Inclusive Participation in Clinical Research Workshop
Virtual workshop conducted March 30-31, 2023
Access available workshop slides in the agenda
The purpose of this workshop is to improve implementation of evidence-based best practices to increase inclusive participation in clinical research, with discussion on:
- How to implement these practices
- Challenges to overcome
- Lessons learned
Workshop topics are organized by stage in the research process:
- Before the study
- During the study
- After the study
Day 2 includes a special session featuring representatives from the different entities involved in supporting and conducting clinical research, such as academia, pharma, community-based organizations, and federal agencies.
Agenda
Download the: Agenda | Speaker bios
Day 1: March 30, 2023
All times listed are Eastern Daylight (UTC-4)
| 11:00 a.m. – 12:10 p.m. | Opening Session Moderators: Gina Roussos, Ph.D., NIMHD; Vanessa Marshall, Ph.D., CCRP, NIMHD
|
| 12:10 p.m. – 12:20 p.m. | Break |
| Session 1: Before the Study This session covers the planning and preparation that occurs before launching a study, including making recruitment plans, choosing a study site and research team members, and engaging with the community. Part 1 focuses on specific initiatives to address pre-study processes that impact diversity in clinical research. Part 2 focuses on specific aspects of the pre-study process. |
|
| 12:20 p.m. – 1:40 p.m. | Part 1: Specific Initiatives Moderator: Yewande Oladeinde, Ph.D., NIMHD; Co-Moderator: Dawn Corbett, M.P.H., Office of the Director, NIH
|
| 1:40 p.m. – 2:00 p.m. | Break |
| 2:00 p.m. – 3:05 p.m. | Part 2: Specific Topics Moderator: Jennifer Alvidrez, Ph.D., NIH Office of Disease Prevention, NIH Office of the Director; Co-Moderator: Debbie Vitalis, Ph.D., M.P.H., NHLBI
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| 3:05 p.m. – 3:10 p.m. | Break |
| Session 2: During the Study This session covers the steps involved in conducting a clinical research study, starting with participant recruitment and ending with the final round of data collection and any follow-up procedures. |
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| 3:10 p.m. – 4:15 p.m. | During the Study Moderator: Debbie Vitalis, Ph.D., M.P.H., NHLBI; Co-Moderator: Rebecca Favor, DrPH, CPH, NIH Office of Director
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| 4:15 p.m. – 4:30 p.m. | Closing Session
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| 4:30 p.m. – 5:00 p.m. | Networking Session
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| 5:00 p.m. | Adjourn |
Day 2: March 31, 2023
All times listed are Eastern Daylight (UTC -4)
| 11:00 a.m. – 11:05 p.m. | Welcome and Day 2 Overview Gina Roussos, Ph.D., NIMHD; Vanessa Marshall, Ph.D., CCRP, NIMHD |
| Session 3: After the Study This session covers the activities that take place after data collection is completed, including data analysis and interpretation; communication of study findings via reports, peer-reviewed publications, and other forms of media; and translation of study findings into clinical practice. |
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| 11:05 a.m. – 12:10 p.m. | After the Study Moderator: Katrina Serrano, Ph.D., NIDDK; Co-Moderator: Jarrett Johnson, DrPH, M.S., NIMHD
|
| 12:10 p.m. – 12:15 p.m. | Break |
| Session 4: Special Populations Panel Discussions These moderated discussions cover best practices for conducting clinical research with populations requiring special considerations, such as children, older adults, and pregnant and lactating persons. During each panel, the moderator asks questions in the first half that the panelists received in advance; panelists answer questions from the audience in the second half. |
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| 12:15 p.m. – 12:55 p.m. |
Panel Discussion 1: Racial and Ethnic Minority Populations Moderator: Olufunmilola (Lola) Olufemi, Ph.D., NINDS; Co-Moderator: Jennifer Alvidrez, Ph.D., NIH Office of Disease Prevention, NIH Office of the Director
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| 12:55 p.m. – 1:00 p.m. | Break |
| 1:00 p.m. – 1:35 p.m. | Panel Discussion 2: Special Consent Considerations Moderator: Sonia Arteaga, Ph.D., NIH Environmental Influences on Child Health Outcomes (ECHO) Program; Co-Moderator: Katrina Serrano, Ph.D., NIDDK
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| 1:35 p.m. – 2:15 p.m. | Panel Discussion 3: Special Populations Moderator: Martin Mendoza, Ph.D., NIH All of Us Research Program; Co-Moderator: Debbie Vitalis, Ph.D., M.P.H., NHLBI
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| 2:15 p.m. – 2:30 p.m. | Break |
| Session 5: Collaborator Perspectives Panel Discussion In these moderated discussions, representatives from the different entities involved in supporting and conducting clinical research offer their perspectives on how to increase the participation of individuals from underrepresented populations. During each panel, the moderator asks questions in the first half that the panelists received in advance; panelists answer questions from the audience in the second half. |
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| 2:30 p.m. – 3:05 p.m. | Panel 1: Community and Patient Perspectives Moderator: Karriem Watson, All of Us, NIH Office of the Director; Co-Moderator: Debbie Vitalis, Ph.D., M.P.H., NHLBI
|
| 3:05 p.m. – 3:45 p.m. | Panel 2: Funder, Regulatory, and Policy Perspectives Moderator: Bob McNellis, M.P.A., P.A., NIH Office of Disease Prevention, NIH Office of the Director; Co-Moderator: Olga Herren, Ph.D., NIMHD
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| 3:45 p.m. – 3:55 p.m. | Break |
| Session 6: Next Steps and Solutions In this session, speakers, attendees, and moderators engage in an interactive discussion about next steps and identify potential actional solutions for increasing inclusive participation in clinical research. |
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| 3:55 p.m. – 4:40 p.m. | Next Steps and Actionable Solutions for Inclusive Research
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| 4:40 p.m. – 4:55 p.m. | Closing Session
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| 4:55 p.m. | Adjourn |
Planning Committee:
Vanessa Marshall, Ph.D., CCRP (Co-Chair)
National Institute on Minority Health and Health Disparities (NIMHD)
Gina Roussos, Ph.D. (Co-Chair)
National Institute on Minority Health and Health Disparities (NIMHD)
Jennifer Alvidrez, Ph.D.
NIH Office of Disease Prevention (NIH ODP)
Dawn Corbett, M.P.H.
NIH Office of Extramural Research (NIH OER)
Deborah Jaffe, Ph.D.
National Cancer Institute (NCI)
Olufunmilola (Lola) Olufemi, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Nicole Redmond, M.D., Ph.D., M.P.H.
National Heart, Lung, and Blood Institute (NHLBI)
Katrina Serrano, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Debbie Vitalis, Ph.D., M.P.H.
National Heart, Lung, and Blood Institute (NHLBI)
Please send general questions about the workshop and specific questions for speakers or panelists to InclusiveClinResWksp@mail.nih.gov
Individuals who need reasonable accommodation to participate should indicate that when registering or by emailing InclusiveClinResWksp@mail.nih.gov at least five business days before the event.
Page updated Dec. 7, 2023
