Check out today’s edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
Tag: Bioethics
If NeuroGaming Enables the Enhancement of Visual Multitasking, Should We Revise Distracted-Driving Regulations?
I recently saw someone walk into a signpost (amazingly, one that signalled ‘caution pedestrians’); by the angle and magnitude that his body rebounded, I estimated that this probably really hurt. What I had witnessed was a danger of walking under the influence of a smart phone. Because this man lacked the ability to tweet and simultaneously attend to and process the peripheral visual information that would enable him to avoid posts, the sidewalk was a dangerous place. If only there existed some way to enhance this cognitive ability, the sidewalks would be safer for multi-taskers (though less entertaining for bystanders).
In a public event on neurogaming held last Friday as part of the annual meeting of the International Society for Neuroethics, Adam Gazzaley from UCSF described a method that may lead to just the type of cognitive enhancement this man needed. In a recent paper published in nature, his team showed that sustained training at a game called NeuroRacer can effectively enhance the ability of elderly individuals to attend to and process peripheral visual information. While this game has a way to go before it can improve pedestrian safety, it does raise interesting questions about the future of our regulations surrounding distracted driving, e.g., driving while texting. In many jurisdictions, we prohibit texting while driving, and a California court recently ruled to extend these regulations to prohibit certain instances of driving under the influence of smart phones (i.e. smart driving).
But if individuals were to train on a descendant of NeuroRacer and improve their ability to visually multitask, should we give them a permit to text while driving?
Educating ELSI
“Examining the intersection of law and health care, biotech & bioethics”
– the subtitle of the Bill of Health blog.
I approach this intersection like many of my fellow students: outfitted with the tools and spectacles of a specific discipline. Whether that is health law, policy, medicine, engineering, philosophy, genetics, or cognitive science, none of us have had the ideal education that would enable not only an approach, but an inhabitation of this intersection.
What would that ideal education be? To consider the ideal education for a citizen, Rousseau conducts an elaborate thought experiment giving that education to a fictional young boy named Emile (hence the title of the work: Emile, or On Education). Let us begin a similar experiment to consider the ideal education for someone to inhabit the intersection of law and health care, biotech & bioethics.
Let’s call our fictional young person, ELSI.
OHRP Revises Guidance on Remuneration for Human Research Subjects
The Office of Human Research Protections (OHRP) has issued revised guidance about research subject compensation. And, although it has not attracted a great deal of fanfare, it deserves attention because the new guidance offers greater flexibility to investigators and to the Institutional Review Boards (IRBs) charged with reviewing proposed human research studies. Under its list of Frequently Asked Questions (FAQ) related to informed consent, there is a question (7) which reads, “When does compensating subjects undermine informed consent or parental permission?” (https://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf).
Aside from the fact that it’s still a very leading question (asking “when does it?” implies that, in fact, it does…), the new answer provided by OHRP clarifies that compensation in and of itself is not necessarily coercive or a source of undue influence. It says that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for some individuals agreeing to participate in research.
That is a real paradigm shift. Read More
“Brains on Trial”: Research on Groups & Concern for Individuals
What are the implications of advances in brain science for the justice system? This was the topic of a panel discussion held Tuesday at MIT’s McGovern Institute and moderated by Alan Alda in conjunction with the premier of his new PBS special, “Brains on Trial”. The discussion ranged from using fMRI for lie-detection to using it to help determine the reliability of an eye-witness.
In general, the panel rightly pointed out practical limitations of these technologies. Panelist Nancy Kanwisher highlighted, for example, that research on lie-detection is done in a controlled, non-threatening environment from which we may be unable to generalize to criminal courts where the stakes are high.
While I was sympathetic to most of this discussion, I was puzzled by one point that the panel raised several times: the problematic nature of applying data based on a group of people to say something about an individual (e.g., this particular defendant). To present a simplified example: even if we could rigorously show a measurable difference in brain activity between a group of people who told a lie in the imager and a group of people who told the truth, we cannot conclude that an individual is lying if he shows an activity pattern similar to the liars. Since the justice system makes decisions on individuals, therefore, use of group data is problematic.
To me, this categorical objection to group data seems a bit odd, and this is why: I can’t see how group data is conceptually different from ordinary circumstantial evidence. Read More
Thinking about brain death
By Seema Shah
It astonishes me how many people do not realize the controversial nature of “brain death” and the fact that it is not the same as death. There is a substantial body of literature showing that brain death is not the equivalent of death. The President’s Council on Bioethics issued a white paper in 2008 acknowledging the deficiencies with our current approaches to determining death. The literature on the topic is fascinating—some brain dead individuals have gestated babies successfully to viability and gone through puberty. Many brain dead individuals can heal wounds, regulate their body temperatures, and persist on ventilators for many years. (If you are unfamiliar with this literature and want to read further, see the citations provided below.)
