Application Process

Who Needs To Apply?

All human subjects research connected with members of the Smith College community (either as researchers or study participants) must be reviewed and approved by the IRB prior to the initiation of the project.

The Smith College IRB defines research 作为一种系统的调查，旨在发展或促进可概括的知识.

A human subject 是一个活生生的个体，从他身上你可以得到;

  1. data through intervention or interaction, including surveys and interviews, and/or
  2. identifiable private information in a form associable with that individual

 

Who Does Not Need to Apply?

For help with determining if IRB review is required for your project, 请使用建议前诊断调查 Mentor IRB system. This should be used if you are at all unsure if your project requires IRB review or not.

Examples of projects that do not fit the IRB’s definition of human subjects research:

  • Classroom projects—see our Classroom Projects Policy for guidance.
  • Quality Improvement/Program Evaluation activities designed to measure the effectiveness of a program, curriculum, or assessment. 目的不是推广到更大的社区，结果不会与其他评估进行比较.
  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), 包括信息的收集和使用, that focus directly on the specific individuals about whom the information is collected.
    • Oral History - IRB review is not required if you are conducting an oral history project focused on an individual and you are not planning to use your findings to generalize about a community or group of people. Refer to the Oral History Association's Best Practices and Statement on Ethics.
    • 采访专家——如果你只是询问专家的专业工作经验和专业意见, 你不需要提交IRB提案. 这只适用于你不询问他们的个人生活或意见的情况.
  • Repository Research/Tissue Banking
    • If you want to use samples or data that have already been collected and have no way to link the samples or data back to the individual (and you will make no effort to re-identify the data), then you do not need IRB review.
  • 数据库/去识别数据的二次分析
    • If you are conducting a secondary analysis using publicly available data and you will not be merging the data sets in such a way that individuals might be identified OR supplementing the public data with potentially identifiable data, 那么你的研究就不需要IRB审查.
    • 如果您计划获取由其他人收集且不包含任何名称的数据, phone numbers, emails, ID numbers, 或其他可用于识别参与者的信息, 你不需要IRB审查你的二次分析. 如果你有办法获取代码来重新识别数据, 你需要在进行二次分析之前进行IRB审查.

The Application Process

以下是IRB流程的基本要素. Please read through and familiarize yourself with these elements before submitting a proposal; it will make the process quicker, easier and more coherent. New researchers are encouraged to make an appointment to meet with the IRB Coordinator, Sherry Wingfield 她会在审批流程、所需文件、最佳实践等方面为你提供建议. 

Training for IRB Researchers

The CITI training for IRB researchers is meant to introduce researchers to the ideas and principles of ethical research involving human participants and the IRB process.

To access the courses, 点击此链接进入花旗计划网站 and the following directions.

Step 1:注册为澳门葡京博彩软件附属用户.

  • Click “Register” on home page, 然后选择你的机构（澳门葡京博彩软件）并输入你的个人信息来创建你的帐户.
    • 注意:你不需要购买CE学分, select “No” when asked that question unless you need it for another purpose.
    • When asked what course you plan to take – “Basic Human Subjects – Social & Behavioral Focus”
  • If you previously set up a CITI account with a different institution, 登录您现有的帐户，并将您的机构隶属关系更改为澳门葡京博彩软件.

Step 2: 将适当的课程添加到您的帐户中.

  • If the “CITI Course Enrollment Procedure” page appears, skip to step 3 below.
  • 如果页面没有自动显示, go to "Courses" - "Learner Tools for Smith College" and select "Add a Course.”

Step 3: Answer questions to help CITI select the appropriate course for your account.

  • Review the page that appears, then click on "Continue to Question 1 at this time." 
  • Question 1 - Since your research involves human subjects, choose "All Researchers." 
  • 问题2 -这部分留空（除非你是在另一门课程/项目中进行动物研究）.
  • 问题3 -选择“目前没有”(除非你正在进行由NSF资助的研究).
  • Question 4 - choose "No."
  • Click “Submit.”

Step 4: 完成花旗主页上列出的IRB研究人员基础课程.

