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院校检讨委员会

伦理委员会促进研究并确保其道德实践.

促进研究是Landmark College实现其改变学生学习方式的使命的一种方式, 教育者教书，公众思考教育. 机构审查委员会(IRB)为研究人员提供指导，使他们的工作可能取得成果, 它确保道德规范得到遵守.

学院致力于所有人类研究对象的伦理待遇, 它遵循相关的联邦标准. IRB监督这一过程，遵守法规 Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) and operating in accordance with the ethical principles of respect for persons, 善行, 正义在 贝尔蒙特的报告.

我如何在地标学院做研究?

从一个好主意变成一个可行的研究需要灵感, 学习意愿, 注重细节. 遇到你.S. federal requirements for re搜索 with human subjects can be complex. 为了帮助这一过程，IRB为研究人员提供了逐步建议的指导方针. We are dedicated to promoting re搜索, so please contact our chair, Dr. 亚当Lalor，如果你想了解更多或有问题.

开始一项研究的要求

  • IRB-approved 研究计划提交表格 新项目
  • 完成 花旗的课程 题为 第二组社会/行为调查员及主要人员
  • 校内辅导员(只适用于外部研究人员)
  • 学院赞助人(仅限学生研究人员)

机构审查委员会(IRB)成员

IRB形式

资源

There are several resources available for the Landmark College re搜索 community. 要了解有关这些资源的更多信息，请联系 Landmark College Institute for 研究 and 培训 (LCIRT).

合作院校培训计划(CITI)

花旗计划标志To ensure that human subject re搜索 is conducted by qualified personnel, Landmark College要求有一门关于研究伦理和实践的培训课程. All re搜索ers and facilitators must complete the 花旗的课程 题为 第二组社会/行为调查员及主要人员. Landmark College employees and 学生 may register free of charge. 请向IRB管理员提交“完成报告”.

CITI Registration for Landmark College 教师, 工作人员, and 学生:

  1. 去 花旗计划网站.
  2. 选择右上方的“注册”选项.
  3. 选择“Landmark College”作为你的机构.
  4. 按照提示操作注册步骤.
  5. Select Course: 第二组社会/行为调查员及主要人员.

This guide is designed to help re搜索ers navigate the IRB approval process. 遵循这些步骤并按照建议构建提案的研究人员的批准率很高. 如果您有任何疑问，请联系IRB主席 Dr. 亚当Lalor.

地标学院教职员工
External Researchers
地标大学生

地标学院教职员工

提出项目建议的建议步骤:

  1. 在现有文献和既定研究方法的基础上形成研究思路.
     
  2. Establish organizational support—check in with your supervisor and the IRB chairperson to determine the feasibility and timeliness of your project. 如果你正在使用调查, 与机构效率办公室(OIE)联系，遵守调查政策.
     
  3. 完成或更新花旗研究人员培训. 所有研究人员必须完成花旗课程 第二组社会/行为调查员及主要人员.
     
  4. 填妥及递交 新项目研究计划提交表格 给税务局. Be sure to include consent forms, CV, and copies of instruments.
     
  5. 根据需要修改提案. Typically there are one to three rounds of revisions to the re搜索 proposal. 这是正常的，也是确保对人类受试者进行道德治疗的过程的一部分.

After your proposal and supporting documents have been approved by the IRB, 你可以开始收集数据. 请遵循以下指引 Active Studies 在你的研究过程中.

External Researchers

We encourage re搜索 at our institution; however, enrollment limits the number of re搜索 opportunities available. 因此, we are selective and approve those proposals that may provide direct or indirect benefit to 学生 who learn differently. All external projects must be facilitated by a Landmark College employee—this person serves as an on-campus contact for matters related to the project. The IRB will assist in locating a facilitator for external re搜索ers; however, 我们不能保证方便.

Recommended Steps for Proposing a Project (External Researchers):

  1. 联系IRB主席或IRB管理员讨论您的项目想法，并确定我们的机构是否适合您.
     
