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Institutional Review Board

伦理委员会促进研究并确保其道德实践.

Promoting research is one way that Landmark College achieves its mission to transform the way students learn, 教育者教书,公众思考教育. The Institutional Review Board (IRB) provides guidance to researchers so their work may come to fruition, 它确保道德规范得到遵守.

The College is committed to the ethical treatment of all human subjects of research, 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, beneficence, 正义在 Belmont Report.

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, willingness to learn, and attention to detail. Meeting U.S. federal requirements for research with human subjects can be complex. To aid the process, the IRB provides guidelines for researchers with step-by-step advice. We are dedicated to promoting research, so please contact our chair, Dr. Adam Lalor,如果你想了解更多或有问题.

Requirements to begin a study

  • IRB-approved 研究计划提交表格 for New Projects
  • Completion of the CITI course titled 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 Forms

Resources

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

合作院校培训计划(CITI)

CITI PROGRAM logoTo ensure that human subject research is conducted by qualified personnel, Landmark College requires a training course on the ethics and practice of research. All researchers and facilitators must complete the CITI course titled 第二组社会/行为调查员及主要人员. Landmark College employees and students may register free of charge. 请向IRB管理员提交“完成报告”.

CITI Registration for Landmark College faculty, staff, and students:

  1. Go to the CITI Program website.
  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 researchers navigate the IRB approval process. The approval rate is high for researchers who follow these steps and construct their proposals as suggested. 如果您有任何疑问,请联系IRB主席 Dr. Adam Lalor.

地标学院教职员工
External Researchers
Landmark College Students

地标学院教职员工

提出项目建议的建议步骤:

  1. Develop research idea based on existing literature and established research methods.
     
  2. Establish organizational support—check in with your supervisor and the IRB chairperson to determine the feasibility and timeliness of your project. If you are using a survey, contact the Office of Institutional Effectiveness (OIE) to comply with the survey policy.
     
  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 and submit the 新项目研究计划提交表格 to the IRB. Be sure to include consent forms, CV, and copies of instruments.
     
  5. Revise proposal as needed. Typically there are one to three rounds of revisions to the research proposal. This is normal and part of the process of ensuring the ethical treatment of human subjects.

After your proposal and supporting documents have been approved by the IRB, you may start collecting data. Please follow guidelines for Active Studies 在你的研究过程中.

External Researchers

We encourage research at our institution; however, enrollment limits the number of research opportunities available. Thus, we are selective and approve those proposals that may provide direct or indirect benefit to students 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 researchers; however, 我们不能保证方便.

Recommended Steps for Proposing a Project (External Researchers):

  1. Contact IRB chair or IRB administrator to discuss your project idea and determine if our institution may be a good fit.
     
  2. Submit one-two page summary of research idea to IRB chair and IRB administrator. This will enable the IRB to determine the feasibility of your project and locate a potential facilitator. The summary must include:
    • Topic of research & research question.
    • 你研究的重要性和相关性, especially as it pertains to the betterment of individuals who learn differently.
    • Methodology.
    • 参与者的目标人数和特征.
    • 参与者的研究活动. What will they be asked to do?
    • 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, scheduling space, 安排采访或其他数据收集活动, 在数据收集过程中在场, collecting and holding data, etc...
    • 引导者的估计时间承诺.
    • Note: It is recommended that you confirm on campus facilitation before continuing with the proposal process.
       
  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. Complete and submit the 新项目研究计划提交表格 to the IRB. Be sure to include consent forms, CV, and copies of instruments.
     
  6. Revise proposal as needed. Typically there are one to three rounds of revisions to the research proposal. This is normal and part of the process of ensuring the ethical treatment of human subjects.

After your proposal has been approved by the IRB, you may start collecting data. Please follow guidelines for Active Studies 在你的研究过程中.

Landmark College Students

地标学院鼓励学生进行研究. Research using human subjects is a key part of academic disciplines including the sciences, statistics, education, psychology, and business. This guide will help student researchers 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 research project separate from my Landmark College coursework?

    If you are doing research that is separate from class work, then IRB review is needed. Most class projects that involve data collection are exempt from review if they are done as educational exercises designed to teach subject matter or research 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, posting, or presenting the results of research beyond the Landmark College Community. If you plan to distribute your findings outside the College, then IRB review is needed.
     
  3. 我的研究是否涉及参与者的风险?

    Risk includes physical harm, psychological harm, 以及敏感信息泄露所造成的危害. Psychological harm may occur in studies that involve tricking participants, or in studies that trigger traumatic memories (such as bullying or sexual assault). Sensitive information is content that could negatively affect participants if released. 敏感信息的例子包括诊断, medications, GPA, sexual history, substance abuse, etc...
     
  4. 我的研究是否会涉及弱势群体?

    Vulnerable populations have a limited capacity to voluntarily participate in research. Vulnerable populations include children under 18 years of age, 智障人士, prisoners, and pregnant women. The vulnerable population most likely to be studied at Landmark College is children, 要么在学校,要么在托儿中心.

IRB Application for Students

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. Find a Faculty Sponsor. Students conducting research that requires IRB approval must obtain a faculty sponsor. 教师赞助商可以是课程的指导老师, advisor, 或Landmark College的其他教员. The student must provide enough information up front so the faculty member may determine if he/she can serve as a sponsor.
     
