IRBMED Seminar Series

November 15, 2022

Human Research and HIPAA: What you Think You Know and What You Should Know

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Seminar Summary: The Health Insurance Portability and Accountability Act's (HIPAA) medical privacy regulations govern the use and release of a patient’s personal health information (PHI). Applying the HIPAA Privacy Rule to research can be puzzling and misunderstood. IRBMED offers this seminar as an opportunity to learn about privacy practices at Michigan Medicine and the HIPAA requirements and permissions when research involves PHI. This seminar provides an opportunity to learn or reaffirm your understanding of how HIPAA applies to research from presenters: Rebecca Hulea from the Michigan Medicine Office of Compliance, Beth Vibbart from IRBMED, Devon Newman from the Data Office for Clinical and Translation Research, Allison Kanous from IRBMED, and Eric Ward from the Office of Research Sponsored Projects.

June 7, 2022

Vulnerability in Research with Human Participants

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     - Decision-Making Tool
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Seminar Summary: Some research participants are members of specifically identified and protected vulnerable research participant populations (such as children, pregnant women, and prisoners) and other groups of individuals entitled to special safeguards (such as those who are cognitively impaired or economically or educationally disadvantaged). This seminar includes discussions on what vulnerability means in the context of recruiting and enrolling participants and focuses on the kinds of vulnerability that may exist in research although not explicitly described in the regulations.

IRBMED and IRB-HSBS co-hosted this seminar and are pleased to have U-M researchers, Professors Sunghee Lee and Robert Hymes, and Clinical Research Project Manager Jaimie Ziolkowski as presenters to share how they evaluate the circumstances under which research participants are being asked to consent and provide additional safeguards for those who may be vulnerable in some way. IRBMED and IRB-HSBS leadership also participated in this important discussion to address vulnerability in the context of research.

October 19, 2021

Considerations for Research Involving Biobehavioral Elements and Mobile Health (mHealth) Technologies

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Agenda

IRBMED hosted its biannual Seminar Series on Tuesday, October 19, 2021, and a recording is now available. Registration to access the recording is required. through 11/18/2021 and registration is limited to the University of Michigan users. Authentication requires the use of a U-M email address while logged into Zoom via a U-M account.

Seminar Summary: Projects involving health and biology data, including genetic and genomic data, with data on individual behaviors, environmental factors, and the use of mHealth technologies have their unique challenges. This seminar includes presentations on the ethical considerations involved in clinical research combined with biobehavioral elements.

The Distinguished University of Michigan researchers Melvin McInnis, M.D. and Sachin Kheterpal, M.D., MBA, discuss their research. Nicole Eyrich, MPH, who works on projects that involve mHealth technologies as a clinical research project manager, describes considerations for the eResearch application. Beverly Yashar, a clinical professor of human genetics and IRBMED board member, presents the bioethical implications of genetic and genomic data collection. Katy Hunsche, an IRBMED senior associate regulatory analyst, addresses additional details for working with IRBMED on these types of projects.

May 4, 2021

A Comprehensive Look at Monitoring and Auditing of Human Participant Research

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IRBMED held its Spring installment of its Seminar Series on May 4, 2021, which provided a comprehensive overview of monitoring and auditing of human participant research. Topics included identifying when a Data and Safety Monitoring Plan (DSMP) and/or a Data and Safety Monitoring Board (DSMB) is required and requirements for submitting DSMB reports, other monitoring reports, and audit results to the IRB. A representative from the Office of Regulatory Affairs presented on FDA inspections as a form of audit and a representative from MICHR's Research Management team discussed monitoring requirements, available monitoring services, and monitoring examples.

October 13, 2020

Regulatory and Financial Implications of Single IRB Review for Multi-Site Research

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IRBMED hosted an installment of its Seminar Series on October 13 that focused on the regulatory and financial implications of Single IRB (sIRB) review for multi-site research (MSR). Presentations described U-M procedures and processes in place to comply with regulatory and institutional requirements under sIRB mandates. New information regarding financial considerations and IRBMED efforts for Quality Assurance for these application types were also shared.  

November 5, 2019

Decoding the FDA Alphabet Soup for Research Involving Drugs and Devices: INDs, IDEs, IVDs, NSR, and MMAs!

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On November 5th, IRBMED hosted an installment of its Seminar Series that focused on deciphering the alphabet soup related to research involving drugs and devices. Presenters decoded and demystified the requirements for Investigational New Drug Applications (INDs), Investigational Device Exemptions (IDEs), In Vitro Diagnostic (IVD) Devices, Non-Significant Risk (NSR) determinations for medical device studies, and Mobile Medical Applications (apps) (MMAs).

The content focus was on the roles and responsibilities of the Principal Investigator and study teams when conducting research involving drugs and/or devices including the requirements and process for when an IND or IDE is required. Tips for working with the FDA and for submitting these application types in eResearch were provided.