Tag: risks and benefits

Bioethics Blogs

We look for a PhD student

At CRB we seek new ways to study how people respond to health information, especially risk information, and how they make trade-offs between risks and benefits. We are right now looking for a PhD student who can work in one of these projects. The task involves both qualitative and quantitative work, including so-called Discrete Choice Experiments.

CRB is an international research environment and the working language is English. However, for this position the applicant must be proficient in Swedish, to be able to carry out the qualitative work.

If you know a Swedish speaking person who might be interested, please inform him or her about the advertised position. The Swedish version of this post contains links to information about the position.

Deadline for applications is 12 September.

Pär Segerdahl

We like real-life ethics : www.ethicsblog.crb.uu.se

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

Identifying individuals while protecting privacy

Research ethics is complex and requires considering issues from several perspectives simultaneously. I’ve written about the temptation to reduce research ethics to pure protection ethics. Then not as much needs to be kept in mind. Protection is the sole aim, and thinking begins to resemble the plot of an adventure film where the hero finally sets the hostages free.

Protection is of course central to research ethics and there are cases where one is tempted to say that research participants are taken hostage by unscrupulous scientists. Like when a group of African-American men with syphilis were recruited to a research study, but weren’t treated because the researchers wanted to study the natural course of the disease.

Everyday life is not one big hostage drama, however, which immediately makes the issues more complex. The researcher is typically not the villain, the participant is not the victim, and the ethicist is not the hero who saves the victim from the villain. What is research ethics in everyday situations?

There is currently a growing concern that coding of personal data and biospecimens doesn’t sufficiently protect research participants from privacy invasions. Hackers hired to test the security of research databases have in some cases been able to identify the individuals who provided their personal data to research (in the belief that the link to them had been made inaccessible to outsiders through advanced coding procedures). Such re-identified information can obviously harm participants, if it falls into the wrong hands.

What is the task of research ethics here? Suddenly we can begin to discern the outlines of a drama in which the participant risks becoming the victim, the researcher risks becoming the villain’s accomplice, and the ethicist rushes onto the scene and rescues the victim by making personal data in research databases completely anonymous, impossible to identify even for researchers.

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 Sporting Chance: Had We Been Willing, We Could Have Moved or Delayed the Rio Olympics

by Adam R. Houston, JD, MA, LLM

It looks like the Rio Olympics are indeed going to happen; fingers crossed that all the things that could go wrong – from filthy aquatic venues, to collapsing infrastructure, to threats of terrorism – do not. The most notorious among these concerns has been the risk posed by hundreds of thousands of international visitors from over two hundred countries returning home with the unwanted souvenir of Zika virus, facilitating its global spread. In response, more than two hundred public health experts signed a letter to the World Health Organization, recommending that the Rio games be either postponed or moved to another venue.

One thing largely missing from the subsequent conversation, however, has been the actual feasibility of moving or postponing the Games. Obviously there are numerous vested interests, from the International Olympic Committee to the Brazilian government to a host of corporate sponsors, who are exceedingly reluctant to have their plans disrupted. Being unwilling, however, is not the same as being unable. Unfortunately, starting from the assumption that moving or postponing the Olympics is simply not possible frames the conversation in a way that directs it towards justifying the refusal to act, as opposed to conducting a proper assessment of the risks and benefits of doing so. The purpose of this piece is not to speculate on whether the Olympics should have been moved or delayed, whether for Zika or any other reason, something extensively debated elsewhere. It is to highlight the fact that if the decision had been made to move, postpone, or even cancel the Games, it could have been carried out.

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 News

New Guidelines Off Six Ways Hospitals Can Stem Opioid Epidemic

June 13, 2016

(Managed Care Magazine) – The American Hospital Association (AHA) and the Centers for Disease Control and Prevention (CDC) have developed new guidelines to help hospitals and providers better communicate with patients about the risks and benefits of prescription opioids. The resource offers six ways hospitals can help end the nationwide opioid abuse epidemic.

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

Unheard Publics in the Human Genome Editing Policy Debate

Though the CRISPR-Cas9 genome editing platform is only three years old, universities and industry are racing forward with a range of research projects, including in human embryos. Given the speed of uptake, and the recent approval of non-clinical experiments with embryos in a number of countries, many are wary of this kind of CRISPR research because it could so easily pave the path to high-tech fertility clinics vending eugenic upgrades.

A vast diversity of publics, communities, and stakeholders are deeply concerned about this prospect of heritable human genetic modification. Yet, a  recent comment in JAMA Forum by Eli Adashi seeks to funnel this textured landscape of opinion into a tale of two cities in an international biomedical arms race in which the American research establishment is falling behind.

Adashi frames this battle royale as “Divergent US vs UK Human Embryo Research Policies in light of the HFEA’s decision to license Kathy Niakan’s CRISPR research with viable human embryos. (Her research program has yet to begin. It recently received a second round of ethical approval to use surplus embryos from IVF clinics, but those may take months to secure.)

On one side, Dr. Adashi places a mostly British cohort of pioneers, including two groups of research charities and stem cell researchers that have separately gone on record advocating for clinical research into genetically modifying embryos for human reproduction, once certain thresholds are met. He writes:

Many UK scientists quoted in the lay and professional media welcomed the HFEA decision. Professor Sir Robert Lechler, MB, ChB, PhD, President of the UK Academy of Medical Sciences, offered that “studies such as [that proposed by Dr Niakan], that focus on asking basic questions about human-embryo development, are needed to help answer the many scientific and ethical questions remaining in this field.”

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 News

We need debate on germline modification, says leading UK scientist


Sir Venki Ramakrishnan / Andy Hall for the Observer    

The new president of the Royal Society, the most prestigious body of scientists in the UK, who is also the 2009 Nobel laureate in chemistry, says that a debate is needed about germline modification.

