MSU HRPP Manual Section 4-11

Applicability of the Revised Common Rule (2018 Requirements)

Revised Common Rule (2018 Requirements)
“(l) Compliance dates and transition provisions:
(1)  Pre-2018 Requirements. For purposes of this section, the pre-2018 Requirements means this subpart as published in the 2016 edition of the Code of Federal Regulations.

(2)  2018 Requirements. For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this subpart. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for §46.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020.
(3)  Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section:
(i)  Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii)  Research for which IRB review was waived pursuant to §46.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii)  Research for which a determination was made that the research was exempt under §46.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)  Transitioning research. If, on or after July 19, 2018, an institution planning or engaged in research otherwise covered by paragraph (l)(3) of this section determines that such research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination.
(i)  If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(1)  Section 46.102(l) of the 2018 Requirements (definition of research) (instead of §46.102(d) of the pre-2018 Requirements);
(2)  Section 46.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of §46.103(f) of the pre-2018 Requirements); and
(3)  Section 46.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of §46.103(b), as related to the requirement for continuing review, and in addition to §46.109, of the pre-2018 Requirements); and
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii)  If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)  Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research:
(i) Research initially approved by an IRB on or after January 21, 2019;
(ii)  Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019; and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.” 45 CFR 46.101(l)(2018 Requirement)

 

Background
The U.S. Department of Health and Human Services (HHS) and other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The HHS regulations codify the Common Rule at 45 CFR part 46, subpart A.  A final rule, also known as the 2018 Requirements, 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.

Definitions
Pre-2018 Requirements: 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: 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."

Transition provision: refers to 45 CFR 46.101(l) of the 2018 Requirements. 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. Finally, it describes the regulatory requirements that apply during the delay period (i.e., from July 19, 2018 through January 20, 2019) to a study that has been transitioned to the 2018 Requirements before January 21, 2019.

Initiated: Consistent with 45 CFR 46.101(l) of the 2018 Requirements, references to "initiated" research encompass research activities (1) initially approved by an institutional review board (IRB), (2) waived pursuant to § 46.101(i), or (3) for which a determination was made that the research was exempt.

Ongoing research or ongoing study: research that was initiated before January 21, 2019 and that continues on or after January 21, 2019.

Transition date: The date that an institution determines, and an IRB or institution dates and documents, that a study initiated before January 21, 2019 will comply with the 2018 Requirements instead of the pre-2018 Requirement. This determination may be made on a per-study basis or with respect to a broader group of studies conducted at an institution.

2018 Requirements
The 2018 Requirements shall apply with limited exceptions to human research studies:

  • Initially approved by the MSU IRB on or after January 21, 2019;
  • For which MSU IRB review is waived pursuant to 45 CFR 46.101(i)(2018 Requirements) on or after January 21, 2019; and
  • For which a determination is made that the research is exempt on or after January 21, 2019
  • Ongoing before January 21, 2019 that have been transitioned by the MSU IRB to the 2018 requirements in accordance with 45 CFR 46.101(l)(4)(ii)(2018 requirements)

For human research studies that must comply with the 2018 requirements, the 2018 requirements apply with limited exception to all human research and/or clinical investigations subject to the MSU HRPP requirements as defined in HRPP Manual Section 4-1, Applicability.

Exceptions include:

  1. Human research studies conducted or supported solely by the U.S. Department of Justice (DOJ); these studies remain subject to the pre-2018 requirements as the U.S. DOJ has not yet adopted the 2018 requirements and remains subject to the pre-2018 requirements.
  2. Non-exempt human research studies where MSU is relying upon another IRB as IRB of record; that institution’s policy and procedures will apply.
  3. Studies not conducted or supported by a Common Rule department or agency that are pending (i.e. submitted to the MSU IRB) as of January 21, 2019 will typically be required to comply with the 2018 requirements unless otherwise determined by the IRB.
  4. Any exception to a particular provision of the 2018 requirements will be described in the relevant HRPP manual section.
  5. Clarifications regarding the 2018 requirements for transitioned studies are included in the “Transition” section below.

If a study requires compliance with the 2018 requirements as well as the pre-2018 requirements and/or the U.S. Food and Drug Administration (FDA) requirements for the protection of human subjects (21 CFR 50) and IRBs (21 CFR 56), the stricter regulatory requirement must be followed. If a study is not conducted or supported by a Common Rule department or agency and is required to comply with the FDA requirements, the study must typically comply with the 2018 requirements unless otherwise determined by the IRB. 

