IRB Submission Review Time
HRPP is currently reviewing new protocol submissions received on August 10th, 2018*.
HRPP is currently reviewing amendment submissions received on August 8th, 2018*.
*The current submission date is updated weekly on Wednesdays*
All progress reports submitted are prioritized based on expiration to ensure approval does not lapse.
Continuing Review: New Common Rule
Currently, all non-exempt research requires continuing review and approval by the IRB at least once a year. Effective on January 21, 2019, Continuing Review will no longer be required for:
Most studies eligible for expedited review (minimal risk research);
Studies that underwent Full Board review for which ongoing activity is limited to data analysis, including analysis of identifiable data/biospecimens OR involve accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
Are there exceptions?
For studies that meet the above criteria the IRB can, on a case-by-case basis with documented justification, impose continuing review requirements.
Continuing review will still be required for FDA regulated research studies.
Changes to the research will still require an amendment submission even if continuing review is no longer required. Reportable events related to the research will still need to be submitted.
At the time of the first continuing review for each currently approved study that takes place after January 21, 2019, the HRPP will work with the research team to assess the applicability of the above criteria. If the study meets the require for no additional continuing review, this determination will be documented and the research team will be notified. If no continuing review is required based on this determination, there will be ongoing quality assurance monitoring efforts conducted to confirm if the study is still ongoing and to prompt investigators to close the study if human subject research activities are complete.
Consent requirements and tools
As first announced by HRPP to our research community in April 2018, the changes to the Common Rule require that consent forms “begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject … in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”
While the HRPP has eased investigators into this requirement since the spring, we are unable to make individual exceptions starting in October 2018 as the January 2019 implementation date draws closer. We will continue to adhere to our previously publicized criteria for updating your existing consent documents:
- The new consent format must be used for all NEW protocol submissions;
- For EXISTING studies, investigators must make the formatting change to their consent document(s) when submitting an amendment that already requires a consent change;
- All investigators must update their consent documents at the time of their next CONTINUING REVIEW, if they have not done so already;
- If your study does not meet the above criteria, you will hear from us this fall/winter prior to the implementation date and will be given a deadline by which you must update your consent documents via an amendment.
The HRPP has templates and tools available on the Forms page of our website to assist investigators with developing consent documents that conform to this requirement.