No Seat at the Table: The Legal Status of Players at the NFL Scouting Combine

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 Michael McCann

In Evaluating NFL Player Health and Performance: Legal and Ethical Issues 165 U. Pa. L. Rev. 227 (2017), the authors (Jessica L. Roberts, I. Glenn Cohen, Christopher R. Deubert and Holly Fernandez Lynch) compellingly explain why the Americans with Disabilities Act and the Genetic Information Nondiscrimination Act supply legal protections to football players at the NFL Scouting Combine (“Combine”). In this blog post, I stress the need for such protections in light of the unusual—and vulnerable—legal status of players at the Combine.

The Combine and its relationship to the NFL Draft

Held in late February and early March, the Combine is the annual scouting spectacle for NFL teams. Over seven days, NFL teams evaluate college football players who are eligible for the NFL Draft. The NFL Draft, of course, is the exclusive method of entry for players into the NFL: only players who are either drafted or who are exposed to NFL Draft and not selected are eligible to play in the NFL.

Held each April, the NFL Draft is ostensibly designed to promote parity in the NFL. For teams that fail to make the playoffs, draft order is based on inverse order of teams’ records. This means that the very worst team obtains the first overall pick and thus the chance to draft the best available player. Continue reading

JOB OPPORTUNITY: The Petrie-Flom Center is searching for a new Executive Director!

PFC Logo-New-Horizontal_slideExecutive Director

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Harvard Law School, Cambridge, MA

Learn more and apply now online!

Duties & Responsibilities

The Executive Director works in partnership with the Faculty Director on strategic planning and vision for the Center, and oversees the Center’s staff, activities, and collaborations, including sponsored research, fundraising, events and conferences, publications, programs for students, administration, finance, communications, and other programmatic activities.  S/he also engages in independent scholarly activities, including research and writing, lecturing, and occasional teaching, as appropriate.

Essential Functions

The Executive Director works with the Faculty Director and independently to build the Center and advance its public profile and impact among policymakers, academics, practitioners, and students.  Primary responsibilities include:

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TOMORROW (3/23)! The Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

17-03-23-aca-past-present-future-visixThe Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

March 23, 2017 4:00 PM

Wasserstein Hall, Milstein East
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.

Speakers

Continue reading

REGISTER NOW (4/5)! Crowdfunding Medical Care: Identifying Ethical Implications

April 5, 2017 12:30 PM 
Tosteson Medical Education Center, Room 227
Harvard Medical School, 260 Longwood Ave., Boston, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Please present a Harvard or other photo ID in order to enter the HMS campus. Register here.

Crowdfunding for medical care—seeking financial contributions from a large number of donors, often via social networks, to pay medical expenses—is growing in popularity in both the US and Canada. While the practice can have tangible benefits for some patients, it also raises challenging ethical and equity questions at the social level and for individual donors and campaigners. In this lecture, Professor Valorie Crooks will examine some of these questions, identify important directions for ethics-focused research, and discuss what we know about the medical expenses people are seeking to have covered.

Valorie Crooks, PhD, is a Full Professor and health geographer at Simon Fraser University (Canada). She holds the Canada Research Chair in Health Service Geographies and a Scholar Award from the Michael Smith Foundation for Health Research. She has authored more than 150 articles, chapters, and commentaries and leads a well funded research program that examines health care mobility and access.

Responding: I. Glenn Cohen, JDProfessor of Law, Harvard Law School, and Faculty Director, the Petrie-Flom Center.

This event is free and open to the public and lunch will be provided, but seating is limited and registration is required. A Harvard or other photo ID to enter the HMS campus. Please register here.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and theCenter for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

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

What Does It Mean to Be a Just Institution?

[Cross-posted from the Public Health Post Blog, where it originally appeared on March 17, 2017.] 

By Lauren Taylor  

The Trump administration is prompting many of us in health services to ask new questions about if, and how, to draw lines between our personal and professional endeavors. Do we sign that petition with our institutional affiliation? Do we retweet that tweet? Do we share news of that protest on the established mailing list? As someone who studies organizational ethics, these individual-level questions soon give way to a larger set of questions about the roles and responsibilities of the institutions within which we spend so much of our professional lives. In a moment in which the role of institutions appears critically important, what does it mean to be a just institution?

