participant data.
q) Rights to publish the results.
r) List of bibliographical references.
Additionally, it should be explained how the following will be done (what, who, how, when will it be done):
i. Recruitment of participants.
ii. Obtaining informed consent, if applicable.
iii. Assent, if applicable.
IV. Communication to the participants of information of interest about the results of the study.
Article 48.- Recruitment of participants . The recruitment procedure will be submitted to the CEC as part of the initial submission and will contain the following requirements:
a) Indication of the means to be used for the recruitment of participants. The CEC may authorize the use of spaces and information media for the recruitment of participants, be it television, written press or any other media that the CEC deems pertinent, in accordance with the design of the recruitment plan proposed in the submission package.
b) Indicate if the participant recruitment procedure includes the request to public or private institutions, treating physicians, any other health professional, for the referral or inclusion of patients, in which case, the CEC must previously approve the recruitment proposal specific to these cases.
c) Access to the medical records of potential participants will require their approval. This approval will in no case replace informed consent.
d) The provisions on recruitment, contemplated in the previous paragraphs, will not apply to the investigations regulated in article 7 of Law No. 9234.
e) Whoever transfers personal information or databases of possible participants, will not be able to receive remuneration of any kind.
Article 49.- Of the Canon . It is the responsibility of the CONIS to verify that the provisions of article 60 of Law No. 9234 are complied with.
The canon must be deposited in the collection account that is opened for this purpose in the name of the Conis.
Article 50.- Of the exemption . All investigations considered in article 61 of Law No. 9234 as exempt from the payment of the corresponding canon, especially those that have been considered as of public interest by the Executive Power or those that are considered a health priority by the Ministry of Health, in consideration to the obligations of the state, they must present to the CONIS an authenticated letter signed by the competent authority that guarantees their condition to be exempt.
Article 51.- File protection . In order to safeguard the information concerning the investigation for 30 years, the investigator may safeguard it in a document storage service, from the end of the investigation. In such a case, the respective CEC must be previously notified, indicating the name of the company, address and documents sent.
Likewise, in order to preserve said information, prior authorization from the Conis, the digitization of the information will also be allowed.
Article 52.- Of the use of the placebo . The CECs will be responsible for authorizing the use of placebo in biomedical research.
The use of placebo in biomedical research must strictly comply with the provisions of article 63 of Law No. 9234, these regulations and the current legal system.
CHAPTER VIII
The handling of the product under investigation
Article 53.- Of the importation, production and use of registered and unregistered products of sanitary interest or their raw materials . For exclusive research purposes, the import, production and use of registered and unregistered products of sanitary interest or their raw materials will be authorized. The import, production and use of these products or materials may only be carried out within the framework of duly authorized and registered investigations as established in these regulations.
Article 54.- Traceability . There must be procedures to ensure the documentary traceability of all investigational products that are imported, manufactured and distributed in the country. This is a responsibility shared by all parties involved in the supply chain up to the investigation site.
Article 55.- Of the requirements for importation .
a) The importation of the product under investigation, including medicines, equipment, devices, laboratory supplies, accessories and other supplies that are classified as products of sanitary interest related to the investigation, may only be carried out once the investigation is duly approved by the the CEC and registered with the CONIS. In the event that the product under investigation is classified as a psychotropic, narcotic or precursor drug, prior approval of the Import Permit from the Drug Surveillance Board of the Ministry of Health is required.
b) Before the first import can be carried out, the researcher or the responsible importer must submit to the CONIS, in the format defined by it, a list that includes the number of units of the product under investigation and other supplies of sanitary interest that are estimated to be necessary to import to complete the investigation, this must be previously approved by the corresponding CEC. The information will be used by the CONIS as a reference to process the sanitary authorization that must be provided as part of the customs procedure for each import carried out during the study. Any increase in the amounts originally projected requires a new approval.
c) In the event that the product under investigation is a pharmaceutical product, the importation may only be carried out by registered drugstores. The drugstore responsible for processing the permit for the release of the product must guarantee that all import, storage, distribution and final disposal operations of said product under its responsibility are carried out in accordance with the provisions of Executive Decree No. 37700- S of January 29, 2013 “Regulation of Good Practices of Storage and Distribution of Medicines in Drugstores”, published in Scope No. 96 to La Gaceta No. 100 of May 27, 2013, as well as the Good Clinical Practices and the protocol Of the investigation.
d) In the case of products under investigation that are blood derivatives of human origin or pharmaceutical products that contain them, the importing drugstore must request and keep for each batch of product, the certificate signed by the person in charge of the manufacturing laboratory that the product is free of the HIV virus, hepatitis B and C, cytomegalovirus, parvovirus B19 as established in article 9, paragraph 9.2) of Executive Decree No. 37006-S of November 15, 2011 ¨Technical Regulation: RTCR 440: 2010. Registration and Control of Biological Medicines¨, published in La Gaceta No. 59 dated March 22, 2012.
e) In the case of the importation of raw material for the manufacture of research products, the importer, manufacturing laboratory or drugstore must have a current Sanitary Operating Permit.
