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CLINICAL OFFICERS IN MALAWI “Pride of the Nation”

CLINICAL OFFICERS IN MALAWI “Pride of the Nation”. Martias Joshua MB, BS MPH Hospital Director Zomba Central Hospital. SELF INTRODUCTION. MB,BS 1998 MPH 2008 DHO Dowa 1999-2005 ZONE SUPERVISOR (CE) JAN-DEC 2006 DIRECTOR OF CLINICAL SERVICES JAN-SEPT 2007

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CLINICAL OFFICERS IN MALAWI “Pride of the Nation”

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  1. CLINICAL OFFICERS IN MALAWI“Pride of the Nation” Martias Joshua MB, BS MPH Hospital Director Zomba Central Hospital

  2. SELF INTRODUCTION • MB,BS 1998 • MPH 2008 • DHO Dowa 1999-2005 • ZONE SUPERVISOR (CE) JAN-DEC 2006 • DIRECTOR OF CLINICAL SERVICES JAN-SEPT 2007 • ZONE SUPERVISOR (CE) OCT 2007-DEC 2008 • ZOMBA CENTRAL HOSPITAL JAN 2009-TODATE. • NHSRC & COMREC MEMBER 2009

  3. Malawi Clinical Officer Carrier PathGovernment Functional Review 2007

  4. Carrier path in civil services • Clinical Technician, Grade K Diploma in Clinical Medicine (Refine MSCE, MB,BS) • Senior Clinical Technician, Diploma in Clinical Medicine Grade J (Refine MSCE, MB,BS) • Clinical Officer Grade I (Diploma in Clinical Medicine, Degree in relevant field) or do MB,BS

  5. Carrier path in civil services • Senior Clinical Officer Grade H (Diploma in Clinical Medicine, Degree in relevant field) or do MB,BS Senior Medical Officer • Principle Clinical Officer Grade G (Diploma in Clinical Medicine, Degree in relevant field) or do MB,BS Principle Medical Officer • Chief Clinical Officer Grade F (Diploma in Clinical Medicine, Degree in relevant field) or do MB,BS Chief Medical Officer

  6. Carrier path in civil services • If MB,BS then specialise promoted to Grade F • Specialist Grade F • Senior Specialist Grade E • Chief Specialist Grade D

  7. End of presentation

  8. RESEARCH COMMITTEE GENERALGUIDELINES ON HEALTH RESEARCH IN MALAWI

  9. “Valuing Collective Responsibility in PromotingExcellence in Scientific and Ethical Conduct ofHealth Related Research in Malawi”

  10. Introduction • Until 1988, all health related research proposals reviewed and cleared by NHSRC secretariat NRCMnow NCST. • For speedy approval of research proposals, NRCM decentralized this function to sectoral institutions.

  11. Introduction • In 1988, MOH established RU - mandate promote & co-ordinate health research in Malawi. • In 1993, the NHSRC secretariat was transferred to the MOH-RU.

  12. Introduction • Government authorized the establishment of the COMREC as a sister committee to NHSRC. • COMREC for faculty members and students of the COM, KCN and their collaborators or affiliated institutions,

  13. Introduction • NHSRC & COMREC are responsible to monitor & evaluate research projects they approve. • Both of these committees derive their authority from the NCST. • These Committees keep each other informed by means of cross representation.

  14. 2.0 Purpose of NHSRC & COMREC • Ethically human subjects are partners and participants in health research and such a research is a privilege. • They serve purpose of accelerating attainment of high quality research while protecting human subjects.

  15. 2.0 Purpose of NHSRC & COMREC • They ensure that review of proposals is standardized and promote the co-ordination of research activities. • They provide researchers with information regarding recommended steps for conducting health research in Malawi.

  16. 3.0 Functions, Organization and Administration of theNHSRC

  17. 3.1 Functions of NHSRC & COMREC • Advise Govt on scientific and ethical aspects of health sciences research. • Foster the rights and welfare of human subjects.

  18. 3.1 Functions of NHSRC & COMREC • Review health science research proposals from prospective researchers whatever their discipline. • Offer guidance in relation to each research proposal e.g. expertise, lab, both inside & outside country.

  19. 3.1 Functions of NHSRC & COMREC • Review and clear for publication all materials originated from studies approved by NHSRC & COMREC. • Encourage and recommend to Govt on contacts among research scientists of varying capabilities for capacity building.

  20. 3.1 Functions of NHSRC & COMREC • Enhance capacity building and promote health research especially among local professionals. • Ensure proper collection, acquisition, dissémination, use, storage and management of research information. • Perform any function related to the protection of health research participants

  21. 3.2 Membership

  22. 3.2.1 Membership requirements • Members are individuals or representatives of organizations protecting human subjects participating in health research. • The committee shall have members with varying backgrounds to promote complete and adequate review of research proposals.

  23. 3.2.1 Membership requirements • To avoid conflict of interest, Research Project Directors are not members. Membership shall include at least one lay public. • Committees ascertain the acceptability of proposed research e.g. institutional commitments, regulations, applicable law and standards of professional conduct & practice.

  24. 3.2.1 Membership requirements • Therefore membership requires persons knowledgeable in such areas. • The standards described above represent minimum requirements which Govt of Malawi typically exceeds. • Committees, therefore, strive to uphold highest standards in order to adequately meet the requirements of research review.

