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Human Research Protections Clubhouse

Empowering Collaboration and Excellence in Human Research Protections

PRIM&R 2023 Luncheon

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Our mission is to empower and unite professionals by providing a FREE venue for education, networking, and collaborative dialogue, enhancing ethical conduct and regulatory compliance. Our vision is to be recognized globally as a leader in fostering a community where human research is conducted with the utmost ethics, integrity, and compliance.

The Human Research Protections Clubhouse (HRPCH) is where professionals in human research protection converge to foster a culture of collaboration, learning, and innovation. Through active engagement in webinars, discussions, and leadership roles, our members share knowledge and promote ethical research practices. This vibrant community is built on mutual respect, continuous growth, and a commitment to the highest standards in human research protection.

Your engagement, contributions, and leadership are essential to shaping the future of ethical research. Together, we can make a significant impact on the lives of research participants and the advancement of scientific discovery. Become part of a vibrant community of professionals dedicated to fostering a culture of collaboration, learning, and innovation in human research protection. Simply register for any future webinar and indicate you want to be added to the mailing list or write to hrpclubhouse@downstate.edu

Thank you for your commitment to promoting ethical research practices and safeguarding the well-being of research participants. We look forward to seeing you!

 

Register Now for the Next HRP Clubhouse Session:

Expanded Access 101 (February 11, 2025 @ 12 NOON ET)

We are pleased to invite you to a FREE informative webinar on Expanded Access 101.
 
This session will explore the regulatory pathways that allow investigational medical products to be used by patients with serious or life-threatening conditions when no approved alternatives exist.
 
The webinar is ideal for IRB professionals, investigators, and healthcare providers interested in learning how to navigate the Expanded Access process effectively.
 
This event is eligible for 1.0-hour CIP credit.
 
This session will cover:
 
✅ What is Expanded Access and how compassionate use and emergency use differ
✅ Emergency Use
✅ Key differences between drugs, biologics, and medical devices in Expanded Access
✅ The role of IRBs and tips for professionals navigating Expanded Access requests
 
📅 Date: February 11, 2025
⏰ Time: 12 NOON (ET)
📍 Location: Virtual (Zoom)
CLICK HERE FOR FREE REGISTRATION 
Register early as space is limited to 500 attendees.
 
Speakers:
- Susan Garrow-Sloan, RN, CCRP, Education and Quality Assurance, Baystate Health, Springfield, MA
- Ben Mooso, MS, Individual Specialist, Office of IRB Administration, University of California, Berkeley
 
HRP Clubhouse Moderators:
- Heather Miller, PhD, CIP (University of Southern California)
- Tanya (Tani) Prestage MPH, CIP (Nemours Children's Health)
- Satish Veerla, MS, PharmD, CIP (UT Southwestern Medical Center)
- Kevin Nellis, MS, MT(ASCP), CIP (SUNY Downstate Health Sciences University)
 
We hope you can join us for this insightful session! Please feel free to share this invitation with colleagues who may be interested. This will be the first of a multipart series on Expanded Access. Stay tuned for additional information or check the HRP Clubhouse website.

Help spread the word. Please save, print, and share our flyer with others.

Click here to open the flyer.

All works of the Human Research Protection Clubhouse website and products have been conducted with due diligence. However, the information shared about or within the club and on this website is for educational and informational purposes only and is made available to users without cost. The information and resources shall not be understood or construed as legal, financial, tax, medical, health or any other professional advice. The opinion of the presenters, moderators, or guests is that of their own and does not represent their institutions.

 


 

Previous Recordings and Follow-Up Resources

November 6, 2024

Description: This is a follow-up Q&A session for the Clubhouse webinar held on October 1, 2024 (see below)

CLICK HERE FOR ZOOM RECORDING

NOTE: SKIP AHEAD TO THE 14 MINUTE MARK TO START THE WEBINAR

IF PROMPTED, ENTER PASSCODE: ?7rUS69Z

CLICK HERE FOR PRESENTATION SLIDES

Tamiko Eto (she/her/hers)
Director of Research Operations
Human Research Protection Program (HRPP) & Institutional Review Board (IRB)
Mayo Clinic 
Mark Lifson (he/him/his)
Director AI/ML Engineering
Center for Digital Health-AI Enablement
Mayo Clinic

The moderators for this session were:

Jan E. Martinez, MS, CIP, CLSSGB (she/her), IRB Manager, (University of Maryland, Baltimore)
Heather Miller, PhD, CIP (she/her), Policy Administrator, HRPP (University of Southern California)
Joel Seah, BSc, PhD Candidate (National University of Singapore)

