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Back NEWS REPUBLIC of INDONESIA No. 1319, 2013 the MINISTRY OF HEALTH. Research. The clinic. The registry. Providence.
REGULATION of the MINISTER of HEALTH of the REPUBLIC of INDONESIA NUMBER 66 by 2013 ABOUT CONDUCTING CLINICAL RESEARCH REGISTRY with the GRACE of GOD ALMIGHTY the MINISTER of HEALTH of the REPUBLIC of INDONESIA, Considering: a. that to ensure a research clinic that accountable and transparent as well as in the framework of the protection of public health, the Government conduct surveillance any clinical research;
b. clinical research that the registry was developed by the national Government in a system of clinical research registry that is accessible to the whole community with the aim of providing clarity of information each clinic research conducted in Indonesia;
c. that based on considerations as referred to in letter a and letter b, need to establish the regulation of the Minister of health regarding Clinical Research Registry;
Remember: 1. Act No. 18 of 2002 concerning the national system of research, development, application of science and technology (State Gazette of the Republic of Indonesia Number 84 in 2002, an additional Sheet of the Republic of Indonesia Number 4219);
2. Act No. 14 of 2008 about the openness of public information (State Gazette of the Republic of Indonesia Number 61 in 2008, an additional Sheet of the Republic of Indonesia Number 4846);
3. Act No. 36 of 2009 about health (State Gazette of the Republic of Indonesia Number 144 in 2009, an additional Sheet of the Republic of Indonesia Number 5063);
4. Government Regulation Number 39 in 1995 on Health Research and development (State Gazette of the Republic of Indonesia Number 67 in 1995, an additional Sheet of the Republic of Indonesia Number 3609);
5. Government Regulation Number 20 in 2005 about intellectual property technology transfer as well as the results of research and development by Universities and research and Development Institutions (State Gazette of the Republic of Indonesia Number 43 in 2005, an additional Sheet of the Republic of Indonesia Number 4497);
6. Government Regulation Number 41 in 2006 about the licensing Activities of research and development For College foreign, Foreign research and Development Institutions, Foreign business entities, and foreigners (Gazette of the Republic of Indonesia Number 104 in 2006, an additional Sheet of the Republic of Indonesia Number 4841);
7. Government Regulation Number 48 in 2009 on the implementation of the Licensing activities of research, Development, and application of science and technology Are at high risk and dangerous (State Gazette of the Republic of Indonesia Number 113 in 2009, an additional Sheet of the Republic of Indonesia Number 5039);
8. The decision of the Minister of health Number 791/Menkes/SK/VII/1999 on the Organization of Coordination of health research and development;
9. The decision of the Minister of health the number 1179A/Menkes/SK/X/1999 about national policy research and the development of Health;
10. The decision of the Minister of health the number 1333/Menkes/SK/X/2002 about Approval for humans to health research;
11. Regulation of the Minister of health Number 656/Menkes/Per/VIII/2009 regarding the delivery and use of Clinical Specimens, Biological Material, and charge Information;
12. Regulation of the Minister of health number: 658/Menkes/Per/VIII/2009 on the Laboratory Diagnosis of infectious disease network of New-Emerging and Re-Emerging;
13. the regulation of the Minister of health the number 003/Menkes/Per/I/2010 of Saintifikasi herbal medicine in the Ministry of Health;
14. Regulation of the Minister of health number: 1144/Menkes/Per/VIII/2010 regarding the Organization of work and the Ministry of health, as amended by regulation of the Minister of health the number 35 by 2013 about changes to the regulation of the Minister of health the number 1144/Menkes/Per/VIII/2010 about the Organization and the Work of the Ministry of health (State News 2013 Number 741);
15. Regulation of the Minister of health Number 2166/Menkes/Per/X/2011 about public information service standard;
16. The decision of the Minister of health the number 182/Menkes/SK/V/2012 about the list of information that is Excluded In the environment of the Ministry of health;
Decide: define: REGULATION of the MINISTER of HEALTH ABOUT the REGISTRY RESEARCH clinic.
