The evolution of withdrawal: negotiating research relationships in biobanking

Abstract

The right to withdraw from research, along with the necessity of adequately informed consent, is at the heart of the post-Nuremburg code of ethical safeguards in biomedical research on human participants. As biomedical research moves away from direct interventional studies towards research using networks of linked human tissue samples and data, however, questions arise about what withdrawal can and should mean in these new contexts. Some of the more expansive traditional understandings, such as the right to withdraw from a study ‘at any time’ are limited in practice by the nature of biobank- supported research, particularly where it makes possible widespread dissemination and ongoing reuse of data. It is time for a more nuanced, granular arrangement for withdrawal, appropriate to the ongoing relationships between participants and long-term biobanking enterprises.

Dynamic Consent: a potential solution to some of the challenges of modern biomedical research

“…A Dynamic Consent platform enables researchers to refine consent in a more nuanced way that the traditional ‘all or nothing’ approach (either participate in the research or not) [43]. For instance, researchers may give participants the choice to consent to some or all aspects of the research depending on their personal preferences and beliefs.…”

“…In these trials, relying solely on statistical methods or average responses to assess new treatment strategies is hardly optimal since the numbers are too small to quantify positive and negative uncertainties such as benefit and risk [57]. Researchers need to rely more on patients’ experiences by regularly collecting data from them regarding health outcomes, quality of life, side effects and personal utility of interventions over time [43]. In the RUDY study, participants use the online platform to fill in health questionnaires, manage their history of illness as well as diagnostics, prescriptions and surgical interventions.…”

Introduction to the article collection ‘Translation in healthcare: ethical, legal, and social implications’

“…This concept challenges established understandings of what informed consent is intended to mean, and raises the possibility that the protections it is supposed to offer may be undermined. Similarly, global, networked flows of data are also redefining the meaning of other traditional protections of human subjects’ research such as the right to withdraw from participation [20]. What are the implications of these changes for public trust and accountability in research?…”

Biobanks, Data Sharing, and the Drive for a Global Privacy Governance Framework

“…Potential participants tend to have two main choices when consenting: they can participate or not -and if they do, they can later withdraw (albeit to a varying extent.) 45 The space for negotiation over the terms of data access and use is virtually non-existent, an important issue for those who view privacy as a necessary dimension of autonomy. Lastly, it bears emphasizing that consent does not fully address privacy concerns, as obtaining participants' consent to share their data does not absolve data stewards (or custodians) and data users from their legal obligations to use data fairly and lawfully.…”