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

Continue reading

Happy Thanksgiving, Bill of Health Readers

Obama_ThanksGiving_Turkey_Pardon_2009Happy Thanksgiving! Today, we want to give a big thank you to our loyal readers, dedicated bloggers, and excellent commenters. You’ve helped make Bill of Health a tremendous success, and we look forward to continuing to bring you excellent commentary and analysis on all things related to health law policy, biotechnology, and bioethics.

Enjoy the holiday with family and friends!

Introducing NPRM Symposium Blogger Govind Persad

GPersad 8-23-12Govind Persad will contribute to Bill of Health’s symposium on the 2015 notice of proposed rulemaking (NPRM) on human subjects regulations.

Govind is a postdoctoral fellow at Georgetown University and will be an Assistant Professor (beginning 2016) in the Department of Health Policy and Management and Berman Center for Bioethics at Johns Hopkins University. His research is at the intersection of political philosophy, applied ethics, and health law.

Govind has been a visiting scholar at the Department of Medical Ethics and Health Policy at the University of Pennsylvania. He holds a JD/PhD from Stanford, where he was a student fellow at Stanford’s Center on Law and Biosciences; he was a pre-doctoral fellow at the Department of Bioethics, National Institutes of Health.

Representative publications:

Fixing the Broken Law of Military Medical Malpractice for Birth-Related Injuries

Bill of Health bloggers Alex Stein and Dov Fox have just filed an amicus brief urging the Supreme Court to hear the case of U.S. Air Force Major Heather Ortiz and her baby, who were denied legal remedies for obstetric malpractice by military doctors that left the baby with severe brain damage. The case is No. 15-488 Ortiz v. U.S. ex rel. Evans Army Community Hospital. Professors Fox and Stein urge the Court to overturn the Tenth Circuit’s holding that the federal government’s immunity against liability for intramilitary torts extends to wrongful injuries like those sustained by Major Ortiz’s baby. They argue that this holding misinterprets the immunity, misapplies the Federal Tort Claims Act (FTCA), and constitutes no less than unconstitutional sex discrimination. Fox and Stein explain:

When a civilian spouse of a serviceman receives negligent prenatal care from military doctors and delivers an injured baby as a result of that malpractice, there is no question that Feres immunity does not apply and that the baby can sue the United States under the FTCA. When military medical malpractice injures the baby of a servicewoman, this baby should be equally able to obtain redress under the FTCA.  A system that would single out the civilian children of servicewomen for adverse treatment discriminates against women who serve in the armed forces. . . To interpret the FTCA as the Tenth Circuit did permits discrimination between these two classes of similarly situated victims of military malpractice and violates fundamental principles of equal protection.

To download this brief, click here.

Changes in seasons, changes for children: Developments at the intersection of behavioral science, developmental neuroscience, and juvenile justice

By Robert Kinscherff

It is fitting that I am writing this first blog of my time as Senior Fellow in Law and Applied Neuroscience as we transition through the change of seasons.  It is a privilege to have the time afforded by this joint Fellowship between Harvard Law School (Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics) and Massachusetts General Hospital (Center for Law, Brain, and Behavior) to focus upon the intersections of behavioral science, developmental neuroscience, and juvenile justice.  The autumnal change of seasons is a fitting metaphor for the slow but profound changes occurring in juvenile justice which have been spurred in large measure by emerging neuroscience increasingly describing the neurobiology of adolescence.  This neuroscience provides the biological complement to what developmental psychologists have well described and what parents have long known:  Children are different.

This emerging neuroscience has become a quiet but increasingly pervasive force in helping us understand why most delinquent youth desist with maturation—even adolescents who are chronically delinquent and violent.  It helps us understand why punitive “tough on teen crime” approaches born of fears in the 1990’s of the rise of violent teen “super-predators” actually compromises public safety over time—especially when youth are tried as adults and incarcerated with adults.  And, it helps us understand why mass detention and incarceration of youth—many of them for non-violent offenses—not only harms those youth but tends to increase their risks of continued misconduct and of later deep penetration into the adult criminal justice system. Continue reading

