Monthly Education & Training Series (METS)

Tips & Tricks for Successful IRB Submission and Review

Submitting an IRB Application - A Step-by-Step Guide

Kaori Kubo Germano, Ph.D.
Sr. Manager, Clinical Research Education & Communications
Human Research Compliance

The focus of this session is to provide a step-by-step walk through of the IRB submission process, beginning with accessing the Weill Research Gateway-Human Subjects (WRG-HS) and Oncore, through the certification of your application.  We will discuss the new IRB Review Application Forms, the required Key Information Section for Informed Consent Forms, and when  Ancillary Reviews must take place, and how. This session is geared to new investigators preparing to submit an IRB application for their study, as well as research team members who may want to re-familiarize themselves with the process. 

Download the slides from this presentation:  Submitting an IRB Application - A Step-by-Step Guide handout

View the presentation: Submitting an IRB Application - A Step-by-Step Guide recording

Single IRB: An Overview

presented November 16, 2023 by

German Jimenez
Human Research Compliance and Reliance Manager
Human Research Compliance

with a special appearance by
Lauren Gripp
Director of Clinical Trials
Joint Clinical Trials Office

The goal of Single IRB review is to enhance and streamline the IRB review process for multi-site research so that research can proceed without compromising ethical principles and protections for human research participants. This presentation will help provide education to WCM investigators, study teams and research administrators on the concept of a Single IRB model in multi-site research.

After this educational session, you will be able to: (1) Understand what Single IRB review is; (2) Recognize what types of studies must comply; (3) Explain the overall process for obtaining Single IRB review; (4) Plan for Single IRB review for a multi-site research study.

Download the slides from this presentation: Single IRB: An Overview handout

View the presentation: Single IRB: An Overview recording

IRB101: Regulating Research: Research Ethics and the Responsible Conduct of Research

presented September 14, 2023 by

Kaori Kubo Germano, Ph.D.
Clinical Research Program Manager
Human Research Compliance

In this session we present a brief history of the evolution of human subjects protections in research and the general ethical principles guiding research regulations.  We also provide an overview of the various regulations that govern the responsible conduct of human subjects research and when they apply. This is an excellent opportunity for research team members to learn about the role of the IRB in ensuring that all human subjects research conducted within an organization meets the applicable guidelines and regulations governing the research.

Download the slides from this presentation:  Regulating Research: Research Ethics and the Responsible Conduct of Research handout

View the presentation: Regulating Research: Research Ethics and the Responsible Conduct of Research recording

Informed Consent in Research:
Regulatory Requirements, Ethical Considerations, and
Creating your Informed Consent Forms

presented June 15, 2023 by

Kaori Kubo Germano, PhD
Clinical Research Program Manager

In this session we provide an overview of the regulatory requirements underlying one of the most important documents in human subjects research, the Informed Consent Form (ICF).  We will review the essential elements of the ICF, when a waiver is warranted and how to address the criteria for waiver or documentation and waiver of consent, and tips for creating an ICF that the IRB can approve. This presentation will provide essential information for the responsible conduct of research and is recommended for all study team members.  

Download the slides from this presentation:  Informed Consent in Research: Regulatory Requirements, Ethical Considerations, and Creating Your Informed Consent Forms handout

View the presentation: Informed Consent in Research: Regulatory Requirements, Ethical Considerations, and Creating Your Informed Consent Forms recording

IRB101: Introduction to the WCM IRB

presented 8/17/2023 by
Kaori Kubo Germano, Ph.D.
Clinical Research Program Manager
Human Research Compliance

In this session we provide an overview of the WCM IRB and answer some of the more common questions we receive, including when an IRB review is required, how to prepare a submission, types of IRB review, and common causes of delays, among others. While open to everyone, this is an excellent opportunity for new research team members to familiarize themselves with the WCM IRB.

Download the slides from this presentation:  IRB101: Introduction to the WCM IRB handout

FDA-Regulated Research

presented October 19, 2023 by

Kaori Kubo Germano, PhD
Sr. Manager, Clinical Research Education & Communications
Human Research Protections

The goal of this presentation is to provide WCM investigators with an understanding of FDA regulatory requirements when conducting research involving drugs and/or medical devices. This is an excellent opportunity for clinical research team members to learn about the sometimes hard-to-navigate requirements set forth by the FDA, and to receive answers to any questions you may have about the applicable guidelines and regulations governing your research.

Download the slides from this presentation: HRP METS: FDA Regulated Research handout

View the presentation: HRP METS: FDA Regulated Research recording

Data Security in Research: PHI, Email, HIPAA, and You

presented February 16, 2023 by
Kaori Kubo Germano, Ph.D.
Sr. Manager, Clinical Research Education & Communications
Human Research Compliance

In this session, we review the IRB’s role as Privacy Board by exploring the different regulatory pathways to utilizing Protected Health Information (PHI) in research according to the Health Insurance Portability & Accountability Act (HIPAA) of 1996. Discussion will include how to determine when your research needs a full or partial HIPAA waiver as opposed to prospective HIPAA Authorization from subjects, and other scenarios. We’ll also discuss what you can do to protect research subjects’ PHI when transmitting it via email and how to report to the IRB in the event of an accidental disclosure.

Download the slides from this presentation:  Data Security in Research: PHI, Email, HIPAA, and You handout

View the presentation: Data Security in Research: PHI, Email, HIPAA, and You recording