The National Health Service (NHS) in England is standing on a burning platform?

By John Tingle

In the introduction to a new report on the state of acute hospitals in the NHS in England, the Chief Inspector of Hospitals, Professor Sir Mike Richards of the Care Quality Commission (CQC) controversially states:

“The NHS stands on a burning platform — the model of acute care that worked well when the NHS was established is no longer capable of delivering the care that today’s population needs. The need for change is clear, but finding the resources and energy to deliver change while simultaneously providing safe patient care can seem near impossible.” (p.4)

This statement raises the fundamental question of whether the current model of the NHS is,’ fit for purpose’? The NHS since its formation has always had both a good and bad press. Since its inception it always been short of resources. Changing times bring with them new demands which can make established health care delivery structures obsolete and no longer capable of delivering optimal performance. One important NHS developing health care trend is the need to keep pace with a growing elderly population with more complex health needs along with other trends. Continue reading

NHS patient care and treatment errors: developing a learning culture.

By John Tingle

PACAC, the House of Commons, (Public Administration and Constitutional Affairs Committee) has just published its analysis of the PHSO’s, (Parliamentary and Health Service Ombudsman ) second report into the tragic death of Sam Morrish, a three year old child whose death from sepsis was found to have been avoidable. PACAC  is composed of MP’s (Members of Parliament) and its remit includes considering matters relating to the quality and standards of administration provided by civil service departments which includes the Department of Health. PACAC also examines the reports of the PHSO.

The PACAC report is very thorough and detailed and really gets to grips with the issues surrounding NHS (National Health Service) health adverse incident investigation. It addresses very clearly the current challenges and opportunities in this area and puts forward some major concerns which need to be fully addressed by the NHS before it can be said to have a listening and learning culture. It is clear from reading the report that the NHS has a very long way to go before it can be said to be even close to reaching its listening and learning culture attainment goal.

The PACAC report also identifies what could be regarded as some muddled thinking by the Department of Health on the concept of the ‘safe space’ in NHS investigations and identifies some important patient safety policy gaps.

Continue reading

The High Cost of Clinical Negligence Claims

By John Tingle

In the UK, the Department of Health (DH) have just published a consultation paper on introducing fixed recoverable costs in lower value clinical negligence claims. The document contains some controversial proposals which many claimant, patient lawyers are very concerned about. They feel the proposals will make it much harder for patients with lower value claims to find a solicitor to fight their case .The publication of the consultation paper comes in the wake of criticism that some clinical negligence claimant lawyers, solicitor firms , make excessive and unreasonable costs demands. The NHS LA (The National Health Service Litigation Authority) which manages negligence and other claims against the NHS in England states:

“Claimant costs for lower value claims are disproportionate and excessive. For claims where compensation is less than £10,000, claimant lawyers recover almost three times more in costs on average.”(p.10)

The DH Consultation Paper begins by stating the annual cost of clinical negligence in the NHS. It has risen from £1.2bn in 2014/15 to £1.5bn in 2015/2016.Legal costs were 34% of the 2015/16 expenditure.The consultation paper states that the current system of claims resolution is often lengthy and adversarial. This creates what can be termed a dual problem. Delaying possible learning of lessons from incidents and also escalating the costs of litigation when claims are brought. Continue reading

MONDAY (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Continue reading

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda

8:30 – 9:00am, Registration

A continental breakfast will be available.

9:00 – 9:05am, Welcome Remarks

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

9:05 – 10:30am: The End of ObamaCare? Health Care Reform Under A New Administration

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • David Blumenthal, President, The Commonwealth Fund
  • Michael K. Gusmano, Research Scholar, The Hastings Center
  • John McDonough, Professor of the Practice of Public Health, Director of the Center for Executive and Continuing Professional Education, Harvard T. H. Chan School of Public Health
  • Abigail R. Moncrieff, Associate Professor of Law and Peter Paul Career Development Professor, Boston University School of Law
  • Moderator: Einer Elhauge, Caroll and Milton Petrie Professor of Law and Founding Faculty Director, Petrie-Flom Center, Harvard Law School

10:30 – 10:45am, Break

10:45 – 11:10am, Precision Medicine Initiative/Cancer Moonshot

11:10 – 11:35am, Common Rule Update

  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

11:35am – 12:00pm, Clinical Trial Data Sharing

  • TBD, MRCT Center at Harvard

12:00 – 12:25pm, All-Payer Claims Databases

  • Gregory D. Curfman, Editor-in-Chief, Harvard Health Publications, Harvard Medical School

12:25 – 1:00pm, Lunch

Lunch will be provided.