The Common Rule NPRM: Biospecimens

By: Academic and Clinical Research Group at Verrill Dana LLP

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

As we previously announced, sixteen federal agencies, including the Department of Health and Human Services (“HHS”), recently published a Notice of Proposed Rulemaking (“NPRM”) in the Federal Register outlining changes to the existing regulations protecting human subjects (the “Common Rule”).  The Common Rule NPRM is the latest development since the Advanced Notice of Proposed Rulemaking (“ANPRM”) was published on July 26, 2011.  The Academic and Clinical Research Group (“ACRG”) will be publishing a series of topic-specific blogs in the coming weeks to assist institutions in digesting various aspects of the proposed regulations, preparing to submit any comments by the December 7, 2015 deadline, and grappling with implementation changes once the final rule issues.  We have also prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed revisions.

In this installment, we discuss the NPRM’s proposed changes to biospecimens research.  The NPRM did not back down from one of the more controversial aspects of the ANPRM, proposing a fundamental shift in the applicability of the human subjects protection framework to non-identified biospecimens research.  However, once the shock of the new definition of “human subject” wears off, the reality is that most of the changes codify how the research community has tried to apply the existing Common Rule to the challenging arena of biobanking, secondary research, and genomic and other “omics” research.  That said, many of the carve-outs (i.e., exclusions and exemptions) intended to balance this shift are more restrictive than at first they seem.

ACRG Rapid Rundown:  Six Things You Need to Know Continue reading

Lecture Tomorrow, 11/10! Euthanasia in Belgium: The most recent legal developments and policy challenges

Euthanasia in Belgium: The most recent legal developments and policy challenges
November 10, 2015 11:00 AM – 12:15 PM

Conference Room, 1st floor
Center for Bioethics at Harvard Medical School
641 Huntington Ave., Boston, MA [Map]

A lecture by Sigrid Sterckx, Professor of Ethics and Political and Social Philosophy, Ghent University, Belgium; End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium; Bioethics Institute Ghent, Ghent University, Belgium.

In 2002, euthanasia by a physician (the intentional termination of a patient’s life at his or her request) was depenalized in Belgium for adults and emancipated minors. In 2014, the law was extended to competent minors, without an age limit. The frequency of performance of euthanasia is rising very rapidly, having more than doubled in the last five years (accounting for one death in twenty, about 8 per day in Flanders, the Dutch-speaking region). Moreover, although the prevalence of euthanasia remains highest in patients with cancer, a clear shift is visible in the characteristics of patients who request euthanasia and whose requests are granted. The largest increases are among women, and those aged 80 or older, with lower education levels, and those dying in nursing homes. Continue reading

REGISTER NOW! Specimen Science: Ethics and Policy Implications Symposium, with NEW Lunchtime Talk on “Biospecimens and the NPRM”

testtube_hand_bw_slideSpecimen Science: Ethics and Policy Implications
NEW Lunchtime Talk on “Biospecimens & the NPRM”
Monday,  November 16, 2015, 8:30 AM – 5:00 PM
8:30am-12:40pm: Austin Hall North (100);
12:40-5:30pm, Langdell Hall South, Room 272

Harvard Law School, Cambridge, MA [Map]

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data.   However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others.  Conference papers eventually will be published as an edited volume with a major academic press.


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Introducing Blogger Robert Kinscherff


The Petrie-Flom Center is pleased to welcome Robert Kinscherff, PhD, JD to the Bill of Health as our newest contributor!

