eResearch Enhancements: IRB Application Updated to Enhance Research Oversight and Safety

New HUM Questions Enhance IRB and Institutional Review Processes

As of May 10, new questions have been added to the IRB application to support institutional compliance, study oversight, and research safety. Study teams must respond to these new questions as a part of any new application and also for all in-progress, returned for revision, or amending applications. Below is a summary of the key updates:

External Collaborator Identification

A new question has been added to Section 1, General Information which helps identify study team members with primary affiliations (e.g., faculty, employee, or student) at external institutions. This ensures U-M can establish the appropriate authorization or reliance agreements required for the study. 

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Export Control Considerations

To flag studies potentially subject to U.S. Export Control and cybersecurity regulations, Section 01-2, Standard Study Information now includes a question on whether the research will be conducted in, or with individuals residing in, embargoed regions (i.e., Cuba, Iran, North Korea, Syria, and the Crimean, Donetsk, and Luhansk Regions of Ukraine).  For more information, visit the Embargoed and Sanctioned Countries webpage or contact the U-M Export Controls Office.

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Bulk U.S. Sensitive Data Regulations

To identify studies with data that may be subject to the new Department of Justice regulations regarding access to bulk U.S. sensitive personal data, including human ‘omic (i.e., genomic, epigenomic, proteomic, and transcriptomic) data, two new questions have been added to section Section 01-2, Standard Study Information.

Researchers must:

• Categorize the type and volume of data to be acquired
• Whether that data will be accessed by or shared with individuals or entities located in, or affiliated with, China (including Hong Kong and Macau), Russia, Venezuela, Iran, Cuba, and North Korea. 

Anyone who answers these questions affirmatively must contact the U-M Office of General Counsel (OGC) for additional guidance. The determination of whether the data are subject to the regulations will be made by OGC.

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Research Safety

In partnership with U-M Environment, Health & Safety (EHS), two new questions have been added to Section 3, U-M Study Functions to better identify and manage research hazards at U-M locations, focusing on:

• In-person activities (e.g., recruitment, screening, interaction, intervention) where research participants will be physically present in or directed to walk through potentially hazardous environments, such as wet labs or animal research areas.
• Procedures involving human-derived substances (e.g., blood draws) conducted in non-traditional U-M research spaces like offices, common rooms, conference rooms, restrooms, or lactation lounges.

A “Yes” response to the questions displays a sub-question to provide location information and triggers an alert to EHS, enabling EHS to follow up with study teams as needed to conduct a comprehensive safety evaluation. For more information, please visit the EHS website.

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Technology Evaluation by Michigan Medicine HITS Information Assurance (IA)

SSome technologies used in research studies, particularly those that connect to Michigan Medicine’s HITS infrastructure or transmit Michigan Medicine data to third-party systems, require an initial IT security review by Michigan Medicine Information Assurance (IA). While important for ensuring data security and compliance, this IA review is a separate process and is not a condition for IRB approval. Relevant data for IA review is collected through reporting functionality, independent of the IRB application workflow.

To improve the timeliness of the IA review and reduce vulnerabilities in IT systems handling sensitive patient and research data, new questions have been added in Section 01-2, Standard Study Information.

Researchers must indicate if their study involves:

• Installing or connecting technology to the Michigan Medicine IT network.
• Entering Michigan Medicine data into a non-Michigan Medicine website or IT system, such as a sponsor or vendor electronic data capture (EDC) system.

If uncertain, researchers should answer “yes” to trigger further IA review. Follow-up questions will either confirm technology approval or request further details if needed.  See Michigan Medicine’s Trusted Service Provider (TSP) Resources webpage for more information, including a list of IA assured vendors (level 2 password required).

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FDA-Regulated Research Involving Healthy Volunteers

New questions in Section 15: Drugs, Biologics, Etc. and Section 16: Devices ask if “normal, healthy subjects” will be exposed to FDA-regulated products in order to correctly characterize the utilization of test articles in the study as “on-label” or “off-label.”

A “Yes” response in Section 15 may trigger MIAP review. If there is already an IND, it may not be triggered. 

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Genetic Research Clarification

For studies involving genetic analysis, a new follow-up question in Section 07: Special Considerations gathers details on the type(s) of analysis performed.  New routing eliminates unnecessary redirection to Section 20: Genetic Analysis

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Termination Report – Data and Biospecimen Management

To align with the Association for Accreditation of Human Research Protection Programs (AAHRPP) requirements, A new section has been introduced to the Termination Report for Standard, Multi-site, and Secondary Use studies to verify if the original plans for data/biospecimen management are still accurate upon study conclusion.  If changes are needed, new plans must be reviewed and approved by the IRB.  This addition:

• Supports study teams in managing the disposition of data and biospecimens at termination
• Ensures that confidentiality plans are evaluated throughout the research lifecycle.