Prelims

Half Title Page

ETHICS AND INTEGRITY IN HEALTH AND LIFE SCIENCES RESEARCH

Series Page

ADVANCES IN RESEARCH ETHICS AND INTEGRITY

Series Editor: Dr Ron Iphofen FAcSS, Independent Consultant, France

Recent Volumes:

Series Editorial Advisory Group

• Professor Robert Dingwall, FAcSS

  Dingwayy Enterprises Ltd and Nottingham Trent University, UK

• Dr Nathan Emmerich

  Institute of Ethics, Dublin City University and Queens University Belfast, UK

• Professor Mark Israel, FAcSS

  University of Western Australia, Australia

• Dr Janet Lewis, FAcSS

  Former Research Director, Joseph Rowntree Foundation, UK

• Professor John Oates, FAcSS

  Open University, UK

• Associate Professor Martin Tolich

  University of Otago, New Zealand

• SPECIAL ADVISORS FOR VOLUME 4

• Dr Francois Hirsch

  French Institute of Health and Medical Research, France (INSERM)

• Professor James A. Houghton

  National University of Ireland, Ireland

• Professor Janet Mifsud

  University of Malta, Malta

• Professor Joseph Schmucker-von Koch

  University of Regensburg, Germany

Title Page

ADVANCES IN RESEARCH ETHICS AND INTEGRITY VOLUME 4

ETHICS AND INTEGRITY IN HEALTH AND LIFE SCIENCES RESEARCH

EDITED BY

ZVONIMIR KOPORC

Catholic University of Croatia, Zagreb

United Kingdom – North America – Japan – India – Malaysia – China

Copyright Page

Emerald Publishing Limited

Howard House, Wagon Lane, Bingley BD16 1WA, UK

First edition 2019

Copyright © 2019 Emerald Publishing Limited

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British Library Cataloguing in Publication Data

A catalogue record for this book is available from the British Library

ISBN: 978-1-78743-572-8 (Print)

ISBN: 978-1-78743-571-1 (Online)

ISBN: 978-1-78743-918-4 (Epub)

ISSN: 2398-6018 (Series)

Series Preface

This book series, Advances in Research Ethics and Integrity, grew out of foundational work with a group of Fellows of the UK Academy of Social Sciences (AcSS) who were all concerned to ensure that lessons learned from previous work were built upon and improved in the interests of the production of robust research practices of high quality. Duplication or unnecessary repetitions of earlier research and ignorance of existing work were seen as hindrances to research progress. Individual researchers, research professions, and society all suffer in having to pay the costs in time, energy, and money of delayed progress and superfluous repetitions. There is little excuse for failure to build on existing knowledge and practice given modern search technologies unless selfish “domain protectionism” leads researchers to ignore existing work and seek credit for innovations already accomplished. Our concern was to aid well-motivated researchers to quickly discover existing progress made in ethical research in terms of topic, method, and/or discipline and to move on with their own work more productively and to discover the best, most effective means to disseminate their own findings so that other researchers could, in turn, contribute to research progress.

It is true that there is a plethora of ethics codes and guidelines with researchers left to themselves to judge those more appropriate to their proposed activity. The same questions are repeatedly asked on discussion forums about how to proceed when similar long-standing problems in the field are being confronted afresh by novice researchers. Researchers and members of ethics review boards alike are faced with selecting the most appropriate codes or guidelines for their current purpose, eliding differences and similarities in a labyrinth of uncertainty. It is no wonder that novice researchers can despair in their search for guidance and experienced researchers may be tempted by the “checklist mentality” that appears to characterize a meeting of formalized ethics “requirements” and permit their conscience-free pursuit of a cherished program of research.

If risks of harm to the public and to researchers are to be kept to a minimum and if professional standards in the conduct of scientific research are to be maintained, the more that fundamental understandings of ethical behavior in research are shared the better. If progress is made in one sphere, all gain from it being generally acknowledged and understood. If foundational work is conducted, all gain from being able to build on and develop further that work.

Nor can it be assumed that formal ethics review committees are able to resolve the dilemmas or meet the challenges involved. Enough has been written about such review bodies to make their limitations clear. Crucially they cannot follow researchers into the field to monitor their every action; they cannot anticipate all of the emergent ethical dilemmas nor, even, follow through to the publication of findings. There is no adequate penalty for neglect through incompetence, nor worse, for conscious omissions of evidence. We have to rely upon the “virtues” of the individual researcher alongside the skills of journal and grant reviewers. We need constantly to monitor scientific integrity at the corporate and at the individual level. These are issues of “quality” as well as morality.