Robert Kinscherff is the 2015-2016 Senior Fellow in Law and Neuroscience at 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. Dr. Kinscherff is a forensic and clinical psychologist and an attorney who has been on the faculty at William James College since 1999, where he is Associate Vice President for Community Engagement with oversight of key clinical service-providing programs. He is also Teaching Faculty in the Doctoral Clinical Psychology Program and for the Doctoral School Psychology Program at William James College, Faculty at the Center for Law, Brain and Behavior, and Senior Associate for the National Center for Mental Health and Juvenile Justice. He is a member of the Massachusetts legislative Special Commission on Sexual Offender Recidivism and designee member for the Administrative Office of the Juvenile Court for the legislative Committee to Develop an Evaluation Process in Cases of Homicide by Juveniles. Kinscherff has previously served as Assistant Commissioner for Forensic Mental Health (MA Department of Mental Health), Director of Juvenile Court Clinic Services (MA Trial Court), and Director of Adult Forensic Services (Psychiatry and Law Program, MGH). For over a decade, he taught classes at the intersection of law and psychology at Boston University Law School. For the American Psychological Association, he is a current member of the Board of Professional Affairs, and has served as Chair of the APA Gun Violence Policy Review Task Force, a past two-term Chair of the Ethics Committee (EC), Chair of the Committee on Legal Issues (COLI) and Member of the Committee on Professional Practices and Standards (COPPS). His research and professional practice areas include legal, ethical, and professional practice issues in clinical and forensic mental health practice, violence risk assessment and management, juvenile homicide, aggressive and sexually problematic behaviors among youth and adults with developmental or mental disorders, and severe and unusual forms of child maltreatment. His many publications include the co-authored book APA Ethics Code: Commentary and Case Illustrations (Washington, DC: American Psychological Association Press, 2009) and more recent publications on topics including mental health practice in juvenile justice contexts, special ethical and practice considerations in work with juvenile and violent offenders, and international human rights law implications for forensic psychologists of the 2012 US Supreme Court case of Miller v. Alabama regarding mandatory life imprisonment without possibility of parole for offenses committed as a juvenile.

TOMORROW, 11/4! Reflections in Honor of the Life and Influence of Professor Alan Wertheimer

Wertheimer_teaching_slideReflections in Honor of the Life and Influence of Professor Alan Wertheimer
November 4, 2015, 1:00 – 5:30 PM
Wasserstein Hall, Milstein West B (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

Please join us for an afternoon of reflection on the life, work, and enduring influence of Professor Alan Wertheimer (1942-2015). Professor Wertheimer was a leading philosopher of law and bioethics, making critical contributions to clinical research ethics; theories of coercion, undue influence, and exploitation; consent in a variety of contexts, and much more. This tribute event will feature leading scholars discussing and engaging with Professor Wertheimer’s many contributions, and exploring how he influenced their own work.

At the time of his death in 2015, Alan Wertheimer was Senior Research Scholar in the Department of Bioethics at the National Institutes of Health. Continue reading

Lunch Talk & Book Launch Tomorrow, 10/28: FDA in the 21st Century

lync17118_frontBook Launch: FDA in the 21st Century
October 28, 2015 12:00 PM
Wasserstein Hall, Milstein East C
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

In September 2015, Columbia University Press published FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen. This edited volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This event will provide a discussion of the book, including questions like: How is the agency faring in the 21st century? What are the greatest challenges to the FDA’s success, and what does success look like? What lessons has it learned and how can it best meet the challenges of today? Should we keep the agency we have, pull it apart, or rebuild from scratch?

Panelists: Continue reading

China to Reform Review and Approval Process for Drugs and Medical Devices

China’s Standing Committee of the National People’s Congress (NPC), the country’s legislature, will hold a meeting from October 30 to November 4 to review the authorization of the State Council, the central government, to carry out a pilot program that will introduce market authorization holder of drug (MAH) system and reform the drug registration system. On August 9, the State Council issued the Opinions on Reforming Review and Approval Process for Drugs and Medical Devices (RAP Opinions). Since several key reform measures initiated by the RAP Opinions involve amendments to China’s Drug Administration Law, the State Council must receive the authorization of the NPC. If the authorization is approved by the NPC, the reform of China’s RAP will be accelerated.

The direct pressure for reform comes from the very serious backlog for RAP in China. As of August, there was a backlog of 21,000 applications, and large backlogs have appeared repeatedly in the past decade. For example, there was a backlog of 17,000 in 2005 and a backlog of 27,000 in 2008. These backlogs attract more and more criticism, both from companies and patients. Patients, unable to benefit from a new drug, especially those made by foreign companies and that have proven successful and effective in other territories, have suffered. Some patients have to either rely on  smuggled drugs or conduct expensive medical tourism. Now, the State Council seems determined to reform the broken RAP system completely, with the following key reforms:

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Introducing New Blogger Peng Zhao

Zhao_peopleThe Petrie-Flom Center is pleased to welcome Visiting Scholar Peng Zhao to the Bill of Health as our newest contributor, who will blog primarily about China’s drug and food law and regulatory policy.

