Petrie-Flom seeks Harvard student RA for project on human subjects research

The PFC Logo-New-Horizontal_slidePetrie-Flom Center for Health Law and Policy, Biotechnology, and Bioethics seeks a part-time research assistant for a project with Harvard Catalyst (Harvard Clinical and Translational Science Center) on challenges and innovation in human subjects research, addressing such issues as the regulatory and ethical aspects of research using electronic and online mediums, payment of research participants, models of community engagement and patient-centered research, and participant comprehension in informed consent. The work will initially involve 6-8 hours per week for 3 months. Applicants who have completed at least one year of a graduate program in law, health policy, or a related field are particularly encouraged to apply. Please contact Luke Gelinas, PhD, lgelinas@law.harvard.edu.

NEXT MONTH (10/24): Health Care after the Election

presidential_nominees_slideHealth Care after the Election
October 24, 2016 12:00 PM
Wasserstein Hall, Milstein West AB (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Description

As we approach the 2016 presidential election and change of administration, there are many questions about the future of health policy that the 45th President and Congress will have to address starting in 2017. This event brings together health care experts from both sides of the aisle to discuss what health care will – and should – look like under the next administration.

Possible topics for discussion include:

  • The Affordable Care Act
  • Drug pricing
  • Delivery system reform
  • Innovation and research funding/NIH
  • Mental health
  • Public health

Continue reading

Social Media Use in Research Recruitment: A New Guidance Document from Petrie-Flom and Harvard Catalyst

stethoscope_computerImagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition. Unfortunately, you are struggling to locate and enroll enough eligible participants and your study is at risk of not completing. Then you discover a Facebook support group for precisely the condition you are studying. The group is open: you do not need to be invited or to suffer from the condition to become a member—anyone can join. Here are the eligible participants you have been looking for!

But what are your obligations in approaching members of this group for recruitment? Would such recruitment be ethically advisable? Under what conditions? And what ethical norms apply when approaching sick and potentially vulnerable people for recruitment over social media? How should you (and the IRB) evaluate this type of activity from an ethical perspective?

Continue reading

Monday, 9/19, HLS Health Law Workshop with Amy Sepinwall

September 19, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “The Challenges of Conscience in a World of Compromise”

Amy Sepinwall is Assistant Professor of Legal Studies and Business Ethics and James G. Campbell, Jr. Memorial Term Assistant Professor of Legal Studies and Business Ethics at the Wharton School at the University of Pennsylvania. Her research interests include individual and collective responsibility for corporate and financial wrongdoing, corporate constitutional rights, and gender and racial justice. Prior to joining the faculty at the Wharton School, she clerked for the Honorable Louis H. Pollak, Eastern District of Pennsylvania.

Sepinwall earned her PhD from Georgetown University and her JD from Yale Law School. She also holds MA and BA degrees from McGill University. From 2007 – 2008, she held a Charlotte Newcombe Dissertation Fellowship at the Woodrow Wilson Foundation.

Monday, 9/12, HLS Health Law Workshop with Patricia Zettler

September 12, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: Pharmaceutical Federalism

Patricia J. Zettler is associate professor of law at Georgia State University College of Law. She has expertise in the regulation of medicine, biotechnology and biomedical research, with an emphasis on the U.S. Food and Drug Administration. Her research focuses on the interaction between state and federal regulation of medicine and science, the challenges that innovation poses for the FDA’s regulatory scheme, and the treatment use of experimental drugs and devices outside of clinical trials. Zettler’s scholarship has appeared or is forthcoming in various legal and medical journals, including the Indiana Law Journal, San Diego Law Review, Yale Journal of Health Policy Law and Ethics, Journal of Law and the Biosciences, Boston University International Law Journal, JAMA Internal Medicine, EMBO Molecular Medicine, and Academic Medicine. Zettler teaches Torts, Health Law: Quality & Access, and Food and Drug Law.

