The Americans with Disabilities Act and Discrimination Based on Predictive Health Data

This post is part of our Blog Symposium “Applying the Americans with Disabilities Act and Genetic Information Nondiscrimination Act to the NFL Workplace.” Background on the symposium and links to other blog posts are here

By Sharona Hoffman

The excellent article, “Evaluating NFL Player Health and Performance:  Legal and Ethical Issues,” argues that some of the existing assessments of NFL players appear to violate the Americans with Disabilities Act (ADA).  The authors call for revisions to the ADA to clarify the statute’s applicability to professional football and the scope of permitted medical examinations under the ADA.

I would like to take the argument a step further and urge that the ADA be extended to cover employer conduct that is now outside the statutory scope but is highly relevant to athletes’ employment prospects.  Specifically, the ADA should cover discrimination based on predictions of future physical and mental impairments. Continue reading

New Blog Symposium! Applying the Americans with Disabilities Act and Genetic Information Nondiscrimination Act to the NFL Workplace

By Christopher R. Deubert

In recent years, there has been a growing amount of attention to different types of technologies (wearable and otherwise) that can measure various health- and performance-related metrics for athletes (see here, here, here, here, and here).  While no categorization is perfect, these technologies generally fall into eight categories: (1) player tracking, (2) heart rate, (3) sleep, (4) readiness, (5) body temperature, (6) force, (7) hydration, and (8) head impact sensors. Teams may use these technologies for evaluating and improving player performance, as well as for preventing or minimizing injury.

These new technologies are exciting, but they also raise concerns about how the data they generate might be used unfavorably towards players. For example, a team might discover that a player is no longer creating the same amount of force as he used to, which could threaten the player’s status with the team.

It was these types of concerns that led our team – Jessica L. Roberts, I. Glenn Cohen, Holly Fernandez Lynch, and me – to conduct an analysis of potential legal concerns related to these technologies, as well as other health and performance evaluations of NFL players, in our recent article, Evaluating NFL Player Health and Performance: Legal and Ethical Issues (165 U. Penn. L. Rev. 227, Jan. 2017).*  Specifically, we focused on the application of two federal employment antidiscrimination statutes: the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA) to the NFL workplace. Continue reading

Bill of Health Blog Symposium: How Patients Are Creating the Future of Medicine

We are pleased to host this symposium featuring commentary from participants in the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences event, “How Patients Are Creating Medicine’s Future: From Citizen Science to Precision Medicine.”  Below, Susan M. Wolf tees up the issues.  All posts in the series will be available here.

How Patients Are Creating the Future of Medicine: Roundtable at the University of Minnesota

By Susan M. Wolf, JD (Chair, Consortium on Law and Values in Health, Environment & the Life Sciences; McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine, University of Minnesota)

Citizen science, the use of mobile phones and other wearables in research, patient-created medical inventions, and the major role of participant-patients in the “All of Us” Precision Medicine Initiative are just a few of the indicators that a major shift in biomedical research and innovation is under way. Increasingly, patients, families, and the public are in the driver’s seat, setting research priorities and the terms on which their data and biospecimens can be used. Pioneers such as Sharon Terry at Genetic Alliance and Matthew Might at NGLY1.org have been forging a pathway to genuine partnership linking patients and researchers. But the legal and ethical questions remain daunting. How should this research be overseen? Should the same rules apply as in more conventional, academically driven research? What limits should apply to parental use of unvalidated treatments on children affected by severe, rare disease? And should online patient communities be able to set their own rules for research?

In December 2016, the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences convened four thinkers with diverse academic and professional backgrounds to analyze these trends. This event, “How Patients Are Creating Medicine’s Future: From Citizen Science to Precision Medicine” was part of the Consortium’s Deinard Memorial Lecture Series on Law & Medicine, co-sponsored by the University’s Center for Bioethics and Joint Degree Program in Law, Science & Technology, with support from the Deinard family and law firm of Stinson Leonard Street. To see a video of the event, visit http://z.umn.edu/patientledvideo.

The four speakers offered diverse and provocative perspectives, each of which is highlighted in this series.

Citizen-Led Bioethics for the Age of Citizen Science: CRexit, BioEXIT, and Popular Bioethics Uprisings

By Barbara J. Evans, MS, PhD, JD, LLM (Alumnae College Professor of Law; Director, Center on Biotechnology & Law, University of Houston)

This post is part of a series on how patients are creating the future of medicine.  The introduction to the series is available here, and all posts in the series are available here.

