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• Does the pragmatic model undermine the importance of the ethical obligations involved in information process? A defence of continuous genetic counselling for research participants.
  Felicitas S. Holzer
  Published on: 18 May 2017

• Published on: 18 May 2017

  Does the pragmatic model undermine the importance of the ethical obligations involved in information process? A defence of continuous genetic counselling for research participants.

  • Felicitas S. Holzer, Master Student
  • Other Contributors:
    • Ignacio Mastroleo

  Hallowell et al. advocate an interesting pragmatic approach to the disclosure of genetic information in research settings. Furthermore, they present a useful framework which explicitly addresses advantages and disadvantages linked to different feedback policies researchers could pursue (Hallowell et al. 2014, table 1).

  We agree with the authors that the feedback of findings from whole- genome sequencing (WGS) o...

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  Hallowell et al. advocate an interesting pragmatic approach to the disclosure of genetic information in research settings. Furthermore, they present a useful framework which explicitly addresses advantages and disadvantages linked to different feedback policies researchers could pursue (Hallowell et al. 2014, table 1).

  We agree with the authors that the feedback of findings from whole- genome sequencing (WGS) or whole-exome sequencing (WES) technologies cannot be considered as automated processes of data disclosure. Since we have to take into account the research participant's autonomy as well as the prevention of possible harms related to the disclosure of genetic information, feedback policies have to be carefully chosen and thought over.

  In its evaluation of feedback policies, the authors state that no feedback undermines participant autonomy (policy A) and choosing their feedback option maximizes it (policy E) (Hallowell et al. 2014, table 1). However, more freedom to choose feedback options is not necessarily related to a more autonomous choice of the participant. It could be argued against Hallowell et al. that if in the information platforms suggested by Kaye et al. (2012) research participants were responsible to select on their own what level of research participation they consent to and which results they would access, this would not necessarily represent a more autonomous decision. This one-dimensional view of autonomy undermines the importance of intelligible communicative information transmission (Manson and O'Neill 2007) an essential and ethically demanded dimension of research participants' autonomous decision making (Eyal 2012).

  As an alternative to Hallowell et al. interpretation of autonomy, Manson and O'Neill (2007) suggest an agency-based approach that is based on informational and communicative obligations between the parties of counsellors and patients in a clinical context that could be extended to the process of information disclosure in genetic research. Assuming that the researcher's interest does not primarily focus on the information submission to the participants but on the generation of scientific knowledge, the agency-based approach between counsellor and participant could provide a better framework for assuring intelligible communicative information for the research participant. Autonomy should not refer only to more options to choose from, but also to an enhanced comprehension of information on possible harms and benefits of WGS/WES technologies.

  Hallowell et al. state that feedback of genetic findings goes hand in hand with extensive resources consumed due to the information costs arising in the communication process. Nonetheless, it can be objected that information costs should not exceed the normal information costs of a clinical setting. E.g. after receiving the research results and counselling the participant, the counsellor may initiate a personalized genetic test in order to correctly approve the general finding in the participant's personal context. Thus, the counsellor who stays in close contact with the participant is responsible for the information disclosure and information revealing is part of the counsellor-participant relationship. The counsellor therefore can be considered as the link between research (research results are usually published in journals or data bases) and the participant.

  Furthermore, it would be incorrect to consider researchers and sponsors as the only responsible agents for the costs of informational and communicative obligations. As it occurs with other ethical requirements in research settings such as post-trial obligations of access to beneficial information and interventions (WMA 2013 paragraphs 26 and 34, Mastroleo 2014), other agents -e.g. host country governments- have interests in and bear responsibility for the participants' health needs. So, following commonly held principles for conducting human health research, it could be argued that in advance of a clinical trial, sponsors, researchers and governments (among other agents) should make provisions and bear the economic costs of continuous genetic counselling for participants who may need it.

  Finally, besides discussing obligations of researchers towards participants and pointing out the numerous problems arising in this case (information costs, data quality, communication restrictions etc.), we should also focus on the communication process between counsellor and research participant as well as the counsellor's obligations towards potential participants prior to the participation in research projects. If we are taking seriously ethical obligation of genetic information process towards research participants, the consequences of data revealing should be discussed before samples are collected. Moreover, data disclosure should be a continuous process underlying the "nature" of genetic information: research on genetic data is an ongoing process; ideally it should be moderated by a counsellor to grant research participants truly informed and autonomous decisions.

  References

  Eyal, N. (2012). "Informed Consent", The Stanford Encyclopedia of Philosophy (Fall 2012 Edition), Edward N. Zalta (ed.), http://plato.stanford.edu/entries/informed-consent/#VolCon

  Hallowell, N., Hall, A., Alberg, C., Zimmern, R. (2014). "Revealing the results of whole-genome sequencing and whole-exome sequencing in research and clinical investigations: some ethical issues". JME; 0:1-5.

  WMA Declaration of Helsinki (2013). "Ethical Principles for Medical Research Involving Human Subjects.", http://www.wma.net/en/30publications/10policies/b3/

  Kaye, J., Curren, L., Anderson, N. (2012). From patients to partners: participant-centric initiatives in biomedical research. Nat Rev Genet; 3: 371-6.

  Manson, N., O'Neill, O. (2007). Rethinking informed consent in bioethics. Cambridge University Press, New York.

  Mastroleo, I. (2014). "Consideraciones sobre las obligaciones posinvestigaci?n en la Declaraci?n de Helsinki 2013." Revista de bio?tica y derecho; 31: 51-65, http://revistes.ub.edu/index.php/RBD/article/view/10438

  Acknowledgments

  We would like to thank Prof. Mertelsmann for helpful comments on this letter.

  Contributors

  Both authors were involved in the drafting and writing of this piece. Both authors approved the final version of the manuscript and are accountable for all aspects included in it.

  Conflict of Interest:

  None declared

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  Conflict of Interest:
  None declared.

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