Citizen science

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Some Swedes are Early Adopters of Biohacking

November 7, 2018

According to a report from National Public Radio, "In Sweden, a country rich with technological advancement, thousands have had microchips inserted into their hands. The chips are designed to speed up users' daily routines and make their lives more convenient — accessing their homes, offices and gyms is as easy as swiping their hands against digital readers." On April 3, 2019, a free, public lecture and webcast will feature Prof. Lisa Ikemoto (UC Davis School of Law) discussing "Biohacking and Cyborg Rights." Her talk is part of this year's Consortium lecture series, "Consumer-driven and DIY Science," which will also feature Sharon Terry (Genetic Alliance) and Michael Imperiale (University of Michigan).

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Lisa Ikemoto

Spotlight on Emerging Legal Approaches to Cyborgs, Biohacking

October 4, 2018

A recent Star Tribune profile of Frances Shen, JD, describes his work in neurolaw, a field he has pioneered. Prof. Shen, an affiliate member of the Consortium, focuses on the intersection of brain science, law and policy. In his research, he uses advances in scanning and other technology to better understand the connections between the brain and human behavior. He notes, “Seeing the world through brain circuitry is a really foundational shift, not just for law, but for policy. . . . A hundred years ago we just had to guess how the mind was working. And we still have to make a lot of guesses. But we know a lot more than we did . . . and it would be nice if the law caught up.” Another take on emerging technologies and the law will be presented by Lisa Ikemoto, JD, LLM (University of California, Davis) on April 3, 2019. Her lecture, "Biohacking and Cyborg RightS: Coping with Promise and Peril," will describe the work of citizen scientists and others who are working outside of academic and institutional labs to enhance human capacity. Prof. Ikemoto will examine the implications of "cyborg rights" for law and for defining the human. Her lecture is part of a series, Consumer-Driven and DIY Science. Learn more and register here

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MobileELSI Explores Ethical Issues in Health Research with Mobile Devices

May 17, 2018

Patient-led medicine, powered by mobile technology like smartphones and wearable fitness trackers, is transforming health research. While these new tools have powerful potential, some of this research is not subject to federal regulations, raising quandaries about how to ensure adherence to independent review, informed consent and privacy standards. A new NIH-funded project, MobileELSIwill develop and disseminate recommendations for the ethical conduct of this emerging research. It's led by Consortium collaborators Mark Rothstein (University of Louisville), Charlisse Caga-anan (National Cancer Institute) and John Wilbanks (Sage Bionetworks); Consortium chair Susan M. Wolf is serving on the Working Group. The Consortium hosted an event, How Patients Are Creating Medicine's Future, in Dec. 2016, featuring four experts in the field; video can be viewed here

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23andMe Wins FDA Approval for Direct-to-Consumer Cancer Test

March 6, 2018

The U.S. Food and Drug Administration (FDA) today authorized the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population. “This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of DTC genetic tests. But it has a lot of caveats,” said FDA spokesperson Donald St. Pierre. “While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test. The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.” After an FDA review determined that the test is accurate (i.e., can correctly identify the three genetic variants in saliva samples) and can provide reproducible results, marketing authorization was granted to 23andMe. Learn more here

Research

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Addressing Ethical, Legal, and Social Issues (ELSI) in Unregulated Health Research Using Mobile Devices (MobileELSI)

To date, there has been very little study of the ethical and legal issues surrounding unregulated health research performed by "citizen scientists." A three-year grant from the National Institutes of Health will enable a team of 30 researchers from leading research institutions, health technology developers, and patient advocates to consider a wide range of issues, including the various types of mobile health research platforms, the potential applicability of various federal and state laws regulating research, possible models of self-regulation, and specific measures from online consent to integrating privacy protection in health apps.