Before joining Georgia State Law in 2015, she was a fellow at the Center for Law and the Biosciences at Stanford Law School. Prior to her fellowship, she served as an associate chief counsel in the FDA’s Office of Chief Counsel, where she advised the FDA and the Department of Health and Human Services on various issues including drug safety, human subjects protection, expanded access to investigational drugs, over-the-counter drugs, dietary supplements, prescription drug advertising and promotion, incentives for developing antibiotics and advisory committees. Continue reading

REGISTER NOW (11/7): The Ethics of Early Embryo Research & the Future of the 14-Day Rule

egg cells flowing in a blue background

The Ethics of Early Embryo Research & the Future of the 14-Day Rule
November 7, 2016 3:00 – 6:00 PM
Austin Hall, North Classroom (100)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA
 

Description

For over 35 years, the “14-Day Rule,” prohibiting in vitro experimentation on embryos beyond 14 days, has stood as an ethical line in the sand for embryo research around the world. Throughout the arc of the rule’s existence it has not been questioned, as scientists have been unable to grow embryos in vitro either up to, or beyond, 14 days; a practical limitation that served as a backstop to the ethical rule. However, in May of this year, labs in the U.S. and the U.K. were the first to report being able to sustain human embryos in vitro for up to 13 days. This development and other advances in in vitro research involving organized, embryo-like cellular structures have raised a number of questions about the rule, its genesis, application, and future scope. This conference will convene experts in bioethics, stem cell research, embryology, and law to discuss the ethical underpinnings and future scope of the rule. Questions to be discussed include:

  • What are the historical, ethical and scientific rationales for establishing the 14-Day Rule?
  • Should the 14-Day Rule be revisited in light of recent advances?
  • Should the 14-Day Rule even apply to research involving the in vitro culture of embryo-like cellular structures?

Tentative Agenda Continue reading

Introducing the 2016-2017 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2016-2017 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.

Sean Finan PhotoSeán Finan is an LLM candidate from Ireland at the Harvard Law School. He recently graduated from the LLB programme at Trinity College, Dublin, where he served as a Senior Editor of the Trinity College Law Review. His research interests include the ethical implications of emerging biotechnologies. For his Fellowship project, he intends to investigate the use of morality tests on patent applications as a means of indirect regulation of research.

Wendy Salkin Square HeadshotWendy Salkin is a Ph.D. candidate in the Department of Philosophy at Harvard University. Her primary research is in political philosophy, moral philosophy, social philosophy, and philosophy of law. She also works on questions in feminist philosophy and bioethics. She is writing a dissertation on informal political representation under the supervision of Tommie Shelby, T.M. Scanlon, Richard Moran, and Eric Beerbohm. She holds a J.D. from Stanford Law School and a B.A. in Philosophy and Africana Studies from New York University. For her Fellowship project, she will examine new directions in the debate over lifespan extension.

Segal photoBrad Segal is currently a medical student at Harvard Medical School where he is enrolled in a dual MD/Master of Bioethics degree program. Brad received his BA and BS from UC San Diego where he double majored in Philosophy and Physiology/Neuroscience. In his first year at HMS Brad’s paper on the ethics of organ transplantation was awarded the Henry K. Beecher Prize in Medical Ethics. He has also studied the ethical implications of our evolving understanding of the brain, and has published on whether and when individual genetics and neurobiology should mitigate a criminal defendant’s moral culpability. During his Fellowship he will be studying what ‘harm’ means in the medical context.

Thomas Shailin PhotoShailin Thomas is a second year law student in a joint MD/JD program between Harvard Law School and the New York University School of Medicine. He received a B.S. from Yale University, where he studied cognitive neuroscience — exploring the anatomy and physiology behind social phenomena. His interests lie at the intersection of clinical medicine and the legal forces that shape it. Prior to law school, Shailin worked on both the administrative and clinical sides of health care, and as a research associate at the Berkman Center for Internet & Society. He is currently an affiliate of the Berkman Center and Outreach Editor for the Harvard Journal of Law & Technology. A fervent proponent of privacy and freedom of expression, Shailin has also served on the Board of Directors of the American Civil Liberties Union of Connecticut. For his Fellowship project, he will focus on a tort solution for faulty eyewitness testimony procedures.

Matthew Young HeadshotMatthew H. H. Young is a fourth-year MD candidate at Harvard Medical School and a second-year JD candidate at Harvard Law School. He graduated with honors from Harvard College with a major in Government and a minor in Global Health & Health Policy. He is interested in healthcare system safety, quality, and outcomes, and serves as the Director of Medical-Legal Affairs for the Institute for Patient Safety and Outcomes (IPSO). For his Fellowship project, he plans to develop a patient-centered checklist to improve perioperative safety, quality, and outcomes, and discuss the checklist’s implications.