1:00 – 1:25pm, Defining Death, Aid in Dying, and Family Rights

  • Paul Ford, Lecturer, Harvard Medical School, Winter 2017; Director, NeuroEthics Program, Cleveland Clinic; Director of Education, Department of Bioethics, Cleveland Clinic; Associate Professor, CCF Lerner College of Medicine of CWRU

1:25 – 1:50pm, Patient Advocacy, FDA, and Right to Try

  • Jerry Avorn, Professor of Medicine, Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

1:50 – 2:15pm, Drug Pricing and Cost

  • Ameet Sarpatwari, Instructor in Medicine, Harvard Medical School and Brigham and Women’s Hospital

2:15 – 2:40pm, Health IP

2:40 – 2:55pm, Break

2:55 – 3:20pm, Women’s Health

  • Aziza Ahmed, Professor of Law, Northeastern University School of Law

3:20 – 3:45pm, Reproductive Technology and Regulatory Oversight

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School

3:45 – 4:10pm, Legal Responses to Zika

  • George Annas, William Fairfield Warren Distinguished Professor and Chair of the Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health; Professor in the Boston University School of Medicine, and School of Law

4:10 – 4:35pm, Flint, Water Safety, and Public Health Infrastructure

  • 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; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs

4:35 – 5:00pm, Concussion Litigation and Legislation in Sports

  • Christopher Deubert, Senior Law and Ethics Associate, Petrie-Flom Center Law and Ethics Initiative, Football Players Health Study at Harvard University

5:00pm, Adjourn

Learn More

How did our prognosticators do in predicting health law and policy developments they expected in 2016? Check out videos of all of the presentations at the 4th Annual Health Law Year in P/Review event, held in January 2016, and find out!

Register Now!

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

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Continue reading

Unified Patents and Brexit: Britain’s Back on Board

By Seán Finan

After several failed attempts, years of protracted negotiations and a glacial ratification process, it seemed as if Brexit would finally put an end to the nascent European Unitary Patent. Last week, however, the UK confirmed its intention to ratify the Unified Patent Court Agreement and to move forward with the plans for the creation of a single European Patent. If the UK goes ahead, the agreement would only be a German ratification away from coming into force. This means that we could see a single European patent by 2017.

So, what is the European Unitary Patent? How would it interact with the current patent regime in the EU? What would its introduction mean for the future of pharma and biotechnology in Europe?

Continue reading

REGISTER NOW (1/23/17)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda Continue reading

Premature baby left to die alone in sluice room, report reveals: A looming patient safety crisis in the NHS?

By John Tingle

BBC News reported, 24/11/2016 on the Pennine Acute Hospitals NHS Trust review of its Royal Oldham and North Manchester General hospitals which identified several ‘unacceptable situations’. The BBC news item states that the review document

“…described how a premature baby had arrived “just before the legal age of viability” – at 22 weeks and six days – but staff did not find “a quiet place” for the child’s mother “to nurse her as she died and instead placed her in a Moses basket and left her in the sluice room to die alone”.

The report goes on to catalogue a number of other shocking events that occurred. Continue reading

New Tech, New Rules: Organoids and Ethics at the CJEU

Introduction

Last week, while attending a conference, organized by the Petrie-Flom Center in conjunction with a number of other Harvard institutions, on the ethics of early embryo research and the future of the 14-day rule, I was struck by the presentations on recent developments in stem cell technology. The speakers outlined fascinating developments in human brain organoids. And, since my own cranial organoid is becoming increasingly single track, I started wondering about the potential patentability of such inventions.

An intestinal organoid grown from Lgr5+ stem cells

An intestinal organoid grown from Lgr5+ stem cells

By way of very brief explanation, a human brain organoid is a structure of cells created in vitro through the stimulation of human stem cells. A recent paper has concluded that, given the right conditions for their development, these cell cultures can grow to resemble a 20 week-old human brain in vivo in a number of important respects.

