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Human Subjects - Institutional Review Board

The Institutional Review Board (IRB) is a 10-15 member committee whose task is to review all research conducted by SJSU students, faculty, and staff that involves the use of human subjects, and to make sure that this research is being done in compliance with university policy. The IRB has purview over any research in which people are asked to either participate physically or where information is sought through interviews, surveys, or observation.  The IRB also has purview when information concerning individually identifiable people is being sought by a researcher through access to files, data bases, or a third party.  Please refer to the links below for information on the required IRB documents, procedures, and IRB related websites.

General Information


IRB Checklist (pdf)
Summarizes all of the documents that need to be submitted for IRB review.

IRB Procedures (pdf)
An expanded version of the IRB Checklist that summarizes the procedures, timelines, and types of IRB review.

List of IRB Committee Members (external link)

IRB Forms and Templates


IRB Application (pdf)
Must be submitted with all IRB paperwork. Includes:

  1. Request to Use Human Subjects in Research
  2. Request to Determine Eligibility for Exemption

Protocol Narrative Template (doc)
Must be submitted with all IRB paperwork.
The template for drafting the narrative section of the IRB protocol that addresses the methods and procedures of the research.

Consent Form Templates (pdf)
The SJSU templates for obtaining informed consent from research participants. Includes: Sample Consent Form for Adult Participants, Sample Consent Form for Research Involving Minors, Sample of Optional Cover Letter, and instructions for creating the consent forms.

Verification of Translation Accuracy Form (pdf)
Must be included with any translated documents that are submitted with the IRB protocol.

Extension Request (pdf)
Can only be submitted after IRB approval is obtained. Investigators wishing to collect data beyond the IRB approval expiration date must file an extension request before the approval period expires.


IRB Registration - Intent to Conduct Human Subjects Research (pdf)
This form should only be used if a) you are an outside investigator that already has IRB approval from another institution to conduct your research at SJSU, or b) if you are an SJSU investigator that has IRB approval from an outside institution to conduct your research elsewhere, or c) if you are an SJSU investigator awaiting approval of a grant proposal and will submit a complete IRB protocol to the SJSU IRB prior to the initiation of the research activities.

IRB Training


SJSU Human Subjects policy requires IRB training for all faculty and staff conducting or sponsoring Human Subjects research. The mandatory training can be fulfilled by completion of the tutorial available through the on-line training provided by CITI (preferred) or through the National Institute of Health.

 

SJSU Human Subjects Policy



s08-7 Policy for Protection of Human Research Subjects (external link)

s05-3 Policy Recommendation Institutional Review Board - Human Subjects Training for Investigators (external link)

IRB Workshops and Announcements


To help familiarize students and faculty with the IRB review process, SJSU requirements, and to answer researchers' questions, the Office of Graduate Studies offers an IRB workshop in the Fall and Spring semesters. The IRB workshop covers procedures, timelines,and required documents. The schedule for the upcoming semester is as follows:

Please check this website at the beginning of each semester for updates regarding the times and location of the IRB workshop. If you are unable to attend you may also download the PowerPoint presentation: The IRB: An Introduction for SJSU Students and Faculty.

Contact Information



Alena Filip
Thesis/IRB Coordinator

Office of Graduate Studies and Research

San José State University
One Washington Square
San José, CA 95192-0025

Telephone: (408) 924-2479
Email: Alena.Filip@sjsu.edu

IRB protocol submissions are not accepted by fax. Please mail two copies of your protocol to the address above.

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Additional IRB Related Resources and External Links:

SJSU Academic Senate

US Office for Human Research Protections (OHRP)

Family Educational Rights and Privacy Act (FERPA)

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

 

 

Important: Documents in PDF format require the most recent version of the free Adobe Acrobat Reader for viewing and saving.

 

 

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