RAMS IRB Patch and the New Common Rule
We’re writing to provide updated information on the RAMS-IRB Patch and the 2018 Common Rule.
In materials from ORSP you will begin seeing references to the “2018 Common Rule” and the “Pre 2018 Common Rule.” This is the terminology used by regulatory agencies. The new version of the Common Rule is referred to as the “2018 Common Rule” because it went into effect in July 2018, with compliance delayed to January 2019.
RAMS-IRB will be patched on Monday, January 28, 2019.
- The patch will take the system offline for several hours.
- After the patch, studies that were in a state of “PI Action” will temporarily revert to IRB staff statuses in order to map IRB comments to the appropriate sections of the new smartform. IRB staff will return these to PIs as quickly as possible.
- The “submit” button will return for new submissions after the patch. PIs who have studies “in development” will find their submissions are automatically converted to the new smartform. While every effort is being made to preserve information entered into the smartform before the patch, responses entered before the patch may need to be updated to adequately respond to the revised smartform.
In the meantime:
- ORSP staff continue to review initial, amendment, and continuing review submissions. While the IRB may approve amendments and continuing reviews, the IRB cannot approve new studies until after the patch in order to ensure compliance with the 2018 Common Rule.
- The ORSP website is in the process of being updated to include information on the new smartform and conversion to the 2018 Common Rule (for eligible studies). Check out conversion resources below.
- Written Policies and Procedures (WPPs) for the IRB have been updated and posted to the ORSP website. All updated WPPs are available in a single PDF document here. The individual entries on the “Policies and Guidance” page are in the process of being updated.
- All ORSP staff and 47 of 54 IRB members have completed orientation to the 2018 Common Rule.
- ORSP is happy to answer your questions about the 2018 Common Rule. Contact us at ORSP@vcu.edu or 804-828-0868.
Reminders:
- All new studies reviewed by the IRB after January 21, 2019 must use the revised smartform.
- Studies approved by the IRB after January 21, 2019 must be reviewed under the 2018 Common Rule unless they are regulated by the FDA or funded by the Department of Justice.
- All ongoing studies will convert to the new smartform in 2019, and if eligible will also convert to the 2018 Common Rule.
- Conversion will happen upon submission of the first amendment to a study after the patch. Otherwise PI’s will be prompted to submit an amendment to convert 6 months prior to the study’s current expiration date.
Recognizing the inconvenience imposed by stopping new submissions in preparation for the 2018 Common Rule, ORSP staff will make initial review of new studies our highest priority post-patch. Please be patient as we expect a high volume of new study submissions and must also meet our obligations to review of ongoing studies.
Conversion Resources:
Categories Announcements and Updates