79C3C34C52B45572883A05D425EB0F82
Reform Regulation to the Biomedical Research Regulatory Law
http://www.pgrweb.go.cr/scij/Busqueda/Normativa/Normas/nrm_texto_completo.aspx?param1=NRTC&nValor1=1&nValor2=81213&nValor3=103450&strTipM=TC
http://leaux.net/URLS/ConvertAPI Text Files/277A0C8134E752FF347841D8E53B9EE9.en.txt
Examining the file media/Synopses/277A0C8134E752FF347841D8E53B9EE9.html:
This file was generated: 2020-12-01 09:06:57
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
Searching for indicator political:
(return to top)
p.(None): HOME | PGR SINALEVI | POWER | HACIENDA | IDH COURT | LEGAL DICTIONARY | HELP | SITE MAP
p.(None): JUDICIAL PJ
p.(None): Search: Regulations >> Executive Decree 39533 >> Date 11/01/2016 >> Full text Internet
p.(None): Search Articles << Articles >> Standard Sheet
p.(None): Regulations Remember that Control F is an option that allows you to search the entire text
p.(None): Pronouncements
p.(None): Constitutional Affairs Go to the end of the document
p.(None): Year: 50 results
p.(None): - You are in the latest version of the standard-
p.(None): Search in: Document file
p.(None): Search Reform Regulation to the Biomedical Research Regulatory Law
p.(None): No. 39533 -S
p.(None): Advanced Search Menu
p.(None): THE PRESIDENT OF THE REPUBLIC
p.(None): Text complete
p.(None): Standard sheet AND THE MINISTER OF HEALTH
p.(None): Regulations affected
p.(None): Descriptors In use of the powers conferred on them by articles 140, subsections 3) and 18) and 146 of the
p.(None): Observations Political Constitution; 25, subsection 1), 27, subsection 1), 28, subsection 2), section b) and 103, subsection 1) of Law No.
p.(None): 6227 of May 2, 1978, "General Law of Public Administration"; 1st, 2nd, 4th and 7th of Law No.
p.(None): Related case law
p.(None): 5395 of October 30, 1973 "General Health Law"; 1st, 2nd and 6th of Law No. 5412 of 8 of
p.(None): Jurisp of the Treasury November 1973 "Organic Law of the Ministry of Health"; Law No. 9234 of April 22, 2014 "Law
p.(None): Biomedical Research Regulator "; 4th of Law No. 8220 of March 4, 2002 and its reform
p.(None): "Law for the Protection of Citizens from Excess of Administrative Requirements and Procedures" and the Decree
p.(None): Executive No. 39061-S of May 8, 2015 "Regulation to the Regulatory Law of Investigation
p.(None): Biomedical "published in La Gaceta No. 138 of July 17, 2015.
p.(None): Options:
p.(None): Save Considering:
p.(None): Print 1 -That the health of the population is a fundamental right and a good of public interest
p.(None): supervised by the State.
p.(None): 2-That the State has the responsibility to guarantee the well-being of citizens, without
p.(None): No discrimination
p.(None): 3rd - That it is the responsibility of the Ministry of Health to define policy, regulation, planning
p.(None): and the coordination of all public and private health-related activities, including the
p.(None): biomedical research
p.(None): 4 - That on April 25, 2014, was published in the Official Gazette La Gaceta, Law No. 9234 of the
p.(None): April 22, 2014 "Biomedical Research Regulatory Law", which regulates research
p.(None): Biomedical with human beings in health, in the public and private sectors.
p.(None): 5-That by Executive Decree No. 39061-S of May 8, 2015, the Executive Power
p.(None): promulgated the Regulation to the Biomedical Research Regulatory Law.
...