CHAPTER I GENERAL PROVISIONS article 1 In this regulation of the Minister, is: 1. Clinical Research is the research and development of health care that uses humans as subjects of research, to find scientific evidence of the causes and risk factors, diagnosis, prognosis, therapy, and rehabilitation of health disorders, including other actions that change the status of the health and human behavior.
2. Clinical Research Registry is the official recording of a research that will be carried out with the use of human beings as subjects of research.
3. Clinical Research Data Sets which are hereinafter referred to as the Data Set is a set of information that constitutes a protocol details the research clinic.
4. Approval of ethics (ethical approval) is a research implementation written evidence by the Commission of ethics of health research for researchers who get top rating Protocol research according the norms and ethics of research.
5. A researcher is any person who is in charge of conducting health research and development.
6. Health Research and development agency of the Ministry of health of the Republic of Indonesia, hereinafter abbreviated body of Patient advocates are the items that are under and is responsible to the Minister of health, who has the task of carrying out research and development in health.
7. The head of the Agency is the leader of a unit of work research and Development Agency.
8. the Minister is the Minister who organized a Government Affairs in the field of health.
Article 2 scope of clinical research registry settings include registry against the research clinic and clinical trials against the registry.
Article 3 the registry setting Research Clinic aims to: a. protect the public from the research results are not accountable and transparent;
b. protecting the subjects of Clinical Research;
c. provide information Research Clinic whose results can be utilized for health development;
d. provides information on the number, types, shapes, and the stages of Clinical Research, including protokolnya;
e. enhance the harmony and the transparency of the information organization of research between Government, communities, and researchers.
CHAPTER II ORGANIZATION of the REGISTRY is considered part of the General CLINIC RESEARCH article 4 (1) each of the Clinic's research will be done in Indonesia can only be held by the institutions and bodies of the State-owned and private law that organizes the health research and development, as well as health care facilities that are eligible for it.
(2) foreign colleges, research institutions and the development of the alien, and aliens who do clinical research activities must work together with the Ministry of health in Indonesia as the guarantor agencies and business partners as well as the need to involve Indonesia researcher who became a member of the Organization/Association of legal health researcher's profession.
Article 5 (1) the registry of research conducted at the clinic work unit appointed by the Minister of health upon the proposal of the head of the Agency.
(2) Against the clinic research done at the Institute, a unit of work and/or health care facilities belonging to the Ministry of health, which conducts research on health functions, required the registry.
(3) Clinical research conducted by institutions, work units, and/or health care facility other than as referred to in paragraph (2) may be made of the registry for transparency.
Article 6 in order to facilitate the implementation of the registry, the head of the Agency on behalf of the Minister may convene working with institutions of higher learning in medicine/dentistry/pharmacy, and other institutions that have competence in the execution of the research clinic.
The second part of the requirements of article 7 (1) of each of the research clinic that will diregistri have to meet the following requirements: a. have approval from Ethics Commission ethics research and researchers have registered as a member of the Organization/Association of the profession of health Indonesia researcher.
b. implementation of the Accords has been getting Test Clinics (PPUK) of the food and drug Supervisory Agency for clinical trials of drugs, biological products, traditional medicine, cosmetics, food supplements/health which will be marketed in Indonesia; and/or c. has received the approval of the agreement over the material (material transfer agreement) for shipment of specimens in accordance with provisions of laws and regulations that apply to Clinical Research after considering the national interests require that the shipping of specimens he does abroad.
(2) the Commission of ethics of the research referred to in subsection (1) letter a is commissions conduct research that is already registered with the National Commission of ethics of health research.
The second stage of the Registry Status of article 8 (1) the registry of research clinic is conducted in three (3) stages the status as follows: a. an initial Stages;
b. Phases of recruits; and c. The stage of completion.
