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Human Subjects: Policies, Clinical Trials, & Inclusion


Virtual PreCon Event:
Day 1: Tuesday, December 6, 2022 / 12:00 – 4:00 PM ET
Day 2: Wednesday, December 7, 2022 / 12:00 – 4:00 PM ET

Human Subjects Research: Policies, Clinical Trials, & Inclusion
  • What are the basic HHS regulations and NIH policies that apply to research involving human subjects, including clinical trials?
  • How do you prepare a research proposal for review that addresses the regulatory requirements?
  • What are some strategies for developing realistic and scientifically acceptable inclusion plans?

Join experts from the NIH Division of Human Subjects Research and HHS Office of Human Research Protections (OHRP) for answers to these questions and additional valuable information and resources. During this 2-day event, these NIH and HHS experts will share policies, resources, guidance, and case studies in this informative and engaging, live event.


One Registration. All-Access. No Cost.
Register one time to gain access to all virtual preconference events,
the 2-day conference, and valuable resources.

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Virtual Event Overview

2-Day Event
Day 1: Tuesday, December 6, 2022
Day 2: Wednesday, December 7, 2022
Time: 12:00 PM – 4:00 PM ET Daily

One-Time Registration Required: NIHGrantsConference.vfairs.com (If you have already registered on the NIH Grants Conference & PreCon Events website, then you do not need to register again!)

Log In: Once registered, you can join live events and explore the NIH Exhibit Hall with additional resources at Institute, Center, & Office Booths.

During this 2-Day event, participants will:
  • Gain a better understanding of HHS regulations and NIH policies that apply to research involving human subjects and clinical trials
  • Obtain guidance on how to prepare a research proposal for review addressing regulatory requirements
  • Learn strategies for developing realistic and scientifically acceptable inclusion plans

Day 1 Agenda

12:00 PM - 12:10 PM

Welcome & Overview


12:10 PM - 1:10 PM

How Do I Know if a Research Study is Human Subjects Research and What Does that Really Mean?


Presenter: Marianna Azar, B.A., M.A.
Program Specialist, Division of Education and Development (DED), Office for Human Research Protections (OHRP), HHS

1:10 PM - 1:15 PM

5-Minute Break


1:15 PM - 2:00 PM

What You Need to Know About FWAs and IRBs to Get Your Grant Money

Presenter: Yvonne Lau, M.B.B.S., M.B.H.L., Ph.D.
Director, Division of Education & Development (DED), Office for Human Research Protections (OHRP), HHS

2:00 PM - 2:15 PM

15-Minute Break


2:15 PM - 3:10 PM

An Overview of NIH Policies on Human Subjects

Presenter: Lyndi Lahl, R.N., M.S.
NIH Human Subjects Officer, Office of Extramural Research (OER), NIH

3:10 PM - 3:15 PM

5-Minute Break


3:15 PM - 3:55 PM

Essentials of sIRB Requirements

Presenter: Lyndi Lahl, R.N., M.S.
NIH Human Subjects Officer, Office of Extramural Research (OER), NIH

3:55 PM - 4:00 PM

Acknowledgments and Closing

Day 2 Agenda

12:00 PM - 12:10 PM

Welcome & Overview


12:10 PM - 1:25 PM

An Overview of NIH Policies on Clinical Trials


Presenter: Pamela Kearney, M.D.
Director, Division of Human Subjects Research, Office of Extramural Research (OER), NIH

1:25 PM - 1:30 PM

5-Minute Break


1:30 PM - 2:15 PM

Including Diverse Populations in NIH Clinical Research

Presenter: Dawn Corbett, M.P.H.
NIH Inclusion Policy Officer, Office of Extramural Research (OER), NIH

2:15 PM - 2:30 PM

15-Minute Break


2:30 PM - 3:15 PM

Using the eRA Human Subjects System (HSS)

Presenter: Rebecca Favor, DrPH, C.P.H.
NIH Human Subjects and Inclusion Policy Analyst, Office of Extramural Research (OER), NIH


3:15 PM - 4:00 PM

Wrap-Up and Extended Q&A with Human Subjects Expert Panel

(Stay in the Zoom Event or join from the Networking Lounge)

Presenters

Click the image to view bios of each presenter.

Marianna Azar , B.A., M.A.
Program Specialist, Office for Human Research Protections (OHRP), HHS

Marianna Azar, B.A., M.A., is a Program Specialist with the Division of Education and Development at the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services. Before joining OHRP, Ms. Azar served as Director and Chair of the Institutional Review Boards for the New York City Department of Education. Prior to that, she was employed as a Human Research Protection Program Manager at the City University of New York Graduate Center, and as an IRB Specialist at Columbia University’s Human Research Protection Office. Ms. Azar holds a B.A. in philosophy from the State University of New York at Oswego, an M.A. in philosophy, and a graduate diploma in health services and policy research from York University in Toronto, Canada, and is also working on completing her Ph.D. in bioethics at York University.

