HOME | PGR SINALEVI | POWER | HACIENDA | IDH COURT | LEGAL DICTIONARY | HELP | SITE MAP JUDICIAL PJ Search: Regulations >> Executive Decree 39533 >> Date 11/01/2016 >> Full text Internet Search Articles << Articles >> Standard Sheet Regulations Remember that Control F is an option that allows you to search the entire text Pronouncements Constitutional Affairs Go to the end of the document Year: 50 results - You are in the latest version of the standard- Search in: Document file Search Reform Regulation to the Biomedical Research Regulatory Law No. 39533 -S Advanced Search Menu THE PRESIDENT OF THE REPUBLIC Text complete Standard sheet AND THE MINISTER OF HEALTH Regulations affected Descriptors In use of the powers conferred on them by articles 140, subsections 3) and 18) and 146 of the Observations Political Constitution; 25, subsection 1), 27, subsection 1), 28, subsection 2), section b) and 103, subsection 1) of Law No. 6227 of May 2, 1978, "General Law of Public Administration"; 1st, 2nd, 4th and 7th of Law No. Related case law 5395 of October 30, 1973 "General Health Law"; 1st, 2nd and 6th of Law No. 5412 of 8 of Jurisp of the Treasury November 1973 "Organic Law of the Ministry of Health"; Law No. 9234 of April 22, 2014 "Law Biomedical Research Regulator "; 4th of Law No. 8220 of March 4, 2002 and its reform "Law for the Protection of Citizens from Excess of Administrative Requirements and Procedures" and the Decree Executive No. 39061-S of May 8, 2015 "Regulation to the Regulatory Law of Investigation Biomedical "published in La Gaceta No. 138 of July 17, 2015. Options: Save Considering: Print 1 -That the health of the population is a fundamental right and a good of public interest supervised by the State. 2-That the State has the responsibility to guarantee the well-being of citizens, without No discrimination 3rd - That it is the responsibility of the Ministry of Health to define policy, regulation, planning and the coordination of all public and private health-related activities, including the biomedical research 4 - That on April 25, 2014, was published in the Official Gazette La Gaceta, Law No. 9234 of the April 22, 2014 "Biomedical Research Regulatory Law", which regulates research Biomedical with human beings in health, in the public and private sectors. 5-That by Executive Decree No. 39061-S of May 8, 2015, the Executive Power promulgated the Regulation to the Biomedical Research Regulatory Law. 6-That the Law on the Protection of Citizens from Excess Requirements and Procedures Administrative Law No. 8220 and its reform Law No. 8990 of September 27, 2011 orders to simplify the procedures and requirements established by the Public Administration against citizens, avoiding duplicities and expeditiously guaranteeing the right to petition and free access to public departments, contributing undeniably in the process of strengthening the principle of legal certainty of the Costa Rican democratic system. 7-That due to the aforementioned considerations, it is necessary and timely to reform the Executive Decree No. 39061-S of May 8, 2015 "Regulation of the Regulatory Law of Biomedical Research "published in La Gaceta No. 138 of July 17, 2015. Therefore, DECREE: Reforms to Executive Decree No. 39061-S of May 8, 2015 "Regulations to the Biomedical Research Regulatory Law " Article 1 - Reforms. Reform articles 3, subsection w), 12, 26, subsection m), 30 and 32 of Executive Decree No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of July 17, 2015 "Regulation a the Biomedical Research Regulatory Law ", to be read as follows: "Article 3 - Definitions and abbreviations. For the purposes of this regulation and its Application is understood by: (.) w) Adverse event: unwanted event or event that occurs during or after the participation in a biomedical research for the use of a medicine, device, procedure or other intervention. It should be characterized as follows: intensity (mild, moderate or severe), relationship with the medication or intervention (not related, probably related or related) and severity (serious or not serious). " (.) "Article 12.-Of the requirements for land, sea or air transport of material biological. For land, sea or air transportation of biological material, it will be necessary to comply with the next: a) All transport of biological and infectious material must comply with UN3373, following all the guidelines of category A for infectious material and category B for Biological material and regulations established for this purpose by the Ministry of Health. b) The laboratory personnel in charge of the transport of the biological material must have a valid, valid and recognized certification for the transport of biological material, as per example, the 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 national or international binding standard. d) Laboratories involved in clinical research are responsible for giving the shows all the handling and packaging necessary to arrive in good condition at your final destination." (.) "Article 26.-Of the authorization to the investigators. The investigators will be authorized to conduct biomedical research by the Conis, in accordance with the provisions of subsection c) of the Article 43 of Law No. 9234, for which they must present the following requirements: (.) m) Report all serious adverse events to the CEC in a period not exceeding 24 hours subsequent to their knowledge, as well as non-serious adverse events related in a way monthly and non-serious adverse events not related in the quarterly report. " (.) "Article 30.-On the Integration of the Scientific Ethical Committees. The Scientific Ethical Committees They will consist of five members. This integration will be as follows: a) A scientific expert with research experience. b) A professional person with knowledge in Bioethics. c) Two professional people with knowledge in biomedical research. d) A person representing the community. In the specific case of the community representative, he will have his respective alternate and These will be chosen as follows: i.) Each CEC, public or private, by means of an office notified personally or by mail electronic, will invite organizations that develop activities related to issues of Biomedical research and to each CEC, to propose a candidate member of the organization, these organizations will have a period of ten business days from Received the invitation to present their candidates. Also each public CEC or private or of the responsible institution, will place the notice on the main cover of the page WEB. ii) Upon receipt of the names of the candidates sent by the organizations, the CEC will proceed to choose the community representative and their respective substitute, complying with the procedure established in the internal regulations of each CEC, for which will have the term of ten working days from the receipt of the names, for the choice of the owner and substitute representative of the community. iii) The appointment of the community representative must be documented in a file and each CEC within ten business days, will communicate it to the Conis. " (.) "Article 32.