 

October 1, 2024

Description:
By the end of this presentation, attendees will walk away with greater confident in tackling the IRB review of AI Human Subjects Research protocols. Learn the different levels of risk introduced in different types and phases of AI research (and why), as well as what to look out for (case studies provided!). We’re going to break down and break through the nuances of AI (software functions), so that you can approach any AI project confidently, and adequately using the current regulatory frameworks. You’ll also learn about the gaps in regulations and what you can (and can’t) do about that. This presentation provides how-to guidance, so feel free to bring along your favorite AI project and apply as we go!

CLICK HERE FOR ZOOM RECORDING

IF PROMPTED, ENTER PASSCODE: ^c4YE16*

CLICK HERE FOR PRESENTATION SLIDES
WHITE PAPER: A Novel, Streamlined Approach to the IRB Review of Artificial Intelligence Human Subjects Research (AI HSR)
Tamiko Eto (she/her/hers)
Director of Research Operations
Human Research Protection Program (HRPP) & Institutional Review Board (IRB)
Mayo Clinic 

The moderators for this session will be:

Jan E. Martinez, MS, CIP, CLSSGB (she/her), IRB Manager, (University of Maryland, Baltimore)
Kevin Nellis, MS, MT(ASCP), CIP (he/him), Executive Director, Human Research Protections and Quality Assurance (State University of New York, Downstate Health Sciences University)
Joel Seah, BSc, PhD Candidate (National University of Singapore)

August 23, 2024 Webinar

Click here to watch on demand.
Webinar Passcode: W8qWb*vL

Click here for presentation slides.

Ben Mooso, MS, CCRP

Director, Office of IRB Administration (OIA)

University of California, San Diego Health

Ben Mooso is the current director for the Office of IRB Administration at UC San Diego where he has served for three years and is a co-chair for the Executive Committee of the Consortium for Applied Research Ethics Quality (CARE-Q) developed by the University of California and Stanford. Ben began his career as a basic and animal researcher studying genitourinary cancers at UC Davis and the VA in Sacramento, eventually becoming involved with the VA IRB. Ben parlayed these experiences into a role in clinical research administration at UC Davis’ Emergency Medicine Department before joining the UC Davis IRB and eventually leading the UC San Diego IRB. Ben has been described as a “policy nerd” by his colleagues and enjoys the challenge of making IRBs more efficient without sacrificing subject protections. Ben appreciates any opportunity to work with colleagues on advancing the national discussion around IRB efficiencies and efficacy.

Objectives:

  • Understand the distinctions of how information can be private, identifiable, both, or neither and how each class is treated under the Common Rule regulation.
  • Learn about and understand the additional ethical implications for private identifiable information which has been made public either intentionally or accidentally.
  • Learn about one ethical framework which builds on Belmont for the ethical review of studies seeking to use publicly available private identifiable information.

Description:

This talk will take attendees through the distinctions between what information is private, identifiable, both, or neither and how these groupings are each treated differently under the Common Rule regulation with a focus primarily on private identifiable information which has been made public. The talk will further explore the juxtaposition of the status of research using such information as potentially exempt under category 4(i) while simultaneously presenting an ethical unease. Finally, this talk will provide an ethical framework for the review of studies dealing with such publicly available private identifiable information derived from real-life research proposals presented in a case study format.

The Moderators for this session will be:

  • Heather Miller, PhD, CIP (University of Southern California)
  • Satish Veerla, MS, PharmD, Senior Regulatory Analyst (UT Southwestern Medical Center)

This program meets the criteria of the CIP recertification guidelines for a maximum of 1.0 credit.

Click here for FREE Zoom Registration.

Review the recordings of a thought-provoking three-part webinar series exploring critical changes in legislation affecting human research. Experts tackle complex topics designed to enhance your understanding and application of ethical standards in research. This webinar series delves into the latest updates on legislative shifts and their impact on research ethics. With experts leading the conversation, you'll gain valuable insights on navigating these changes and charting new ethics in human research.

We'll delved into three critical areas:

1. Challenges to Justice, Equity, Diversity, Inclusion (JEDI). We discussed how new legislation at state and federal levels has restricted JEDI efforts in human research, targeting divisive concepts.

2. LGBTQ+ Rights: We explored the consequences of anti-LGBTQ+ legislation and the implications for human research studies.

