The Office of Human Research Compliance is pleased to offer a monthly education and training series for our stakeholders.  The goal of this program is to provide a rotating series of sessions that will assist you in making sure your team receives the information they need to navigate the IRB process. Sessions are scheduled on a Thursday in the middle of each month, and registration is required to attend.  

We hope you can join us for our next session:

Single IRB and Reliance

Thursday, November 17th, 2022
11:00am until 12noon

Please join us for our next METS session presented by our very own Single IRB Administrator and Reliance Manager, German Jimenez! 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

Registration is required; please register here

Future METS

  • 12/15/22: Tips and Tricks for Successful IRB Submissions and Reviews (register here)
  • 1/12/23: Cultural Competency and the Responsible Conduct of Research (register here)
  • 2/16/23: Data Security in Research: PHI, Email, HIPAA, and You (register here)

Past METS

July 2022: Introduction to the WCM IRB

IRB101: Introduction to the WCM IRB

presented 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.

Click here for the pdf handout

Click here to view the recorded presentation

August 2022: The Informed Consent Form

IRB101: The Informed Consent Form: Elements of the Informed Consent Form, Checking Readability, and Ensuring Understanding

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

and

Lauren Gripp
Director, Clinical Trials
Joint Clinical Trials Office

In this session we review the basic elements of the informed consent form (ICF) and provide practical tips on constructing an ICF that the IRB will love! We are joined by a special guest from the Joint Clinical Trials Office (JCTO), presenting on the informed consent process and ensuring your participants' understanding of the ICF.  

Click here for the pdf handout

Click here to view the recorded presentation

September 2022: Regulating Research

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

presented 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.

Click here for the pdf handout

Click here to view the recorded presentation

October 2022: FDA Regulated Research

FDA Regulated Research

presented by

Yefrenia Henriquez Taveras, MPH, MHA, CHES
Clinical Research Program Manager
Human Research Compliance

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.

Click here for the pdf handout

Click here to view the recorded presentation

November 2022: Single IRB: An Overview

Single IRB: An Overview

presented by

German Jimenez
Human Research Compliance and Reliance Manager
Human Research Compliance

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; Recognize what types of studies must comply; (2) Explain the overall process for obtaining Single IRB review; (3) Plan for Single IRB review for a multi-site research study.

Click here for the pdf handout

Click here to view the recorded presentation