December 20, 2018
Dear Investigators,
The Research Protections Office at UVM is once again preparing for the Common Rule Changes that were placed on hold over the summer. We have received no indications that there will be any further delays in the compliance date of January 21, 2019.
Some studies may be grandfathered under the pre-2018 rule, however if we wish to take advantage of the possible reduction in burden, we need to apply all the applicable Common Rule changes to each protocol. For instance, if your protocol meets criteria for no more continuing reviews but there is a consent form, the consent form must include all the required Common Rule consent elements prior to ceasing the continuing reviews. It is all or nothing.
For your convenience, please find below a list of the upcoming changes. The implementation and transition plan can be found on our Regulatory Changes (opens in a new window) web page.
Continuing Review
Continuing review will no longer be required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. Just prior to the Click protocol conversion, some researchers were notified that their protocols fit the criteria and therefore will no longer need to submit continuing reviews. Until you are officially notified, please respond to requests for a continuing review as your analysts need to make this determination.
Exemption Category Changes
This applies to new exempt protocol submissions on or after January 21. Existing exempt projects are grandfathered. There are revisions to existing categories as well as new categories for exemption. Some exemptions now allow prospective collection of data as well as allowing collection of identifiable data (health record reviews). These types of exemptions require new limited IRB review (similar to an expedited review process), but do not require continuing review. New exemptions 7 & 8 will not be implemented at UVM. A powerpoint covering the changes can be downloaded for reference.
Informed Consent Concise Summary
All new consents must have a concise summary on page one to include study activities, risks and benefits. Our website is up-to-date with a new consent template as well as a lay language dictionary and other guidance materials. Subjects who have already signed a consent will not need to be re-consented. Existing consents may or may not require revision based on other elements of the Common Rule changes. IRB analysts will make this determination at time of continuing review.
Informed Consent Posting
Consents must be posted to a Federal website after the clinical trial is closed to recruitment. Guidance on this requirement is still pending. The initial thoughts are that consents can be posted to ClinicalTrials.gov (opens in a new window).
Thank you,
RPO Staff