  2. Communicate with faculty 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. Revise proposal as needed. Typically there are revisions needed on the research proposal. This is normal and part of the process to ensure the ethical treatment of human subjects.
     
  7. 在获得批准后再开始收集数据. 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. Therefore, a student should submit the research 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 students follow the guidelines for conducting responsible research with human subjects as outlined in the Code of Federal Regulations.
     
  • Review and sign the student IRB Research Proposal identifying course information under the Project Support Section of the student’s IRB proposal.
     
  • Support the student, 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, you may start collecting data. Please follow guidance for Active Studies 在你的研究过程中.

IRB对主动研究的期望

Researchers are responsible for the following during an active study:

  1. Implement study exactly as described in approved research proposal.
     
  2. File 项目状态和结束表 or Renewal Application annually as requested by the IRB administrator. The IRB continues to review studies for the duration of time that human subjects or their data is being collected.
     
  3. 如有需要,提交项目变更申请. Changes to your project, 包括新研究员的加入, change in protocol, change in variables, change in instrumentation, 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. The Adverse Event Report documents “unanticipated problems that arise and pose risk to subjects or others.”

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 research project, 需要在地标学院学习吗, staff, students, their families, 数据或记录(过去或现在), must be reviewed and approved by the Landmark College Institutional Review Board (IRB).

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. Informed consent will be obtained by adequate and appropriate methods.
     
  4. The research project may be reviewed at regular intervals to insure the rights and welfare of human subjects continue to be safeguarded.

The Landmark College Institutional Review Board (IRB) ensures that research conducted adheres to high scientific, as well as ethical, standards. Proposals are reviewed for methodology and research design considerations.

The IRB also ensures the integrity and relevance of research proposals with regard to judicious use of College resources.

All research proposals must be submitted using the Landmark College Institutional All research proposals must be submitted using the Landmark College Institutional Review Board 研究计划提交表格.

Training Policy for Researchers

Purpose: Landmark College maintains professional standards in research by requiring that all researchers complete the CITI course titled 第二组社会/行为调查员及主要人员 (“SBE” in this document).

Scope: This policy applies to all researchers at Landmark College and external research partners including, faculty, staff, college employees, 以及本科生, graduate students, and postdoctoral researchers participating in the research project.

Definitions: Research [on human subjects] means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Policy Statement: Landmark College promotes a culture of ethical research activities. 保持专业水准, the College requires that researchers continually build a foundation in the ethics and practice of protecting human subjects while engaging in research 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 research and their application (respect for persons, beneficience, justice)
  • The definition and rights of human subjects and vulnerable populations
  • Informed consent
  • 什么构成了研究中的危害
  • 隐私、保密和匿名
  • Research in special contexts, including schools and overseas
  • Internet research ethics
  • HIPAA and FERPA

Procedures: Go to the CITI link on the IRB website and follow directions to register for the course. After taking the course, provide a completion report to the IRB Administrator.

SBE training must be completed prior to the start of any research project. Proposals are subject to the IRB review and approval is not contingent upon this policy or the completion of SBE Training.

Principal investigators of grant-funded projects are responsible for submitting CITI certificates to the Grants Administrator. Investigators working on grants are also responsible for meeting the funding agency’s requirements, including requirements for specific trainings not covered as part of this policy.

Responsibility: Landmark College的机构审查委员会(IRB), specifically the IRB Chair and the IRB Administrator are responsible for this policy.

Effective Date: 11/1/2014

Training Policy for IRB Members

All members of Landmark College’s Institutional Review Board (IRB) must complete with a passing grade the College’s human subjects’ protection research educational 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. All IRB members must continue to take the training every two years, per College policy.

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, that person shall not need to retake IRB training until such time that their two year period is up, provided that written documentation of prior training is provided to Landmark College’s IRB Administrator.
  • If an IRB member remains a full-time employee of another college or university, that college or university’s IRB guidelines for IRB training shall remain in effect for that IRB member.

Policy on Recruitment and Advertising Requests from External Entities

Purpose:

External Research Requests:

Advertising: Because all advertisements for research 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, emails, posters, etc. that have not gone through the College’s Institutional Review Board (IRB) process.

Scope: This policy applies to any external researchers or recruiting specialists wishing to advertise or recruit research participants at Landmark College.

Institutional Official: 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 Chair: 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. The IRB Chair ensures that the IRB composition is adequate and adheres to federal regulations. The IRB Chair at Landmark College is a qualified faculty or staff member and normally has an earned doctorate.

IRB Administrator: The IRB Administrator is an appointed faculty or staff member that works under the administrative direction of the IRB Chair. The IRB Administrator at Landmark College is a qualified faculty or staff member and normally has experience in research and daily administrative duties.

Recruiting specialists: Any person or business seeking to enlist human research subjects for research studies; recruiters can be directly associated with the institution seeking participants or indirectly (for-hire company/person) associated.

Procedures:

If requests of this nature come into Landmark College they should be directed to the IRB 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 Research Proposal Process.
  • When the formal proposal process for external research 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 to the IRB Chair for review. Prior to final approval, the IRB request will be reviewed by the Institutional Official.
  • If the project is determined not to be consistent with the Landmark College mission, the IRB administrator will send a letter to the research applicant with feedback obtained from the IRB.
  • 当/如果收到审查委员会的批准, the IRB administrator will distribute advertisements as outlined in the IRB application form.

Responsibility: The Institutional Review Board and the College’s Institutional Official.

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