  2. Submit one-two page summary of re搜索 idea to IRB chair and IRB administrator. 这将使IRB能够确定您的项目的可行性，并找到潜在的促进者. 摘要必须包括:
    • 研究课题 & 研究问题.
    • 你研究的重要性和相关性, especially as it pertains to the betterment of individuals who learn differently.
    • 方法.
    • 参与者的目标人数和特征.
    • 参与者的研究活动. 他们会被要求做什么?
    • 主持人的计划任务. 你预计需要引导者做什么? Examples of facilitator roles include but are not limited to: Recruiting subjects, 调度空间, 安排采访或其他数据收集活动, 在数据收集过程中在场, 收集和保存数据, 等...
    • 引导者的估计时间承诺.
    • 注意:建议您在继续提案过程之前确认校园便利.
       
  3. Communicate with facilitator about how you will work together.
     
  4. 完成或更新花旗研究人员培训. 所有研究人员必须完成花旗课程 Group 2 Social and Behavioral Investigators and Key Personnel.
     
  5. 填妥及递交 新项目研究计划提交表格 给税务局. Be sure to include consent forms, CV, and copies of instruments.
     
  6. 根据需要修改提案. Typically there are one to three rounds of revisions to the re搜索 proposal. 这是正常的，也是确保对人类受试者进行道德治疗的过程的一部分.

After your proposal has been approved by the IRB, 你可以开始收集数据. 请遵循以下指引 Active Studies 在你的研究过程中.

地标大学生

地标学院鼓励学生进行研究. 以人为研究对象的研究是包括科学在内的学术学科的重要组成部分, 统计数据, 教育, 心理学, 和业务. This guide will help student re搜索ers through the IRB process.

由学生领导的研究可能需要也可能不需要审查委员会的批准. 回答以下四个问题. If you answer YES to one or more questions, you will need an IRB Application.

  1. Is my re搜索 project separate from my Landmark College coursework?

    如果你正在做的研究与课堂作业分开，那么IRB审查是必要的. Most class projects that involve data collection are exempt from review if they are done as 教育al exercises designed to teach subject matter or re搜索 skills.
     
  2. 我是否打算添加一般化的知识?

    增加一般化的知识意味着出版, 发布, or presenting the results of re搜索 beyond the Landmark College Community. 如果你计划在学院之外发布你的发现，那么IRB审查是必要的.
     
  3. 我的研究是否涉及参与者的风险?

    风险包括身体伤害, 心理上的伤害, 以及敏感信息泄露所造成的危害. Psychological harm may occur in studies that involve tricking participants, 或者在引发创伤性记忆的研究中(如欺凌或性侵犯). 敏感信息是指一旦泄露可能对参与者产生负面影响的内容. 敏感信息的例子包括诊断, 药物, 平均绩点, 性史, 药物滥用, 等...
     
  4. 我的研究是否会涉及弱势群体?

    弱势群体自愿参与研究的能力有限. Vulnerable populations include children under 18 years of age, 智障人士, 囚犯, 孕妇. Landmark学院最有可能研究的弱势群体是儿童, 要么在学校，要么在托儿中心.

IRB学生申请

如果你是一个里程碑学院的学生寻求IRB的批准, you must follow the steps below as part of the application process.

  1. 找一位学院赞助人. 学生进行研究需要审查委员会的批准必须获得教师的赞助. 教师赞助商可以是课程的指导老师, 顾问, 或Landmark College的其他教员. The student must provide enough information up front so the 教师 member may determine if he/she can serve as a sponsor.
     
  2. Communicate with 教师 sponsor about how you will work together.
     
  3. 完成或更新花旗研究人员培训. 所有研究人员必须完成花旗课程 第二组社会/行为调查员及主要人员.
     
  4. Complete the 新项目研究计划提交表格.
     
  5. 提交提案给IRB审查.
     
  6. 根据需要修改提案. Typically there are revisions needed on the re搜索 proposal. 这是正常的，也是确保对人类受试者进行道德治疗的过程的一部分.
     
