Tag: broad consent

Bioethics News

Is There a Duty to Participate in Biospecimen Research?

July 6, 2017

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In an essay in the May-June 2017 Hastings Center Report, Holly Fernandez Lynch and Michelle N. Meyer assess the impact of the revised Common Rule on biospecimen research. They believe that the proposed “broad consent” approach – which involves participants agreeing to the storage of blood and other biological samples for subsequent use in a broad range of research projects –will rarely be used because of practical challenges in implementing it. In addition, they argue that ethical justifications are not robust enough to encourage researchers to use broad consent. To justify this claim, they write, “Many have argued that there is a duty based in justice and reciprocity to allow one’s biospecimens to be used in this way.” My concern is with the ethical calculus they describe and its use of the idea that people have a duty to participate in medical research.

Bioethicists debate whether there is a duty to participate and how it impacts ethical decision-making. Arguments for the duty to participate have been grounded in both beneficence and justice, but justice is the primary justification being offered here. The justice argument is that since everyone can benefit from medical research then everyone has an obligation to participate. This obligation is most often framed as a prima facie obligation—if no other duty or obligation conflicts, then one should participate in research. In many ways, biospecimen research is the perfect case for a duty to participate. It is a low-risk, potentially high-reward type of research, especially in the case of specimens remaining after a medical test or treatment.

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

The privacy debate over research with your blood and tissue

Many people don’t realize that their leftover tissue, blood or other samples – otherwise known as “biospecimens” – taken during a visit to the doctor or hospital might be stripped of identifying information and used in research without their consent.

This makes some people uncomfortable.

So when the federal government decided to revise its “Common Rule” regulations governing federally funded research involving humans for the first time in decades, the draft revision included a proposal to require consent for all research with biospecimens, whether they have identifying information accompanying them or not. The original regulations required a person’s consent for research with biospecimens only if they had information with them that made them identifiable.

But when the updated Common Rule was released on Jan. 18, there was no change to this part of the regulation.

Human research regulations need to keep up with major advances in technology. They also need to balance enabling scientific progress with attempting to ensure safety and privacy for human participants in research.

So why wasn’t the proposal requiring consent for all biospecimen research adopted, and how do the new regulations recognize people’s concern in what happens to pieces of themselves in the future?

Research with nonidentified biospecimens doesn’t require consent.
Blood vials via www.shutterstock.com

Why we need human biospecimens for research

Exciting new research projects, like the Precision Medicine Initiative (PMI), aim to personalize medical interventions and therapies for things like cancer care.

But knowing how to personalize treatment requires comparing data from thousands of biospecimens to discover the relationship between genetic variation, health behaviors and medical outcomes.

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

ICYMI: Unpacking the NPRM – Biospecimens Research and Broad Consent

In Case You Missed It (ICYMI): From time-to-time, Ampersand will feature particularly well-received posts from the recent past.  These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and […]

The post ICYMI: Unpacking the NPRM – Biospecimens Research and Broad Consent 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

Critique of the motivation for dynamic consent to biobank research

Biobank research has undeniably challenged research ethics and the requirement for informed consent. We are after all dealing with collection of biological samples for future, yet unspecified research. Thus, one cannot give donors specific information about the research in which their samples will be used. It might seem like asking them to consent to unknown research projects x, y, z.

While some argue that broad consent for future research is specific enough to be genuine consent to something – one can inform about the framework that applies to the research – others argue that biobank research undermines the autonomy of research participants. Something must therefore be done about it.

Dynamic consent is such a proposed measure. The idea is that participants in biobank research, through a website, will be kept continuously informed about planned research, and continually make decisions about their participation. Through this IT measure, participants are placed at the center of decision making process rather than transferring all power to the researchers. Dynamic consent empowers research participants and supports their autonomy, it is claimed.

In an article in the journal Bioethics, Linus Johnsson and Stefan Eriksson critically examine the understanding of autonomy in the debate on dynamic consent.

First, the authors argue that autonomy is misunderstood as a feat. Autonomy is rather a right people have to decide for themselves what to do in situations that matter to them.

Second, they argue that the concept of autonomy is used too broadly, hiding important distinctions. In fact, three different ways of respecting people are conflated:

  1. Autonomy: respecting people’s right to decide for themselves about what to do.

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

For whom the bell tolls: precision medicine, private virtue and the public good

On Saturday our Assistant Director Peter Mills was in Washington, DC, to present at the AAAS Annual Meeting on Global Science Engagement. The following is a transcript of his talk from the session on Precision medicine and bioethics

I want to preface my remarks by saying something about what I see as the work of bioethics in relation to the emergence of precision medicine. Bioethics is often seen, wrongly, as impeding science and innovation: an unnecessary subterfuge that distracts from the ‘vital’ work of science and raises obstacles in the path of progress. I want to recall that what drives developments in bioscience and biomedicine – and the funding of science and scientists – is a profoundly moral impulsion to improve human health and wellbeing. Bioethics is not against but on the side of this impulse. It recognises, however, that to achieve its ends this impulse has to find expression in a more complex moral and social reality.