Political / vulnerable
Searching for indicator vulnerability:
(return to top)
p.(None): researchers and the nature and sources of research funding.
p.(None): 16. What will the participant's medical records and biological samples be used for?
p.(None): 17. If you plan to destroy the biological samples obtained when the investigation is finished and,
p.(None): if not, the details about its storage (where, how, for how long and its
p.(None): final disposition). The participant may refuse storage.
p.(None): 18. That the researcher must provide or manage medical services to the participant for the
p.(None): attention to reactions or damages related to your participation in the study, at no cost
p.(None): Some for the participant.
p.(None): 19. That there is an insurance policy that will compensate the subject, his family or his
p.(None): Dependents in case of proven illness, disability or death
p.(None): with your participation in the study and how you can access these benefits, the name,
p.(None): telephone (s) and the address of the CEC that approved the research study and inform that
p.(None): is accredited by the Conis. "
p.(None): (.)
p.(None): "Article 48.-On the recruitment of participants. The recruitment procedure shall be
p.(None): submitted to the CEC as part of the initial submission and will contain the following requirements:
p.(None): (.)
p.(None): Recruit participants for a biomedical research, must be approved by the CEC
p.(None): respective, which will review in the sense that advertising is not alarming, that does not generate
p.(None): excessive or misleading expectations, which does not take advantage of physical vulnerability or
p.(None): psychological of people who could be recruited. This must be communicated to the Conis
p.(None): within ten days before publication. "
p.(None): Article sheet
p.(None): Article 3-Derogatory.
p.(None): Repeal articles 3 subsections x) and y), 31, 35, 36, 37, 38, 39, 40, 41 and article 44, subsection
p.(None): gg); of Executive Decree No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of 17
p.(None): July 2015 "Regulation to the Biomedical Research Regulatory Law".
p.(None): Article sheet
p.(None): Article 4º-In force as of its publication in the Official Gazette.
p.(None): Given in the Presidency of the Republic.-San José, on the eleventh day of the month of January of the two
p.(None): One thousand sixteen.
p.(None): Article sheet
p.(None): Generation date: 02/16/2020 10:03:53 p.m.
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.(None): beneficial to health, once the study is over
p.(None): 12. Any intervention or alternative treatment currently available.
p.(None): 13. What measures will be taken to ensure respect for the privacy and confidentiality of
p.(None): the records in which the participants are identified.
p.(None): 14. What are the rules on the use of genetic test results and information
p.(None): family genetics In addition, the precautions taken to prevent the disclosure of
p.(None): results of the participant's genetic tests to their immediate or other relatives (for
p.(None): for example, insurance companies or employers) without the participant's consent.
p.(None): 15. Which are the sponsors of the research, the institutional affiliation of the
p.(None): researchers and the nature and sources of research funding.
p.(None): 16. What will the participant's medical records and biological samples be used for?
p.(None): 17. If you plan to destroy the biological samples obtained when the investigation is finished and,
p.(None): if not, the details about its storage (where, how, for how long and its
p.(None): final disposition). The participant may refuse storage.
p.(None): 18. That the researcher must provide or manage medical services to the participant for the
p.(None): attention to reactions or damages related to your participation in the study, at no cost
p.(None): Some for the participant.
p.(None): 19. That there is an insurance policy that will compensate the subject, his family or his
p.(None): Dependents in case of proven illness, disability or death
p.(None): with your participation in the study and how you can access these benefits, the name,
p.(None): telephone (s) and the address of the CEC that approved the research study and inform that
p.(None): is accredited by the Conis. "
p.(None): (.)
p.(None): "Article 48.-On the recruitment of participants. The recruitment procedure shall be
p.(None): submitted to the CEC as part of the initial submission and will contain the following requirements:
p.(None): (.)
p.(None): Recruit participants for a biomedical research, must be approved by the CEC
p.(None): respective, which will review in the sense that advertising is not alarming, that does not generate
p.(None): excessive or misleading expectations, which does not take advantage of physical vulnerability or
p.(None): psychological of people who could be recruited. This must be communicated to the Conis
p.(None): within ten days before publication. "
p.(None): Article sheet
p.(None): Article 3-Derogatory.
p.(None): Repeal articles 3 subsections x) and y), 31, 35, 36, 37, 38, 39, 40, 41 and article 44, subsection
p.(None): gg); of Executive Decree No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of 17
p.(None): July 2015 "Regulation to the Biomedical Research Regulatory Law".
p.(None): Article sheet
p.(None): Article 4º-In force as of its publication in the Official Gazette.
p.(None): Given in the Presidency of the Republic.-San José, on the eleventh day of the month of January of the two
p.(None): One thousand sixteen.
p.(None): Article sheet
p.(None): Generation date: 02/16/2020 10:03:53 p.m.
