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Beyond the ‘therapeutic misconception’: Research, care and moral friction

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Abstract

In research ethics regulation, health care and research are depicted as serving distinct goals, and policies are in place to prevent what is seen as patients’ misconceived understanding of research as health care. On the basis of ethnographic research in four Danish hospitals in conjunction with a cardiovascular drug trial in patients with chronic disease, we argue that the objectives of health care and research often merge in mutually constitutive practices. We build on observations of trial activities, interviews with physician-investigators, research nurses, patient-participants and trial sponsors and a survey of the patient-participants. We found an organization of clinical drug trials allowing extraordinary care relationships to form, which makes trial participation attractive for patients and allows information to flow more freely. However, the research-care intermingling generates moral concerns for those involved. We conceptualize these concerns as a productive moral friction resulting from research staff caring too much for patients. We identify four situations in which friction arises: when care-giving comes to replace specialist contact, when caring for individuals appears unfair for the collective, when care motives may be doubted and when patients invent their own ways of helping staff in order to reciprocate their care. We conclude that the presentation of the research-care tension as an ethical dilemma is misleading and even part of the problem that must be dealt with by those involved.

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Notes

  1. Owing to confidentiality concerns, the names used in this manuscript are all pseudonyms.

  2. The Helsinki Declaration from 1964. The principles of the Helsinki Declaration are elaborated in guidelines by the Council for International Organizations of Medical Sciences (CIOMS) (www.recerca.uab.es/ceeah/docs/CIOMS.pdf, website accessed 30 September 2013). For EU regulations, see Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 (www.eortc.be/services/doc/clinical-eu-directive-04-april-01.pdf, website accessed 30 September 2013). For Danish regulations, see The Danish Act on Research Ethics Review of Health Research Projects (www.retsinformation.dk/Forms/r0710.aspx?id=137674, website accessed 30 September 2013).

  3. www.cioms.ch/publications/layout_guide2002.pdf (website accessed 30 September 2013).

  4. A particularly well-known form of ethics is termed “principle-based ethics”. It refers to a tradition focused on the principles of autonomy, non-maleficence and justice articulated in The Belmont Report (www.hhs.gov/ohrp/humansubjects/guidance/belmont.html, website accessed 30 September 2013) and, in fact, marks a shift in the ethics debate from determining ‘what is ethical’ to a concern with how to develop processes that will lead to more ethical decision-making. See Beauchamp and Childress (2013) for a thorough theoretical account.

  5. Empirical research methods are becoming more widespread in contemporary ethics literature, for instance brought forward in the traditions of “pragmatist ethics” (McGee, ed., 2003) and “contextual ethics” (Hoffmaster (ed.), 2001). For a critique of the “empirical turn” in bioethics see Ashcroft (2003).

  6. In drug development and testing it is custom to divide the trials into phases. Phase I trials refer to tests conducted with a few healthy volunteers to explore drug metabolism and safety, while phases II and III trials are undertaken with small and large patient populations, respectively, to assess drug efficacy and safety. Phase IV studies refer to post-marketing surveillance studies undertaken in conventional care settings.

  7. The list was developed in collaboration with a leading Danish cardiologist and the trial sponsor. Symptoms included diarrhea, swollen ankles, feet or hands, skin eruption, dizziness, swelling in the face, headache, respiratory problems, itching and nausea. The symptoms were chosen because they typically do not require hospitalization. Except for headache and nausea, all the listed symptoms are registered as adverse effects for the drug under trial.

  8. The staff mentioned, for example, investigation and treatment of frozen shoulder, plantar fasciitis, trigger finger, hip pain and heart disease.

  9. Act on Research Ethics Review of Health Research Projects section 20, subsection 1 (www.dnvk.dk/English/actonabiomedicalresearch.aspx, website accessed 30 September 2013).

  10. The demonstration of statistically significant test results depends both on the strength of the association between intervention and patient outcomes and the number of observations (research participants) (Rothman and Greenland, 1998, pp. 183–186). Patient volume is, therefore, vital in the demonstration of drug efficacy required for drug marketing.

  11. Drop-outs can hamper the internal validity of studies if vital status data for the participants cannot be obtained, a phenomenon known in epidemiology as “loss to follow-up”. Uncertainty arises if information about vital status for patients who drop out of trials cannot be obtained, because it cannot be assessed whether there is a systematic difference in the outcomes between patients in the trial and drop-outs that can be related to the treatment under trial (uncertainty about potential bias). Moreover, if the reasons behind drop-outs are unknown, it can raise the suspicion that the drop-outs are related to adverse events but without an opportunity for assessing this.

  12. The Danish Act on Research Ethics Review of Health Research Projects, section 20, subsection 1, specifies that a condition for ethical permission is that “any payment or other compensation for trial subjects in return for participation in a health research project is not such as to affect the giving of consent” (www.dnvk.dk/English/actonabiomedicalresearch.aspx, website accessed 30 September 2013). The Danish National Research Ethics Committee’s guideline specifies that “it may not be the payment or the remuneration that motivates participation in the trial and the giving of consent. Consent shall be based on the trial subject’s voluntary acceptance of participation in research that aims to generate new knowledge within biomedical research” (www.dnvk.dk/English/guidelinesaboutnotification.aspx, website accessed 30 September 2013).

  13. None would report 8/9 or 7/9 symptoms; 7 per cent would report 6/9 symptoms; 5 per cent would report 5/9 symptoms; 12 per cent would report 4/9 symptoms; 17 per cent would report 3/9 symptoms; 7 per cent would report 2/9 symptoms; 12 per cent would report 1/9 symptoms; and none would report 0/9 symptoms. No clear pattern was seen across symptoms: swollen ankles, feet or hands (83 per cent), dizziness (76 per cent), respiratory problems (73 per cent), itching (56 per cent), headache (54 per cent), nausea (51 per cent), skin eruption (51 per cent), swelling in the face (46 per cent).

  14. This raises, of course, critical issues about which clinical studies patients should be enrolled in – especially, taking into account an ever more persistent critique of the lack of innovative potential in industry-initiated research. However, these are issues to be dealt with separately and, thus, are outside the scope of this article.

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Acknowledgements

First of all, the authors thank the informants, who generously shared their time, tasks and tensions with us, and the Nordea Foundation who generously funded this study. Moreover, this manuscript has benefitted substantially from insightful comments and suggestions from two anonymous reviewers, journal editors and discussions with colleagues at the Section for Health Services Research, Department of Public Health, University of Copenhagen. The authors especially thank Annamaria Carusi, David Schenck, Lia Evi Bang, Jill Fisher, Sebastian Mohr and Vibeke Pihl for their valuable comments and suggestions.

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  1. Department of Public Health, Section for Health Services Research, University of Copenhagen, Øster Farimagsgade 5B, PO Box 2099, Copenhagen, 1014, DK, Denmark

    Sarah Wadmann & Klaus Hoeyer

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  1. Sarah Wadmann
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Correspondence to Sarah Wadmann.

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Wadmann, S., Hoeyer, K. Beyond the ‘therapeutic misconception’: Research, care and moral friction. BioSocieties 9, 3–23 (2014). https://doi.org/10.1057/biosoc.2013.37

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