Within the research ethics field new problems, issues, and concerns and new ways of collecting data continue to emerge regularly. This should not be surprising as social, economic, and technological change necessitate constant re-evaluation of research conduct. Standard approaches to research ethics such as valid informed consent, inclusion/exclusion criteria, vulnerable subjects, and covert studies need to be reconsidered as developing social contexts and methodological innovation, interdisciplinary research, and economic pressures pose new challenges to convention. Innovations in technology and method challenge our understanding of “the public” and “the private”. Researchers need to think even more clearly about the balance of harm and benefit to their subjects, to themselves, and to society. This series proposes to address such new and continuing challenges for both ethics committees and researchers in the field as they emerge. The concerns and interests are global and well recognized by researchers and commissioners alike around the world but with varying commitments at both the “procedural” and the “practical” levels. This series is designed to suggest realistic solutions to these challenges – this “practical” angle is the USP for the series. Each volume will raise and address the key issues in the debates, but also strive to suggest ways forward that maintain the key ethical concerns of respect for human rights and dignity, while sustaining pragmatic guidance for future research developments. A series such as this aims to offer practical help and guidance in actual research engagements as well as meeting the often varied and challenging demands of research ethics review. The approach will not be one of abstract moral philosophy; instead, it will seek to help researchers think through the potential harms and benefits of their work in the proposal stage and assist their reflection of the big ethical moments that they face in the field often when there may be no one to advise them in terms of their societal impact and acceptance.

While the research community can be highly imaginative both in the fields of study and methodological innovation, the structures of management and funding, and the pressure to publish to fulfill league table quotas can pressure researchers into errors of judgment that have personal and professional consequences. The series aims to adopt an approach that promotes good practice and sets principles, values, and standards that serve as models to aid successful research outcomes. There is clear international appeal as commissioners and researchers alike share a vested interest in the global promotion of professional virtues that lead to the public acceptability of good research. In an increasingly global world in research terms, there is little point in applying too localized a morality, nor one that implies a solely Western hegemony of values. If standards “matter,” it seems evident that they should “matter” to and for all. Only then can the growth of interdisciplinary and multinational projects be accomplished effectively and with a shared concern for potential harms and benefits. While a diversity of experience and local interests is acknowledged, there are existing, proven models of good practice which can help research practitioners in emergent nations build their policies and processes to suit their own circumstances. We need to see that consensus positions effectively guide the work of scientists across the globe and secure minimal participant harm and maximum societal benefit – and, additionally, that instances of fraudulence, corruption, and dishonesty in science decrease as a consequence.

Perhaps some forms of truly independent formal ethics scrutiny can help maintain the integrity of research professions in an era of enhanced concerns over data security, privacy, and human rights legislation. But it is essential to guard against rigid conformity to what can become administrative procedures. The consistency we seek to assist researchers in understanding what constitutes “proper behavior” does not imply uniformity. Having principles does not lead inexorably to an adherence to principlism. Indeed, sincerely held principles can be in conflict in differing contexts. No one practice is necessarily the best approach in all circumstances. But if researchers are aware of the range of possible ways in which their work can be accomplished ethically and with integrity, they can be free to apply the approach that works or is necessary in their setting. Guides to “good” ways of doing things should not be taken as the “only” way of proceeding. A rigidity in outlook does no favors to methodological innovation, nor to the research subjects or participants that they are supposed to “protect”. If there were to be any principles that should be rigidly adhered to they should include flexibility, open-mindedness, the recognition of the range of challenging situations to be met in the field – principles that in essence amount to a sense of proportionality. And these principles should apply equally to researchers and ethics reviewers alike. To accomplish that requires ethics reviewers to think afresh about each new research proposal, to detach from pre-formed opinions and prejudices, while still learning from and applying the lessons of the past. Principles such as these must also apply to funding and commissioning agencies, to research institutions, and to professional associations and their learned societies. Our integrity as researchers demands that we recognize that the rights of our funders and research participants and/or “subjects” are to be valued alongside our cherished research goals and seek to embody such principles in the research process from the outset. This series will strive to seek just how that might be accomplished in the best interests of all.