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.(None): example, randomness, double blind), and in case of blind studies, the
p.(None): treatment assigned to the participant until the study is completed and the experiment
p.(None): I have blindly lost such a character.
p.(None): 5. What is the expected duration of the person's participation (number and duration of visits
p.(None): to the research center and the total time involved) and the possibility that the study or the
p.(None): Participation of the person conclude in advance.
p.(None): 6. If the expenses incurred by the participant will be paid as a reason for their participation in the
p.(None): study.
p.(None): 7. That after completing the study, participants will be informed of the findings of the
p.(None): research in general, and individual findings related to your health status
p.(None): in particular.
p.(None): 8. Any foreseeable discomfort, pain, risk or inconvenience related to the
p.(None): Participation in the study.
p.(None): 9. What are the direct benefits expected from your participation in the study.
p.(None): 10. What are the expected benefits for the community or society in general, or its
p.(None): contribution to scientific knowledge.
p.(None): 11. How the participant will have access to the research product in case it is
p.(None): beneficial to health, once the study is over
p.(None): 12. Any intervention or alternative treatment currently available.
p.(None): 13. What measures will be taken to ensure respect for the privacy and confidentiality of
p.(None): the records in which the participants are identified.
p.(None): 14. What are the rules on the use of genetic test results and information
p.(None): family genetics In addition, the precautions taken to prevent the disclosure of
p.(None): results of the participant's genetic tests to their immediate or other relatives (for
p.(None): for example, insurance companies or employers) without the participant's consent.
p.(None): 15. Which are the sponsors of the research, the institutional affiliation of the
p.(None): researchers and the nature and sources of research funding.
p.(None): 16. What will the participant's medical records and biological samples be used for?
p.(None): 17. If you plan to destroy the biological samples obtained when the investigation is finished and,
p.(None): if not, the details about its storage (where, how, for how long and its
p.(None): final disposition). The participant may refuse storage.
p.(None): 18. That the researcher must provide or manage medical services to the participant for the
p.(None): attention to reactions or damages related to your participation in the study, at no cost
p.(None): Some for the participant.
p.(None): 19. That there is an insurance policy that will compensate the subject, his family or his
p.(None): Dependents in case of proven illness, disability or death
p.(None): with your participation in the study and how you can access these benefits, the name,
p.(None): telephone (s) and the address of the CEC that approved the research study and inform that
p.(None): is accredited by the Conis. "
p.(None): (.)
p.(None): "Article 48.-On the recruitment of participants. The recruitment procedure shall be
p.(None): submitted to the CEC as part of the initial submission and will contain the following requirements:
p.(None): (.)
p.(None): Recruit participants for a biomedical research, must be approved by the CEC
p.(None): respective, which will review in the sense that advertising is not alarming, that does not generate
p.(None): excessive or misleading expectations, which does not take advantage of physical vulnerability or
p.(None): psychological of people who could be recruited. This must be communicated to the Conis
p.(None): within ten days before publication. "
p.(None): Article sheet
p.(None): Article 3-Derogatory.
p.(None): Repeal articles 3 subsections x) and y), 31, 35, 36, 37, 38, 39, 40, 41 and article 44, subsection
p.(None): gg); of Executive Decree No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of 17
p.(None): July 2015 "Regulation to the Biomedical Research Regulatory Law".
p.(None): Article sheet
p.(None): Article 4º-In force as of its publication in the Official Gazette.
p.(None): Given in the Presidency of the Republic.-San José, on the eleventh day of the month of January of the two
p.(None): One thousand sixteen.
p.(None): Article sheet
p.(None): Generation date: 02/16/2020 10:03:53 p.m.