The citizen science movement goes beyond merely letting people dabble in science projects. It involves giving regular people a voice in how science should be done. And citizen science calls for a new, citizen-led bioethics.

Twentieth-century bioethics was a top-down affair. Ethics experts and regulators set privacy and ethical standards to protect research subjects, who were portrayed as autonomous but too vulnerable and disorganized to protect themselves. The Common Rule’s informed consent right is basically an exit right: people can walk away from research if they dislike the study objectives or are uncomfortable with the privacy protections experts think are good for them. An exit right is not the same thing as having a voice with which to negotiate the purposes, terms, and conditions of research.

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Participant Power

By Jason Bobe, MSc (Associate Professor, Icahn School of Medicine at Mount Sinai; Executive Director, Open Humans Foundation; Co-founder, DIYbio.org)

This post is part of a series on how patients are creating the future of medicine.  The introduction to the series is available here, and all posts in the series are available here. Jason Bobe will be participating in an NIH videocast on return of genetic results in the All of Us research program starting at 8AM on Monday, March 6, 2017.  You can tune in here

People across the world regularly rank health and health care near the top of what they value. Yet most people don’t volunteer to participate in organized health research. This is the “participation paradox.” We appear to be neglecting the very inquiry that feeds our ability to understand our bodies and to evaluate approaches to preserve, improve, or recover health from disease.

Better advertising and more effective recruitment strategies for research studies may help drive numbers up. But catchy slogans won’t drive a cultural shift toward a new future, where research participation becomes a regular part of life and organized health research is seen as a first step toward solving our health challenges, not merely the last hope for people with devastating illnesses.

Given how long it took patient-centered medicine to catch on, participant-centered research may face a long road ahead. Warner Slack was publishing about “patient power” at least as far back as 1972 (in his chapter on “Patient Power: A Patient-Oriented Value System,” in Computer Diagnosis and Diagnostic Methods, edited by John A. Jacquez, 1978). More than forty years later, great strides have been made, yet “patient power” is still a work in progress.

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The Wearables Revolution: Personal Health Information as the Key to Precision Medicine

By Ernesto Ramirez, PhD (Director of Research & Development, Fitabase)

This post is part of a series on how patients are creating the future of medicine.  The introduction to the series is available here, and all posts in the series are available here.

Personal health data has historically been controlled by the healthcare industry. However, much has changed in the last decade. From wearable devices for tracking physical activity, to services that decode the personal microbiome, there has been an explosion of methods to collect and understand our personal health and health behavior. This explosion has created a new type of data that has the potential to transform our understanding of the deep interactions of health behaviors, exposure, and outcomes — data that is large-scale, longitudinal, real-time, and portable.

New devices, applications, and services are creating large amounts of data by providing methods for collecting information repeatedly over long periods of time. For example, I have tracked over 20 million steps since 2011 using a Fitbit activity tracker. Many of the new tools of personal health data are also connected to the Internet through Bluetooth communication with smartphones and tablets. This connectivity, while commonly used to update databases as devices sync, also provides an opportunity to view data about ourselves in real-time. Lastly, there is an increasing interest in making this data accessible through the use of application programming interfaces (APIs) that allow third parties to access and analyze data as is becomes available. Already we are seeing unique and useful tools being developed to bring consumer personal health data to bear in clinical settings, health research studies, and health improvement tools and services.

The availability of this type of personal health data is having a big impact. The examples provided by the #WeAreNotWaiting and #OpenAPS communities showcase the groundbreaking potential of portable, usable, personal data. It is transforming the quality of life for individuals living with type 1 diabetes. Through access to data from continuous glucose monitors and wireless control of insulin pumps, over 100 individuals have implemented their own version of an artificial pancreas. These pioneering individuals are at the forefront of a revolution using personal health data to take charge of care and customize treatment decisions.

Personal health data will play a major role in the future of precision medicine, healthcare, and health research. Sensors will continue to improve. New data streams will become available. More analytical tools will surface. There will be more support for portable and sharable data. The availability of large-scale, longitudinal, and real-time personal health data will improve not only the ability of individuals to understand their own health, but when pooled, may produce new insights about what works, for what people, under what conditions.