Recently, local leaders have shone light on this question. Over a weekend of protests in January, Harvard Business School faculty member Ariel Dora Stern (an expert in management of innovation in health care) imagined aloud about how to prioritize her academic responsibility to a journal and her social responsibilities to her community. The tweet accrued nearly two thousand retweets and replies from fellow faculty including “Isn’t that the truth?” and “I’m in the same boat.” One response asked whether the journal had issued a formal statement against an executive order, suggesting that if it had not, Professor Stern should no longer be willing to review. Continue reading

NEW EVENT (4/18)! Healing in the Wake of Community Violence: Lessons from Newtown and Beyond – Panel discussion and screening of the documentary Newtown (2016)

NEW EVENT: Healing in the Wake of Community Violence: Lessons from Newtown and Beyond imageHealing in the Wake of Community Violence: Lessons from Newtown and Beyond: Panel discussion and screening of the documentary Newtown (2016)

April 18, 2017 4:00pm screening; 5:30pm panel discussion

Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Register here.

Join us for a film screening and panel discussion on challenges that arise from tragic acts of community violence. The event will begin with a screening of Newtown, a documentary examining the impact of the mass shooting at the Sandy Hook Elementary School in December 2012. The screening will be followed by a panel of experts in health law policy, the neurobiology of trauma, and community approaches to violence in a discussion of public health, gun violence, and responses to community trauma. Discussion will highlight the issue of “healing the helpers”—the first responders, medical staff, clergy, mental health providers, and others who respond to the needs of victims, families, and communities in the wake of community violence.

Welcome

  • Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

Panelists

  • Michelle Bosquet Enlow, Assistant Professor of Psychology, Harvard Medical School and Associate in Psychology, Boston Children’s Hospital
  • Rufus J. Faulk, Program Director, Gang Mediation Initiative, Boston TenPoint Coalition
  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support, Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
  • Moderator: Ahmed Ragab, Richard T. Watson Associate Professor of Science and Religion and Director, Science, Religion, and Culture Program, Harvard Divinity School

This event is free and open to the public, but seating is limited and registration is required. Register here.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Cosponsored by William James College and the Science, Religion, and Culture Program at Harvard Divinity School.

PANEL (4/3): Opiate Regulation Policies – Balancing Pain and Addiction

Opiate Regulation Policies: Balancing Pain and Addiction 

April 3, 2017 12:00 PM

Austin Hall, West Classroom (111)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA

Description

The current opiate epidemic has spurred long-overdue scrutiny on the pharmaceutical production and distribution of opiate medication, but it also raises questions of public policy and law regarding the regulation of medical access to and use of opiate medications with high potential for addiction. Expert panelists will address the challenges that arise from efforts to balance restrictions on access to opiates to limit addiction while also preserving sufficient access for legitimate medical management of pain.

Panelists

  • Monica Bharel, MD, MPH, Commissioner, Massachusetts Department of Public Health
  • David Borsook, MD, PhD, Associate Professor in Anesthesiology, Harvard Medical School; co-director, Center for Pain and the Brain at Boston Children’s Hospital, Massachusetts General Hospital, and McLean Hospital; and affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital
  • Rita Nieves, Deputy Director, Boston Public Health Commission
  • Moderator: Amanda C. Pustilnik, JDProfessor of Law, University of Maryland Carey School of Law; affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital; and 2014-2015 Senior Fellow in Law and Applied Neuroscience as part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center

This event is free and open to the public. Lunch will be provided.

Learn More

Check out the new EdX course “The Opioid Crisis in America,” developed by faculty at Harvard Medical School, to learn more about opioid addiction, evidence-based treatment models, harm reduction approaches that law enforcement and public health officials are using to reduce opioid overdose deaths, and non-opioid alternatives for medical pain management. This online course is free and self-paced; the first session will be available online on March 27, 2017.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

THURSDAY, 3/23! The Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

17-03-23-aca-past-present-future-visixThe Affordable Care Act: Past, Present and Future: A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

March 23, 2017 4:00 PM

Wasserstein Hall, Milstein East
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.

Speakers

Continue reading

Will the Recent Workplace Wellness Bill Really Undermine Employee Health Privacy?