Pre-2018 Requirements
The pre-2018 Requirements apply to the following research, unless the research has been transitioned by the MSU IRB to comply with the 2018 Requirements:

  • Research initially approved by the MSU IRB under the pre-2018 Requirements before January 21, 2019;
  • Research for which MSU IRB review was waived pursuant to §46.101(i) of the pre-2018 Requirements before January 21, 2019; and
  • Research for which a determination was made by the MSU HRPP that the research was exempt under §46.101(b) of the pre-2018 Requirements before January 21, 2019.

Transition
Beginning on January 21, 2019, an ongoing study may be transitioned by the MSU IRB to the 2018 requirements. If a study is transitioned, all 2018 requirements apply to the ongoing study with clarifications provided below. The determination to transition will be made on a project by project basis.

Unless otherwise required by Common Rule departments and agencies, the following clarifications apply to transitioned studies:

  1. Determinations made by the IRB prior to January 21, 2019 remain in effect (i.e. granting of a waiver of informed consent).
  2. Posting of clinical trial consent forms are only applicable to studies under the oversight of Common Rule departments and agencies and must be posted as required by that department or agency.
  3. For subjects who provided informed consent under the pre-2018 requirements with no additional follow-up, re-consent should not typically be necessary. The IRB will determine if re-consent is required, or whether additional information should be provided.
  4. If subjects are still being enrolled on or after January 21, 2019, the consent form(s) used after the transition must be in compliance with the 2018 requirements.   
  5. For other studies in which re-consent of subjects is required for an independent reason (such as changes to material risks or benefits in the study), the IRB will determine how the re-consent process should be undertaken (e.g. new consent form compliant with the 2018 requirements, the pre-2018 form revised to include the 2018 requirements, new supplemental form to present and highlight the new information alone). The IRB should consider which option is most accurate, most informative and least confusing from the subject’s point of view.

Process
The MSU IRB will typically consider whether to transition an ongoing study at the time of the next continuing review on a case by case basis. As part of the pre-review, the IRB administrator will review the study for transition considerations. If the study appears eligible for transition, the IRB administrator will notify the PI and obtain confirmation as needed.

If the study qualifies for expedited review, the transition determination can be made by the assigned IRB member as part of the expedited review procedure. If the study does not qualify for expedited review, the transition determination can be made by the convened IRB. If the transition involves an exemption category that requires limited IRB review, the limited IRB review must be conducted as part of the transition. The relevant HRPP manual sections will be followed (e.g. HRPP Manual Section 8-1, Exemptions; 8-2, Expedited Review Procedure; 8-3, Full Board Review Procedure; 8-7, Renewed Approval).

When determining whether to transition an ongoing study, the IRB will consider factors such as:

  • Enrollment status
  • Consent process and/or form(s)
  • Reliance agreement(s)
  • Review level
  • Funding
  • Regulatory oversight

Typically, the following types of studies will not be transitioned:

  • Studies regulated by the U.S. FDA
  • Studies subject to oversight by the U.S. Department of Justice
  • Studies that involve reliance agreement(s) where MSU is serving as IRB of record
  • Studies with subjects enrolled with active recruitment, unless the IRB determines that transitioning is appropriate, in consultation with the PI
  • Studies that are more than minimal risk or otherwise require full IRB review

The transition determination may require ongoing discussion with the Principal Investigator to evaluate the impact of the transition on the ongoing research study. A Principal Investigator may decline to transition their study to the 2018 requirements (e.g. prefer to continue complying with the pre-2018 requirements, do not want to modify the consent form).

If the IRB determines that an ongoing project will be transitioned, the IRB must document the transition determination and the date of the documentation. The documentation will also include documentation of the exempt determination, if applicable. The ongoing research study shall, beginning on the date of such documentation, comply with the 2018 Requirements. A standard form shall be used to document the transition.

A determination not to transition a study to the 2018 requirements at the time of the first continuing review on or after January 21, 2019 will not preclude a study from being transitioned at a future time.

Requests to Transition
If a request is made by the PI to transition a study before the next continuing review, a continuing review submission must still be submitted to provide the current status of the research and to alter the continuing review date, if the study meets the criteria to eliminate continuing review.  If the transition requires a change in consent, then a modification would have to be submitted as well.

This policy and procedure supersedes those previously drafted.

Approved By: Senior Vice President for Research and Innovation, 1-18-2019.

Related HRPP Manual Sections