Hoping when there is no hope

November 27, 2017

Pär SegerdahlPatients participating in phase I oncology trials have terminal cancer and are near the end of life. Participating in research cannot cure them or even extend their lives. Not only because they have terminal cancer, but also because in phase I trials one tests the safety profile of the treatment, not effectiveness against cancer.

Nevertheless, many patients state that hope is an important reason for them to participate in phase I oncology trials. This is worrying from an ethical perspective. Do they understand what they agree to when they enroll as research participants? Have they been properly informed?

In an article in the Journal of Oncology Practice, Tove Godskesen discusses the issue, together with Ulrik Kihlbom. They argue that it is a norm in cancer care to provide hope to patients, and that this norm may support a tendency in personnel who recruit research participants to not always discourage hope, but rather reinforce it.

Since supporting hope in cancer patients is humanly important, it is not entirely easy to find a solution to the problem. Godskesen and Kihlbom proceed cautiously by distinguishing three kinds of hope that cancer patients may have concerning their participation in phase I trials.

The first is independent hope: patients hope for something that is independent of cure, such as receiving more attention by participating in research. The second kind of hope is realistic hope: patients understand that there is really no hope of cure or prolonged life, but they still hope against hope. The third kind is unrealistic hope: patients misunderstand the situation and think they are offered a treatment that doctors/researchers believe can help.

It is reasonable to support independent and realistic hope in phase I trials, according to Godskesen and Kihlbom. However, unrealistic hope is ethically worrying. It should be discouraged when patients enroll as research participants.

Discouraging unrealistic hope requires awareness of the norm to provide hope to cancer patients. The authors describe how a hopeful attitude is activated simultaneously with the cancer diagnosis. Words like treatment, hope and cure are immediately emphasized in the conversations with patients. The risk is that these words are used in the same hopeful spirit also when participation in a phase I trial is discussed.

Another problem in this context is that patients participating in phase I trials rarely receive palliative care, which would be reasonable given their terminal cancer. This may create the false appearance that research participation means being offered a new treatment. Perhaps the norm to provide hope creates this reluctance to mention palliative care. Staff is afraid that they may discourage hope. That fear is problematic, the authors claim.

What measures do Godskesen and Kihlbom propose? First of all, we need to put extra high demands on the information to participants in phase I oncology trials so that this vulnerable patient group is not exploited. Secondly, the information should contain palliative options. Thirdly, patients should receive palliative counseling throughout the trial.

Integrating research participation with palliative care reduces the risk of encouraging unrealistic hope in this patient group. The fact that trial participation is research and not treatment becomes clearer.

Pär Segerdahl

Godskesen T. and Kihlbom, U. (2017), “I have a lot of pills in my bag, you know”: institutional norms in the provision of hope in phase I clinical cancer trials. Journal of Oncology Practice 13(10): 679-682. DOI: 10.1200/JOP.2017.021832

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Stop talking about predatory journals?

November 22, 2017

Pär SegerdahlAlmost no researcher escapes the incessant emails from journals that offer to publish one’s research. A desire for gain, however, lies behind it all. Although it is not mentioned in the emails, the author typically is charged, and peer review is more or less a façade. Just submit your text and pay – they publish!

The unpleasant phenomenon is standardly referred to as predatory publishing. Worried researchers, publishers, and librarians who want to warn their users, they all talk about predatory journals. These journals pretend to be scientific, but they hardly are.

Lately, however, some researchers have begun to question the vocabulary of predation. Partly because there are scholars who themselves use these journals to promote their careers, and who therefore do not fall prey to them. Partly because even established journals sometimes use the methods of predatory journals, such as incessant spamming and high publishing fees. This is problematic, but does it make these journals predatory?

Another problem pointed out is the risk that we overreact and suspect also promising trends in academic publishing, such as publishing open access. Here too, authors often pay a fee, but the purpose is commendable: making scientific publications openly available on the internet, without payment barriers.

So, how should we talk, if we want to avoid talking about predatory journals?

Stefan Eriksson and Gert Helgesson annually update a blacklist of predatory journals in medical ethics, bioethics and research ethics. They have also published articles on the phenomenon. In a recent opinion piece in Learned Publishing, however, they propose talking instead about two types of problematic journals: deceptive and low-quality journals.

Deceptive journals actively mislead authors, readers and institutions by providing false information about peer review, editorial board, impact factor, publishing costs, and more. Deceptive journals should be counteracted through legal action.

Low-quality journals are not guilty of possibly illegal actions. They are just bad, considered as scientific journals. In addition to poor scientific quality, they can be recognized in several ways. For example, they may publish articles in a ridiculously broad field (e.g., medicine and non-medicine). They may send inquiries to researchers in the “wrong” field. They may lack strategies to deal with research misconduct. And so on.

Stefan Eriksson and Gert Helgesson emphasize that the distinction between deceptive and low-quality journals can help us more clearly see what we are dealing with. And act accordingly. Some journals are associated with actions that can be illegal. Other journals are rather characterized by poor quality.

Time to drop the colorful vocabulary of predation?

Pär Segerdahl

Eriksson, S. and Helgesson, G. (2017), Time to stop talking about ‘predatory journals’. Learned Publishing. doi:10.1002/leap.1135

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Minding our language - the Ethics Blog

Global data sharing, national oversight bodies

November 8, 2017

Pär SegerdahlScience has an international character and global research collaboration is common. For medical research, this means that health data and biological samples linked to people in one nation often are transferred to researchers in other nations.

At the same time, the development of new information and communication technology increases the importance of people’s data protection rights. To provide satisfying data protection in the new internet world, data protection regulations are tightening, especially within the EU.

In an article in Health and Technology, lawyer Jane Reichel discusses challenges that this development poses for biomedical research.

I am not a lawyer, but if I understand Reichel right, legislation can accompany personal data across national borders. For example, the EU requires that the foreign receiver of European data subjects’ personal data will handle the data in accordance with EU legislation – even if the receiver is a research group in the United States or Japan.

The fact that one nation may need to follow a foreign nation’s legislation not only challenges concepts of sovereignty and territoriality. It also challenges the responsibility of research ethics committees. These committees operate administratively at national level. Now it seems they might also need to monitor foreign rights and global standards. Do these national bodies have the expertise and authority for such an international task?

Read the article about these exciting and unexpected legal issues!

Pär Segerdahl

Reichel, J. Health Technol. (2017). https://doi.org/10.1007/s12553-017-0182-6

This post in Swedish

Thinking about law - the Ethics Blog

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