Novel Technologies (AI/ML, digital health tools, wearables, etc.)

Novel technologies are reshaping how research is designed, conducted, and reviewed across disciplines. Whether your institution supports biomedical trials, social-behavioral studies, educational research, or community-based inquiry, IRBs and HRPPs are increasingly expected to evaluate studies that incorporate these tools without adequate regulatory guidance or established review criteria.

 

We support research institutions looking to develop or deploy various novel technologies in research, whether as part of research administration, the research review process itself, or as a direct research intervention or clinical investigation. Novel technologies might include:

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AI & Intelligent Systems: These tools may appear in research as diagnostic decision-support, participant screening algorithms, automated data coding, chatbot-based interventions, or AI-generated study materials. Reviewers should flag any study where an algorithm influences participant selection, treatment assignment, or data interpretation.

• Artificial Intelligence (AI) and Machine Learning (ML),

• Natural Language Processing (NLP)

• Large Language Models (LLMs) / Generative AI

• Predictive Analytics,

• Computer Vision / Image Analysis

 

Digital Health Technologies: These tools are often used to collect real-time participant data, deliver interventions remotely, or monitor health outcomes outside of a clinical setting. Reviewers should flag studies involving any app, device, or software that collects, transmits, or acts on participant health or behavioral data.

• Digital health Tools (DHT)

• Wearables & Sensors,

• Mobile Health (mHealth) applications

• Software as a Medical Device (SaMD)

Data & Research Infrastructure: These technologies shape how research is conducted, where data lives, and how participants are enrolled or consented, oftentimes without being visible as a "technology" in the protocol narrative. Reviewers should flag studies using remote or virtual platforms, AI-generated datasets, or non-traditional consent mechanisms.

• Synthetic Data & Simulation Tools

• Software-based data collection

• Decentralized Research Platforms

Autonomous or Robotic Systems: These tools may appear as physical devices that interact with participants directly or as automated systems that make decisions without real-time human oversight. Reviewers should flag any study where a machine, rather than a person, the tool administers a procedure, delivers a stimulus, or responds to participant behavior.

• Autonomous decision-support tools

• Robotic systems used in research interventions

Through this service line, Savini Consulting clients gain access to Tamiko Eto's nationally recognized expertise in AI and novel technology oversight including:

• Regulatory classification (FDA device risk and device determinations)

• Risk analysis and mitigation

• Review frameworks application

• Institutionally-Customized SoPs, Checklists, and Policies

• Team and Individual Training

• Protocol Review

• and more!

We help you ensure your program stays ahead of the science, the guidance, and the gap between them.