Patient-Driven Medical Innovations: Building a Precision Medicine Supply Chain for All

Kingshuk K. Sinha, PhD (Department Chair and Mosaic Company-Jim Prokopanko Professor of Corporate Responsibility Supply Chain and Operations Department, Carlson School of Management, University of Minnesota)

This post is part of a series on how patients are creating the future of medicine.  The introduction to the series is available here, and all posts in the series are available here.

While the promise and potential of precision medicine are clear, delivering on that promise and making precision medicine accessible to all patients will require clinical adoption and a reliable and responsible supply chain. We already know this is a big problem in pharmacogenomics technology; the science is advancing rapidly, but clinical adoption is lagging. While Big Data can be a powerful tool for health care – whether it be an individual’s whole genome or an online aggregation of information from many patients with a particular disease – building implementation pathways to analyze and use the data to support clinical decision making is crucial. All of the data in the world doesn’t mean much if we can’t ensure that the development of precision medicine is linked with the efficient, safe, and equitable delivery of precision medicine.

Effective implementation means addressing the stark realities of health disparities. Leveraging citizen science to develop and deliver precision medicine has the potential to reduce those disparities. Citizen science complements more traditional investigator-driven scientific research and engages amateur and non-professional scientists, including patients, patients’ families, and communities across socio-economic strata as well as country boundaries.

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Henrietta Lacks and the Great Healthdata Giveaway

Part Seven of Seven-Part Blog Series by Guest Blogger Patrick Taylor

A suggestion runs through the debate on the NPRM to amend the Common Rule that the proposed changes are a tribute to Henrietta Lacks, a necessity so her story is not repeated.

That story was told in a the national bestseller  The Immortal Life of Henrietta Lacks, a moving biography of the young woman whose  aggressive tumor was the source of the ubiquitous HeLa cells (probably without her consent, certainly without her awareness of what followed); her family;  the  cells’  (and her) dehumanization into a research tool to be exploited unthinkingly; and the poverty, disconnection, racism,  lack of health care and lack of concern for her family. Society and scientists received a bonanza, and did nothing for her family in return.  The book criticizes phony consent, and advocates sharing  cell line proceeds with donors and their families. It rekindled discussion of consent and racist legacies, while urging that injustice required social change.

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NPRM Symposium: Consent, Causality, and Castles in the Air

Part Six of Seven-Part Blog Series by Guest Blogger Patrick Taylor

Reading the NPRM and its government commentary, one is subtly, slowly led to a sense of inevitability.  Arguments from abstract principles emerge, leave a footprint and then, in the wake of another tide of interests and arguments, another principal supplants them.  But we are to believe that each previous  footprint endures intact.  There’s “autonomy,” said to require expanding opportunity to consent to honor individual preferences, overtrodden by scientific convenience, which demands just one-time consent, and suggests that world-changing choices to be privacy-bare may be irrevocable.  There’s privacy demanding that information meet HIPAA deidentification standards at least some of the time; but there is some undisclosed vector requiring that there is no limit on who government may share your medical information with.  Surrender to the illusion that these are not inconsistent,  and the proposal is the best of all possible worlds, in which every inconsistent good is maximized and every tradeoff ignored.  Surrender the illusion itself and one sees a mix of juxtaposed  partial-prints going different directions, each incomplete.

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NPRM Symposium: “I prefer to be asked”

Part Five of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The preamble to the NPRM justifies requiring consent for data and specimen research by contending  that studies indicate that people want to be asked for permission.  However, the literature on this topic is relatively thin.  Available evidence suggests that many people, upon being informed that their heath data and tissues could or would be used in research without their consent (and nothing further is said to prompt the idea that research might delve into controversial matters) are generally fine with such use.  But when also queried whether they would prefer to have been asked, people say they would.  What the literature does not show is that people say: “I object to any use without my consent,” let alone “and I choose that over all the advantages of minimal risk research involving analysis by a computer of digitized files not humanly readable limited to disease-gene associations of thousands of medical records where consent would not be possible but the results will be essential or important to my health, the health of others, and the national health.”  Pluralistic discussion of tradeoffs over time, or an extended, candid national dialogue about the reasons for the present rules, were not in the mix.   Yet still, people said the opposite of “This must not occur without my consent!”