Sir Venki Ramakrishnan says that genetic engineering has great potential for curing genetic diseases and that society must weigh up the risks and benefits.

In an interview with the Guardian, Sir Venki took a broadly positive view of germline modification, even though it is currently banned in the UK.

“There is great potential in germline therapy. There are clearly diseases that you could help by editing the germline. This is a case of a new technology where there are significant potential benefits, but also significant ethical implications.”

However, he believes that it needs to be studied thoroughly to get a consensus.

“It’s definitely a major step, there’s no getting around that. That’s why it’s important to really slow down and not rush any decisions. What we need is a diverse and transparent group of people to really come together and get to grips with how do we go about using this tool and are there red lines. They may well decide there are red lines we shouldn’t cross.” 

This article is published by Michael Cook and BioEdge under a Creative Commons licence. You may republish it or translate it free of charge with attribution for non-commercial purposes following these guidelines. If you teach at a university we ask that your department make a donation.

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 News

Genetic Engineering of Humans Has Great Potential, Says Nobel Winner

May 25, 2016

(The Guardian) – The genetic engineering of humans has great potential to help those destined to inherit serious, incurable diseases, according to one of Britain’s most prominent scientists, who says the risks and benefits should be debated by society. The invention of powerful new genome editing tools means researchers can now make precise changes to genetic material, and so consider correcting faulty DNA in human sperm, eggs and embryos.

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

Event: St Cross Special Ethics Seminar: The role of therapeutic optimism in recruitment to a clinical trial: an empirical study, presented by Dr Nina Hallowell

On Thursday 12 May 2016, Dr Nina Hallowell delivered the first St Cross Special Ethics Seminar of Trinity Term.  The talk is available to listen to here http://media.philosophy.ox.ac.uk/uehiro/TT16_STX_Hallowell.mp3

Title:  The role of therapeutic optimism in recruitment to a clinical trial: an empirical study

Abstract: Hope, or therapeutic optimism, is an important aspect of the provision and experience of medical care. The role of therapeutic optimism in clinical research has been briefly discussed within the empirical and bioethics literature, but the concept, and whether it can be transferred from care to research and from patients to clinicians, has not been fully investigated. Interviews with clinical staff involved in a peripartum randomised placebo-controlled trial– the Got-it trial  – revealed that therapeutic optimism has an important role to play facilitating clinical staff engagement with trial work. In this paper I will unpack the concept of therapeutic optimism in trial settings, describe how it is sustained in practice and outline some of the ethical risks and benefits.

About the speaker: Nina Hallowell is a medical sociologist who has recently been appointed to a research post in Ethox Centre in NDPH; where she will be responsible for developing a programme of research on ethical issues arising in big data research.  She has over twenty years’ experience of undertaking empirical research on the ethical and social issues generated by genetic testing in clinical and research contexts and different stakeholders’ views and experiences of research participation, at Cambridge, Edinburgh and Newcastle Universities. Recently, she has been involved in researching clinical staffs’ experiences of delivering RCTs and the ways in which they manage some of the ethical dilemmas they encounter.

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

Doctor Knows Best?

Photo Credit: NIH

Here is a write-up of a talk I recently gave at the NIH. The topic is a good one, about doctors and decision making and all that crap. But the real importance of linking you to the story is to find out if you hate my sport coat as much as my wife does. It is the only one I own now, and I’ve had it for 25+ years. Time for a new one?

Does doctor always know best? Patients often ask their doctor: “What would you do in my situation?” But as the doctor explains the risks and benefits of treatment options and imparts advice, it’s important to remember there’s a human behind that medical chart, a patient with unique values, opinions and personal preferences.

A doctor’s recommendation often influences a patient’s treatment choice, so the clinician has a huge moral responsibility to recommend well, said Dr. Peter Ubel, a physician and behavioral scientist who teaches public policy and business at Duke University. He led an animated, thought-provoking discussion about shared decision-making among doctors and patients at a bioethics lecture Mar. 22 in Lipsett Amphitheater.

“People want to be heard and understood. That, to me, is what shared decision-making is; that’s what partnership is,” said Ubel, who helps prepare business students for jobs in health care. “What we need to do as clinicians is to get better at eliciting those patient preferences. [Clinicians should tell patients]:‘I’m the expert on medical facts, but you’re the expert on you.’”

Ubel used the example of a patient with low-grade prostate cancer who was trying to decide between surveillance or surgery and radiation.

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

Whose lifestyle benefits? Regulatory risk-benefit assessment of enhancement devices

Nearly everyone would agree that a device or drug that relieves pain, or alleviates symptoms of depression confers a benefit – plausibly, a substantial benefit – on its user. No matter what your goals are, no matter what you enjoy, you are likely to agree that your life will go better if you are not in pain and not depressed: whether you’re a painter, a footballer, a Sudoku-enthusiast or a musician, you will be better able to pursue your projects and engage in the activities you love. It is unlikely that you will even question whether pain relief or alleviation of depression indeed constitute benefits.

This general consensus with respect to medical benefits makes it relatively straightforward for regulators to conduct risk-benefit assessments of medical products when they decide whether a particular product can be put on the market. A very small risk of a mild rash or gastrointestinal upset, for example, will be considered reasonable in the context of effective pain relief, as long as patients or consumers are informed. Even as the risks get more significant, substantial pain relief will be considered a large enough benefit to out-weigh a range of negative side effects in many cases.

So far, so straightforward.

However, a new class of consumer devices, promising enhancement effects, create a challenge for this sort of risk-benefit assessment, were a similar approach to be adopted. Whilst there is a general consensus that pain relief is a benefit, and that the size of this benefit can be substantial, it is much harder to say how beneficial a small improvement to ‘healthy’ working memory is, for example.

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.