A blog from the Centre for Research Ethics & Bioethics (CRB)

Tag: patients (Page 5 of 5)

Don’t shoot at the patient (or at the messenger)

The newly proposed European Data Protection Directive overprotects research participants and exposes patients to greater risks of contracting illness and dying.

Thus dramatically a recent article in The Lancet Oncology can be summarized, written by Mats G. Hansson at CRB together with Gert Jan van Ommen, Ruth Chadwick and Joakim Dillner.

People who provide data to research registers are not exposed to physical risks, like participants in interventional research. The risks associated with register-based research are informational: unauthorized release of information about participants. One might ask if it even makes sense to say that people “participate in research” when researchers process large data sets.

Patients (and people in general) have significant protection from disease thanks to register-based research. For example, it is estimated that the HPV vaccine will save about 200 women from dying in cervical cancer each year, in Sweden alone. This cancer-preventive treatment became possible because researchers had access to samples dating back to the 1960s providing evidence for a causal connection between a certain virus infection and cervical cancer later in life.

  • Despite this vital value in biobanks and registers,
  • despite the fact that risks are only informational,
  • despite rigorous safety routines to prevent unauthorized spread of information,
  • despite the fact that researchers don’t study individuals but statistical patterns, and
  • despite the question if people really are “participants” in register-based research,

the EU committee proposing the new directive treats the integrity of “research participants” as so pivotal that researchers who process data not only must be subjected to the same ethical review process as for invasive research, but also must obtain informed consent from each and every one who once gave their data to the register, whenever the researchers want to study a new disease pattern.

Data protection efforts easily lose their sense of proportions, it seems, at least concerning register-based research. Not only is one prepared to expose patients to greater physical risks in order to protect research participants from (already rigorously controlled) informational risks.

One also is prepared to disturb data providers who hardly can be described as “participating” in research, by forcing researchers to recontact them about informed consent. Not only on one occasion, but time and again, year after year, each time a new disease pattern is explored in the registers. That’s what I call privacy intrusion!

Pär Segerdahl

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No consent for maintaining high-quality health care?

Collecting biological samples and health information from healthy donors in the construction of biobanks and research registers obviously requires the donors’ informed consent.

But is a similar demand for consent reasonable when patients provide their doctor with samples for diagnosis, undergo medical examination and treatment, and answer the doctor’s questions? Or can patients be expected to accept that their traces in the health care system – for example, data about experienced side effects – are monitored to optimize the quality of medical diagnosis and treatment?

A recent article by Mats G. Hansson at CRB discusses the issue. The article in Theoretical Medicine and Bioethics is well-argued and challenges common assumptions.

The basic argument is that quality registers and biobanks within the health care system play such a decisive role in optimizing the quality of the care that we expect as patients, that no consent should be required for collecting and studying our traces as patients (provided that the purpose is maintenance of high-quality health care, and nothing else).

Consent is associated with costs, in the form of drop-out of data. This impairs the value of the information in quality registers and biobanks, and thereby also the conditions for optimizing medical diagnosis and treatment.

Privacy is not the only ethical concern. Quality of care carries moral weight too.

Perhaps we are prepared to accept certain access to our patient histories, if such access is a precondition to maintaining and developing high standards of health care?

Pär Segerdahl

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Research for the sake of the patient

We regularly tell strangers about sensitive aspects of our lives. We do it every time we visit the doctor. We do it without hesitating, in spite of the fact that the information won’t stay with the doctor to whom we give it.

The information is archived and will be read by health care staff in the future, when we visit a hospital again. As patients, we are satisfied with this state of affairs. Typically, we are happy that our samples are saved for future use, and that research is being done on our data to improve the quality of the care.

It is obvious to us that these actions are taken for our sake as patients, or as future patients.

However, when the same kind of data is collected for similar overall purposes, but outside of the health care sector, in the construction of biobanks and registers for future medical research, it suddenly becomes more tempting to worry about the safety of our data.

In spite of the fact that the researchers’ information about us

  1. normally is less comprehensive than in the doctor’s journal,
  2. is coded so that the connection to us is as safe as in a bank vault,
  3. isn’t used to do research on us individually, but to explore human patterns of disease,

a tendency to imagine nightmarish scenarios of surveillance appears. – Why?

One reason could be an assumption that researchers only want to answer their own questions. They don’t do research for our sake. They are curious and need our support to realize their own research goals.