Article 56.- Manufacturing, packaging, labeling and coding .
a) In the event that the product under investigation must be manufactured or conditioned in its final form in the country, the establishment in charge of said operations must have its current registration and guarantee that it complies with the applicable aspects of Good Manufacturing Practices, including systems and procedures for adequate control and quality assurance.
b) In the case of pharmaceutical products for research use, local manufacturing may only be carried out by registered and authorized pharmaceutical laboratories. The laboratory that carries out this activity is responsible for ensuring that all the operations it is responsible for are carried out in accordance with the provisions of Executive Decree No. 35994 of April 19, 2010 “Technical Regulations on Good Manufacturing Practices for the Pharmaceutical Industry, Pharmaceutical Products and Medicines for Human Use”, published in La Gaceta No. 91 of May 12, 2010, as well as with the Good Clinical Practices and the research protocol.
c) The sponsor, as well as any entity contracted by it for the manufacture, packaging, labeling and coding of the investigational product must:
i. Ensure that the product under investigation is manufactured in accordance with the applicable Good Manufacturing Practices (GMP).
ii. Ensure that the investigational product (including active comparator and placebo, if applicable) is visibly labeled with the legend “Investigational Product – Use restricted to authorized personnel” or equivalent text.
iii. Ensuring that the investigational product is coded and labeled appropriately for the study design including protection from blinding, if necessary.
IV. Ensure that the investigational product is packaged to prevent contamination or unacceptable deterioration during transport and storage.
v. Inform all parties involved in the handling of the product under investigation, the ranges of temperature, humidity and any other special measures, such as protection from light, maximum storage times, reconstituted liquids, that apply for its proper conservation, as well as the instructions and equipment for its proper use and administration, if any.
d) The coding system for the investigational product should include a mechanism that allows rapid identification of the product in the event of a medical emergency, but does not allow undetectable or inadvertent breaks in blinding.
e) The application of labels with supplementary information is allowed on the packaging of products used in research for traceability purposes, additional identification or to provide special indications such as: bar codes, participant or protocol identification numbers, as well as indications specials. This supplemental labeling must not obscure essential information from the original label. In the case of pharmaceutical products, this procedure can be carried out at the importing drugstore, the pharmacy or at the research site under the supervision of the pharmaceutical regent.
f) If the sponsor or manufacturer makes significant changes in the formulation or design of the investigational product, including the active comparator during clinical development, the results of any additional studies of the investigational product such as: stability, rate of dissolution, bioavailability necessary to To assess whether these changes would significantly alter the product profile, they must be made available before the new formulation or design is used in clinical trials.
g) In the case of investigational products whose expiration or expiry date is reevaluated and modified by the manufacturer to extend the useful life of the product, the investigator must request a duly documented permit from CONIS, to modify said information on the product label. which is kept in custody at the investigation site. This modification must be done following a documented procedure. In the case of pharmaceutical products, the permit may be requested by the pharmaceutical manager of the drugstore or pharmacy that guards the product and the modification may be made in the same establishment or directly at the research site under the supervision of the pharmaceutical manager.
Article 57.- Information on the product under investigation . When planning the studies, the sponsor, as the entity responsible for the development of the investigational product, must ensure that safety and efficacy data from non-clinical and clinical studies are available to support the administration of the product in humans, indicating the route , doses, time period and study population.
The sponsor must update the Investigator’s Manual as soon as significant new information becomes available regarding the efficacy or safety of the investigational product. Said updates must be sent in a timely manner to the investigator for review, and the latter, in turn, must send them immediately to the respective CEC.
