Project Summary

One of PCORI’s goals is to improve the methods that researchers use for patient-centered outcomes research. PCORI funds methods projects like this one to better understand and advance the use of research methods that improve the strength and quality of comparative effectiveness research.

What is the project about?

Using digital strategies like mobile apps in health care is known as digital health. Digital health makes it easy for people to take part in research studies because they can provide data without having to go to a clinic. But digital health may also bring risks, such as concerns about patient privacy and keeping personal health information secure.

In this study, the research team is developing and testing a risk assessment tool to identify and manage the risks that come with using digital health in research. The team is also creating new ways to share study information with people who may take part in studies that use digital health, as part of their informed consent process. During informed consent, a doctor or researcher explains the purpose of the study and the potential benefits and harms of taking part. Patients then choose whether to enroll in the study.

How can this project help improve research methods?

Results may help researchers and regulatory experts when considering ways to identify and communicate information about a study’s possible benefits and harms during the informed consent process.

What is the research team doing?

This study has two parts. In the first part, the research team is testing a new risk assessment tool for digital health research studies. The tool is based on an existing checklist but uses structured brainstorming to help researchers and regulatory experts identify sources of risk in digital health studies. Users then identify ways to reduce those risks. After considering these plans, users rate how likely the risks are to occur and how severe outcomes would be if they did occur.

The research team is recruiting 40 researchers and regulatory experts to test the tool. First, the team is assigning all 40 people by chance to assess one of two digital health research studies without using the new tool. Then, the team is assigning the people by chance to one of two groups. In the first group, people are assessing one of two other digital health research studies using the tool. In the second group, people are assessing one of the same two research studies without using the tool.

In the second part of the study, the research team is working with patients to design a new informed consent process for research that uses digital health. The team is asking patients for their opinions on ways to improve the process. For example, the team wants to know what type of study information patients want to see and how to present this information clearly. The team is also asking patients if they want to be able to choose what data to share with others. Also, the team is looking to see how researchers might use artificial intelligence, or AI, to better communicate the potential harms of taking part in a study. To do so, the team is comparing how people perceive summaries of risk written using AI versus those written by experts.

The research team is using findings from the study to design informed consent templates. Then, the team is testing the templates with patients through a series of design workshops.

Research methods at a glance

Design ElementDescription

Aim 1. To evaluate a risk management tool designed to identify potential benefits and harms of digital health research and to better manage those potential harms

Aim 2. To work with patients to co-design a new informed consent process and prototypes for obtaining informed consent in digital health research


Aim 1. Controlled experiment

Aim 2. Unstructured brainstorming, prototype design

*Methods to Support Innovative Research on AI and Large Language Models Supplement
This study received supplemental funding to build on existing PCORI-funded comparative clinical effectiveness research (CER) methods studies to improve understanding of emerging innovations in large language models (LLMs).

Project Information

Camille Nebeker, EdD, MS
The Regents of the University of California, San Diego
Studying Methods for Ethical and Human Subjects Protections Issues in Digital Health PCOR/CER

Key Dates

July 2021
December 2025


Award Type
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: February 28, 2024