Human Medical Research: Ethical, Legal and Socio-Cultural Aspects

187 Pages·2012·2.712 MB·English

by  Jan Schildmann, Verena Sandow, Oliver Rauprich, Jochen Vollmann (auth.), Jan Schildmann, Verena Sandow, Oliver Rauprich, Jochen Vollmann (eds.)

Human Medical Research
Jan Schildmann Verena Sandow
•
Oliver Rauprich Jochen Vollmann
•
Editors
Human Medical Research
Ethical, Legal and Socio-Cultural Aspects
123
PD Dr.Jan SchildmannM.A. Dr. Oliver Rauprich Dipl.-Biol
InstituteforMedical Ethicsand History Instituteof Ethics
of Medicine Historyand Theoryof Medicine
RuhrUniversityBochum Ludwig-Maximilians-Universität München
Markstrasse 258a Lessingstrasse 2
44799Bochum 80336Munich
Germany Germany
Verena SandowM.A. Prof.Dr. Dr.Jochen Vollmann
InstituteforMedical Ethicsand History InstituteforMedical Ethicsand History
of Medicine of Medicine
RuhrUniversityBochum RuhrUniversityBochum
Markstrasse 258a Markstrasse 258a
44799Bochum 44799Bochum
Germany Germany
ISBN 978-3-0348-0389-2 e-ISBN978-3-0348-0390-8
DOI 10.1007/978-3-0348-0390-8
SpringerBaselHeidelbergNewYorkDordrechtLondon
LibraryofCongressControlNumber:2012933157
(cid:2)SpringerBaselAG2012
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Contents
1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Jan Schildmann, Verena Sandow, Oliver Rauprich
and Jochen Vollmann
Part I Historical and Socio-Cultural Contexts in Medical Research
2 British Responses to Nazi Medical War Crimes. . . . . . . . . . . . . . 7
Fiona McClenaghan
3 History and its Relevance in the Development and Teaching
of Research Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Rael D. Strous
4 Human Embryo Research and Islamic Bioethics:
A View from Iran. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Mansooreh Saniei
5 From Farming to Pharming: Transcending of Bodily Existence
as a Question of Medical Ethics in an Intercultural Context . . . . 43
Axel Siegemund
Part II Considerations on Ethical and Legal Regulations
for Medical Research
6 Rethinking the Therapeutic Obligation in Clinical Research . . . . 55
Nunziata Comoretto
v
vi Contents
7 Biomedical Research in Developing Countries
and International Human Rights Law. . . . . . . . . . . . . . . . . . . . . 65
Ilja R. Pavone
8 Research Involving Human Subjects and Human Biological
Material from a European Patent Law Perspective.
Autonomy, Commodification, Patentability . . . . . . . . . . . . . . . . . 87
Tomasz Zimny
9 The Development and Validation of a Guide for Peruvian
Research Ethics Committees to Assist in the Review
of Ethical-Scientific Aspects of Clinical Trials . . . . . . . . . . . . . . . 97
Susy Olave Quispe, Duilio Fuentes Delgado,
Gabriela Minaya Martínez, Rosa Surco Ibarra,
Martín Yagui Moscoso, Manuel Espinoza Silva,
Juan Antonio Senent de Frutos and Nuria Homedes
Part III Conflicts in Medical Research
10 Conflicts of Interest in Medical Research:
What can Ethics Contribute? . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Verena Sandow, Jan Schildmann and Jochen Vollmann
11 Research Ethics in Genomics Research: Feedback
of Individual Genetic Data to Research Participants . . . . . . . . . . 127
Annelien L. Bredenoord and Johannes J. M. van Delden
12 Regulating ‘‘Higher Risk, No Direct Benefit’’ Studies
with Children: Challenging the US Federal Regulations. . . . . . . . 137
Anna E. Westra, Jan M. Wit, Rám N. Sukhai and Inez D. de Beaufort
Part IV New Developments in Medical Research
and Ethical Implications
13 A Paradigm Change in Research Ethics . . . . . . . . . . . . . . . . . . . 155
Rieke van der Graaf and Johannes J. M. van Delden
14 Translation of Cancer Molecular Biomarkers:
Ethical and Epistemological Issues . . . . . . . . . . . . . . . . . . . . . . . 163
Flavio D’Abramo and Cecilia Guastadisegni
Contents vii
15 Rethinking the Ethics of Human Biomedical
