Technology Use in Research

Software, Apps, Algorithms, Artificial Intelligence (AI), and Wearables in Research

Emerging technologies have raised new ethical considerations related to data privacy when used in the research setting. Technology use covered in this guidance includes, but is not limited to:

• Software used for data collection, storage, or analysis in research
• Software that may be considered a medical device
• Phone apps used for research data collection
• Algorithm development and testing
• Use of artificial intelligence (AI)
• Wearable devices used for research purposes 

UofL Data Privacy and Security Considerations 

When planning your research project, it’s important to consider any third-party access to the research data, including de-identified data. Start by reviewing The Guide for Privacy/Data Security Issues for Research.

University of Louisville has specific policies in place related to data access, vendor vetting, and contract requirements. It’s important to be familiar with these requirements and ensure research studies adhere to University policy when planning and developing your research protocol.

Additional planning support is available for research involving wearable devices. To connect with UofL resources for this category of research, contact the UofL Custom Wireless and Electronics Laboratory. Researchers should also complete the Wearable Device Research Planning Form. Submitting this form early helps navigate the research process from ideation through IRB approval. By identifying institutional pathways, it minimizes procurement delays and offers design guidance for both commercial-grade and custom-engineered solutions.

Research Protocol Considerations

When preparing your research protocol, you will need to define the research intent of the technology being used. This will assist in determining if FDA requirements apply to the research project.

It’s also important to consider the minimum data necessary to be able to answer the research question. One of the biggest challenges of using new technologies in research is navigating data privacy risks. The protocol will need to outline:

• The data that will be collected/stored/shared by the technology.
• Whether direct identifiers will be put in the technology.
• The safest way to move the data from the technology to the research database.
• Who will have access to the data (note any third-party access will fall under institutional requirements outlined in the section above).

Limiting the amount of information that enters the technology can help in navigating data privacy risks. Consider the project and determine whether the technology will have access to a participants identifying information. Is it possible for the data collected to be coded back to the participant with a separate link the study team keeps? Is it possible that the data is not linked to an individual participant at all? 

It’s important to think about the minimum amount of data necessary to be able to answer the research question. Additionally, the more safeguards that can be put into place related to data collection, the better.

FDA Considerations

Clearly outlining the research intent is key in determining FDA requirements that may apply to a research study.

FDA requirements come into consideration when the research tests the safety and/or effectiveness of a technology’s ability to cure, treat, diagnose, prevent or mitigate a disease. 

The FDA has established an interactive decision tool help in determining whether a product's software functions are potentially the focus of the FDA's oversight.  This tool is

designed to walk through each step to determine where a research project falls within the FDA requirements. 

Additionally the FDA has resources and information available for researches on the FDA Device Advice page. This page includes email contact information for communicating questions with the FDA as well.

Additional resources for investigators navigating FDA device requirements for research can also be found on the Regardd website. This website was developed by several academic institutions to provide researchers with tools and resources needed to navigate investigator initiated projects involving FDA requirements.