Revised Common Rule FAQ – December 6, 2018

To: UNC Research Community

On January 21, 2019 the Final Revision to the “Common Rule” will go into effect as announced by The U.S. Department of Health and Human Services (DHHS).  The “Common Rule” is a short name for “The Federal Policy for the Protection of Human Subjects” and accounts for the HHS regulations (45 CFR part 46).  The revised “Common Rule” will be followed by 20 agencies and will continue to outline the basic provisions for Institutional Review Boards (IRB), informed consent, and Assurances of Compliance [additional information can be found at: Federal Policy for the Protection of Human Subject (Common Rule). The Food and Drug Administration (FDA) regulates clinical investigations of drugs, biological products and medical devices and is not considered a common rule agency and at this time has not harmonized their regulations with the revised “Common Rule”.   In preparation for these revisions, the Office of Human Research Ethics (OHRE) will be presenting an informational session hosted by NC TraCS on January 15, 2019 from 10:00 am – 11:30 am (register at: https://tracs.unc.edu/index.php/calendar/2845)

The OHRE will also be updating its website over the months of December and January to reflect revised informed consent templates, draft and finalized SOP’s, and other guidance documents (flowcharts, OHRP videos, and instructions).

In response to many questions about how the Common Rule revisions will affect research for those under the purview of the UNC-Chapel Hill OHRE, we have developed a “FAQ” for your reference:

Existing Full Board/Greater than Minimal Risk Studies: 

Studies that are reviewed by a full board and obtain initial final approval prior to January 21, 2019 will remain under the previous “Common Rule” regulations and will not be affected.  If requested by the sponsor or the study team, the informed consent documents can be updated to reflect the new informed consent requirements. 

Existing Expedited/Minimal Risk Studies: 

Studies that are reviewed by expedited procedures and obtain initial final approval prior to January 21, 2019 remain under the previous “Common Rule” regulations and will not be affected, unless UNC’s OHRE re-evaluates the study and determines it meets the new exemption criteria.  The OHRE will confirm with the study team that an exemption evaluation is appropriate prior to any formal IRB action.  If the study team feels as though the study meets the new definition of exemption under the revised “Common Rule” they may request a re-evaluation by submitting a continuing review and noting the request in the “Application Cover Memo” in IRBIS.  

Existing Exempt Studies: 

Studies that received an exemption determination before January 21, 2019 remain under the previous “Common Rule” and will not be affected.

As a reminder, studies that receive an exemption determination are exempt from specific regulations and requirements, however is still considered human subject research.

Full Board/Greater than Minimal Risk Studies:

Studies that are reviewed by a full board and obtain initial final approval on or after January 21, 2019 will be required to comply with the revised “Common Rule” including new informed consent requirements.   

In preparation, the consent form builder have been updated in IRBIS to reflect these changes and posted on the OHRE website at: Sample Consent Forms.  Any study that is submitting a consent form after December 6, 2018 for a new study should consider updating their template to include the new required elements to ensure appropriate review by the full board or facilitate an effective response to stipulations.  

Expedited/Minimal Risk Studies: 

Studies that are reviewed by expedited means and obtain initial final approval on or after January 21, 2019 will be required to comply with the revised “Common Rule” including new informed consent requirements, if applicable.  Many studies that previously did not meet exempt criteria and required expedited review under the previous common rule may now meet the exempt criteria.  Existing expedited categories (unchanged) can be found at: OHRP Expedited Review Categories 

Exempt Studies:

Studies that are submitted to the IRB requesting an exemption determination on or after January 21, 2019 will be required to comply with the revised “Common Rule”, which introduces several new categories for exempt review.  An exempt table, similar to UNC’s existing table, will be available prior to January 21, 2019. 

As a reminder, an exemption determination does not mean that the study is not “human subjects research”, but that it is human subjects research and exempt from specific regulations and requirements.  

Currently under the existing regulations, the use of identifiable data and biospecimens is permitted on a study by study basis through study specific consent, permissible waivers of consent, or by de-identifying data.  The revised “Common Rule” provides the option of “Broad Consent”.  “Broad Consent” is an alternative process for obtaining consent for the storage, maintenance, and secondary use of identifiable data or biospecimens at an institutional level.   

This type of consent requires tracking of individuals who consent or decline to participate.  Broad consent does not eliminate the need for prospective IRB approval for each project that utilizes samples of those who have consented.  All individuals who do not agree to provide broad consent must be excluded from all future research unless study specific consent is obtained.  Due to these implications, the requirement for Institutional tracking, and lack of available guidance from OHRP currently, UNC will not implement the use of “Broad Consent” at this time. 