Article 58.- Custody and storage .
a) At the research site, the research product must be kept under the environmental conditions specified by the manufacturer or sponsor, in a clean, safe place with access restricted to unauthorized persons.
b) Registered pharmacies may store and safeguard investigational pharmaceutical products for supply to the investigator, study personnel or directly to the study participant. In the event that there is no pharmacy to supply the product under investigation, the importing drugstore must have a documented procedure for the storage, custody and controlled supply of said products to the investigator or his designated personnel and is responsible for supervising that the conditions of product storage at the research site are adequate.
c) In the event that the product under investigation is classified as a psychotropic, narcotic or precursor medication, these may only be stored in registered drugstores and once distributed they may only be guarded and dispensed in registered pharmacies in compliance with the regulatory requirements established by the Drug Watch Board.
d) The manager responsible for the pharmacy or drugstore that stores, guards and supplies investigational products must have documented training in Good Clinical Practices, procedures for accounting for investigational products, as well as for the specific handling of investigational products. , for each investigation in which your establishment participates.
Article 59.- Of the use . The investigator must ensure that the investigational product is used only in accordance with the approved protocol. When applicable, the investigator, pharmacist or a person duly trained and designated by the investigator, must explain the correct use of the investigational product to each participant and must verify at intervals appropriate for the study, that each participant is following the instructions properly. .
Article 60.- Accounting at the research site .
a) At the research site, the responsibility for accounting for said product rests with the researcher.
b) The investigator may assign some or all of the investigational product accounting duties at the site where the study is conducted to a pharmacy or a pharmacist, in the case of pharmaceutical products, or to other study personnel duly trained in Good Practices. Clinics and the study protocol and that it is under the supervision of the investigator or the institution where the research is carried out.
c) The investigator, pharmacist, or other study personnel designated by the investigator, as applicable, must maintain records of product receipt at the investigation site, on-site inventory, use by each study participant, and the final disposition of the unused or returned product. These records must include dates, qualities, batch and serial numbers, expiration dates if applicable, and the unique code numbers assigned to the investigational product and study participants. Investigators must maintain records that adequately document that study participants were given the doses specified in the protocol as applicable and reconcile all investigational product(s) received on site.
d) The drugstore, pharmacy, and research site must have written procedures that include clear instructions for proper and safe receipt, handling, storage, delivery, collection of product not used by participants, and return of research product unused to the sponsor or other alternative final disposal, including local destruction if authorized by the sponsor, in compliance with applicable regulatory requirements for waste management.
Article 61.- Of the final disposition .
a) Both the sponsor, importer and the researcher are responsible for the adequate and safe treatment and final disposal of the research product that remains unused, returned, damaged or expired, as well as other waste related to the product, for which they must establish and maintain written procedures and records that properly document said disposal, in accordance with Law No. 8839 of June 24, 2010 “Law for Comprehensive Waste Management”, published in La Gaceta No. 135 of July 13, 2010 and its applicable regulations according to the type of waste, its dangerousness and form of final disposal.
b) In the case of pharmaceutical products, the final disposal at the local level must be carried out based on the provisions of Executive Decree No. 36039-S of March 2, 2010 “Regulations for the Final Disposal of Medicines, Raw Materials and their Waste”, published in La Gaceta No. 122 of June 24, 2010.
c) Alternatively, the investigator, the OAC or the OIC is authorized to carry out the process of repatriation of the unusable investigational product to the country of origin or its re-export to a third country for the purpose of centralized collection and destruction by the sponsor. or a third party hired by it. The re-export of research products, raw materials or residues that are classified as psychotropic drugs, narcotics or precursors will not be allowed. In these cases, the destruction must be carried out locally in accordance with the regulations established by the Drug Surveillance Board.
d) The reports or certificates of destruction or re-export of investigational products and other supplies of sanitary interest must contain detailed information that allows the traceability of the products involved.
e) The sponsor, the investigator, the OAC or the OIC must inform the CONIS about the procedure carried out for the final disposal of the leftover, unused, returned, damaged or expired product under investigation, as well as other waste related to the product, indicating the name, quantity, and lot among others.
Article 62.- Extended or compassionate access for continuity of treatment .
a) When applicable and in order to guarantee the free access of the participants to the investigational product after the conclusion of their participation in a clinical investigation and respecting the exceptions established by Law No. 9234, the investigator must timely submit to the CEC for your approval, an extended or compassionate access program to the investigational product. Said program must detail the conditions to provide said access, the organization and the parties involved in the controlled supply of the product until its delivery to the patient, as well as the procedures to monitor the safety of patients during the time they remain in treatment. under this modality.
b) The approval by the CEC of the extended or compassionate access program is a requirement to authorize the importation, production and use of unregistered products of health interest beyond the completion of the study. The sponsor may continue to import the investigational product as long as it is necessary and in sufficient quantity to supply it to patients who remain active in the program.