Non-Interventional Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Kristi Lõuk
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Contributors
Annelien L. Bredenoord PhD is an Assistant Professor of Medical Ethics at the
University Medical Center in Utrecht. She graduated in theology and political
sciencesatLeidenUniversityandobtainedherPhDatMaastrichtUniversitywith
a thesis on ethical issues at the interface of reproductive medicine and genetic
technology. Her current research focuses on the ethics of the novel biosciences,
with an emphasis on regenerative medicine, stem cells, genetics/genomics,
biobanks,andreproductivetechnologies.SheiscurrentlythePIinprojectsonthe
ethics of paediatric biobanks and the ethics of innovative regenerative technolo-
gies. She is a member of several committees, among which are UMC Utrecht’s
ResearchEthicsCommittee,theYoungHealthCouncilofTheNetherlandsandthe
Ethics Working Group of the International Stem Cell Forum.
Nunziata Comoretto MD PhD is a researcher in bioethics and an Assistant
Professor. Following her medical studies and her MD in legal medicine at the
University of Udine, she received her PhD in bioethics from the Catholic
UniversityoftheSacredHeart,Rome.ShehasbeenavisitingscholarattheCenter
for Clinical Bioethics, Georgetown University, Washington D.C. She teaches
bioethicsandclinicalethicsattheCatholicUniversitySchoolofNursing.Sheisa
member of the Institutional Ethics Committee ‘‘RM-H’’ in Rome. Her research
focuses on clinical ethics (especially virtues and end-of-life issues) and research
ethics (especially foundational issues).
Flavio D’Abramo PhD is a researcher in epistemology and philosophy of med-
icine and biology at the University of Rome, La Sapienza. He was a visiting
researcheratthedepartmentofEpidemiologyandPublicHealth,ImperialCollege
London, where he utilised a sociological approach to analyse the models and
beliefs researchers use and the laboratories practice with which they produce the
data.Hisresearchfocusesonthehistoryandphilosophyofbiologyandmedicine,
particularly on genetics and epigenetics, and on research and medical ethics.
Manuel Espinoza Silva MD is a physician. He studied medicine in Peru at the
San Marcos University. After completing his clinical training in the medicine of
ix
x Contributors
infectiousandtropicaldiseases,hejoinedtheNationalInstituteofHealthinPeru,
where he has been the chief of the General Office of Research and Technology
since2011.HecompletedaMaster’sdegreeineconomicsinhealth,andaPhDin
medicine at the San Marcos University. He has been the General Secretary of the
Peruvian Society of Infectious diseases since 2010.
Duilio Fuentes Delgado MD is a physician. He studied medicine in Arequipa,
Peru,attheSanAgustinNationalUniversity.Aftercompletinghisclinicaltraining
ininternalmedicineattheSanMarcosUniversity,hejoinedtheNationalInstitute
ofHealthinPeru,whereheisaprincipalreviewerandinspectorofclinicaltrialsin
the General Office of Research and Technology. He completed a Master’s degree
inbioethicsattheBorjaInstituteandUniversityLullofBarcelona,Spain.Hehas
been the Chief of the National Centre of Intercultural Health since 2010.
Cecilia Guastadisegni MD MSc DPMSA is a senior researcher at the Istituto
SuperiorediSanità, Rome, Italy.Shestudiedmedicine atthe UniversityofRome
and she received a MSc in toxicology at the University of Surrey, UK. After she
hadworkedforseveralyearsonthehealtheffectsofenvironmentalpollutants,she
got a Diploma in Ethics and Philosophy of Health-care at the Wellcome Trust,
London.ShejoinedtheMolecularEpidemiologyUnit,wheresheisresponsiblefor
the ethics of cancer molecular biomarker research. She works on the history and
theoryofcarcinogenesis.Herethicalresearchfocusesonpersonalisedmedicinein
oncology and on how to optimise patients’ access to palliative care.
