角色、权限、行动和管辖权

IRB的作用

The primary responsibility of the vnsr威尼斯城官网登入大学 院校检讨委员会 (IRB) is the review of research 为 the protection of human subjects who are participants in research. 审查通过 an IRB is the cornerstone of an institution’s program 为 the protection of human subjects participating in research. IRBs are responsible 为 ensuring that the rights and welfare of the participants in research are adequately protected. IRB means an institutional review board established in accord with and 为 the purposes expressed in Office 为 Human Research 保护政策(美国联邦法规45 CFR 46).102(g)).

降低风险, the IRB ensures that the ongoing conduct 研究的一部分 protects subjects at vnsr威尼斯城官网登入大学 and at other sites as negotiated through Federal Assurances. 这些 protections ensure that human subjects participate in research only after providing legally effective, fully in为med consent when consent is required by law 为 the ethical and legal conduct 研究的一部分. The IRB operates under the rules of conduct established from the Code of Federal Regulations, 最频繁 45 C.F.R. §46 A子部分 (PDF), as well as Wisconsin state laws, and policies established by vnsr威尼斯城官网登入大学. The IRB’s decisions are based on the ethical principles in the Belmont Report.

The IRB reports directly to the vnsr威尼斯城官网登入大学 President, who officially serves as the Institutional Official (IO) with oversight of the vnsr威尼斯城官网登入 IRB and Human Research Protections Program. The IRB exercises full autonomy in deciding whether human subjects research reviewed under its auspices meets ethical requirements.

IRB权威

The IRB is constituted by the IO and is registered with Department of 健康 and Human Services, 人类研究保护办公室 (OHRP) under vnsr威尼斯城官网登入大学’s Federal Wide Assurance (FWA#FWA00012561). 本局有以下权力:

• 批准研究, require modifications to research protocols in order 批准研究, 或不赞成研究;
• to require progress reports or other in为mation from investigators in order to effectively oversee the conduct 研究的一部分 and the in为med consent process;
• 并加以限制, 暂停, or terminate the approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected 对受试者造成严重伤害.

IRB的行为

The IRB ensures the adequacy of human subject protections by taking the following actions:

• Conduct the initial and continuing review of research protocols;
• 报告IRB的决定和决定, 以书面形式, 研究者和研究发起人;
• Determine which research protocols require review more frequently than once per year;
• Determine which research protocols require verification from other sources, 除了调查员, that no material changes have occurred since the most recent IRB review and 批准;
• Require that proposed changes in research are promptly reported;
• Require that changes in approved research are not initiated without prior IRB review and approval, 除了, when necessary to eliminate apparent immediate hazards to subjects;
• Require that any unanticipated problems involving risks to subjects or others be promptly reported to the IRB Chair and, 在适当的时候, 由IO向相关联邦机构提交;
• Require that any serious or continuing noncompliance with vnsr威尼斯城官网登入大学’s Human Research Program Protection 政策 and/or federal regulations, 或者是要求 IRB的决定, 立即向内部审核委员会报告, 在适当的时候, 通过IO发送给相关联邦机构; and
• Report any suspension or termination of IRB approval to the IO and, 在适当的时候, 通过IO发送给相关联邦机构.

IRB管辖

The IRB has jurisdiction only over the following categories of research when that research involves the use of human subjects or identifiable data or tissues derived from human subjects:

• Research per为med on the premises of vnsr威尼斯城官网登入大学 or using equipment owned by vnsr威尼斯城官网登入大学.
• Research conducted on an identified population of students, 员工, 阿尔维诺的职员或其他附属成员.
• Research to satisfy a requirement imposed by vnsr威尼斯城官网登入大学 为 the award of a degree or the completion of a course of study.
• 由教员进行的研究, 工作人员, and others affiliated with vnsr威尼斯城官网登入大学 when the 研究员, 在研究过程中, represents himself or herself as an vnsr威尼斯城官网登入大学 研究员.
• 由教员进行的研究, 工作人员, and others affiliated with vnsr威尼斯城官网登入大学 when the vnsr威尼斯城官网登入 研究员 is the Principal Investigator.
• Research conducted under vnsr威尼斯城官网登入大学’s auspices.

For research conducted on vnsr威尼斯城官网登入 premises or on an identified population of vnsr威尼斯城官网登入 students, 教师, 或员工, 阿尔弗诺学院是当地的IRB和, 相应的, 作为内部审查委员会的记录 with its required approval of the final design 研究的一部分 protocol and its specified procedures 为 the protection of human subjects, 除非阿尔弗诺学院伦理委员会主席提供 written letter that officially delegates this final authority (or some portion of it) to another IRB. vnsr威尼斯城官网登入 has articulated policies that address circumstances when multiple IRBs have 共享权限. 这些 policies may assist a 研究员 to avoid unnecessary duplication of ef为t. However, vnsr威尼斯城官网登入 affiliated students should always begin with the vnsr威尼斯城官网登入 IRB’s 标准提交表格和程序.