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.(None): 11. How the participant will have access to the research product in case it is
p.(None): beneficial to health, once the study is over
p.(None): 12. Any intervention or alternative treatment currently available.
p.(None): 13. What measures will be taken to ensure respect for the privacy and confidentiality of
p.(None): the records in which the participants are identified.
p.(None): 14. What are the rules on the use of genetic test results and information
p.(None): family genetics In addition, the precautions taken to prevent the disclosure of
p.(None): results of the participant's genetic tests to their immediate or other relatives (for
p.(None): for example, insurance companies or employers) without the participant's consent.
p.(None): 15. Which are the sponsors of the research, the institutional affiliation of the
p.(None): researchers and the nature and sources of research funding.
p.(None): 16. What will the participant's medical records and biological samples be used for?
p.(None): 17. If you plan to destroy the biological samples obtained when the investigation is finished and,
p.(None): if not, the details about its storage (where, how, for how long and its
p.(None): final disposition). The participant may refuse storage.
p.(None): 18. That the researcher must provide or manage medical services to the participant for the
p.(None): attention to reactions or damages related to your participation in the study, at no cost
p.(None): Some for the participant.
p.(None): 19. That there is an insurance policy that will compensate the subject, his family or his
p.(None): Dependents in case of proven illness, disability or death
p.(None): with your participation in the study and how you can access these benefits, the name,
p.(None): telephone (s) and the address of the CEC that approved the research study and inform that
p.(None): is accredited by the Conis. "
p.(None): (.)
p.(None): "Article 48.-On the recruitment of participants. The recruitment procedure shall be
p.(None): submitted to the CEC as part of the initial submission and will contain the following requirements:
p.(None): (.)
p.(None): Recruit participants for a biomedical research, must be approved by the CEC
p.(None): respective, which will review in the sense that advertising is not alarming, that does not generate
p.(None): excessive or misleading expectations, which does not take advantage of physical vulnerability or
p.(None): psychological of people who could be recruited. This must be communicated to the Conis
p.(None): within ten days before publication. "
p.(None): Article sheet
p.(None): Article 3-Derogatory.
p.(None): Repeal articles 3 subsections x) and y), 31, 35, 36, 37, 38, 39, 40, 41 and article 44, subsection
p.(None): gg); of Executive Decree No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of 17
p.(None): July 2015 "Regulation to the Biomedical Research Regulatory Law".
p.(None): Article sheet
p.(None): Article 4º-In force as of its publication in the Official Gazette.
p.(None): Given in the Presidency of the Republic.-San José, on the eleventh day of the month of January of the two
p.(None): One thousand sixteen.
p.(None): Article sheet
p.(None): Generation date: 02/16/2020 10:03:53 p.m.
...
Health / visual impairment
Searching for indicator blind:
(return to top)
p.(None): Executive No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of July 17, 2015
p.(None): "Regulation to the Biomedical Research Regulatory Law", to be read as follows
p.(None): way:
p.(None): "Article 8º-On informed consent.
p.(None): (.)
p.(None): l) In the case of observational investigations in minors who are
p.(None): captive as in educational centers, the CEC may allow the sending of consent
p.(None): informed the legal representative to register the signature authorizing the participation of the
p.(None): less."
p.(None): "Appendix 1
p.(None): Obtaining informed consent: Essential information for potentials
p.(None): research participants
p.(None): Before requesting the consent of a person to participate in an investigation, the
p.(None): researcher must provide verbally or in another form of communication that the person can
p.(None): understand the following information
p.(None): 1. That the person is invited to participate, the reasons for considering it appropriate and that the
p.(None): Participation is voluntary.
p.(None): 2. That the person is free to refuse to participate and withdraw from the investigation in any
p.(None): moment without penalty or loss of benefits to which he would be entitled.
p.(None): 3. What is the purpose of the investigation, the procedures that the investigator will perform and
p.(None): the participant, and an explanation on how research differs from medical care
p.(None): usual.
p.(None): 4. In the case of interventional studies, the research design must be explained (by
p.(None): example, randomness, double blind), and in case of blind studies, the
p.(None): treatment assigned to the participant until the study is completed and the experiment
p.(None): I have blindly lost such a character.
p.(None): 5. What is the expected duration of the person's participation (number and duration of visits
p.(None): to the research center and the total time involved) and the possibility that the study or the
p.(None): Participation of the person conclude in advance.
