IRB:人类作为研究的参与者

E-mailed submissions are encouraged; however, IRB需要申请签名页的原件或传真(FAX或扫描PDF)才能发出批准. 如果你有任何问题，请发邮件给IRB IRB@practicaldrilling.com.

知情同意文件的要素 电子数据安全和保安政策

联邦和USM保护人类受试者的政策要求FSU及其雇员保护研究中人类参与者的权利和福利. 遵守这些规定, all faculty, 计划在研究中使用人类参与者的教职员工和学生必须事先获得FSU机构审查委员会(IRB)的批准。.

Questions and answers regarding how to obtain approval are detailed below. 如果您有任何关于在FSU研究中使用人类参与者的问题，下面没有回答, please contact the OSP.

Who needs IRB approval?

All research (see below)，涉及人类参与者，由FSU教员进行, staff, 学生的申请需要审核委员会的批准. All projects must be fully approved before any use of human participants occurs.

 

FSU IRB的管辖权是什么?

建议的活动如符合下列任何一项，将会被考虑纳入聘管局的管辖范围:

  1. 这项研究是由这个机构赞助的.
  2. The research is conducted by or under the direction of any employee or agent of this institution
    1. 与他或她的机构职责或
    2. 使用本机构的任何财产或设施.
  3. 该研究涉及使用本机构的非澳门赌城官方网站来识别或联系人类研究受试者或潜在受试者.

What qualifies as research?

Please note that if the project does not need to be approved by the IRB, then the instructor is responsible and liable for the appropriateness of the activities.

如果项目不符合研究的监管定义，则不需要由内部审查委员会审查, in brief, "a systematic investigation, including research development, testing, and evaluation, 被设计用来发展或促进一般化的知识.“澳门十大赌城官方网站伦理委员会的政策是，如果项目主任打算发表或提出任何发现，则将项目视为合格的“监管研究”. 这条通则可能有例外, but the IRB should review the project and make that determination.

There are gray areas, but in general if you can answer "no" to the following questions, 那么你的项目就不需要由IRB审查:

  • 这个项目不仅仅是一个教学练习吗?
  • 研究结果会被发表或展示吗?

Classroom Activities
Research that is conducted exclusively as part of a course assignment or classroom activity (i.e., where the results will only ever be presented to the instructor and/or students within the course), or a presentation to a campus audience consisting of only FSU students, faculty and staff, is considered an instructional exercise and not "regulatory" research. 当然也有例外情况, 通常，此类活动不需要IRB审查.

However, in order for a student to be able to publish their data or present them publicly, 包括在本科生或研究生研究研讨会上, IRB审查应在数据收集开始之前进行. 联邦法规禁止事后批准. And so, 如果该活动或任务有可能导致数据的公开展示, then an IRB application should be submitted before the project begins.

Surveys
In general, marketing and opinion surveys, even if they are not anonymous, 是否专注于特定的问题或组织, therefore, 不能产生“一般化”的知识. 一般来说，它们不被认为是“监管研究”." An obvious exception would be if the results were to be analyzed, generalized, and published as research.

校园学生演讲
本科生和研究生的研究成果将在公众参加的校园活动中展示, including friends and family, 须经审查委员会覆核. 这包括在本科生研究研讨会和研究生研究研讨会上的研究报告, 以及在FSU主办的区域会议上的演讲.

 

什么是“人体实验”研究?

即使它有资格作为“监管研究”," a project need not be reviewed by the IRB if it does not involve human subjects. 人类主体的监管定义是"一个活着的个体，研究者通过干预或互动获得(A)数据，或(b)获得, uses, studies, 分析或生成可识别的私人信息.“可识别的私人信息”包括可用于推断个人身份的任何非澳门赌城官方网站. Depending on the sample size and the type of information collected, it may be relatively easy to identify individuals even without such data as name, address, or telephone number.

如项目符合“规管研究”的资格(see above), then, if the answer to at least two of the following questions is "yes,"该项目必须由内部审查委员会审查;

  • 你会收集现存个体的数据吗?
  • 你会以任何方式直接与参与者互动吗? (在线信息收集被认为是互动的.)
  • Will you use private information that could identify individuals?

 

Do I need to obtain consent from human participants involved in my research project?

Yes. 在让任何潜在的人类参与者参与研究之前，必须获得他们的知情同意. Unless the IRB waives the requirements to obtain informed consent, you must provide the participants with informed consent documents written in simple, lay language. Please see 知情同意文件的要素 for more detailed information.

 

我应该什么时候申请审核?

IRB批准申请应在人类受试者使用前至少30天提交给OSP. 如果有IRB要求的修订需要申请人解决，那么更多的时间是可取的. IRB review is more limited during official school holidays or vacations, winter session (January), or during the summer. Therefore, 如果您需要IRB审查，澳门十大赌城官方网站建议您在学年的活跃部分向委员会提交申请.

 

What are the IRB's requirements for working with electronic data?

Please see the 电子数据安全和保安政策 page.

 

有什么培训要求吗?

Anyone who is listed as a PI, Co-PI, 或IRB申请的指导老师, 与参与者互动的人员(包括在线人员), 或者有权访问可识别的数据, 必须提交由 合作院校培训计划(CITI) 才会得到批准. 研究人员需要完成“人类受试者培训-第一阶段-基础课程”才能获得此认证. The IRB may accept human subjects training certificates from other organizations.

PIs, Co-PIs, 指导教师必须完成一个进修课程, 哪些还可以通过 CITI, if their human subjects training certificate is more than 3 years old. This course is called ‘Human Subjects Training – Stage 2 – Refresher.’

