什么是院校覆检委员会?
An 院校覆核委员会 is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which the IRB is affiliated. IRB有权批准, 要求修改, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.
MECC为何设有院校检讨委员会?
MECC has moved increasingly toward a more data-driven decision-making model in recent years, creating the need to conduct more targeted studies on teaching methods and the impact of student services on student success. 除了, federal agencies are increasingly requiring grantees to incorporate rigorous program 伊娃luation activities into grant-funded programs. As a result, research activities at the College have expanded significantly. MECC established its IRB in 2010 in order to ensure the protection of human research participants.
伦理委员会的指导道德原则是什么?
靠谱的买球网站 has adapted the ethical principles for protection of human subjects as stated in the Code of Federal Regulations: 美国联邦法典第45条第46条. 1979年根据国家研究法案成立, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established to enact these regulations. 委员会公布了 贝尔蒙特报告, which set forth the following basic ethical principles for the conduct of research involving human subjects:
- Respect for Persons – Acknowledgement of the autonomy of the individual and the responsibility to provide special protection for individuals with reduced autonomy.
- 善行-不做伤害的责任, 最大化可能的利益, 并尽量减少可能的伤害.
- Justice – An expectation of fairness in distribution of benefits realized from research as well as its burdens.
MECC是否有批准的IRB政策?
是的. MECC有一个 IRB政策 上一次修订是在2013年12月.
IRB多久开会一次?
MECC’s Institutional Review Board meets at least once each year, 通常在秋天, and schedules additional meetings throughout the year as needed to conduct business.
Are there deadlines for 提交ting an IRB review application?
MECC’s Institutional Review Board accepts applications on an ongoing basis. We recommend that applicants initiate the review process at least two months in advance of their desired approval date, 为了适应会议的安排.
我如何知道我的研究项目是否需要IRB审查?
在一般情况下, if your project can be described as a systematic investigation designed to develop or contribute to generalizable knowledge, 包括收集信息, 或者与, 人类的生活, then it may meet the definition of human subject research and should be 提交ted for IRB review. 如有疑问，调查人员应联系 IRB经理 获取更多指导.
我在哪里可以找到IRB申请表格?
The application form that should be used to initiate an IRB review is located in the menu on the left side of this page, “申请审核”一栏.” Once an initial determination is made regarding what type of review is required, additional required forms will be provided by the IRB经理.
我是否需要完成人类受试者保护培训?
All MECC IRB approvals are contingent upon completion of approved human subject protection training.
If you are looking for a free training option, we recommend the 保护人类研究参与者 国立卫生研究院的培训. 本课程允许用户创建一个帐户, 保存进度, 并在多个阶段完成培训. Investigators are encouraged to print a copy of the certificate of completion that is generated at the end of the course in order to document training completion.
What are my responsibilities after my research is approved by the IRB?
Investigators have a number of responsibilities beyond the initial IRB approval, including:
- Ensuring that no research activities begin until IRB approval is granted;
- Ensuring that all researchers (co-investigators, research assistants, 等.) working with the research subjects have completed appropriate human subject research training;
- Submitting a modification request if the purpose or design of the research protocol changes (investigators may not initiate changes in approved research without IRB review and approval, except in cases where changes are necessary to eliminate apparent immediate hazards to subjects);
- Submitting an application for continuing review (renewal) at least two months prior to the expiration of an existing IRB approval, if research activities (including data analysis) are expected to continue beyond the expiration date;
- Reporting any 不良事件 that occur during the research project;
- Submitting a close out report at the conclusion of the project;
- Maintaining records of all human subject research protocols for a minimum of three years after project completion; and
- Ensuring that research records are well organized an easily accessible by the IRB and the appropriate funding agent.
*For additional information on Principle Investigators’ responsibilities, 修改请求, 不良事件, 等.，请参阅 MECC IRB操作手册.
Where can I find additional resources on the protection of human subject research participants?
该网站为美国.S. 卫生与公众服务部 人类研究保护办公室(OHRP) provides a number of resources on the protection of human research subjects, including a variety of education and training opportunities.
