Research Ethics Committees (RECs)
Supplementary document 2
University of Khartoum Research Ethics Committee:-
Research ethics committees (RECs) harmonize public and professional opinion in reaching decisions about proposed research. Their members reflect the diversity of society and do not represent vested interests.
The objectives of research ethics committees are to:
- Protect the research participants
- Protect the researchers
- Define research priorities
Three Major Principles:
All research should be conducted in accordance with three basic ethical principles, namely
- respect for persons,
- beneficence and non-malificence
- Respect for persons :-
incorporates at least two fundamental ethical considerations, namely:
- Respect for autonomy which requires that those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self-determination.
- Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or vulnerable be afforded full security against harm or abuse.
- 2. Beneficence and non-malificence :-
refers to the ethical obligation to maximize benefits and to minimize harms, respectively. This gives rise to norms requiring that the risks of research to be reasonable in the light of the expected benefits, that the research design to be sound, and that the investigators to be competent to conduct the research and to safeguard the welfare of the research subjects.
refers to the ethical obligation to treat each person in accordance with what is morally right and proper; to give each person what is due to him or her. In the ethics of research involving human subjects the principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the benefits of participation in research.
The University of Khartoum shall establish FOUR Research Ethics Committees at the different campuses of the university as follows;
- Research Ethics Committee at the Medical Campus for all health sciences faculties (Faculties of Medicine, Dentistry, Pharmacy, Laboratory Sciences, Nursing, Public Health, Institute of Endemic Diseases, Soba University Hospital, Saad Aboella Hospital, Salma Centre For Renal Medicine, The University Clinic And Hospital and other allied institutes)
- Shambat Research Ethics Committee all institutes and faculties at Shambat Campus (Faculties of Veterinary Medicine, Agriculture, Animal Production, Forestry, Centre for Research on Camels, University Farm and Other Relevant Centres and Institutes)
- Main Campus Research Ethics Committee 1: this is For Faculties Of Science, Engineering, Mathematics and Geography and relevant institutes and centres.
- Main Campus Research Ethics Committee 2 for Faculties of Economics and Social Studies, Arts, Law, School of Public Administration, Centre for Administrative Governance, Abdallah Eltayeb Institute for Arabic Language and relevant institutes and centres.
- The committees should look into research undertaken on University premises or outside but authorized by the university; whether conducted by university staff and students of the University or other authorized individual
- The Research Ethics Committees are responsible for ALL research conducted on human subjects, animals or scientific and social sciences. This includes a Varity of biomedical research techniques and procedures including computer modeling, non-invasive imaging, in vitro techniques and ethically approved research involving volunteer humans.
- The use of animals in biomedical research programmes is accepted only where replacement alternatives are not available and where such work is fundamental to advances in knowledge and understanding of science.
Composition of REC:
The membership of each committee should include:
- scientists representing the different faculties and institutes,
- leaders of civil society,
- religious leaders
- non-affiliated members.
- Due consideration for gender representation should be given.
- Members must have expertise and diversity.
- Each REC should have between 9-11 members.
- The chairperson of the committee shall be a senior person with interest and training in research ethics; preferably from outside the campus, or from the campus but shall not hold a position that will affect the independence of the committee.
Responsibilities of REC:-
The committee shall have the following responsibilities:
- Reviewing and approving all types of research proposals with a view to safe-guard research subject in accordance to international and national accepted guidelines.
- 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-malfeasance 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
- The committee will also examine compliance with all regulatory requirements applicable guideline and laws.
- Maintain confidentiality of individual proposal detail and feedback.
- Give advice to staff and students of the University on ethical considerations of conduct of research.
- Promote professional responsibility and accountability within the research and teaching domain.
- To keep the University Code of Practice on research on human participants under review and to recommend to the Ethics Committee such modifications as from time to time are deemed necessary.
- Review and approve justice in planning, conduct and reporting of research
- Submit annual reports of all research approved to the ORI at the university
- RECs can also perform other functions such as setting policies or offering opinion on ongoing issues.
- Each research proposal is subject to review by no more than one REC within the University.
- RECs should have a written standard operating procedures regulating its functions
Independence and impartiality:-
RECs are independent and impartial. A REC’s opinion must be free and must be seen to be free from conflict of interest. This includes freedom from pressure of:
- Political influence
- Institutional affiliation
- Trade union or profession-related interests
- Direct or indirect financial inducement or any impression thereof
- Strategic concerns
- Market forces
- Agency, discipline or topic related bias
- Each REC should be constituted so that it can function properly for the duration of its scheduled meetings.
- For the purpose of effective debate, a REC quorum should be 50+1 including the chairman or deputy chairman, and at least one expert member and one lay member.
Support and oversight:-
- Each REC should be supported by its establishing body providing it with adequate staff, facilities, and financial resources to allow the REC to carry its responsibilities independently.
- The university should support training of REC members.
- There should be a measure of performance through auditing, accreditation and self assessment.
- As a condition of appointment, REC members must agree to take part in initial and continual training appropriate to their role.
- REC members must maintain confidentiality regarding applications, meeting deliberations, information about research participants and related matters.
- Each REC member must be supplied with a personal statement regarding the indemnity provided by the appointing authority and its conditions.
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