By

Ron Iphofen (Series Editor)

About the Series Editor

Ron Iphofen, FAcSS, is Executive Editor of the Emerald book series Advances in Research Ethics and Integrity and edited Volume 1 in the series, Finding Common Ground: Consensus in Research Ethics Across the Social Sciences (2017). He is an Independent Research Consultant, a Fellow of the UK Academy of Social Sciences, the Higher Education Academy, and the Royal Society of Medicine. Since retiring as Director of Postgraduate Studies in the School of Healthcare Sciences, Bangor University, his major activity has been as an adviser to the European Commission (EC) and its agencies, the European Research Council (ERC), and the Research Executive Agency (REA) on both the Seventh Framework Programme (FP7) and Horizon 2020. His consultancy work has covered a range of research agencies (in government and independent) across Europe. He was Vice Chair of the UK Social Research Association, updated their Ethics Guidelines and now convenes the SRA’s Research Ethics Forum. He was scientific consultant on the EC RESPECT project – establishing pan-European standards in the social sciences and chaired the Ethics and Societal Impact Advisory Group for another EC-funded European Demonstration Project on mass transit security (SECUR-ED). He has advised the UK Research Integrity Office; the National Disability Authority (NDA) of the Irish Ministry of Justice; the UK Parliamentary Office of Science and Technology; the Scottish Executive; UK Government Social Research; National Centre for Social Research; the Audit Commission; the Food Standards Agency; the Ministry of Justice; the BIG Lottery; a UK Local Authorities’ Consortium; Skills Development Scotland; Agence Nationale de la Recherche (ANR the French Research Funding agency) among many others. Ron was founding Executive Editor of the Emerald gerontology journal Quality in Ageing and Older Adults. He published Ethical Decision Making in Social Research: A Practical Guide (Palgrave Macmillan, 2009 and 2011) and coedited with Martin Tolich The SAGE Handbook of Qualitative Research Ethics (Sage, 2018). He is currently leading a new €2.8M European Commission-funded project (PRO-RES) that aims at promoting ethics and integrity in all non-medical research (2018–2021).

https://roniphofen.com/

About the Editor

Zvonimir Koporc has international recognition for expertise on research in life sciences (immunology) and professional standards in research ethics. His primary consultative activity in ethics and life sciences at present is for the European Commission (EC) Ethics Unit, Directorate General for Science and Innovation, the Research Executive Agency (REA), and the European Research Council (ERC). He has acted as Consultant, Adviser, and/or delivered training on research ethics at the European and national level. He has worked in several life science teams in Europe, and his PhD in Chemistry was awarded by the Technical University of Vienna, Austria. At the beginning of 2007 he returned to his home country through the national program called “Return of the scientists,” which was announced from the Croatian Ministry of Science. As a scientist he took up a position at the prominent Croatian scientific institution – Institute Rudjer Boskovic, Zagreb. Receiving his university tenured track position, he moved then to the Department of Biotechnology, University of Rijeka, where he stayed until 2015. From that year on, he joined Catholic University of Croatia Zagreb where he currently holds a position of University Associate Professor in Physiology where he is also a member of the Ethics Review Board. He has published extensively on immunology. Over and above the life sciences, his current professional interests are in research ethics and scientific integrity. Developing a fruitful cooperation with the Croatian Data Protection Agency in October of 2017, he organized a symposium on “Data protection in research – an insight in to the EU General Data Protection Regulation (GDPR) 25/5/2018” where he acted as a president of the organizing committee. Another fruitful cooperation has been developed with the Croatian National Agency for Mobility and EU Programmes funds where Dr Koporc regularly holds guidance workshops on ethics and research integrity for scientists and research professionals intending to apply for EU funds.

List of Contributors

Joana Araújo is Lecturer and Vice-Director of the Instituto de Bioética, Universidade Católica Portuguesa (Porto, Portugal), where she acts as Research Coordinator and collaborates in several research projects. She holds a doctorate and master’s degree in Bioethics awarded from the Instituto de Bioética, Universidade Católica Portuguesa. She is Member of the Office of Ethical Evaluation and Science Integrity at the Portuguese Foundation for Science and Technology and Expert for ethics evaluation of the European Commission. She is also member of the Ethics Committees of the Escola Superior de Saúde de Viseu, Hospital da Luz Arrábida, and Universidade Católica Portuguesa (Porto).