We have already seen one way in which the claim to be respecting the preference to be asked is untrue – it applies to only some research by some organizations.   Now here is another. The commentaries to the NPRM celebrate as fact that a patient need be asked only once, for all time, and then the only acceptable “yes” answer grants permission for any research by anybody.    It seems doubtful that a one-time consent to any future scientific research by any researcher for any purpose, without ever going back to inform or re-query,  without any regulatory provisions ensuring it was revocable, was what  participants meant by  “being asked.” Rationally, that option is far worse than no consent, for reasons we shall come to. Continue reading

NPRM Symposium: So many left behind…

Part Four of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The development of research benefits depends on research participation.  Research participation, in turn, depends on being asked to participate, and how people evaluate what is being asked of them.  This post focuses on a few, not all, of those disproportionately excluded from research through one mechanism or another.  It illustrates some of what the proposed amendments to the Common Rule governing human subjects research will likely mean in practice absent some special vector that changes the outcome.  We will discuss what such a social vector might look like at the end.

We will start with those people who, understanding the real impact and meaning of providing their “blanket consent” to research, and uncomfortable with the sweeping right to invade and permit others to invade their privacy, refuse to sign it.   Who are they? Continue reading

NRPM Symposium: “We are holding health care for ransom, just get naked already!” or “Consent neutrality is non-neutral in effect”

Part Three of Seven-Part Blog Series by Guest Blogger Patrick Taylor

In the previous post of this series, we took a look at how comprehensively certain proposed revisions to human subject research regulations would apply and whether they would, if effective, really fulfill a broad goal of enabling the consent of everyone to researchers’ use of their clinical data.  The answer is a big “No,” based on their scope.  If public trust in science depends, as the government claims, on individuals’ consent reliably and consistently governing research use of their data, then science is in trouble; all the government has proposed is a restriction on the institutions a supermajority of the people trust already to protect their privacy: healthcare providers, researchers funded by the NIH, and a handful of other federal agencies.   Everyone else, from Google to spymaster, drug company to next-door neighbor, is unaffected except to the extent that those entities, or reviewing IRBs, require contracts that say something more, which in this case is left to chance.

The proposed regulations call for government to draft a general blanket consent to govern tissue banking and banked data.  “Blanket” means that it covers everything, in undifferentiated language, with no opt outs – all or nothing.   Such an approach will eliminate most or any choice about what one is consenting to.  It will require consent to any research by anybody using any technique, with any goal in mind.  The options will be to consent to that or not consent at all. Continue reading

NPRM Symposium: Privacy and Promises, Promises, Promises

Part Two of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The first blog post in this series probably provided a few surprises, but the surprises are just beginning. Can the NPRM to amend the Common Rule keep its promises?

The NPRM promises that patients will be able to consent to use of their clinical data in research, which is actually two promises, not one. The first is that the consent will be given effect. The second is that the refusal will be given effect.  As to refusal, the NPRM absolutely does not keep its promise.

The NPRM is filled with page after page of exceptions where your consent is not required. These include examples like trailing you and spying on you in public, some tests done on how to affect children’s behavior, and more. Continue reading

NPRM Symposium: Your Privacy or Your Life – Human Research Subjects and the Great Healthdata Giveaway

Part One of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The recent Apple-FBI controversy has highlighted the fact that our government, obligated to protect our privacy in some contexts, actively undermines it in others. The same internal conflict of interest is responsible, at least in part, for the U.S. government’s recent proposal to revise longstanding regulations to protect people who participate in research.

The proposals emerged last September, 2015, and were hailed as the first major reworking of the regulations in several decades, four years after an Advance Notice of Proposed Rulemaking buried somewhat different approaches to the same desired adverse privacy effects in a tome of hundreds of pages. It’s a safe bet that few if any members of the public not professionally involved ever read them. The feds gave themselves four years to consider and devise the current proposal, but they gave the public about four months to consider it and with no evident structured interaction with public opinion. Continue reading

The Common Rule NPRM Blog Series: Posting of Consent Forms

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

The Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), proposes a new provision that would require a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency to be posted (within 60 days after the trial is closed for recruitment) on a publically available federal website that would be established for such purpose.