  • 完成所有要求的7个模块(阅读和带有3-5个选择题的测验).
  • 所有测验的平均成绩至少达到75%. 如有必要，您可以重复每个模块的测试.
  • The time commitment varies widely depending on your familiarity with these topics, 但通常需要2-3小时才能完成.
  • You can save your progress and complete the training over several days if necessary.

Who Needs to Complete CITI Training

All Investigators and key personnel who are engaged in research with living human beings, 人体组织样本或可识别的私人信息, 需要参加花旗培训计划吗.

Federal guidelines define “Key Personnel” who are “engaged in research” with human subjects as staff or students who meet any of the following criteria:

  • Enroll individuals in studies
  • Obtain participants' informed consent by doing more than handing out or collecting forms or telling participants how to get in touch with the Investigators
  • 干预或与参与者互动进行侵入性(如.g., drawing blood) or noninvasive (e.g., survey) procedures
  • 直接从参与者那里收集数据或直接跟踪参与者
  • Collect identifiable private information from participants or have access to information that links participants' names or other identifiers with their data
  • Act as authoritative representatives for the investigators (faculty advisers)

Proof of Completion

For Smith students, faculty and staff:
When you complete the CITI course, a copy of your Completion Report will automatically be sent to the IRB office. All CITI accounts are also linked to Smith College Mentor IRB accounts. As such, it is not necessary to submit this report with your IRB application.


其他机构的调查人员:
Anyone who has registered and completed a CITI Program Training Course for research involving human subjects at their home institution may download their Completion Report from their own institution and submit it to the Smith IRB to meet the training requirement.

  • Go to: about.citiprogram.org/en/homepage/
  • 通过输入用户名和密码登录.
  • 进入“我的课程”或“我的记录”，在课程的完成记录栏中选择“查看-打印-分享”.
  • 下载相应的完成记录，并将其与您的IRB提案一起上传到导师IRB.

Refresher Courses

因为联邦政策和法规在使用人类参与者方面正在不断发展和变化, 澳门葡京博彩软件伦理委员会要求研究人员 recertified every four years.

Online IRB Submission

The Smith College IRB is now using the Mentor IRB system.

Setting up your account
  • 第一次澳门葡京博彩软件的教员, staff, or students use Mentor IRB, 他们需要按照界面第一个屏幕上的说明激活他们的帐户 Mentor IRB website and entering their Smith single sign-on account username and email address.
  • 如果你没有澳门葡京博彩软件的账户, send an email to the IRB coordinator requesting a Mentor IRB account. You will receive an email from the IRB coordinator with your username for Mentor.
Pre-proposal survey (optional)

您可以选择在Mentor中通过进行提案前调查来启动IRB审查过程. This will help determine if your project is "not subject to IRB review", or if it requires an exempt, expedited, or full IRB review. 回答这些问题对一些研究者是有帮助的, but you have the option to skip this step if you are ready to submit your IRB proposal. 

Submission

The Mentor IRB proposal surveys will guide you through the proposal submission process. 您将填写一份基本的提案调查，以便在您的帐户中建立新的IRB项目记录, 然后，您将被要求回答补充问题，以便为IRB提供足够的信息来完成审查过程.

  • Your research proposal must indicate that adequate provisions will be made for the protection of the rights and welfare of prospective research participants, 并将遵守相关政策法规. 您对提案中具体问题的回答将允许IRB评估您提议的研究是否完全解决了这些问题. Please answer every question, doing so in clear, concise, 自我解释的语言，使IRB审稿人, 谁可能不熟悉你的学科领域, 会很容易理解提出的研究.
  • An important component of the description of your research plan is the documentation of informed consent. 内部审查委员会已经创建了模板，以协助准备本文件，可在 Forms & Templates page. 在提交您的提案进行审查之前，通过Mentor IRB系统将您定制的知情同意文件上传到您的IRB提案中.
Messages & Notifications from Mentor IRB
  • IRB的邮件和提醒将发送“IRB Smith” noreply@axiommentor.com" in the header details.
  • 如果你使用优先收件箱，而导师的邮件被分类到你不经常查看的地方, 通过打开消息将其标记为重要, 点击信息工具栏中的三个点“more”图标，然后选择“标记为重要”。. 随后来自Mentor的消息应该被标记为重要.

