The Presidential Commission for the Study of Bioethical Issues recently published a “Request for Comments on Issues Related to Incidental Findings That Arise in the Clinical, Research, and Direct-To-Consumer Contexts.” In this publication, the Bioethics Commission requests public comment on “the ethical, legal, and social issues raised by incidental findings that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research, and direct-to-consumer contexts.” You can read the full “Request for Comments,” which includes instructions on how to submit comments, online here.
Public Health Law Research has released its fifth call for proposals on studies that focus on the effects of laws and policies on public health.
The new call for proposals is available online: www.rwjf.org/cfp/phlr5
The deadline for submitting proposals is July 24, 2013 at 3 p.m. ET.
As much as $1 million is available in this round of funding for short-term studies. Studies up to 18 months long will be funded at up to $150,000 each.
While PHLR funds studies that mainly focus on the intersection between law and public health, researchers from other disciplines, such as medicine, economics, sociology, psychology, and public policy and administration are encouraged to be part of multi-disciplinary teams of applicants.
PHLR’s previous four calls for proposals were issued in 2009, 2010, 2011, and 2012. Fifty-one studies have been funded to date, addressing a wide range of legal and public health issues, including: the impact of lead laws on public health; effective legal decision-making during public health emergencies; issues related to the public health infrastructure at the state and local levels; the impact of laws on distracted driving and teen driver injury and mortality rates; and many more.
A conference call for applicants will be held June 18, 2013. Applicants are required to register through the RWJF website: www.rwjf.org/cfp/phlr5.
Over the course of the last fifteen or so years, the belief that “de-identification” of personally identifiable information preserves the anonymity of those individuals has been repeatedly called up short by scholars and journalists. It would be difficult to overstate the importance, for privacy law and policy, of the early work of “re-identification scholars,” as I’ll call them. In the mid-1990s, the Massachusetts Group Insurance Commission (GIC) released data on individual hospital visits by state employees in order to aid important research. As Massachusetts Governor Bill Weld assured employees, their data had been “anonymized,” with all obvious identifiers, such as name, address, and Social Security number, removed. But Latanya Sweeney, then an MIT graduate student, wasn’t buying it. When, in 1996, Weld collapsed at a local event and was admitted to the hospital, she set out to show that she could re-identify his GIC entry. For twenty dollars, she purchased the full roll of Cambridge voter-registration records, and by linking the two data sets, which individually were innocuous enough, she was able to re-identify his GIC entry. As privacy law scholar Paul Ohm put it, “In a theatrical flourish, Dr. Sweeney sent the Governor’s health records (which included diagnoses and prescriptions) to his office.”
Sweeney’s demonstration led to important changes in privacy law, especially under HIPAA. But that demonstration was just the beginning. In 2006, the New York Times was able to re-identify one individual (and only one individual) in a publicly available research dataset of the three-month AOL search history of over 600,000 users. The Times demonstration led to a class-action lawsuit (which settled out of court), an FTC complaint, and soul-searching in Congress. That same year, Netflix began a three-year contest, offering a $1 million prize to whomever could most improve the algorithm by which the company predicts how much a particular user will enjoy a particular movie. To enable the contest, Netflix made publicly available a dataset of the movie ratings of 500,000 of its customers, whose names it replaced with numerical identifiers. In a 2008 paper, Arvind Narayanan, then a graduate student at UT-Austin, along with his advisor, showed that by linking the “anonymized” Netflix prize dataset to the Internet Movie Database (IMDb), in which viewers review movies, often under their own names, many Netflix users could be re-identified, revealing information that was suggestive of their political preferences and other potentially sensitive information. (Remarkably, notwithstanding the re-identification demonstration, after awarding the prize in 2009 to a team from AT&T, in 2010, Netflix announced plans for a second contest, which it cancelled only after tussling with a class-action lawsuit (again, settled out of court) and the FTC.) Earlier this year, Yaniv Erlich and colleagues, using a novel technique involving surnames and the Y chromosome, re-identified five men who had participated in the 1000 Genomes Project — an international consortium to place, in an open online database, the sequenced genomes of (as it turns out, 2500) “unidentified” people — who had also participated in a study of Mormon families in Utah.