p.(None): 6. If the expenses incurred by the participant will be paid as a reason for their participation in the
p.(None): study.
p.(None): 7. That after completing the study, participants will be informed of the findings of the
p.(None): research in general, and individual findings related to your health status
p.(None): in particular.
p.(None): 8. Any foreseeable discomfort, pain, risk or inconvenience related to the
p.(None): Participation in the study.
p.(None): 9. What are the direct benefits expected from your participation in the study.
p.(None): 10. What are the expected benefits for the community or society in general, or its
p.(None): contribution to scientific knowledge.
p.(None): 11. How the participant will have access to the research product in case it is
p.(None): beneficial to health, once the study is over
p.(None): 12. Any intervention or alternative treatment currently available.
p.(None): 13. What measures will be taken to ensure respect for the privacy and confidentiality of
p.(None): the records in which the participants are identified.
p.(None): 14. What are the rules on the use of genetic test results and information
p.(None): family genetics In addition, the precautions taken to prevent the disclosure of
p.(None): results of the participant's genetic tests to their immediate or other relatives (for
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): "Law for the Protection of Citizens from Excess of Administrative Requirements and Procedures" and the Decree
p.(None): Executive No. 39061-S of May 8, 2015 "Regulation to the Regulatory Law of Investigation
p.(None): Biomedical "published in La Gaceta No. 138 of July 17, 2015.
p.(None): Options:
p.(None): Save Considering:
p.(None): Print 1 -That the health of the population is a fundamental right and a good of public interest
p.(None): supervised by the State.
p.(None): 2-That the State has the responsibility to guarantee the well-being of citizens, without
p.(None): No discrimination
p.(None): 3rd - That it is the responsibility of the Ministry of Health to define policy, regulation, planning
p.(None): and the coordination of all public and private health-related activities, including the
p.(None): biomedical research
p.(None): 4 - That on April 25, 2014, was published in the Official Gazette La Gaceta, Law No. 9234 of the
p.(None): April 22, 2014 "Biomedical Research Regulatory Law", which regulates research
p.(None): Biomedical with human beings in health, in the public and private sectors.
p.(None): 5-That by Executive Decree No. 39061-S of May 8, 2015, the Executive Power
p.(None): promulgated the Regulation to the Biomedical Research Regulatory Law.
p.(None): 6-That the Law on the Protection of Citizens from Excess Requirements and Procedures
p.(None): Administrative Law No. 8220 and its reform Law No. 8990 of September 27, 2011 orders to simplify
p.(None): the procedures and requirements established by the Public Administration against citizens, avoiding
p.(None): duplicities and expeditiously guaranteeing the right to petition and free access to
p.(None): public departments, contributing undeniably in the process of strengthening the
p.(None): principle of legal certainty of the Costa Rican democratic system.
p.(None): 7-That due to the aforementioned considerations, it is necessary and timely to reform the
p.(None): Executive Decree No. 39061-S of May 8, 2015 "Regulation of the Regulatory Law of
p.(None): Biomedical Research "published in La Gaceta No. 138 of July 17, 2015. Therefore,
p.(None): DECREE:
p.(None): Reforms to Executive Decree No. 39061-S of May 8, 2015 "Regulations
p.(None): to the Biomedical Research Regulatory Law "
p.(None): Article 1 - Reforms.
p.(None): Reform articles 3, subsection w), 12, 26, subsection m), 30 and 32 of Executive Decree No.
p.(None): 39061-S of May 8, 2015 published in La Gaceta No. 138 of July 17, 2015 "Regulation a
p.(None): the Biomedical Research Regulatory Law ", to be read as follows:
p.(None): "Article 3 - Definitions and abbreviations. For the purposes of this regulation and its
p.(None): Application is understood by:
p.(None): (.)
p.(None): w) Adverse event: unwanted event or event that occurs during or after the
p.(None): participation in a biomedical research for the use of a medicine, device,
p.(None): procedure or other intervention. It should be characterized as follows: intensity
p.(None): (mild, moderate or severe), relationship with the medication or intervention (not related,
p.(None): probably related or related) and severity (serious or not serious). "
p.(None): (.)
