AI/ML Advisory & Training Services
AI/ML Advisory & Training Services
Strengthen your AI/ML research oversight — contact us today to design a tailored advisory and training plan.
Service Overview
Research involving artificial intelligence (AI), machine learning (ML), and other emerging technologies is expanding rapidly across disciplines. These innovations drive new opportunities for discovery, but they also create unique ethical, regulatory, and human subjects protections challenges.
We partner with institutions to design, implement, and optimize oversight frameworks that align with ethical principles, regulatory requirements, and best practices for AI/ML research; while also building internal expertise through targeted training and continuing education.
AI & ML Research Oversight Services
AI/ML-powered research often challenges traditional classifications, risk assessment methods, and regulatory pathways. We help your institution interpret the regulatory landscape, apply clear oversight frameworks, and make defensible decisions across the lifecycle of AI-enabled research.
Key components of our oversight support include:
- Regulatory Classification Guidance: Determine when AI/ML tools and studies qualify as research, human subjects research, exempt activities, or QA/QI. Our guidance ensures clear classifications aligned with the Common Rule and other applicable standards.
- QA/QI Determinations: We provide structured review support that helps differentiate quality assurance (QA) or quality improvement (QI) activities from research requiring full IRB oversight.
- IRB Review Frameworks for AI/ML Studies: We provide access to proven, field-tested review frameworks that enable IRBs to assess AI-enabled protocols consistently. Services include implementation of evaluation criteria, decision pathways, and standardized review questions tailored to AI/ML characteristics, with customization for your institution’s specific needs.
- Risk Assessment Strategies: We help you identify, evaluate potential risks in AI human subjects research including model bias, algorithmic opacity, data governance challenges, and participant harms. We then recommend mitigation strategies against those risks.
- Privacy & Data Protection Compliance: AI/ML research often depends on large datasets that raise complex data protection and privacy questions. We help institutions develop compliant data governance strategies consistent with HIPAA, Common Rule, and other applicable requirements.
- FDA Device Determination Support: For research involving AI that may meet the FDA’s definition of a device, we provide early regulatory strategy support including device determinations, risk categorization, and planning for FDA interactions.
- Protocol Review & Feedback: We offer expert review and constructive feedback on AI and other novel technology protocols improving clarity, compliance, and defensibility before they reach your IRB.
IRB Training & Capacity Building
Strong oversight depends on well-trained IRB members and staff who can apply thoughtful, consistent judgment across a broad range of research modalities. Our training programs are designed to strengthen review skills, enhance regulatory understanding, and build confidence in evaluating both AI-enabled and traditional research.
Our training solutions include:
- Emerging Technologies Training: Focused education for IRB members and staff on AI/ML, digital health platforms, wearable sensors, adaptive algorithms, and other emerging research technologies.
- Reviewer Training for Complex Protocols: Practical, scenario-based training that sharpens reviewers’ abilities to evaluate high-complexity studies with emphasis on AI/ML, digital health, and other novel methodologies.
- AI & Non-AI Protocol Review Skills: Workshops and interactive sessions that reinforce core human subject protections principles and regulatory interpretation adapted to both traditional and emerging research designs.
- Privacy & Data Protection Compliance: AI/ML research often depends on large datasets that raise complex data protection and privacy questions. We help institutions develop compliant data governance strategies consistent with HIPAA, Common Rule, and other applicable requirements.
- Regulatory Compliance Updates & Continuing Education: Ongoing education modules to keep your IRB up to date on evolving policy, new guidance from federal agencies, and contemporary best practices in research oversight.
Key Benefits
Institutions that implement structured AI/ML oversight and training typically achieve:
- Reduced review cycles through clearer protocols and fewer major revisions
- Lower contingency rates for complex digital health and ML submissions
- More consistent minutes and determinations across reviewers and panels
- Defensible classification records for audits, sponsors, and accreditors
- Stronger data protection practices for secondary use and large datasets
- Improved investigator satisfaction with predictable expectations and guidance
Ready to Strengthen Your AI Oversight?
Whether you need a one-time framework review or a comprehensive training program, we’ll tailor an approach that fits your research portfolio and governance structure.
Complete the form below and we will promptly follow up to schedule a call. Or feel free to contact us directly at (347) 862-9321 or info@thehrpconsultinggroup.com.
