Human Subjects Research (IRB)

Research Program Overview

澳门新葡京娱乐城网址将遵守所有联邦法律法规以及乔治亚大学系统规定的管理人类研究使用的任何政策. 申请批准人类受试者研究的所有信息, the Application for Approval of Exempt Research with Human Subject Participants, 《澳门新葡京娱乐城网址》和《澳门新葡京娱乐城网址》符合学院的监管义务 Federal Policy for the Protection of Human Subjects (the “Common Rule”). 教务长办公室和负责学术事务的副校长办公室作为人类学科研究的行政办公室,并将保存有关在共同规则范围内的研究项目的申请和批准的所有记录.

According to federal guidelines, 人类受试者研究涉及在世的个体,研究人员通过干预或与受试者互动来获取和研究这些个体的信息或生物标本. Additionally, 收集的数据旨在成为系统调查的一部分,旨在为可推广的知识做出贡献. 当研究人员为了更多地了解所研究的特定个体而采访受试者时(例如在历史学术或文学批评的情况下),一般规则不适用.

涉及人类受试者的研究作为系统调查的一部分,无论研究的性质或地点如何,都必须由澳门新葡京娱乐城网址的人类受试者机构审查委员会(IRB)进行审查. 审查的目的是确保研究人员采取了必要的预防措施,以保护研究参与者的权利和福利. 该委员会审查申请,以确保研究人员已经考虑到对受试者的风险最小化, they have ensured the risks are reasonable in relation to the anticipated benefits, 他们根据联邦指导方针制定了获得知情同意的程序, 并且他们有一个在数据收集期间和之后保护受试者信息隐私的计划.

共同规则允许机构在与人类受试者互动期间免除一些正在进行的委员会审查. Research activities that pose more than a minimal risk to the subjects require ongoing review by the IRB; research activities that pose only a minimal risk to the subjects do not require ongoing review. 教务长和负责学术事务的副校长将在批准时通知研究人员,如果他们的研究需要持续审查. 研究人员应审查其批准文件中的任何条件,以确保保护参与者的隐私和福利.

共同规则还确定了一些不受联邦指导方针约束的人体受试者研究. However, only the IRB can designate a project as exempt under these guidelines. Therefore, 所有涉及人类受试者的研究活动必须提交给审查委员会审议. To determine whether research could be exempt, 研究人员应审查豁免的监管要求中所述 Common Rule, §46.104(d). Researchers may also wish to complete the NIH InfoPath Questionnaire 新葡京网址赌城涉及人类受试者的研究,以帮助确定他们涉及人类受试者的研究可能的状态.

如果您对人类受试者研究的性质或提交申请的过程有疑问, please contact the IRB at irb@ngskmc-eis.net.

TRAINING INFORMATION

Prior to completing any application, researchers must complete a training course on protecting human subject participants. Dalton State employees and students can self-register for the Human Subjects Research Training in GeorgiaVIEW; all other researchers should contact the IRB at  irb@ngskmc-eis.net for more information on training options. 研究人员应保存一份培训证书的副本,以便与申请一起上传。. For more information on training options, see Human Subjects Training Information.

APPLICATION FORMS

只有在完成所需的培训并确定其拟议的调查是否可能属于豁免类别之一之后,研究人员才能完成以下列出的人体受试者研究申请之一. For more information on exemption categories, see Common Rule Exemptions Information. Students who design their own research projects should fill out the appropriate student application; professors who design projects for all students to complete as part of the coursework should fill out the class application.

  1. Application for Approval of Research with Human Subject Participants
  2. Application for Approval of Exempt Research with Human Subject Participants
  3. Student Application for Approval of Research with Human Subject Participants
  4. Student Application for Approval of Exempt Research with Human Subject Participants
  5. Class Application for Approval of Research with Human Subjects Participants
  6. Application for Approval of Institutional Effectiveness Research
  7. Application to Amend a Human Subject Research Project
  8. 作为人类受试者研究项目共同研究者的意向通知