Tag: ethical review

Bioethics Blogs

Lessons from the West African Ebola epidemic

Conventional wisdom—and an article in the Journal of Medical Ethics reviewed on this blog two years ago—advise that health research should not be conducted during times of crisis. Yes, such conditions compromise the controlled environments that studies typically require to produce reliable results, but they can also threaten the ethical integrity of research. Without institutional mechanisms to hold them accountable, investigators may cut corners, violate standards of privacy and informed consent, and even endanger participants. Disruption in the normal function of medical services can also apply pressure on individuals unable to access care by traditional means to seek it out by participating in risky research. And even if one assumes that researchers display honesty beyond reproach, it is still unreasonable to expect that they would be able to keep their cool in the midst of widespread panic and social collapse. But there is a fly in the ointment, at least when it comes to crises caused by epidemics. Public health organizations are first-responders at these moments, but they would be dead in the water without relevant data collected under real-world conditions to guide their actions. In this situation, the precautionary principle alone is not enough to stop a study altogether. In fact, it could be argued that an absolute prohibition against biomedical research in such situations may itself be unethical. The question then becomes, not whether, but how to guarantee ethical research during outbreaks?

The Ethics Review Board (ERB) of Médecins Sans Frontières (MSF) had to contend with this question during the 2014 Ebola epidemic. They recently chronicled their experience in the April issue of Public Health Ethics.

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

Knowing What You Know

It’s hard to grasp how little you know. Having worked as an IRB administrator at a research hospital for a little over a year, I think I’ve come far in understanding ethical review of medical research. The learning curve is steep, but my study of the regulations and supporting materials, as well as help from the professionals I work with, provided me with a base of knowledge about ethical research. I applied what I learned in my day-to-day work, and when unique events arose, I went back to source material or relied on my colleagues to find to a solution.

The post Knowing What You Know appeared first on Ampersand.

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

Biopolitical News of 2016

The biggest surprise of the year was probably the birth, in Mexico, of a baby who was conceived following controversial mitochondrial manipulation (“3-parent IVF”). The location was chosen by a New York-based fertility doctor who noted that in Mexico “there are no rules.” Since 3-person IVF is technically a form of inheritable genetic modification, one big question is whether its increasing use and normalization will open the door to wider acceptance of gene editing for human reproduction.

The gene editing shockwaves of 2015 – when Crispr was first applied in human embryos, and controversy about the prospect of using it for human reproduction became explicit – developed into a somewhat more predictable flood of activity and comment in 2016. The big, and unfortunate, news here is perhaps the non-news: the absence of any significant efforts to encourage public participation in deliberations about whether powerful new genetic manipulation tools should be used in efforts to control the traits of future children and generations.

The most consequential news of the year for biopolitics as for so much else may well turn out to be the US presidential election result, but the consequences themselves remain somewhat unclear. Trump’s comments about having “the right genes” are ominous warning signs, which are perhaps getting worse, as partly described below.

Cross-border commercial surrogacy was in the news this year because of scandals, disputes, and changes in the laws of several nations where it had taken hold. Commercial pressures were particularly apparent in the slick marketing being used to promote egg freezing among young women with no fertility problems.

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

Big Data researchers call for IRB review, based on shaky premises

Jacob Metcalf of the Data & Society Research Institute and Kate Crawford of Microsoft Research, MIT Center for Civic Media, and New York University Information Law Institute (I think those are three different things) want to subject Big Data research to IRB review, at least in universities. Their argument rests on shaky premises.

[Jacob Metcalf and Kate Crawford, “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” Big Data & Society 3, no. 1 (January–June 2016): 1–14, doi:10.1177/2053951716650211.]

Assumptions about assumptions

Metcalf and Crawford understand that the current Common Rule does not require IRB review of publicly available datasets. Claiming to be “historicizing extant research ethics norms and regulations” and drawing lessons “from the history and implementation of human-subjects research protections,” they proceed to invent a history of the relevant provisions.

They write,

US research regulations (both the current rules and proposed revisions) exempt projects that make use of already existing, publicly available datasets on the assumption that they pose only minimal risks to the human subjects they document. (1)

And

The Common Rule assumes that data which is already publicly available cannot cause any further harm to an individual. (3)

And

The criteria for human-subjects protections depend on an unstated assumption that we argue is fundamentally problematic: that the risk to research subjects depends on what kind of data is obtained and how it is obtained, not what is done with the data after it is obtained. This assumption is based on the idea that data which is public poses no new risks for human subjects, and this claim is threaded throughout the NPRM.

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

Big Data researchers call for IRB review, based on on shaky premises

Jacob Metcalf of the Data & Society Research Institute and Kate Crawford of Microsoft Research, MIT Center for Civic Media, and New York University Information Law Institute (I think those are three different things) want to subject Big Data research to IRB review, at least in universities. Their argument rests on shaky premises.

[Jacob Metcalf and Kate Crawford, “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” Big Data & Society 3, no. 1 (January–June 2016): 1–14, doi:10.1177/2053951716650211.]

Assumptions about assumptions

Metcalf and Crawford understand that the current Common Rule does not require IRB review of publicly available datasets. Claiming to be “historicizing extant research ethics norms and regulations” and drawing lessons “from the history and implementation of human-subjects research protections,” they proceed to invent a history of the relevant provisions.

They write,

US research regulations (both the current rules and proposed revisions) exempt projects that make use of already existing, publicly available datasets on the assumption that they pose only minimal risks to the human subjects they document. (1)

And

The Common Rule assumes that data which is already publicly available cannot cause any further harm to an individual. (3)

And

The criteria for human-subjects protections depend on an unstated assumption that we argue is fundamentally problematic: that the risk to research subjects depends on what kind of data is obtained and how it is obtained, not what is done with the data after it is obtained. This assumption is based on the idea that data which is public poses no new risks for human subjects, and this claim is threaded throughout the NPRM.