Preliminary Feedback & Revision Requests

初读时，无论指定的复习状态如何， the board will often request additional information or suggest changes to your proposal, before it is formally reviewed. This feedback will improve the proposal and speed the formal review process. As such, 你的提案能否及时获得批准取决于你对董事会问题的迅速回应.

Types of IRB Review

审查状态取决于参与者的预期风险水平，并由内部审查委员会主席确定. Each type of review—exempt, expedited, 从提案提交到最终批准需要不同的时间. For information purposes, the typical length of reviews is listed below.

Exempt review
5-7 business days
Federal regulations limit the categories of research that qualify for exemption.

Expedited review
7-14 business days
属于某些类别并满足最小风险条件的研究可能有资格获得加速审查状态.

Full review
15-30 business days (视乎提交日期与会议日期的距离而定)
针对弱势受试者或对参与者的风险超过最小的研究必须经过全体委员会的审查. 整个委员会在学年期间每月召开一次会议. 会议时间表和提交截止日期列在 home page.

IRB Decision

After its review, the IRB will notify you of action taken regarding your proposal:

  • Approval: The application is complete, 受试者的风险是最小的, and the procedures are appropriate. IRB批准进行研究.
  • Approval with Contingencies/Stipulations: 应用程序已经完成，但在项目开始之前必须解决一些问题/更改. 一旦收到对这些突发事件的满意答复并得到内部审查委员会主席的批准, the review is complete.
  • Deferral: Applications that are found to have significant concerns (risk to subjects, unclear procedures, serious omissions, 伦理问题或重大突发事件)将被推迟. 研究人员将收到一份必须解决的问题清单，以便批准继续进行. 研究人员的回答将由IRB重新考虑.
  • Non-Approval: While an extremely rare occurrence, applications that are found to have risks which outweigh the potential benefits to subjects and/or society will receive a non-approval and the research will not be allowed to be conducted. 如果审查委员会决定不批准一项研究活动, 委员会应在其书面通知中说明其决定的理由，并给予调查人员以书面答复的机会. 在收到书面上诉后，IRB将再次投票. The second vote of the IRB is final. Institutional administrative officials may not override this decision.

如果您希望在澳门葡京博彩软件进行研究，并且该研究已被其他机构批准(初级IRB), 您将被要求向澳门葡京博彩软件IRB提交您的协议和所有相关材料和文件, along with the approval letter from the other institution for review. In most cases, the Smith IRB will defer oversight to the primary IRB. 主IRB执行的审查必须符合Smith IRB的人类受试者保护要求. Approval by the primary IRB does not guarantee approval by the Smith IRB.

Instructions for Submission

要提交已被其他机构批准的协议，请登录您的 Mentor IRB account. 进入“我的协议”，点击“创建新协议”. Be sure to select 'Study Approved by Another IRB' as the 'Review Type'.

After You Have Received Approval

If at any time you wish to make any change 你最初提交给内部审查委员会的研究程序, 您必须通过web提交协议更改(COP)请求 Mentor IRB. 在初始化更改之前，您必须等待IRB批准协议请求的更改.

经全面审查批准的提案必须每年更新一次. The Mentor IRB system will notify you when the IRB approval for your proposal is due for renewal.  

如果你是一名主要调查员，当你的年度报告到期时，你将不再隶属于学院(例如, graduation, end of employment, etc.), 您必须在出发前与IRB联系，并提供您项目的替代联系信息.

A protocol deviation is an incident involving noncompliance with the approved proposal, 但通常不会对研究的完整性或参与者的权利产生重大影响, safety or welfare.

As the primary investigator (PI), 你有责任报告研究人员采取的任何超出或超出IRB批准的行动. Submit a protocol deviation report through your Mentor IRB account.

