请求的信息
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What is the IRB and what is its purpose?
The Review Board is composed of members of the 密歇根州立大学丹佛 faculty and 工作人员 and the community at-large. IRB成员的任务是保护研究参与者的权利和福利.
IRB审查并决定由密歇根州立大学丹佛分校教师进行或与之合作的拟议的人类受试者研究, 工作人员, 和/或学生. IRB follows regulatory requirements and the ethical principles of 尊重他人, 善行, 正义 in reviewing research that involves participants and/or identifiable private information.
The following are excerpts from 45 CFR 46, 卫生与公众服务部, 人类研究保护办公室规定机构审查委员会的组成和功能;
§46.107 IRB成员.
(a) Each IRB shall have at least five members, 与不同背景的人合作，以促进对研究所通常进行的研究活动进行全面和充分的审查. IRB shall be sufficiently qualified through the experience and expertise of its members, the diversity of the members, 包括种族考虑, 性别, cultural backgrounds and sensitivity to such issues as community attitudes, 促进尊重其在维护人类主体的权利和福利方面的意见和建议. 除了具备必要的专业能力来审查具体的研究活动, 审查委员会应能就机构承诺和规定确定拟议研究的可接受性, 适用的法律, standards of professional conduct and practice. IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, 比如孩子, 囚犯, 孕妇, or handicapped or mentally disabled persons, 应考虑包括一个或多个对这些主题有知识和工作经验的个人.
(b)将尽一切不歧视的努力确保内部审查委员会不完全由男子或全部由妇女组成, including the institution’s consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of 性别. No IRB may consist entirely of members of one profession.
(c)每个内部审查委员会应包括至少一名主要关注科学领域的成员和至少一名主要关注非科学领域的成员.
(d)每个内部审查委员会应至少包括一名成员，该成员在其他方面不隶属于该机构，也不是隶属于该机构的人员的直系亲属.
(e)内部审核委员会不得让任何成员参与内部审核委员会对任何与该成员有利益冲突的项目的初始或持续审查, except to provide information requested by the IRB.
(f)内部审查委员会可以, 在其自由裁量权, 邀请在特殊领域有能力的个人协助审查需要超出或超出审计委员会现有专业知识的问题. These individuals may not vote with the IRB
§46.108 IRB functions and operations.
In order to fulfill the requirements of this policy each IRB shall:
(a) Follow written procedures in the same detail as described in §46.103(b)(4) 而且，在某种程度上， §46.103(b)(5).
(b) Except when an expedited review procedure is used (see §46.110), 在内部审查委员会多数成员出席的会议上审查拟议的研究, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be 批准, it shall receive the approval of a majority of those members present at the meeting.
§46.IRB对研究的审查.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.
(b)内部审查委员会应要求作为知情同意的一部分提供给受试者的信息符合 §46.116. IRB may require that information, in addition to that specifically mentioned in §46.116, 当IRB认为该信息对保护受试者的权利和福利有意义时，应向受试者提供该信息.
(c)内部审查委员会应要求提供知情同意文件，或可根据 §46.117.
(d)内部审查委员会应书面通知研究人员和研究机构其批准或不批准拟议研究活动的决定, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, 委员会应在其书面通知中说明其决定的理由，并给予调查人员亲自或书面答复的机会.
(e)内部审查委员会应根据风险程度适当的时间间隔对本政策所涵盖的研究进行持续审查, 但每年不得少于一次, 并有权观察或让第三方观察同意过程和研究.
IRB成员
莫·弗林博士.D.
IRB的椅子
副教授
心理科学
迈克Heathcote
Assistant Director of Human Subject Research Protections
狄佳博士.D.
助理教授
刑事律政司 & 犯罪学
Hyon Namgung博士
助理教授
刑事律政司 & 犯罪学
托尼Nuñez博士.D.
副教授
人力绩效部 & 体育、运动科学
凯瑟琳·杨博士
Professor of Secondary Education
卡桑德拉·贝利博士
助理教授
心理科学
Prabhdeep Sandha博士
助理教授
营养部
泰国Intara
办公室助理经理
心理科学
凯瑟琳麦考德
社区成员
终身学习 & 可访问性 Fellow, 丹佛 Art Museum
IRB会议
春季学期2024:
- 1月26日
- 2月23日
- 4月5日
- 5月10日
2024秋季学期:
- 9月6日
- 10月4日
- 11月1日
- 12月6日
Most human research studies do not require review by the convened IRB, but rather are reviewed via an Exempt or Expedited process. 需要完整IRB监督的研究是那些对受试者风险大于最小的研究.
During the Summer months, Expedited and Full Board reviews are NOT conducted. Only those projects determined as Exempt will be reviewed & 批准. All projects will continue to be accepted, although Expedited and Full Board reviews will have to wait until the Fall semester to undergo review. The HSPP will continue to assist and provide feedback, in order to better prepare your project for official review in the Fall semester.
WE ARE ALWAYS ACCEPTING SUBMISSIONS!!
可能需要全面董事会审查的拟议研究应在计划开始研究日期之前至少六个月提交. 请与 HSPP as soon as possible if you believe your project may require a full board review.
*Investigators should note that the IRB does not convene during the summer months.*
IRB会议不向公众开放，并遵守联邦法规和指南中概述的保密措施.
我的留言nstitutional Official
IRB是确保保护参与密歇根州立大学丹佛分校研究的人类受试者的权利和福利的重要组成部分. 教师, 工作人员, 社区成员自愿提供重要而密集的大学级服务，这不仅需要对联邦和州法规以及大学政策有深刻的理解, 同时也要运用这些法规和政策来最大限度地保护人类受试者. Service on the Board includes (but is not limited to):
- Attendance at monthly meetings which includes reasoned discussion and reviews – Board members attend approximately 6-8 full board meetings per academic year; these meetings may consist of full board reviews, 常规训练, 政策讨论,/or a variety of other issues as necessary.
- 个别审查协议-董事会成员根据收到的数量和/或所需的专业知识，在自己的时间定期审查加急协议.
- 必要时进行全员审查-所有董事会成员都有责任彻底审查建议进行全员审查的协议.
- 初始和持续培训-董事会成员必须完成花旗银行内部审计委员会成员特定的培训模块, 维护这些凭据, participate in regular scenario training.
- Recruitment and assessment of new members (as needed) – Board members reach out to the university and the community to help fill in membership gaps; additionally, they utilize assessment tools to ensure new members will be a good “fit” for the Board.
- 作为丹佛州立大学研究界的“大使”——董事会成员经常帮助同事准备协议, 可向各部门呈报, 类, or other groups about human subjects research ethics, represent at the annual 本科 Research Conference, facilitate training sessions throughout the University.