By Jessica L. Roberts

While the effort to repeal and replace the Affordable Care Act (ACA) has taken center stage, another health-related bill has been making its way through the House without nearly as much attention. On March 2, 2017, Representative Virginia Foxx (R-NC) introduced House Resolution (HR) 1313 on behalf of herself and Representative Tim Walberg (R-MI).   The bill would lift current legal restrictions on access to genetic and other health-related information. Specifically, HR 1313 targets provisions of the Americans with Disabilities Act (ADA) that prohibit employers from conducting unnecessary medical examinations and inquiries that do not relate to job performance; the Genetic Information Nondiscrimination Act’s (GINA) provisions proscribing employers from requesting, requiring or purchasing the genetic information of their employees; and GINA’s prohibition on group health insurance plans acquiring genetic information for underwriting purposes and prior to enrollment. The bill passed through the Committee on Education and the Workforce last Wednesday along strict party lines with 22 Republicans supporting the proposed legislation and 17 Democrats opposing it.

Despite the public outcry against the bill, HR 1313 may not be as far-reaching as it initially appears. First, while advocates of genetic privacy fear the worst, both the ADA and GINA contain exceptions for wellness programs that already allow employers to access at least some employee health data. Second, even if HR 1313 passes, employees would still enjoy the ADA’s and GINA’s antidiscrimination protections.   HR 1313 could well give employers additional access to genetic and other health-related information about their employees but it is not a license to then use that information to discriminate.

Continue reading

Manufacturers Of Biosimilar Drugs Sit Out The ‘Patent Dance’

This new post by Claire Laporte appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

Believe it or not, the Patient Protection and Affordable Care Act (Obamacare, or here, ACA) has intellectual property provisions. In addition to establishing mandates, subsidies and insurance exchanges, the ACA also created a new pathway for the approval of biosimilar drugs, which are akin to generic drugs. That pathway appears in a corner of the ACA that has its own title: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is rich with intellectual property (IP) provisions that are now the subject of litigation in the Supreme Court.

Background: Generic Drugs And Biosimilars

Many of us take generic drugs for granted, but we have them only because the Hatch-Waxman Act (1984) provided an abbreviated pathway by which FDA could approve them. Under this pathway, a generic drug could be approved based on the safety and efficacy of the branded drug, plus a showing by the generic that it was essentially identical to the branded drug. This pathway also included provisions by which generic drug manufacturers could challenge the validity of patents protecting the branded drug. […]

Read the full post here.

TOMORROW: Critical Pathways to Improved Care for Serious Illness

Close up of helpful carer hand and happy old man

Friday, March 10, 10:30am – 2:30pm

Harvard Law School, Wasserstein Hall, Milstein East BC, 1585 Massachusetts Ave.

Join leading health care executives, experts, policymakers, and other thought leaders as they embark upon a project to develop a guiding framework for providing improved care for people with serious illness. You are invited to observe the inaugural working session where distinguished panelists will discuss innovations in program design and pathways for delivering high quality care to an aging population with chronic illnesses, especially those with declining function and complex care needs.

Check out the full agenda and list of roundtable participants on the website!

Attendees are welcome to participate in Q&A sessions, and lunch will be provided. Please RSVP for lunch here.

This project is funded by the Gordon & Betty Moore Foundation, and this convening is part of the Project on Advanced Care and Health Policy, a collaboration between the Coalition to Transform Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

NEW EVENT (4/18)! Healing in the Wake of Community Violence: Lessons from Newtown and Beyond – Panel discussion and screening of the documentary Newtown (2016)

NEW EVENT: Healing in the Wake of Community Violence: Lessons from Newtown and Beyond imageHealing in the Wake of Community Violence: Lessons from Newtown and Beyond: Panel discussion and screening of the documentary Newtown (2016)

April 18, 2017 4:00pm screening; 5:30pm panel discussion

Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Register here.

Join us for a film screening and panel discussion on challenges that arise from tragic acts of community violence. The event will begin with a screening of Newtown, a documentary examining the impact of the mass shooting at the Sandy Hook Elementary School in December 2012. The screening will be followed by a panel of experts in health law policy, the neurobiology of trauma, and community approaches to violence in a discussion of public health, gun violence, and responses to community trauma. Discussion will highlight the issue of “healing the helpers”—the first responders, medical staff, clergy, mental health providers, and others who respond to the needs of victims, families, and communities in the wake of community violence.