T. Nelson Campbell directed and wrote PlantPure Nation. This feature film examines the political and economic factors that suppress information on the benefits of plant-based nutrition, while making the connections of this idea to larger issues such as medical practice, farming, and food deserts. He also leads an organization that he established to organize a grassroots movement around the health message of plant-based nutrition (HealingAmericaTogether.com). In addition, he founded a nonprofit organization (PlantPureCommunities.org) to spearhead a network of hundreds of plant-based support groups, involving (as of the time of this publication) well over 100,000 people, as well as a strategy for bringing nutrition education and affordable foods into underserved communities. Prior to this, Nelson had 25 years of entrepreneurial experience building various companies. He has undergraduate and graduate degrees from Cornell University in political science and economics.

T. Colin Campbell, PhD, has been actively researching diet and health issues for more than six decades. He also spent about 20 of those same years participating in national and international policy development on diet and health. His experimental research initially centered on the demonstration that dietary animal protein sharply increases experimental cancer development in laboratory rodents. Findings from his and other research groups shows that nutrition, provided by whole plant-based foods, creates more health and prevents more disease than all the conventional pills and procedures combined. More generally, it begs the question why nutrition has been so long ignored by the field of medicine.

Ana Sofia Carvalho is Associate Professor with Aggregation in Bioethics, Director of the Instituto de Bioética, and Chair of the Portuguese UNESCO Chair in Bioethics at the Universidade Católica Portuguesa (Porto, Portugal), where she coordinates the Doctoral Program in Bioethics. She holds a doctorate degree in Biotechnology (Escola Superior de Biotecnologia, Universidade Católica Portuguesa). Prof. Carvalho coordinates the Office of Ethical Evaluation and Science Integrity at the Portuguese Foundation for Science and Technology, and is a Member of the National Ethics Council for the Life Sciences. She is member of the European Group on Ethics in Science and Technology and Expert for ethics evaluation of the European Commission.

Kate Chatfield is Deputy Director of the Centre for Professional Ethics University of Central Lancashire (UCLan), UK. She has a background in philosophy, holistic healthcare provision, and bioethics, and now works as a bioethicist and qualitative researcher across a range of projects. Her main areas of research include global research ethics, animal rights and responsible research and innovation. Previously, Kate was at the forefront of university developments in e-learning, creating innovative postgraduate courses that enabled communal learning for groups of students from all over the world. This included the development of cross-disciplinary modules in research methods, research ethics and critical thinking.

Rok Čivljak is a Specialist in Infectious Diseases and the Head of the Department for Respiratory Tract Infections of the University Hospital for Infectious Diseases in Zagreb, Croatia, also holding the position of the Deputy Hospital Director. He is the Assistant Professor at the University of Zagreb School of Medicine. His major research interests and expertise include acute respiratory infections, healthcare-associated infections, hospital infection control, HIV/AIDS, and infections in travelers and migrants.

Julie Cook is a Research Fellow in the Faculty of Health & Wellbeing at the University of Central Lancashire (UCLan), UK, where she has worked with the Centre for Professional Ethics since 2005. In addition to TRUST, she has contributed to a range of European Commission-funded projects around international justice and ethics in health, science, and technology, specializing and publishing in gender and consent issues. Since 2014, Julie has been co-manager of the Faculty’s Academic Research Support Team and is Good Clinical Practice certified. She is Deputy Vice Chair of UCLan’s STEMH Ethics Committee.

Kathinka Evers leads philosophy research for the European Flagship Human Brain Project. She is also Senior Researcher and Professor of Philosophy at the Centre for Research Ethics & Bioethics (CRB) at Uppsala University and Professor ad honoram at the Universidad Central de Chile. She has been Invited Professor on the Chair Condorcet at École Normale Supérieure, Paris (2002); at Collège de France, Paris (2006–7); and at Centro de Investigaciones Filosoficas, Buenos Aires (2012). Focusing on philosophy of mind, neurophilosophy, bioethics and neuroethics, Kathinka directs the teaching and research on neuroethics at Uppsala University, where she started the first courses in the subject.