At the conference, Dr John Aach, of the Department of Genetics at Harvard Medical School highlighted the potential of these technologies to form the basis of innovative research and treatments. However, he also highlighted new ethical questions posed by them. In particular, (and I fear I may be grossly oversimplifying his much more subtle presentation) he noted that a sufficiently developed human brain organoid might have the capacity to feel pain. Such technologies might fall to be regulated alongside human embryos created for research. In most jurisdictions, developing an embryo beyond 14 days of gestation is prohibited, whether by law or soft regulation. The rule originally struck a balance between the interests of research and the demands of ethics: day 14 usually marks the appearance of the primitive streak in an embryo and presents a convenient point to place an ethical limitation on research.  Dr Aach noted, however, that a brain organoid does not fall under the traditional definition of embryo. As such, its development is not necessarily subject to the 14-day rule. And yet, the creation of a clump of cells that feels pain is clearly a cause for ethical concern. He argued that the time has come to re-examine the rule in light of technological advancements like organoids. Its replacement, he argued, should not be based on canonical limits but on the underlying moral concerns. Continue reading

Improving the safety of maternity care in the National Health Service (NHS) and other medico-legal matters

By John Tingle

There are some very interesting Government patient safety and access to justice policy development activities currently going on in England.

Maternity Services

In maternity services, there is a clear recognition by Government that safety is inconsistent and that there is significant scope for improvement. Our still birth rates are amongst the highest in Europe despite the National Health Service (NHS) making advances in patient safety in this area. In the National Maternity Review we are reminded that half of the Care Quality Commission (CQC) inspections of maternity services result in safety assessments that are either ‘inadequate’ (7%) or ‘requires improvement (41%) (page 22). The CQC is the independent regulator of health and social care in England.

In a speech to the Royal College of Obstetricians and Gynaecologists (RCOG) in London, the Secretary of State for Health, 17th October, 2016, Jeremy Hunt laid out plans to make giving birth safer, including maternity safety funding and other related matters. The Government’s ambition is to halve neonatal death, stillbirth, maternal death and brain injuries caused during or shortly after labour by 2030 and a series of measures were  launched. There will be a £250,000 maternity safety innovation fund and a new national Maternity and Neonatal Health Quality Improvement Programme. New maternity ratings will also be published to help improve transparency, raise standards and will give families better information about the quality of local maternity services.

A safe space Continue reading

Scottish clinical guidelines on patients’ pressure ulcer care published

By John Tingle

Failures in assessing the patient properly for pressure ulcers can result in adverse incident reports, complaints and even litigation. A look at medical malpractice lawyer web sites in both the UK and USA will reveal a number of attorneys offering specialism in pressure sore litigation and publishing compensation awards. In the NHS poor pressure area care is a key patient safety issue and positive steps have been taken to reduce the occurrence of these incidents which can cause result in severe harm and even death to patients. The incidents also cost healthcare services a lot of money in remedying the problems of neglect.

The problem of poor pressure area care can also be seen in other countries. Health is a fairly generic concept, whilst the context of health care may well be different, valuable patient safety lessons can be learned from looking at the health quality reports of other countries. Developing an informed comparative patient safety perspective to issues can save both time and money by not reinventing the wheel.

There is new guidance from Scotland, Healthcare improvement Scotland (HIS) on the prevention and management of pressures ulcers which will be of interest to nurses and all those concerned with health quality and governance. Continue reading

Patient Safety and Clinical Risk in Neonatal Care

By John Tingle                                     

The CQC (The Care Quality Commission)  is the independent regulator of health and adult social care in England. They make sure that health and social care services provided to people are safe, effective, compassionate, high-quality care and they encourage care services to improve. The  CQC inspects health facilities and they have important statutory regulatory powers and sanctions.They have recently produced a report on neonatal care and  on  providing care for infants in the community who need respiratory support. As well as some positive findings, the report does reveal a number of major patient safety risks and failings.

In England, one in every nine babies is born needing care from neonatal services and  this is on the increase. The care process here can be challenging with sick babies with complex health needs receiving hospital care and then care at home and in the community. The care of the baby traverses’ distinct pathways or care areas and sometimes problems can occur:

A lack of consistency in care and communication across a pathway can result in poor outcomes for both babies and parents.” (p.3)

The report looks at current practice in three different aspects of care: Continue reading

Child safeguarding: the National Health Service (NHS) can do much better

By John Tingle

Our children are our future and we need to look after them well. There is however a lot of evidence to suggest that we are failing our children in a number of key health areas. UNICEF in a report put the UK in 16th position – below Slovenia, the Czech Republic and Portugal – in a league table of child well-being in the world’s richest countries. The report considers five dimensions of children’s lives – material well-being, health and safety, education, behaviours and risks, and housing and environment – as well as children’s subjective well-being.

