Ghaiath M. A. Hussein MBBS, MHSc. (Bioethics) Department of Research & Research Ethics in Sudan Research Ethics in Sudan Outline of Presentation Historical Background National Health Research Council (NHRC) Structure and Activities SOPs Institutional and States RECs Challenges and Future Steps DIRECTORATE OF RESEARCH History Current Status Relation to Research ethics Research Ethics in Sudan Development of Research in Sudan 1903: the Welcome Tropical Research Laboratories (WTRL) were established 1924: Kitchener School of Medicine (KSM) 1927 the Stack Medical Research Laboratories 1935 made the SMRL and the WTRL became the Wellcome Chemical Laboratories (WCL). 1949 : The creation of a Sudanese Ministry of Health (MOH) Research Ethics in Sudan Development of Research in Sudan 1953: The Sudan Medical Journal 1963: The Faculty of Medicine, University of Khartoum (U of K) started to grant postgraduate research degrees in the health sciences. 1970: The National Council for Research 1971: Ministry of Higher Education and Research Research Ethics in Sudan Development of Research in Sudan 1972: The MRC established the Institute and the Hospital for Tropical Medicine. 1976: Gezira Faculty of Medicine 1978: Research (thesis) became perquisite for MD In 1991: The National Research Centre Research Ethics in Sudan Development of Research Dept. 1996: Health System Research Unit established in FMoH In 1998, the FMOH changed it to the Research Directorate (RD) to be responsible to the Under-Secretary. 2000: National Research Priority set in collaboration with COHRED Research Ethics in Sudan Development of Research Ethics Review 1968: historically the first committee for ethics was established in order to formulate ethics for the medical professions 1969: the act of the ethics of the medical professions. 1979: A committee was formed on the ethics of the health research in under the Directorate of Federal Laboratories and Health Research Research Ethics in Sudan Development of Research Ethics Review 1980: the research ethics committee was established in the Fac. of Med. (U of K), In 1998, the Undersecretary of the FMOH, issued Decree No. 60/1998 for forming a committee to review health research ethics. 1999: the committee for review of health research ethics was set up by the Decree No. 31 / 1999 Research Ethics in Sudan National Health Research Council (NHRC) Established by a Ministerial Decree in 2002 Consists of: 1. Technical & Advisory Committee 2. National Health Research Ethics Committee The Directorate of Research is the Secretariat of the Council, and its director is the rappourteur of NHRC ( ) 2007 Ministerial Decree to nominate the members of the national committees of the NHRC Research Ethics in Sudan 2008 Research Ethics for the FIRST time in the Public Health Law National Health Research Ethics Committee Research Ethics in Sudan NHREC Objectives 1- Setting ethics guidelines that ensure protection of the welfare of research participants. 2- Reviewing and approving health research that are conducted: At national and interstate levels. In collaboration with or submitted to foreign donors/ Experimental research that involves human participants. Research Ethics in Sudan NHREC Functions 1- Setting ethics guidelines for reviewing and approving health research that are conducted: At national and interstate levels. In collaboration with or submitted to foreign donors/ Clinical Trials that involves human participants. 2- Accrediting institutional and state ethics committees Research Ethics in Sudan NHREC Membership : The membership of ( NHRERC) will include members: 1. The Chairperson of the committee. 2. The legal advisor of the FMOH. 3. Representative of the GoSS. 4. The secretary general of the Health Research Council (Rapporteur). 5. Representatives for universities and research institutions. NHREC Membership : 6. Researchers. 7. Representative of the Medical Council. 8. The representative of the Veterinary Research Council. 9. representative of the National Health Laboratory 10. The representative of the SMSB. Research Ethics in Sudan NHREC Membership : 11. Representatives of the national civil society organizations 12. The Representative of Press and Publications Council. 13. Representatives of the Islamic and Christian religious men. 14. Community leaders. Research Ethics in Sudan Term of the membership: The members, the chair person and the deputy will be selected by the Minister of Health. The term of the member can end by resignation, death, termination or completing three years Research Ethics in Sudan Reviewed Proposals: June May 2008: Total no. of reviewed proposals: 40 Average of 2-7/ months Process of Ethical Clearance Research Ethics in Sudan Projects including humans (including identifiable information) INSTITUTIONAL & STATE RECS Research Ethics in Sudan State and Institutional RECs The State Ministries of Health and Head of the research institutions should constitute research ethics committees to approve research proposals