Important Updates Regarding the 2018 Common Rule Implementation
Important Updates Regarding the 2018 Common Rule Implementation:
- Investigators will not be able to submit any new studies to the VCU IRB between January 8, 2019 and completion of the RAMS-IRB patch expected on/around January 22, 2019.New study submissions already in process that do not reach a status of “approved” prior to January 21, 2019 will be returned to investigators for revision in order to comply with the new regulations. New study submissions that are in development will need to convert to the new smartform after the patch in order to comply with the new regulations.
ORSP is implementing a hold on submission of new studies for two reasons:
- The compliance date of the revised Federal Policy for the Protection of Human Subjects (the “2018 Common Rule”), is January 21, 2019. Studies approved by the VCU IRB on or after the compliance date must meet the provisions of the revised policy. A study submitted on January 9 is unlikely to be approved before the compliance date and would not include information critical to being able to approve the study after the compliance date.
- The temporary hold will allow ORSP staff to focus efforts on completing IRB review and approval of new research proposals already under review which may be approved prior to the compliance date of the 2018 Common Rule.
- Amendments created after the patch will automatically force transition to the new smartform, and for eligible studies will require updates to comply with the 2018 Common Rule. Amendments created before completion of the RAMS-IRB patch will be processed using the existing smartform. Amendments created after the patch will use the new smartform.
Amendments created before the patch to address the 2018 Common Rule will be unaffected, but researchers should be aware that the first amendment to their study after the patch will impact their study in one of two ways:
- All amendments created after the patch will use the new smartform. As we transition to the new form, our teams are working hard to ensure that data already entered into the existing smartform transitions to the new smart form to the extent possible. Because some questions are undergoing dramatic changes, or being removed all together, researchers will need to review the new smartform closely before submitting. For the same reason, the historic smartform may not be accurate after the patch. If researchers need to access their approved smartform, this can be found in the “snapshot” feature of the study’s most recently approved submission in RAMS-IRB.
- Studies that are not regulated by the FDA or funded by the Department of Justice will be forced to convert to the 2018 Common Rule upon creation and submission of their first amendment post-patch. The majority of conversion is addressed by the revised smart form. Beyond the smartform, consent forms created using the VCU template prior to March 2018 will need to be updated to meet the standards of the 2018 Common Rule. ORSP is developing resources to assist in this conversion to the new rule that will be posted online in the coming weeks.