The SMART IRB platform has replaced the JDP Coversheet for documenting review-reliance for graduate student research proposed for thesis or dissertation that engages both SDSU and UCSD in human Subjects research. See the Guidance page for more details.
What's New!
July 11, 2024
*IRB Protocols Moving to iRIS : Go Live Announcement*
To all investigators with Human Subjects Research Protocols in InfoEd!
*August 15: Submit all InfoEd submissions by midnight to ensure a smooth transition of all recently submitted records from InfoEd to iRIS.
*September 1: The InfoEd platform for IRB protocols will be deactivated on September 1, 2024. Protocol data for existing studies in InfoEd has been migrated to iRIS for you.
*October 1: iRIS (Integrated Research Information System) will “go live” as the new and improved protocol management system for all SDSU IRB protocols.
iRIS software, currently used for SDSU IACUC and IBC protocols, is a cloud-based protocol management system featuring:
- Faster protocol completion with Smart forms.
- CITI training updated in iRIS every 4 hours.
- Investigators can track protocol review status with flow charts.
- User-friendly dashboard
- Automated reminders, alerts, and notifications with many other user-friendly features to improve your IRB protocol management experience.
Weekly virtual training sessions will be offered end of July through September by Research Support Services to familiarize you with the new system.
For access use your SDSUid credentials (All InfoEd account holders have access to iRIS) iRIS: Login (Click on the URL to find out how to obtain an account). To activate your account in iRIS, log in with your SDSUid Single Sign-on credentials.
Check out our new site or contact [email protected] for more information.
March 21, 2023
The SDSU HRPP Office has created a new IRB-approved Consent Translation Policy, effective January 2024, for use in human participant research protocols.
Translation of Informed Consent Documents Policy
- Ensures informed consent be understood by research participants
- Requires translated documents reflect language of study population
- Provides options for translation services
- Defines translation terminology
February 15, 2023
Revised consent templates are now available on the SDSU IRB SharePoint site.
October 19, 2022
Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data
To advance efforts under its new Data Management and Sharing Policy (DMS Policy), NIH is providing supplemental information assisting researchers in addressing privacy considerations when sharing human research participant data. This information is not intended to provide a guide for compliance with regulatory requirements nor is it establishing binding rules for NIH awardees, but instead provides a set of principles, best practices, and points to consider for creating a robust framework for protecting the privacy of research participants when sharing data.
NIH Enhanced Checks on Non-Compliance With Trial Registration in Effect October 1, 2021
Enhanced Checks for Compliance with Clinical Trial Registration and Reporting
SDSU IRB is a participating institution in the SMART IRB Reliance Agreement!
April 8, 2022
For a brief walk-through about the SMART IRB Review-Reliance Process, check out this video. More specific information is coming soon. Keep checking for the latest updates.
June 30, 2021
SDSU is now a participating institution in the nationwide SMART IRB Reliance system. Single IRB (sIRB) review is required for all federally funded research as of January 2020. There are some exceptions to this requirement. These exceptions can be found at the Office of Human Research Protections website and at the National Institutes of Health (NIH) website. The SMART IRB reliance agreement facilitates sIRB review. The SMART IRB Reliance agreement can be invoked for non-federally funded research as well. As of June 30, 2021, there are 893 participating institutions. For cooperative, multi-site studies, investigators can search to see if their collaborators are at a participating institution at this link.
Resources for investigators and their study teams can be found here. Other information regarding policies and how to get started can be found on the
SDSU SMART IRB webpage. The SDSU IRB webpage also includes consent templates so that SDSU investigators
can share consent templates with their collaborators who rely on the SDSU IRB for
review under the SMART IRB Reliance agreement. For more information or to schedule
a meeting to discuss the SMART IRB reliance agreement with an IRB Analyst contact
Anne Dodge-Schwanz, the SDSU SMART IRB Point of Contact (POC) or Pat Gordon the Alternate POC.
UPDATE March 24, 2021
- Information regarding the use of Zoom in research and data security practices for sensitive data storage have been placed on the Guidance Page of the IRB website.
- Clinical Trials information https://research.sdsu.edu/research_affairs/human_subjects/clinical_trials
UPDATE September 11, 2020
All About Grants – Am I Doing Human Subjects Research?