During the conduct of your research, you may have findings whose nature, severity and/or frequency are not described in the proposal approved by the IRB. Examples include, but are not limited to, unexpected complications in a subject, 研究程序或同意文件中的错误, or breaches of confidentiality. Alternatively, 您可能会遇到对参与者或研究人员都有潜在危害的问题或事件. In either case, you must report these facts immediately to the IRB using an adverse/unanticipated events report in Mentor IRB.

调查人员必须以确保参与者信息保密的方式存储签署的同意文件. 研究人员需要在研究完成后的3年内将同意书存档.

Smith College will prepare and maintain documentation of IRB activities. 该文件在研究完成后至少保存3年，包括：所有审查过的研究计划的副本, evaluations, approved sample consent documents, progress reports, and reports of injuries to subjects; minutes of IRB meetings; copies of IRB correspondence; a list of IRB members; and copies of policies and guidelines.

Please log in to your Mentor IRB 帐户在您的研究完成后终止您的协议. 

Research Methods

Qualtrics是澳门葡京博彩软件授权的软件，社区成员可以使用它进行匿名在线调查.

Anonymity: 在使用Qualtrics时，您必须采取适当的步骤来确保收集的数据没有附加识别信息, making the survey truly anonymous. Read instructions for anonymizing responses on the Qualtrics website.

Verifying Age: Participants must be 18 years or older in order to consent to participate in a study. 如果他们未满18岁，必须得到父母或监护人的同意. 通过匿名在线调查，调查人员不可能确定参与者是否年满18岁. 增加参与者年满18岁的可能性:

  1. State in your recruitment that participants must be 18 or older to participate
  2. 在“点击”同意书的底部附上声明，如“我确认我已年满18岁”."

Informed consent: 进行无风险或低风险匿名在线调查, 有可能，缩短段落格式的知情同意语言可以与“点击同意”一起使用." Click consent refers to the participant clicking on an "agree" or "continue" button to indicate their consent to participate after they have read the informed consent language.

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  • 拒绝或退出的权利:请记住，参与者始终有权以任何理由终止参与调查. 他们也有权跳过调查中的任何问题(如.e. no question should be "required").

Compensation: If you wish to collect participant contact information in order to offer compensation, to maintain anonymity, 您必须创建一个单独的质量表单，参与者只能在其中输入他们的联系信息. 在主调查问卷的末尾应该显示一个单独表单的链接，这样参与者就不用在调查问卷中输入他们的联系信息, 澳门葡京博彩软件不能与他们的数据相关联. (Also see "Payments to Subjects" below).

Certain populations are considered more vulnerable to coercion than others. 专门针对弱势群体的研究需要额外的保护，这些保护必须在议定书中加以描述. 以下是一些(但不是全部)潜在弱势群体的清单(见下文针对这些群体应采取的具体预防措施):

  • children
  • prisoners
  • decisionally impaired individuals
  • educationally disadvantaged individuals
  • economically disadvantaged individuals

Participants in these categories need not be excluded from research; rather, researchers must make a special effort to ensure that potential participants are given every opportunity to exercise free choice in consenting to participate in a research project. For some participants, 这将包括请求父母或合法授权代表的知情同意以及潜在参与者的同意.

Children/Minors (under 18 years old)

Please review the Research with Children page for more information. 

Prisoners

联邦法规将囚犯定义为非自愿地被监禁或拘留在刑事机构中的任何个人. This definition includes individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, 以及在传讯前被拘留的人, trial or sentencing. Research involving prisoners must have as its goal either a direct benefit to the individual subject or seek an understanding of issues and conditions specific to prisoners.

Decisionally Impaired Individuals

Decisionally impaired individuals are those who have a diminished capacity for decision-making and who may be unable to fully understand the risks of research. Research may only involve decisionally impaired individuals if it offers a direct benefit to the individual subject or to the subject's class or condition. 如果被试者不能自行表示同意, 必须向其合法授权的代表人索取. 在这种情况下，还必须取得当事人的同意.

Educationally Disadvantaged Individuals

研究者必须使用招募和同意的语言，让潜在的参与者容易理解, 这可能涉及修改同意书的语言.

