Human Research Protections Clubhouse
Empowering Collaboration and Excellence in Human Research Protections
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!
UPCOMING WEBINAR: "Gender Inclusivity in Research: Overcoming Current Political and Regulatory Challenges"
Event Date: September 16, 2025 @ 12 Noon (ET)
Hayden McIntyre, LICSW, MSW, SUDP Kaiser Permanente, WA
Heather Miller (she/her) is most passionate about providing compassionate, ethical, and pragmatic education to investigators and IRB/HRPP professionals. She is always looking for the best way to help investigators and IRB/HRPP professionals to do their best work. Heather is a fierce advocate for human subjects in research and is committed to full disclosure, transparency, and quality improvement in HRPP’s and IRB’s for the good of participants in research and for the morale and work environment of IRB/HRPP staff. Heather has spoken nationally on a number of topics but is most proud of her work regarding accessibility for IRB members and research participants, the protections of sovereign American Indian and Alaskan Native communities, unconscious bias in research, gender inclusivity in recruitment and consent documents, QA/QI within the IRB/HRPP to streamline the process for investigators and staff. Currently Heather is a proud reviewer and board member of North Star Review board, MD Anderson Cancer Board, Life West Chiropractic College and Grand Canyon University IRB. The Human Research Protection Clubhouse is one of Heather’s favorite IRB/HRPP activities as she is committed to providing free CIP credits and working with excellent speakers. When not thinking about compliance you’ll find Heather hiking with her 4 (yes! 4!! dogs) working on being a great mom and wife and trying out 5 star recipes from the NY Times cooking.
Kevin Nellis (he/him) is Executive Director of Human Research Protections and Quality Assurance at SUNY Downstate Medical Center, where he has led major initiatives to streamline IRB operations and strengthen compliance. A certified medical technologist and former federal regulatory advisor, he has held leadership roles with the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP), the VA’s Program for Research Integrity Development and Education (PRIDE), NIH’s National Cancer Institute, and Maimonides Medical Center. Kevin is also the creator and founder of the Human Research Protections Clubhouse, a collaborative forum dedicated to advancing best practices in research ethics and IRB oversight. He has published, presented nationally, and is widely recognized for balancing regulatory rigor with reducing burdens for investigators. Outside of work, Kevin enjoys hiking near waterfalls, playing volleyball, exploring cafés in search of the perfect latte, and spending quality time networking with colleagues, friends, and family.
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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
📅 Recorded: May 6, 2025
Click here for FREE cloud recording
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Click here for presentation slides
This FREE webinar will explore the regulatory pathways that allows for the one-time use of an investigational drug or device (test article) for a single participant in a life-threatening (emergency use) situation.
The webinar is ideal for IRB professionals, investigators, and healthcare providers interested in learning how to navigate the Emergency Use process effectively.
We have requested PRIM&R approval for 1.0-hour CIP credit.
This session will cover:
✅ What is Emergency Use and how it differs from Expanded Access?
✅ Describe the processes and consent considerations involved in Emergency Use
✅ The role of IRBs and tips for professionals navigating Emergency Use requests
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 (North Star IRB)
- Satish Veerla, MS, PharmD, CIP (UT Southwestern Medical Center)
- Cassandra Charles, BA (SUNY Downstate Health Sciences University)
If prompted, use Password: g%U!Yb3g
This FREE webinar 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.
- Presentation Slides
- SUNY Downstate IRB Expanded Access Application
- Reagan-Udal Foundation for the FDA
- FDA Expanded Access webpage: Summarizes categories and initial requirements of Expanded Access process to include information for treating physicians and patients
- FDA Form 3926
- Expanded Access consent templates:
- Emergency Use Worksheets:
February 11, 2025
- The FDA Expanded Access webpage
- Summarizes categories and initial requirements of Expanded Access process to include information for treating physicians and patients
- FDA Form 3926
- Expanded Access consent templates:
- Emergency Use Worksheets:
November 6, 2024
Description: This is a follow-up Q&A session for the Clubhouse webinar held on October 1, 2024 (see below)
NOTE: SKIP AHEAD TO THE 14 MINUTE MARK TO START THE WEBINAR
IF PROMPTED, ENTER PASSCODE: ?7rUS69Z
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!
IF PROMPTED, ENTER PASSCODE: ^c4YE16*
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.
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:
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Grasp the latest legislative updates and their specific impact on IRBs/HRPPs.
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Understand how these updates influence the "111 Criteria for IRB approval and principles of The Belmont Report".
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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
- Christina Pacheco, JD, MPH (KU School of Medicine)
- April L. Smith, CCRP, CIP (HRP Consulting Group)
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.
- Michelle Burgett-Moreno, MS (University of Southern California)
- Karen Christianson (HRP Consulting Group)
- April L. Smith, CCRP, CIP (HRP Consulting Group)
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
- Lubabah Helwani, MA, CIP (University of Southern California)
- Linnea Rademaker, PhD, CIP (SIRB team, Baystate Health)
- April L. Smith, CCRP, CIP (HRP Consulting Group)
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:
- The Chronicle Staff, 2024, DEI Legislation Tracker
- American Civil Liberties Union (ACLU), 2024, Mapping Attacks on LGBTQ Rights in U.S. State Legislatures in 2024
- Center for Reproductive Right, 2024, Interactive Maps
- National Conference of State Legislatures, April 2, 2024, Access to Mifepristone
- American Society for Reproductive Medicine, by Susan Crockin, JD and Francesca Nardi, JD, Frozen Embryos are “Unborn Children”
- Tennessee Lookout, April 11, 2024, Anita Wadhani, Tennessee Senate Crime Bill to Aid Minor Seeking an Abortion
- National Strategy on Gender Equity and Equality
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:
- 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).
- Discuss some of the unique ethical dilemmas that community research partners face in doing their work.
- 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:
- Harry C.S. Wingfield, ABJ, MFA, CIP, author of “Human Subjects Research: An Insider’s View.”
- Click here for Harry's Bio
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
- Resources listed in PowerPoint slides:
- Hypothetical definitions from survey
- Downstate IRB Guidance and Forms discussed during the session:
Note: The plan is to update these documents after the survey research is completed.
- Enrolling or Excluding Pregnant People, Contraception, Pregnancy Testing, and Partners of Participants Who Become Pregnant
- Form 11-8: Exclusion of Pregnant People and/or Plans to Study Outcomes of Unexpected Pregnancies
- Form 11-9: Research involving Pregnant People and/or Fetuses
- 8-1: Simple Version Informed Consent Template
- 8-2: All-In-One Version Informed Consent Template
- 8-9: Pregnancy Follow-Up Consent
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 |
| 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 |