WASP (Write a Scientific Paper): Ethics approval for a research study (2). (September 2018)

• Record Type: Journal Article
• Authors: Mallia, Pierre
• Is Part Of: Early human development. Volume 124(2018)
• Page Start: 49
• Page End: 51
• Publication Date: 2018-09
• Subjects: Compositions of RECs -- Requirements -- Documentation -- Protocol -- Data handing -- Consent process; Fetus -- Periodicals; Neonatology -- Periodicals; Prenatal influences -- Periodicals; 612.65
• DOI: 10.1016/j.earlhumdev.2018.04.023
• Languages: English
• ISSNs: 0378-3782

Abstract

Abstract: Research Ethics Committees are composed of a minimum of five members which include a lay person, a member from a different institution and at least another three members which should be versed in ethics. Legal and expert advisors can be sought by the committee. The REC will require a detailed protocol from the researcher including the curriculum of the principal investigator and all other researchers under him/her. The protocol should include all details of the research to be undertaken including a detailed description, the reasons for the research, literature pertaining to the research, a clear description of the target population, the actual consent form including what information is to be given to the participants, a declaration where necessary that things prohibited by the law (such as use of embryonic stem cells if this is the case in the country [2] will not be researchers, and a declaration that the relevant directives and rules and procedures which the REC falls under will be followed. The REC will also require a description of any risks and what actions are to be undertaken to eliminate hazards. The researchers must adhere only to the protocol given and any changes, minor or major, must be reported to the REC and approved.