BACKGROUND: Globally, ethical issues in research are becoming of major importance, being well established in developed countries with little information about research ethics committees (RECs) in Africa to assess whether these committees are actually improving the protection of human research participants. OBJECTIVE/AIM: To describe the establishment, structure, function, operations and outcome of the Medical Research Ethics Committee (MREC) of the National Research Center (NRC) of Egypt from 2003 to 2011. METHODS: The committee established its regulatory rules for human and animal research ethics based on the Declaration of Helsinki 2000-2008 and WHO regulations 2000-2011. RESULTS: There were 974 protocols revised in the 7 years (2005-2011). The outcome of the committee discussions was to clear 262 of the protocols without conditions. A full 556 were cleared conditionally upon completion of modifications. Another 118 were deferred pending action and further consideration at a subsequent meeting. And 16 researchers did not reply, while 22 protocols were rejected. CONCLUSION: Since 2005, the MREC in NRC Egypt has built up considerable experience of evaluating the ethical issues arising within the field of medical research.
BACKGROUND: Globally, ethical issues in research are becoming of major importance, being well established in developed countries with little information about research ethics committees (RECs) in Africa to assess whether these committees are actually improving the protection of human research participants. OBJECTIVE/AIM: To describe the establishment, structure, function, operations and outcome of the Medical Research Ethics Committee (MREC) of the National Research Center (NRC) of Egypt from 2003 to 2011. METHODS: The committee established its regulatory rules for human and animal research ethics based on the Declaration of Helsinki 2000-2008 and WHO regulations 2000-2011. RESULTS: There were 974 protocols revised in the 7 years (2005-2011). The outcome of the committee discussions was to clear 262 of the protocols without conditions. A full 556 were cleared conditionally upon completion of modifications. Another 118 were deferred pending action and further consideration at a subsequent meeting. And 16 researchers did not reply, while 22 protocols were rejected. CONCLUSION: Since 2005, the MREC in NRC Egypt has built up considerable experience of evaluating the ethical issues arising within the field of medical research.
Authors: Reham M Dawood; Rehab I Moustafa; Tawfeek H Abdelhafez; Reem El-Shenawy; Yasmine El-Abd; Noha G Bader El Din; Jean Dubuisson; Mostafa K El Awady Journal: BMC Infect Dis Date: 2019-11-05 Impact factor: 3.090