3.1 National Research Health Ethics Committee (NRHEC)
3.1.1 Historical background:
There is an information gap regarding research ethics committees in Sudan since last century. However, historically the first committee for ethics was established in 1968 to formulate ethics for the medical professions and the act of the ethics of the medical professions in 1969. In this context, a committee was formed on the ethics of the health research in 1979 under the federal laboratories and health research whose targets included the following:
· Protection of the persons
· Protection of the researchers
· Definition of the research priorities
In 1980, the research ethics committee was established in the Faculty of Medicine, the University of Khartoum where it reviewed 400 researches. In 1998, the Undersecretary of the Federal Ministry of Health, issued Decree No. 60/1998 for forming a committee to review health research ethics. As a result, the committee for review of health research ethics was set up by the Decree No. 31 / 1999
In 2002, the Federal Minister of Health issued a Ministerial Decree no 11 / 2002 for the constitution of National technical( NTC) and National ethical Committees( NEC). According to this decree a number of tasks were assigned for the NHREC:
1- Formulating guidelines for research ethics.
2- Undertaking the ethics approval of the research that takes place at the national level in which it participates or that presented to external bodies.
3- Endorsement and delegation of the powers to the state and institutional research ethics committees.
4- The research ethics committee should include in its membership lawyers, Islamic and Christian religious men and the leaders of civil society and should not be confined only to the doctors and scholars in medical and scientific field.
* The FMOH would approach WHO EMRO to allocate some funds in the WHO through JPRM.
3.1.2 Regulation of the National Health Research Ethics Committee(NHREC)
3.1.2.1 Authority under which NHREC will be constituted:
The FMOH will approve the authority of the constitution and membership of the NHREC. It will be approved and notified by the Fedral Ministry of Health.
3.1.2.2 Responsibilities of (NHREC):
The committee shall have the following responsibilities:
· Formulating guidelines for the approval of the research ethically.
· The approval of health research that take place at the national level or in more than one state from an ethical point of view.
· The ethical approval of the research in which external participant or that presented to external bodies.
· The ethical approval of the experimental research on human.
· Reviewing and approving all types of research proposals involving human participants directing or indirectly, with a view to safe guard the dignity, rights, safety and well being of all actual and potential research participants and to take care of all the cardinal principles of research ethics i.e. autonomy, beneficence, non maleficience and Justice, in planning, conduct and reporting of the proposed research.
· Look into the aspects of informed consent process, risk benefit ratio, distribution of burden and benefit and provisions for appropriate compensation, wherever required.
· Review the proposals before start of the study as well as monitor the research throughout the study until and after completion of the study through appropriate well documented procedures for example annual reports, final reports and site visits etc. .
· The committee will also examine compliance with all regulatory requirements applicable guideline and laws.
3.1.2.3 Membership of the ( NHREC) :
The NHREC should be multidisciplinary and multisecterial. Independence and competence are the two hall marks for membership.
The membership of ( NHRERC) will include 20-25 members:
1. The Chairman of the committee.
2. The legal advisor of the FMOH.
3. Representative of the Government of Southern Sudan.
4. The secretary general of the Health Research Council (Rapporteur).
6. Representatives for universities and research institutions.
7. Researchers.
8. Representative of the Medical Council.
9. The representative of the Veterinary Research Council.
10.The representative of the National Health Laboratory
I1.The representative of the Sudanese Medical Specializations Board.
12.Representatives of the national civil society organizations
13.The Representative of Press and Publications Council.
14.Representatives of the Islamic and Christian religious men.
15.Community leaders.
· Chairperson:
The chairperson of the committee should preferably be from outside the Ministry of Health to maintain the independence of the committee.
· Deputy chairman if need able:
· Secretariat:
The Directorate of Research in the Federal Ministry of Health will be the secretariat of the committee. It will take the responsibility of arranging meetings of the committee and implementing its decisions and recommendations. It will coordinate the meetings and keep liaison with state, institutions and international ethics committees. All documents regarding the reviewing process of the proposals received by or sent to the committee are the responsibility of the secretariat.
3.1.2.4 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.
3.1.3 Meetings:
1-The committee will hold a regular meeting every two months, and it may hold an extra meeting if need arises.
2-The committee chairman or his deputy chairs the meeting, and in case of the absence of the chairman and his deputy the members choose the one who heads the meeting.
3.1.3.1 Quorum:
The meeting shall be legal with the attendance of half of the members. In case of the lack of quorum, a following meeting must be determined during one week and it shall be legal by any number of members.
3.1.4 Independent consultants:
a. NHREC may call upon subject experts as independent consultants who may
provide special review of selected research protocols, if need be.
b. These experts may be specialists in ethics or specific diseases or methodologies,
or represent specific communities, patient groups e. g. cancer patients, HIV/ Aids
positive persons or ethnic minority.
c. They are required to give their specialized views but do not take part in the
decision making process which will be made by the the members of the NHREC.
3.1.5 Operational cost:
The MOH will avail the budget for the operational cost of the committee. The committee will prepare an annual budget covering all the expenses for the meetings, reviewers, consultations……etc. Fees for application will be decided annually.
3.1.6 Record keeping and Archiving:
1. Curriculum Vitae (CV) of all members of NHREC.
2. Copy of all study protocols with enclosed documents, progress reports, and SAEs.
3. Minutes of all meetings duly signed by the Chairperson.
4. Copy of all existing relevant national and international guidelines on research
ethics and laws along with amendments.
5. Copy of all correspondence with members, researchers and other regulatory bodies.
6. Final report of the approved projects.
All documents should be archived for a prescribed period.
3.1.7. Updating NHREC members
a. All relevant new guidelines should be brought to the attention of the members.
b. Members should be encouraged to attend national and international training programs in research ethics for maintaining quality in ethical review and be aware of the latest developments in this area.
3.2 State and Institutional Ethics Committees guidelines
I. In 2002, the Federal Minister of Health issued a ministerial decree no. 11/2002 for the constitution of National Technical and Advisory ( NTAC) and National Health Research Ethics Committees( NHREC). According to this decree the NHREC has been assigned to take the task of:
1. Endorsement and delegation of its powers to the state and institutional research ethics committees.
2. 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.
3. 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.
4. State and research institutions ethics committees have the power of ethical approval for all health research that takes place inside the state excluding the following researches:
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).
4. The State and institutional ethics committees work under the supervision of the NHREC.
5. The State and institutional ethics committees should present regular biannual reports of their research reviewing activities and the research proposals that have been approved ethically to the NHREC.
6. A copy of approved research proposals and copies of the ethical certificates should be enclosed with the report.
7. The NHREC discusses the research proposals and the reports of the State and institutions ethics committees in their regular meetings.
II. The state and institution ethic committee should follow the same guidelines, relevant to the research proposal submitted to them.
3.9 References:
1. Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects
(CIOMS) Geneva 2002.ISBN 92 9036 075 5
2. Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects( An Islamic Perspective):
3. Indian Council of Medical Research. Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research. URL: http://www.icmr.org.ind/ Produced by ICMR. Date created by ICMR. Accessed May 2006.
4. Pakistan Medical Research Council. National Bioethics Committee. URL:
http://www.pmrc.org.pk/ Produced by PMRC . Date created by ICMR. Accessed
May 2006.