Health Sciences and Minimal Risk IRBs, IRB News/Volume 11, Number 1, pt. 1, January 2019
Revised Common Rule Updates – Part 1
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.
Screening Activities and Waivers 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:
- Communication with the prospective subject (e.g., via phone screening); and/or
- Accessing records (e.g., screening medical records) or stored identifiable biospecimens
For study teams completing an IRB application, this will have two significant impacts:
- Waiver of informed consent in the consent section no longer needs to be selected for pre-screening of medical records.
- Alteration of elements of informed consent and waiver of documentation of informed consent no longer need to be selected for phone screening.
Waiver of informed Consent for Identifiable Biospecimens and Information
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.
New Option for Waiver of Documentation of Informed Consent
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.
New Informed Consent Requirements and Templates
The revised Rule adds new required and additional elements of informed consent:
- 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, organized and presented in a way that facilitates comprehension.
- For research that collects identifiable private information or biospecimens, a statement that identifiers might be removed and the information or biospecimens used or shared for future research without subjects’ additional consent; or that the information or biospecimens will not be used or shared for future research even if identifiers are removed.
- A statement that biospecimens may be used for commercial profit and whether subjects will or will not share in the profit.
- A statement regarding whether clinically relevant research results will be disclosed to subjects, and if so, under what conditions.
- For research involving biospecimens, whether the research will or might include whole genome sequencing.
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:
- Using the updated HS IRBs consent templates (available soon) whenever possible will make it easier to create consent forms that comply with the revised Rule. Instructions as well as template language will be revised.
- HS IRBs staff use an Informed Consent Checklist when reviewing consent forms to check for required information. Study teams can also use this checklist, which will be posted on the HS IRBs Informed Consent webpage, for reference when composing consent forms. The checklist can be especially helpful when working with consent templates from other institutions or sponsors.
- Additional model language on the HS IRBs website will also be revised and posted shortly. Using the updated instructions and language will help ensure that consent forms meet both revised Rule and institutional requirements.