请注意，CITI将只显示其中一个课程, “基础课程”或“进修课程”,' at a time. 如果CITI没有显示您默认需要的课程, 向下滚动到页面底部，上面写着, "Learner Tools for Frostburg State University' and click on 'Add a Course.如果你需要基础课程(i.e., 你没有人类科目培训证书), then under "Question 1 - Human Subjects Research' select 'Human Subjects Training'. 如果你需要进修课程(i.e., you do have a human subjects training certificate but it is more than 3 years old), then under 'Question 1 - Human Subjects Research' select 'Human Subjects Refresher'. Once you have selected the correct course, scroll to the bottom of the page and click 'Submit.'

Do not select any options, 包括那些根据“负责任的研究行为(RCR)”-不会为您提供必要的培训证书.

Again, all PIs, Co-PIs and Faculty Advisors must have completed a full human subjects training course, 例如花旗集团的基础课程. The Refresher Course is only needed if a person’s most current certification is over 3 years old.

If you have any trouble accessing the necessary course, please email the IRB at irb@practicaldrilling.com.

 

Who are the members of the IRB?

The IRB is a committee, appointed by the President, to oversee the use of human participants in research conducted by FSU faculty, 教职工与学生一致 马里兰大学政策系统 and 保护人类受试者的联邦政策. This Committee consists of faculty from various colleges and departments at FSU, 与不同背景的人合作，以促进对研究所通常进行的研究活动进行全面和充分的审查. They are appointed to the Committee because of their expertise in one or more areas. 联邦法规要求该委员会至少由五个人组成，其中至少有一名非科学家和至少一名非附属成员. 赞助项目办公室(OSP)为IRB提供政策监督和指导以及行政支持. The Director of Sponsored Programs is not a Committee member and does not review research protocols.

 

How do I apply for IRB approval?

An "Application for Initial Review of Research Using Human Participants" form must be submitted to obtain approval for research involving human participants. One protocol form must be submitted for each individual (different) project.

Completed applications should be submitted electronically to irb@practicaldrilling.com, and the signed signature page can be scanned and emailed or delivered as a hard copy. 表单的任何部分都不应该被删除. 如果表格上有一个或多个问题不适用于您的工作，请在提供的空白处注明“N/A”. (Please feel free to add more lines under any of the questions if you need additional space.)如对表格有任何疑问，请致电 irb@practicaldrilling.com.

 

What is the approval process?

There are 3 types of review categories: (1) Exempt (2) Expedited and (3) Full. IRB决定哪种类型的审查是合适的.

Projects that qualify as Exempt 是否免于广泛审查. "Exempt" does not mean that the proposed research is exempt from being reviewed, 只是审查程序通常不那么费力. 豁免审查通常需要2 - 3周才能完成. 有资格获得豁免审查的研究通常只需要与匿名参与者进行最少的互动, such as online surveys.

Projects that qualify for Expedited 审核将被发送给至少两名IRB委员会成员，平均需要大约4周才能完成. 在IRB审查后，将向研究者发送批准通知或修改请求. 有资格获得快速审查的研究通常需要与参与者进行更深入的接触, such as with recorded interviews and/or the collection of confidential data.

Projects that qualify for Full 审查将发送给IRB的所有委员会成员，并要求委员会大多数成员召开会议(见下文的会议日期)。. 完整的审查通常需要4 - 6周才能完成, 取决于申请提交的时间. 需要全面审查的申请将在收到后的下一次委员会会议上进行审查, but the application must be submitted at least 3 weeks ahead of time. 在IRB审查后，将向研究者发送批准通知或修改请求. Research that requires a full board review typically involves vulnerable populations (e.g., 未成年人——尽管不是针对未成年人的研究, 比如典型的教育活动, requires a full board review) or where there is more than minimal risk of harm to participants.

 

内部审查委员会安排的2024年春季会议日期如下:

  • February 7th
  • March 6th
  • April 3rd
  • May 1st

 

IRB将以书面形式通知研究人员其批准或不批准拟议研究活动的决定，或确保IRB批准该研究活动所需的修改. If revisions are required, 修订后的申请的覆核时间表将按照上述豁免指引进行, Expedited and Full reviews (i.e., the time until the review will be completed ‘starts over’ at the point when revisions are received). IRB approvals are good for one year unless otherwise stated on the approval form. 如果审查委员会决定不批准一项研究活动, 委员会将在书面通知中说明其决定的理由，并给予调查人员亲自或书面答复的机会.

 

What are some pertinent policies and guidelines for human research?



What if my approved research project needs to be extended beyond one year?

You must complete an "使用人类参与者的研究续期申请，并将此表格提交给OSP at least 30 days prior 你批准的协议到期了. 填妥的表格可以电子方式提交给OSP, 但是，还必须提交签名的纸质副本. 表单的任何部分都不应该被删除. 如果表格上有一个或多个问题不适用于您的工作，请在提供的空白处注明“N/A”. (Please feel free to add more lines under any of the questions if you need additional space.)如果您对表格有任何疑问，请联系OSP.



如何更改已批准的研究项目?

Once a project is approved it can be modified with the IRB's approval. Minor modifications, 比如问题的小改写, 可以不经审查委员会批准而制作, 但必须在下次审查时报告. 影响参与者选择的修改, risks and benefits, 或保密或涉及研究方法的重大变化被认为是实质性的，需要IRB审查. 这可以通过完成IRB续期申请(位于页面顶部)并将其提交到IRB@frostburg来实现.edu.



当我的项目正式完成时，我该做什么?

当一个项目完成后，你应该提交一份“项目终止通知表格" to the OSP within 30 days. 如果您对表格有疑问，请联系OSP.

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