Dawn Corbett, M.P.H.  NIH Inclusion Policy Officer, Office of Extramural Research (OER), NIH

Dawn Corbett, M.P.H., is the NIH Inclusion Policy Officer in the Office of Extramural Research’s Office (OER), where she provides oversight of trans-NIH efforts to ensure the inclusion of women, minorities, and individuals across the lifespan in NIH-defined clinical research. Prior to joining OER, Ms. Corbett led efforts to increase the efficiency and transparency of clinical research through enhanced recruitment monitoring and increased compliance efforts as a Health Science Policy Analyst in the National Institute of Mental Health (NIMH), Office of Clinical Research, Clinical Trials Operations, and Biostatistics Branch.  

Ms. Corbett began her federal career at NIH in the NIMH Office for Research on Disparities in Global Mental Health (formerly Office for Special Populations), where she coordinated programs related to diversity in clinical research. While at NIMH, she was also responsible for designing and conducting portfolio analyses in the areas of global mental health and mental health disparities. Ms. Corbett has a master’s degree in public health from the Johns Hopkins School of Public Health and a bachelor’s degree in political science from the University of Illinois at Urbana-Champaign. 

Rebecca Favor, DrPH, C.P.H.
Human Subjects and Inclusion Policy Specialist, Office of Extramural Research (OER), NIH

Rebecca Favor, DrPH, C.P.H., is a Human Subjects and Inclusion Policy Analyst in the Division of Human Subjects Research within the NIH Office of Extramural Research (OER). Ms. Favor works primarily with OER’s Inclusion Policy Officer to implement new policies, enhance the understanding of inclusion-related requirements, and coordinate preparations for mandated reports to Congress. She also provides guidance on human subjects regulations and NIH policies. Prior to working with OER’s Division of Human Subjects Research, Ms. Favor worked in clinical trial research at MD Anderson Cancer Center and managed a variety of studies in hematologic disorders. She also conducted research on HIV-related stigma in Ghana. Ms. Favor obtained a master’s degree and doctorate degree in public health from the University of Texas Health Science Center at Houston School of Public Health.

Pamela Kearney, M.D.
Director, Division of Human Subjects Research, Office of Extramural Research (OER), NIH

Pamela Reed Kearney, M.D., is the Director of the Division of Human Subjects Research within the NIH Office of Extramural Research (OER). Prior to joining OER in February 2019, she was the Deputy Chair of the Combined Neurosciences (CNS) IRB in the Intramural program for approximately a decade. In this capacity, she sat on three, and at times four, duly constituted IRBs - chairing one and serving as the vice chair of the others. She graduated with Distinction from The George Washington School of Medicine and completed an Otolaryngology Residency at George Washington University. Dr. Kearney was a Neurolaryngology Clinical Fellow with the National Institute of Neurological Disorders and Stroke (NINDS) in the Medical Neurology Branch’s Laryngeal and Speech Section (LSS) and later served as the Staff Clinician of the section. She has also worked clinically at the George Washington University, Walter Reed Army Medical Hospital, and the NIH Clinical Center. 

Lyndi Lahl, R.N., M.S.
Human Subjects Officer, Office of Extramural Research (OER), NIH

Lyndi Lahl, R.N., M.S., is a Human Subjects Officer in the Division of Human Subjects Research (DHSR), Office of Extramural Research (OER). Ms. Lahl provides expertise and guidance in the areas of policy implementation and development for human subjects research. Ms. Lahl has served as an IRB member since 2013. Prior to joining DHSR, she served as a Policy Health Specialist with the National Institute of Allergy and Infectious Disease (NIAID), Division of AIDS, as a Public Health Analyst with the Office for Human Research Protections (OHRP), and as a Research Nurse Specialist with the Intramural Division of the National Cancer Institute (NCI). Ms. Lahl received her BSN and M.S. in nursing informatics from the University of Maryland at Baltimore, and a Certificate of Achievement from American University, School of Public Affairs, Key Executive Leader Program. 

Yvonne Lau, M.B.B.S., M.B.H.L., Ph.D.
Director, Division of Education and Development (DED), Office for Human Research Protections (OHRP), HHS

Yvonne Lau, M.B.B.S., M.B.H.L., Ph.D., is the Director of the Division of Education and Development (DED) at the U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP). Dr. Lau received her medical degree from the University of Hong Kong and is a Fellow of the Royal College of Surgeons of Edinburgh (FRCSEd) in the United Kingdom. She obtained her masters in bioethics and health law (M.B.H.L.) and her Ph.D. in bioethics from the University of Otago in New Zealand.

Once logged into the virtual NIH Grants Conference Center, visit the Human Subjects Research booth in the virtual Exhibit Hall for more NIH and HHS resources that can be viewed and downloaded. During the 2-day NIH Grants Conference, February 1-2, 2023, this booth will be staffed with Human Subjects staff and offer 1:1 Meet the Experts appointments.
Accessibility:
The NIH Office of Extramural Research strives to host inclusive, accessible events that enable all individuals to engage and participate fully. All presentations during the NIH Grants Conference and Pre-Con Events will include closed captions and ASL interpreters. In addition, look for this icon when navigating the virtual conference platform. It will allow you to customize the online conference pages to be more accessible based on needs.
Contact:

Event Questions and Special Requests: NIHGrantsEvents@nih.gov (Submit no less than 3 days prior to the event, if possible.)

Technical Issues: nihgrantsconference@getvfairs.io

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