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

  1. 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. (Note, some browsers' pdf viewers no longer display previews of certain pdf forms. You may need to download the form directly to your computer and view it in Adobe Reader or Adobe Acrobat.)
  2. 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.
  3. 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

  1. 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.
  2. 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 pageEmail or fax submissions are not accepted.
  3. Await a screening email from the Human Protections Analyst confirming that your protocol was received and containing information about how it will be reviewed (7-10 business days).
  4. 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 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.
  5. 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 Modifications and Extensions

Modifications: 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 Human Protections Analyst summarizing the changes and attaching any protocol documents that have changed as a result.

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 Human Protections Analyst, 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 Human Protections Analyst 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.