2018 Common Rule Changes
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What is the revised Common Rule?
The U.S. Federal Policy for the Protection of Human Subjects, also known as the ‘Common Rule’, is the baseline standard of research ethics by which any research in the U.S. is held; nearly all U.S. academic institutions hold their researchers to these standards regardless of funding. UC applies the Common Rule standards to all human subjects research studies.
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions the Common Rule. A final rule was published in the Federal Register (FR) on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018, and June 19, 2018. The revised Common Rule will be effective on January 21, 2019.
This revised rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight committee does not add inappropriate administrative burdens, particularly to low-risk research. It also allows more flexibility in keeping with today’s dynamic research environment.
The Revised Common Rule does not apply to FDA-regulated and Department of Justice-funded human subjects research studies.
What are the major changes of the Revised Common Rule?
Major Regulation Changes
- Continuing Review - No longer required for most 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. However, there are exceptions to this rule.
- Exemptions – There are new exemption categories and clarification of existing categories. Some exemptions may require * “limited IRB review”. The UC system has already been exercising the new exempt category for certain research.
- * Limited IRB review is a process that is required only for certain exemptions and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met. Limited IRB review may be done via the expedited review mechanism, that is, by the Chair or an experienced IRB member designated by the Chair (although it can also be conducted by the full IRB). Continuing review is not required.
- Informed Consent Document - A new ‘key information’ section will be required for those detailed consents, such as those required for Clinical Trials. This section must present a summary of all pertinent information to participants in the study. Additionally, this re-arrangement of content must be designed to facilitate a potential subject's decision to participate or not.
- Single IRB-of-Record (sIRB) - IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020. This may mean you will need to use either the Reliance Registry or SMART IRB for central IRB review for federally funded, multi-site studies. For use of sIRB, please contact ORI in advance of your proposal.
Please be advised that UC will not be using the Broad Consent exemptions (categories 7 & 8) at this time. These two exemptions will not be implemented because UC as an institution cannot track consent as is required for these categories.
Minor Regulation Changes
- Addition of 4 categories of scholarly and journalistic fields that do not constitute research in and of themselves. However, it only excludes certain activities, the new common rule (post-2018) does not excuse the entire academic field
- Changes to how the IRB maintains membership, operations and record keeping, including appropriate access to meeting space and staff to support IRB review and recordkeeping duties
- A requirement for the establishment of written procedures for conducting IRB reviews and for ensuring prompt reporting of changes to the IRB
- Pregnant women or handicapped or physically disabled individuals are no longer included as examples of populations that are potentially vulnerable to coercion or undue influence.
- The term “individuals with impaired decision-making ability” now replaces the term “mentally disabled persons.”
Does the new Common Rule allow researchers to self-identify their projects as exempt?
No. This requirement remains unchanged from the current Common Rule to the Revised Common Rule. An assessment by an IRB member will still be needed in order to determine if a project meets guidelines for exemption.
How will the Revised Common Rule affect the review of IRB applications?
IRB Applications submitted after the implementation date (January 21, 2019) will be subject to the Revised Common Rule requirements.
- Pending (In Review/Not yet approved)
Applications submitted prior to the implementation date but are still in the review process as of January 21, 2019, will be subject to the revised Common Rule requirements. As such, additional revisions may be requested to comply with the revised regulations.
- Existing applications
All projects reviewed and approved prior to the implementation date remain under the old rule. These projects retain their existing level of review and all other IRB requirements, including continuing review requirements. Existing applications that would like to convert to the revised requirements will be provided case-by-case information on transitioning to the new rules (if applicable).
How will the Revised Common Rule affect the Continuing Renewal review process?
For new studies approved on or after January 21, 2019, continuing review will no longer be required for most minimal risk studies. For new studies determined to qualify for exempt or limited IRB review under the revised Common Rule, continuing review requirements do not apply. For new studies determined to qualify for expedited review under revised Common Rule, the regulations now stipulate that continuing review is not required unless justified by the IRB. Therefore, most expedited studies will not require continuing review. Justifications for continuing review might include:
- The project involves additional regulatory oversight.
- Study procedures or risks indicate greater oversight is necessary.
- Other research specific considerations.
Additionally, continuing review is not required for research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
- data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
Although continuing review will not be required for some eligible Expedited studies, Principal Investigators are still responsible for the following:
How will the revised Common Rule affect Existing and Ongoing Research?
The revised Common Rule requires existing research (approved or determined exempt prior to January 21, 2019) to remain compliant with the previous regulations. Therefore, for existing studies, researchers do not need to take any action at this time beyond maintaining active IRB approval. Maintaining IRB approval includes submitting for continuing review (unless previously granted exemption). Existing research can be transitioned to operate under the revised Common Rule only after being reviewed and determined to comply with the revised Common Rule. To be brought into compliance with the revised regulations, existing studies may require substantial revisions.
The revised Common Rule offers flexibility to allow existing studies to remain under the previous regulations, existing studies are not required to comply with the revised Common Rule. Studies cannot pick and choose components between the two sets of regulations. In order to transition to the revised Common Rule, a study must be determined to satisfy ALL criteria under those new (aka revised) regulations. Once a study transitions to the revised Common Rule, it cannot transition back to the old Rule. The only exception would be if a study approved under the revised Common Rule obtains funding by the Department of Justice or becomes subject to FDA oversight. In this instance, the study would then need to transition to the old rule.
Existing studies requesting to transition to the revised Common Rule will be assessed for transition readiness on a case-by-case basis.
How will the revised Common Rule affect the Informed Consent Process and documentation?
The revised Common Rule requirements implement changes to the content, organization, and presentation of information to facilitate a participant’s comprehension and decision about whether to take part in research. These changes include the use of a Key Information section prior to the detailed (i.e., full) consent form. The key information section should be a concise and focused presentation of the key details that is most likely to assist in understanding the reasons why one might or might not want to participate in the research. Following the key information page, the detailed consent form will follow all previous requirements but may include some of the new required elements listed below.
New required element of informed consent for studies involving collection of identifiable private information or identifiable biospecimens. One of the following statements must be in the informed consent:
- A statement that the identifiers might be removed from the information, and after such removal, the information could be used for future research studies or distributed to another investigator for future research without additional informed consent; OR
- A statement that the subject’s information or specimens, even if identifiers are removed, will not be used or distributed for future research
New additional elements of informed consent will be required for applicable research studies. These additional elements are:
- A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
- A statement regarding whether clinically relevant research results; including individual research results, will be disclosed to subjects, and if so, under what conditions; and
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing
Whom do I contact if I have questions about the revised Common Rule changes?
The Office of Research Integrity is available to answer questions regarding the Revised Common Rule changes and can be contacted via email at firstname.lastname@example.org.
There are also several online resources available as well:
What are some of the items NOT in the final revised Common Rule?
- Self-exemption determinations by researchers;
- Federally issued tools such as consent templates, checklists;
- IRB review and approval requirement for de-identified bio-specimens;
- A Requirement to include non-required elements of consent in an appendix