Frank Miller and I have argued that best the way to think about the status quo is that brain death is a status legal fiction, much like the legal construct that a corporation is a person. A corporation is similar enough to a person that it is convenient to treat corporations as persons under the law, rather than writing an entirely new body of law meant to apply to corporations alone. We have argued that brain death is similar to death—Frank Miller and Bob Truog express this by saying that a person who is brain dead is “as good as dead.” For this reason, we can ethically and legally treat the two states in the same way for the purposes of determining death and allowing vital organ transplantation.
There are many open and interesting questions about brain death that I will be exploring on this blog for the next few weeks. Michael Nair-Collins has a recent article in the Kennedy Institute of Ethics Journal that argues that the current approach to determining death in the U.S. is paternalistic and, presumably, unjustified. He cites as evidence the kinds of information that are shared with people deciding whether to become organ donors. But is this true, or is there evidence that the public is able to distinguish between brain death and death? Kenneth Kasper, Frank Miller, and I are investigating this at the moment, and we are finding some surprising answers in the literature. Read More
Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies
By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H.
Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.
Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells. ASCs are found throughout the body. Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells. It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad.
A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices. Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells? In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.[2]
Harvard HIP (High Impact Philanthropy): Toby Ord speaking tonight
Are you interested in foreign aid, global development, medicine? Want to know how philanthropy and charitable giving can do the most good?
Aid Works (On Average) – By Toby Ord
Tuesday, March 26th; Emerson Hall 108; 8 PM
There is considerable controversy about whether foreign aid helps poor countries, with several prominent critics arguing that it doesn’t. Dr. Ord shows that these critics have only reached this conclusion because they have failed to count the biggest successes of aid, such as the eradication of smallpox, which have been in the sphere of global health rather than economic growth. These health successes have often been neglected in analysis of aid because they have only made up a small proportion of aid spending. When we look at the impact of this spending, though, we see that it the big wins have been so utterly vast that they more than justify all aid spending to date.
Dr. Toby Ord is a philosopher at the University of Oxford and a research associate at the Uehiro Center for Practical Ethics and the Future of Humanity Institute. He is also the founder and director of Giving What We Can, an international society dedicated to eliminating poverty in the developing world.
Join Dr. Ord tonight, March 26, at 8 PM for a talk and discussion of the effectiveness of foreign aid. Refreshments will be provided, and a reception will follow.
Planning to come? Please RSVP on Facebook to help us plan refreshments.
You Talkin’ to Me?
The principle of justice articulated in The Belmont Report requires equitable selection of human research subjects. Equitable in this context means that the risks and benefits of the study are distributed fairly. Fairness has two components: 1) avoiding exploitation of the vulnerable (e.g. preying upon a poor, uneducated population) and 2) avoiding the unjustified exclusion of any population ( whether out of bigotry, laziness or convenience).
Recruitment strategies invariably shape the selection of research subjects and the extent to which a pool of participants really represents a cross-section of society. Institutional Review Boards (IRBs) are charged with evaluating whether study recruitment plans and materials used to obtain informed consent are easily understood and free of misleading information. This is relatively straightforward when researchers, IRB members, and study subjects all speak the same language. But when studies are done in geographical areas that include numerous cultural and language communities, it can be quite tricky.
One of the barriers that prevents people from enrolling in (or even knowing about) studies is a lack of awareness and planning by researchers to address language differences. The human research protection regulations at 45 CFR Part 46.116 require that informed consent information must be provided to research participants (or their representatives) in language understandable to them. IRBs are supposed to be vigilant about this and require investigators to obtain translated Informed Consent Documents (ICDs) for use with non-English speaking research subjects. But researchers commonly balk at this expectation, saying it’s unreasonable. (A disproportionate number of objections have been raised to me thusly, “And what am I supposed to do if someone shows up speaking only Swahili?!”) Read More
Apr 4: Dan Brock delivering the Gay Lecture on “The Future of Bioethics”
Please join the Division of Medical Ethics for:
The 2013 George W. Gay Lecture in Medical Ethics
Dan W. Brock, PhD
Frances Glessner Lee Professor of Medical Ethics, Department of Global Health and Social Medicine, HMS
“The Future of Bioethics”
Thursday, April 4, 2013
4:00 PM
Harvard Medical School
Tosteson Medical Education Center
Carl W. Walter Amphitheater
260 Longwood Avenue, Boston
Please pass this invitation along to other interested friends and colleagues.
RSVP to DME@hms.harvard.edu.
The George W. Gay Lecture is the oldest endowed lectureship at Harvard Medical School, and quite possibly the oldest medical ethics lectureship in the United States. The lectureship was established in 1917 by a $1,000 gift from Dr. George Washington Gay, an 1868 graduate of HMS. Since its inception, many of the nation’s most influential physicians, scientists, researchers and social observers, including Erich Fromm, Felix Frankfurter, Margaret Mead, Elizabeth Kübler Ross, E.O. Wilson, and Joshua Lederberg have given the Gay Lecture. Elie Wiesel, Marian Wright Edelman, Paul Krugman, Nicholas Kristof and Donald Berwick have given recent Gay Lectures.
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