Researchers can continue to seek consent of subjects to allow for future use of identifiable data and biospecimens through the avenues mentioned in the first section of this question’s answer. 

The revised “Common Rule” removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review.

At this time however, the FDA has not revised its regulation to align with the revised “Common Rule”.  UNC-Chapel Hill is also accredited by the Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) and their standards still require that a review be conducted. Continuing review requests are processed in IRBIS via a Renewal submission.

Full Board/Greater than Minimal Risk Studies (Existing and New): 

Studies that require full board review under the previous and revised “Common Rule” will not be affected and will continue to require that a continuing review be completed at a determined time period not to exceed 12 months, regardless if they were approved before or after January 21, 2019. 

Existing Expedited/Minimal Risk Studies:

Studies that are reviewed by expedited means and have initial final approval prior to January 21, 2019 and under the previous “Common Rule” will be evaluated at time of continuing review to determine if they meet the exemption criteria.  The OHRE will confirm with the study team that an exemption evaluation is appropriate prior to any formal IRB action.  If the study team believes the study meets the new definition of exemption under the revised “Common Rule” they may request a re-evaluation by submitting a continuing review and noting the request in the “Application Cover Memo” in IRBIS.  Studies currently indicated as Exempt will continue to not require continuing review at UNC-Chapel Hill, however other areas may have requirements, such as Conflict of Interest.  

For all studies that remain expedited and have initial final approval prior to January 21, 2019, will remain under the previous regulations in 2019; however, the OHRE office will review specific characteristics to identify appropriate studies to potentially transition (i.e., FDA regulated, informed consent documents) in the future.  Any study that transitions to the revised “Common Rule” will need to comply with all aspects of the revised “Common Rule”.  This will be done by the OHRE staff and should not affect the timeline or process for study teams. 

New Expedited/Minimal Risk Studies: 

Studies that are reviewed by expedited means and have initial final approval on or after January 21, 2019 under the revised “Common Rule” will be evaluated at time of approval to determine if a continuing review is required and at what time period.  Studies that do not require a continuing review will be flagged in the system and starting in January 2020 may be able to complete an abbreviated review. 

Examples of why studies may require a full continuing review: 

  • FDA regulated, or by other agencies that did not align with the revised“Common Rule”, or sponsors that require continuing review. 
  • Identified New Safety Information, which may include continuing or serious noncompliance that the board determines additional oversight is appropriate. 

New and Existing Exempt Studies:

Exempt studies currently do not require continuing review at UNC-Chapel Hill. This will remain unchanged; however, other areas may have requirements, such as Conflict of Interest.  

Most of the changes are reflected above that encompass the revised “Common Rule”:

  • Informed Consent
  • Exemption Categories
  • Continuing Review

Closures/Administrative Closures:

In order to be able to appropriately determine which “Common Rule” regulations a study is under and whether an abbreviated annual review as identified in question 4 is applicable, the OHRE will start administratively closing studies that have been expired for 90+ days unless you have been in contact with the OHRE.  

Studies that have expired and will be administratively closed can be duplicated/cloned by use of the IRBIS “copy” button if you wish to re-open, however if this occurs after January 21, 2019, the new study will be under the revised “Common Rule”.

The OHRE presented a session hosted by NC TraCS on January 15, 2019 from 10:00 am – 11:30 am, you may view it here:  https://panopto-web.med.unc.edu/Panopto/Pages/Viewer.aspx?id=8c883812-d0e9-4a36-a077-518d2864252f.  If your department or area would like a brief overview of the revised “Common Rule” and how these revisions will affect you, please reach out to one of the individuals below. 

UNC IRB Reviewed Studies:

Cat Collins, Senior Analyst
919-966-2740 | catcollins@unc.edu

Mike Matamoros, Quality Assurance/Improvement Manager
919-966-2738 | matamoros@unc.edu

Cassandra (Cassie) Myers, OHRE Director
 919-966-6893 | cassandra.myers@unc.edu

Externally Reviewed/Reliance Agreements:

John Roberts, Reliance Manager
919-966-3113 | jtr@unc.edu


Previous Updates:

HHS and 16 Other Federal Departments and Agencies Issue a Final Rule to Delay for an Additional 6 Months the General Compliance Date of Revisions to the Common Rule While Allowing the Use of Three Burden-Reducing Provisions during the Delay Period

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are issuing a Final Rule to delay for an additional 6 months the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule).

