Human Subjects Research: Policies, Clinical Trials, & Inclusion - Day 1

Healthcare professional sitting with a man reviewing information on a tablet.
Date: Tuesday, December 6, 2022
Time: 12:00PM ET - 4:00PM ET
Location: Virtual
Cost: Free
This Event is Recorded: The recording and resources will be available 7-10 business days after the event
Hosted by: Office of Extramural Research (OER)
See event recording, transcript, and slide deck

Event Overview:

Description:

  • 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.

Objective:

  • 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

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Agenda

Welcome & Overview
 

12:00 pm ET

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?
 

12:10 pm ET

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
An Overview of NIH Policies on Human Subjects
 

02:15 pm ET

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
Essentials of sIRB Requirements
 

03:15 pm ET

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
 

03:55 pm ET

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

Presenter(s):

Profile Picture for Marianna Azar
Marianna Azar
Public Health Program Specialist
Office for Human Research Protections (OHRP)
Division of Education and Development
HHS
Read Bio
Marianna Azar
<p>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.</p>
Profile Picture for Dawn Corbett
Dawn Corbett
NIH Inclusion Policy Officer
Office of Extramural Research (OER)
Office of the Director (OD)
NIH, HHS
Read Bio
Dawn Corbett
<p>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.</p><p><br></p><p>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.</p>
Deysi Duque
Human Subjects and Clinical Trials Specialist
Office of Extramural Research (OER)
Office of the Director (OD)
NIH, HHS
Read Bio
Deysi Duque
<p>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.</p>
Rebecca Favor
Human Subjects and Inclusion Policy Specialist
Office of Extramural Research (OER)
Office of the Director (OD)
NIH, HHS
Read Bio
Rebecca Favor
<p>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.</p>
Profile Picture for Pamela Kearney
Pamela Kearney, M.D
Director
Division of Human Subjects Research (DHSR)
Office of the Director (OD)
NIH, HHS
Read Bio
Pamela Kearney
<p>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.</p>
Profile Picture for Lyndi Lahl
Lyndi Lahl
Human Subjects Officer
Division of Human Subjects Research (DHSR)
Office of the Director (OD)
NIH, HHS
Read Bio
Lyndi Lahl
<p>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.</p>
Yvonne Lau, Ph.D
Director, Office for Human Research Protections (OHRP)
HHS
Read Bio
Yvonne Lau
<p>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.</p>

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