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
- 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.
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Register one time to gain access to all virtual preconference events,
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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.
- 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
Event Resources:
- Session Recording Day 1 - Human Subjects Research: Policies, Clinical Trials, & Inclusion
- Session Recording Day 2- Human Subjects Research: Policies, Clinical Trials, & Inclusion
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Presentations (PowerPoint)
- Day 1
-
Day 2
- Slideset - An Overview of NIH Policies on Clinical Trials
-
Slideset - Including Diverse Populations in NIH Research
- Slideset - Using the Human Subjects System (HSS)
- Transcript Day 2
Upcoming 2-Day Conference
Past PreCon Events
Recording is available 7-10 business days following the event.
Day 1 Agenda
Welcome & Overview
Moderator: Lyndi Lahl, R.N., M.S.
NIH Human Subjects Officer, Office of Extramural Research (OER), NIH
How Do I Know if a Research Study is Human Subjects Research and What Does that Really Mean?
Moderator: Lyndi Lahl, R.N., M.S.
NIH Human Subjects Officer, Office of Extramural Research (OER), NIH
Presenter: Marianna Azar
Program Specialist, Division of Education and Development (DED), Office for Human Research Protections (OHRP), HHS
5-Minute Break
What You Need to Know About FWAs and IRBs to Get Your Grant Money
Moderator: Lyndi Lahl, R.N., M.S.
NIH Human Subjects Officer, Office of Extramural Research (OER), NIH
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
15-Minute Break
An Overview of NIH Policies on Human Subjects
Moderator: Pamela Kearney, M.D.
Director, Division of Human Subjects Research, Office of Extramural Research (OER), NIH
Presenter: Lyndi Lahl, R.N., M.S.
NIH Human Subjects Officer, Office of Extramural Research (OER), NIH
5-Minute Break
Essentials of sIRB Requirements
Moderator: Pamela Kearney, M.D.
Director, Division of Human Subjects Research, Office of Extramural Research (OER), NIH
Presenter: Lyndi Lahl, R.N., M.S.
NIH Human Subjects Officer, Office of Extramural Research (OER), NIH
Acknowledgments and Closing
Moderator: Pamela Kearney, M.D.
Director, Division of Human Subjects Research, Office of Extramural Research (OER), NIH
Day 2 Agenda
Welcome & Overview
Moderator: Lyndi Lahl, R.N., M.S.
NIH Human Subjects Officer, Office of Extramural Research (OER), NIH
An Overview of NIH Policies on Clinical Trials
Moderator: Lyndi Lahl, R.N., M.S.
NIH Human Subjects Officer, Office of Extramural Research (OER), NIH
Presenter: Pamela Kearney, M.D.
Director, Division of Human Subjects Research, Office of Extramural Research (OER), NIH
5-Minute Break
Including Diverse Populations in NIH Clinical Research
Moderator: Rebecca Favor, DrPH, C.P.H.
NIH Human Subjects and Inclusion Policy Analyst, Office of Extramural Research (OER), NIH
Presenter: Dawn Corbett, M.P.H.
NIH Inclusion Policy Officer, Office of Extramural Research (OER), NIH
15-Minute Break
Using the eRA Human Subjects System (HSS)
Moderator: Dawn Corbett, M.P.H.
NIH Inclusion Policy Officer, Office of Extramural Research (OER), NIH
Presenter: Rebecca Favor, DrPH, C.P.H.
NIH Human Subjects and Inclusion Policy Analyst, Office of Extramural Research (OER), NIH
Continuing the Conversation with NIH & HHS Human Subjects Experts
*Includes all NIH & HHS presenters from Day 1 and Day 2
Moderator: Deysi Duque, M.S, PMP.
NIH Human Subjects and Clinical Trials Specialist, Office of Extramural Research (OER), NIH
Presenters
Click the image to view bios of each presenter.
Marianna Azar
Public Health Program Specialist, Office for Human Research Protections (OHRP), HHS
Marianna Azar is a Public Health 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.
Deysi Duque, M.S., PMP
Human Subjects and Clinical Trials Specialist, Office of Extramural Research (OER), NIH
Deysi Duque, M.S., PMP, is a Human Subjects and Clinical Trials Specialist in the Office of Extramural Research (OER), NIH. Ms. Duque supports human subjects and clinical trials implementation activities in the Division of Human Subjects Research and is primarily responsible for reviewing clinical trial Funding Opportunity Announcements before publication. She also provides guidance on clinical research with a focus on policy analysis, implementation, and project management. Ms. Duque obtained a bachelor’s degree in cell biology and molecular genetics from the University of Maryland College Park and a master’s degree in biotechnology, biodefense, and biosecurity from the University of Maryland University College.
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.
Marianna Azar
Public Health Program Specialist, Office for Human Research Protections (OHRP), HHS
Marianna Azar is a Public Health 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.
Deysi Duque, M.S., PMP
Human Subjects and Clinical Trials Specialist, Office of Extramural Research (OER), NIH
Deysi Duque, M.S., PMP, is a Human Subjects and Clinical Trials Specialist in the Office of Extramural Research (OER), NIH. Ms. Duque supports human subjects and clinical trials implementation activities in the Division of Human Subjects Research and is primarily responsible for reviewing clinical trial Funding Opportunity Announcements before publication. She also provides guidance on clinical research with a focus on policy analysis, implementation, and project management. Ms. Duque obtained a bachelor’s degree in cell biology and molecular genetics from the University of Maryland College Park and a master’s degree in biotechnology, biodefense, and biosecurity from the University of Maryland University College.
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.
Engage and Connect
On-Demand Videos: Podcasts:- All About Grants Podcasts (Link pre-filtered for Clinical Trials, Human Subjects, and Inclusion topics)
-
Resources: Human Subjects Protections, Inclusion, and Clinical Trials (Includes links to Policies, Notices, Tools, Resources, & Training on the following:)
- Human Subjects Protections
- Clinical Trials
- Inclusion
- General Information
- NIH Human Subjects Research Home Page
- NIH Inclusion Policies Home Page
- NIH Single IRB for Multi-Site or Cooperative Research Page
- NIH Certificates of Confidentiality (CoC) Page
- NIH Clinical Trial Policies Home Page
- HHS Office for Human Research Protections (OHRP) Page
- eRA Human Subjects System (HSS) Resource Page


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