Basic Process and Overview

Navigating the SBS IRB (.pdf 07.17.2019) covers some basic history, definitions, review types, and timelines. 

Review Determinations

The SBS IRB Office can help investigators determine whether their project constitutes human subjects research that requires IRB review or exemption. For general questions, please call or email our office. Official determinations can be requested through the AURA application system. Not obtaining IRB approval for regulated human subjects research activities can have serious consequences (e.g., ability to publish findings, keep or receive funding, use data towards future research, as well as institutional consequences).

Initial Review

All research activities involving human subjects must be reviewed and approved by the IRB unless prospectively determined that the research falls into a category of exemption. Determinations about whether an activity is exempt or constitutes research involving human subjects are made by designated SBS IRB staff. Investigators may not initiate human subjects research activities (including recruitment, consent, data access, etc.) until they have received approval from the appropriate IRB or official notification that the research has been determined to be exempt.

Amendments

All proposed changes in research activities (amendments) must be reviewed and approved by the IRB before implemented, except as necessary to eliminate apparent immediate hazards to subjects. Investigators may not implement changes until final approval is received. Amendments are requested in AURA within the study-specific page. 

Continuing Review

 Approval letters will specify the date of expiration of IRB approval. Exempt research and most minimal risk research will not have official expiration dates and are instead approved as written for the time period specified (any changes require an amendment).

If required, approval letters will indicate the data of expiration. The AURA-IRB system will also send all investigators reminders to request continuation prior to the expiration date of IRB approval. Please keep in mind that the Principal Investigator must endorse all submissions before they are submitted to the IRB in AURA and continuing reviews can take several weeks to process (this time allows for any clarifications needed during the review process or to get on the next meeting agenda). Please submit the continuing review application through AURA at least 3 weeks before your study’s expiration date for expedited projects, and at least 5 weeks in advance for studies that require full board review.  

If IRB approval expires, all research activities involving human subjects MUST STOP, including subject contact, data collection, and data analysis. The only exception to this requirement is for activities that should be continued for reasons of participant safety. No new subjects may be enrolled after IRB approval lapses. If human subjects research activities continue after the expiration date, the investigator is out of compliance with the federal regulations. If a continuing review request has not been filed within sixty days of the expiration date, the project will be closed in the system a new, initial application will need to be submitted in order to request to continue the research.

Adverse Events and/or Unanticipated Problems

Any unanticipated problems involving risks to subjects or complaints from subjects must be reported promptly to the SBS IRB (generally no later than 10 days following the event). Reporting is done online through AURA-IRB. The IRB Chairperson will report in writing any serious report of serious adverse events or significant noncompliance to the Institutional Official, who will in turn report as needed to the relevant Department or Agency Head (if the research is funded by a federal department/agency), any applicable regulatory body and the HHS Office of Human Research Protections.

Study Closure

Investigators are responsible for notifying the IRB when a study is completed or is being closed. It is important to note that all research activities involving human subjects, including data analysis with individually identifiable or coded private information, must be complete in order to terminate IRB approval for a study. Closure/termination can be requested in AURA.