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

7 Highlights from Nuffield Council

The UK Nuffield Council on Bioethics’ recently released report, Genome Editing: an ethical review  (full version available here) is the most substantial and thorough assessment of its kind. It delves deeply into the ethical, social, and political underpinnings and implications of genome editing, and touches on related, converging technologies including synthetic biology, gene drives, and de-extinction. A second report with ethical guidance regarding the use of genome editing for human reproduction is due in early 2017 from a Council working group chaired by Karen Yeung

This first report will be an important reference for people across disciplines for some time, and I will not do justice to its scope and breadth here. However, I want to draw attention to just seven concepts that are particularly helpful and illuminating, as much for their framing of the questions at stake as for their content. I briefly summarize each point, and select key quotes from the report.

1. On emerging technology and innovation

Contrary to frequent assumptions, innovation in science and technology is neither linear, autonomous, nor pre-destined. It is continuously co-produced in relation to a complex intersection of actors, institutions, market-drivers, and serendipity. Momentum and sunk costs can however encourage adherence to certain technological pathways, meaning the choice of paths we take should not be undertaken blindly, or lightly.

“A commonplace but now largely discredited perspective viewed science as a resource from which innovators draw, leading to new technological innovations that provide social or commercial benefits, such as increased wellbeing and productivity. The flaws in this ‘linear model’ are generally thought to stem from its failure to give due attention to the complexity of innovation processes, the importance of feedbacks, the role of markets and other actors, and the effects of uncertainty and serendipity.

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 eulogy for the UK Donation Ethics Committee

Guest Post: David Shaw

Paper: The Untimely Death of the UK Donation Ethics Committee

Most people I know want to donate their organs after they die. Why wouldn’t they? If you have to die, you might as well do your best to save several other lives once you’re gone. But organ donation is a more ethically complex topic than many people realise. From Spring 2014 until April this year I was a member of the UK Donation Ethics Committee (UKDEC), which advised NHS Blood and Transplant and the various UK health departments on the ethics of organ donation and transplantation. The committee included doctors, lawyers, nurses, ethicists like me, and ‘lay’ members – ordinary members of the public. In my JME article, I discuss the committee’s work and why it came to an end.

UKDEC dealt with a wide variety of topics. We advised the Welsh Government on the ethical implications of a switch to ‘deemed consent’ to organ donation in Wales, undertook an analysis of the role of the family in donation, and engaged with ethnic minorities and religious groups to facilitate discourse about donation. Most of all, our work was important because we provided practical ethical guidance to healthcare professionals who were often unsure about the ethics and sometimes the legality of new developments in organ donation. Every year new technologies emerge that can enable donation where it was previously impossible, or which can improve the viability of donated organs. Sometimes doctors would approach UKDEC for our advice on their protocols that wished to make use of these new innovations.

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

Genome editing – the key ethical issues

Written by Dr Christopher Gyngell

This article originally appeared on the OMS website

The Nuffield Council of Bioethics released a report last Friday outlining the key ethical issues raised by genome editing technologies.

Genome editing (GE) is a powerful, and extremely rapidly developing technology. It uses engineered enzymes to make precise, controlled modification to DNA. It has the potential to radically transform many industries, including medicine, agriculture and ecology.  Despite only being developed in the past few years’, GE has already been used to create malaria-fighting mosquitoes, drought resistant wheat, hornless cows and cancer killing immune cells. The potential applications of GE in a decade are difficult to imagine. It raises a wide range of ethical issues that require careful scrutiny.

The Nuffield Council of Bioethics has formed a working group to analyse these issues. Their report titled “Genome editing: an ethical review”, is the first output of this working group.  It is a mapping project which identifies the major ethical issues arising from GE.

The report identifies several areas of GE that raise pressing ethical issues.  GE for human reproduction, and GE in livestock, are classed as requiring ‘urgent’ attention. GE for the purposes of xenotransplantation, and to alter wild populations of mosquitoes (and other disease causing animals), are classed as requiring attention ‘in the near future’.

It is unsurprising that genome editing for human reproduction is listed as requiring urgent attention. It has been at the centre of public debates about GE since scientists used the technology to alter human embryos for the first time last year.

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

An Interview with Tom Beauchamp, Early Bioethics Innovator

By Elizabeth Galt

Tom Beauchamp, PhD, has been a principle pioneer in the field of bioethics. As a young philosophy professor at Georgetown, he created the first applied ethics program in the United States. In 1975, he was recruited by the newly formed National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, where he wrote the bulk of The Belmont Report, the first federal document outlining the ethical principles and guidelines for research on human subjects.

Dr. Beauchamp and his collaborator, James Childress, were the foremost exponents of ethical decision making known as “principlism.” In their seminal work, Principles of Biomedical Ethics (1979), they laid out the guidelines of autonomy, beneficence, non-maleficence, and justice as the framework for bioethical evaluation. These were to serve as “action guides” to dictate the types of actions that are permitted, required, or prohibited in certain situations. The idea is that no one principle is, prima facie, ultimate or absolute. Rather, biomedical ethical dilemmas are best resolved through the balancing and specification of the various principles in their application to clinical research situations. These principles continue to be the basis of bioethics today.

At seventy-six years of age, Dr. Beauchamp is Professor of Philosophy and Senior Research Scholar at the Georgetown Kennedy School of Ethics. He has authored many volumes on bioethics, and he continues to influence and contribute substantially to the field. In 2004, Dr. Beauchamp received the Lifetime Achievement Award from the American Society of Bioethics and Humanities in recognition of his outstanding contributions and significant publications in bioethics and the humanities.

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.