The 院校检讨委员会 (IRB) of Randolph College follows the federal and state guidelines governing the conduct of research with human participants to ensure that the rights and welfare of all research participants are adequately protected.
365亚洲版学院IRB的政策和程序来源于 Title 45 Part 46 of the Department of Health and Human Services (DHHS) Code of Federal Regulations (CFR), 人体受试者的保护. The policies and 程序 set forth in the Randolph College IRB website are the Standard Operating Procedures for the Randolph College IRB. 所有由学生进行的人体研究, 教师, 和工作人员, 无论是在校内还是校外, 必须被审查.
会议
内部审查委员会会议将在实际需要的基础上举行.
365亚洲版学院的人类受试者保护
Randolph College affirms that in the pursuit of knowledge individual rights must be preserved. The IRB policies and 程序 are designed to comply with the federal law protections for human subjects involved in research. 所有系统生物医学, 行为, or social research directly involving human subjects which is associated with this college must comply with the policies and 程序 set forth below and must be properly reviewed and approved by the IRB before the research begins. IRB政策不仅适用于学术部门所做的研究, 也适用于所有系统的生物医学, 行为, 或由365亚洲版学院任何办公室或部门执行的社会研究.
Another important aspect of the human subjects’ protection program is that Randolph College be in compliance with its Federalwide Assurance agreement with the U.S. 人类受试者保护办公室(OHRP). 遵守本正式协议, signed by the College 总统 and administered by the Vice 总统 for Academic Affairs, entails applying the ethical principles of the Belmont Report to all human subjects research, 不管资金来源如何. This agreement also stipulates that Randolph College will apply the federal policy known as “the Common Rule” to “all of its human subjects research” as well as subparts B, C, 和D 卫生和人类服务部联邦法规45 CFR 46. 此外，365亚洲版学院的IRB政策旨在符合§32.1-162.16-20 弗吉尼亚法典 以及其他与保护人类研究对象有关的州法律.
防止伤害
调查人员负责辨认, 证明, and minimizing the risks of real or potential harm accruing to human subjects involved in their proposed research; such risks include physical, 心理, 以及社会危害. Physical harm may range from unnecessary discomfort or inconvenience to physical pain or disfigurement. 心理伤害包括情绪困扰, 丧失自尊, 以及受试者判断行为或做出决定的能力受损. 社会损害包括名誉和社会或法律地位的损害.
防止胁迫和欺骗
Investigators must respect a subject’s right to autonomy and guard against unnecessary deception. 因此, investigators are required to obtain in writing the informed consent of their subjects, 除非IRB事先批准. In obtaining “informed consent,” investigators must meet the following conditions:
- 在同意参加这项研究之前, prospective subjects must be given the most detailed and accurate description of the study as the research design will allow.
- 同意和随后的参与是不能强迫的, and prospective subjects must be provided with written and oral reassurance that they are free to refuse to participate or to withdraw from the study at any time.
- If parties other than the investigators identified with the study are to have access to the individual contributions of the participants, prospective subjects must be provided with a written statement identifying these parties.
- Under no circumstances may prospective subjects be misled or uninformed as to any risks associated with the study.
- When the design of the study necessitates concealment or deception on other matters, investigators are ultimately required to reveal to participants the reasons for the action.
- 法律规定的其他条件.
The IRB is legally required to determine whether the proposed “informed consent” contains the necessary types of information. 在理想的情况下, prospective subjects should understand all features of the research that reasonably might be expected to influence willingness to participate. 此外, 在研究结束时, 研究者应自由地向参与者提供, 要求, 说明研究目的的信息, 设计的真实本质, det365亚洲版是. This access to information should be clearly stated in writing on the consent form that the participants sign. 如果受试者年龄小于18岁, the prior informed consent of a parent or legal guardian is required and the conditions prescribed herein pertain also to the parent or guardian.
防止侵犯隐私和个人诚信
调查人员必须尊重调查对象的隐私和人格尊严. Research participants possess the right to decide how much of themselves to share with others. 在可能的情况下，受试者应匿名参与. 如果研究设计排除了参与者的匿名性, then information that is traceable to the individual subjects or to their contributions to the study must be treated with strict confidentiality. 一旦获得, personal data about subjects may not be revealed to any third parties or the public in such a way as to make possible the identification of individual participants. A statement explaining the anonymity or confidentiality of information associated with the individual participants and their contributions to the research must be presented in writing to proposed subjects prior to their participation. Investigators should make every effort to preserve the personal integrity and dignity of human subjects, including refraining from research that could conceivably humiliate or belittle participants. 重复使用特定群体作为研究对象.g. 仅仅为了方便而参加某些学术课程的学员也是不鼓励的.
致谢
Randolph College is grateful to the Internal Review Boards of the University of Richmond and Agnes Scott College for permission to incorporate some language from their policies, 程序, 和网站.