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.
摘要:
研究伦理委员会至少由五名成员组成,其中包括一名非专业人士,来自不同机构的成员和至少另外三名应精通道德的成员。委员会可以寻求法律和专家顾问。REC将要求研究人员提供详细的协议,包括主要研究人员和他/她领导的所有其他研究人员的课程。该方案应包括要进行的研究的所有细节,包括详细描述,研究的原因,与研究有关的文献,目标人群的清晰描述,实际的同意书,包括要向参与者提供的信息,在必要时宣布法律禁止的事情(例如在该国使用胚胎干细胞[2],并声明将遵循REC所遵守的相关指令、规则和程序。REC还将要求描述任何风险以及应采取哪些措施来消除危险。研究人员必须仅遵守给定的协议和任何更改,辅修或主修,必须向REC报告并获得批准。