Welcome

  • Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

Panelists

  • Michelle Bosquet Enlow, Assistant Professor of Psychology, Harvard Medical School and Associate in Psychology, Boston Children’s Hospital
  • Rufus J. Faulk, Program Director, Gang Mediation Initiative, Boston TenPoint Coalition
  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support, Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
  • Moderator: Ahmed Ragab, Richard T. Watson Associate Professor of Science and Religion and Director, Science, Religion, and Culture Program, Harvard Divinity School

This event is free and open to the public, but seating is limited and registration is required. Register here.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Cosponsored by William James College and the Science, Religion, and Culture Program at Harvard Divinity School.

Reproductive Health Under Assault

This new post by Aziza Ahmed appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

American political, social, and religious history has made abortion a deeply partisan issue. This despite the reality that many women (as well as trans and gender non-conforming individuals) from diverse racial, cultural, class, and religious backgrounds regularly access abortion-related services. The outcome of the 2016 elections has set into motion an expected but nonetheless deeply damaging anti-abortion agenda that is slowly taking form in the Trump administration’s early days — aided by the Republican majority House and Senate. These early moves signal that the new administration aims to roll back gains made toward reproductive justice in 2016.

The attack on abortion rights and, in turn, reproductive justice, by this administration is no surprise. The GOP Platform released during the elections makes many references to defunding or restricting abortion services. The document specifically attacks key victories for reproductive health including the 2016 Whole Woman’s Health v. Hellerstedt Supreme Court decision overturning key provisions of the 2013 Texas House Bill 2. The law required that doctors who provide abortion services must obtain admitting privileges at local hospitals no farther than 30 miles away from the clinic, and abortion providers comply with guidelines to become Ambulatory Surgical Centers. The Supreme Court found the regulations to be unconstitutional because they result in substantial obstacles in the path of women seeking pre-viability abortions — contrary to the claim made by the Texas Department of State Health Services that the laws make abortions safer. […]

Read the full post here.

NEW EVENT (3/23)! The Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

17-03-23-aca-past-present-future-visixThe Affordable Care Act: Past, Present and Future: A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

March 23, 2017 4:00 PM

Wasserstein Hall, Milstein East
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.

Speakers

Continue reading

The Balancing Act Between Mental Illness and Gun Rights

Editor’s Note: This is an update of the post “Second Amendment Rights and Mental Illness,” originally published on September 1, 2015. 

By Mariam Ahmed, JD/MSPP

In September 2015, we offered a glimpse of the current landscape of laws addressing mental health and gun violence. Many of the laws addressed public safety concerns that arose from active shooters with mental illnesses. At both the state and federal levels, government officials continue to debate the relationship between gun violence and mental health issues. Questions of safety and stigma continue to be asked, and are leading to changes in the laws. Here’s where we stand now:

In July 2015, Congress introduced the Safer Communities Act of 2015, but after being passed around four different committees, it was never released to the House floor for a vote. If the bill had passed, it would have further clarified who is restricted from possessing a gun based on their mental health and treatment.

After the bill died in committee, agencies such as the Department of Health and Human Services (HHS) and the Social Security Administration (SSA) have passed regulations to further define reporting and restriction requirements for people with mental illnesses. On January 4, 2016, HHS finalized a rule that modified the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The modification allows HIPAA-covered entities to release personal information to the National Instant Criminal Background Check System (NICS) if the person has a “mental health prohibitor” on their record that limits ability to possess, transport, receive, or ship a firearm under federal law. The rule went into effect on February 5, 2016. Continue reading

All-Payer Claims Databases After Gobeille

This new post by Gregory Curfman appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

With health care spending approaching 20 percent of Gross Domestic Product (GDP), controlling health care costs is a top priority not only for the federal government, but also the individual states. To develop successful strategies for cost control, states need comprehensive data on utilization of and spending on health care services. Medicare data are valuable but not representative of the entire national population or of the prices that private payers pay. In private insurance, prices are not under administrative control as they are in Medicare, and they vary widely in different geographic regions.

All-payer claims databases (APCDs) were developed, first in Maryland in 1995, to provide comprehensive state-level data on health-care utilization and spending, and there are now 16 APCDs nationwide. As the name implies, APCDs collect data from all payers, and the spending data reflect the actual negotiated prices of services. Thus, APCDs are a valuable source of information for state health policymakers and health services researchers. For example, in Massachusetts, the Health Policy Commission uses the state’s APCD to set state-wide health care spending targets, which have been important in achieving state cost control. […]

Read the full post here!

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

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 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.

Continue reading