Health Sciences and Minimal Risk IRBs, IRB News/Volume 11, Number 1, pt. 1, January 2019
This is the first part of a two-part newsletter on the revised Common Rule (hereafter revised Rule), which is effective January 21, 2019. Part two of the newsletter will focus on the impact of the revised Rule on exemptions and continuing review as well as the transition plan for already approved studies. This part will focus on the impact of the revised Rule on informed consent documents and waivers and alterations of informed consent.
The revised rule no longer requires waivers of informed consent for researchers to obtain information or biospecimens for the purposes of screening, recruitment, or determining eligibility if the study team will obtain information through:
For study teams completing an IRB application, this will have two significant impacts:
While the revised Rule provides some more flexibility for screening and recruitment activities, it does include a new criterion for waiver of informed consent. To grant a waiver of informed consent when research involves using identifiable private information or identifiable biospecimens, the IRB must determine the research could not be practicably carried out without using such information or biospecimens in an identifiable format. This criterion will be added to the waiver of informed consent page of the ARROW application.
The revised Rule includes a new provision that allows an IRB to waive documentation of informed consent (i.e., subjects needing to sign a consent form) if subjects are part of a distinct cultural group or community where signing forms is not the norm. This new criterion applies only to minimal risk research and the ARROW application will be updated to include this new option.
The revised Rule adds new required and additional elements of informed consent:
The HS IRBs will be posting updated information on our Informed Consent webpage and updated consent form templates to address these new elements soon. The most noticeable changes relate to the “concise and focused presentation of key information” and clinically relevant research results. For lengthy consent forms (more than 10 pages), our templates address the concise presentation requirement by adding a brief introductory section based on our familiar Study Summary template. To address clinically relevant research findings, the updated consent templates add a new section to describe how research results will be handled. Additional changes to instructions and model language throughout the consent form templates are designed to comply with the revised Rule and institutional requirements.
Suggestions for study teams: