IRB经常问的问题-常见问题

• 我在哪里提交我的IRB申请?

  Applications are submitted through the web-based research administration system, Streamlyne.  流线网站可于以下网址浏览: http://research.奇怪的People.streamlyne.org

• Who is responsible for ethical conduct in research with human subjects?

  The primary responsibility for maintaining ethical standards and protecting human rights rests with individual researchers and research advisors. 的制度 Review Board (IRB) offers an added measure of assurance and serves as a local resource 对于道德准则的解释.

• What is the responsibility of the Institutional Review Board?

  The IRB is a committee, charged by UNC's Institutional Official (IO) for the Protection of Human 研究 Subjects, with the responsibility for reviewing all proposed research involving human subjects for adherence to ethical standards. IRB成员与 individual researchers to ensure that federal and university policies are followed 人权得到保障.

• What kinds of research are subject to review 由内部审核委员会?

  The federal regulations governing research using human subjects define research as "a systematic investigation, including research development, testing, and evaluation, designed 发展普遍化的知识发展或贡献普遍化的知识.“研究要经过伦理委员会的审查 when an investigator, in the course of conducting research, obtains:
  • Data through intervention or interaction with a living individual or

  • Identifiable private 信息 about a living individual Examples of generalized knowledge include, but are not limited to (1) studies being conducted with the intent of publishing journal articles; (2) theses, dissertations, or other investigations that will be biographically available (3) research that is presented at conferences or other professional venues; and (4) pilot studies that form the bases of subsequent research or are conducted in collaboration with investigators from other institutions.

  学生 who present research data as part of in-class presentations may need to obtain IRB approval if they are also intending to present their results at conferences or 提交论文发表.

  研究 that analyzes archival records from individuals may also be subject to review 由内部审核委员会. Evaluations of workshops and programs are not considered "research" if results are not to be distributed outside the institutional setting.

• 谁有义务遵循IRB程序?

   All UNC faculty, staff, and students who conduct research with human subjects are 有义务遵守联合国军司令部的政策和程序.

• 进行什么样的审查?

  Protocol applications for IRB review fall into three categories. 在完成之前 an IRB protocol, investigators are advised to thoroughly study the IRB guidelines to determine the type of review their research will require - exempt, expedited, or 回顾全包.

  Each of these three categories of review has specific guidelines for submission, and receives 在审查过程中进行不同程度的审查.

  Please refer to the Procedures for 研究 Involving Human Participants for more 信息.

• 审查委员会成员如何审查建议的研究?

  IRB members have been trained in ethical principles and in UNC procedures governing 人类研究对象. They review applications to ensure that all 信息 包括指南中指定的内容. 密切关注道德原则 conduct, IRB members examine applications to ensure that risk and harm are minimized; benefits to science, humanity, and research subjects are maximized; the autonomy and privacy rights of subjects are protected; and the cost and benefits of research are 公平分配的:在个人和群体中公平分配的. 内部审查委员会成员特别审查同意表格 closely to ensure that the necessary language and instructions are included and that subjects are fully informed of the risks as well as their rights.

•  谁是IRB的成员?

  The IRB is comprised of UNC faculty members with diverse disciplinary and methodological 专业知识. In addition, the board includes a community member and a non-scientific 符合联邦法规的会员. 研究办公室 & 赞助项目 提供管理支持. 目前的内部审查委员会成员.

• What if my research involves collaborators at other institutions who have received 机构的IRB批准?

  UNC faculty members and students who are collaborating with individuals at another institution must attach a copy of the other institution's approved IRB protocol with 他们的UNC协议应用. The UNC IRB will usually confirm that adequate provisions have been taken to protect the rights of human participants through a review of the other institution's approved protocol, although occasionally the UNC IRB may find 有必要要求澄清. In some cases, UNC or the other collaboration institution may function as the authorized agent for IRB review for both institution. UNC IRB Chair and the IRB administrator at ORSP can provide additional 信息.

• 还需要什么许可?

  Written permission from appropriate authorities (individuals who are authorized to make commitments on behalf of another organization or institution) is required when researchers 在其他机构收集数据. 例子包括学校、托儿中心、 hospitals, sports arenas, shopping malls, and other universities. 这封签名信 of permission must be submitted as part of the IRB protocol applications.

• What if my students need to conduct research as a class assignment?

  IRB procedures include provisions for instructors who require student to conduct research 在课堂上作为综合安排的一部分. 请参考“教室”的描述 研究 and the Procedures of 研究 Involving Human Participants for detailed 信息.