Informed Consent in Genomic Research: The Iterative Feedback Model

Felicitas Holzer

Keywords: genome sequencing, informed consent, iterative feedback, incidental findings, autonomy, practicality

DOI: 10.17160/josha.2.6.64

Languages: English

Recently, there has been a discussion on the best way to implement informed consent for the disclosure of incidental findings in research using whole genome sequencing (WGS)/whole exome sequencing (WES) procedures. Appelbaum et al. (2014:29) present four different “prototypical models” for the return of incidental findings, drawing on a literature review on return of incidental findings, a survey of a large number of genomic researchers and in-depth interviews with researchers and genomic research participants. I agree with Appelbaum et al. (2014) that consent models could be evaluated with the ethical criterion of “consistency with researchers’ ethical obligations” which is based on the ethical principles “respect for persons, beneficence, and justice” stated in the Belmont Report (1979). However, I propose to draw a different conclusion than Appelbaum et al. from this ethical evaluation. Appelbaum et al. (2014:30) state that selecting a consent model leads to inevitable tradeoffs between normative implications, referring to the criterion as well as to the practicality of the models. Hence, there is no model likely to represent a permanent solution to the challenges of obtaining meaningful consent. I will defend a fifth model, “the iterative consent model”, an informed consent model that grants full disclosure and comprehension of all relevant facts and circumstances of a research study using WGS/WES procedures prior to the study conduct – a prerequisite of the principle “respect for persons” which demands the ethical requirement of autonomous choice by research individuals (Belmont Report 1979). Thus, it will be responded to the main objection that practicality necessarily trumps “autonomy/respect for persons” in research using WGS/WES by reshaping the requirements of both colliding principles. Furthermore, I will propose a practical threshold for “relevant information” to understand the requisite of “full disclosure” of incidental findings before enrollment that it is consistent with “autonomy/respect for persons” and “practicality”.

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