Bioethics; Synthetic Biology; Nanomedicine; First-in-human trials
Rakic Milenko, Dittrich Tolga, Elger Bernice S, Shaw David (2017), Enhancing patients' autonomy by involving them in research ethics committees., in International journal for quality in health care : journal of the International Society for Quality
Rakic Milenko, Wienand Isabelle, Shaw David, Nast Rebecca, Elger Bernice S (2017), Autonomy and Fear of Synthetic Biology: How Can Patients' Autonomy Be Enhanced in the Field of Synthetic Biology? A Qualitative Study with Stable Patients., in Science and engineering ethics
, 23(2), 375-388.
Heidari Raheleh, Shaw David Martin, Elger Bernice Simone (2017), CRISPR and the Rebirth of Synthetic Biology, in Science and engineering ethics
Heidari R, Shaw DM, Elger BS (2017), CRISPR and the rebirth of Synthetic Biology., in Science and Engineering Ethics
, 23(2), 351-363.
Satalkar P, Elger B S, Shaw D M (2016), Stakeholder views on participant selection for first-in-human trials in cancer nanomedicine., in Current oncology (Toronto, Ont.)
, 23(6), 530-537.
Satalkar Priya, Elger Bernice Simone, Shaw David M (2016), Defining Nano, Nanotechnology and Nanomedicine: Why Should It Matter?, in Science and engineering ethics
, 22(5), 1255-1276.
Satalkar Priya, Elger Bernice Simon, Hunziker Patrick, Shaw David (2016), Challenges of clinical translation in nanomedicine: A qualitative study, in Nanomedicine : nanotechnology, biology, and medicine
, 12(4), 893-900.
Satalkar Priya, Elger Bernice Simone, Shaw David (2016), Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials., in Nanomedicine (London, England)
, 11(8), 933-940.
Satalkar Priya, Elger Bernice Simon, Hunziker Patrick, Shaw David (2016), 2016, in Nanomedicine : nanotechnology, biology, and medicine
, 12(4), 893-900.
Genske Anna, Engel-Glatter Sabrina (2016), Rethinking risk assessment for emerging technology ￼first-in-human trials., in Medicine Health Care and Philosophy
, 19(1), 125-139.
Satalkar Priya, Elger Bernice E, Shaw David M (2015), Prioritising Healthcare Workers for Ebola Treatment: Treating Those at Greatest Risk to Confer Greatest Benefit., in Developing world bioethics
, 15(2), 59-67.
Satalkar Priya, Shaw David (2015), Not Fit for Purpose: The Ethical Guidelines of the Indian Council of Medical Research., in Developing World Bioethics
, 15(1), 40-47.
Shaw David, Elger Bernice (2014), Putting patients on research ethics committees, in Journal of the Royal Society of Medicine
, 107(8), 304-307.
Nast Rebecca, Badarau Domnita, Shaw David (2014), The vulnerability of the individual vulnerability argument, in American Journal of Bioethics
, 14(12), 17-18.
Shaw David (2013), The right to participate in high-risk research, in The Lancet
, 383(9921), 1009-1011.
Genske Anna, Engel Sabrina, Elger Bernice (2012), Synthetische Prothese gegen Gicht?, in PrimaryCare
, 12(20), 392-393.
Rakic M, Wienand I, Shaw D, Nast R, Elger BS, Autonomy and Fear of Synthetic Biology: How Can Patients' Autonomy Be Enhanced in the Field of Synthetic Biology? A Qualitative Study with Stable Patients, in Science and Engineering Ethics
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.