IRB:表格和文件
Required Forms and Templates for New Study Submissions
IRB Mentor首次申请样本[pdf]
Embedded as an interactive form in IRB Mentor, the IRB application for initial submissions
是由研究人员在线填写的吗. 当您填写在线应用程序时，新的字段
and sections will open up, depending on how you have answered previous questions.
A sample of the application, with most sections and questions made visible, is provided
here as a preview only. This fictional sample protocol also demonstrates the quality of writing, level of
细节和响应应该有的组织. You can also access this blank copy with most of the sections and questions visible [pdf]. The smart form may be updated periodically and this preview may not reflect any
edits we have made. This preview is not relevant to investigators who wish to rely
on an external IRB review.
All post approval forms (study status check-in, modification forms, incident reports, and deviation reports) are provided under the respective tabs at the bottom of the protocol information page for a specific study in IRB Mentor.
Consent Templates
标准同意模板[docx]
Contains the required elements of informed consent and signature lines to be used
for non-exempt studies. If you wish to request a waiver of documentation of consent (i.e., no signatures
will be collected), you may remove the signature lines and replace with appropriate
verbiage such as “Please keep this information for your records.” The IRB may waive
签名要求 certain criteria are met. When applicable, the study team should verify whether the participant prefers
给他们留一份签名的记录.
同意书范本[docx]
Basic information sheet for participants to keep for their records that can be used
对于大多数符合条件的最小风险研究 exempt review. No signatures are collected if a consent notice is used. 同意通知书应
include elements such as the name and contact information of the principal investigator,
the purpose of the research, the study procedures, and how confidentiality will be
维持，如果适用的话.
父权限模板[docx]
用于涉及未成年人的研究. 有关取得许可的资料
from minors who are research subjects (assent) see our Informed Consent Handbook below.
知情同意手册[pdf]
Provides comprehensive instructions for preparing consent and assent documents for
不同种类的研究. Expectations for obtaining meaningful consent are outlined,
并提供同意和同意文件样本.
同意文件的格式和提交说明
- Make sure that the bottom margins of your consent documents have at least one inch
of space on all pages to enable the approved consent documents to be digitally stamped
by the IRB office.
- If you will be embedding consent information into an online survey, submit the consent
information as a separate attachment so that it can be stamped by the IRB office when
approved. For consent documents embedded into a survey, you may use an unstamped version
so long as you: 1) include a link to the stamped version that participants can print/download,
and 2) the text on the version preceding the survey does not deviate in any way from
the stamped version.
- You must use the stamped version(s) of your approved consent documents if the IRB office stamps your consent document (not all consent documents may be stamped).
Other Forms
核实译文准确性表格[pdf]
必须包含在任何翻译文件中吗.
学生/教师RSCA协议表格[pdf]
Optional form for faculty supervisors when research activities involve sensitive,
有争议的或潜在的令人不安的话题. 这张表格概述了我的职责
a student would be responsible for as well as the potential risks related to exposure
针对特定的话题或情况. 此外，资源被确定为
the students and faculty can utilize if they experience distress. Faculty are encouraged
to use this form as vehicle for discussion with their students when the research involves
sensitive topics.
参考文件及连结
内部审查委员会提交资料核对表[pdf]
Summarizes the documents needed for new protocol submissions.
数据管理核对表[pdf]
A 2-page checklist based on our data management handbook that summarizes the most
important points.
数据管理手册[pdf]
An educational resource intended to help researchers who want to conduct research
with human participants construct an effective data management plan as part of their
research proposals.
数据管理Excel模板
A spreadsheet template that investigators can use to manage their use of data throughout
研究的生命周期.
豁免类别表[pdf]
A list of the exemption review categories, how they apply to vulnerable groups, and
the 菠菜网lol正规平台-specific consent requirements for each category.
Students as Research Subjects – A Guide to IRB Protocol Considerations [pdf]
Pre-Mentor IRB Forms
下面列出的表格可以 only be used by investigators who received IRB approval prior to the implementation of
在2023年6月1日之前.
修改要求表格[docx]
Use this form to report changes to your pre-IRB Mentor approved protocol. Please fill
将此表格发送至irb@sjsu.Edu，以及任何随附的文件
have changed, with revisions highlighted for easy reference. 包括IRB跟踪
标题行中的数字. After June 1, 2024, you must submit a new protocol via the IRB Mentor system if you
wish to modify a previously approved pre-IRB Mentor study.
年度状况报告[pdf]
If your pre- IRB Mentor study was approved under an exempt or expedited IRB review
category, as indicated on your approval notification, you must file this form with
IRB，这样我们就可以跟踪正在进行的研究. 表格应通过电子邮件发送至
irb@brewrecords.net. 在主题行中包括你的IRB追踪号. 没有相关的审查
填妥此表格后. 然而，如未能每年提供此表格，将会被删除
result in closure and deletion of your IRB study file after a period of three years
如果我们没有收到你的消息，从最初的批准开始.
事故报告[docx]
Principal investigators must file this form within 7 calendar days upon discovery
of an unanticipated problem, adverse event, or injury affecting human subjects related
您的预irb导师批准的研究. 此表格应通过电子邮件发送至irb@brewrecords.net.
在主题行中包括你的IRB追踪号.
Assurance Form [pdf]
Required by faculty/staff principal investigators and supervisors.
