UPDATED PRACTICE 12/15/2017
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 with no funding from a Common Rule agency are not expected to address any changes prior to the regulatory Effective Date of January 19, 2018.
Transition to 2018 Regulations
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 will go into effect on January 19, 2018 (“Effective Date” for the 2018 Revised Common Rule).
After the Effective Date
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.
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 SACHRP 5/2017 Recommendations on Compliance Dates and Transition Provisions, U-M IRBs will not require continuing review for applicable studies and will not trigger other 2018 Requirements.
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
Added informed consent document requirements apply only to studies where ALL of the following apply:
- Current or pending funding from a federal department or agency applying the Common Rule
- Future study activity after 1/19/2018 includes
- Ongoing consent process (new enrollment or anticipated occasions warranting re-consent), and
- greater than minimal risk to subjects
At next Amendment (before or after Effective Date) these studies should Amend 10-1.1 to include a supplemental cover page at the beginning of informed consent document(s) that will be used in 2018.
Contact your IRB staff to obtain the latest “supplemental cover page” template.
The supplemental cover page includes both
- the new “key information” overview (45 CFR 46.116 (a)), and
- additional specifically required statements (45 CFR 46.116(b)(9) and 45 CFR 46.116(c)(7), (c)(8) and (c)(9))
Previously approved consent documents that are already concise, focused, and presented to facilitate comprehension (e.g. IRBMED-approved Specialty Template) need not utilize the supplemental cover page, but any applicable newly required statements must still be added. For instance, a study that uses a separate Eligibility screening consent may need to include separately the (b)(9) statement about re-use of information that has been de-identified, and the (c)(8) statement whether clinically relevant research results will be disclosed to subjects. See details below.
Details on Informed Consent changes
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:
- 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
- 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).
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.