p.(None): "Article 12.-Of the requirements for land, sea or air transport of material
p.(None): biological.
p.(None): For land, sea or air transportation of biological material, it will be necessary to comply with the
p.(None): next:
p.(None): a) All transport of biological and infectious material must comply with UN3373,
p.(None): following all the guidelines of category A for infectious material and category B for
...
p.(None): moment without penalty or loss of benefits to which he would be entitled.
p.(None): 3. What is the purpose of the investigation, the procedures that the investigator will perform and
p.(None): the participant, and an explanation on how research differs from medical care
p.(None): usual.
p.(None): 4. In the case of interventional studies, the research design must be explained (by
p.(None): example, randomness, double blind), and in case of blind studies, the
p.(None): treatment assigned to the participant until the study is completed and the experiment
p.(None): I have blindly lost such a character.
p.(None): 5. What is the expected duration of the person's participation (number and duration of visits
p.(None): to the research center and the total time involved) and the possibility that the study or the
p.(None): Participation of the person conclude in advance.
p.(None): 6. If the expenses incurred by the participant will be paid as a reason for their participation in the
p.(None): study.
p.(None): 7. That after completing the study, participants will be informed of the findings of the
p.(None): research in general, and individual findings related to your health status
p.(None): in particular.
p.(None): 8. Any foreseeable discomfort, pain, risk or inconvenience related to the
p.(None): Participation in the study.
p.(None): 9. What are the direct benefits expected from your participation in the study.
p.(None): 10. What are the expected benefits for the community or society in general, or its
p.(None): contribution to scientific knowledge.
p.(None): 11. How the participant will have access to the research product in case it is
p.(None): beneficial to health, once the study is over
p.(None): 12. Any intervention or alternative treatment currently available.
p.(None): 13. What measures will be taken to ensure respect for the privacy and confidentiality of
p.(None): the records in which the participants are identified.
p.(None): 14. What are the rules on the use of genetic test results and information
p.(None): family genetics In addition, the precautions taken to prevent the disclosure of
p.(None): results of the participant's genetic tests to their immediate or other relatives (for
p.(None): for example, insurance companies or employers) without the participant's consent.
p.(None): 15. Which are the sponsors of the research, the institutional affiliation of the
p.(None): researchers and the nature and sources of research funding.
p.(None): 16. What will the participant's medical records and biological samples be used for?
p.(None): 17. If you plan to destroy the biological samples obtained when the investigation is finished and,
p.(None): if not, the details about its storage (where, how, for how long and its
p.(None): final disposition). The participant may refuse storage.
p.(None): 18. That the researcher must provide or manage medical services to the participant for the
p.(None): attention to reactions or damages related to your participation in the study, at no cost
p.(None): Some for the participant.
p.(None): 19. That there is an insurance policy that will compensate the subject, his family or his
p.(None): Dependents in case of proven illness, disability or death
p.(None): with your participation in the study and how you can access these benefits, the name,
p.(None): telephone (s) and the address of the CEC that approved the research study and inform that
p.(None): is accredited by the Conis. "
p.(None): (.)
p.(None): "Article 48.-On the recruitment of participants. The recruitment procedure shall be
p.(None): submitted to the CEC as part of the initial submission and will contain the following requirements:
p.(None): (.)
p.(None): Recruit participants for a biomedical research, must be approved by the CEC
p.(None): respective, which will review in the sense that advertising is not alarming, that does not generate
p.(None): excessive or misleading expectations, which does not take advantage of physical vulnerability or
p.(None): psychological of people who could be recruited. This must be communicated to the Conis
p.(None): within ten days before publication. "
p.(None): Article sheet
p.(None): Article 3-Derogatory.
p.(None): Repeal articles 3 subsections x) and y), 31, 35, 36, 37, 38, 39, 40, 41 and article 44, subsection
p.(None): gg); of Executive Decree No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of 17
p.(None): July 2015 "Regulation to the Biomedical Research Regulatory Law".
p.(None): Article sheet
p.(None): Article 4º-In force as of its publication in the Official Gazette.
p.(None): Given in the Presidency of the Republic.-San José, on the eleventh day of the month of January of the two
p.(None): One thousand sixteen.
p.(None): Article sheet
p.(None): Generation date: 02/16/2020 10:03:53 p.m.