There are a number of health and other child well-being challenges for the UK to meet. The UNICEF report provides some useful context from which to view the recently published Care Quality Commission (CQC) report on the arrangements for child safeguarding and healthcare for looked after children in England.The CQC is the independent regulator of health and social care in England.Whilst the report does contain some positive findings, when read as a whole, these seem subsumed by the large number of negative findings, some of which are very worrying. Continue reading

The vexed problem of properly discharging elderly patients from hospital back into the community

By John Tingle

The National Health Service (NHS) just does not seem to be able to deal properly with discharging elderly patients from hospital back into the community. There have been major issues in this area going back decades. Stories in the media and official reports regularly appear about ‘bed blocking’ by elderly patients or hospitals discharging them back into the community without proper care arrangements being made.

There is a real fear that the NHS will never be able to turn things around here and that the lessons of the past are not being learnt .There are seemingly intractable problems being faced by trusts, social services and others in doing a proper job with elderly patient discharge.The high financial cost to the NHS of keeping well elderly patients in hospital has also been widely discussed.

Hospitals and social services have faced a barrage of criticism of failing to have coordinated care policies and arrangements leading in some cases to deaths of patients.
Two reports have been published recently which show that patient safety is being seriously compromised in this area. Continue reading

NOW ONLINE! Oxford Union Debating Society DNA Manipulation Debate

DNA fingerprints.The Oxford Union Debating Society at Oxford University has published full video of its DNA Manipulation Debate, filmed on May 26. The Motion under debate was, “This House Believes the Manipulation of Human DNA is an Ethical Necessity.” Oxford billed its DNA Manipulation Debate as “historic” in a year when rapid advances in gene editing and genome synthesis suddenly confront humans with the possibility of being able to write, edit, re-write, and ultimately control their own genetic destinies.

The team supporting the Motion was led by Sir Ian Wilmut, famous for cloning Dolly the Sheep and now Chair of the Scottish Centre for Regenerative Medicine at the University of Edinburgh, and included Oxford’s noted moral philosopher Julian Savulescu and Oxford student debater Lynda Troung, a fast-rising star in RNA research.

The team opposing the Motion included Dr. Norman Fost, professor emeritus of pediatrics and director of the medical ethics program at the University of Wisconsin; Professor Barbara Evans, Director of the Center for Biotechnology & Law at the University of Houston Law Center and a frequent participant in Petrie-Flom conferences; and Oxford student debater Dr. Rahul Gandhi, a young medical doctor and monk focusing on rural healthcare, who is pursuing an MBA at Oxford this year as a prelude to seeking an MPH at Harvard next year.

Continue reading

Human Rights Advocacy under Attack

One of the world’s most important human rights law firms is now under attack from a government whose leader has, to put it mildly, a mixed record on human rights.  The firm is the Lawyer’s Collective, which has done some of the most important work within India on HIV, LGBT and gender issues.  The firm’s lawyers have also made great contributions internationally. Indira Jaising has served as a member of the UN Committee on the Elimination of Discrimination Against Women. Anand Grover was the UN Special Rapporteur on Right to Health from 2008 to 2014, during which service he issues several fearless reports that helped move the world forward towards an enabling environment for HIV among the most legally marginalized people.

On June 1, the Indian Union Ministry for Home Affairs suspended the firm’s license to receive foreign funding, contending that the Lawyer’s Collective had violated the Foreign Contribution Regulation Act. The Lawyer’s Collective faces the prospect of having their license cancelled permanently, which would seriously impact their work. Both the suspension order and the Lawyer’s Collective’s response have been widely reported in the Indian media. Continue reading

Brexit: I woke up this morning and the world had changed

By John Tingle

I voted in the referendum yesterday along with many others. The referendum turnout was 71.8%, with more than 30 million people voting. It was the highest turnout in a UK-wide vote since the 1992 general election.

My area, Broxtowe in Nottingham where I live, voted to leave the EU, 54.6%, 35754 votes, remain 45.4% 29672 votes. I live in the East Midlands, Middle England. Deep regional divisions have been laid bare by this referendum. It was notable that London largely voted to stay in the EU whereas in my region there was a notable push to leave, 58.5%.The  referendum result shows British politics has, according to the Guardian newspaper, fractured beyond all recognition since the last referendum on Europe in 1975.

