Project

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Ethical issues of cutting edge biotechnology: Embedded interdisciplinary risk benefit evaluation of first-in-human trials in synthetic biology and nanomedicine

English title Ethical issues of cutting edge biotechnology: Embedded interdisciplinary risk benefit evaluation of first-in-human trials in synthetic biology and nanomedicine
Applicant Elger Bernice
Number 137194
Funding scheme ProDoc
Research institution Institut für Bio- und Medizinethik (IBMB) Universität Basel
Institution of higher education University of Basel - BS
Main discipline Health Education
Start/End 01.08.2012 - 29.02.2016
Approved amount 301'964.00
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All Disciplines (2)

Discipline
Health Education
Sociology

Keywords (4)

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

Lay Summary (English)

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.
Direct link to Lay Summary Last update: 21.02.2013

Responsible applicant and co-applicants

Employees

Publications

Publication
Enhancing patients' autonomy by involving them in research ethics committees.
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 , 1-5.
Autonomy and Fear of Synthetic Biology: How Can Patients' Autonomy Be Enhanced in the Field of Synthetic Biology? A Qualitative Study with Stable Patients.
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.
CRISPR and the Rebirth of Synthetic Biology
Heidari Raheleh, Shaw David Martin, Elger Bernice Simone (2017), CRISPR and the Rebirth of Synthetic Biology, in Science and engineering ethics, 1-33.
CRISPR and the rebirth of Synthetic Biology.
Heidari R, Shaw DM, Elger BS (2017), CRISPR and the rebirth of Synthetic Biology., in Science and Engineering Ethics, 23(2), 351-363.
Stakeholder views on participant selection for first-in-human trials in cancer nanomedicine.
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.
Defining Nano, Nanotechnology and Nanomedicine: Why Should It Matter?
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.
Challenges of clinical translation in nanomedicine: A qualitative study
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.
Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials.
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.
2016
Satalkar Priya, Elger Bernice Simon, Hunziker Patrick, Shaw David (2016), 2016, in Nanomedicine : nanotechnology, biology, and medicine, 12(4), 893-900.
Rethinking risk assessment for emerging technology first-in-human trials.
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.
Prioritising Healthcare Workers for Ebola Treatment: Treating Those at Greatest Risk to Confer Greatest Benefit.
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.
Not Fit for Purpose: The Ethical Guidelines of the Indian Council of Medical Research.
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.
Putting patients on research ethics committees
Shaw David, Elger Bernice (2014), Putting patients on research ethics committees, in Journal of the Royal Society of Medicine, 107(8), 304-307.
The vulnerability of the individual vulnerability argument
Nast Rebecca, Badarau Domnita, Shaw David (2014), The vulnerability of the individual vulnerability argument, in American Journal of Bioethics, 14(12), 17-18.
The right to participate in high-risk research
Shaw David (2013), The right to participate in high-risk research, in The Lancet, 383(9921), 1009-1011.
Synthetische Prothese gegen Gicht?
Genske Anna, Engel Sabrina, Elger Bernice (2012), Synthetische Prothese gegen Gicht?, in PrimaryCare, 12(20), 392-393.
Autonomy and Fear of Synthetic Biology: How Can Patients' Autonomy Be Enhanced in the Field of Synthetic Biology? A Qualitative Study with Stable Patients
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, 1.

Collaboration

Group / person Country
Types of collaboration
Prof. Mark Bedau United States of America (North America)
- in-depth/constructive exchanges on approaches, methods or results

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Oxford Global Health and Bioethics International Conference. Talk given at a conference Balancing the 'global' and the 'local': Case of clinical trials regulation in India. 28.09.2015 Oxford, Great Britain and Northern Ireland Satalkar Priya;
International Neuroethics Society Annual Meeting Poster Defining and Defying Death: Making Sense of Brain Death and Cadaveric Organ Donation in India 08.11.2014 San Diego, United States of America Satalkar Priya;
International conference of American Anthropological Association Talk given at a conference What is risk anyway? Differential discourse on risk of first in human trials in nanomedicine, 20.11.2013 Chicago, United States of America Elger Bernice; Satalkar Priya;
5th International Conference on pharmaceutical life cycle Talk given at a conference The embryogenesis of nanomedicine: working through ethical challenges of FIH trials, 02.09.2013 Driebergen,, Netherlands Elger Bernice; Satalkar Priya;
International conference for young scholars on research ethics Talk given at a conference Challenges of translational research in medical applications of nanotechnology 26.08.2013 Hannover, Germany Satalkar Priya;
27th European Conference on Philosophy of Medicine and Health Care Talk given at a conference Nano Tech, Mega Risks? Ethical uncertainties in first- in-human trials of nanotechnology. 14.08.2013 Basel, Switzerland Elger Bernice; Satalkar Priya;
TRANSDISS-Klausurtagung Talk given at a conference Ethical issues in synthetic biology clinical research – an interview study with chronically ill patients in Switzerland 24.06.2013 Hamburg, Germany Genske Anna; Elger Bernice;
CLINAM Conference (Clinical Nanomedicine and Targeted Medicine) Poster First in Human (FIH) Trials of Nanomedicine: A fine balance between caution and progress 23.06.2013 Basel, Switzerland Genske Anna; Satalkar Priya; Elger Bernice;
CLINAM Conference (Clinical Nanomedicine and Targeted Medicine) Poster First in Human (FIH) Trials of Nanomedicine: A fine balance between caution and progress. 23.06.2013 Basel, Switzerland Satalkar Priya; Genske Anna; Elger Bernice;
Annual IAS-STS Conference “Critical Issues in Science and Technology Studies” Talk given at a conference The translation of synthetic biology medical devices into medical practice – Guiding the process 05.05.2013 Graz, Austria Elger Bernice; Genske Anna;
12th Annual IAS-STS Conference “Critical Issues in Science and Technology Studies” Talk given at a conference Assessment of risks and benefits of FIH trails in nanomedicine-Enquiry through empirical research in Bioethics 05.05.2013 Graz, Austria Genske Anna; Satalkar Priya; Elger Bernice;
ITAS (Institute for technology assessment and systems analysis) Karlsruhe Talk given at a conference Incomplete knowledge and the translation of synthetic biology medical devices into clinical practice 18.04.2013 Karlsruhe, Germany Genske Anna; Elger Bernice;


Knowledge transfer events

Active participation

Title Type of contribution Date Place Persons involved
Young Scientists debate on ethics of synthetic biology Talk 16.02.2016 Lausanne, Switzerland Satalkar Priya;


Communication with the public

Communication Title Media Place Year
Media relations: print media, online media Es herrscht die diffuse Angst, das sei alles Frankenstein- Forschung Interview of Shaw DM at NZZ, published on 15th March 2016 German-speaking Switzerland 2016
Media relations: print media, online media Rubrik: Rund um Forschung - Funf Fragen an Bernice Elger Biocenter Journal German-speaking Switzerland 2016
Talks/events/exhibitions Fame Lab Switzerland, participation of Satalkar P German-speaking Switzerland Western Switzerland 2015

Awards

Title Year
Priya Satalkar won Basel semifinals of FameLab Switzerland, where she explained ethical challenges of first in human trials of cutting edge biotechnology to lay audience in 180 seconds. 2015
Antelope career coaching program for female researchers at University of Basel. It encompassed 3 specialized professional trainings, one visit to an academic mentor overseas and participation in a conference. 2014

Abstract

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.
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