3. Reproductive Rights: We explored possible ramifications of laws affecting reproductive rights, including the overturning of Roe v. Wade and abortion bans, as it relates to risk to research participants.

We navigated the evolving landscape of research ethics to achieve the following objectives:

  • Grasp the latest legislative updates and their specific impact on IRBs/HRPPs.

  • Understand how these updates influence the "111 Criteria for IRB approval and principles of The Belmont Report".

  • Explore the effects on "single IRB review" (sIRB) and the review process for multisite studies.

SESSION 1: May 7th, 2024 from 1 to 2 PM ET: Dive into legislative updates from across the United States.

Click here to view or register for on demand viewing of the recording for Session 1.

Webinar Passcode: %Ba=6FNW

Click here to view the slides for Session 1

 

SESSION 2: May 14th, 2024 @ 1 to 2 PM ET: Explore how legislative changes impact the "111 Criteria for IRB approval and principles of The Belmont Report.”

Click here to view or register for on demand viewing of the recording for for Session 2.

Webinar Passcode: c9#.VnTc 

Click here to view the slides for Session 2.

 

SESSION 3: June 4th, 2024 @ 1 to 2 PM ET: Delve into the effects on "sIRB review and multisite studies.”

Click here to view or register for on demand viewing of the recording for for Session 3.

Webinar Passcode: +5*N=*p5

The moderators for these sessions will be:

  • Sherry Cheng (NYU Langone Health)
  • Hallie Kassan, MS, CIP (University of Texas MD Anderson Cancer Center)
  • Heather Miller, PhD, CIP (University of Southern California)
  • Kevin Nellis, MS, MT(ASCP), CIP (State University of New York, Downstate Health Sciences University)

Additional Resources:

Event Date: February 22, 2023

Session Overview:

Community and patient partners are often included in research projects as co-investigators, recruiters, data collectors and team members responsible for obtaining informed consent. These individuals require training in human research protections, but standards programs may not always be the best fit.

At this session you will learn about two unique (and free) research ethics training programs – CIRTification and Research Ethics For All – developed specifically for (and with) community partners.

Learning Objectives:

After attending the sessions, attendees should be able to:

  1. Describe the unique training needs of community research partners (individuals with no previous research background who will be engaged in recruitment, informed consent, data collection/analysis and/or dissemination of research findings).
  2. Discuss some of the unique ethical dilemmas that community research partners face in doing their work.
  3. Identify and implement resources for training community research partners.

Speakers:

Emily E. Anderson, PhD, MPH, Professor of Bioethics, Loyola University Chicago, Stritch School of Medicine

Emily developed CIRTification: Community Involvement in Research Training (available free online in English, Spanish, and Haitian Creole) after working for several years on community engaged research projects and studying research ethics during her PhD program. Her research and scholarship focuses on, among other things, developing accessible research ethics education and thinking about ways to engage public perspectives in discussions and decisions about what makes research ethical. She has served on 5 different IRB over the past 20 years.

Katherine McDonald, PhD, FAAIDD, Senior Associate Dean of Research & Administration, Syracuse University, Falk College of Sport and Human Dynamics

In collaboration with Ariel Schwartz at the University of New Hampshire and a national group of stakeholders, Katie developed Research Ethics for All, disability-accessible research ethics education for community research partners with developmental disabilities. Katie uses socio-ecological theory and community-engaged research to promote the inclusion of adults with disabilities in research as research partners and research participants to advance new knowledge to promote social and health equity. Katie has served on 3 different IRBs and is Chair of the IRB at Syracuse University.

Moderators:

  • Sherry Cheng
  • Heather Miller, PhD, CIP
  • Satish Veerla, MS, PharmD

Recording Duration: 1 hour of insightful exchange and discussion.

Register here to watch on demand.
Passcode: 9=6*eDaR

Event Date: January 10, 2024

Session Overview:
In this HRP Clubhouse event, we held engaging discussions around human research protections, IRB responsibilities, Institutional responsibilities, and special interests.

Lead Moderator:
Joel Seah, BSc

Co-Moderators:

  • Hallie Kassan, MS, CIP
  • Heather Miller, PhD, CIP
  • Kevin Nellis, MS, MT(ASCP), CIP
  • Satish Veerla, MS, PharmD 

Thank you for your commitment to promoting ethical research practices and safeguarding the well-being of research participants. We look forward to your presence at this important event.

Register here to watch it on demand.
Passcode: @?2OT=r. 

