人体受试者的保护
000.250保护人类受试者政策
A. 介绍
履行其法律和道德义务，确保人类主体的权利 在研究中得到适当的保护，这是皇冠8868会员登录谷学院的政策 维持院校覆核委员会. 的组成和程序 IRB将遵守适用的保护人类的法规 主题,包括 联邦法规第46部分第45篇 和 RCW 42.48.020.
B. 基本原则
The basic principles adhered to by the college are drawn from the 贝尔蒙特的报告，由国家生物医学人体受试者保护委员会撰写 和1979年的行为研究.
- 对人员的尊重:研究者有义务对每个参与者进行治疗 them as a person fully capable of making an informed decision regarding his or her 参与研究. 每位参与者都必须充分了解 the nature of the study, 包括 any risks or benefits. 确保…的自治权 本课题，学院要求每位参与者签署知情同意书 in the study unless the study meets the exception criteria outlined in the section 在豁免.
- Beneficence: The investigator has an obligation to each participant to attempt to maximize benefits for each participant 和/or society, while minimizing the risk of 对每个参与者的伤害.
- 正义(我.e. avoiding unfair coercion): The investigator is also obligated to provide for equitable distribution of benefits 和 burdens among the selected population.
C. 要求审查拟议的研究
这是皇冠8868会员登录谷学院(WVC)的政策，所有的研究涉及人类 主题,包括 (1) research planned or conducted by students or employees of the college, or (2) research planned or conducted by entities outside the college 将招募WVC学生或员工作为参与者，或(3)任何涉及 使用大学设施的人类受试者必须经过审查并获得批准 在研究活动开始前，由审查委员会批准. 可能会要求IRB审查 through the steps outlined in WVC 人类受试者保护程序 1000.250.
“研究”的定义是“系统的调查，包括研究开发， 测试和评估，旨在发展或有助于推广知识.” 符合此定义的活动构成为本政策目的而进行的研究。 whether or not they are conducted or supported under a program that is considered 为其他目的进行研究. 例如，一些示范和服务项目 可能包括研究活动.” (美国联邦法典第45条第46条.102). All proposed research activity will be submitted to the IRB for approval, even 当该活动似乎免于人类受试者审查要求时; IRB拥有决定项目是否免于审查的唯一权力 or may undergo an expedited review procedure as 中定义的 美国联邦法典第45条第46条.110.
Experiments or clinical activities conducted in a class setting for the purposes of instruction 和 student learning are not considered research under this definition; 这些活动是由WVC在教学活动中使用人文学科来解决的 300年政策.330.
请求由学院以外的实体进行研究而不需要 WVC教员的直接合作(例如.g. 研究生研究，非盈利 组织(或调查)将对研究的目的进行审查和认可 by the president’s cabinet before being forwarded to the IRB.
D. 调查
It is the policy of 皇冠8868会员登录 Valley College (WVC) to require a review process for 调查:
- Will be administered on a campus or at a college-operated location or event;
- Will recruit WVC students or employees as participants based on their relationship with the college; or
- Will be administered outside WVC, either in person or electronically, 和 will be 以学院名称、WVC标志或研究者的关系来标识 暗示WVC赞助.
Proposals for survey projects will be reviewed by the president’s cabinet. 回顾 may be requested through the steps outlined in WVC 调查过程 1000.255.
Survey projects may be considered “research” 和 are required to go through the IRB review process outlined in WVC 人类受试者保护程序 1000.250 if:
- 在调查员和。之间有互动(个人人际接触) 参加者，如个人访谈;
- 调查中收集的个人身份信息-身份 调查人员确定的或与调查结果相关的参与者; or
- The purpose of the survey is to develop or contribute to generalizable knowledge: for example, the results will test a hypothesis 和 permit conclusions to be drawn, 计划在出版物或专业会议上发表，还是将被应用 到WVC以外的种群.
调查活动作为一种课程活动进行的教学和目的 student learning do not need to undergo review, but should include a statement to 参与者解释目的. 征求内部反馈的调查 WVC的目的是评估或改进程序和服务，如课程 evaluations, alumni surveys, or employer surveys, do not require a review.
Approved by the president’s cabinet: 2/7/12, 8/26/14, 6/4/19
Adopted by the board of trustees: 3/21/12, 9/11/14, 6/19/19
最近回顾:5/7/20
政策联系:制度有效性
相关政策及程序
000.250 人类受试者保护程序
300.330 Use of Human Subjects in Instructional Activities 政策
1000.255 调查过程
1300.330 Use of Human Subjects in Instructional Activities 过程
1000.人类受试者保护程序
A. 目的
本程序的目的是确保研究中人类受试者的权利 受到适当的保护，皇冠8868会员登录谷学院及其授权代表 是否符合保护人类受试者的适用法规; 包括 联邦法规第46部分第45篇 和 RCW 42.48.020.
