Humans Subjects Research - Institutional Review Board (IRB)
The IRB is a committee responsible for reviewing research proposals submitted by SJSU students, faculty, and staff that involve the use of human subjects. IRB members make sure that the proposed research is in compliance with university policy and federal regulations established to ensure the safety of research participants and the ethical and responsible conduct of investigators.
If you plan on pursuing research with human participants either through direct interaction (interviews, surveys, experimental interventions, etc.) or through the use of private records about individuals, a protocol must be submitted to and approved by the IRB before the research begins.
Due to the shelter in place order for many Bay Area counties, including Santa Clara County, researchers must switch to remote data collection or postpone their studies, regardless of their previous IRB approvals. Please make sure to obtain approval before initiating any changes to your work. To submit a modification request, please fill out a modification request form and email it to firstname.lastname@example.org, along with any protocol documents that have been revised. The Office of Research is making every effort to fast track modification requests.
We ask faculty to ensure that students under their supervision are told to cease any in person contact with study participants. Studies that cannot be conducted remotely must be put on hold. For those submitting protocols or overseeing student submissions, please be aware that no in-person interactions will be approved during the current time frame.
Please check this website for updates as the situation unfolds.
SJSU Researchers: Getting Started
- Fill out the exclusion worksheet (pdf) to determine whether your work meets the federal regulatory criteria for review and needs to be submitted to the Office of Research. This involves determining whether the work meets the federal definitions of "research" and "human subjects." If, after using this worksheet, you determine that your work does not need to be submitted for review, please keep the worksheet for your records. This worksheet does not need to be submitted to our office.
- View our IRB tutorials. These videos describe everything you need to know about the IRB process, including when IRB approval is needed, how long it takes to get approval for different kinds of research, and what kinds of forms are needed. Additional informational documents are available on our forms and documents page.
- Make sure you have completed a preliminary training course if you are a faculty or staff member submitting your own protocol or supervising
student research. The training is also recommended but not mandatory for students.
Refresher training courses are currently required every five years.
Submitting Documents for IRB Review
- When submitting a new protocol refer to the IRB checklist for a summary of required documents, and fill out the required forms. Be sure to access forms directly from our website for each new submission, as we may update them periodically. Note that some forms may not look complete if you preview them on your web-browser. Please be sure to download, view, and fill out forms on your computer rather than on your web-browser.
- Protocol documents should be submitted to email@example.com. Paper submissions will no longer be accepted.
- Await a screening email from the Human Protections Analyst confirming that your protocol was received and containing information about how it will be reviewed (approximately 5 business days).
- Once your protocol has been reviewed, further instructions will be emailed to you by the Human Protections Analyst. Depending on the nature of the revisions, you may be asked to submit a new protocol or only the revised documents. If you’re a student submitting a new protocol, you will need a faculty supervisor to review the protocol and provide a signature on an assurance form (pdf). If you only have minor revisions to submit, your professor’s signature is not required.
- Once you have obtained IRB approval, follow the instructions below for reporting modifications
Submitting Modifications, Extensions, and Status Reports
To report changes to your research methods and procedures, design, data instruments, personnel, type or number of subjects, consent process, or location, please fill out the Request for Modifications to Approved Research Form (docx) and email it to firstname.lastname@example.org, along with any accompanying documents that have changed.
Annual Status Reports
If your protocol was approved under an exempt or expedited IRB review category, as indicated on your approval notification, you must file an annual status report (pdf) with the IRB so that we may keep track of active research. The form should be emailed to email@example.com. 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 protocol file after a period of three years from initial approval if we do not hear from you.
New regulations no longer require IRBs to conduct a continuing review of research that was approved under the exempt or expedited review process. Extension requests need only be submitted for protocols that were reviewed by the full/convened IRB. Researchers whose protocols were evaluated by full review should contact us to obtain an extension request form at least one month prior to the expiration date indicated on their approval notification.
Reporting Unanticipated Problems, Adverse Events, or Injuries
Primary Investigators must file an incident report (docx) within 7 calendar days upon discovery of an unanticipated problem, adverse event,
or injury affecting human subjects. This form should be emailed to firstname.lastname@example.org.
SJSU Researchers with External Approval
The Office of Research accepts approvals from outside IRBs. As an SJSU investigator, your name and role must be outlined in the IRB protocol of the reviewing institution. You may register your research with our office instead of submitting a protocol to SJSU for review. The External IRB Approval Registration Form (docx) contains more details about what documents need to be submitted along with the form.
For complex collaborations, please contact us in advance to work out the most efficient process for obtaining approval.
External Researchers with IRB Approval
External researchers should consult our Non-SJSU Researchers page for instructions on registering their IRB approval with our office.