Revised Common Rule at Emory

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.
 
For detailed information about this process, see this information from OHRP.

Terminology

Based on the OHRP Website


Pre-2018 Requirements: The old Rule. Specifically, it refers to subpart A of 45 CFR part 46 (i.e., the Common Rule) as published in the 2016 edition of the Code of Federal Regulations. The pre-2018 Requirements were originally promulgated in 1991, and subsequently amended in 2005. The pre-2018 Requirements may also be referred to as the "pre-2018 Common Rule."

2018 Requirements: The new Rule, or "2018 Common Rule." This refers to the Common Rule as published in the July 19, 2018 edition of the e-Code of Federal Regulations. The 2018 Requirements were originally published on January 19, 2017 and further amended on January 22, 2018 and June 19, 2018. The 2018 Requirements may also be referred to as the "Revised Common Rule."

Why "2018" and not "2019," the year it actually goes into effect? Because the regulation was finalized when the Rule was expected to take effect in 2018, and now we are stuck with the term.

Transition provision: This provision outlines which studies must comply with the pre-2018 Requirements and which studies must comply with the 2018 Requirements. It also describes how an institution can voluntarily transition a study subject to the pre-2018 Requirements (i.e., a study initiated before January 21, 2019) to instead be subject to the 2018 Requirements. (See 45 CFR 46.101(l) of the 2018 Requirements.)

Transition date: Not all existing studies will be "transitioned" from the old Rule to the new Rule. For those that are, the transition must be explicitly documented by the IRB. "Transition Date" is the date that an institution determines, and an IRB or institution dates and documents, this transition. This determination may be made on a per-study basis or with respect to a broader group of studies conducted at an institution. If the institutional determination occurs prior to the documentation, the date of the documentation is the transition date.

FDA Regulated Research: Research using a drug, device or biologic, approved for marketing or not, outlined under 21 CFR 312 (drugs), 21 CFR 812 (devices), and 21 CFR 600 (biologics). FDA regulations for informed consent (21 CFR 50) and Institutional Review Boards (21 CFR 56) also apply.

Long term follow up: Studies that are still seeing subjects who were already enrolled in the study before, for activities considered standard of care.

Data analysis only: Studies that are analyzing identified data, without the collection of new data.

Minimal Risk studies: Studies that are determined by the IRB to present no more than minimal risk to human subjects. They can receive expedited review if the procedures fall into one or more of the expedited categories. Find the expedited categories here.

Note: The Emory IRB did not institute the "three burden-reducing provisions" of the 2018 requirements

Transition Date (implemented in 2019)

Two dates to remember:

January 1st, 2019: New studies created or edited after this date will automatically be designated "2018" studies in eIRB. They will need to be reviewed after January 21, 2019.

IRB staff will revert studies back to the pre-2018 Rule if they are FDA-regulated or funded by the Department of Justice (DOJ). But if federally funded, the additional informed consent elements still apply!

January 21st, 2019: Studies approved (or determined exempt) after this date are subject to the Revised Common Rule. (Migrated studies may appear as "Pre-2018" in eIRB if FDA Regulated or DOJ funded. This made sure we required continuing review in our old system.)

Emory IRB Transition Plan-revised for new eIRB system

The Emory IRB plans to generally require the transition of the following studies to the Revised Common Rule:

  • Studies not FDA-regulated or supported by the Department of Justice, which:
    • Are in long term follow up or data analysis only, as of the prior continuing review, or are
    • Are limited to the secondary analysis of identifiable data or biospecimens under a waiver of consent, and
    • If the study is conducted at an international site, they are no longer under the local ethics committee's review
If the above applies to your study, the IRB will transition it to the revised common rule at the time of continuing review.  No additional actions are required from you at this point.  

The Emory IRB plans to generally allow optional transition of certain other studies to the Revised Common Rule:

  • Studies not FDA-regulated or supported by the Department of Justice which:
    • Are minimal risk (eligible for expedited review) per the Emory IRB. and 
    • If the study is conducted at an international site, are no longer under the local ethics committee's review, and 
    • Do not have a significant history of compliance issues
What do I need to do to transition my study if not required by the IRB?