  25. 3.2.2 Membership of the NHSRC • The Committee shall have the following membership: • National Research Council of Malawi 1 • Ministry of Health Headquarters 2 • COMREC 2 • Community Health Sciences Unit (CHSU) 1 • National AIDS Commission 1 • Center for Social Research 1 • Queen Elizabeth Central Hospital 1

  26. 3.2.2 Membership of the NHSRC • Zomba Central Hospital 1 • Kamuzu Central Hospital 1 • CHAM) 1 • Lay/Community member 1 • Mzuzu University 1 • Mzuzu Central Hospital 1 • Nurses and Midwives Council of Malawi 1 • Ministry of Justice (Lawyer) 1 • COMREC members.

  27. 3.2.2 Membership of the NHSRC • COMREC membership is nominated by heads of departments of COM, KCN, representatives from NHSRC and lay individual. • The secretariats cross represents too.

  28. 3.2.3 Appointment of members • The NHSRC comprises members nominated by organizations listed in 3.2.2. • Their appointment to serve on NHSRC shall officially and procedurally be done by the Chairman of the Commission of Science and Technology (CST) i.e CS for Public Service.

  29. 3.2.3 Appointment of members • Both the CST and MOH play an active role in recommending the appointment of members. • Once constituted, the committee has powers to recommend the co-option of certain individuals with special expertise to serve as honorary member of the committee.

  30. 3.2.3 Appointment of members • Members shall serve for three years and are liable for reappointment if the organizations they represent re-appoint them.

  31. 3.2.4 Appointment of the Chairperson and Vice Chairperson • The Chairperson and the Vice–Chairperson of the NHSRC are elected by members from among themselves. • The chair and vice chair are individuals with credibility and standing to command respect in the research community/committee, committed to the protection of human subjects in research.

  32. 3.2.4 Appointment of the Chairperson and Vice Chairperson • Their term last for three fiscal years. However, they are eligible for re-election for further terms if the committee is satisfied with their performance.

  33. 3.2.5 Alternate members • At times it may not be possible for a member to attend the NHSRC meeting in person. • In such a case prior arrangement should be made with the chairperson for an alternate person to attend the meeting.

  34. 3.2.6 Non-voting Members • The secretariat are non-voting member. Their presence at meetings are secretarial in nature and to aid in conducting its business. • Non-voting members are not included in determining or establishing a quorum. The committes reflect the presence of non-voting member(s).

  35. 3.2.7 Membership confidentiality agreement • Members are expected to keep all business of the committee confidential, therefore they sign a confidentiality agreement. • Any external reviewers reviewing specific study and visitors during the deliberations meetings sign a confidentiality agreement.

  36. 3.2.8 Orientation and training of members • Once a member have been appointed, attends the first one or two meetings as observer to learn before being assigned as reviewer. • New member undergoes orientation sessions covering Guidelines and committee SOPs & any practical matters with secretariat and chair.

  37. 3.2.8 Orientation and training of members • CME for all members in matters of health research ethics and related disciplines in human research protections are essential. • Short courses, workshops and exchange visits for achieving member continuing education. • The chairman lead in fostering local and international networks, links and partnerships for purposes of CME.

  38. 3.2.9 Termination/disqualification of membership • Appointment is terminated before the expiration of the three-year term if the Chairman of the NRCM upon recommendation from the committee Chairperson. • This is generally when the committee determines that the member fails to perform his or her duties as a member.

  39. 3.2.9 Termination/disqualification of membership • Specifically, membership is terminated/ disqualified due to the following reasons: • Unsound mind. ii. Grave breach of conduct like corruption, confidentiality, conflict of interest, and failure to attend more than three consecutive times without proper reasons.

  40. 3.2.9 Termination/disqualification of membership • When a member goes on long leave of absence, writes the chairman of the committee expressing voluntary termination of appointment. • If long leave of absence is observed, the chairman shall recommend the termination of the member’s appointment.

  41. 3.2.10 Member resignation • Members are allowed to resign in writing to committee Chairperson through the head of the institution. • Resignation from the organization that nominated a member may not necessarily translate into resignation from the committee.

  42. 3.2.10 Member resignation • If an individual ceases to be a member for the organization where nominated, the committee makes a decision on a member to serve full term.

  43. 3.2.11 External Reviewers • The committee invite individuals with special competence to assist in the review of issues that require expertise beyond serving members. • Such individuals are not be members and not included in determining or establishing a quorum at meetings if they are present. • Such individuals are referred to as external reviewers.

  44. 3.2.12 Conflict of interest • In the event that committee is discussing a proposal where a member has specific interest, it is mandatory that such a member declares conflict of interest. • In such cases a member gets out of the meeting before deliberations on that proposal. He/she sign a Conflict of Interest Declaration Form. Secretariat document that action in minutes.

  45. 3.2.12 Conflict of interest • At the maximum, the member with a conflicting interest may only provide relevant information if so requested by the committee. • Conflicts of interest could include but not limited to : a member of committee who serves as an investigator on research under review;

  46. 3.2.12 Conflict of interest • a member who holds a significant financial interest in a sponsor or product under study; • A member whose spouse or close relative has the research under review; • A member who has any other special form of relationship with the investigator or sponsor of the research under review.

  47. 3.2.13 Liability coverage for members • Committee members function as govt. agents. • As such their actions are covered by Govt provided they perform within course & scope of their committee responsibilities. • This means that members not held personally liable in the course of performing their duty.

  48. 3.2.14 Compensation for members • Membership is based on principle of voluntarily rendering state service to the nation. • As such members shall not be provided monetary compensation for their service while serving in the committee.

  49. 3.2.14 Compensation for members • However, they are entitled to accommodation coverage, subsistence allowance and sitting-in-allowance at existing Government rate. • For all donor funding, Govt and donors’ agreement on payment of allowances & accommodation coverage is applicable. • In addition, refreshments and/or food as a token of limited compensation.

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