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.(None): HOME | PGR SINALEVI | POWER | HACIENDA | IDH COURT | LEGAL DICTIONARY | HELP | SITE MAP
p.(None): JUDICIAL PJ
p.(None): Search: Regulations >> Executive Decree 39533 >> Date 11/01/2016 >> Full text Internet
p.(None): Search Articles << Articles >> Standard Sheet
p.(None): Regulations Remember that Control F is an option that allows you to search the entire text
p.(None): Pronouncements
p.(None): Constitutional Affairs Go to the end of the document
p.(None): Year: 50 results
p.(None): - You are in the latest version of the standard-
p.(None): Search in: Document file
p.(None): Search Reform Regulation to the Biomedical Research Regulatory Law
p.(None): No. 39533 -S
p.(None): Advanced Search Menu
p.(None): THE PRESIDENT OF THE REPUBLIC
p.(None): Text complete
p.(None): Standard sheet AND THE MINISTER OF HEALTH
p.(None): Regulations affected
p.(None): Descriptors In use of the powers conferred on them by articles 140, subsections 3) and 18) and 146 of the
p.(None): Observations Political Constitution; 25, subsection 1), 27, subsection 1), 28, subsection 2), section b) and 103, subsection 1) of Law No.
p.(None): 6227 of May 2, 1978, "General Law of Public Administration"; 1st, 2nd, 4th and 7th of Law No.
p.(None): Related case law
p.(None): 5395 of October 30, 1973 "General Health Law"; 1st, 2nd and 6th of Law No. 5412 of 8 of
p.(None): Jurisp of the Treasury November 1973 "Organic Law of the Ministry of Health"; Law No. 9234 of April 22, 2014 "Law
p.(None): Biomedical Research Regulator "; 4th of Law No. 8220 of March 4, 2002 and its reform
p.(None): "Law for the Protection of Citizens from Excess of Administrative Requirements and Procedures" and the Decree
p.(None): Executive No. 39061-S of May 8, 2015 "Regulation to the Regulatory Law of Investigation
...
Social / education
Searching for indicator educational:
(return to top)
p.(None): which will have the term of ten working days from the receipt of the names, for the
p.(None): choice of the owner and substitute representative of the community.
p.(None): iii) The appointment of the community representative must be documented in a
p.(None): file and each CEC within ten business days, will communicate it to the Conis. "
p.(None): (.)
p.(None): "Article 32.-Functioning of the Ethical Scientific Committees.
p.(None): a) The members of the Scientific Ethical Committees will remain in their positions for the period
p.(None): accredited by the Conis and may be re-elected for equal periods. Despite its
p.(None): appointment may be revoked by the authority responsible for the public entity or
p.(None): private, before expiring the term for which he was appointed, so that the authority
p.(None): responsible will notify Conis of this situation.
p.(None): b) The operation of the CEC will be governed by the provisions of these regulations and the
p.(None): internal regulation of each CEC, the latter will be approved by the Conis during the process of
p.(None): accreditation Any subsequent modification must be approved by Conis. "
p.(None): Article sheet
p.(None): Article 2 - Editions.
p.(None): Add a subparagraph l and ANNEX I to article 8 and subparagraph f) to article 48; of the decree
p.(None): Executive No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of July 17, 2015
p.(None): "Regulation to the Biomedical Research Regulatory Law", to be read as follows
p.(None): way:
p.(None): "Article 8º-On informed consent.
p.(None): (.)
p.(None): l) In the case of observational investigations in minors who are
p.(None): captive as in educational centers, the CEC may allow the sending of consent
p.(None): informed the legal representative to register the signature authorizing the participation of the
p.(None): less."
p.(None): "Appendix 1
p.(None): Obtaining informed consent: Essential information for potentials
p.(None): research participants
p.(None): Before requesting the consent of a person to participate in an investigation, the
p.(None): researcher must provide verbally or in another form of communication that the person can
p.(None): understand the following information
p.(None): 1. That the person is invited to participate, the reasons for considering it appropriate and that the
p.(None): Participation is voluntary.
