Tag: law

Bioethics Blogs

Virginia Universities Take on Virginia Human Subjects Law

Virignia universities, including the University of Virginia, Virginia Tech, and Virginia Commonwealth University, want to reform Virginia’s human subjects laws, which in theory impose IRB requirements on all research in the state, even constitutionally protected speech like surveys conducted by news organizations and political polling firms.

[Derek Quizon, “New UVa Rector Discourages Post-Vote Dissent, Use of Email,” Richmond Times-Dispatch, August 17, 2015.]

The Richmond Times-Dispatch reported this in August. I had missed it, and I thank the IRBNet Newsletter for alerting me. Since the NPRM was released after the story came out, I don’t know how it affects the state-level initiative. Also, though not mentioned in the story, I am told that my home, George Mason University, is involved in the effort.

In any case, here’s the relevant portion of the Times-Dispatch report:

UVa joined institutions around the state, including Virginia Tech and Virginia Commonwealth University, in calling for simpler regulations for human research projects deemed “low-risk.”

The university follows a complex web of state and federal regulations for research involving human subjects, Sullivan said.

“The administrative burden is greater because we’re basically following two sets of rules,” Sullivan said.
Some of the regulations could be trimmed for research that do not put a subject’s health or well-being at risk — surveys, for example, or testing a new teaching model in a public school. The federal regulations can’t be changed, so this would only apply to research that receives no federal funding.

One suggested change to the language in state law would expand the types of research that require “written informed consent” from subjects to include research that “presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.”

Another expands the categories of projects that would be up for “expedited review” by each institution’s human-research review committee.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Police and Persons with Mental Illness: The Overlooked Frontline Care Providers

My original plan for this blog was to consider whether or not there remained a need for the old “Drunk Tank” way of managing persons who are acutely intoxicated by allowing them to sleep off or wait out their inebriation at the police station before determining whether or not further mental health care was needed, rather than bringing individuals to hospital emergency rooms for supervised sleep and conversation about detox services or psychiatric evaluation. Though the task of caring for acutely intoxicated persons, sometimes folks who are frequently seen in ERs repeatedly, can seem to be an inappropriate use of resources by clinicians we must appreciate that the motivation is often about safety, protection, and the welfare of the patient as well as the public. In the social context of fear and mistrust toward law enforcement following the many egregious cases of police brutality, my focus is a reminder of the ways in which police can, and often do, intervene with persons who have mental illness and addiction in order to protect these vulnerable mentally ill individuals. In no way do I condone the misconduct and violence we have come to hear about too often, but rather will focus on the important ways police can and very often do work with mental health professionals to assist persons in acute crises.

In recent years, police and mental health professionals have begun partnerships in order to provide effective interventions when responding to calls where there is a behavioral health concern. The term ‘Streetcorner Psychiatrist’ has been applied to police who must evaluate the type and nature of a citizen’s debility in order to provide the most appropriate intervention, but have historically had little to no formal training in mental health evaluation.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Biological and health data: 8 months on

The Council’s report on the impact of big data technologies on privacy, public interest and how these are conceptualised was published in February 2015.

Electronic health records, genome sequencing, clinical trial data, body and brain scans, lifestyle information collected on apps and other ‘self-quantifying’ tools appear to create a tantalising variety of data promising to paint a much more complete picture of population and individual health. The opportunities this might offer for a wider evidence base and better healthcare have long been a focus in the UK’s national research strategy with a notable track-record of population studies, and later the development of UK Biobank. While our report was being written up, the 100,000 Genomes project took off, and in the healthcare sector the care.data project made headlines on an almost weekly basis.

Our report was shaped against the background of this very dynamic new field of ‘data ethics’, and we tried to outline an adequately broad horizon against which some key features of what came to be called ‘data initiatives’ in the report with their focus on re-use and data linkage can be assessed in ethical terms.

Since the launch of the report, we have talked to many others working on big data initiatives in biomedical research and healthcare, including government departments and agencies, the BMA and the Wellcome Trust amongst others, and have looked for ways of putting our recommendations into practice. The issues that are pertinent now revolve, for example, around the trustworthiness of data-holding institutions particularly as these increasingly share data with third parties, be they academic researchers, administrative bodies, or commercial companies.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

MIND THE GAP: Physician-Assisted Death in Quebec

Jocelyn Downie warns that Quebec’s legislation will leave some physician-assisted death legal but unregulated.

