PRIiSIDENCE OF THE REPUBLIC GENERAL SECRETARIAT OF GOVERNMENT REPUBLIC OF GUINEA Work-Justice-Solidarity DECREE N ° D /. . ... *. ! .8 PRG / SGG Creating, Powers and Organization of the National Ethics Committee for Health Research (CNERS) The Basic Law Ordinance No. 030 / PRG / SGG of June 15, 1988 on fundamental principles for the creation and control of structures Public Services; Law NO 021 / AN / 97 of June 19, 1997, relating to the Public Health Code in its article 303; Dccret L * ° 009 / PRG / S GG of July 10, 1996, modified by dcci‘et N ° 013/96 PRG / SGG of February 14, 1997, modified by decree N ° D / 97/245 / PP G / SGG of October 21, 1997 bearing ministerial action and the decree L ° D / 97/267 / PRG / SGG of IS November 1997 nonwant of ministers; The Decree N ° 96/11 1 / PRG / SI G of August 29, 1996, relating to the attributions of the Members of the Government of the Republic of Guinea; Decree N ° 97/068 / PRG / SGG of 5 May 1997 on the organization of the Ministry of Health; The Council of Ministers in its ordinary session of September 22, 1995, DECREED CHAPTER I: GENERAL PROVISIONS Article 1: A National Ethics Committee for Research in San.té (CNRS) with legal personality. Article 2: CNERS is placed with the Ministry of Public Health (MSP) which gives it the means to operation. It has its headquarters in Conakry. Article 3: CNERS 'mission is to ensure the scientific and ethical quality of research conduct in the Republic of Guinea in the field of health. 3 Article 4: CNRES has the following responsibilities: to examine the health research protocols submitted to it, and to give an opinion on their acceptability of the double scientific and ‹ethical point of view; to ensure that research is carried out in accordance with the provisions of the Code of Ethics for Research in health ; - to propose, if necessary, modifications to the Code of Ethics; to examine the ethical problems relating to health research submitted to it by Institutions or individuals. CHAPTER II: ORGANIZATION Article 5: The CNERS is composed of 17 (seventeen) members, chosen for their interest .for the ethical problems of research, their competence, their experience and their representativeness. They are appointed by decree on the proposal of the Minister responsible for Public Health. Their mandate is to three years renewable. Article 6: CNERS includes Two people representing religious denominations; Eight qualified people in the disciplines that cooperate in health research: Doctors Clinicians, Epidemiologists, B iologists, Pharmacists, Statisticians, Methodology specialists and research ethics etc. Seven people proposed by organizations such as: College of Health Professionals, Departments Ministerial staff concerned, Research Institutions, Association of Patients, Non-Governmental Organizations (NGOs), Human Rights organizations etc. Article 7: CNERS meets in Ordinary Session twice a year in Session extraordinary at the invitation of its President Article 8: At its first meeting, the CNERS elects a bureau composed of four members : a President, a Vice-President, and two Secretaries. It has internal regulations specifying the conditions for organizing and holding Committee meetings and the rights and obligations members. Article 9: The President convenes the Sessions of the Committee, appoints the Rapporteurs of the files submitted to the Committee, decides questions to be discussed in plenary and those that can be settled by the office, fixes the plenary agenda. Article 10: The Vice-President assists the President and begs him if he is unable to attend. Article 11: The secretaries are responsible, under the responsibility of the President, for mail, dcs minutes, annual report, and committee records. Article 12: CL’ERS deliberates independently on all research protocols subject to its approval. CHAPTER III: FINAL PROVISIONS Articlc 13: Lc this Decree which takes effect to count dG II date of its signature s z: u registered and published in the Official Journal of the Republic CON