California Initiative to Advance Precision Medicine Equitable Consent Frameworks and Guidance for Community Members and Researchers

Every participant has the right to freely volunteer to be a part of a study and be fully aware of what it means to be a participant.

What is Clinical Research?

Clinical research are studies that help society learn better ways to treat people when they are sick, prevent disease, develop new technologies, and learn fundamentals about the human body. There are many different types of clinical research. Some of these are:

  • Treatment research, or clinical trials, which tests the safety and efficacy of medications, devices, surgeries, and other medical treatments,
  • Prevention research, which studies ways that we can prevent disease onset or progression through the use of medication, vaccines, or lifestyle changes,
  • Diagnostic research, which tries to better identify diseases,
  • Genetic research, which studies how differences in your DNA and between people and changes over time are linked to disease.

It is important that people from all backgrounds participate in research. Some types of people, including those from racially and ethnically diverse communities, people over the age of 55, pregnant and lactating people, gender and sexually diverse populations, and people with disabilities do not participate in clinical trials as much as other people. This means that medical tests, treatments, and devices may not be equally effective and safe for ALL potential patients.

About this Project

This project was launched and is managed by the California Initiative to Advance Precision Medicine (CIAPM), located in the CA Governor's Office of Planning and Research.

When research trials are not inclusive and do not engage a wide variety of participants, prevention strategies and treatments might not be as safe or effective for all patients. A movement continues to grow to increase representation in biomedical research and clinical trials, to ensure health advancements benefit all communities. Members of the California Precision Medicine Advisory Council and CIAPM Staff conducted a deep-dive into published studies and reports to provide this resource to the public, intended for community members, researchers and research staff, caregivers, clinics, and funders. Resources and best practices for researchers, sponsors and other interested parties is currently underdevelopment. The Initiative provides funds for precision medicine demonstration projects, and acts as a knowledge and activity hub for California's precision medicine community.

For More Information

Theresa Spezzano, PhD
Theresa Spezzano is Health Equity Officer of the California Initiative to Advance Precision Medicine at OPR. She co-leads the Representative Research Collaborative.

Special thanks to Policy Fellow Bridgette Smith for assembling information for the Equitable Consent webpages.