Most recently, Sweeney and colleagues re-identified participants in Harvard’s Personal Genome Project (PGP), who are warned of this risk, using the same technique she used to re-identify Weld in 1997. As a scholar of research ethics and regulation — and also a PGP participant — this latest demonstration piqued my interest. Although much has been said about the appropriate legal and policy responses to these demonstrations (my own thoughts are here), there has been very little discussion about the legal and ethical aspects of the demonstrations themselves. As a modest step in filling that gap, I’m pleased to announce an online symposium, to take place here at the Bill of Health the week of May 20th, that will address both the scientific and policy value of these demonstrations and the legal and ethical issues they raise. Participants fill diverse stakeholder roles (data holder, data provider — i.e., research participant, re-identification researcher, privacy scholar, research ethicist) and will, I expect, have a range of perspectives on these questions:
I hope readers will join us on May 20.
3rd Annual Workshop in Applied Ethics
Northeastern University, Boston, MA, September 27-29, 2013
Informed, autonomous consent is widely considered to be central to the ethics of human subjects research. However, it remains both conceptually and practically underspecified. A conceptually clear account of informed consent that is appropriate to the broad array of human subjects research, from medical to social science, has been elusive. Moreover, it has proven to be difficult to operationalize informed consent in practice. These challenges to the ethics of informed consent have been compounded by the globalization of research and rapid technological developments.
This interdisciplinary workshop will bring together practitioners and theorists at the leading edge of the ethics of informed consent to share their research and discuss the future of informed consent. The workshop is designed to be highly interactive, and to provide speakers with constructive feedback from colleagues working on related issues.
We invite the submission of abstracts (no more than 750 words) from researchers working on the theoretical and practical challenges of informed consent. Possible topics include, but are not limited to, the following:
- Conducting research on vulnerable populations
- Conducting cross-cultural research
- Conducting research in virtual environments
- Informed consent and incidental health findings (MRI, genetic)
- Community health research
- Community-based participatory research and its challenges to traditional informed consent
- Community research boards
- Ethical issues in reporting data to participants
- When IRBs confuse human subjects protection with research design
- Genetic testing outside institutional contexts (e.g. mail order)
- Theories/definitions of informed consent
- Alternatives to informed consent for human subjects research
- Theoretical/definitional work on informed consent and its role in human subjects research
- Informed consent, parental/guardian responsibilities, and minors
- Extending informed consent to nonhuman research subjects
Please email submissions (and questions) to Ronald Sandler (email@example.com).
The abstract submission deadline is May 1st, 2013. Abstracts will be reviewed by a program committee. Those selected for the program will be asked to submit completed papers one month prior to the workshop, and papers will be made available on the workshop website. Papers can be of any length, but speakers will be limited to twenty-five minutes to present their ideas, followed by thirty minutes of discussion. For more information about the workshop go to http://www.northeastern.edu/ethics/. This workshop is sponsored by Northeastern’s Ethics Institute, Social Science Environmental Health Research Institute, and Department of Philosophy and Religion.
The Petrie-Flom Center at Harvard Law School is happy to announce the penultimate session of this year’s Health Law Policy, Biotechnology and Bioethics Workshop in the Spring 2013 semester. We’re delighted to welcome a stellar lineup of leading researchers and opinion-makers in the fields at the intersection of health and law. Professors Elhauge and Cohen lead the 2012-13 workshop series.
This spring’s next presenter is Petrie-Flom Academic Fellow Nicholson Price. He will be presenting his paper “Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing” on Monday, April 8th at 5pm in Hauser 105. The full text of the paper is available here, and the abstract is copied below the “read more”
The workshop will conclude on Monday, April 15th with a lecture from WilmerHale Professor of Intellectual Property Law at HLS and Faculty Director of the Berkman Center, Terry Fisher. Workshops are open to the public and copies of papers will generally be posted a week in advance on the Petrie-Flom Website: http://www.law.harvard.edu/programs/petrie-flom/workshop/index.html.
Implementation of Federal and State Health Reform:
PPACA + Chapter 224 = opportunities, dynamism, and risk
12:00 Noon – 5:00 P.M.