The HRP Clubhouse Board of Advisors hosted our exclusive Lunch Networking Session at the National PRIM&R Conference on Tuesday, December 5th from 11:30 AM to 1:00 PM. This was a remarkable chance to connect and network with fellow professionals in person.  

Thank you to all who were able to attend.

Event Date: November 28, 2023

The Human Research Protection Clubhouse held an engaging and insightful Zoom webinar featuring the esteemed Harry C.S. Wingfield, the author of “Human Subjects Research: An Insider’s View.” This event was tailored for IRB and HRPP professionals, students, investigators, and our valued members of the patient community, who champion ethical research practices.

Why You Should Review the Recording:

  • Connect with a community of peers dedicated to ethical research practices.
  • Gain valuable insights from Harry’s vast wealth of knowledge from an illustrious career spanning pivotal roles within the research ethics realm, including Student Researcher, Research Participant, Community and National Advocate, Activist, Clinical Regulatory Coordinator, IRB Technical Writer, Senior IRB Staff, and Retiree.
  • Participate in a vital conversation about the evolution of the research process and the research enterprise.
  • Take part in an open dialogue on enhancing community advisory boards, prioritizing impactful research, and optimizing resources.
  • Voice your perspectives, network with peers and empower each other while contributing to the collective mission of advancing human research protections.

Featured Speaker:

Moderators:

  • Heather Miller, PhD, CIP (she/her)
  • Satish Veerla, MS, PharmD (he/him)

Recording Duration: 1 hour of insightful exchange and discussion.

Post Session Resources:

Important note about the recording: If you have not already registered or if you are using a new device, Zoom may prompt registration for the event. Once registered, enter the passcode: o0y34+r8 

Event Date: October 31, 2023

Session Overview:

During this engaging and informative session, we explored the impact of gendered language on the participation of LGBTQIA+ individuals in research. Gendered language appears in the regulations, particularly in Subpart B. Gendered language is also common in participant-facing materials, such as consent forms. This session illustrated how such language both introduces ambiguity in how regulations are applied, as well as negatively impacting the experience of LGBTQIA+ research participants.

Thank you for celebrating Halloween with us, to those who helped contribute to the success of this event, and for your commitment to promoting ethical research practices and safeguarding the well-being of research participants.

Key Discussion Points:

  • The need for inclusive language in regulations and participant-facing materials
  • The real impact of gendered language on the lived experiences of LGBTQIA+ research participants

Featured Panelists:

  • Nyssa Towsley, MS, CIP (they/she)
  • Ronnie Lichtman, CNM, LM, PhD, FACNM (she/her)
  • Michelle Burgett-Moreno, MS (she/her)
  • Kevin Nellis, BS, MS, MT(ASCP), CIP (he/him)


Moderators:

  • Heather Miller, PhD, CIP (she/her)
  • Satish Veerla, MS, PharmD (he/him)

Post Session Resources:

Important note about the recording: If you have not already registered or if you are using a new device, Zoom may prompt registration for the event. Once registered, enter the passcode: 60&!Le+i

Note: The plan is to update these documents after the survey research is completed.


Advisory Board

The following members graciously serve on the HRP CH Advisory Board:

Cecilia Brooke Cholka, PhD, CIP

Human Research QA & Education Manager, Human Research Protection Operations

Weill Cornell Medicine | New York Presbyterian
Office of Research Integrity, Human Research Compliance 
New York, NY 

Fanny Ennever, PhD

University Research Compliance Officer

City University New York

New York, New York

Hallie Kassan, MS, CIP

Houston, Texas

Heather Miller, PhD, CIP

Policy Administrator

Human Research Protection Program

University of Southern California

Los Angeles, California

Joel Seah, BSc

PhD Candidate 

Centre for Biomedical Ethics, Yong Loo Lin School of Medicine 

National University of Singapore

Singapore

Kevin L. Nellis, MS, MT(ASCP), CIP

Executive Director, Human Research Protections and Quality Assurance

SUNY Downstate Health Sciences University

Brooklyn, New York

Melissa A. Epstein, PhD, MBE, CIP

Executive Director, Human Research Protection and Compliance

Weill Cornell Medicine | New York Presbyterian

New York, New York

Satish Veerla, MS, PharmD

Sr. Regulatory Analyst

Department - Opthalmology

UT Southwestern Medical Center 

Dallas, Texas

Sherry Cheng

Protocol Review and Monitoring Committee Coordinator

NYU Langone Health

New York, New York