c) In the case of extended or compassionate access programs involving investigational pharmaceutical products, importation may only be carried out by registered drugstores. The dispensing of the product to the patient may be carried out at the research site by the researcher or its designated personnel or through registered pharmacies.
d) Extended or compassionate access programs are subject to the same applicable requirements and responsibilities already established in this chapter for all parties involved in the handling of the investigational product even when the original investigation has ended.
e) To suspend an extended or compassionate access program for continuity of treatment, the investigator must justify the reasons for said suspension before the CEC. In the event of a conflict between the investigator and the treating physician, the provisions of article 28 of Law No. 9234 prevail.
CHAPTER IX
Research with Vulnerable Groups
Article 63.- Conditions for the approval of research in vulnerable groups .
a) The participation of vulnerable people or human groups will be allowed in the following cases:
i. When they can produce real or direct benefits for your health.
ii. When comparable results cannot be obtained in individuals with other conditions.
b) When a direct benefit of the research for the health of the participants is not anticipated, the research may be authorized exceptionally if the following conditions concur:
i. That research contributes to the understanding of the disease.
ii. That the result of biomedical research be beneficial for other people with the same condition.
iii. The research involves minimal risk and burden to the participant.
c) Interventional research may not be contrary to the best interests of the participant and the expected benefit will be greater than the anticipated risk.
Article 64.- Research with minors . In biomedical research with minors, it must be guaranteed that the benefit is greater than the minimum acceptable risk and that the research is not harmful to their health, physical, mental, spiritual, moral or social development. For the purposes of conducting research with minors, the provisions of article 64 of Law No. 9234 must be complied with.
Article 65.- Of the rights of people with cognitive, volitional and behavioral mental disabilities . All people who have a mental disorder or illness retain all the civil, political, economic, social and cultural rights recognized in the Universal Declaration of Human Rights, the Inter-American Convention on Human Rights, the International Covenant on Civil Rights and Politicians, the Convention on the Rights of Persons with Disabilities, and its Optional Protocol, the Inter-American Convention for the Elimination of All Forms of Discrimination against Persons with Disabilities, as well as other relevant instruments.
Article 66.- Clinical or interventional research in people with moderate behavioral or cognitive mental disorders . People with moderate behavioral or cognitive mental disorders will be allowed to participate in the following cases:
a) When they have the purpose of obtaining pertinent or relevant knowledge to the particular health needs of the participant.
b) When it is anticipated that its results may produce real or direct benefits for your health.
c) In the cases indicated in article 64 of Law No. 9234.
In order for these people to participate, informed consent or assent must be obtained to the best of their ability, with the support services required to make the decision, and the participant’s refusal to be part of the research must be respected, as long as when your life or health does not depend on your participation in the research.
These investigations must meet the following conditions:
1. They may not be contrary to the best interests of the patient.
2. Therapeutic benefit is anticipated 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 or assent process will be implemented in the most reasonable way possible to meet your demands, including the participation of family members and the representative.
5. In cases in which the participant 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 attention and care.
Article 67.- Clinical or interventional research in people with severe behavioral or cognitive mental disorders . Biomedical research and/or clinical studies with the participation of:
a) People with disabilities highly dependent on care and attention, without volitional and/or cognitive capacity.
b) People with severe cognitive and/or volitional impairment.
c) Serious psychiatric patients, whether or not they are hospitalized , and
d) persons declared judicially incompetent.
They may only be carried out if they have the prior approval of a CEC duly constituted as a competent, independent and impartial review body to guarantee the rights of this population, in accordance with the provisions of this Regulation.
For the process of approval of investigations that foresee the inclusion of participants with volitional, total or partial disability, according to the definition of the Law, the CEC will incorporate a representative of the governing national entity in disability and a representative of the research discussion sessions. specialist in psychiatry or clinical psychology, who may participate in the respective sessions with voice, the foregoing in accordance with the provisions of the Law and these Regulations regarding research with vulnerable groups. These representatives must also sign the confidentiality and conflict of interest agreements.
