What is an 院校检讨委员会 (IRB)?
IRB是一个委员会, 委员会, or other group formally designated by an institution to review research involving humans as subjects. IRBs have authority to approve, 需要修改, or disapprove all research activities covered by the HHS and FDA Protection of Human Subjects Regulations. Following initial approval, IRBs must conduct periodic reviews of such research. Every institution engaged in human subjects research conducted or supported by a Federal department or agency that has adopted the Common Rule (Federal Policy for the Protection of Human Subjects) is required to designate one or more IRBs under an assurance of compliance.
另外, when FDA-regulated products are investigated in human subjects, the protocol is subject to review and approval by an IRB. 医院, 学术医疗中心, 政府单位, and others engaged in federally conducted or supported health research activities involving human subjects and entities conducting FDA regulated clinical investigations, 等, 有指定的审核委员会. Human subjects research that is conducted or supported by a Federal department or agency that has adopted the Common Rule (found for HHS at 45 CFR第46部分, subpart A) and that does not meet the criteria for exemption or is regulated by the FDA is subject to review and approval by an IRB. 在大多数情况下, 为了批准研究, IRB必须确定这一点 specified criteria have been satisfied. 在这些标准中, IRB必须确定这一点, 在适当的时候, the research protocol includes “adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data” (see 45 CFR 46.111(a)(7)和21 CFR 56.111(a)(7)).
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. 为了达到这个目的, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
- 知情同意
The informed consent requirements found in HHS 45 CFR 46 Regulation for the Protection of Human Subjects in 研究 provide bedrock protections for individuals participating in research studies. While the regulatory default for non-exempt research is to obtain and document the informed consent of all participants, the regulations anticipated scenarios where this default requirement would be inappropriate given the proposed research methods, the context in which the research would be conducted or the subject population. The regulations included provisions allowing IRBs to waive some or all elements of informed consent when specific conditions have been met.
http://www.hhs.gov/ohrp/sachrp-committee/recommendations/2013-january-10-letter-attachment-d/
- Principal Investigator (教师/工作人员/Student) 设计和提交
Investigators must indicate if the application requires exempt, expedited, or full board review. The final determination of the review category is made by the IRB.
- Dean/Departmental head Sign-off:
Once the application is 提交ted the Dean/departmental head must review and sign off on the application. In some cases, a departmental representative must also sign the application. This sign-off represents consideration of scientific merit, 资源的可用性, or other issues at the department level.
- IRB委员会:
After Dean/department head approval is obtained, an initial review of the application is conducted by the IRB Committee or IRB designee. 在全球十大外围足球平台, the IRB 委员会 conducts a thorough pre-review of the application to verify the correct level of review, and to evaluate the protocol and supporting documents (e.g., consent form, recruitment materials). If a study is approved as exempt or determined to be “not human subjects research,” no further IRB action is required. Any significant changes to the approved study must be 提交ted and reviewed by the IRB prior to the implementation of changes. For studies designated as expedited or full board, IRB review is required from a designated reviewer or the full board, 分别.
- Study Approved and PI Notified:
The researcher will be notified through a letter when the study has been approved.
