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04/19/2018: HHS issued a proposal to further delay the implementation of the "2018 Common Rule" until January 21, 2019. Per the previous Interim Final Rule (IFR), institutions can implement provisions of the 2018 Common Rule that do not conflict with the pre-2018 (i.e., current) regulations. The new informed consent elements represent one such change that can be implemented prior to the proposed January date. Note: this information is subject to change.
Under the revised 2018 Common Rule, the requirements for informed consent will change, with the addition of:
- "Key information" to be presented at the beginning of the consent form
- New consent elements
- Changes to waiver criteria and documentation (plus other process changes)
- A "broad consent" option for unspecified future use of identifiable data/bisopecimens
The intent of these changes is to facilitate the subjects' understanding of the proposed research and also ensure that they understand how their data and biospecimens may be used.
The preamble to the Final Rule (revised) lists five (5) factors as suggested "key information" that would likely assist a potential subject in understanding the nature of the project and in determining participation.
How a study team applies the "key information" requirement, and to what level of detail, will depend on the complexity of the research project. Many social/behavioral research projects already employ a brief informed consent document, so including a "key information" section may be redundant. The Final Rule preamble includes some considerations regarding the application of this requirement, but further federal guidance is expected at a later date.
If you have questions about how to apply the new "key information" requirement for a particular project, contact your U-M IRB for advice.
|When your project will involve...||Include in the informed consent...|
|The collection of identifiable private information or identifiable biospecimens||
A statement indicating whether:
|Use of biospecimens||
A statement indicating whether:
|Clinically relevant results||
A statement indicating whether the clinical results, including individual research results, will be returned to the subject, and if so, under what conditions
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
|A statement indicating that the research will or might include whole genome sequencing|
- A waiver of informed consent for the secondary use of identifiable private information/biospecimens (not covered by Broad Consent) must justify why the use of identifiers is necessary to carry out the research.
- Use of identifiable information/biospecimens to identify potential subjects (i.e., screening for recruitment purposes) is allowed without informed consent under certain circumstances. A waiver of consent will no longer be needed for these screening activities.
Note: HIPAA requirements still apply - including asking for a HIPAA waiver.
- For federally-sponsored clinical trials, a copy of the consent form must be posted to a "publicly available, federal website" (TBD) post-recruitment and no later than 60 days after the last study visit by any subject.
Broad Consent Defined
"Seeking prospective consent to unspecified research."
~ Revised Common Rule: Federal Register, Vol. 82 No. 12 (January 19, 2017)
Under the current regulations, secondary research use of identifiable data/biospecimens is permissible through study-specific consent, by obtaining an IRB waiver of consent, or by removal of identifiers.
In the revised Common Rule, "Broad Consent" is an (optional) alternative consent process for use only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research. To utilize "Broad Consent," the study team and/or the unit/biorepository responsible for the storage of the identifiable data/biospecimens are required to:
- identify the types of research that may be conducted with the data/biospecimens,
- record and track who has agreed to or refused consent, and
- to track the terms of consent to determine whether proposed future secondary research use falls within the scope of the identified types of research
For full details about "Broad Consent" including the requirements (in addition to tracking), limitations, and considerations for use, see SACHRP's Recommendations for Broad Consent Guidance.
U-M Business Process
At this time, the U-M HRPP and IRBs will not mandate nor implement the institutional use of Broad Consent, as the tracking requirements may be burdensome. Exemption categories 7 and 8, which rely on Broad Consent, will not be available in the eResearch Regulatory Management (eRRM) system. U-M will continue to support study teams seeking subject permission for the collection and storage of identifiable private information/biospecimens for future secondary use research through the following processes:
- Study-specific consent and comprehensive IRB review
- IRB waiver of consent (as eligible) and comprehensive IRB review
- Exemption #4
- De-identification to remove the research activity from Common Rule purview and not require IRB review or consent
Note: For studies designed to collect identifiable data and/or biospecimens solely for the purpose of maintaining a repository, the study team may find it useful to employ a specialty informed consent template (e.g., biorepository template).
U-M Transition Process
Informed Consent Templates
The U-M IRBs will post updated informed consent templates to their respective websites later this autumn. Study teams should begin using the updated informed consent templates as soon as they are available on the websites.
Section 10, Informed Consent, of the IRB application in the eResearch Regulatory Management (eRRM) system will be reorganized to help investigators select the correct informed consent category and to reflect the other consent-related regulations (e.g., waiver criteria).
Due to the differing nature of the research and the volume of approved studies, the U-M IRBs are taking separate approaches towards transitioning existing studies to comply with the revised Common Rule, including any updates to informed consent documentation. Contact your U-M IRB for further information.
IRBMED has specific guidance for transitioning existing projects reviewed under their purview prior to the proposed January 21, 2019 effective date. See the IRBMED's Transition to 2018 Regulations website for complete details.
New studies submitted for IRB review after January 21, 2019 must utilize an updated informed consent template to ensure compliance with the revised Common Rule.
IRB applications submitted shortly before January 21, 2019 may not be reviewed in time to qualify under the current human subjects protection regulations. Applications undergoing the review process at the time of transition may be returned to the study team to update the informed consent elements.