Important Changes to the Common Rule
On January 21, 2019, revisions to the Federal Policy for the Protection of Human Subjects will go into effect. This new version of the “Common Rule,” as it is typically known, represents the first revision to the rule since its publication in 1991.
Many of us in the world of Human Subjects Protection have been alternately excited by the promise of flexibility in the new rule and frustrated by delays in implementation. Nonetheless, the VCU Office of Research Subjects Protection is prepared for the new rule, and excited to see the changes the rule will bring.
This notice includes key information as we move toward implementation:
1. Three things you need to know about implementation at VCU
2. A summary of the major changes in the new rule
3. Resources
Three things you need to know:
1. Between December 1, 2018 and January 18, 2019 ORSP will emphasize completing IRB review and approval of new research proposals already under review. Our intent is to move studies in the process of their initial review to an approved status prior to the implementation date of the new rule. New study submissions and amendments that have not reached a status of “approved” prior to January 18, 2019 will need to be revised to complete the new smartform after January 21.
If you have a new study or amendment under review with the IRB please be prompt in responding to IRB requests. This will help us move your submission forward to an approved status as quickly as possible under the existing rule and using the current smartform. The November 2018 RAMS IRB Patch put in place a 3-day reminder to PIs for outstanding responses in an effort to move forward as quickly as possible; the three-day reminder will be changed to every 7 days after implementation of the new rule.
If you are planning to submit a new study or amendment to the IRB, please plan to submit as soon as possible to increase the probability of reaching approval prior to January 18, 2019. Otherwise, you may wish to postpone your submission until after implementation of the new rule. If you don’t anticipate making your submission before the winter closure, you may be better off waiting until after January 21, 2019 to make your submission on the new smartform.
2. RAMS IRB will be patched on January 18, 2019 to implement significant changes to address the new rule. Between January 18 and 21, ORSP will be unable to approve submissions while the system is updated to comply with the new rule. After the patch, the smartform will have a completely new look and feel. Changes include:
Fewer Pages – Wherever possible, we are collapsing pages to reduce the overall number of pages for researchers to complete. In addition branching logic and pop-out questions are being adjusted to make the smartform more user-friendly.
Updated Questions – Many questions in the smartform are being revised to be more descriptive of the information the IRB is seeking or merged to reduce redundancy. In many cases, the questions will now include in them content that was previously embedded in help text.
Some questions are being removed or relocated. We have placed an emphasis on ensuring that questions asked in the smartform relate directly to determinations the IRB must make for compliance with the new rule and with institutional policies. Many questions that do not pertain to IRB review are being removed. Questions that do not necessarily relate to IRB determinations, but which have been included at the request of other University offices and programs are being moved to the end of the smartform.
3. Ongoing studies will be converted to the new rule. In order to streamline processes and procedures for the VCU research community, and to extend the benefits of the new rule to ongoing research, ORSP has decided to move all eligible ongoing studies to the new rule. This applies to any study that receives its initial approval prior to January 21, 2019. Beginning February 1, 2019, PI’s with studies expiring in July will begin receiving requests for an amendment to update ongoing studies to the new rule and smartform. The schedule we have developed is meant to keep an even workload for reviewers while shifting ongoing studies to the new rule. We will provide additional information about the conversion of existing studies on our website in the coming weeks.
Studies that are funded or regulated by the Department of Justice or Consumer Product Safety Commission, or that are regulated by the FDA are not eligible to convert at this time. The FDA plans to harmonize its regulations with the new Common Rule; we will provide updates on FDA’s progress.
You will notice in conversation materials that the new rule is referenced as the “2018 Common Rule” by regulatory agencies and in our forthcoming written policies and procedures (the rule was effective in July 2018, with the bulk of its provisions postponed to 2019).
Major changes in the new rule:
1. Expansion of Categories of Exempt Research
The new rule expands the scope of research that is exempt from IRB review. We anticipate that some studies which previously required expedited review – or even full board review – may qualify for exemption under the new rule.
Researchers should be aware at this time VCU is not implementing two categories of exemption that make use of “broad consent” for future use of identifiable information for research purposes. This has been one of the more controversial provisions of the new rule and it remains to be seen whether “broad consent” constitutes meaningful – and legally effective – informed consent for research.
Some of the expanded exemption categories now include a requirement for “limited IRB review.” Because exempt determinations are made by ORSP staff who are also IRB members, our current processes regarding review of exempt research do not need to change to address the “limited IRB review” requirement.
2. Informed Consent
The new rule involves changes to the requirements for informed consent. ORSP implemented revised informed consent and assent templates in March 2018 which has been required for initial review of all studies since then. These new templates meet the requirements of both the existing Common Rule and the new rule.
If a study received its initial approval prior to March 2018, the study will need to update to the new consent template when submitting an amendment to convert to the new rule unless the study is no longer accruing.
3. Continuing Review
Under the new rule minimal risk research does not require continuing review unless the IRB determines otherwise. Overall, this will reduce workload for researchers and for ORSP staff and IRB members.
As studies convert to the new rule, those that are determined to be minimal risk will be evaluated to determine if continuing review will be required going forward. In the coming weeks we will provide additional details about the new status update process that studies will use when continuing review is not required for a study.
4. Single IRB
While NIH has lead the way in requiring a single IRB for multi-site research, the revised Common Rule will codify this requirement for all federally-funded research conducted under a Common Rule Agency. The effective date of the Common Rule requirement for single IRB is one year after implementation of the new rule (January 2020). ORSP will provide additional details as the compliance date approaches.
Resources:
1. VCU Office of Research and Innovation
Keep an eye on the web page’s Human Research page and the ORSP blog for updates. In the coming weeks we will be updating nearly all of our written policies and procedures, adding pages for conversion to the new rule, and updating guidance documents to address the provisions of the new rule. Email us with your questions at ORSP@vcu.edu.
2. Office For Human Research Protections (OHRP)
The US Department of Health and Human Services’ Office of Human Research Protections (OHRP) maintains a web page with details on the revised Common Rule. The page includes links to the details of the final rule, and the delay in implementation. The page also includes a timeline of the events leading to the new rule.
3. Public Responsibility in Medicine & Research (PRIM&R)
PRIM&R, the primary professional organization for Human Subjects Protections Professionals, maintains a publicly accessible web page “Focus on the Revised Common Rule.” The page includes a number of quick links to key regulatory updates, resources and tools, all of which help to paint a full picture of the revised rule and its impact.
4. CITI Program
The CITI Program also maintains a webpage with a comprehensive set of resources related to the revised Common Rule. The CITI training modules for VCU will be updated to address the new rule.
Since the Advanced Notice of Proposed Rule Making seven years ago, the revised rule has changed shape dramatically. Implementation has been delayed twice – to both cheers and jeers – yet many of the impacts of the new rule are yet to be seen. We expect the first few years under the new rule to be a learning experience for all of us and we look forward to working together with the research community at VCU to make the transition as smooth as possible.
Categories Announcements and Updates