IMPLEMENTATION DATE: JANUARY 21, 2019

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).
    • 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.
Implementing the Informed Consent Changes
The revised Common Rule includes several revisions to informed consent requirements.
The new consent form template is available at: http://bsdirb.bsd.uchicago.edu/forms-guidelines/index.html

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. The consent form template includes suggested language for this section. In addition, sample text has been provided based upon study type.

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 all new studies submitted for IRB review. Research which is approved on or after January 21, 2019, 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:
    • The IRB will consider, at the time of continuing review, whether or not existing studies will need to be amended to 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.


Posting of Consent Forms:
The new regulations also require posting of the consent form document for all federally funded clinical trials on a publically accessible website. One IRB approved consent form that was used to enroll subjects must be posted on a federal website once the study has been closed to recruitment and within 60 days of the last study visit by any subject.

At this time, two publicly available federal websites that will satisfy the consent form posting requirement: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).  We have been told that HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement. However, this guidance has not been published.

It should be noted that this requirement will only be relevant for studies approved under the new  Common Rule. At this time, there is no expectation to post clinical trial consent forms for studies approved prior to this date.

AURA-IRB Changes:
The AURA-IRB form is undergoing changes to reflect requirements in the revised Common Rule. The new version of the AURA-IRB form is expected to go live January 15.
For More Information:
In light of these changes, the IRB will be presenting three sessions discussing the new Common Rule requirements. If possible, please plan on attending one of these sessions:

Friday, January 11 – 11:30 am – 12:30 pm   Dora de Lee Auditorium (L168)
Monday, January 14 – 10:00 am– 11:00 am   Dora de Lee Auditorium (L168)
Wednesday, January 23 – 10:00 am – 11:00 am Dora De Lee Auditorium (L168)
Monday, February 4th - 3:00 pm - 4:00 pm Dora De Lee Auditorium (L168)

If you are not able to attend one of these sessions and need additional guidance, please contact
Millie Maleckar, IRB Director at mmalecka@bsd.uchicago.edu.