Peng Zhao earned his BA (2003), MA (2009), and PhD (2009) in law from the China University of Political Science and Law (CUPL, Beijing). He serves as associate professor of law and vice director of the Center for Government Reform and Development at CUPL. Peng’s research and teaching interests include food law, administrative law, and risk regulation theory. He has authored more than a dozen articles on food law and risk regulation theory, and is now presiding over two research projects sponsored by the Chinese central government on these two fields. Peng is a director and member of the Chinese Association of Administrative Law, and deputy secretary general of a committee affiliated with this organization which focuses on legal issues on governmental regulation. Peng has also participated actively in professional service activities. He had served as member of an expert commission for the National Health and Family Planning Commission on amendments to Chinese Food Safety Law, and currently is serving as advisor to the Ministry of Science and Technology on amendments to Chinese regulation of laboratory animal management. In addition, Peng was recently recognized by CUPL students as one of the Top Ten Popular Teachers at CUPL from 2013 to 2015.  Continue reading

Introducing the Harvard Health Law Society

10689774_809751895714130_4010610321675415773_nThe Harvard Health Law Society (HHLS) is a student organization at Harvard Law School, dedicated to exploring issues at the intersection of health and law while connecting students and experts for active engagement. It is made up of students at Harvard Law, as well as other Harvard students, interested in health policy, health care law, biotechnology, bioethics, health and human rights, and a range of other health and law topics.

We are excited to announce that, as part of an ongoing collaboration with the Petrie-Flom Center, members of the Health Law Society will be contributing bloggers this year. Our first two bloggers will be:

Matt Ryan photo_HLS

Matthew Ryan

HLS Class of 2017



HHLS Blogger Goerge Maliha

George Maliha

HLS Class of 2018



Welcome to Bill of Health, HHLS!

EVENT (11/12-13): The New Health Care Industry – Integration, Consolidation, Competition in the Wake of the Affordable Care Act

SolomonConfLogoThe New Health Care Industry: Integration, Consolidation, Competition in the Wake of the Affordable Care Act

Thursday, November 12 Center Launch, Celebratory Reception with speaker Kathleen Sebelius — former Secretary, Health and Human Services 4:00–6:30pm
Friday, November 13 Inaugural Conference 8:30am–5:00pm
Attendance to both events it free, but registration is required.

This conference marks the launch of the new Solomon Center for Health Policy and Law at Yale Law School. The Solomon Center is the first of its kind to focus on the governance, business, and practice of health care in the United States. This conference will mark the first under the Center, which will focus on bringing together leading experts and practitioners from the public and private sectors to address cutting-edge questions of health law and policy. Continue reading

Seeking Applicants! Executive Director, Solomon Center for Health Law and Policy at Yale Law School

Sterling_Law_Building,_YaleSolomon Center for Health Law and Policy at Yale Law School: Executive Director

The Yale Law School is delighted to announce the launch of the Solomon Center for Health Law and Policy, an exciting new Center at Yale Law School dedicated to training the next generation of health law leaders—academics, CEOS, lawyers, and government officials—and having an impact today on the most important health care issues.

The Solomon Center is seeking applications for the position of Executive Director. The Solomon Center coordinates a diverse program of activities that serve students and scholars at Yale and contribute both locally and internationally to the study of health law—with a particular focus on health governance, industry and the practice of medicine. Continue reading

Pre-Approval Access Symposium: Can Compassion, Business, and Medicine Coexist?

Dates: October 28 – 29, 2015
Location: The New York Academy of Sciences, 7 World Trade Center, NYC
Presented by: NYU School of Medicine and the New York Academy of Sciences
Event URL:

Explore challenges surrounding pre-approval access to investigational medicines through a series of debates featuring prominent representatives of governments, pharmaceutical companies, patient groups, NGOs, and foundations in this two-day colloquium.

Agenda topics include:

  • Perspectives from Patient Advocates on Compassionate Use and Expanded Access
  • The Case of Josh Hardy and Social Media’s Impact
  • Lessons Learned from the Ebola Virus Epidemic on Compassionate Use during a Crisis
  • Key Issues from Stakeholders’ Perspectives When Considering a Compassionate Use Request
  • Legislative or Regulatory Changes on Compassionate Use and Expanded Access

Continue reading