After IRB Approval: Continuing Reviews, Amendments, and Unanticipated Problems

News (08/17/2018): Policy Updates and Continuing Reviews to be Eliminated for Most Minimal Risk Research. The SBS IRB Policies and Procedures Manualhas been updated in order to begin taking advantage of the Three Burden-Reducing Provisions available to federally funded research, and to begin phasing in additional flexibilities for non-federally funded research. Look for more information (as well as updates to guidance, webpages, templates, AURA, etc.) soon.

A. Continuing reviews

With the exception of projects that are determined to be exempt from the regulations, the IRB is required to conduct continuing review of research at intervals appropriate to the degree of risk to human subjects. For federally funded research, the IRB approval period cannot be longer than one year. For minimal risk research that is not federally funded, the SBS IRB may grant an approval period of up to 3 years.  For research involving greater than minimal risk, the IRB will determine the appropriate approval period. Approval letters will specify the date of expiration of IRB approval.

The AURA-IRB system will send all investigators reminders to request continuation several months prior to the expiration date of IRB approval.   Keep in mind that the Principal Investigator must endorse all submissions before they are submitted to the IRB in AURA.The average time for the SBS IRB to process a continiung review submission is 2 to 3 weeks (this allows time for any clarifications needed during the review process), so please submit the continuing review application through AURA at least 3 weeks before your study's expiration date.  

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.  The IRB cannot grant retroactive approval for research done after the expiration date.

If a Continuing Review request has not been filed within sixty days of the expiration date, the protocol will be administratively closed by the IRB.

B. Changing and amending your research protocol

After an initial submission has been approved by the IRB, all subsequent changes (including changes to the protocol, recruitment materials, and consent documents) must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the research subjects. Complete an Amendment application through AURA that describes the proposed changes to the research.

C. 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 no later than 10 days following the event. This can be 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.