B. 院校评审委员会成员
机构审查委员会(IRB)的成员应包括学院教师 和 staff with relevant experience 和 training 和 at least one external member as 中定义的 美国联邦法典第45条第46条.102. Board members must have completed DHHS compliant human subjects review training 在过去两年担任内部审查委员会成员.
C. 评审过程
The researcher or investigator responsible for the research study shall contact the IRB prior to initiating any contact with students or employees that are intended as 研究对象. The contact person shall be the WVC Executive Director of Institutional 有效性. The researcher or investigator will provide, in writing, the following 信息:
- 一份完整的、已签署的IRB审查和批准请求表格(可在人力资源网页上获得).
- 描述研究项目和问题的意图/目的的简短陈述 在调查中.
- A description of the intended participants in the research (employees; students; specific 项目或课程等.).
- A copy of the informed consent information to be provided to participants.
- 任何广告或招聘材料的副本和/或参与描述 提供奖励(如有).
- A statement describing how confidentiality of data will be maintained, if personal 需要收集信息. 声明应包括对措施的描述 为保护被收集的非个人信息回应的匿名性而采取的措施.
- A copy of the instrument/s to be used, or a summary of the research procedures as 参与者经历.
- If the researcher or investigator is a WVC faculty or staff member, a statement of support from the appropriate administrator/supervisor. 如果是WVC的学生，一份声明 来自指导教师的支持. 教师/员工声明应该解决 工作量和/或发布时间(如果适用).
- 主要研究人员或研究者已完成培训的证据 在对人类研究参与者的保护中涉及伦理原则 研究和联邦法规.
D. 申请豁免
一些以人类为研究对象的研究不受此程序的要求 if it meets the following criteria (taken from the Code of Federal Regulations, 美国联邦法典第45条第46条.101).
- 在已建立或普遍接受的教育环境中进行的研究，涉及
正常的教育实践，例如:
- Research on regular 和 special education instructional strategies, or
- Research on the effectiveness of or the comparison among instructional techniques, 课程，或课堂管理方法.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude,
成就)、调查程序、访谈程序或对公众行为的观察;
除非:
- 所获得的信息以这样一种方式记录，即可以识别人类受试者; directly or through identifiers linked to the subjects; 和
- 在研究之外对人类受试者反应的任何披露都是合理的 使当事人面临刑事或民事责任的风险，或损害当事人的利益。 财务状况、就业能力或声誉.
- 涉及收集或研究现有数据、文件、记录、病理的研究 specimens, or diagnostic specimens, if these sources are publicly available or if 信息由研究人员或调查人员以下述方式记录 不能直接或通过与受试者相关联的标识符识别受试者.
If the researcher or investigator believes that the project meets one of the above 豁免的标准，这必须在内部审查委员会要求提供的空白处注明 用于审核和批准表格. The IRB will make a final determination of eligibility for exemption; research may not proceed until verification of the exemption is received 由IRB的研究员或调查员提供.
E. 推迟事先审查
研究者或调查人员可以要求WVC的IRB遵从先前机构的裁决 另一机构的检讨委员会. 该机构的IRB必须符合WVC的标准 for review 和 be compliant with federal 和 state regulations on human subjects’ 研究与回顾. The researcher or investigator will indicate a request for deferment 根据他们的要求填写审核表格(可在人力资源网站上找到)，并提供所有文件 与先前机构的内部审查委员会的行为有关. 如果WVC的IRB批准延期，它 may later choose to withdraw this different at any time.
F. IRB的决定
The IRB will review all requests 和 will contact the investigator with a decision to approve the project; approve with modifications or restrictions; grant an exemption from review; defer to a prior IRB of another institution, table the request pending receipt of additional information; or disapprove. 为确保有足够时间进行检讨， requests should be submitted with complete documentation at least six weeks prior 研究计划的开始.
Approved by the president’s cabinet: 2/7/12, 1/7/14, 6/4/2019
Presented by the board of trustees: 2/15/12, 2/26/14, 6/16/2019
最近回顾:5/7/20
程序联系:机构有效性
相关政策及程序
000.250 人类受试者保护政策
300.330 Use of Human Subjects in Instructional Activities 政策
1000.255 调查过程
1300.330 Use of Human Subjects in Instructional Activities 过程