Response to letter entitled: Re: Mainstreaming informed consent for genomic sequencing: A call for action

In a recent paper we note that oncologists are increasingly ordering genomic sequencing tests directly, without the involvement of clinical geneticists, for the purposes of differential diagnosis and personalised medicine. Non-geneticist clinicians are expected to assist their patients with decision-making about genetic testing, but guidance for doing so is lacking. In our paper, we take key tenets of the strong ethical tradition of informed consent as it has evolved within the practice of clinical genetics and extend them to the ‘mainstream’ setting of oncology. As part of the informed consent process, we argue, oncologists should inform patients about the possibility that suspected germline mutations, variants of uncertain significance (VUS), and unsolicited findings pertaining to other conditions may be detected as such information may be harmful. Also, we argued, patients have a right to opt out of receiving information about such additional findings.