(2) The initial stage referred to in subsection (1) letter a is finished when all stages of the preparation of research as article 7 paragraph (1) (3) Stages of recruits as referred to in paragraph (1) letter b is the stage when the research is carried out until the completion of the recruitment of subjects of research.
(4) Stages of completion referred to in subsection (1) the letter c represents the stages of recruitment since the end of the research subjects until the completion of the implementation of the research.
Article 9 in the event of the Research Clinic is held for a period of more than 1 (one) year, then the registry is done in the first year, and further research organizer should convey the status of clinical research in progress.
Article 10 (1) at any stage of the status of the registry contains data and information that is specified as a Set of Data in accordance with the level of implementation of the Clinical Research.
(2) every Set of Data as referred to in paragraph (1) to be filled, fitted, and signed by the Chairman of the research clinic.
(3) Data and information contained in the particular Set of Data, for the benefit of intellectual property can be concealed by implementing clinical research by giving the code which is confidential (confidential) in accordance with the legislation in force.
(4) the details of the Data Set and Data Set of instructions referred to in subsection (1), subsection (2) are listed in the annex which is an integral part of part of the regulation of the Minister.
The third part evidence of the registry section 11 (1) of each of the research clinic who have diregistri given the registry number of the clinic's research as evidence of the registry.
(2) every registry number as referred to in subsection (1) is valid only for one (1) title of the research clinic.
Article 12 Registry Process Research Clinic is free of charge.
Article 13 Research clinic that is not diregistri cannot be published in national and international scientific journals recognized by the Ministry of health.
The fourth part of the obligation of Implementing the Research Clinic who has had a Registry Number Article 14 Implementing Clinical Research that has had a registry number Research Clinic has an obligation as follows: a. implementing Clinical Research according the approval of ethics (ethical approval) and comply with the provisions of the applicable legislation;
b. perform quality clinical research on guard;
c. providing or facilitating the holding of external quality evaluation system (External Quality Assessment System); and d. do the updates the status phase of the Clinical Research and development related information Data Set changes.
The fifth section of the Registry System Access Clinic Research Article 15 information obtained from Data sets on the system Registry Research Clinics accessible to the public in accordance with the provisions of the applicable legislation.
CHAPTER III COACHING and SUPERVISION article 16 Ministers, heads of agencies, the head of the Provincial Health Office, head of Department of health district/city health researchers, professional organizations, Chief organizer of the research clinic, and related institutions do of coaching and supervision against the implementation of Clinical Research Registry in accordance with the duties and functions of each.
Article 17 (1) coaching and supervision as referred to in article 16 is directed to improve, develop, and advance the quality and number of Research Clinic.
(2) the construction and the supervision referred to in subsection (1) is carried out through: a. advocacy and dissemination;
b. monitoring and evaluation.
Article 18 (1) in conducting the coaching, the Minister may give a written reprimand in the form of administraif sanctions to the institution managing Clinic Research and/or clinical research researchers who do not perform registry.
(2) in the case of the written reprimand as referred to in paragraph (1) are not above begging, the Minister may make an announcement written on national and international scientific journals and send to the Organization/Association of Indonesia health research profession to do construction keprofesian.
(3) the announcement referred to in paragraph (2) contain a notice of the research clinic that is not diregistri.
CHAPTER IV CLOSING PROVISIONS article 19 this ministerial regulation came into force one (1) year after promulgation.
In order to make everyone aware of it, ordered the enactment of this Ministerial Regulation with its placement in the news of the Republic of Indonesia.
Established in Jakarta on October 31, 2013, the MINISTER of HEALTH of the REPUBLIC of INDONESIA, NAFSIAH MBOI Enacted in Jakarta on November 12, 1995 the MINISTER of LAW and HUMAN RIGHTS REPUBLIC of INDONESIA, AMIR SYAMSUDDIN fnFooter ();
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