Institutional Review Board

The policies and procedures of the Randolph College IRB are derived from 美国卫生与公众服务部(DHHS)联邦法规第46部分第45卷, Protection of Human Subjects. 在365亚洲版学院IRB网站上规定的政策和程序是365亚洲版学院IRB的标准操作程序. All research conducted on human subjects by students, faculty, and staff, whether on or off campus, must be reviewed.

Meetings

IRB meetings will be held virtually on an as-needed basis.

Protection of Human Subjects at Randolph College

365亚洲版学院申明，在追求知识的过程中，个人权利必须得到保护. IRB的政策和程序旨在遵守联邦法律对参与研究的人类受试者的保护. All systematic biomedical, behavioral, 与本学院相关的直接涉及人类受试者的社会研究必须遵守以下政策和程序，并且必须在研究开始之前由IRB进行适当的审查和批准. The IRB policies apply not only to research done in academic departments, but also to all systematic biomedical, behavioral, or social research executed by any office or department at Randolph College.

人类受试者保护计划的另一个重要方面是，365亚洲版学院必须遵守与美国国立卫生研究院签订的联邦保障协议.S. Office for Human Subjects Protections (OHRP). Compliance with this formal agreement, 由院长签署，教务副院长管理, 需要将贝尔蒙特报告的伦理原则应用于所有人类受试者的研究, regardless of its funding source. 该协议还规定，365亚洲版学院将适用被称为“共同规则”的联邦政策，以“其所有人类受试者研究”以及子部分B, C, and D of the Department of Health and Human Services Code of Federal Regulations 45 CFR 46. In addition, Randolph College’s IRB policies are designed to conform with §32.1-162.16-20 of the Code of Virginia and other State laws related to the protection of human subjects of research.

Protection against Harm

Investigators are responsible for identifying, justifying, and minimizing the risks of real or potential harm accruing to human subjects involved in their proposed research; such risks include physical, psychological, and social harm. 身体伤害的范围从不必要的不适或不便到身体疼痛或毁容. Psychological harm includes emotional distress, loss of self-esteem, and impairment of the subject’s ability to judge behaviors or make decisions. Social harm includes damage to reputation and social or legal standing.

Protection against Coercion and Deceit

调查人员必须尊重受试者的自主权，防止不必要的欺骗. Therefore, 研究者必须以书面形式取得受试者的知情同意, except as otherwise approved in advance by the IRB. 在获得“知情同意”时，调查人员必须满足以下条件:

1. Before agreeing to participate in the study, 在研究设计允许的情况下，必须给予潜在受试者最详细和准确的研究描述.
2. Consent and subsequent participation cannot be coerced, 未来的受试者必须得到书面和口头保证，他们可以在任何时候拒绝参加或退出研究.
3. 如果参与研究的调查人员以外的其他各方可以获得参与者的个人贡献, 准受试者必须提供一份确定这些当事人的书面声明.
4. 在任何情况下，前瞻性受试者不得被误导或不被告知与研究相关的任何风险.
5. 当研究的设计需要隐瞒或欺骗其他事项, 调查人员最终被要求向参与者透露行动的原因.
6. Any other conditions required by law.

法律要求IRB确定拟议的“知情同意”是否包含必要的信息类型. Ideally, 前瞻性受试者应了解研究中合理可能影响参与意愿的所有特征. Furthermore, at the conclusion of the study, investigators should freely provide to participants, upon request, information explaining the purposes of the study, the genuine nature of the design, and the results. 知情权应在参与者签署的同意书上以书面形式明确说明. If a prospective subject is less than eighteen years of age, 必须事先获得父母或法定监护人的知情同意，本协议规定的条件也适用于父母或监护人.

Protection against Violations of Privacy and Personal Integrity

Investigators must respect the privacy and human dignity of subjects. 研究参与者有权决定与他人分享自己的多少信息. When possible, subjects should participate anonymously. If the research design precludes the anonymity of research participants, 然后，可追溯到个体受试者或他们对研究的贡献的信息必须严格保密. Once obtained, 有关受试者的个人资料不得透露给任何第三方或公众，以使个别参与者的身份得以识别. 在受试者参与之前，必须以书面形式向受试者提交一份声明，说明与个体参与者及其对研究的贡献相关的信息的匿名性或保密性. 调查人员应尽一切努力维护人类受试者的人格完整和尊严, 包括避免可能羞辱或贬低参与者的研究. The repeated use of particular groups as subjects (e.g. members of certain academic courses) merely for convenience is also discouraged.

Acknowledgements

365亚洲版学院感谢里士满大学和艾格尼丝·斯科特学院的内部审查委员会允许从他们的政策中纳入一些语言, procedures, and websites.

Sources

The Department of Health and Human Services
The Office of Human Research Protections