Study Teams: What to Know and How to Prepare

The effective date for the 2018 Federal Policy for the Protection of Human Subjects ("2018 Common Rule") will likely be further delayed until January 21, 2019. This delay gives the U-M IRBs time to:

• Pilot new business processes related to some of the burden-reducing measures in the proposed Common Rule; and
• Implement and evaluate enhancements to the IRB application developed in preparation for the regulatory changes.

On June 11, 2018, the U-M IRBs, in conjunction with ITS-eResearch, will release a new version of the IRB application in support of an HRPP flexibility initiative to pilot three burden-reducing 2018 Common Rule processes for non-federally sponsored and non-FDA regulated human subjects research only:

1. New and expanded exemption categories 1 - 6;
2. New exemption review paths, specifically the "self-determination" workflow for exemptions 1, 2, and 3; and
3. No continuing review for most expedited studies

Summary of Upcoming IRB Application Changes

The following IRB application changes will display for all studies regardless of funding source or review path as of June 11. However, federally-sponsored or FDA-regulated projects are not eligible to participate in the pilot. During the pilot, the IRB teams will work with study teams to ensure these projects receive the correct type of review and outcome determination while using the revised IRB application.

Application Type changes:

• The Standard application will be renamed "Human Subjects research involving interaction or intervention";
• The Secondary Use application will be renamed "Secondary research uses of private information or biospecimens." The application questions have been re-ordered and streamlined to facilitate workflow and review; and
• The Exempt application will be discontinued, and the exempt functionality merged into the "Interaction/Intervention" for exemptions 1, 2, 3, 5, and 6 or the "Secondary Research" application for exemption 4.

Thus, regardless of review path (i.e., full board, expedited, or exempt) study teams will use one application type for all studies that involve an interaction or intervention with human subjects and a separate application type for all research limited to secondary use of data and/or biospecimens.

Exemption functionality changes:

• New "exemption screener" functionality, used to identify if the research qualifies for exemption and to select which exemption category applies, will display in the Application Type section (1-1) in the Interaction/Intervention application;
• The exemption questions in the Interaction/Intervention application will be updated to reflect the 2018 Common Rule exemption category criteria;
• Disqualifying answers to an exemption question will reroute the applicant automatically to the next appropriate question in the Interaction/Intervention application. Study teams will no longer need to start over by selecting a new application type.

New & improved features:

• The Sponsor Information section (2) will be updated to replace the subquestions with functionality to select PAFs and/or UFAs associated with the study. More details about the selected sponsor funding/support also will display in the IRB application.
• The Informed Consent section (10) will be reorganized to better indicate categories of consent (e.g., with signature, waivers, etc.) for informed consent/child assent.
• A new Termination Report submission will be available.

To view the system changes prior to June 11, see the Overview of Changes document or log in to the eRRM Sandbox.

Study Team Action Items

To ensure a smooth transition to the new version of the IRB application, the U-M IRBs recommend the following:

• For non-secondary use exempt projects expected to start in early June: submit Exemptapplications no later than June 1, 2018. Exempt studies that are in progress at the time of transition (June 10) may need to be re-started using the appropriate application type.
• For secondary use projects: two weeks prior to June 11, hold the submission of Exempt #4 and other Secondary Use projects to take advantage of the improved functionality and organization of the new Secondary Research application type.

As of June 11:

• For existing expedited studies that qualify for the pilot, do not file an amendment simply to transition a project to a "no continuing review" status. The U-M IRBs will determine whether or not studies will require Continuing Review at the time of amendment.
• To change the scope of the research protocol for existing exempt projects, complete a new Interaction/Intervention or Secondary Research application, as applicable.

Questions?

For questions about, or assistance with, the impact of the pilot and the eResearch system enhancements on your research contact your U-M IRB.

To provide feedback about the HRPP flexibility initiative to pilot three burden-reducing provisions of the 2018 Common Rule, contact hrppumich@umich.edu.