Project

Discipline

Bioethics; Synthetic Biology; Nanomedicine; First-in-human trials

Lead
Lay summary
BACKGROUND Research regarding  existing and planned studies in synthetic biology and nanomedicine – so called converging technologies is urgently needed. Recommendations issued globally on these new and developing technologies remain rather general and of limited help. Most do not provide specific guidance to experts and researchers who have to decide whether, and under which circumstances, a first-in-human (FIH) trial is justified using these new and promising technologies. Possible risks are not only relevant for patients, factory worker and scientists who come in contact with the new devices and materials, but also for the wider population and environment. Given the considerable range and the complexity of the ethical questions involved, an interdisciplinary evaluation of present and future studies is required taking into account patient values and bringing together the expertise of ethicists and scientists. AIM The goal of this project is to develop clear  strategies on balancing benefits and harms as the study results will propose evaluation steps helpful to researchers who plan FIH studies, to funding sources and REC members who evaluate them, to patients who make participation decisions in these trials as well as to policy makers and the society. METHODS The project will be divided into two subprojects, synthetic biology and nanomedicine, and will consist of the following three steps: 1.    Existing guidelines for FIH trials in both synthetic biology and nanomedicine will be compared. A summary will also be developed detailing how other studies have examined patients’ attitudes on these two topics and the process of informed consent. 2.    A comprehensive exploration of how experts and patients balance conflicting values and what their perceived needs for information and safety are will then be conducted by interviewing and surveying experts, patients and participants of FIH trials. 3.    Finally, FIH trials in general will be examined. Four specific projects in particular will be analysed using classical methods of ethics and integrating stakeholders’ views obtained in the previous parts. IMPORTANCE AND IMPACT The present study is unique in that it combines the ethical evaluation of existing and planned cutting edge research, in two different fields, both of which are in need of recommendations regarding FIH trials. This is advantageous for a number of reasons.  First, because these so called converging technologies have some aspects in common when it comes to FIH trials, the project will benefit from synergic effects. Second, the interaction and linkage of the two projects is crucial to ensure comprehensive data collection and to realise a truly interdisciplinary endeavour necessary to find realistic and ethically acceptable solutions to these important problems. Finally, the project presents a unique opportunity to disseminate solutions and recommendations developed in an interdisciplinary context where expert knowledge and opinions of different stakeholders were taken into account.

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Last update: 21.02.2013

Active participation

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Communication	Title	Media	Place	Year

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BACKGROUND OF THE RESEARCH MODULEEmbedded research related to existing or planned projects is urgently needed in synthetic biology and the field of nanomedicine. During the past 5 years, several US and European bodies have issued separate guidelines on the ethical issues of (a) synthetic biology and (b) nanotechnology and/or nanomedicine. These recommendations remain rather general and of limited help to researchers in these fields. Indeed, although many guidelines acknowledge the heterogeneity of research projects in the fields of both synthetic biology and nanotechnology and the need for individual ethical assessment of different research projects, they tend to address ethical issues in global terms. Most of these reports do not provide specific guidance to stakeholders who have to decide whether and under which circumstances a first-in-human trial is justified using any of the two new and promising technologies. Decision making concerns patients, scientists, policy makers and the public because of the various risks and benefits of these technologies. Possible risks are relevant not only for patients, factory worker and scientists in contact with the new devices and materials, but also for the wider population and the environment. In light of the considerable range and the complexity of the ethical questions, an interdisciplinary evaluation of present and future research projects is required bringing together the expertise of ethicists and scientists while taking into account patient values. AIMS OF THE RESEARCH MODULE(a) Obtain data from the literature and the analysis of guidelines to compare decisions and criteria related to first-in-human trials using nanomedical or synthetic biology devices. Identify consensus and disagreement of guidelines and develop a synopsis about accepted and not accepted trials where the cut-off points become visible.(b) Obtain comprehensive facts on benefits and harms as well as data on how experts and patients balance the conflicting values and what are their perceived needs for information and safeguards.(c) Develop transparent strategies how to balance benefits and harms in 4 projects in Basel and in general. Propose evaluation steps that are helpful for researchers who plan FIH studies, funding sources and REC members who evaluate them, patients who make decisions to participate or not in these trials, as well as policy makers and society.METHODS OF THE DIFFERENT PROJECT PARTSBoth subprojects will evolve in parallel and contain 3 parts. The 1st part (a.) consists of a literature review of guidelines, of FIH trials in the two domains, and of studies on patient attitudes and informed consent. In the 2nd part (b.) data about knowledge and attitudes of 40 experts, 20 gout patients (i.), 100 other patients and 200 other possible participants of FIH trials (ii.) will be obtained through semi-structured interviews (i.) and a questionnaire study (ii.) using established social science methods of quantitative and qualitative research. The 3rd part (c.) uses classical methods of ethical analysis of FIH trials in general and of four specific projects in particular, and integrates stakeholders’ views examined in the previous parts.IMPORTANCE AND IMPACT OF THE MODULE AND OF THE LINKS BETWEEN ITS TWO PROJECTSThe present study fills an important gap and is unique in that it combines, within one research module, the ethical evaluation of existing and planned cutting edge biotechnology studies in two departments and fields. The objective is to profit from the synergic effects of carrying out simultaneously the ethical evaluation of human trials concerning both D-BSSE research projects and future studies using nanomedicine devices. This is advantageous, first, because the so called converging technologies have some aspects in common when it comes to first-in-human trials. Second, the interaction and linkage of the two projects within the planned research module will be crucial to ensure comprehensive data collection on these important ethical issues and to realise a truly interdisciplinary endeavour necessary to find realistic and ethically acceptable solutions to the existing problems.The project will permit to collect important new data and to cross-link results from the ethical analysis of FIH in both subprojects. It presents a unique opportunity to disseminate solutions and recommendations that have been developed in an interdisciplinary context, taking into account expert knowledge and opinions of different stakeholders.