  7. Wait until you have approval before starting to collect data. 注意:一个项目的批准可能需要几个星期, 特别是在需要修改或修改的时候. 因此, a student should submit the re搜索 proposal at least 3 weeks in advance of the date he/she wishes to begin data collection.

教师赞助人职责:

  • Ensure that 学生 follow the guidelines for conducting responsible re搜索 with human subjects as outlined in the Code of Federal Regulations.
     
  • Review and sign the student IRB 研究 Proposal identifying course information under the Project 支持 Section of the student’s IRB proposal.
     
  • 支持学生, 包括在必要时开会讨论结果, 帮助关注项目的方向.

After your proposal has been approved by the IRB, 你可以开始收集数据. Please follow guidance for Active Studies 在你的研究过程中.

IRB对主动研究的期望

研究ers are responsible for the following during an active study:

  1. Implement study exactly as described in approved re搜索 proposal.
     
  2. 根据IRB管理员的要求，每年提交项目状态和关闭表或续期申请. IRB在收集人类受试者或其数据期间继续审查研究.
     
  3. 如有需要，提交项目变更申请. 对项目的更改, 包括新研究员的加入, 协议变更, 变量变化, 更换仪器, 等等，都必须经过IRB的审查和批准.
     
  4. 如有需要，提交不良事件报告. 不良事件报告记录了“出现的意想不到的问题并对受试者或其他人构成风险”.”

Policy to Protect Human Subjects of Research

Training Policy for Researchers

Training Policy for IRB Members

Policy on Recruitment and Advertising Requests from External Entities

Policy to Protect Human Subjects of Research

It is the policy of Landmark College that any re搜索 project, 需要在地标学院学习吗, 工作人员, 学生, 他们的家庭, 数据或记录(过去或现在), 必须由地标学院机构审查委员会(IRB)审查和批准.

地标学院遵守第45章的规定, Part 46 of the Code of Federal Regulations (45CFR46) to assure the following:

  1. The benefit to the subject and the importance of the knowledge to be gained outweigh the risks to the subject to the extent that the decision to allow the subject to accept these risks is warranted.
     
  2. The rights and welfare of human subjects will be adequately protected.
     
  3. 知情同意 will be obtained by adequate and appropriate methods.
     
  4. The re搜索 project may be reviewed at regular intervals to insure the rights and welfare of human subjects continue to be safeguarded.

地标学院机构审查委员会(IRB)确保所进行的研究坚持高度科学, 同时也是道德的, 标准. Proposals are reviewed for methodology and re搜索 design considerations.

内部审查委员会还确保研究建议的完整性和相关性，以明智地使用学院资源.

All re搜索 proposals must be submitted using the Landmark College Institutional All re搜索 proposals must be submitted using the Landmark College 院校检讨委员会 研究计划提交表格.

Training Policy for Researchers

目的: Landmark College maintains professional 标准 in re搜索 by requiring that all re搜索ers complete the 花旗的课程 题为 第二组社会/行为调查员及主要人员 (本文件简称“SBE”).

范围: 这一政策适用于所有的研究人员在地标学院和外部研究合作伙伴，包括, 教师, 工作人员, 大学的员工, 以及本科生, 研究生, and postdoctoral re搜索ers participating in the re搜索 project.

定义: 研究 [on human subjects] means a systematic investigation, 包括研究开发, 测试与评估, 被设计用来发展或促进一般化的知识. 符合这一定义的活动构成本政策的研究, 是否在其他目的的研究项目下进行或支持. 例如，一些示范和服务项目可能包括研究活动.

政策声明: Landmark College promotes a culture of ethical re搜索 activities. 保持专业水准, the College requires that re搜索ers continually build a foundation in the ethics and practice of protecting human subjects while engaging in re搜索 and scholarly activities. The required CITI Social/Behavioral Investigators and Key Personnel course supports this goal by providing content in the following areas:

  • 人类研究的定义
  • The ethical principles of re搜索 and their application (respect for persons, beneficience, 正义)
  • The definition and rights of human subjects and vulnerable populations
  • 知情同意
  • 什么构成了研究中的危害
  • 隐私、保密和匿名
  • 研究 in special contexts, including schools and overseas
  • 网络研究伦理
  • HIPAA和FERPA

程序: 访问IRB网站上的CITI链接，并按照说明注册该课程. After taking the course, provide a completion report 给税务局 Administrator.