This policy was originally promulgated as a Common Rule in 1991, and was revised on January 19, 2017 (82 Fed. Reg. 7149) (the revised Common Rule is also known as the “2018 Requirements”). The effective and general compliance date for the 2018 Requirements was delayed to July 19, 2018 by an interim final rule that was published on January 22, 2018 (83 Fed. Reg. 2885). Subsequently, a Notice of Proposed Rulemaking (NPRM) was published on April 20, 2018 (83 FR 17595), which proposed an additional 6-month delay for the general compliance date for the 2018 Requirements and a flexibility that would allow regulated entities to take advantage of three burden-reducing provisions of the 2018 Requirements during the delay period.

The Final Rule adopts the proposals that were described in the April 2018 NPRM. The Final Rule delays the general compliance date of the 2018 Requirements for an additional 6-month period until January 21, 2019. The transition provision in the Final Rule is structured so that regulated entities cannot implement the revised Common Rule in its entirety, in lieu of compliance with the current version of the Common Rule, until the general compliance date of January 21, 2019. As a result of this delay to the general compliance date, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Common Rule until January 21, 2019. The exception to this general rule is that institutions will be permitted (but not required) to implement, for certain studies, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018 through January 20, 2019). The three provisions are:

(1) The revised definition of “research,” which deems certain activities not to be research;
(2) The allowance for no annual continuing review of certain categories of research; and
(3) The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.

If institutions choose to implement these three burden-reducing provisions for particular studies, such studies will be subject to the 2018 Requirements beginning on January 21, 2019.

The Final Rule has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/06/19/2018-13187/protection-of-human-subjects-delay-of-general-compliance-date.


HHS and 15 Other Federal Departments and Agencies Announce an IFR That Delays the Effective Date & General Compliance Date of the Revisions to the Federal Policy for the Protection of Human Subjects to July 19, 2018

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018.

The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.

The IFR has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.

Until July 19, 2018, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations (i.e., the Federal Policy for the Protection of Human Subjects, originally published on June 18, 1991, and subsequently amended on June 23, 2005) that can be accessed at: https://www.gpo.gov/fdsys/pkg/CFR-2016-title45-vol1/pdf/CFR-2016-title45-vol1-part46.pdf . This means that before July 19, 2018, institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule. An example of a revised provision that does not conflict with the pre-2018 rule is one that addresses new elements of informed consent (revised rule at §__.116(b)(9), (c)(7)-(9)). It is permissible to incorporate these new elements of consent now because the pre-2018 rule does not prohibit including these elements in informed consent.

An example of a revised provision that conflicts with the pre-2018 rule, and thus could not be implemented prior to July 19, 2018, is the provision eliminating the requirement for continuing review in certain circumstances (as described in the revised rule at §__.109(f)). Because the pre-2018 regulations require continuing review at least annually for all ongoing non-exempt human subjects research, halting continuing review for such research before that date would be considered non-compliance.

The IFR does not delay the compliance date for the cooperative research provision of the revised Common Rule (found at §__114(b)), which remains January 20, 2020.

Federal departments and agencies listed in the IFR are also in the process of developing a notice of proposed rulemaking (NPRM) seeking public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019). If such an NPRM is published, after consideration of the public comments, the federal departments and agencies will determine whether a final rule to further delay the revised Common Rule will be issued.


CHANGES TO THE FEDERAL REGULATIONS THAT GOVERN HUMAN SUBJECTS RESEARCH (“COMMON RULE”)

The Final Rule to update the current regulations at 45 CFR 46, Subpart A – “Federal Policy for the Protection of Human Subjects” (Common Rule) was published by the U.S. Department of Health and Human Services (HHS) on 19 January 2017 in the Federal Register.  Changes to the Common Rule, the primary rule regulating human subjects research, are currently set to go into effect on January 19, 2018.

On January 19, 2018, OHRE is planning to begin implementation of the revised Common Rule changes into IRBIS. The first step will primarily impact new studies submitted on or after January 19, 2018. As not all federal agencies have signed on to be covered by this new rule, certain studies such as those regulated by the Food and Drug Administration and the Department of Justice, remain subject to the prior regulations.  OHRE is in the process of identifying these projects and making sure they are reviewed accordingly.

Two requests to delay the date have been filed, however, both are pending review by the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB). In the event the date is delayed, an announcement on the OHRE website will be made. There will also be an FAQ page available on the OHRE website soon.