In Part 3 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM, we address the rationale behind this proposal and its potential benefits, downsides, and missed opportunities. Continue reading

Some Commentary on How to Think About Secondary Research with Biospecimens

The public comment period on the NPRM to revise the Common Rule has just closed, and now we wait to see what happens (if anything), and when.  One of the most controversial proposals in the NPRM would require at least broad consent for secondary research with biospecimens (i.e., research on specimens originally collected for another purpose, either clinical care or a different study), regardless of whether those specimens retain identifiers.  This is a substantial change from the status quo, which does not require consent for such research with de-identified specimens.  How should we feel about this status quo, and the proposed change?  My own view is that it’s really not so bad: the risks to individual research participants are quite low, and the current approach facilitates critically important scientific advancement.  There is certainly room for improvement, e.g., to impose punishment on those who would act to re-identify de-identified specimens without permission, to inform the public that such research takes place, and to educate them about its value, perhaps allowing those who still feel very strongly that they prefer not to be included an opportunity to opt-out.  But what has been actually proposed has more problems than what it would replace, and in fact, wouldn’t solve some of those it seems to be a response to.

Rebecca Skloot feels otherwise.  She is the author of a book called The Immortal Life of Henrietta Lacks, which chronicles the origin of one particularly important cell line – HeLa  – derived from cells that had been excised from Ms. Lacks in the course of a 1951 surgery to treat her cancer, and later used for research without her knowledge or permission.  Ms. Lacks was poor, uneducated, and black, and her descendants have also faced more than their fair share of adversity.  Ms. Skloot paints a compelling story of exploitation, but in my opinion, it is much more effective as a narrative about the horrible and enduring legacy of racism in this country than as proof that researchers who conduct secondary research with biospecimens without consent (as permitted under the current regulations, remember) or even without profit-sharing have behaved badly. After all, if individual risks are low and social benefits high – both true – then what’s the problem?  And it is far from clear that specimen sources deserve compensation for no other reason than that their discarded material actually proves valuable to scientists.  Nonetheless, the book has been used as a rallying cry by people from all walks of life who believe that they should be allowed to control whether, and potentially how, their specimens are used for research. Indeed, The Immortal Life of Henrietta Lacks is probably the single most important development that pushed the proposed revisions to the Common Rule forward, for the first time since they were released in 1991.

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NPRM Symposium: How Should We Think About Whether To Donate Our Leftover, Non-Identified Tissue to Research?

By Michelle Meyer

Proposed changes to the federal Common Rule would ask patients for the first time to decide whether to allow their non-identified, leftover tissue to be used for research or thrown away. For that choice to be meaningful, the public needs to be aware of the nature, risks, and benefits of biospecimens research, and of what the proposed changes will—and will not—do. In my latest Forbes essay, “No, Donating Your Leftover Tissue To Research Is Not Like Letting Someone Rifle Through Your Phone,” I consider the power of analogies and other reflections on Rebecca Skloot’s recent New York Times op-ed on the NPRM.

NPRM Symposium: When will regs be revised again? & Marcia Angell in NYRB

There is plenty to say about the proposed changes to the Common Rule that the Office of Human Research Protections announced in September. But it’s striking to consider what is left unsaid—that the regulations will need to be revised again in the near future.

When the final revisions are published (in late 2016, so they say), the rules should include a plan to revise again in ten years. This plan is already in place in for a few areas covered in the proposed revisions, but it is imperative that OHRP extend this requirement to the entire new rule.

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Blog Series on NPRM at PRIM&R’s “Ampersand”

Our colleagues at PRIM&R are hosting a series on “Unpacking the NPRM.” Check it out at their blog Ampersand, or by clicking on the links below!

The Common Rule NPRM: Single IRB Review

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

To rely or not to rely? Under the recent Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), this would generally no longer be a question in the U.S. Part 2 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM addresses the NPRM’s proposal to require U.S. institutions engaged in domestic cooperative research to rely on a “single IRB” to provide review of the research on their behalf in most circumstances. This proposal remains a constant from the Advanced Notice of Proposed Rulemaking (“ANPRM”) that was published in 2011, despite comments from the regulated community suggesting that HHS take steps to encourage various types of IRB reliance arrangements but stop short of a mandate. We expect that many institutions may be planning to comment again on whether single IRB review should become a mandate and on the associated relative burdens and benefits of such review (whether it is mandatory or permissive). This blog post does not comment on logistical implementation issues or on the cost assumptions provided by HHS in support of the proposal. Rather, we outline below some additional questions and issues that organizations may wish to consider or address in submitting comments on the proposal.

Thanks to a just-granted 30-day extension of the public comment period for the NPRM, comments on the NPRM are now due to HHS by January 6, 2016. The ACRG has prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed changes.

ACRG Rapid Rundown: Six Things You Need to Know

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