Academic journal article Philosophy and Public Policy Quarterly

ELSI and the Philosophy of Science

Academic journal article Philosophy and Public Policy Quarterly

ELSI and the Philosophy of Science

Article excerpt

In March, 2012, the genetic testing firm 23and Me announced a clinical study "to learn more about how genes influence a person's response to bevacizumab (also known as Avastin[R]) in the treatment of metastatic breast caner." To enroll in the study, one had only to take surveys and provide by return mail a test tube (the "spittoon") with a saliva sample, which contains cheek cells to be genotyped. The firm states, "We are looking for 1,000 women with metastatic breast cancer who took bevacizumab in 2010 or 2011. Normally this kind of clinical trial would take years to do. We believe that by leveraging the web and modern technology we can do this study much faster, more effectively and for less money." (1)

Internet-Leveraged Clinical Studies

A dramatic fall in the cost of gene sequencing has resulted in a dramatic rise in the amount of sequencing data that is obtained, stored, archived, and analyzed in clinical and other genomic research. Personal Genomics (PG), Do-It-Yourself(DIY), and Direct-to-Consumer (DTC) Internet platforms conduct an increasing number of clinical studies in which individuals - cohorts sometimes of many thousands - affected by a particular disease fill in informational forms over the Internet, mail a saliva sample in a prepaid kit, and click "consent" on a form that usually permits researchers wide access to the resulting data.

A growing number of clinical studies leverage Internet platforms such as genomera.com, PatientsLikeMe, and 23andMe.(2) The Dr.Susan Love Research Foundation, for example, has announced an "international online study for breast cancer." It will "track hundreds of thousands of women (and men)" over time to learn what causes breast cancer."(3)Many of these clinical studies and trials neither receive federal support nor seek federal agency approval; because of this they are not regulated under the Common Rule.(4) Inspired by the Nuremberg Code (1947) and the Declaration of Helsinki (1964), regulations known as the Common Rule were adopted about 20 years ago (codified at 45 CFR Part 46) to apply "to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency." In place of the Common Rule, Internet-leveraged studies improvise, using a variety of idiosyncratic protocols for informed consent, privacy protection, and interactions with Institutional Review Boards (IRBs).

Patient-driven projects that run over the Internet often espouse an "openness" policy, which they contrast with Common Rule constraints. PatientsLikeMe.com (PLM), for example, states on its site: "Currently, most healthcare data is inaccessible due to privacy regulations ... But it doesn't have to be that way. When you and thousands like you share your data, you open up the healthcare system. ... We believe that the Internet can democratize patient data and accelerate research like never before."(5) PatientsLikeMe.com has enlisted more than 200,000 members who "contribute patient-reported data on more than 2,000 conditions, including 1 million symptom and treatment reports."(6) Sage Bionetworks (sagebase.org) argues, "The experimental data underlying disease biology, like the genome itself, needs to be open access because the data is simply the beginning of the process."(7) The Consent to Research project "seeks to create the world's largest pool of openly available, user-contributed data about health and genomics." It offers online tools needed to create "a 'cohort' who not only gather data about themselves and their health, but donate that data to the growing numbers of data-driven research scientists."(8) Advocates argue that "the reality of the new genetics and genomics urges us to abandon the traditional concept of medical confidentiality."(9)

Because of the variety of normative constraints and ethical protocols associated with citizen science, it is often no simple matter to determine how these protocols differ from those expected from clinical studies that are subject to the Common Rule. …

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