Cristina Gavrilovici, MD, is Associate Professor in Biomedical Ethics at the University of Medicine and Pharmacy, Grigore T. Popa, Iasi, Romania. She graduated the master studies in Bioethics from Case Western Reserve University, Cleveland, Ohio. She holds a PhD degree and a Doctor Habilitatus title. She is member of the Romanian National Ethics Council and serves in several research ethics committees. She has worked as an expert in research ethics for the Ethics Sector of the European Commission since 2006. She is the author of 7 books and 27 books chapters in the field of bioethics. She published over 60 articles in both the bioethics and medicine domain.

James Giordano, PhD, MPhil, is Professor in the Departments of Neurology and Biochemistry and Chief of the Neuroethics Studies Program of the Pellegrino Center for Clinical Bioethics at the Georgetown University Medical Center, Washington DC. He is a Research Fellow of the European Union Human Brain Project; is Chair of the Neuroethics Subcommittee of the IEEE Brain Initiative, serves as a consultant in brain science and neurotechnology to the Organisation for Economic Cooperation and Development (OECD); and was an appointed member of the US Department of Health and Human Services Secretary’s Advisory Council for Human Research Protection. He has been elected to the European Academy of Science and Arts, and the Dana Alliance of Brain Initiatives; and has been named a Fellow of the Royal Society of Medicine (UK); and a Distinguished Lecturer of the Institute for Electrical and Electronics Engineers (IEEE).

Pablo Hernández-Marrero is Senior Researcher and Invited Lecturer at the Instituto de Bioética and CEGE: Centro de Estudos em Gestão e Economia, Universidade Católica Portuguesa (Porto, Portugal). He obtained his doctorate degree in Health Services Organization and Management and his master’s degree in Health Sciences: Health Administration from the Institute of Health Policy, Management and Evaluation, University of Toronto (Canada). Dr Marrero has been dedicating the last years of his scientific path to research in palliative care, ethics, and dementia. He also worked in healthcare management, international consultancy, and university teaching. He integrates the Steering Group of the Taskforce on Preparation for practice in palliative care nursing of the European Association for Palliative Care.

François Hirsch graduated in Immunology in the Institut Pasteur and holds a certificate in Science and Medical Ethics from Paris-Sud University. He spent 30 years at the Institut National de la Santé et de la Recherche Médicale (Inserm) occupying various positions, and 3 years at the Unit “Governance and Ethics” in the European Commission (EC) where he helped in setting-up the ethics review of EC-funded proposals. François Hirsch is now member of the Inserm ethics committee and member of several European and national ethics boards.

Monique Ischi has an academic background in international policy and development. Over the last 20 years she has worked professionally in various international environments ranging from field work to policy related activities. Over the last 15 years she has increasingly focused on comprehensive security related issues in her work. In recent years Monique has co-authored articles in the area of dual use, ethics, and biosecurity. She is currently working as an Independent Consultant.

Jasenka Gajdoš Kljusurić is Full Professor at the Faculty of Food Technology and Biotechnology, University of Zagreb, teaching classes in nutrition on the bachelor, diploma and doctoral studies courses. She focuses on ethics and the majority of her scientific papers are in the fields of food control and safety.

Mihalis Kritikos is a Policy Analyst at the European Parliament working as a legal/ethics advisor on Science and Technology issues (STOA/EPRS) and Fellow of the Law Science Technology & Society Programme of the University of Brussels (VUB-LSTS). Mihalis is a legal expert in the fields of EU decision-making, food/environmental law, the responsible governance of science and innovation, and the regulatory control of new and emerging risks. He has worked as a Research Programme Manager for the Ethics Review Service of the European Commission, as a Senior Associate in the EU Regulatory and Environment Affairs Department of White and Case (Brussels office), as a Lecturer at several UK Universities, and as a Lecturer/Project Leader at the European Institute of Public Administration (EIPA). He also taught EU Law for several years at the London School of Economics and Political Science (LSE). He holds a Bachelor in Law (Athens Law School), master’s degrees in European and International Environmental Law and Environmental Management (University of Athens and EAEME respectively), and a PhD in European Risk Regulation (London School of Economics-LSE). In 2008, he won the UACES Prize for the Best Thesis in European Studies in Europe.