__________________________________________

In June 2014, the Quebec National Assembly passed An Act respecting end-of-life care, which will come into force in December 2015. Under the Act, “’medical aid in dying’ means care consisting in the administration by a physician of medications or substances to an end-of-life patient, at the patient’s request, in order to relieve their suffering by hastening death.” In order to obtain medical aid in dying under the Act, a person must:

29(1) be an insured person within the meaning of the Health Insurance Act (chapter A-29);

(2) be of full age and capable of giving consent to care;

(3) be at the end of life;

(4) suffer from a serious and incurable illness;

(5) be in an advanced state of irreversible decline in capability; and

(6) experience constant and unbearable physical or psychological suffering which cannot be relieved in a manner the patient deems tolerable.

On February 6, 2015, the Supreme Court of Canada declared that the Canadian Criminal Code prohibitions on physician-assisted death (including both physician-assisted suicide and voluntary euthanasia) violate the Canadian Charter of Rights and Freedoms. The Court then suspended the effect of that declaration for 12 months to give the federal, provincial, and territorial governments time to design and implement a regulatory framework for physician-assisted death. As a result, on February 6, 2016, the Criminal Code will no longer prohibit physician-assisted death for a competent adult person who:

(1) clearly consents to the termination of life; and

(2) has a grievous and irremediable medical condition (including an illness, disease or disability) that causes enduring suffering that is intolerable to the individual in the circumstances of his or her condition.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Technologies of the extended mind: Implications for privacy of thought

by Peter Reiner, PhD

Dr. Reiner is Professor and co-founder of the National Core for Neuroethics, at the University of British Columbia. Dr. Reiner began his academic career studying the cellular and molecular physiology of the brain, and in 1998, Dr. Reiner became President and CEO of Active Pass Pharmaceuticals, a drug discovery company that he founded to tackle the scourge of Alzheimer’s disease. Upon returning to academic life in 2004, Dr. Reiner refocused his scholarly work in the area of neuroethics. He is also an AJOB Neuroscience board member.

Louis Brandeis in his law office, 1890.
In 1890, Samuel Warren and his law partner Louis Brandeis 
published what has become one of the most influential essays in the history of US law. Entitled The Right to Privacy [1], the article is notable for outlining the legal principles that protect privacy of thought. But it is not just their suggestions about privacy that are illuminating – it is their insight into the ways that law has changed over historical time scales that makes the paper such a classic. In very early times, they write, “the law gave a remedy only for physical interference with life and property…[and] liberty meant freedom from actual restraint.” Over time, as society began to recognize the value of the inner life of individuals, the right to life came to mean the right to enjoy life; protection of corporeal property expanded to include the products of the mind, such as literature and art, trademarks and copyrights. In a passage that resonates remarkably well with the modern experience, they point out that the time was nigh for the law to respond to changes in technology.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Science, Virtue, and the Future of Humanity

The new book Science, Virtue, and the Future of Humanity, just published by Rowman & Littlefield, brings together essays examining the future — particularly scientific and technological visions of the future, and the role that virtue ought to play in that future. Several of the essays appeared in The New Atlantis, including essays about robots and “friendly AI,” and most of them grew out of a conference that New Atlantis contributing editor Peter A. Lawler hosted at Berry College in Georgia back in 2011. (Professor Lawler edited this new book, along with Marc D. Guerra of Assumption College.)

Lawler’s own introductory essay is a real treat, weaving together references to recent movies, American and European philosophers, the goings-on in Silicon Valley, political philosophy, and a Tocquevillian appreciation for the complicated and surprising ways that liberty and religion are intertwined in the United States. No one is better than Lawler at revealing the gap between who we believe ourselves to be and who we really are as a people, and at showing how our longing for liberty is really only sensible in a relational context — in a world of families, communities, institutions, citizenship, and interests.

Charles Rubin’s marvelous essay about robots and the play R.U.R. is joined by the essay that Ari Schulman and I wrote on so-called “friendly” AI. The libertarian journalist Ron Bailey of Reason magazine makes the case for radical human enhancement, arguing, among other things, that enhancement will allow people to become more virtuous. Jim Capretta and William English each contribute essays on demographics and our entitlement system.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Gov. Brown’s veto of right-to-try bill

by Lisa Kearns, MS, MA

The conservative press’s reaction to Gov. Jerry Brown’s veto of California’s “right-to-try” bill recently was surprising—not because of the vitriol expressed, or because the writers strongly supported the legislation, which was overwhelmingly popular in the state. What was surprising was that in their rush to criticize the Democratic governor, the veto’s opponents failed to see the harm right-to-try legislation poses for patients—providing mythical hope of a 1-in-5,000 shot at a drug that offers a very slim chance of working anyway.

Some background: On Oct. 11, Gov. Brown vetoed Assembly Bill 159, becoming the first state executive to reject right-to-try legislation since the first law was enacted, in Colorado in May 2014. The legislative right-to-try movement was conceived by the libertarian Goldwater Institute as a way of giving terminally ill patients compassionate, or pre-approval, access to promising therapies that have passed only Phase 1 testing and thus haven’t received FDA approval. Twenty-four states have enacted a right-to-try law to date, and every bill (plus California’s) was passed unanimously or nearly so. Yet Brown didn’t follow suit, writing in his veto that the FDA’s compassionate use program already allows patients to request pre-approval access and that the agency’s efforts to streamline the application process should be given time to work.