The issues around EU membership have been hotly debated and there was a high level of public interest in what went on. Immigration has been the dominant theme in many areas and health along with a number of other issues has also come up. At this moment we are in a post referendum, after shock stage and picking through the fallout to see what is happening and what is going to happen. People are happy, sad and anxious over the result.It was not that long after the vote was announced by the BBC that our Prime Minister David Cameron said he was going to stand down in October, that was a lot to take in so soon after the result. Looking at some of the posts on Facebook it is striking how many young people feel a sense of betrayal by the vote to leave the EU. Many seem to harbour a deep sense of resentment that they have been robbed of a future by an elder generation, it’s the baby boomers against the millennials. Continue reading

General Medical Practice: Complaint Handling Issues

By John Tingle

There is a new report from Health Service Ombudsman (HSO) on GP (General Medical Practitioner) complaint handling and major failings are revealed. The HSO makes the final decisions on complaints that have not been resolved in England and lies at the apex of the NHS complaints system. The report reveals that some GP practices are failing to handle patient complaints properly. The report is based on evidence from HSO casework files and intelligence gathered by the Care Quality Commission (CQC) , NHS England and Healthwatch England. One hundred and thirty-seven closed complaint cases from November 2014 – November 2015 were analysed. General medical practice forms 90% of all NHS interactions with the general public.The quality of complaint handling by GPs was found to be highly variable:

“…over half of the cases were either good (46%) or outstanding (9%). However, over a third required improvement (36%) and a tenth were inadequate (10%) (p7).”

The report states that there are five areas where general practice has the most scope for improvement: Continue reading

Use of Estimated Data Should Require Informed Consent

Guest post by Donna M. Gitter, Zichlin School of Business, Baruch College, based on Professor Gitter’s presentation at the Petrie-Flom Center’s 2016 Annual Conference, “Big Data, Health Law, and Bioethics,” held May 6, 2016, at Harvard Law School.

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

The Icelandic biotech firm deCODE Genetics has pioneered a means of determining an individual’s susceptibility to various medical conditions with 99 percent accuracy by gathering information about that person’s relatives, including their medical and genealogical records. Of course, inferences have long been made about a person’s health by observing and gathering information about her relatives. What is unique about deCODE’s approach in Iceland is that the company uses the detailed genealogical records available in that country in order to estimate genotypes of close relatives of individuals who volunteered to participate in research, and extrapolates this information in order to make inferences about hundreds of thousands of living and deceased Icelanders who have not consented to participate in deCODE’s studies. DeCODE’s technique is particularly effective in Iceland, a small island nation that, due to its largely consanguineous population and detailed genealogical records, lends itself particularly well to genetic research.

While Iceland’s detailed genealogical records enable the widespread use of estimated data in Iceland, a large enough U.S. database could be used to make similar inferences about individuals here. While the U.S. lacks a national database similar to Iceland’s, private companies such as 23andme and Ancestry.com have created rough gene maps of several million people, and the National Institutes of Health plans to spend millions of dollars in the coming years sequencing full genome data on tens of thousands of people. These databases could allow the development of estimated data on countless U.S. citizens.

DeCODE plans to use its estimated data for an even bolder new study in Iceland. Having imputed the genotypes of close relatives of volunteers whose DNA had been fully catalogued, deCODE intends to collaborate with Iceland’s National Hospital to link these relatives, without their informed consent, to some of their hospital records, such a surgery codes and prescriptions. When the Icelandic Data Protection Authority (DPA) nixed deCODE’s initial plan, deCODE agreed that it will generate for only a brief period a genetic imputation for those who have not consented, and then delete that imputation from the database. The only accessible data would be statistical results, which would not be traceable to individuals.

Are the individuals from whom estimated data is gathered entitled to informed consent, given that their data will be used for research, even if the data is putatively unidentifiable? In the U.S., consideration of this question must take into account not only the need for privacy enshrined in the federal law of informed consent, but also the right of autonomy, which empowers individuals to decline to participate in research. Although estimated DNA sequences, unlike directly measured sequences, are not very accurate at the individual level, but rather at the group level, individuals may nevertheless object to research participation for moral, ethical, and other reasons. A competing principle, however, is beneficence, and any impediment to deCODE using its estimated data can represent a lost opportunity for the complex disease genetics community.

Continue reading