Thursday, May 9, 2013
MCLE Conference Center,
10 Winter Place, via Winter Street
Addressing the growing cost of health care, desire to leave no person uninsured, and expectation that care should be delivered at the highest levels of quality have caused major changes to the health care landscape in the Commonwealth over the past several years. In 2012 there were two significant developments propelling these changes. First, Federal Health Reform, through the Patient P—assured by the Supreme Courts ruling and the reelection of President Obama. Second, Massachusetts has embarked on Health Reform II through the passage of Chapter 224 of the Acts of 2012. These two forces combine to make 2013 a busy year for lawmakers, regulators, payors, providers, drug and device manufacturers, patients, and the lawyers who serve these diverse groups.
This cutting-edge Conference is designed to address these dramatic changes in the Massachusetts health care marketplace and beyond from a sophisticated legal perspective. What do lawyers need to anticipate in order to advise clients? What new business opportunities await the industry and their legal counsel? What should organizations be doing now to prepare for change in the near term?
With many important perspectives to be heard about these developments, the Conference seeks to bring together diverse viewpoints and experiences to give attendees both breadth and depth on these important subjects. Hear from health lawyers as well as health care industry insiders living with a dynamic market. Lawyers that help their clients respond to a market in flux, exposing both risks and opportunities, are providing a critical service at this time. This Conference distills and addresses key issues and provides essential insight on the skills of lawyering in this evolving practice area.
Registration information and agenda available at the conference website.
EPA’s Office of the Science Advisor (OSA), Office of Research and Development (ORD) is seeking a senior executive and scientific leader for the position of Human Subjects Research Review Official (HSRRO) in Washington, DC, who is the Agency’s focal point for providing guidance and leadership, and who serves as the expert technical resource to EPA in matters related to human research ethics and human subjects protection. The HSRRO provides strategic vision and leadership for a scientific program whose results serve as a basis for informing Agency decisions in areas related to human subjects research.
The edited volume stemming from the Petrie-Flom Center’s 2011 Annual Conference – The Globalization of Health Care: Legal and Ethical Issues, I. Glenn Cohen, ed. (Oxford University Press, 2013) – is now available for purchase through the publisher, Amazon, or other outlets. You can also download the introduction and front matter for free here.
The Globalization of Health Care: Legal and Ethical Issues is the first book to offer a comprehensive legal and ethical analysis of the most interesting and broadest reaching development in health care of the last twenty years: its globalization. It ties together the manifestation of this globalization in four related subject areas – medical tourism, medical migration (the physician “brain drain”), telemedicine, and pharmaceutical research and development, and integrates them in a philosophical discussion of issues of justice and equity relating to the globalization of health care. The time for such an examination is right. Medical tourism and telemedicine are growing multi-billion-dollar industries affecting large numbers of patients. The U.S. heavily depends on foreign-trained doctors to staff its health care system, and nearly forty percent of clinical trials are now run in the developing world, with indications of as much of a 10-fold increase in the past 20 years. NGOs across the world are agitating for increased access to necessary pharmaceuticals in the developing world, claiming that better access to medicine would save millions from early death at a relatively low cost. Coming on the heels of the most expansive reform to U.S. health care in fifty years, this book plots the ways in which this globalization will develop as the reform is implemented. The book features leading academics from across the world and different academic disciplines (law, philosophy, medicine, public health, government, business and geography) and outside academia to provide an international and interdisciplinary perspective.
TOC below the fold:
From the Northeastern University School of Law Program on Health Policy and Law:
Join us for a day of informative discussion and exploration with some of the nation’s leading policymakers and researchers in health policy and law. Engage in conversations that examine the new directions for health policy and law, regionally, nationally and globally in the wake of the tumultuous events of 2012, including the Supreme Court’s ACA decision and the US Presidential Election.
April 19, 2013. Please see conference website for agenda and registration information.
Touro College Jacob D. Fuchsberg Law Center invites applications from experienced health law teachers and scholars for the Kermit Gitenstein Distinguished Visiting Chair in Health Law and Policy. Touro is seeking a nationally-known professor in the field of health law and policy to fill the chair for the spring semester in 2014. The Gitenstein visiting professor will teach at least one course at the law school, deliver public lectures, and participate fully in faculty and student life. Touro Law Center is part of Touro College, which includes New York Medical College—one of the largest private health sciences universities in the nation. The visiting chair will have the opportunity to develop collaborative initiatives with the medical profession in general and New York Medical College in particular. Women, members of minority groups and others whose background will contribute to the diversity of the faculty are encouraged to apply.