Nuria Homedes MD Dr P.H. is an Associate Professor and coordinator of the
Global Health Program at the University of Texas School of Public Health. She
has worked for multiple multilateral agencies (World Bank, WHO, UNCTAD),
USAID,andthegovernmentsoftheDominicanRepublic,Mexico,Colombia,and
Spain.Herareasofexpertiseincludecomparativehealthsystemsandpharmaceutical
policies,withanemphasisonLatinAmericaandtheUS-Mexicoborder.Since1998,
shehasbeentheeditorofaSpanishelectronicbulletinpromotingtheappropriateuse
of pharmaceuticals in Latin America (http://www.boletinfarmacos.org). In 2003,
she co-founded Salud y Farmacos and in 2007, the Latin American Network for
Ethics and Pharmaceuticals. She has worked in the following countries: the
Dominican Republic, Costa Rica, Mexico, Peru, Bolivia, Panama, Honduras,
Chad, Papua New Guinea, Mozambique, Spain, Colombia, and Guyana.
Kristi Lõuk MA is working as a project manager in the Centre for Ethics,
UniversityofTartu,Estonia.ShehasBachelorofArtsandMasterofArtsdegrees
in philosophy from the Department of Philosophy of the University of Tartu. She
has been a member of the Research Ethics Committee of the University of Tartu
since 2007, and since 2008, a member and secretary of the Estonian Council on
Bioethics. In 2009–2011, she participated in the Advanced Certificate Program
‘‘Research Ethics in Central and Eastern Europe’’ at the Union Graduate College,
Albany,NY.Sheworksinthefieldsofresearchethics,bioethicsandethicsofnew
technologies.
Contributors xi
FionaMcClenaghan BSciscurrentlyafinal-yearstudentinclinicalmedicineat
St Bartholomew’s and the Royal London Medical School in London, UK. She
interrupted her medical studies to pursue a BSc in the History of Medicine at the
Wellcome Institute for the History of Medicine at University College, London.
In 2010, she completed her dissertation on Nazi medical war crimes, focusing on
the British response to these events, before recommencing her medical studies.
She hopes to continue her research into the ethics of human experimentation
during the Second World War in the future.
Gabriela Minaya Martínez MD is a physician. He studied medicine in Peru at
the Federico Villareal University. After completing his clinical training in infec-
tious and tropical illness at the San Marcos University, he joined the National
Institute of Health in Peru, where he is a principal reviewer and inspector of
clinical trials in the General Office of Research and Technology. He completed a
Master’s degree in ethics in health and clinical bioethics at the San Marcos
National University, Lima, Peru.
Susy Olave Quispe PhD Pharm is a pharmacist. She studied pharmacy in Cusco
Peru at the San Antonio Abad National University. After completing her training
in pharmacoepidemiology at the University of Barcelona, Spain, she returned to
Peruin2000andworkedinahospitalandattheGeneralDirectorateofMedicines
and Devices of the Minister of Health, where she carried out activities on phar-
macovigilance and clinical trials. She finished her PhDwith European mention at
the University of Seville, Spain, with a visiting research position at the School of
Law, Queen Mary, University of London, and she completed her Master’s degree
inbioethicsandlawattheUniversityofBarcelona,Spain.Herresearchfocuseson
clinicaltrials,researchethicsandpharmacovigilance.Shehasbeenworkingatthe
Spanish Medicine Agency focusing on supporting Latin American Regulatory
Authorities since 2011.
