Guidance

Transition to 2018 Regulations

IRBMED
Jan 16, 2019 4:00 pm

On January 21, 2019 most provisions of the Revised Common Rule become fully effective ("Effective Date” and "general compliance date"; single IRB-of-Record provisions will go into effect in January 2020). As of that date, the eResearch system changes made in 2018 to support the HRPP Flexibility Initiative will apply to all studies regardless of funding source.

U-M Human Research Protections Program (HRPP) webpage Common Rule & Other Changes has ongoing updates in response to the upcoming changes to IRB regulations. Department of Health and Human Services (HHS) component Office for Human Research Protections (OHRP) has a webpage on the process of regulatory revision during this decade, and OHRP issued draft guidance on "Transition Provision" on January 10, 2019.

  • After the Effective Date (January 21, 2019)

    University of Michigan web-based IRB application system eResearch Regulatory Management, as well as IRBMED Standard Consent Template, were updated over the course of 2018 to accommodate the Revised Common Rule. All studies, regardless of funding, are expected to fill out the eResearch application as directed by “smartform” logic at Amendment.

    IRBMED intends to apply the full "2018 Requirements" only to federally funded studies initially approved after the Effective Date. Following the OHRP draft guidance on "Transition Provision," ongoing approved studies will generallly continue under the "pre-2018 Requirements." However, some provisions of the 2018 Requirements may be applied to improve human research protections or to reduce administrative burden.

    Studies where risk to subjects is minimal, and/or intervention and interaction with all subjects is complete, often do not require for annual Continuing Review under the "2018 Requirements." For studies with federal funding, IRBMED will end the requirement for continuing review only if the study also complies with "2018 Requirements" on informed consent document(s) and processes (see below), as applicable to ongoing and future study activity.

    NOTE: Clinical investigations subject to FDA regulation will continue to be approved according to FDA regulations at 21 CFR 50.25 and 21 CFR 56.111. These generally match "pre-2018 Requirements." FDA-regulated studies receiving funding from Common Rule agency/ies will also transition to Revised Common Rule as applicable to ongoing research activity. Annual continuing review is still required of FDA-regulated studies.

  • Burden-reducing provisions

    Common Rule "2018 Requirements" include several provisions designed to reduce administrative burden:

    U-M piloted most of these provisions as a flexibility initiative for non-federally funded human subjects research since June 2018. As of January 21, 2019 federally funded studies will also be eligible for these burden reductions.

  • Informed Consent process and documents

    Regulatory changes

    45 CFR 46.116 (a)(5)(i) (Revised) adds a requirement,

    Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

    45 CFR 46.116 (b)(9) (Revised) adds a new required element of informed consent:

    One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

    1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or

    2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

    45 CFR 46.116 (c)(7), (c)(8) and (c)(9) are additional elements of consent required only when appropriate given the nature of the research at hand:

    • 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 (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

    Application of new requirements

    IRBMED Standard Consent Template and several Specialty Templates were updated to latest requirements and guidance during 2018. IRBMED strongly encourages the use of our templates. 

    Subject to all Common Rule "2018 Requirements" are:       

    • Studies initially approved on or after the Effective Date
    • Studies initially approved before Effective Date, ONLY if ALL of the following apply
      • Current or pending funding from a federal department or agency applying the Common Rule
      • Future study activity after Effective Date includes
        • Ongoing consent process (new enrollment or anticipated occasions warranting re-consent), and
        • greater than minimal risk to subjects

    In the interest of transparency, IRBMED is also requiring the additional statements about the re-use of information or biospecimens, and about the potential for profit, from other studies with ongoing consent processes.

  • Waiver or alteration of informed consent

    An IRB may waive the requirement for informed consent, or may omit/alter one or more elements of informed consent, if certain regulatory criteria are justified. The waiver or alteration can apply to part or all of a research study with comprehensive IRB approval.

    "2018 Requirements" remove the need for a waiver of consent for screening/eligibility ("to access records or stored identifiable biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects" by interaction or by access to records or stored identifiable biospecimens, per 45 CFR 46.116 (g) (Revised)).

    However, for studies that require a waiver/alteration of consent for ongoing study activity, 45 CFR 46.116 (f)(3)(iii) (Revised) adds a new criterion that must be justified.

    "Pre-2018 Requirements" have 4 criteria; "2018 Requirements" adds a 5th:            

    If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.

    At the next Amendment after the Effective Date:

    • Screening/recruitment waivers can be retired  by updating answers in 10.1 and/or 10.2 in the eResearch application.
    • Currently approved studies that still require a partial or full waiver/alteration will add the justification for the 5th criterion in 10-3.2 in the eResearch application.
  • Posting of clinical trial consent form

    45 CFR 46.102 (b) (Revised) defines clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”

    Clinical trials funded by Common Rule agency/ies will be required to post an IRB-approved consent form “on a publicly available Federal Web site that will be established as a repository for such informed consent forms,” after recruitment is closed, per 45 CFR 46.116 (h) (Revised). Two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule, have been identified by OHRP as of August 28, 2018:

    1. ClinicalTrials.gov
    2. 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.

    There is no expectation that studies without funding from HHS or another Common Rule agency will post consent forms.

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: larkspur@umich.edu
Last Updated: January 16, 2019 4:00 PM