IRBMED Seminar Series

 

May 4, 2021

A Comprehensive Look at Monitoring and Auditing of Human Participant Research

Agenda
Presentation Slides

Recording (login to U-M Google account to access)

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

Agenda
Presentation Slides
Recording (login to U-M Google account to access)

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!

Agenda
Presentation Slides

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 demystifyed 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 for 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. 

Earlier Seminar Series Presentations

December 2018 - An Eleventh-Hour Look at the Common Rule Changes

December 18, 2018

An Eleventh-Hour Look at the Common Rule Changes

This installment of the IRBMED Seminar Series provided an overview of the revisions to the Common Rule issued by the Department of Health and Human Services. The general compliance date for the revised Common Rule (45 CFR 46 subpart A) was January 21, 2019. The seminar included a mock IRB session demonstrating a review of a new Oncology study, which highlighted the new requirements for Informed Consent.

The updated Standard Informed Consent template is already available for use and meets the requirements of the existing Common Rule and the revised Common Rule.

April 2018 - Multi-Site Research: Accepting & Ceding of IRB Oversight

APRIL 10, 2018

Multi-Site Research — The Accepting and Ceding of IRB Oversight:
What Investigators and Study Teams Need to Know

The April 10, 2018 installment of the IRBMED Seminar Series focused on the changing environment of multi-site research. We hope the program provided awareness to the various components to multi-site research projects, including institutional decision-making, Reliance Agreements, the process for ceding oversight to an external IRB and the various responsibilities of a study team when IRBMED accepts IRB oversight for a multi-site trial.

We appreciate the contributions of the Mock IRB members and presenters from the U of M Office of Research, IRBMED, and Research Pharmacy.

Click on any of the following links to access the slide presentations:

January 2018 - Updates: U of M Transition to 2018 Regulations

JANUARY 9, 2018

Updates: U of M Transition to 2018 Regulations

Presentation slides

November 2017 - Changes to the Common Rule

NOVEMBER 21, 2017

Changes to the Common Rule

Presentation slides

October 2017 - Common Rule Changes

OCTOBER 17, 2017

Common Rule Changes

Presentation slides

September 2017 - Changes to the Common Rule

SEPTEMBER 26, 2017

Changes to the Common Rule

Presentation slides

April 2017 - Revisions to the 'Common Rule' – Changes Ahead

APRIL 4, 2017

"Revisions to the Federal Policy for the Protection of Human Subjects ('Common Rule') – Changes Ahead"

Agenda

This installment of the IRBMED Seminar Series provided an overview of the Revisions to the Common Rule issued by the Department of Health and Human Services on January 18, 2017.

More information will be forthcoming as we develop processes in anticipation of implementation of the bulk of the revisions on January 19, 2018.

Please look for future seminar series where we will have more information on this important topic.

Click on any of the following links to access the slides of the presentations or U-MICs:

October 2016 - Phase I Clinical Trials and Safety

OCTOBER 4, 2016

“Phase I Clinical Trials and Safety- Consideration of a Subject’s Death in France”

Agenda

We hope this session provided our audience with insight into how an IRB would review a Phase I Trial where an injury occurred, subsequent institutional evaluation and reporting, and possible outcomes and consequences.

We appreciate the contributions of the Mock IRB members and presenters from the IRBMED, U of M Office of Research, and Regulatory Affairs.  

Click on any of the following links to access the slide presentations:

May 2014 - Various Regulatory Topics

MAY 21, 2014

Thank you to everyone that contributed their time, knowledge, and expertise in order to make the Seminar Series a success.  To everyone that was able to attend, we hope you found the sessions to be informative and beneficial.

Click on any of the following links to access the slide presentations:

 

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.