Article 68.- Special conditions that must be verified for the approval of research in the case of patients with moderate or severe behavioral or cognitive mental disorders . Research with patients with moderate or severe behavioral or cognitive mental disorders, as well as those investigations carried out in the cases established in article 65 of Law No. 9234 must comply, in addition to what is established in the other provisions of this regulation, with the following requirements:
a) They may not be contrary to the best interests of the patient.
b) A therapeutic benefit is anticipated with a reasonable possibility of superiority over standard treatment.
c) They may not have a greater risk than that of the patient’s conditions and alternative treatment methods.
d) The informed consent or assent process will be implemented in the most reasonable way possible to meet their demands, including the participation of family members and the authorized representative.
e) In cases in which the participant is not the one who gives consent, he or she will be informed as soon as possible and may withdraw from the research without any consequences for his or her due attention and care.
Article 69.- Additional measures for the execution of investigations in the case of patients with moderate or severe behavioral or cognitive mental disorders . In order to comply with the previous article, the CEC must confirm that the research protocol that is requested to be approved contains additional measures to protect the rights of the participants that guarantee:
a) That there is an adequate analysis of the risk-benefit ratio.
b) That the researcher or the person authorized in accordance with these regulations will explain informed consent or assent to the participants, providing the corresponding support services, obtain their consent or assent, to the extent that they are able to give it, without this exclude, in the case of participants with volitional incapacity, the obligation that, additionally, their representative must authorize their participation.
c) That the refusal of the person to participate must be sufficient cause to not allow their participation without the need for additional justification.
d) That in the procedure for taking informed consent or assent, it will be investigated and considered, for the purposes of approving the incorporation of a participant, what their preferences and interests are or what they were prior to their declaration of incapacity. For these purposes, the information provided by relatives or persons in charge of the participant’s care will be considered.
e) That the eventual participation of a person who is in the conditions mentioned in this article, will not be allowed in those cases in which a direct benefit for the patient is not anticipated, unless there is evidence that the patient has manifested at some time or express, at the time the informed consent is explained, their interest in participating.
f) That the participants must be represented by a person who asserts their interests, preferably a close friend or a member of their family and that said persons must make the decision based on what the person would have decided if they were able to do so and keeping your best interests in mind.
g) That in the case of participants whose volitional or cognitive incapacity has been judicially declared, their participation in the research will require the authorization of the legal representative duly appointed by judicial resolution, and in the case of participants not judicially declared incapable but with mental disorders, behavioral or cognitive, their participation in the research will require the authorization of a relative or a close friend with sufficient capacity to understand the information of the informed consent and adequately represent the interests of the eventual participant.
h) In those cases in which the CEC deems it pertinent, it will appoint a qualified independent professional to supervise the informed consent process.
i) That the CEC may determine, in those cases in which the participants are unable to give their consent or assent or dissent, what additional protection measures will be necessary in order to guarantee the rights of these participants.
Article 70.- 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, devices, vaccines and other research elements that may represent therapeutic or preventive benefit for them. Notwithstanding the foregoing, these investigations may only be carried out in the cases indicated in these regulations. In these cases, the CEC must have a person who represents the interests of the prisoner.
For the purposes of approving or rejecting such research, the CEC must pay special attention to guarantee voluntariness and autonomy both at the time of granting informed consent and throughout the entire research process. Likewise, the CEC must verify that the person deprived of liberty who chooses to participate in an investigation is never in conditions that may directly or indirectly affect autonomy and the freedom to participate in an investigation.
Article 71.- Research involving members of indigenous communities, migrants and particularly vulnerable groups . For the process of approval of research that foresees the inclusion of participants from the indicated communities, the CEC must meet with the presence of a representative chosen by the community to which it belongs, who will participate in the respective sessions with voice, in accordance with the established in Law No. 9234 and these regulations, regarding investigations with vulnerable groups. These representatives must also sign the confidentiality and conflict of interest agreements.
CHAPTER X
Of the procedure and sanctions
Article 72.- Of the complaints to the breach of the law and its regulations .
a) Complaints for violation of Law No. 9234 and these regulations may be filed by any natural or legal person, verbally, in writing or digitally, before the CONIS, the CEC or the Customer Service Department. at the central level, the Regional Directorate of Health Stewardship at the regional level and the Directorate of the Health Stewardship Area at the local level, all from the Ministry of Health.
b) The written or verbal complaint must contain the following information:
i. Full name of the complainant, identity card number or any other identity document and place or means to attend notifications.
ii. Motives or foundations of fact: detailed account of the situation that is denounced.
iii. Signature of the complainant and the person receiving the complaint.