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Sharon Terry

Citizen Science Pioneer Diagnoses Medical Research Shortcomings

June 22, 2017

In a newly-released TEDMED talk, Sharon Terry of Genetic Alliance describes her journey to becoming a citizen scientist after her two children were diagnosed with the genetic condition pseudoxanthoma elasticum (PXE), which causes the symptoms of premature aging. She quickly learned “that there was no systematic effort to understand PXE . . . researchers competed with each other because the ecosystem is designed to reward competition rather than alleviate suffering.” In response, Terry and her husband, Patrick, educated themselves on the disease and gathered thousands of similarly affected people to initiate studies and clinical trials. The message of her talk is that “citizen scientists, activists using do-it-yourself science, and crowdsourcing are all changing the game.” Ms. Terry is a member of the working group for the LawSeq project, which is laying the policy groundwork to translate genomic medicine into clinical application; the principle investigators are Consortium Chair Susan M. Wolf, JD; Ellen Wright Clayton, MD, JD of Vanderbilt University; and Frances Lawrenz, PhD of the University of Minnesota. Last December, the Consortium sponsored an event on patient-led medicine and citizen science; video can be viewed here.

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Barbara Evans

Evans Proposes 21st-century Governance Model for Health Data

May 30, 2017

A new article in the American Journal of Law & Medicine by Consortium collaborator Barbara J. Evans, MS, JD, LLM, expands on ideas she shared at last December's forum, "How Patients Are Creating Medicine's Future." "Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science" draws on past citizen science efforts; empirical research such as the Health Data Exploration Project; guidelines like the Common Rule and HIPAA; and property law. Evans argues that laypeople who work together to assemble datasets could serve research and health care needs better than the current system. She notes: "The aim of consumer-driven data commons is to allow consenting groups of individuals to assemble datasets on a meaningful scale, empowering themselves through collective action to exercise greater control over the fate of their data than individuals can achieve acting alone." Evans also discusses the opportunity presented because "new forms of [personal health data (PHD)], such as data from mobile and wearable sensing devices, are generally not regulated by the Common Rule and HIPAA Privacy Rule. This regulatory gap offers an opportunity to design a new PHD privacy and access models on a blank slate, perhaps avoiding pitfalls of existing regulations." A PDF of the article is available here.

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New Research Explores Public Genomic Data Sharing

May 10, 2017

A new paper just published in PLOS ONE examines the motivations and characteristics of people who openly share the results of direct-to-consumer genetic testing using the web platform OpenSNP. The team of authors, who are affiliated with the University of Zurich, University of Cambridge, and Goethe University in Frankfurt, found those who shared their data were motivated by a desire to learn more about themselves; to advance medical research and improve genetic testing; and because they considered it fun. The researchers noted "Whereas most respondents were well aware of the privacy risks of their involvement in open genetic data sharing and considered the possibility of direct, personal repercussions troubling, they estimated the risk of this happening to be negligible." Among the paper's authors was Effy Vayena, who spoke at the Consortium's recent conference on research ethics. You can see her talk here.

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FDA Approves Direct-to-Consumer Genetic Tests

April 6, 2017

In a turnaround for the Food and Drug Administration (FDA), the agency has announced it will "allow a company to sell genetic tests for disease risk directly to consumers," according to the New York Times23andMe, a private genomics and biotechnology company based in Mountain View, California, pioneered products to allow customers to learn about their genome without the involvement of a doctor, genetic counselor or other health care professional. There are two levels of test offered; the default will only include the gene variants that could lead to the development of 10 rare conditions such as factor XI deficiency, Gaucher disease type 1 and celiac disease. For the genes associated with illnesses such as Parkinson's and Alzheimer's, there is a separate track that includes access to genetic counselors. An attempt by 23andMe to offer similar direct-to-consumer tests in 2013 was quashed by the FDA because of concerns about how patients might misinterprete potentially bad news without professional guidance. However, according to Dr. Robert C. Green, a Consortium collaborator who has researched the matter, studies since then have "there is some potential for distress, but it is much, much smaller than was anticipated.” Read the entire article here

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Patient-led Medicine Symposium on Harvard Bill of Health Blog

March 6, 2017

A symposium published today on Bill of Health, a blog edited by the Petrie-Flom Center at Harvard Law School, expands on discussions held at the Consortium's Deinard Memorial Lecture last December, "How Patients Are Creating Medicine’s Future." The Deinard lecture featured four speakers – Ernesto Ramirez of Fitabase, Jason Bobe of the Mount Sinai School of Medicine, Barbara Evans of the University of Houston Law Center, and Kingshuk K. Sinha of the Carlson School of Management at the University of Minnesota. The Bill of Health symposium provides commentary on their lectures and further reflections on the ways citizen science and wearables are transforming both health care and medical research. A video of the entire Deinard lecture can be viewed here

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