The right-wing media was up in arms. “Brown to State: Drop Dead,” read a Wall Street Journal headline (a play on a headline that the Daily News ran after President Gerald Ford refused bailout funds for New York City).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Frozen on the Dock of the Bay October 8, 2015 Yet another dispute by a divorced couple over …

October 08, 2015

by Professor Bonnie Steinbock, Ph.D., The Bioethics Program 

Yet another dispute by a divorced couple over what to do with their frozen embryos is in the news. This one may lead to new legal rules over how to decide such cases.

Dr. Mimi Lee was diagnosed with breast cancer shortly before her marriage to Stephen Findley in 2010. Informed that pregnancy would be unadvisable, as Dr. Lee would have to take a drug that could harm the fetus, the couple created five frozen embryos. Mr. Findley began having doubts about the relationship shortly after they were married, and asked for a divorce in 2013. The divorce became final in April 2015.

California law requires fertility clinics to offer couples creating frozen embryos a consent agreement about their disposition in case of death or divorce. The consent agreement signed by the couple stated that the embryos were to be destroyed if the couple divorced. Part of the dispute is about the status of the consent agreement. His lawyers say that it is a binding legal contract. Her lawyers regard it as a mere advance directive that either side could change. Dr. Lee also maintains that she merely skimmed the agreement, which she signed at a turbulent time in her life.

Many people think the issue should be resolved solely by looking at the contract. The advantage of this approach is that it is definite and provides security for the parties. However,sometimes people should be able to change their minds, even if they have signed a contract.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

A Question of Conscience September 10, 2015 The problem with conscience claims and religious…

September 10, 2015

by Sean Philpott-Jones

On Tuesday, in front of a large crowd of supporters that included Republican presidential candidates Mike Huckabee and Ted Cruz, Kim Davis was released from federal custody.

As you all undoubtedly know, Kim Davis is the Kentucky county clerk who refused to issue marriage licenses following the U.S. Supreme Court ruling that legalized same-sex marriage. Kentucky law requires marriage licenses be issued under the authority of an elected county clerk like Ms. Davis. A devout Apostolic Christian, however, Kim is opposed to same-sex marriage. She believes that being forced to issue marriage licenses to same-sex couples would violate her religious liberties.

Although she has six deputy clerks working under her, Ms. Davis also refused to let them issue marriage licenses. Since her name appears on the marriage license itself, she believes that issuing these licenses to a same-sex couple constitutes her “stamp of approval” of something she believes to be a sin.

After two straight and two gay couples sued Ms. Davis for refusing to issue them marriage licenses, she was ordered to do so by U.S. District Judge David Bunning. Despite Judge Bunning’s order and despite her appeals to the Sixth District and U.S. Supreme Court being rejected, she remained defiant and was eventually jailed for contempt of court. She was released only after her deputy clerks began issuing marriage licenses this week, but could again face contempt charges if she interferes with the license process.

Now Ms. Davis isn’t the only government official who is refusing to issue marriage licenses to same-sex couples.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Wrongful Birth and Wrongful Life August 24, 2015 At present, wrongful life suits should be r…

August 24, 2015

by Bonnie Steinbock, Bioethics Program Faculty

Yesenia Pacheco, a mother of two from Seattle, Washington, decided that her family was complete, and that she did not want any more children. To ensure that she would not have an unwanted pregnancy, she sought medical advice from NeighborCare Health, a federally funded health clinic, about her birth control options. The clinic gave her an injection of Depo-Provera, an extremely reliable long-acting contraceptive method, which must be repeated every three months.

Ms. Pacheco duly scheduled subsequent injections at three-month intervals. But during one of those visits, she was not injected with Depo-Provera, but instead was given a flu shot.  Apparently, the clinic did not record in Ms. Pacheco’s chart that she was supposed to be given a Depo-Provera shot, nor did they get her informed consent for a flu shot, minimal requirements for responsible medical practice. Ms. Pacheco only learned what had occurred when she attempted to schedule her next Depo-Provera injection.  By that time, she was two and half months pregnant.

The clinic informed her that she would not have to have the child, that it would provide her with an abortion at no cost. Ms. Pacheco refused, because of religious objections to abortion. She gave birth to a daughter, Sandra, now aged 3, who has a genetic brain disorder, known as polymicrogyria (PMG). The condition produces symptoms that range from mild to severe, depending on how much of the brain is affected. Sandra’s motor and language skills, attention span, and cognitive functions have been impaired.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.