IV. Name of the natural person, legal entity, entity or institution that is denounced.
v. Name or purpose of the investigation being denounced.
c) Once the complaint is received, the admissibility of the complaint will be reviewed and it will be channeled as appropriate within a period of 10 business days in accordance with article 264 of the General Law of Public Administration.
d) The complainant may provide testimonial and/or documentary evidence. The evidence may be provided in any technological format including videos and digital photographs.
e) When the complaint is filed verbally, the information indicated in this article must be recorded, through the minutes that will be drawn up for that purpose and must be signed by the complainant.
f) Likewise, note must be taken of the anonymous complaints that are filed and the truthfulness of what has been reported must be verified by the means available.
g) If the complaint is admissible, it must be submitted within a period not exceeding three business days to the corresponding CEC or the CONIS for due process.
h) In the event of a complaint, the CONIS or the CEC must act subject to the principle of due process and exhaustive verification of the real truth of the facts.
i) The CONIS or the CEC must assess the seriousness of the health risk that the complaint represents for the research participants, their family and community environment and initiate the investigation and documentation of the reported facts in less than three business days.
j) The CONIS will issue a recommendation based on the verification of the truth of the facts investigated. In each case, it will define the corresponding sanctions or recommend filing the file when there is no merit or sufficient evidence for the application of sanctioning measures.
k) The CEC will verify the truth of the facts investigated and will execute the corresponding or file the file when there is no merit or sufficient evidence for the application of punitive measures.
l) The CONIS or the CEC within a period not exceeding eight business days, will issue the final act of the procedure.
m) When the final resolution was issued by a CEC, the accused, within a period not exceeding five business days, counted from the receipt of the notification, may file a revocation appeal before the CEC and an appeal before the CONIS, in accordance to the provisions of article 75 of Law No. 9234.
n) The resolutions issued by the CONIS may be appealed within the terms established in the following and concordant articles 345 of the General Law of Public Administration, before the Minister of Health.
o) Unless the complaint deals with the subjective rights or legitimate interests of the complainants, they will not be considered part of the procedure and consequently will not have access to the file, although if they have identified themselves, they will be able to know the result of the final report.
p) Failure to comply with the deadlines stipulated in this article by the administration will be a reason for responsibility on the part of the official who has caused the inertia and will not affect the right of the company.
Article 73.- Sanitary and administrative measures . Researchers, CECs, OICs or OACs, sponsors who carry out biomedical research contrary to the provisions of Law No. 9234 and this Regulation, may be sanctioned by the CONIS or the CEC, as established in the articles of the 70 to 84 of chapter X of the aforementioned Law, without prejudice to the special health measures provided for in articles 355 and following of the General Health Law, all of the above without prejudice to the civil, criminal or disciplinary liability that may correspond to the offender .
Article 74.- Coordination . The Ministry of Health and the CONIS will determine the necessary coordination mechanisms for the most correct and efficient application of Law No. 9234 in the following aspects:
a) Design and implementation of the biomedical research registration system with the Directorate of Scientific and Technological Development in Health and with the Directorate of Informatics.
b) The importation of drugs and medical devices for research purposes, which are registered with the Directorate for the Regulation of Products of Health Interest.
c) Receipt and processing of complaints filed for infractions in biomedical research before the Customer Service Directorate at the central level, the Regional Directorate of Health Stewardship at the regional level and the Health Stewardship Area Directorate at the local level , all from the Ministry of Health.
d) The planning of training processes in bioethical and scientific aspects with the Department of Scientific and Technological Development in Health.
e) The application of special sanitary measures with the pertinent organizational units.
f) Others that are decided by mutual agreement and for the benefit of improving biomedical research in the country.
Article 75.- Of the infractions . The sum that results and must be paid as a penalty, must be deposited in the collection account that is opened for this purpose in the name of the Conis , within a period of fifteen business days, counted from the notification of the penalty.
In the event that the offender fails to comply with the obligation to pay the pecuniary sanction imposed, the CONIS will issue the debit certificate, which for such purposes constitutes an executive title, which will be enforceable in the corresponding jurisdictional channel.
Article 76.- Applicable from its publication.
Given in the Presidency of the Republic.-San José, on the eighth day of the month of May, two thousand and fifteen.
Transitory dispositions
Transitory I.- The Ministry of Health is hereby authorized to receive the sums collected by concept of sanctions or fees applied by the CONIS , until it has its respective bank account for such purposes.
Transitory II.- The Internal Audit of the Ministry of Health is authorized to legalize the minutes books of the CEC until the CONIS has its own internal audit.
Transitory III.- The CECs are authorized to endorse the Courses of Good Clinical Practices presented by researchers who have at least 16 hours of training, while the CONIS defines the corresponding.