Changes in the federal Common Rule governing research with human participants go into effect on January 21, 2019. To prepare for these changes, there will be a temporary freeze imposed on new study submissions (initial IRB and Exempt applications) between Wednesday, January 16th at 4 p.m. and Sunday, January 20th at 8 p.m. Other submission types will be accepted during this interval. Buck-IRB will be briefly offline on Sunday, January 20th beginning at 6 p.m. while the system is updated to comply with revised Common Rule changes.
What the Final Common Rule Changes Mean for Your Research
As we approach the end of the year and the upcoming general compliance date of January 21, 2019, here is what you need to know:
- There is no phase-in period. Any study approved on or before January 20, 2019, must comply with the current Rule, and any study approved on or after January 21, 2019, must comply with the new Final Rule.
- Buck-IRB will be briefly offline on January 20th while the system is updated. In addition, there will be a temporary freeze imposed on new study submissions between Wednesday, January 16th and Sunday, January 20th. This freeze is to ensure that investigators do not get caught between versions of the rule, and to avoid having to modify submissions to meet the new rule.
- Initial IRB submissions submitted on or after January 1, 2019, will likely be approved after January 21, 2019 based on typical review timelines. Further, you may experience a temporary increase in IRB approval timelines during this period while our office implements Common Rule changes.
What you can do:
Currently Approved Studies
- ANNUAL REVIEW: If your study will expire before February 15, 2019, submit your continuing review/annual status report as soon as possible. As noted above, approval timelines may be slightly longer than normal; allowing ample time for screening and review will decrease the likelihood of study expiration.
- AMENDMENTS: Please note in Buck IRB once a continuing review is submitted an amendment cannot be submitted until the continuing review has been approved, please prioritize accordingly. If your study expires in the next 60 days, you may wish to submit your continuing review/annual status report prior to submitting new amendments, since approval timelines may be slightly longer than normal.
New Initial Submissions
- MODIFY QUICKLY: If your initial submission is currently in the review process, respond to modifications as quickly as possible to ensure review and approval will be completed by January 20, 2019, under the current Common Rule regulations. Otherwise, application and consent form revisions may require additional (in some instances significant) modifications to comply with the Final Rule.
- HOLD or WITHDRAW/RESUBMIT: You may want to wait until after the Final Rule compliance date to submit your initial IRB application. Under the Final Rule, some types of research will no longer require IRB review and instead will qualify for exemption. If your initial submission is received after December 31, 2018, it will be screened for possible review options consistent with the Final Rule.
- PLAN AHEAD: If you are currently in the process of preparing an initial submission, ensure your study documents include the updated consent templates that are located on the ORRP website at http://orrp.osu.edu/irb/investigator-guidance/consent/.