DELAYED until July 19

Major Changes
The 2018 Requirements focus on reducing administrative burden and aligning protection of human subjects with level of research risk. Several of the changes reduce or remove requirements for low-risk research, while other changes offer additional flexibility within the current framework.

  • New Exempt Categories:
    • Research with benign behavioral interventions; will likely result in the majority of currently-expedited social-behavioral-educational research being exempt
    • Secondary research use of information/biospecimens protected by HIPAA; will allow exempt review of retrospective chart reviews
  • Removal of renewal requirements for expedited research, and full Board research which is now in long-term follow-up only or data analysis only. U of C will consider the flexibility of this approach on an individual protocol basis at the time of continuing review for all previously approved research, as the FDA regulations have NOT been revised to remove the continuing review requirement.
  • Informed Consent Impacts:
    • Consent must begin with a concise and focused presentation of key information which participants want in order to make a decision (e.g. statement that the project is research and that participation is voluntary and a summary of the purpose, duration, procedures, risks, discomforts, benefits, appropriate alternatives, costs and payment). This summary will be included in a revised informed consent template.
    • New elements of informed consent must be included (when applicable):
      • Potential for future use of deidentified information
      • Potential for commercial profit and sharing of profits with subjects
      • Whether clinically relevant research results will be disclosed to subjects and, if so, under what conditions
      • For research involving biospecimens, whether the research will involve whole genome sequencing

What to Expect
The 2018 Requirements will result in a large number of changes to Institutional Review Board policies and procedures. More specific information about the changes will be offered throughout next few months, in addition to educational sessions in early 2018.
Implementing the Informed Consent Changes
The revised Common Rule includes several revisions to informed consent requirements.
Please see new informed consent template.

Concise Presentation:
The new regulations require that consent begin with a concise and focused presentation of key information which participants need to make a decision, and which explains why a potential subject might or might not want to participate. The goal of this concise presentation is to provide a summary of the research up front so potential participants can more easily understand the research and the consequences of participation, both positive and negative.


New Elements of Informed Consent:
The revised regulations also add four new elements of informed consent. These elements represent additional information which must be included in the informed consent form and presented to potential subjects, when applicable. The working group has proposed boilerplate language for each of these new elements which is included in the revised informed consent template.

  • Whether research information may be deidentified and used for future research
  • Whether commercial profit is expected and, if so, whether profits may be shared with subjects (previously included in the consent template)
  • Whether clinically relevant research results will be disclosed to subjects and, if so, under what conditions
  • For research involving biospecimens, whether the research will involve whole genome sequencing

Using the Informed Consent Templates:
Revised informed consent templates have been published to the IRB website.
New research: The revised informed consent template should be utilized for new studies submitted for IRB review as soon as possible. Research which is approved on or after January 19, 2018, must meet the new requirements; as such, informed consent forms for those studies must include the concise presentation/summary and additional elements of informed consent.

  • Ongoing research:
    • Previously-approved research which is open to enrollment may update to the new informed consent template, or add the concise presentation/summary and additional elements of informed consent to the current consent form, at time of renewal.
    • Future enrolled subjects should be consented using the revised consent form.
    • Previously enrolled subjects would not need to be reconsented using the revised consent document.
    • IRB staff will work closely with investigators at time of renewal to help them understand and comply with the new requirements.

Revisions to Waiver of Consent Criteria:
Research which meets certain criteria may be eligible for a waiver (or modification) of the informed consent process. The revised Common Rule adds one new criterion to this list. Specifically, if the research involves utilization of identifiable information or biospecimens, the investigator must justify that the research could not practicably be carried out without the use of identifiers.


How to Prepare

  • Begin using new consent form template
  • Sign up to receive OCR ¬†newsletters by emailing clinicresearch@bsd.uchicago.edu.
  • Watch for educational sessions throughout the coming months, or request a departmental-specific training session by contacting the IRB Director, Millie Maleckar (mmalecka@bsd.uchicago.edu).