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

Two dates to remember:

January 1st, 2019: 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 will be subject to the Revised Common Rule (unless FDA Regulated or DOJ funded)

Does this mean that if I submit after January 1, 2019, my study will not be reviewed until after January 21st?

It depends. If your study is not FDA- or DOJ-regulated, then we will screen the study but not review it until the January 21st effective date of the Revised Rule.
If your study is FDA- or DOJ-regulated, we will revert it to the old Rule and review it in our normal fashion.
Three weeks is within our normal turnaround times, so we do not anticipate a negative impact on researchers.

I need approval before January 21, 2019.  Can I have my study reviewed as usual?

First, remember that if your study is FDA- or DOJ-regulated, it will be reviewed as usual regardless.
Otherwise: If your situation is time-sensitive (e.g. for funding reasons), please include that request with your submission. If your study is reviewed prior to January 21, 2019, we will need to apply the pre-2018 Common Rule and your study will have an expiration date.

Emory IRB Transition Plan

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 secondary analysis of identifiable data or biospecimens under waiver of consent (and where data will not be submitted to the FDA), and
    • Only take place in domestic (U.S.) sites

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 (eligile for expeditred review) per the Emory IRB. and 
    • Do not involve international sites, and 
    • Do not have a significant history of compliance issues

What do I need to do to transition my study?

For all studies transitioning, whether per IRB requirement or optional, please do the following:

  • Fill out this attestation form that includes a detailed guide of the process
  • Submit an amendment and attach the attestation form 30 to 45 days before study expiration
  • If you are not required to transition and you are requesting your study to transition, also submit a continuing review application as usual.  
    • If you are still enrolling subjects, you will be required to revise your informed consent. The IRB may require reconsent of subjects affected by the changes in the 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:

 

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

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.