title: Overview of research committees status in Egypt: challenges aspirations and current situation.
abstract: We analyze the current situation of clinical research regulatory overview in Egypt to acknowledge the strengths and define the frailties, thus inciting relevant stakeholders to find solutions and bring about change. Uniquely, Egypt possesses favorable factors ideal for a dynamic clinical research market: accessible subjects, a mosaic panel of research areas, and incomparably low cost. Yet, with a majority of participant population needy and illiterate, and in absence of robust legislative constraints, concerns are increasingly being raised, whether ethical pitfalls of clinical research are adequately addressed, and whether the safety and the rights of subjects are constantly prioritized and maintained. In a descriptive explicit literature review, we identify, review, and interpret findings from recent publications backed up by existing data derived from current declared regulations and personal experience in the field. Inferences were made that despite an affiliation to international referential guidelines, real settings implementations are far from being consistent or adherently conforming. Focal attempts at reform are observed, but without joint stakeholders' support, those attempts are doomed never to get off the ground.
authors.affiliation: a General Department of Foreign Health Affairs and International Cooperation , Ministry of Health , Cairo , Egypt.
authors.forename: Inas M
authors.initials: IM
authors.lastname: Younis
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000458:organization & administration*; D003906:Developing Countries; D004534:Egypt; D028744:Ethics Committees, Research / Q000941:ethics / Q000458:organization & administration*; D006801:Humans; D016730:Program Development; D015397:Program Evaluation