Human Subjects Research: Policies, Clinical Trials, & Inclusion - Day 1
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
Past PreCon Events
Event Resources
See Also
On-Demand Videos:
Podcasts:
- All About Grants Podcasts (Link pre-filtered for Clinical Trials, Human Subjects, and Inclusion topics)
Documents:
- 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)
Website Links:
- 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
- Basic Experimental Studies Involving Humans (BESH) Page
- HHS Office for Human Research Protections (OHRP) Page
- eRA Human Subjects System (HSS) Resource Page
Agenda
Welcome & Overview | |
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12:00 pm ET Welcome & OverviewModerator: 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? | |
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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 | |
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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 | |
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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 | |
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03:55 pm ET Moderator: Pamela Kearney, M.D., Director, Division of Human Subjects Research, Office of Extramural Research (OER), NIH |
Presenters:
Contact:
FAQs
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Accessibility
The NIH Office of Extramural Research strives to host inclusive, accessible events that enable all individuals to engage and participate fully.
All live, virtual events include closed captions and American Sign Language (ASL) interpreters. Reasonable accommodations should be submitted in advance to NIHGrantsevents@nih.gov.
Respect
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