conducted by their own researchers and/or that conducted in the state only. State and research institutions ethics committee should NOT start their functions and tasks of ethical reviewing unless their constitution has been approved and endorsed by the NHREC. Research Ethics in Sudan State and Institutional RECs State and research institutions ethics committees have the power of ethical approval for all health research that takes place inside the state EXCEPT: i. The experimental research on the human subjects. ii. Researches linked to external bodies. iii. Researches that take place in more than one state (Interstate ). Research Ethics in Sudan State and Institutional RECs The State and institutional ethics committees should present regular biannual reports of their research reviewing activities to the NHREC. The state and institution ethic committee should follow the same guidelines, relevant to the research proposal submitted to them. Research Ethics in Sudan A primary technical & ethical review committee was established to: Screen the submitted proposals and check their fulfillment to the guidelines Provide assistance on technical and ethical issues in submitted proposals Delegated to give ethical clearance for low- risk exempted studies NATIONAL GUIDELINES FOR RESEARCH INVOLVING HUMAN Research Ethics in Sudan Milestones of preparing the guidelines: In 2002, The Ministerial Decision no 11 / 2002 was issued for the formation of Health Research Council (HRC). The first meeting of Health Research Council was held in March 2003 with the recommendations of formation of the National Ethics Review Committee (NHREC). In 2005 a meeting was organized for the NHREC in the Federal Ministry of Health. The members of the committee reached a common consensus that research ethics guidelines and research ethics directory should be developed, approved and the endorsed. Research Ethics in Sudan The NHREC nominated two subcommittees: for research ethics guidelines for investigators, and the for writing the proposal reviewing process. In th and 13 th of June two meetings of the NHREC were held in the FMOH. Two members of the committee were assigned to prepare National Ethics Format and Checklist for ethical review of the research proposals. Research Ethics in Sudan Milestones of preparing the guidelines: The secretariat of the NHREC reviewed the outcome of the above activities and prepared the final draft of these guidelines. The final edited draft was submitted to the NHREC. It was finally printed in December Research Ethics in Sudan Milestones of preparing the guidelines: Research Ethics in Sudan Logistic difficulties: Instability/lack of a constant venue to hold the meetings and training activities Lack of necessary equipment and facilities to process the reviews Running costs of the review and meetings Manual and hardcopy documentation Lack of accessibility to the databases Research Ethics in Sudan Technical difficulties: Lack of formal training of the ethics committee members Establishment of new research ethics committees in some states and federal hospitals without prior training Delay in approval and dissemination of National Research Technical & Ethical Guidelines Lack of reporting system to reflect the activities of the committee. Research Ethics in Sudan Collaboration and Coordination There are many "players" in the fields of both health research an research ethics. Better collaboration and coordination is needed with other health research stakeholders: Academic institutes, other governmental research bodies: NCR, MoST other NGOs (e.g. WHO, UNESCO) Research Ethics in Sudan Regulatory challenges Lack of mechanism of follow-up of the implementation of research in the field (e.g. DSMB) Lack of regulating laws and professional codes for conduct of research Research Ethics in Sudan Current & Future Approaches Establishment of new RECs in states and federal hospitals Training of members of national and local RECs Introduction of research ethics to undergraduate and postgraduate curricula Building networks and collaborations HOW TO START YOUR IRC? Research Ethics in Sudan The ministerial decree for establishing States Research Ethics Committees (SRC) delegates states to establish their own RECs. Then comes the logical question How to start? Research Ethics in Sudan Practical Steps Learn more about Research Ethics Try to know how is doing what and where in research e.g. a rough database of research institutes in your state/institute. Involve them in your planning, especailly senior staff Consult with local and federal experts Research Ethics in Sudan Practical Steps Collaborate with state university, local institutes and other stakeholders Disseminate the guidelines, the results of research, the research ethics Network with other RECs Build real and virtual communities of support through meeting and internet Train your colleagues and juniors Research Ethics in Sudan Its always good in be in team! Discussion Research Ethics in Sudan