Another reason could be an assumption that if medical research has commendable purposes related to health and health care, these purposes are very general and societal: Improved Public Health; Decreased Health Care Costs; A Flourishing Pharmaceutical Sector etc.

Who cares about little me?

When I visit the doctor, the connection to my own health and care is obvious. When I donate blood to the biobank for future research, on the other hand, the connection to me as a patient, or as a future patient, is less obvious.

Still, today’s health care depends on yesterday’s research.

The information I give the doctor would not help me a bit as a patient, if millions had not already provided medical research with their data. My doctor wouldn’t even be able to suggest a diagnosis, or recommend an effective treatment.

I believe we need to defuse the issue of personal data in biobanks and research registers; calm down our tendency to think that the information is collected without regard to us, and for wholly different purposes than in health care. Even in research, our data are collected for our sake: so that we, the day we visit the hospital and tell the doctor about our troubles, can expect well-founded diagnoses and effective treatments.

If you want to reflect more about our interest as future patients that there is ongoing biobank and register research, I want to recommend a coming dissertation:

  • Biobank Research – Individual Rights and Public Benefit

Author is Joanna Stjernschantz Forsberg at CRB, who defends her dissertation the 6th of October in Uppsala.

I also want to recommend the interactive conference, HandsOn: Biobanks, in Uppsala 20-21 September, which tries to illuminate the values of biobanking. You can register for the conference until the 11th of September.

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

Swedish debate on the protection of animals in research

A very controversial question was recently debated in a Swedish daily paper, Svenska Dagbladet:

–          Has the Swedish protection of animals in research gone too far?

The question was raised by Mats G. Hansson at CRB, Rikard Holmdahl (Professor of Medical Inflammation Research) and Anne Carlsson (President of the Swedish Rheumatism Association). I published a post about the debate on our Swedish blog: Det dubbla ansvaret för djur och människor. In the post, and in its comments, you find links to the three articles in Svenska Dagbladet.

If you don’t read Swedish, here is a summary of the debate:

The basic principle when animal experiments are evaluated ethically is that the scientific merit of the experiment must be greater than the suffering the animals may be exposed to. In the article that started the debate, “scientific merit” was interpreted as an interest for patients. Medical research is done not for its own sake, but to find new treatments for patients. The article thus added a suffering group to the laboratory animals: the patients.

The stage was set, and dramatically so, for intense debate: suffering animals versus suffering patients. The article argued that forgetfulness about the ultimate purpose of medical research has caused an imbalanced emphasis (especially in Sweden) on one of the vulnerable groups: the animals. Ethical committees evaluating animal experiments include representatives of animal welfare organizations, but patient organizations have no representatives in the committees. Moreover, the authority responsible for surveying the Animal Welfare Act has sidestepped the ethics committees by introducing regulations that prohibit certain very common and important experimental procedures with animals, thereby precluding the difficult ethical balancing of expected scientific merit against animal suffering. Researchers can apply for exception from the prohibitions, but the procedure is bureaucratic. The result is that research that could be in the service of patients never gets done. Responsibility for animals is taken in ways that fail patients.

Three representatives of animal rights organizations soon responded that almost all animal experiments are approved by the ethics committees. They also pointed out that the animal welfare representatives in these committees are a minority. Moreover, adding to this disadvantage, only the researchers can appeal against the decision of the committee; no one representing the animals can. The authors expressed concern about suffering patients and the need of high quality science, but questioned that good and useful science required painful animal experiments. There are alternatives to animal experimentation. These may even be scientifically superior.

In the final reply, the authors initiating the debate suggested that the reason that almost all applications for animal experiments are approved by ethics committees is that researchers take ethical questions seriously and write well prepared applications. They also remarked that researchers do consider alternatives to animal experiments, and try to limit the number of animals used. Still, medical science in general is impracticable without experiments with animals. The last new consideration in the final reply was that although interest groups legitimately work to protect animals’ interests, the same one-sided ambition becomes problematic when it occurs on a societal level, in the exercise of public authority.

If I may conclude with a short personal consideration, I’d say that each party repeated its own form of morality, perhaps taking it to a somewhat more eloquent level. One party compared the suffering of two vulnerable groups (animals and patients), and claimed that the other party failed to make the responsible balancing act, one-sidedly favoring the interests of animals. But the other party hardly failed to achieve a responsible comparison, since the legitimacy of comparing animal and human suffering was questioned. Comparing is irresponsible. These two forms of morality are so fundamentally different that I don’t see how they can stop repeating themselves, forever.

Pär Segerdahl

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