What Guarantees Privacy and Safety for Participants in Genetic Studies, When Personal Genes Aren't Owned?
In a groundbreaking move, researchers are planning to collect information from one million Americans as part of the Precision Medicine Initiative. The goal is to make specific recommendations for patients based on their genes, environment, and lifestyle, with the aim of developing targeted drugs and treatments that vary from individual to individual.
The initiative, which was the topic of a White House forum on February 25, is governed by a "web of protections" that includes federal and state laws. Under the Federal Common Rule, research studies must be reviewed and approved by an Institutional Review Board (IRB). This body evaluates the adequacy of the consent process and confidentiality protections, whether risks are minimized and are reasonable in relation to the benefits, and whether the selection of subjects is equitable.
Researchers must disclose the research's purpose, procedures, and any risks and benefits of participating to study subjects. Participants are protected by data protection laws such as the General Data Protection Regulation (GDPR), strict consent requirements, de-identification of genetic data, and regulations that limit the use and sharing of genetic information after project completion. The Genetic Information Nondiscrimination Act (GINA) also prohibits use of genetic information to discriminate against asymptomatic individuals in employment and health insurance decisions.
However, some risks are informational. For example, if an insurer learned that a research participant had a gene that increases the risk of Alzheimer's, it might refuse long-term care coverage. Courts have consistently decided that once biological materials are given to researchers, they belong to the researchers or the institutions that employ them, not the research participants.
In some circumstances, the Common Rule doesn't require participant consent when the study poses little risk to the participant. Facebook's 2014 study manipulating newsfeeds of 700,000 users to determine the effect of negative or positive words on their emotions falls outside the Federal Common Rule.
The Precision Medicine Initiative may propose ways to update or supplement laws to address concerns like those expressed by President Obama regarding participant protections and public trust. Some states have adopted laws that apply similar protections to research not subject to either the Common Rule or the FDA regulations, but these laws vary considerably from state to state.
A comprehensive analysis of these federal and state laws has been undertaken by a team of experts, including Leslie E. Wolf, Professor of Law at the College of Law, Georgia State University, Erin Fuse Brown, Assistant Professor of Law at the College of Law, Georgia State University, and Dr. Laura Marie Beskow, Associate Professor of Medicine at Duke University Medical School. The analysis describes how these laws work together, identifies gaps, and suggests ways to improve protections.
In addition, the Precision Medicine Initiative may provide participants additional controls over their data on a voluntary basis, such as reevaluating preferences for data sharing, withdrawing consent for future use of their data, and controlling types of communications regarding their information.
The Precision Medicine Initiative, with its ambitious goals and potential for personalised medicine, raises important questions about participant protections and public trust. This comprehensive analysis aims to provide clear answers and guide the way forward in ensuring the privacy and safety of all involved.
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