Institutional Effectiveness & Research

What is the Institutional Review Board (IRB)

机构审查委员会(IRB)是由机构设立的一个委员会,旨在保护被招募参加研究活动的人类受试者的权利和福利. The IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. 该小组审查在保护人类研究对象的权利和福利方面发挥着重要作用. 联邦和州法规要求所有人类受试者研究由罗文·卡巴罗斯社区学院的教员进行, staff, 和学生,在进行研究之前,必须得到审查委员会的批准.

内部审查委员会不承担评估拟议研究的合理性的角色, the merits of the research design, 也不是研究对学术文献的潜在贡献.

IRB通过以下方式保护参与联邦资助研究的个人:

  • risks have been considered and minimized;
  • the potential for benefit has been identified and maximized;
  • 研究志愿者只有在获得法律上有效的知情同意后,才会被告知有关研究的实质性信息,并自愿参加研究;
  • that all private information will be handled with confidentiality; and
  • 该研究以合乎道德的方式进行,并符合既定标准.

Application Form for IRB

All Rowan-Cabarrus IRB requests must be submitted via the IRB Request form by a Rowan-Cabarrus Community College employee. 没有受雇于Rowan-Cabarrus公司的研究人员必须获得一名员工担保人,以提交给Rowan-Cabarrus公司的IRB批准. 如果您对研究赞助或提交有任何疑问,请发送电子邮件 irb@chihua-remo.com.

Rowan-Cabarrus Community College IRB Application Form

Frequently Asked Questions

Does my project require review?

任何向联邦政府申请资金并进行涉及人类受试者的研究的主要研究者都需要获得IRB的批准.

Determining project’s need for IRB review -要确定您提出的项目是否需要IRB批准,请参考此 decision chart.

Research – systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102 (e)(1)).

Human Subject -进行研究的调查人员通过干预或与个人互动获得有关其的数据或可识别的私人信息(45 CFR 46.102 (e)(1)).

Some types of research may not require IRB review. 如果您不确定,请查看决策表或发送电子邮件至 irb@chihua-remo.com.

Human subjects research may include surveys and interviews, behavioral investigations, and demonstration and service programs and clinical trials. In addition, the FDA includes under the definition of reviewable research, FDA监管产品的任何使用,但在医学实践中使用上市产品除外.

“豁免”并不意味着您的研究被排除在IRB审查之外. All exempt studies are initially reviewed by the IRB. After its review, IRB将决定协议申请的豁免状态和适用的任何要求.

研究者不允许在没有IRB审查的情况下对研究进行修改. 如果您的研究有任何变化,您必须通过填写一份表格通知IRB modification form before they can be implemented.

Why is institutional review required?

这是保护你的需要,也是保护罗文-卡巴罗斯社区学院的需要. 首席研究员(PI)负责纠正在其研究项目中对参与者造成的任何损害. IRB是学院提供的一项服务,以帮助PI避免他们可能无意中提出敏感问题的情况.

When do I need to obtain IRB approval?

IRB approval is required before starting any data collection. 如果您在没有事先获得IRB批准的情况下开始您的研究并开始收集数据,您将面临丢失所有数据的风险,并且如果获得批准,必须重新开始收集过程.

What is involved in an institutional review of research?

In many cases, 在Rowan-Cabarrus进行的研究将满足在另一个机构攻读博士学位的要求. In those cases, 你需要获得学位授予机构的机构审查委员会(IRB)的批准, and Rowan-Cabarrus will be a cooperating institution. 如果研究不是与其他学院或菲律宾十大网赌网站联合进行的, Rowan-Cabarrus will conduct its own review of the project, applying the standards set forth by the U.S. 卫生与公众服务部-联邦法规中的人类研究保护办公室(OHRP) (45 CFR 46.102 (e)(1)).

Are there other resources I can turn to?

The Office of Human Research Protections website is the authoritative source on all things IRB.

How do I start the process?

In most situations, 这个过程从你的学位授予机构(如果不是Rowan-Cabarrus)开始,并申请IRB批准. However, 当您还处于设计阶段时,我们愿意与您会面,并帮助您在设计项目时避开常见的陷阱. Remember that to get approval, 您需要详细说明您设计的所有细节,并提交所有文书的副本, consent forms, and certification(s); the sooner you establish these details, the better.

一旦您获得授权机构(如果适用)的IRB批准,并且在Rowan-Cabarrus工作或在Rowan-Cabarrus确定了员工担保人, you must complete the IRB Request Form.

IRB根据你的研究项目的性质和范围进行几种类型的审查. 复习的时间框架和所需的随附材料取决于复习的类型.

  • 快速审查-某些类型的研究不超过最小风险的清单, or for minor changes in already-approved research. Review process will take approximately seven calendar days.
  • 全面审查-所有其他联邦政府支持的涉及人类受试者的研究. Review process will take approximately thirty calendar days.

Reporting Problems and Violations

Any staff or student at Rowan-Cabarrus who is aware of any problems involving risks to subjects or others; serious or continuing noncompliance with the federal regulations or the requirements or determinations of the IRB must report the information to the IRB Chair. The report can be made by contacting the IRB chair directly at irb@chihua-remo.com. 然后主席将通知适当的机构官员, the head of the agency supporting the research, any applicable regulatory body, and the Office for Human Research Protections.

Related Links

Questions?

请联络Rowan-Cabarrus机构研究部(iedata@chihua-remo.com or irb@chihua-remo.com).