人体受试者政策
所有的研究都是由太阳城娱乐城学院进行的, 工作人员 和 students 和 involving human subjects (whether externally funded or not) must be approved by the Institutional Review Board for Protection of Human Subjects (IRB).
The IRB is responsible for protecting the rights 和 welfare of individuals who serve as subjects of research. All research involving human subjects should follow the safeguards established by the University for such work 和 on file with OSPR.
IRB审查和批准
IRB approval (or a formal indication that research is exempt) must be obtained before research activities may begin. 要获得批准或豁免,必须向IRB提出申请. 内部审查委员会进行不同层次的审查, 取决于所涉及的研究活动和主题的类型. 某些类型的最小风险研究可以进行快速审查, 联邦指南允许的范围(45 CFR Part 46). 其他审查必须由内部审查委员会在定期会议上进行. The IRB will determine what type of review is applicable to each submitted protocol.
Approval for some projects must be renewed annually; others do not require annual review. Your approval letter will indicate whether annual continuing reviews are required.
哪些地方需要进行年度审查, 继续审查表格在IRB办公室(humansubjects@clarku).edu) at least 45 days 之前 to protocol expiration (typically one year after the approval date). 这些是通过 导师IRB 网站.
If a continuing review form to extend approval for ongoing research is not received by the deadline, 批准将到期,研究必须停止.
程序 to obtain a reliance agreement with IRBs of other institutions is located here: 与其他机构内部审查委员会的信赖协议政策和程序
内部审查委员会的批准是机构进行研究的许可. 校方并未同意提供太阳城娱乐学生的数据, 工作人员, 或教师(包括联系信息)招募人类受试者. Please also note that the university will not assist in disseminating surveys or interview requests using university email addresses. Recruitment of subjects must be conducted by the principal investigator through other means.
The names of current members of Clark’s IRB may be obtained from the 办公室 Sponsored Programs. Questions concerning protocols for the protection of human subjects should be addressed to the 办公室 Sponsored Programs.
规定 & 程序
Safeguarding the rights 和 welfare of human subjects involved in research 和 training at 太阳城娱乐, 或校外,由太阳城娱乐管理, 这是机构的责任吗. 公共卫生服务政策规定不给予补助, 奖, or contract for the support of research involving human participants shall be made unless the research is given initial 和 continuing review (where required) 和 approval by an appropriate committee of the applicant institution.
太阳城娱乐’s IRB operates under an assurance agreement with the 美国卫生与公众服务部. 根据本协议, the IRB reviews all human subjects research to ensure that the rights 和 safety of subjects are protected. 以下45 CFR第46部分, 以便批准受审查委员会监督的研究, 内部审查委员会须确定申请人是否符合下列所有要求:
- 对受试者的风险降到最低:
- By using procedures that are consistent with sound research design 和 that do not unnecessarily expose subjects to risk, 和
- 只要适当的, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- 受试者面临的风险相对于预期收益是合理的, 如果有任何, 话题, 以及可以合理预期的知识的重要性. 评估风险和收益, the IRB should consider only those risks 和 benefits that may result from the research (as distinguished from risks 和 benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- 科目的选择是公平的. In making this assessment the IRB should take into account the purposes of the research 和 the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, 比如孩子, 囚犯, 决策能力受损的人, 或经济或教育上处于不利地位的人.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, 根据…, 在一定程度上, §46.116.
- Informed consent will be appropriately documented or appropriately waived 根据… §46.117.
- 在适当的时候, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
在适当的时候, there are adequate provisions to protect the privacy of subjects 和 to maintain the confidentiality of data.
导师聘雇审查程序
建议申请指引、截止日期及表格可于 导师IRB 网站. 在收到并审查完成的提案后, 内部审查委员会可能采取各种行动, 包括(1)批准, (2) granting an exemption from further IRB review (3) request for major or minor revisions, 或(4)拒绝. 调查人员必须保留同意书(或其他同意文件), as relevant) 和 other research records for a minimum of three years following the date of protocol approval.
Investigators who wish to change a previously approved protocol must submit a formal request for amendment (or modification) to the IRB. 修改请求应使用 导师IRB 网站,选择协议页面底部的“修订”选项卡. 调查人员只能对已批准的研究实施变更 之前 IRB审核和批准, if the changes are necessary to eliminate apparent immediate hazards to the subject (45 CFR 46.2018年要求下的108(a)(3)(iii)和45 CFR 46.103(b)(4)(iii)(2018年之前的要求).
经批准的IRB提案的研究人员必须通知IRB主席 立即 of:
- 任何 不曾预料到的 problems that occur during the research 和 affect subject welfare (adverse events), 和
- 任何 deviations from the approved protocol (whether intentional or unintentional).
这些报告也通过 导师IRB 网站 by choosing the “Adverse 事件” or “Protocol Deviations” tab at the bottom of the protocol page.
The IRB is only responsible for reviewing human subjects research to ensure the rights 和 welfare of subjects, 如45 CFR 46所述. Other questions regarding research conduct 和 ethics should be directed to the Office for 赞助项目和研究.