NEXT WEEK (9/7): Battling Blood in the Streets Neuroscience Panel, followed by PFC Open House

2016.09.07_battling_blood_for_printBattling Blood in the Streets: How Can Neuroscience Promote Public Health and Support Public Policy to Prevent Community Violence?
September 7, 2016 4:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

 

 

IMMEDIATELY FOLLOWED BY:

15.09.07, 2016 Open House Visix2016 Petrie-Flom Center Annual Open House
September 7, 2016 5:30 PM
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

 

 

Battling Blood in the Streets: How Can Neuroscience Promote Public Health and Support Public Policy to Prevent Community Violence?
Far too many people across the country are left dead, injured, or traumatized by community violence. Communities can be safer when neuroscience, public health strategies, and collective advocacy are aligned in practice and policy. What are the best next steps to fostering a broad science-informed advocacy movement to effectively address community violence? Continue reading

CALL FOR ABSTRACTS! 2017 Annual Conference, “Transparency in Health & Health Care: Legal & Ethical Possibilities & Limits”

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading

DUE AUGUST 5: Call for Apps – Petrie-Flom Center Harvard Grad Student Fellowship

THE PETRIE-FLOM CENTER

STUDENT FELLOWSHIP PROGRAM, 2016-2017

CALL FOR APPLICATIONS 

The Center and Student Fellowship. The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support closely-mentored student research in these areas. For more information on our recent fellows and their work, see our website.

Eligibility. The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.

Requirements. All student fellows will have the following responsibilities: Continue reading

New Resource: BPCIA Legislative History Documents

The Petrie-Flom Center is pleased to announce the availability of a new resource on its website: the legislative history of the Biologics Price Competition and Innovation Act (BPCIA).  The BPCIA, passed as part of the Affordable Care Act (ACA), created a pathway for the approval of biosimilar products and awarded innovator biologic companies twelve years of exclusivity for their products.  Modeled after the Hatch-Waxman Act of 1984, which established our system of generic small-molecule drug approvals while simultaneously creating a five-year period of exclusivity for new drugs, consideration of the BPCIA’s history is often lost in the discussion over the ACA’s history as a whole.  This resource selects only those documents relating to the BPCIA and may thus prove particularly useful for scholars of FDA law.

This new resource comes at an opportune time, as the courts and Congress have both turned their focus to the provisions of the BPCIA.  In 2015, the Federal Circuit issued a divided opinion interpreting the BPCIA’s instructions to biosimilar and innovator drug sponsors, and that opinion has now been appealed to the Supreme Court.  Just last month, the Justices called for the views of the Solicitor General on this question, a step which may significantly increase the likelihood of an eventual cert grant.  At the same time, several members of Congress have introduced a bill that would decrease the BPCIA’s grant of exclusivity from twelve years to seven years, bringing it more in line with the five-year period in the Hatch-Waxman Act or seven-year period in the Orphan Drug Act.  The twelve-year period of exclusivity may have been the most contentious aspect of the BPCIA as passed, with even the FTC arguing strongly against such a lengthy period at the time.

Members of the public may also be interested in an article written by Professor Erika Lietzan and colleagues providing an excellent analysis of the BPCIA’s legislative history.

Introducing our 2016 Summer Student Bloggers

The Petrie-Flom Center is pleased to welcome Kelly Dhru and Shailin Thomas to Bill of Health as our 2016 Summer Student Bloggers!

Kelly Dhru - photo1 (2)Kelly Amal Dhru is an incoming LLM student at the Harvard Law School, and a 2016-17 Fulbright-Nehru Master’s Fellow in Public Health Law and Bioethics from India. Previously, Kelly has completed her BCL (Distinction) and MPhil in Law from University College, University of Oxford, where thesis focused on the gap between rights and duties in the context of laws preventing cruelty to animals. Kelly holds a law degree from Gujarat National Law University, and has been the Research Director at Research Foundation for Governance in India, where she has been involved in drafting laws relating to public health, bioethics and human rights. Kelly has been a research assistant for Public Health Law at King’s College London, taught the Law of Tort, Jurisprudence and Bioethics at the University of Oxford, and Ethics and Philosophy at Ahmedabad University in India. She is a co-founder and storywriter for Lawtoons: a comic series on laws and rights, and been involved spreading awareness about public health and human rights through the use of street theatre.