Ilja R. Pavone PhD is a researcher of international law at the Institute for
InternationalLegalStudies(ISGI)oftheItalianNationalResearchCouncil(CNR),
UnitofBioethics,ResearchIntegrityandLaw.HeisalsoProfessorofBioethicsat
theUniversityofSiena,andamemberofthe BioethicsCommissionofCNR.His
research interests in the field of bioethics and international law concern mainly
human medical research, beginning of life and end-of-life issues, genetic testing,
biotechnologies, and bioterrorism.
Oliver Rauprich PhD Dipl.-Biol. graduated in biology and received his PhD in
philosophy from the Ludwig-Maximilians-Universität München (LMU), in
Munich, Germany. He held positions as Assistant Professor in Medical Ethics at
the Friedrich-Alexander-Universität Erlangen-Nürnberg and as head of the
research group ‘‘Justice in Modern Medicine’’ at the Institute for Medical Ethics
and History of Medicine, Ruhr University Bochum, Germany. Currently, he is
seniorresearchscholarattheInstituteforEthics,HistoryandTheoryofMedicine
at the LMU. Research stays brought him to the Kennedy Institute of Ethics,
xii Contributors
GeorgetownUniversity,WashingtonDCandtothePrograminEthicsandHealth,
Harvard University, Boston. His main research interests include theoretical
approaches to biomedical ethics, especially principlism; allocation and justice in
health care; public health ethics; and evolutionary ethics.
Verena Sandow MA is a researcher in medical ethics and applied ethics. Fol-
lowing her studies in philosophy, media studies and economic history at the
Heinrich-Heine-UniversityDüsseldorf,shewasamemberoftheresearch training
group ‘‘Bioethics’’ at the International Centre in Science and Humanities, Eber-
hard-Karls-University Tuebingen. She has been research assistant at the Institute
forMedicalEthicsandHistoryofMedicine,RuhrUniversityBochumsince2010.
She works in the field of human medical research, research ethics and especially
conflict of interest, and co-organised the conference ‘‘Human Medical Research’’
on which this volume is based.
MansoorehSaniei iscurrentlydoingherPhDinbiomedicineandsocietystudies
at King’s College, University of London. In her PhD project, she is working on
ethics, policy and the regulation of human embryonic stem cell research in Iran
(funded by a Wellcome Trust Biomedical Ethics Developing Countries Student-
ship). She has a background in bioethics from the Erasmus Mundus Masters
Program. She also has a Master’s degree in Nursing Education from Shaheed
BeheshtiUniversity,Iran.Mansoorehhasspentfiveyearsworkingasaresearcher
and counsellor in social policy and ethics in health and medicine at Shaheed
BeheshtiUniversity,combiningthiswithnursingteachingatdifferentuniversities
in Iran. Her main research interests are the sociology and ethics of bioscience, as
well as the regulatory policy of biotechnology in Muslim and Middle Eastern
countries.
Jan Schildmann MD, MA is a medical ethicist and physician. He studied
medicine at the Charité Medical School, Berlin and received an MA in medical
law and ethics from King’s College, University of London. After completing his
clinicaltrainingininternalmedicine,hebecameheadoftheNRW-Juniorresearch
group ‘‘Medicalethics attheendoflife:normandempiricism’’at theInstituteof
Medical Ethics and History of Medicine, Ruhr University Bochum. His research
focuses on clinical ethics (i.e. end-of-life decisions, ethics support services),
research ethics (i.e. personalised medicine in oncology, conflict of interest) and
methodological aspects of empirical medical ethics.
Juan Antonio Senent de Frutos PhD is a lawyer and Associate Professor of
Philosophy and Law at the Department of Philosophy and Law, University of
Seville, Spain. He works in the field of human rights and current challenges,
bioethics and biotechnology, and critical theory of law in Latin America.
Axel Siegemund Dr. phil., Dipl.-Ing. is an engineer and theologian working in
thefieldofenvironmentalandappliedethicswithaspecialfocusonsocialscience
andtechnologyissues.Afterhisstudiesofwaterengineering,historyandtheology
at Dresden Technical University, theological colleges in India, as well as IIT