IRBMED Seminar Series

November 5, 2019

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

On November 5th, IRBMED will host an installment of its Seminar Series that will focus on deciphering the alphabet soup related to research involving drugs and devices. Presentations will decode and demystify 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).

Presentations will focus 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 will be provided. A dedicated session of the seminar will feature a Q&A session on these topics. 

Light refreshments will be available during the break.

Registration available here.

December 18, 2018

An Eleventh-Hour Look at the Common Rule Changes

This installment of the IRBMED Seminar Series will provide the most up-to-date 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) is January 21, 2019. The seminar will include a mock IRB session demonstrating a review of a new Oncology study, which will highlight the new requirements for Informed Consent.

An 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 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 9, 2018

Updates: U of M Transition to 2018 Regulations

Presentation slides

NOVEMBER 21, 2017

Changes to the Common Rule

Presentation slides

OCTOBER 17, 2017

Common Rule Changes

Presentation slides

SEPTEMBER 26, 2017

Changes to the Common Rule

Presentation slides

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 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:

JANUARY 29, 2016

Agenda
AAHRPP Accreditation: Navigating the Interview Process
Possible Regulatory Changes in Oversight of Human Subjects Research: Notice of Proposed Rule-Making (NPRM)
Biorepositories and Biospecimen Studies Under the NPRM

APRIL 28, 2015

Agenda
Anatomy of a Breach
Data Security
Quick Tips
Protecting Science and Human Subjects in Online Research

SEPTEMBER 19, 2014

Agenda
Challenges of FDA Regulated Research: Pitfalls and Promises
Mobile Apps: When do FDA Regulations Apply
Quick Tips:

MIAP: Introduction to INDs and IDEs
Mock IRB

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.