IRB: Forms and Documents
Required Forms and Templates for New Study Submissions
Sample Initial Application in IRB Mentor [pdf]
Embedded as an interactive form in IRB Mentor, the IRB application for initial submissions is filled out by researchers online. As you fill out the online application, new fields 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 detail, and organization that responses should have. 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.
Standard Consent Template [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 the signature requirement if certain criteria are met. When applicable, the study team should verify whether the participant prefers to have a signed copy for their records.
Consent Notice Template [docx]
Basic information sheet for participants to keep for their records that can be used for most minimal risk studies that qualify for exempt review. No signatures are collected if a consent notice is used. The consent notice should 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 maintained, if applicable.
Parent Permission Template [docx]
To be used when research involves minors. For information on obtaining permission from minors who are research subjects (assent) see our Informed Consent Handbook below.
Informed Consent Handbook [pdf]
Provides comprehensive instructions for preparing consent and assent documents for different kinds of research. Expectations for obtaining meaningful consent are outlined, and sample consent and assent documents are provided.
Formatting and Submission Notes for Consent Documents
- 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).
Verification of Translation Accuracy Form [pdf]
Must be included with any translated documents.
Student/Faculty RSCA Agreement Form [pdf]
Optional form for faculty supervisors when research activities involve sensitive, controversial, or potentially disturbing topics. The form outlines the duties that a student would be responsible for as well as the potential risks related to exposure to the specific topic or circumstance. In addition, resources are identified that 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.
Informational Documents and Links
IRB Submission Checklist [pdf]
Summarizes the documents needed for new protocol submissions.
Data Management Checklist [pdf]
A 2-page checklist based on our data management handbook that summarizes the most important points.
Data Management Handbook [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.
Data Management Excel Template
A spreadsheet template that investigators can use to manage their use of data throughout the lifecycle of the research.
Table of Exemption Categories [pdf]
A list of the exemption review categories, how they apply to vulnerable groups, and the SJSU-specific consent requirements for each category.
Pre-Mentor IRB Forms
The forms listed below may only be used by investigators who received IRB approval prior to the implementation of
the IRB Mentor system before June 1st 2023.
Modification Request Form [docx]
Use this form to report changes to your pre-IRB Mentor approved protocol. Please fill out and email this form to firstname.lastname@example.org, along with any accompanying documents that have changed, with revisions highlighted for easy reference. Include your IRB tracking number in the subject line. 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.
Annual Status Report [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 the IRB so that we may keep track of active research. The form should be emailed to email@example.com. Include your IRB tracking number in the subject line. No review is associated with submission of this form. However, failure to provide this form annually will result in closure and deletion of your IRB study file after a period of three years from initial approval if we do not hear from you.
Incident Report [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 to your pre-IRB Mentor approved study. This form should be emailed to firstname.lastname@example.org. Include your IRB tracking number in the subject line.
Assurance Form [pdf]
Required by faculty/staff principal investigators and supervisors.