-Functioning of the Ethical Scientific Committees. a) The members of the Scientific Ethical Committees will remain in their positions for the period accredited by the Conis and may be re-elected for equal periods. Despite its appointment may be revoked by the authority responsible for the public entity or private, before expiring the term for which he was appointed, so that the authority responsible will notify Conis of this situation. b) The operation of the CEC will be governed by the provisions of these regulations and the internal regulation of each CEC, the latter will be approved by the Conis during the process of accreditation Any subsequent modification must be approved by Conis. " Article sheet Article 2 - Editions. Add a subparagraph l and ANNEX I to article 8 and subparagraph f) to article 48; of the decree Executive No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of July 17, 2015 "Regulation to the Biomedical Research Regulatory Law", to be read as follows way: "Article 8º-On informed consent. (.) l) In the case of observational investigations in minors who are captive as in educational centers, the CEC may allow the sending of consent informed the legal representative to register the signature authorizing the participation of the less." "Appendix 1 Obtaining informed consent: Essential information for potentials research participants Before requesting the consent of a person to participate in an investigation, the researcher must provide verbally or in another form of communication that the person can understand the following information 1. That the person is invited to participate, the reasons for considering it appropriate and that the Participation is voluntary. 2. That the person is free to refuse to participate and withdraw from the investigation in any moment without penalty or loss of benefits to which he would be entitled. 3. What is the purpose of the investigation, the procedures that the investigator will perform and the participant, and an explanation on how research differs from medical care usual. 4. In the case of interventional studies, the research design must be explained (by example, randomness, double blind), and in case of blind studies, the treatment assigned to the participant until the study is completed and the experiment I have blindly lost such a character. 5. What is the expected duration of the person's participation (number and duration of visits to the research center and the total time involved) and the possibility that the study or the Participation of the person conclude in advance. 6. If the expenses incurred by the participant will be paid as a reason for their participation in the study. 7. That after completing the study, participants will be informed of the findings of the research in general, and individual findings related to your health status in particular. 8. Any foreseeable discomfort, pain, risk or inconvenience related to the Participation in the study. 9. What are the direct benefits expected from your participation in the study. 10. What are the expected benefits for the community or society in general, or its contribution to scientific knowledge. 11. How the participant will have access to the research product in case it is beneficial to health, once the study is over 12. Any intervention or alternative treatment currently available. 13. What measures will be taken to ensure respect for the privacy and confidentiality of the records in which the participants are identified. 14. What are the rules on the use of genetic test results and information family genetics In addition, the precautions taken to prevent the disclosure of results of the participant's genetic tests to their immediate or other relatives (for for example, insurance companies or employers) without the participant's consent. 15. Which are the sponsors of the research, the institutional affiliation of the researchers and the nature and sources of research funding. 16. What will the participant's medical records and biological samples be used for? 17. If you plan to destroy the biological samples obtained when the investigation is finished and, if not, the details about its storage (where, how, for how long and its final disposition). The participant may refuse storage. 18. That the researcher must provide or manage medical services to the participant for the attention to reactions or damages related to your participation in the study, at no cost Some for the participant. 19. That there is an insurance policy that will compensate the subject, his family or his Dependents in case of proven illness, disability or death with your participation in the study and how you can access these benefits, the name, telephone (s) and the address of the CEC that approved the research study and inform that is accredited by the Conis. " (.) "Article 48.-On the recruitment of participants. The recruitment procedure shall be submitted to the CEC as part of the initial submission and will contain the following requirements: (.) Recruit participants for a biomedical research, must be approved by the CEC respective, which will review in the sense that advertising is not alarming, that does not generate excessive or misleading expectations, which does not take advantage of physical vulnerability or psychological of people who could be recruited. This must be communicated to the Conis within ten days before publication. " Article sheet Article 3-Derogatory. Repeal articles 3 subsections x) and y), 31, 35, 36, 37, 38, 39, 40, 41 and article 44, subsection gg); of Executive Decree No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of 17 July 2015 "Regulation to the Biomedical Research Regulatory Law". Article sheet Article 4º-In force as of its publication in the Official Gazette. Given in the Presidency of the Republic.-San José, on the eleventh day of the month of January of the two One thousand sixteen. Article sheet Generation date: 02/16/2020 10:03:53 p.m. Go to the beginning of the document