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.
Consent Templates
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).
Other Forms
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.
List of Expedited Review Categories
Students as Research Subjects – A Guide to IRB Protocol Considerations [pdf]
