We are excited to share our latest review article on informed consent practices in the age of genetic medicines, published in the peer-reviewed, open access journal, Therapeutic Advances in Rare Disease (TAIRD).
On The Pulse director, Laurence Woollard, joined forces with Dr Rich Gorman and Dr Dakota Rosenfelt, to produce the comprehensive paper titled: “Improving patient informed consent for haemophilia gene therapy: the case for change.”
All three co-authors combined their in-depth knowledge and expertise in patient education, bioethics and science as well as lived-experience of the severe form of the condition. This is the second formal write-up by the group, having previously collaborated on an editorial urging community leaders to address educational equity in haemophilia gene therapy.
Publishing in TAIRD
To give some perspective on the article, Laurence explained:
“My co-authors and I were delighted to receive an invitation for submission of a review article to TAIRD, which are only commissioned by the Editor. We took this privileged opportunity to continue our advocacy efforts related to patient welfare and emerging novel technologies in haemophilia and the broader rare disease field, by focusing on patient informed consent and gene therapy.
We are each passionate about enabling people living with haemophilia to empower themselves to make evidence-informed treatment choices, whether as part of a clinical trial or for an approved product. This is especially pertinent given the enormity of weighing-up the ‘irreversible step’ of genomic medicine versus traditional medicine, whereby doses can be altered or stopped.
Considering the first gene therapy for haemophilia could be licensed for use within the next couple of years, we wanted to describe the fundamental principles of informed consent and explore current processes for consenting to haemophilia gene therapy clinical trials. We believe more needs to be done to protect and safe-guard the rights, interests and autonomy of research participants and patients, therefore have recommended several evidence-based strategies to enhance the consent procedure.
We hope that researchers, physicians and physician-investigators, the pharmaceutical industry and patient advocacy groups, who each have a moral and ethical responsibility, will strongly consider our proposals to ensure that patients are fully cognisant of the consent they give or deny.”
Tinna Urv, Editor in Chief of TAIRD, kindly commented:
“With the excitement of rapidly evolving technologies in therapeutics, there is often a sense of urgency to deliver treatments to patients as quickly as possible. However, with this need to deliver on the promise of science there comes a responsibility to ensure that patients are able to recognise their clinical situation, understand the implications of treatment and integrate every facet of their life into their decision. The importance of informed consent can not be overemphasised, nor can the understanding that ‘informed’ is more than just sharing information.
This paper provides excellent strategies to establish a consent process that leads to patients making educated decisions about their healthcare and lives.”
The publication is freely available to read and download online here.
TAIRD was launched in 2020 to publish the highest quality research, reviews and scholarly comment on pioneering efforts and innovative studies across all rare diseases. The journal is primarily aimed at clinicians and researchers and promotes inclusive, open science that reflects the disciplinary, human and geographic diversity of the rare disease community.
For more information about TAIRD, click here.
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