Touro Law Center is a dynamic institution that is at the forefront of legal education in this country, dedicated to producing practice-ready graduates. Touro’s students have the unique opportunity to take advantage of the first-ever law campus in the United States—a law school adjacent to and working with both a federal courthouse and a state courthouse. The law school is located in Suffolk County, Long Island, approximately an hour outside of New York City.
Interested candidates should send a cover letter and resume at the earliest possible date for full consideration. Contact: Fabio Arcila, Jr., Appointments Committee Chair and Associate Dean for Research and Scholarship, at firstname.lastname@example.org.
Touro College is committed to the principles of equal employment opportunity. Our practices and employment decisions regarding employment, hiring, assignment, promotion, compensation, and other terms and conditions of employment are not to be based on an employee’s race, color, sex, age, religion, national origin, disability, ancestry, military discharge status, sexual orientation, marital status, genetic predisposition, housing status, or any other protected status, in accordance with applicable law. Our policies are in conformance with Title IX, 1972 Education Amendments.
HJF is seeking a Bioethicist to provide support under an NIH-funded contract to the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases (NIAID), a component of NIH, located on Rockledge Drive in Bethesda, Maryland. Under the NIH Contract, HJF’s separate operating division, HJF-DAIDS, provides scientific and operations support to DAIDS including the Basic Sciences Program (BSP). Responsibilities include researching and preparing background materials on bioethical issues relevant to NIH/NIAID research for use by NIAID staff; reviewing clinical trial protocols upon request; working with NIAID staff to identify, coordinate, and resolve issues concerning ethical principles and the application of United States and international regulations and ethical guidelines in international settings; providing expert input in planning and organizing stakeholder meetings on bioethics topics. Excellent research, oral communication and writing skills needed, and experience and advanced training in bioethics required.
For more information and to apply, please see www.hjf.org and click on Careers.
June 17-21, 2013
Georgetown University Law Center
As global efforts to address non-communicable diseases (NCDs) are accelerating, complexity is increasing and the importance of law is becoming more apparent. Understanding the powers, duties and constraints created by law is now essential not only for lawyers, but also for officials and advocates working on NCDs.
The O’Neill Institute Summer Program on NCDs and the Law will take a global approach to the issues, while also drawing upon case studies from domestic law. Participants will enhance their understanding of the global burden of NCDs, contemporary developments at the international level, international instruments governing NCDs, best practice regulation, the intersection of human rights and NCDs and the intersection of trade, investment and NCDs.
Monday, June 17: Introduction to Non-Communicable Diseases (NCDs)
Day 1 will provide an introduction to global health law and an overview of the NCD burden.
Tuesday, June 18: Comparative Regulatory Approaches
Day 2 will explore a number of regulatory approaches used to address NCDs, including packaging and labeling measures; restrictions on marketing, advertising and sponsorship; and taxation measures.
Wednesday, June 19: Human Rights and NCDs
Day 3 will examine the relevance of human rights law to NCDs. Economic, social and cultural rights provide an important justification for government intervention to address NCDs. Civil and political rights associated with individual liberty may also restrain government intervention.
Thursday, June 20: Trade, Investment and NCDs
Day 4 will examine the restraints that international trade and investment agreements impose on domestic regulation in the context of NCDs. These restraints have been highlighted by recent disputes, such as legal challenges to plain packaging of tobacco products at the World Trade Organization and under a bilateral investment treaty.
Friday, June 21: NCDs and the Law: Where to from Here?
The final day of the summer program will focus primarily on the normative question of what role law should play in efforts to address NCDs. The role of self-regulation and public-private partnerships will also be examined.
For more information about the O’Neill Institute Summer Program on Global Health Law and Governance: NCDs and the Law, please email email@example.com.
Application site is now OPEN
To apply, please visit: http://www.oneillinstitute.org/summerprogram
and select the “Apply” tab