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, observation, 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.
SJSU Researchers: Getting Started
- 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 - including a submission checklist, FAQs, sample protocols, and discipline specific considerations - 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 advising on a student protocol. 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, fill out the required forms. Be sure to access forms directly from our website for each new submission, as we may update them periodically.
- Submit 2 copies of a complete IRB protocol to the Office of Research. The mailing address, location, and office hours can be found on our contact page. Email or fax submissions are not accepted.
- Await a screening email from the IRB coordinator confirming that your protocol was received and containing information about how it will be reviewed (7-10 business days).
- Once your protocol has been reviewed, further instructions will be emailed to you
by the IRB coordinator. 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 advisor to review the protocol and provide
a signature. If you only have minor revisions, your professor’s signature is not required.
Document revisions are not accepted by email or fax.
- Once you have obtained IRB approval, follow the instructions below for reporting changes,
problems, or to request continuing review beyond the one year approval period.
Submitting Addendums and Extensions
Addendums: to report significant changes to your research methods, design, personnel, type or
number of subjects, consent process, or location, please send an email to the IRB coordinator summarizing the changes and attaching any protocol documents that have changed as
Extensions: to conduct the research beyond the one year approval period, continuing review is required. An extension request form (pdf) can be emailed to the IRB coordinator, along with any documents that have changed, at least four weeks prior to the expiration of your IRB approval to ensure continuous approval. NOTE: if you fail to submit an extension request before your protocol expires, you will need to submit a new protocol with all of the required documents included to resume data collection. Data collected outside of the IRB approval period cannot be used for research purposes.
Reporting Problems or Injuries
To troubleshoot problems that may place subjects at risk of harm or to report a research-related
injury, please send an email to the IRB coordinator as soon as possible, within five business days at the latest, describing the problem
or injury in detail.
SJSU Researchers with External Approval
The Office of Research accepts approvals from outside IRBs with federal wide assurance (FWA). 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 for review. The SJSU IRB Registration Form (pdf) 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 getting approval from multiple institutions.