My current research analyzes the contracts and privacy policies used by direct-to-consumer genetic testing (DTCGT) companies. My original aim was to examine the current legal mechanisms for protection of the rights of consumers in their genomic sequence data and to suggest possible reforms. However, examining DTCGT contracts has forced me into the depths of online contract law, and this in turn has made me think more carefully whenever I am faced with an option to click away. This article will provide a brief overview of the world of online contracts in the context of DTCGT.
What is DTCGT? Before proceeding further, it is necessary to explain briefly what DTCGT is. DTCGT, also sometimes referred to as personal genome testing (PGT), is a new industry that has developed as a consequence of the recent advances in genetic and genomic science. DTCGT companies offer a variety of services, but their normal procedure is to allow people to order a genetic test from their website. Customers then receive a kit in the mail and use the kit to take a sample of their DNA. After the sample has been analyzed, the company will convey the results of the test to the consumer and sometimes provide ongoing updates on the individual’s health information. A web-based interface is the primary mode of delivering this information to consumers, often without recourse to genetic counseling.
For health-related testing, the most common services are predisposition, presymptomatic, and carrier testing. Predisposition testing provides an indication of an individual’s absolute lifetime risk and/or relative risk of developing a particular condition, while presymptomatic testing evaluates whether a healthy, asymptomatic individual “has a high probability of developing a condition” (Human Genetics Commission, A Common Framework of Principles for Direct-to-Consumer Genetic Testing Services, 2010; tinyurl.com/ndekmmc). One type of testing that shows particular promise for personalized medicine is that of pharmacogenetics, which is concerned with assessing an individual’s responsiveness to particular drugs or therapies.
Online contracts and DTCGT. Most DTCGT companies’ contracts and privacy policies take the form of either clickwrap or browsewrap agreements. These contracts are mass-consumer standard form contracts. Most afford no opportunity for the consumer to negotiate and are drafted by the company heavily in its favor. Whenever you buy a product online, participate in an online auction, update computer software, or access content from a plethora of websites, you may at some point be asked to agree to corresponding terms and conditions. Most of the time you will do this without reading and sometimes without even glancing at these terms and conditions. Why do we not read them? Is it a matter of trust? Is it a lack of time? Unfortunately, the reality is that many of us do not have sufficient time to read these contracts. There is also a strong element of trust here. Many of us do trust companies to a certain extent, and we also tend to think that harm befalls other people and not us.
Of course, many of us would still not choose to read online contracts, even if we had sufficient time to do so. Furthermore, for the ordinary consumer who chooses to read these documents, the process is not necessarily one of enlightenment. This is largely owing to the length of online contracts and also the language used, as many contracts use language that requires a high level of education to understand. There is also a significant level of misunderstanding on the part of consumers of the meaning and effect of online privacy policies.
So what does the common DTCGT contract look like? Some of the clauses that can normally be found in these contracts include: compulsory arbitration; choice of law; broad disclaimers of liability, including stating that the company cannot guarantee fitness for purpose; intellectual property; indemnification; unilateral change of terms; and clauses stating that the information provided is for informational, recreational, and research purposes only.
One of the most prominent DTCGT companies, 23andMe, has faced multiple class actions in the past year in the aftermath of the U.S. Food and Drug Administration’s warning letter of November 2013. The recent order centered on an arbitration clause. However, the 23andMe contract is by no means unique. Similar clauses have been included in the contracts of other companies.
Some clauses commonly included in DTCGT contracts may not surprise the reader, as it is standard business practice to limit a company’s liability wherever possible. However, undergoing genetic testing is not the same thing as purchasing an ordinary consumer product, such as a television or book. Once a person’s DNA sample has been sequenced, the information is irrevocable—an aspect that several companies mention in their contracts. Sequenced genetic data can also count as personally identifiable information, and it can potentially reveal sensitive information regarding a person’s health status and ethnicity. It can also serve as a unique identifier of the person tested, and at the same time it can be used to reveal information about individuals to whom that person is related.
Toward improved online contracts. When we take genetic testing outside the clinic, where there are more checks and balances, there are arguably more dangers for the test subject, and it seems advisable for these companies to improve their contracts, and especially their consent mechanisms. This could be done in an innovative and educational way; it need not be harmful for the company. Contracts could be improved by making them more interactive, with attention being drawn to key clauses; educational videos could explain the types of information a person is likely to receive from the company and also explain some of the most important terms; there could be more opportunities for customers to opt out of particular services; and companies could provide more information about use, storage, and disclosure of data. The security and privacy risks ought not to be underestimated here. For participation in research, companies could also look to other consent models used in the medical research context. Terms such as broad indemnity clauses ought to be omitted, and it may be inappropriate to specify that certain disease risk tests are provided for recreational purposes.
The proposed way forward does not have to be detrimental for the DTCGT industry. It is possible for contracts to be improved without severely disadvantaging companies. If DTCGT is to live up to its promises and assist the cause of personalized medicine, it would be beneficial for contracts to be more fairly balanced and to empower consumers through providing adequate information in a comprehensible form. If DTCGT genetics is to have a real connection with consumer empowerment and enabling people to take charge of their genetic information, then consumers need more tools to do this. If DTCGT companies want to conduct participatory research projects, then consumers ought to be able to participate knowingly and more actively.
Regulatory reform is also needed, but improving contracts and privacy policies would be a cost-effective and useful strategy in the short term.
ABA Section of Science and Technology Law
This article is an abridged and edited version of one that originally appeared on page 8 of The SciTech Lawyer, Winter 2015 (11:2).
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