Economically Disadvantaged Individuals

Economically disadvantaged subjects may be easily persuaded to participate in research if the economic compensation is so great that it would result in the subject ignoring or disregarding the research risks because of the income generated by the study. 在这种情况下，调查人员应该小心地将经济补偿设定在一个有意义的水平，以补偿受试者的时间, 但它还没有大到变成强制性的. 同样重要的是，在这种情况下，向受试者清楚说明对受试者的风险.

有时，适当的做法是向受试者支付报酬，以补偿他们的时间和支付他们参加活动所产生的费用. However, 提供如此高的报酬是不合适的，它会鼓励个人忽视或无视研究风险. Excessive compensation, 无论是以货币形式还是以实物形式支付, is coercive and will not be allowed.

澳门葡京博彩软件雇员和学生薪酬政策 - Gifts to employees and students from college funds are generally not allowed. However, 财务主任已同意研究人员可要求豁免这项政策. 要请求豁免，请通过电子邮件向控制者发送您的请求和以下信息:

  • 每位参加者的补偿金额
  • the method of payment
  • the letter of IRB approval for the study
  • 将被保留的收据的描述.

Following approval, 财务主任办公室将协助现金支付, 您也可以用p卡购买礼券或购物卡. Please include the approval email, the IRB letter, and other supporting documentation with your Expense Report on Smart Data.  

您可以为参与者保密，但必须将参与者名单保存在一个安全的地方，以供IRS使用.

Materials aimed at recruiting participants for studies should include a clear description of the purpose of the study and what the person would be expected to do if they choose to participate. 一般来说，你的招聘声明应该包括:

  • 研究人员姓名及联络资料
  • 研究人员与澳门葡京博彩软件的关系
  • Purpose of the research
  • General eligibility criteria (i.e.(比如你招聘那个人的原因)
  • 简短的描述这个人将被要求做什么.e. 填写一个10分钟的调查或参加一个1小时的访谈)
  • Accurate and honest description of risks, benefits, and/or compensation involved in the study without coercion to participate.

广告不应该做过分的宣传, use attention-getting techniques, nor pressure readers to participate.

联邦法规禁止使用欺骗手段，使受试者处于大于最小风险的境地.

欺骗的解释和理由

In studies involving deception, the IRB requires that the investigator: (a) acknowledge to the IRB that they are deceiving (not fully informing participants) (b) provide justification to the IRB for the deception (e.g., fully informing the participant would destroy the psychological effect under investigation) (c) argue that it would be difficult to do the study without the deception, (d)说服IRB参与者在得知研究的真实目的后不太可能感到不安.

Informed Consent

The following statement, or some similar statement, must appear in every consent form/information sheet for studies involving deception:

  • 一些研究设计要求在参与之前不解释研究的全部意图. 虽然我们已经描述了你将被要求执行的任务的一般性质, 直到研究完成后，才会向您解释研究的全部意图. At that time, we will provide you with a full debriefing which will include an explanation of the hypothesis that was tested and other relevant background information pertaining to the study. 您也将有机会提出您对研究中使用的假设和程序的任何问题.
Debriefing

Participants should be debriefed after the research procedures are completed. 汇报应包括对使用欺骗手段的详细描述. 研究者有责任确保受试者离开研究环境时对欺骗行为有准确的理解. The debriefing process, including any written materials, 应作为提交的协议的一部分向审核委员会解释. 

汇报陈述对任何参与研究的人都有教育作用. 写一段关于研究假设和理论的文章可以让研究参与者产生好感, particularly with student participants, serve an important educational purpose.

Debriefing statements are not required by the IRB except in instances where deception is used or if the study addresses topics that may provoke strong emotions in research participants (e.g.(个人创伤、被污名化的社会身份、心理健康症状、微侵犯). If your study addresses upsetting topics, you must provide a list of relevant resources in the debriefing statement. 研究者不适合为参与者提供心理健康服务.

See 来自沙赫特健康中心的危机资源 & Wellness.

Additional Resources

Association Ethics Codes

Useful Information & Links

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