请求的信息
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IRB是什么?它的目的是什么?
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. 成员 of the IRB are tasked with protecting the rights and welfare of participants in research studies.
IRB reviews and makes determinations on proposed human subjects research that is conducted by or in collaboration with 密歇根州立大学丹佛 faculty, 工作人员, 和/或学生. IRB遵循监管要求和道德原则 尊重他人, 善行, 正义 在审查涉及参与者和/或可识别的私人信息的研究时.
以下是45 CFR 46的节选, 卫生与公众服务部, Office of Human Research Protections regulations governing the makeup and function of 院校检讨委员会s:
§46.107 IRB成员.
(a)每个内部审查委员会至少应有五名成员, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. 内部审查委员会应凭借其成员的经验和专业知识，具备足够的资格, 以及成员的多样性, 包括种族考虑, 性别, 文化背景和对社区态度等问题的敏感性, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. 除了具备必要的专业能力来审查具体的研究活动, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, 适用的法律, 以及职业行为和实践标准. 因此，内部审查委员会应包括在这些领域有知识的人员. 如果IRB定期审查涉及弱势群体的研究, 比如孩子, 囚犯, 孕妇, 或残疾人士或智障人士, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, 包括该机构对男女合格人员的考虑, 只要内部审查委员会不以性别为基础进行选择. 任何内部审查委员会不得完全由同一专业的成员组成.
(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(e) No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, 除非提供IRB要求的信息.
(f)内部审查委员会可以, 在其自由裁量权, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. 这些人可能不会与IRB一起投票
§46.108 . IRB的功能和操作.
为了满足本政策的要求，每个IRB应:
(a)按照与中所述同样详细的书面程序 §46.103(b)(4) 而且，在某种程度上， §46.103(b)(5).
(b)除非采用快速审查程序(见 §46.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, 包括至少一名主要关注非科学领域的成员. 为了让这项研究得到批准, 它应得到出席会议的过半数成员的批准.
§46.IRB对研究的审查.
(a)内部审查委员会应审查并有权批准, 要求修改(以获得批准), 或不同意本政策所涵盖的所有研究活动.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. 内部审查委员会可能需要这些信息，除了特别提到的 §46.116, be given to the subjects when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117.
(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, 或为确保研究活动获得审查委员会批准所需的修改. 如果审查委员会决定不批准一项研究活动, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
(e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, 但每年不得少于一次, shall have authority to observe or have a third party observe the consent process and the research.
IRB成员
莫·弗林博士.D.
IRB的椅子
副教授
心理科学
迈克Heathcote
人类受试者研究保护部助理主任
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
中学教育教授
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 & 丹佛艺术博物馆无障碍研究员
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
大多数人类研究不需要召集的伦理委员会审查, 而是通过豁免或加速程序进行审查. Studies that require oversight from the Full IRB are those studies that involves greater than minimal risks to subjects.
在夏季的几个月里，不进行快速审核和全员审核. 只有那些被确定为豁免的项目才会被审查 & 批准. 所有项目将继续接受, 尽管快速审核和全员审核必须等到秋季学期才能进行审核. HSPP将继续协助并提供反馈, 以便更好地为秋季学期的正式审查做准备.
皇冠官网网站总是接受投稿!!
Proposed studies that may require full Board review should be submitted at least six months prior to the planned start date of the research. 请与 HSPP 如果你认为你的项目可能需要全面审查，就尽快进行.
*调查人员应注意，IRB在夏季不召开会议.*
IRB meetings are not open to the public and adhere to confidentiality measures outlined in the federal regulations and guidance.
机构官员的话
IRB is a vital part of ensuring the protection of the rights and welfare of human subjects who participate in research at 密歇根州立大学丹佛. 教师, 工作人员, community members volunteer significant and intensive university-level service that not only requires a deep understanding of federal and state regulations and university policies, but also application of those regulations and policies to maintain the utmost integrity of human subjects’ protection. 在董事会任职包括(但不限于):
- 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, 和/或其他必要的问题.
- Individual reviews of protocols – Board members routinely review Expedited protocols on their own time either based upon quantity received and/or expertise required.
- Full board reviews when necessary – All board members are responsible for thoroughly reviewing protocols that have been recommended for full board review.
- Initial and on-going training – Board members are required to complete IRB member-specific modules of CITI training, 维护这些凭据, 并定期参加情景培训.
- 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, 他们利用评估工具来确保新成员“适合”董事会.
- Serve as “ambassadors” to 密歇根州立大学丹佛’s research community – Board members often help colleagues prepare protocols, 可向各部门呈报, 类, 或者其他关于人类研究伦理的团体, 代表参加年度本科生研究会议, 并在大学内举办培训课程.