Major Regulation Changes
In December 2016, the United States enacted the 21st Century Cures Act (Cures). Enactment of Cures was the culmination of a bipartisan, multi-year effort by Congress to modernize the cycle of discovery, development, and delivery of innovative medical products.
Cures authorized resources for the National Institutes of Health (NIH) to support biomedical research through the funding of basic, translational, and clinical research. Cures gave the NIH the tools and flexibility to alleviate administrative burdens that can hamper biomedical innovation, increase data sharing among NIH-supported researchers, authorize innovation prize competitions, support high-risk, high-reward research, increase funding opportunities for young investigators, improve privacy protections in research volunteers, and encourage the inclusion of diverse populations in clinical research.
In Sec. 2034. Reducing Administrative Burden for Researchers, the Secretary of HHS is required, within two years of enactment, to make revisions to harmonize existing regulatory policies and reduce administrative burden.
Additionally, Cures provided the Food and Drug Administration (FDA) with new authorities to modernize the regulation of medical products throughout the lifecycle of discovery, development and delivery.
On a similar timeline, in January 2017, the U.S. Department of Health and Human Services (HHS), along with 15 other federal departments and agencies, issued a final rule updating the Policy for the Protection of Human Subjects (also referred to as the “Common Rule”). The Common Rule is the set of regulations governing the conduct of human subjects research conducted or sponsored by the federal departments and agencies that subscribe to the rule. UVM applies the Common Rule to all human subject research conducted at the two institutions.
The FDA has not signed onto the Common Rule changes and therefore FDA regulated studies are not currently subject to these Common Rule changes. However, as mandated by the Cures Act, HHS and the FDA must work together to harmonize long-standing differences within the next three years.
The Research Protections Office (RPO) staff have been working to educate themselves about the new regulatory changes and how they will affect our current business processes, policies, and InfoEd. We have created a new web page that provides a snapshot of all the Regulatory Changes (opens in a new window). We have described where there are discrepancies between current FDA and HHS regulations, and provided a corresponding transition plan for each of the changes. As the January 19, 2018 date approaches we encourage you to check this web page periodically for updates. Additionally, we will forward notifications via email when we have updates to share.
One of the more prominent changes to the Common Rule is the elimination of the requirement for continuing reviews for most minimal risk, non-FDA regulated, (expedited) protocols as well as for research that has progressed to the point that it involves only data analysis or accessing follow-up clinical data as part of clinical care. The rule allows for instances where continuing review would still be required with adequate justification. PIs must continue to submit amendments, key personnel changes, etc. in real-time to the IRB.
Please note that this change does not apply to protocols that are FDA regulated. The requirement to conduct continuing human subjects review has not changed for this specific group of studies. Researchers will continue to be reminded of this requirement as usual.
While the final rule does not require continuing review by the IRB, it is important that the IRB is aware of all ongoing research activities at our institutions. To that end, we will still require researchers to provide an annual update to the IRB simply indicating the status of the research. This annual update will also serve to remind researchers of their obligations to submit amendments, safety submissions and keep their key personnel rosters updated.
Beginning January 1st, the continuing review reminders that you receive will have new instructions for expedited protocols that do not require further continuing review and that expire after January 18, 2018.
For a more information about UVM’s transition plan for continuing reviews as well as other changes in the Common Rule and NIH policies, visit the Regulatory Changes (opens in a new window) web page.
Single IRB for NIH Funded Projects and Western IRB
As of January 25, 2018, NIH policy requires that all NIH multi-site protocols use a single IRB of record. UVM researchers who are developing NIH proposals of this type and wish UVM to be the IRB of record will subcontract with Western IRB (WIRB). WIRB is an independent IRB located in Olympia, Washington that provides services for academic and non-academic institutions. WIRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). WIRB is part of the WIRB-Copernicus Group (WCG) which includes Copernicus Group IRB, Aspire IRB, MidLands, IRB and New England IRB. Further information regarding use of WIRB can be found on our Western IRB page (opens in a new window).
Currently, UVM will only allow review by an external IRB for NIH funded multi-site clinical trials in order to comply with the NIH Single IRB mandate. The requirement to use single IRB for other funded protocols is not required until 2020 under the new Common Rule.
Ongoing Consent - Consent Addendums
When changes to the risk/benefit ratio occur during the conduct of a protocol, it may be necessary to inform currently enrolled subjects. The IRB may determine that subjects must be informed of new findings or toxicities not known at the time of initial consent and be given the opportunity to consent to continued participation. Sponsors have often requested that subjects previously entered into a protocol sign a full revised consent document each time there are changes to the risk/benefit balance.
Over the years, the IRB has noted at several monitoring visits that subjects were being requested to sign full consents multiple times over the life of a protocol. It was not clear in these cases what information was being shared with the subjects and whether subjects understood what the changes in risks were and what the risks meant to them. The IRB determined in these instances that it is more respectful to subjects to present only the new information. As the consent addendum includes only the new information and a signature area for the subject to sign, it allows for a better understanding of the new risks making for a more informed decision regarding continued participation. Please see Research Manual section 8.B.9. (opens in a new window) for more information regarding ongoing consent.
New Required Form - Research Data Management and Security Plan
In our last newsletter we informed you that we had developed a Research Data Management and Security Plan (DOCX) form along with a guidance sheet (DOCX) that was undergoing beta testing. The form is now ready for release. Going forward, this form is required to be submitted along with all new full and expedited level protocols as well as any protocols where the IRB requires a clearer plan for the protection of data. This supplemental information affected multiple of our existing forms, so be sure to use the most current version of any submission forms so that you are not entering redundant information. InfoEd has been modified to allow for this new document category to be uploaded when completing your submission. Please visit our IRB forms library (opens in a new window) to get the most recent version of our forms.
Protocol Contact Information
The success of electronic protocol management depends upon the receipt of email from our office. If you feel like you have not been receiving notifications and are either a PI or a delegated contact on a protocol, you should take a moment to do the following:
1. To ensure we have the correct email address in InfoEd, you may check and/or update the address by logging into InfoEd, clicking on “My Profile” and clicking on “Edit” to change (if necessary) your email address. You must click “Save” after any edits are made.
2. Many of you have dual appointments which also means that you have two email addresses, one for each institution. You may want to check to make sure that mail is being forwarded to your preferred address (i.e. the address in InfoEd). For more information about email forwarding, visit the UVM TECH TE@M (opens in a new window).
If neither of these two steps appears to correct the issue, contact the RPO office at 656-5040 to assist you.