For research teams choosing to transition their studies when it is not required:

  • Fill out this attestation form that includes a detailed guide of the process
  • Attach the form with the continuing review application, letting the analyst know you are asking for the study to be transitioned to the revised common rule.
  • If you are still enrolling subjects, you will be required to revise your informed consent. The IRB may require to re-consent of subjects affected by the changes in the consent form.  Submit a modification to submit the required changes to your consent form.

Attestation Form and Guidance

The IRB has presented three webinars resuming the Emory IRB views and transition plan.  You can find those under our webinar section.

Here are some guidance documents we have put together to help our investigators transition to the revised common rule:

 

I am still enrolling subjects and I am electing to transition to the Revised Common Rule. What revisions should I make to my consent form?

If you are eligible to transition (see "Emory IRB Transition Plan" section in this page for more information), and you are still enrolling subjects, make sure that your consent form includes the following changes to comply with the revised Common Rule:

  • Checklist requirement: study teams need to cut and paste this section into another document and fill it out. The completed checklist should be included in the initial submission under the Informed Consent Process section
  • Additional Cover letter (concise presentation of key concepts)
  • More Detail Required or Formatting Changes in:
    • Storing and Sharing your Information Section
    • Withdrawal from the Study
    • HIPAA section: “Optional Study” section
    • Signature line for LAR

Useful Information from Other Institutions

The IRB has consulted the following useful documents from other Institutions:

  • The Common Rule, Updated By Jerry Menikoff, Julie Kaneshiro, and Ivor Pritchard; New England Journal of Medicine, January 19, 2017 (Vol. 376 No. 3).View this article online
  • Redline of Unofficial Final Revised Common Rule (January 18, 2017) Against Health and Human Services (“HHS”) Common Rule At 45 C.F.R. Part 46, Subpart A (2005) by Verryl Dana LLP.  View this document here.
  • OHRP Guidance: The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))

Regulatory Information and News from OHRP

From OHRP website

Announcement: Federal websites that will satisfy the revised Common Rule’s requirement to post clinical trial consent forms (45 CFR 46.116(h))

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and
agencies announce where clinical trial consent forms can be posted as will be required by the revised
Common Rule beginning on January 21, 2019. The revised Common Rule requires that for any clinical
trial conducted or supported by a Common Rule department or agency, one consent form be posted on
a publicly available federal website within a specific time frame. The consent form must have been used
in enrolling participants in order to satisfy this new provision. The compliance date for this provision is
January 21, 2019. You can read more information about the revised Common Rule on the OHRP website
(https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html).
At this time two publicly available federal websites that will satisfy the consent form posting
requirement, as required by the revised Common Rule, have been identified: ClinicalTrials.gov and a
docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). HHS and other Common Rule
departments and agencies are developing instructions and other materials providing more information
to the regulated community about this posting requirement.

2018 Requirements FAQs

Find current frequent questions and answers for the 2018 Common rule at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/2018-requirements-faqs/index.html 

Additional Delay Proposed

On April 19, 2018, HHS and 16 Other Federal Departments and Agencies announced a NPRM Proposing to delay for an additional 6 months the general compliance date of the revisions to the common rule.  To access the NPRM Federal Register Notice, go to https://www.federalregister.gov/documents/2018/04/20/2018-08231/federal-policy-for-the-protection-of-human-subjects-proposed-six-month-delay-of-the-general.  To be assured consideration, comments on the NPRM must be received no later than 11:59 p.m. Eastern Standard Time on May 21, 2018. To submit comments during the open comment period or browse posted comments, https://www.regulations.gov/document?D=HHS-OPHS-2018-0007-0001 

Delay in Common Rule Implementation

On Jan 17, HHS announced an interim Rule that would delay the effective and compliance dates of the Revised Common Rule to July 19, 2018. This will allow time for the regulatory agencies to develop more guidance around the Rule, and they will also work wtih stakeholders to determine when the Rule should ultimately go into effect. eIRB changes related to the revised Rule were implemented, but will be "turned off" until the Rule becomes effective. Note that the NIH policy changes related to clinical trials and single IRB review are still in place.

Here is the official announcement from HHS:

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.

Final Revisions to the Common Rule

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.