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Human Research Protections: Times Like These 9.26-9.27.2024

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Add to Calendar Human Research Protections: Times Like These 9.26-9.27.2024 9/26/2024 12:00:00 PM 9/27/2024 4:30:00 PM America/New_York For More Details: https://cchmc.cloud-cme.com/course/courseoverview?EID=52990 Description: Join us for our annual human subject protection conference entitled "Human Research Protections: Times Like These." This year's event will address issues of significant importance to human subject protections and bioethics, including:* Food and Drug Administration informed consent regulatory updates* Leveraging technology for recruitment and retention* Emerging trends in clinical trial operations* Arti... Online false MM/DD/YYYY


Date & Location
Thursday, September 26, 2024, 12:00 PM - Friday, September 27, 2024, 4:30 PM, Online

Target Audience
Specialties - Research

Overview
Join us for our annual human subject protection conference entitled "Human Research Protections: Times Like These." This year's event will address issues of significant importance to human subject protections and bioethics, including:

* Food and Drug Administration informed consent regulatory updates
* Leveraging technology for recruitment and retention
* Emerging trends in clinical trial operations
* Artificial Intelligence in informed consent
* Sexual and gender minority health and wellbeing
* Facilitating participant advisory boards

Conference brochure and registration coming soon!

Questions?
Please email [email protected]

Objectives
  1. Examine evolving ethical considerations in human research.
  2. Analyze the impact of recent updates to regulatory frameworks on human subject protections in FDA-regulated research.
  3. Evaluate strategies to foster community engagement and participatory approaches in research governance, emphasizing partnerships with underrepresented groups.
  4. Work collaboratively to develop actionable strategies that integrate ethical research practices, community engagement, and regulatory compliance in human research protection.

Accreditation

In support of improving patient care, Cincinnati Children’s Hospital Medical Center is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.


Physician:
This activity has been approved for AMA PRA Category 1 Credit™.

Nursing: This activity is approved for continuing nursing education (CNE) contact hours.

 

IPCE: This activity was planned by and for the healthcare team, and learners will receive Interprofessional Continuing Education (IPCE) credits for learning and change. 

Certified IRB Professional (CIP):  This activity is approved for CIP continuing education hours.

The credit hours listed below are not final, please check back closer to the activity for final approved credit hours.


Credits
AMA PRA Category 1 Credits™ (7.50 hours), CME - Non-Physician (Attendance) (7.50 hours), IPCE (7.50 hours), Nursing CE (7.50 hours)


Keywords:
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Mitigation of Relevant Financial Relationships


Cincinnati Childrens Hospital Medical Center adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CE activity, including faculty, planners, reviewers or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.

Cecilia Brooke Cholka, PhD
Human Research QA & Education Manager
Weill Cornell Medicine
Fort Collins, CO
Terry L Keys, BA
Patient Advocacy Manager
UK Markey Cancer Center
Lexington, KY
Lauren Milner, PhD
Regulatory Policy Advisor
US Food & Drug Administration
Silver Spring, MD
Brian Mustanski, PhD
Northwestern University
Chicago, IL
Suzanne Pattee, JD
Regulatory Counsel
US Food and Drug Administration
Silver Spring, MD
Jeremy Sugarman, MD
MD
Johns Hopkins University
Baltimore, MD
Karriem Watson, DHSc
Chief Engagement Officer
NIH All of Us Research Program
Bethesda, MD
Julie Wijesooriya, MPA, Administrator
Research Community Liaison
CCHMC
Cincinnati,Cincinnati, OH,OH

Thursday, September 26, 2024
Welcome, Opening Remarks, and Introductions
12:00PM - 12:15PM
Anticipating and Responding to the Ethical Challenges of Externally Disrupted Research
12:15PM - 1:30PM
Jeremy Sugarman, MD

Armed conflicts, natural disasters, pandemics and limiting laws and regulations can externally disrupt research. Such disruptions can pose risks for research participants, communities where research is conducted and research staff. In addition, they may threaten research integrity and foreclose important future research efforts. Accordingly, researchers, sponsors, and those charged with research ethics oversight should anticipate the possibility of externally disrupted research and when necessary, implement approaches for mitigating their impact.
Break
1:30PM - 1:45PM
Can a Robot Write a Consent Form?
1:45PM - 3:00PM
Cecilia Brooke Cholka, PhD

AI seems to be appearing more frequently and is useful in many contexts, so how might it be helpful in research compliance? Informed consent forms have been fraught with challenges that have persisted even after decades of improvement efforts, so how might AI be able to help us with consent writing? This session will share some basic information about natural language processing (a subset of AI) and ChatGPT specifically. Then with audience participation, we will use ChatGPT as we work on a consent form together.
Break
3:00PM - 3:15PM
Human Subject Protections at FDA – Updates and Future Directions
3:15PM - 4:30PM
Suzanne Pattee, JD
Lauren Milner, PhD

In recent years, FDA has undertaken a number of activities to modernize and streamline human subjects protections (HSPs) for FDA-regulated research, including finalizing a regulation allowing IRBs to waive or alter informed consent for certain types of minimal risk research and developing multiple guidances providing Agency thinking on different aspects of informed consent. For this session, FDA representatives will discuss the main regulatory and policy changes that the Agency has undertaken for HSPs, as well as identify some specific HSP topics that are becoming increasingly important/relevant to FDA-regulated research.
Friday, September 27, 2024
Welcome and Introductions
12:00PM - 12:15PM
Elevating Community Voices: A Participatory Approach to Research Governance - Insights from the NIH All of Us Research Program
12:15PM - 1:30PM
Karriem Watson, DHSc

This talk builds on last year's PRIM&R discussion of participant voices in research governance. Dr. Watson will delve deeper into community and participant engagement, exploring how the NIH All of Us Research Program integrates these principles. By analyzing the socioecological model, he will identify best practices for IRBs, researchers, and community members to forge stronger partnerships and ensure research reflects the needs and voices of the communities it impacts.
Break
1:30PM - 1:45PM
Evidence-Based Recommendations for Ethical Research Practices with Sexual and Gender Minority Adolescents
1:45PM - 3:00PM
Brian Mustanski, PhD

This talk will summarize the importance of conducting health research with LGBTQ adolescents and over a decade of ethics research on how to do so in ways that maximize opportunities for teen involvement, participant safety, and regulatory compliance. Studies described LGBTQ youth comfort with answering questions about sexual and mental health overall and in comparison to everyday experiences, willingness to participate in different kinds of HIV research studies, perspectives about the impact of asking for parental permission, and capacity to understand and reason with the informed consent process. Other studies are described that interview parents about their perspectives on their children participating in health research and the impact of requiring parental permission. Novel multimedia approaches to describing research will be shown. The implications of this body of empirical evidence is then discussed in terms of the applications of human subjects regulations for adolescent research participation.
Break
3:00PM - 3:15PM
The Power of the Patient/Community Perspective in Research: Stories of Engagement and Advocacy
3:15PM - 4:30PM
Julie Wijesooriya, MPA, Administrator
Terry L Keys, BA

In this session you’ll hear from two health research advocates who bring scientists and the lay public into community with each other to improve health outcomes – by facilitating bi-directional communication, fostering an atmosphere of trust and improving the dissemination of scientific information.


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