No man is an island

My starting point is a simple observation about precision medicine that may appear trite but that I think, nevertheless, has some non-trivial and mostly unresolved implications. The observation is this: that, in general, the precision with which we can treat any one person depends upon the quantity, quality and variety of information we can obtain from a great number of other people. The more data we have about the multitude, the better we may treat the individual.

In the early seventeenth century, recovering from a sickness that brought him close to death, the English metaphysical poet and divine, John Donne, put it well when he wrote:

No man is an island entire of itself;
every man is a piece of the continent,
a part of the main;

The proposition that the advance and the very effectiveness of precision medicine depends upon the cooperation or contribution of many people together immediately foregrounds something about the relationship between an individual and the other members of the population of which they are a part.

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

Unpacking the NPRM: Biospecimens Research and Broad Consent

On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, or “Common Rule.” If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects […]

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

Bioethicists suggest broad consent for biobank research

It is still unclear what kind of consent should be used when collecting biological samples for future research. Different forms of consent are practiced, which creates another uncertainty: which research is actually permitted with the collected samples?

This haphazard situation leads to unintended constraints on research. But it also leads to research sometimes being carried out without consent.

Against this background, the US National Institutes of Health (NIH) organized a workshop to discuss whether it is ethically reasonable to manage these uncertainties by using broad consent for future research when collecting biological samples.

The group of bioethicists who attended the workshop, including Mats G. Hansson, recently published their thoughts and conclusions in the American Journal of Bioethics:

The group’s proposal is that broad consent is ethically reasonable and often the best option, if it has three components:

  1. Consent is conducted initially, in connection with sample collection.
  2. There is a system for oversight and approval of future research.
  3. As far as possible, there should be ongoing communication with, and information to, donors.

Biological samples are collected in a variety of contexts. It is here that the haphazard situation arises, if different forms of consent are used, or perhaps no consent at all. By initially informing potential donors of the wide range of research that can be carried out, they can take a position on risks and benefits of donation (given the oversight and the general conditions of the future research that they are informed about).

The group emphasizes that broad consent gives donors control over the use of samples, while minimizing costs and burdens for both donors and 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

Second issue of our newsletter about biobanks

Now you can read the second newsletter this year from CRB and BBMRI.se:

The newsletter contains four news items:

1. Anna-Sara Lind presents a new book, Information and Law in Transition, and the contributions to the book by CRB researchers.

2. Anna-Sara Lind describes the situation for the temporary Swedish law on research registries.

3. Mats G. Hansson reports on a modified version of broad consent for future research.

4. Josepine Fernow presents a new article by Jennifer Viberg on the proposal to give research participants freedom of choice about incidental findings.

(Link to PDF version of the newsletter)

Pär Segerdahl

We recommend readings - the Ethics Blog

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

Research Ethics Roundup: Legal status of chimpanzees, paper microscopes, and more

As the April showers turn to May flowers, take a moment to check out some of the research ethics and oversight news that has been making headlines this month.

Should a Chimp Be Able to Sue its Owner?: Reporter Charles Siebert explores the work of lawyer Steven Wise and the Nonhuman Rights Project (NhRP), who are systematically filing court cases on behalf of animals with higher-order cognitive abilities such as chimpanzees, other members of the great ape family, orcas, dolphins, belugas, and elephants in an effort to expand the legal rights of animals. Wise and the NhRP, who hope to eventually convince a judge to recognize these higher-order animals as individuals that have a fundamental right not to be wrongfully imprisoned, are being met with both praise and criticism.

Science Tools Anyone Can Afford: Scientific research is not distributed equally around the world; the bulk of scientific research is conducted in only a few regions. To combat this inequity, Manu Prakesh, PhD, a biophysicist and assistant professor at Stanford University, is working to advance “frugal science” by creating and distributing powerful but inexpensive laboratory instruments to regions that have historically been left out of the production of scientific and biomedical research.

From Volunteers, A DNA Database: The Personal Genome Project, a collaboration between 16 research groups, aims to find 100,000 volunteers willing  to contribute data from their genomes, health records, microbiomes, and more. The success of the project depends on the willingness of participants to provide broad consent for the use of their health information.

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.