Thomas Shailin PhotoShailin Thomas is a second year law student in a joint MD/JD program between Harvard Law School and the New York University School of Medicine.  He received a B.S. from Yale University, where he studied cognitive neuroscience — exploring the anatomy and physiology underlying social phenomena.  His interests lie at the intersection of clinical medicine and the legal forces that shape it.  Prior to law school, Shailin worked on both the administrative and clinical sides of health care, and as a research associate at the Berkman Center for Internet & Society.  He is currently an affiliate of the Berkman Center and Outreach Editor for the Harvard Journal of Law & Technology.  A fervent proponent of privacy and freedom of expression, Shailin has also served on the Board of Directors of the American Civil Liberties Union of Connecticut.

Harvard Grad Students Apply Now! Petrie-Flom Center Student Fellowship, 2016-2017

PFC_Logo_300x300The Center and Student Fellowship: The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas. More information on our current fellows and their work, is available on the Center’s website.

Eligibility: The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.

Resources: The Center will award each fellow a $1,500 stipend, paid at the end of the academic year once all fellowship requirements (including submission of an acceptable paper) are completed. Additionally, fellows may be eligible to request additional funding to cover reasonable costs associated with their research projects (e.g., copying, publications, conference fees, travel).

Application: Applications will be accepted on a rolling basis until 9AM, Friday, August 5, 2016. Notifications of awards will be made by August 19, 2016.

Apply now! View the full requirements and application instructions on our website: http://petrieflom.law.harvard.edu/fellows/student-application.

REGISTER NOW! Aligning Policy and People: Why the Time is Right to Transform Advanced Care

hands_Ingram Publishing_slideJune 21, 2016, 9am – 1pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

This event is free and open to the public, but seating is limited. Register now!

Description

Please join us for the inaugural event of the Project on Advanced Care and Health Policy, a collaboration between the Coalition for Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. This conference will feature policymakers, thought leaders, family caregivers, clinicians, consumer advocates, and others working to identify the timely, practical, and actionable opportunities to transform care for people with advanced illness nearing end-of-life.

Confirmed Speakers

Continue reading

Making Big Data Inclusive

Guest post by Sarah Elizabeth Malanga, Fellow, Regulatory Science Program, James E. Rogers College of Law, University of Arizona, based on her presentation at the Petrie-Flom Center’s 2016 Annual Conference, “Big Data, Health Law, and Bioethics,” held on May 6, 2016, at Harvard Law School.

Cross-posted from the Hastings Center’s Bioethics Forum.

Big Data, which is derived from a multitude of sources including, social media, “wearables,” electronic health records, and health insurances claims, is increasingly being used in health care and it can potentially improve the way medical professionals diagnose and treat illnesses.

But what happens when Big Data only captures a snapshot of the population, rather than an overall picture of the population as a whole? The sources that generate Big Data – the Internet and credit card use, electronic health records, health insurance claims – are not utilized by everyone. Certain demographics may be missing from or underrepresented in Big Data because they do not own smartphones, have access to the Internet, or visit doctors on a regular basis because they lack health insurance. These sectors of the population disproportionately include low-income individuals, minority groups such as blacks and Hispanics, and the elderly. Continue reading

REGISTER NOW: Aligning Policy and People: Why the Time is Right to Transform Advanced Care

hands_Ingram Publishing_slideJune 21, 2016, 9am – 1pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

This event is free and open to the public, but seating is limited. Register now!

Description

Please join us for the inaugural event of the Project on Advanced Care and Health Policy, a collaboration between the Coalition for Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. This conference will feature policymakers, thought leaders, family caregivers, clinicians, consumer advocates, and others working to identify the timely, practical, and actionable opportunities to transform care for people with advanced illness nearing end-of-life.

Confirmed Speakers

Continue reading

REGISTER NOW! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

2016 Annual Conference:
Big Data, Health Law, and Bioethics
May 6, 2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data).

Defined as such, health care has become one of the key emerging use cases for big data. For example, Fitbit and Apple’s ResearchKit can provide researchers access to vast stores of biometric data on users from which to test hypotheses on nutrition, fitness, disease progression, treatment success, and the like. The Centers for Medicare & Medicaid Services (CMS) have vast stores of billing data that can be mined to promote high value care and prevent fraud; the same is true of private health insurers.  And hospitals have attempted to reduce re-admission rates by targeting patients that predictive algorithms indicate are at highest risk based on analysis of available data collected from existing patient records. Continue reading