SBE training must be completed prior to the start of any re搜索 project. 提案须经IRB审查，批准不取决于本政策或SBE培训的完成情况.

Principal investigators of grant-funded projects are responsible for submitting CITI certificates to the 奖助金 Administrator. 研究拨款的调查人员还负责满足资助机构的要求, including requirements for specific trainings not covered as part of this policy.

责任: Landmark College的机构审查委员会(IRB), 特别是IRB主席和IRB管理员负责这项政策.

生效日期:2014年11月1日

Training Policy for IRB Members

All members of Landmark College’s 院校检讨委员会 (IRB) must complete with a passing grade the College’s human subjects’ protection re搜索 教育al program within 60 days of becoming a member of Landmark College’s IRB. Failure to do so in a timely manner will result in the suspension of IRB member status until such time that the training is completed. 根据学院政策，所有IRB成员必须继续每两年接受一次培训.

下列例外情况适用:

  • If an IRB member joins Landmark College having had training from a previous institution and that training is current within the two year time frame set by Landmark College policy, 该人员在其两年任期届满之前不需要重新接受IRB培训, 前提是向Landmark College的IRB管理员提供先前培训的书面文件.
  • If an IRB member remains a full-time employee of another college or university, 该学院或大学的IRB培训指导方针对该IRB成员仍然有效.

Policy on Recruitment and Advertising Requests from External Entities

目的:

外部研究请求:

广告: Because all advertisements for re搜索 must be reviewed and approved by an IRB and adhere to the Code of Federal Regulations 45 CFR Part 46, 地标学院不会派发传单, 电子邮件, 海报, 等. that have not gone through the College’s 院校检讨委员会 (IRB) process.

范围: This policy applies to any external re搜索ers or recruiting specialists wishing to advertise or recruit re搜索 participants at Landmark College.

机构官员: The Institutional Official is the acting authority for Landmark College and assumes overall responsibility for compliance with federal regulations for the protection of human subjects and the College’s IRB. The Institutional Official at Landmark College is the President or his designate.

IRB椅子: The IRB Chair is the appointed official responsible for the day to day management of the IRB work of all IRB members and the IRB administrator. IRB主席确保IRB的组成是适当的，并遵守联邦法规. Landmark College的IRB主席是一名合格的教职员工，通常拥有博士学位.

IRB管理员: The IRB Administrator is an appointed 教师 or 工作人员 member that works under the administrative direction of the IRB Chair. The IRB Administrator at Landmark College is a qualified 教师 or 工作人员 member and normally has experience in re搜索 and daily administrative duties.

招聘专业: Any person or business seeking to enlist human re搜索 subjects for re搜索 studies; recruiters can be directly associated with the institution seeking participants or indirectly (for-hire company/person) associated.

程序:

If requests of this nature come into Landmark College they should be directed 给税务局 administrator and the following process will take place:

  • The IRB Chair or the chair designate will contact the person requesting to have information distributed and give instruction on the External 研究 Proposal Process.
  • When the formal proposal process for external re搜索 has been completed, the IRB Chair will send the proposal and related information to the Institutional Official (IO) or the IO designate to see if the project is consistent with our mission.
  • If the project is determined to be consistent with the Landmark College mission, the IRB application form will be completed and sent 给税务局 Chair for review. 在最终批准之前，IRB请求将由机构官员进行审查.
  • 如果项目被确定不符合地标学院的使命, IRB管理员将向研究申请人发送一封信，其中包含从IRB获得的反馈.
  • 当/如果收到审查委员会的批准, IRB管理员将按照IRB申请表格中列出的内容分发广告.

责任: The 院校检讨委员会 and the College’s Institutional Official.

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