Guidance

Transition to 2018 Regulations

May 31, 2018 4:45 pm

Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule") were issued by the Department of Health and Human Services (HHS) on January 18, 2017.  The majority of changes are scheduled to go into effect on July 19, 2018 (“Effective Date” and "general compliance date" for the 2018 Revised Common Rule), although a further delay is being considered by the federal government. 

U-M Human Research Protections Program (HRPP) webpage Common Rule & Other Changes has ongoing updates in response to the upcoming changes to IRB regulations.

  • Flexibility Pilot Starting June 11, 2018

    IRBMED will pilot the burden-reducing provision of the 2018 Common Rule for non-federally funded human subjects research:

    This flexibility initiative is not available for studies that have direct or prime federal funding, or to studies subject to FDA regulation. IRB staff will work with the study team to ensure each project receives the correct type of review and outcome determination, including asking study teams to confirm eligibility for a flexibility initative.

  • eResearch IRB application update

    The flexibility pilot is being implemented in conjunction with a major update to the eResearch IRB application, eResearch "release 4.3." As with other eResearch updates, submissions in process at the time of the update (weekend of June 9-10, 2018) may have new system-required questions or sections activated even if the flexibility pilot workflows do not apply to that specific submission. Amendments created after the release will activate new questions on required sections for previously approved studies. Please consult the Overview of Changes for release 4.3 and other step-by-step guides that will be updated in the eResearch Regulatory Management Training page, heading "Procedure Documents & Tips." IRB staff will also be able to provide assistance.

    Submissions that receive contingent approval ("Contingencies Pending") prior to June 11, 2018 will not be considered for the flexibility pilot, as the IRB previously determined that the study would meet the current Common Rule regulatory criteria for approval. Previously approved studies with no funding from a Common Rule agency will be “transitioned” to the flexibility pilot only to the extent that this reduces administrative burden: this decision will be made on a case-by-case basis for incoming Amendments (Ames) and Continuing Reviews (CRs).

  • After the Effective Date (July 19, 2018 unless delayed further)

    University of Michigan web-based IRB application system, eResearch Regulatory Management, will be updated to include all 2018 Common Rule requirements. 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 Revised Common Rule regulations only to studies funded by DHHS (including NIH) and/or other federal agencies applying the Common Rule. For ongoing approved studies with current or pending federal funding:

    •  the next Amendment, and any subsequent submissions, will be approved according to 2018 Requirements
      • For some studies this will include new requirements related to informed consent
    • Continuing Review(s) scheduled prior to next Amendment will be approved according to pre-2018 Requirements

    Studies where risk to subjects is minimal and/or intervention and interaction with all subjects is complete are subject to fewer requirements under the 2018 Common Rule, because the requirement for annual Continuing Review is generally removed. Following the latest notice from OHRP on "transitioning procedures," 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 the pre-2018 Common Rule requirements. FDA-regulated studies receiving funding from Common Rule agency/ies will also “transition” to 2018 Common Rule requirements as applicable to ongoing research activity. Annual continuing review is still required of FDA-regulated studies.

  • Informed Consent process and documents

    45 CFR 46.116 (a) (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).

    Added informed consent document requirements under the 2018 regulations will apply to:       

    • 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, although it is not yet a regulatory requirement, in spring 2018 IRBMED consent templates revisions incorporate additional required statements about the re-use of information or biospecimens, and about the potential for profit to researchers, companies, or others.

  • 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.

    Under the pre-2018 Common Rule, a waiver of consent was required 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. Waiver of consent for this purpose is no longer required under 45 CFR 46.116 (g) (Revised).

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

    Pre-2018 regulations have 4 criteria; the 2018 rule 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. No guidance is currently available beyond the 45 CFR 46.116(h) (Revised) and the Preamble published with it. 

     

    Posted 12/15/2017

    Updated 5/31/2018

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: mhayward@umich.edu
Last Updated: June 1, 2018 1:00 PM