Albena Kuyumdzhieva works in the Ethics and Research Integrity Sector, Scientific Advice Mechanism Unit at DG Research and Innovation, European Commission. Albena is a certified data protection officer whose work is focused on ensuring ethics compliance of personal data processing as part of the Horizon 2020 Ethics Review Process. In this capacity, Albena has been involved in drafting policy guidelines and recommendations related to ethics and data protection in research context. Before joining the European Commission, Albena has provided advisory services to 16 governments in the Eastern European Neighbourhood Policy Region, the Balkans, Central Asia and West Africa. Albena holds the degree of Doctor of Philosophy and master’s degrees in Law and Finances.

Janet Mifsud is a Member of the Department of Clinical Pharmacology and Therapeutics, University of Malta. Her area of expertise is in the pharmacology of drugs used in epilepsy, toxicology, and also ethical issues in health. She is a Fulbright Scholar and is involved in several EU-wide research projects. She was formerly Vice-President (Europe) International Bureau for Epilepsy. She has a degree in Theology, has sat on several national ethics committees, and has been chosen several times by the European Commission to contribute as external expert evaluator for Ethics Panels. She sits on several National Committees such as the President’s Foundation for Social Well Being and also as a board member of the Malta Council for Science and Technology. She has published extensively in her area of expertise.

Lluis Montoliu (Barcelona, 1963) is a Biologist working at the National Centre for Biotechnology (CNB-CSIC) in Madrid since 1997, member of the Spanish initiative on Rare Diseases (CIBERER-ISCIII), and Director of the Spanish node of the European Mouse Mutant Archive (EMMA/INFRAFRONTIER). His laboratory has generated numerous animal models of human rare diseases, such as albinism, through standard genetic modifications or using CRISPR-Cas9 genome-editing tools. He is a member of the CSIC Ethics Committee and of the ERC Ethics Panel. He founded the International Society for Transgenic Technologies (ISTT) and is now the President of the European Society for Pigment Cell Research (ESPCR). He is currently leading the Association for Responsible Research and Innovation in Genome Editing (ARRIGE) initiative.

Sandra Martins Pereira is Senior Researcher and Invited Lecturer at the Instituto de Bioética and CEGE, Universidade Católica Portuguesa (Porto, Portugal), where she is Principal Investigator of Project InPalIn: Integrating Palliative Care in Intensive Care. In 2013, she was awarded with a Marie Curie International Training Network post-doctoral research fellowship in palliative and end-of-life care research at the Vrije Universiteit Medisch Centrum and EMGO+  Institute for Health and Care Research in Amsterdam (Netherlands). She holds a doctorate and master degree in bioethics awarded from the Instituto de Bioética, Universidade Católica Portuguesa. She is screening editor and member of the Editorial Board of Palliative Medicine (SAGE journals).

Nicola Petrosillo has a degree in Medicine (1977), and specialization in Infectious Diseases (1981) and Internal Medicine (1985). Currently, he is Director of the Clinical and Research Infectious Disease Department at the National Institute for Infectious Diseases “Lazzaro Spallanzani” in Rome. He is President of Infection Control Multidisciplinary Joint Committee of UEMS. He is co-leader of the ESCMID Emerging Infections Taskforce. He was WHO clinical and IPC consultant in Lagos, Nigeria, for the 2014 Ebola epidemic, running the hospital for Ebola patients. He has been President of the Italian Society for Healthcare Associated Infections (SIMPIOS). He is Editor-in-Chief of Infectious Disease Reports.

Johannes Rath has academic background in molecular biology, toxicology, and law. He has worked for 20 years as staff scientist at the University of Vienna and published extensively on dual use, security, and safety-related issues. He also worked as Chief Inspector for the United Nations Special Commission in Iraq and is currently responsible for all safety-related issues of an international organization. Over the last 15 years he has worked as independent ethics and science advisor to various organizations and multinational projects.

Doris Schroeder is Director of the Centre for Professional Ethics, University of Central Lancashire (UCLan), UK, and Professor of Moral Philosophy in the School of Law at UCLan Cyprus. Her academic background is in philosophy, politics, and management/economics. She has coordinated several international EU projects, including TRUST, and acts regularly as a consultant for the European Commission. Doris’ main areas of research interest are in human rights, responsible research and innovation, global research ethics and conceptual work, for instance, on dignity, justice, and vulnerability. She is the lead author of the Global Code of Conduct for Research in Resource-Poor Settings, developed by TRUST.