制度的有效性 & 研究
NCCCS问责措施
什么是院校覆核委员会?
的 院校覆核委员会 is a committee established by an institution to protect the rights and welfare of human subjects recruited to participate in research activities. IRB有权批准, 要求修改(以获得批准), 或者不赞成研究. This group review serves an important role in the protection of the rights and welfare of human research subjects. Federal and state regulations require all human subjects research conducted by Rowan Cabarrus Community College faculty, 工作人员, and students to be approved by the IRB 之前 the research can be conducted.
的 IRB does not assume the role of evaluating the soundness of the proposed research study, 研究设计的优点, nor the potential contribution of the research to scholarly literature.
IRB safeguards individuals involved in federally supported research by ensuring that:
- 风险已被考虑并最小化;
- 已确定并最大限度地发挥潜在的效益;
- research-volunteers are provided with substantial information about the study and volunteer only after being provided with legally effective informed consent;
- that all private information will be handled with confidentiality; and
- that research is conducted in an ethical manner and in compliance with established standards.
IRB申请表格
所有Rowan-Cabarrus IRB请求必须通过 IRB申请表格 是罗文-卡巴罗斯社区学院的员工干的. 研究ers who are not employed with Rowan-Cabarrus must obtain an employee sponsor to submit for IRB approval with Rowan-Cabarrus. If you have questions about research sponsorship or submission, please email irb@bandbdistribution.com.
常见问题
我的项目需要复查吗?
IRB批准是必需的 for any primary investigator who is applying for funds from the federal government and is conducting research involving human subjects.
确定项目是否需要IRB审查 – To determine whether your proposed project will need IRB approval, please refer to this 决策表.
研究 -系统调查, 包括研究开发, 测试与评估, 旨在发展或有助于概括的知识(45 CFR 46.102 (e)(1)).
人类的主题 – a living individual about whom an investigator conducting research obtains data through intervention or interaction with individual(s) or identifiable private information (45 CFR 46.102 (e)(1)).
某些类型的研究可能不需要IRB审查. If you are unsure please review the 决策表 or send an email to irb@bandbdistribution.com.
人类受试者研究可能包括调查和访谈, 行为调查, 示范服务项目和临床试验. 除了, 包括在可审查研究的定义下, any use of an FDA regulated product except for use of a marketed product in the practice of medicine.
“Exempt” does not mean that your research is excluded from IRB review. 所有豁免研究都由IRB进行初步审查. 检讨后, the IRB will determine a protocol application’s exempt status and any requirements that apply.
Investigators are not permitted to make changes to the research without IRB review. You must notify the IRB to any changes in your study by completing a 修改形式 才能付诸实施.
为什么需要机构审查?
It is required for your protection, as well as that of Rowan-Cabarrus Community College. 的 Principal Investigator (PI) is responsible for rectifying any damage caused to a participant in their research project. 的 IRB is a service that the college provides to assist the PI in avoiding situations where they may inadvertently ask sensitive questions.
我什么时候需要获得审查委员会的批准?
IRB批准是必需的 之前 开始任何数据收集. If you begin your research and start collecting data without prior IRB approval you risk losing all of that data and must begin again with the collection process if approved.
机构审查研究涉及到什么?
在很多情况下, research at Rowan-Cabarrus will be conducted to satisfy requirements for a Doctoral degree at another institution. 在这些情况下, you will need to get 院校覆核委员会 approval from the degree-granting institution, 罗文-卡巴罗斯将是一个合作机构. If the research is NOT conducted in conjunction with another college or university, Rowan-Cabarrus将对该项目进行自己的审查, 应用美国政府制定的标准.S. Department of Health and Human Services — 人类研究保护办公室 (OHRP) in Federal regulations (45 CFR 46.102 (e)(1)).
我可以求助于其他资源吗?
的 人类研究保护办公室网站 是IRB的权威来源吗.
我该如何开始这个过程?
在大多数情况下, the process starts with your degree-granting institution (if not Rowan-Cabarrus) and filing for IRB approval. 然而, we are open to meet with you when you are still in the design stage and help you steer around common pitfalls when designing your project. 记住这一点，以获得认可, you will need to specify all of the details of your design and submit copies of all instruments, 同意表格, and certification(s); the sooner you establish these details, 更好的.
Once you have obtained IRB approval from your granting institution (if applicable) and are either employed at Rowan-Cabarrus or have identified a employee sponsor at Rowan-Cabarrus, 你必须填妥 IRB申请表格.
的 IRB conducts several types of reviews depending on the nature and scope of your research project. 的 timeframe for review and required accompanying material depends on the type of review.
- Expedited Review – list of certain kinds of research involving no more than minimal risk, 或者对已经批准的研究进行微小的修改. 审查过程大约需要7个日历天.
- Full Board Review – all other federally supported research involving human subjects. 审查过程大约需要30个日历天.
报告问题和违规行为
Any 工作人员 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. 报告可通过以下方式直接与IRB主席联系 irb@bandbdistribution.com. 的 Chair will then alert the appropriate institutional officials, 支持这项研究的机构负责人, 任何适用的监管机构, 以及人类研究保护办公室.
相关链接
问题?
Please contact the Rowan-Cabarrus 制度研究 department (iedata@bandbdistribution.com or irb@bandbdistribution.com).