Human Research Protections: HUMAN AFTER ALL Annual Virtual Conference 9.25-26.2025

The presentation is designed to familiarize the audience with different types of artificial intelligence (AI), their applications in clinical research, and ethical concerns that arise from them. Topics to be covered
include rule- versus data-driven AI, known technological and conceptual challenges to AI-assisted research, ethical issues in research, concerns about fraud, and the environmental impacts of AI.

Objectives:

• Identify different types of AI and their applications
• Discuss social, ethical, and conceptual concerns emerging from artificial intelligence in clinical research contexts

Investigators and IRBs are both challenged by the process of IRB review of research involving artificial intelligence (AI). Using case examples, this interactive session will provide guidance for IRBs and researchers to effectively navigate this terrain.

Objectives:

• Identify practical tools and tips for submitting and reviewing research projects involving AI
• Utilize existing tools and resources that can help facilitate preparation of applications involving AI for IRB review and assist IRB members and staff in performing their review

This session will introduce both engineering and non-technical strategies to promote inclusion of individuals with different skin tones and hair types in neurotechnology-based studies. We will explore how
these methodological choices raise critical questions in human subjects research.

Objectives:

• Identify how standard human research methodologies may result in the unintentional exclusion of participants
• Discuss the ethical implications of this design bias
• Evaluate research protocols and device-based methodologies for potential bias

This is a story of unwavering love, dedication and determination. When you are in the depths of uncertainty you are not alone.

Objectives:

• Promote reflection and personal growth
• Change the stereotype of Multiple sclerosis (MS) patients

At the most basic level, vulnerable populations are those requiring additional or special protections when enrolled in research. While there is a broad consensus that some groups need such protections, there is no universally agreed upon definition of vulnerability. In this presentation, we will consider different definitions of vulnerability and how they apply to adult populations. Once we are able to understand sources of vulnerability, we can identify ethical challenges as well as means of addressing them.

Objectives:

• Explain what is meant by “vulnerable”
• Identify populations that may be vulnerable
• Discuss ethical issues that arise when vulnerable populations participate in research
• Consider practical means of addressing these issues

The presentation will cover the definition scope of noncompliance, IRB regulatory responsibilities and general approaches to review these incidents. We will discuss the concept of Root Cause Analysis (RCA), types and limitations of various types of RCA, and its use as a tool by research teams as a framework for Corrective Action Plans (CAPs). Finally, we will address the proper components of CAPs that make them robust, meaningful, and achievable.

Objectives:

• Discuss the role of the IRB in determinations of noncompliance
• Describe purpose and approaches to root cause analysis
• Outline the various components of a robust corrective action plan