p.(None): 2. That the person is free to refuse to participate and withdraw from the investigation in any
p.(None): moment without penalty or loss of benefits to which he would be entitled.
p.(None): 3. What is the purpose of the investigation, the procedures that the investigator will perform and
p.(None): the participant, and an explanation on how research differs from medical care
p.(None): usual.
p.(None): 4. In the case of interventional studies, the research design must be explained (by
p.(None): example, randomness, double blind), and in case of blind studies, the
p.(None): treatment assigned to the participant until the study is completed and the experiment
p.(None): I have blindly lost such a character.
p.(None): 5. What is the expected duration of the person's participation (number and duration of visits
p.(None): to the research center and the total time involved) and the possibility that the study or the
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): b) A professional person with knowledge in Bioethics.
p.(None): c) Two professional people with knowledge in biomedical research.
p.(None): d) A person representing the community.
p.(None): In the specific case of the community representative, he will have his respective alternate and
p.(None): These will be chosen as follows:
p.(None): i.) Each CEC, public or private, by means of an office notified personally or by mail
p.(None): electronic, will invite organizations that develop activities related to issues of
p.(None): Biomedical research and to each CEC, to propose a candidate member of the
p.(None): organization, these organizations will have a period of ten business days from
p.(None): Received the invitation to present their candidates. Also each public CEC or
p.(None): private or of the responsible institution, will place the notice on the main cover of the page
p.(None): WEB.
p.(None): ii) Upon receipt of the names of the candidates sent by the
p.(None): organizations, the CEC will proceed to choose the community representative and their
p.(None): respective substitute,
p.(None): complying with the procedure established in the internal regulations of each CEC, for
p.(None): which will have the term of ten working days from the receipt of the names, for the
p.(None): choice of the owner and substitute representative of the community.
p.(None): iii) The appointment of the community representative must be documented in a
p.(None): file and each CEC within ten business days, will communicate it to the Conis. "
p.(None): (.)
p.(None): "Article 32.-Functioning of the Ethical Scientific Committees.
p.(None): a) The members of the Scientific Ethical Committees will remain in their positions for the period
p.(None): accredited by the Conis and may be re-elected for equal periods. Despite its
p.(None): appointment may be revoked by the authority responsible for the public entity or
p.(None): private, before expiring the term for which he was appointed, so that the authority
p.(None): responsible will notify Conis of this situation.
p.(None): b) The operation of the CEC will be governed by the provisions of these regulations and the
p.(None): internal regulation of each CEC, the latter will be approved by the Conis during the process of
p.(None): accreditation Any subsequent modification must be approved by Conis. "
p.(None): Article sheet
p.(None): Article 2 - Editions.
p.(None): Add a subparagraph l and ANNEX I to article 8 and subparagraph f) to article 48; of the decree
p.(None): Executive No. 39061-S of May 8, 2015 published in La Gaceta No. 138 of July 17, 2015
p.(None): "Regulation to the Biomedical Research Regulatory Law", to be read as follows
p.(None): way:
p.(None): "Article 8º-On informed consent.
p.(None): (.)
p.(None): l) In the case of observational investigations in minors who are
p.(None): captive as in educational centers, the CEC may allow the sending of consent
p.(None): informed the legal representative to register the signature authorizing the participation of the
p.(None): less."
p.(None): "Appendix 1
p.(None): Obtaining informed consent: Essential information for potentials
p.(None): research participants
p.(None): Before requesting the consent of a person to participate in an investigation, the
p.(None): researcher must provide verbally or in another form of communication that the person can
p.(None): understand the following information
p.(None): 1. That the person is invited to participate, the reasons for considering it appropriate and that the
p.(None): Participation is voluntary.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| blind | visual impairment |
| disability | Mentally Disabled |
| educational | education |
| family | Motherhood/Family |
| home | Property Ownership |
| illness | Physically Disabled |
| political | political affiliation |
| vulnerability | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input