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:
Submitting an IRB Application:
A Step-by-Step Guide
Thursday, March 16, 2023
11:00am until 12noon
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.
Registration is required; please register here
Future METS
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
December 2022: Tips & Tricks for Successful IRB Submission and Review
Tips & Tricks: Successful IRB Submission and Review Process
presented by
Yefrenia Henriquez Taveras
Clinical Research Program Manager and Sr. IRB Navigator
Please join us for our next METS session presented by our very own Sr. Research Navigator, Yefrenia Henriquez Taveras. The goal of this presentation is to provide researchers with effective tips for completing a successful IRB application. This presentation will help provide education to WCM investigators, study teams and research administrators on describing basic requirements for successful submissions to the IRB and minimizing common errors that may delay submission progression.
Click here for the pdf handout
Click here to view the recorded presentation
January 2023: Cultural Competence
Cultural Competence and the Responsible Conduct of Research
presented by
Kaori Kubo Germano, PhD
Clinical Research Program Manager
With the increasing expansion of our research endeavors comes the increased onus of responsibility to ensure that we are engaging with our stakeholders responsibly. This includes being aware of how our own cultural beliefs and values may influence our interactions with others. Cultural competence is the ability to understand and respect the values, attitudes, and beliefs that differ across cultures, and to enact a set of behaviors that enable effective communications in cross-cultural situations (Cross et al., 1989). The goal of this presentation is to define cultural competence in research, to describe the multi-faceted nature of culture, and to encourage individuals to adapt specific practices to ensure cultural awareness. This presentation is recommended for all members of the research team, as well as research administrators and leadership.
Click here for the pdf handout
Click here to view the recorded presentation
February 2023 METS: Data Security in Research: PHI, Email, HIPAA, and You
Data Security in Research: PHI, Email, HIPAA, and You
presented 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.
Click here for the pdf handout
Click here to view the recorded presentation
