DISSERTATIONS | SANNA-MARIA NURMI | ETHICALLY CONDUCTED CLINICAL RESEARCH IN HOSPITALS... | No 486
uef.fi
PUBLICATIONS OF
THE UNIVERSITY OF EASTERN FINLAND Dissertations in Health Sciences
ISBN 978-952-61-2903-7 ISSN 1798-5706
Dissertations in Health Sciences
THE UNIVERSITY OF EASTERN FINLAND
SANNA-MARIA NURMI
ETHICALLY CONDUCTED CLINICAL RESEARCH IN HOSPITALS: VIEWS OF THE STAKEHOLDERS
The aim of this study was to describe ethically conducted clinical research in hospitals from the
perspective of stakeholders. The results show that human subjects’ autonomy was considered a central yet threatened ethical principle in clinical
research. Collaborative partnership among stakeholders was identified as a cornerstone for ethical clinical research. The social value of
clinical research was considered increasingly important precondition for clinical research. The
views of the different stakeholders should be considered in the planning and implementation
of clinical research to ensure ethical research.
SANNA-MARIA NURMI
Ethically conducted clinical research in
hospitals: Views of the stakeholders
SANNA-MARIA NURMI
Ethically conducted clinical research in hospitals: Views of the stakeholders
To be presented by permission of the Faculty of Health Sciences, University of Eastern Finland for public examination in Medistudia MS302, Kuopio, on Friday, October 5th, 2018, at 12 noon
Publications of the University of Eastern Finland Dissertations in Health Sciences
Number 486
Department of Nursing Science, Faculty of Health Sciences, University of Eastern Finland
Kuopio 2018
SANNA-MARIA NURMI
Ethically conducted clinical research in hospitals: Views of the stakeholders
To be presented by permission of the Faculty of Health Sciences, University of Eastern Finland for public examination in Medistudia MS302, Kuopio, on Friday, October 5th, 2018, at 12 noon
Publications of the University of Eastern Finland Dissertations in Health Sciences
Number 486
Department of Nursing Science, Faculty of Health Sciences, University of Eastern Finland
Kuopio 2018
Grano Oy Jyväskylä, 2018
Series Editors:
Professor Tomi Laitinen, M.D., Ph.D.
Institute of Clinical Medicine, Clinical Physiology and Nuclear Medicine Faculty of Health Sciences
Professor Kai Kaarniranta, M.D., Ph.D.
Institute of Clinical Medicine, Ophthalmology Faculty of Health Sciences
Associate Professor (Tenure Track) Tarja Kvist, Ph.D.
Department of Nursing Science Faculty of Health Sciences
Associate Professor (Tenure Track) Tarja Malm, Ph.D.
A.I. Virtanen Institute for Molecular Sciences Faculty of Health Sciences
Lecturer Veli-Pekka Ranta, Ph.D. (pharmacy) School of Pharmacy
Faculty of Health Sciences Distributor:
University of Eastern Finland Kuopio Campus Library
P.O. Box 1627 FI-70211 Kuopio, Finland http://www.uef.fi/kirjasto ISBN (print): 978-952-61-2903-7
ISBN (PDF): 978-952-61-2904-4 ISSN (print): 1798-5706
ISSN (PDF): 1798-5706 ISSN-L: 1798-5706
Author’s address: Department of Nursing Science University of Eastern Finland KUOPIO
FINLAND
Supervisors: Professor Anna-Maija Pietilä, Ph.D.
Department of Nursing Science University of Eastern Finland
Kuopio Social and Health Care Services KUOPIO
FINLAND
Docent Arja Halkoaho, Ph.D.
Kuopio University Hospital (Science Service Centre), KUOPIO
FINLAND
Docent Mari Kangasniemi, Ph.D. Department of Nursing Science University of Eastern Finland KUOPIO
FINLAND
Reviewers: Docent Tarja Pölkki, Ph.D.
University of Oulu Oulu
FINLAND
Professor Marja Kaunonen, Ph.D. Faculty of Social Science
University of Tampere TAMPERE
FINLAND
Opponent: Professor Helvi Kyngäs, Ph.D.
Department of Nursing Science and Health Administration University of Oulu
OULU FINLAND
Grano Oy Jyväskylä, 2018
Series Editors:
Professor Tomi Laitinen, M.D., Ph.D.
Institute of Clinical Medicine, Clinical Physiology and Nuclear Medicine Faculty of Health Sciences
Professor Kai Kaarniranta, M.D., Ph.D.
Institute of Clinical Medicine, Ophthalmology Faculty of Health Sciences
Associate Professor (Tenure Track) Tarja Kvist, Ph.D.
Department of Nursing Science Faculty of Health Sciences
Associate Professor (Tenure Track) Tarja Malm, Ph.D.
A.I. Virtanen Institute for Molecular Sciences Faculty of Health Sciences
Lecturer Veli-Pekka Ranta, Ph.D. (pharmacy) School of Pharmacy
Faculty of Health Sciences Distributor:
University of Eastern Finland Kuopio Campus Library
P.O. Box 1627 FI-70211 Kuopio, Finland http://www.uef.fi/kirjasto ISBN (print): 978-952-61-2903-7
ISBN (PDF): 978-952-61-2904-4 ISSN (print): 1798-5706 ISSN (PDF): 1798-5706
ISSN-L: 1798-5706
Author’s address: Department of Nursing Science University of Eastern Finland KUOPIO
FINLAND
Supervisors: Professor Anna-Maija Pietilä, Ph.D.
Department of Nursing Science University of Eastern Finland
Kuopio Social and Health Care Services KUOPIO
FINLAND
Docent Arja Halkoaho, Ph.D.
Kuopio University Hospital (Science Service Centre), KUOPIO
FINLAND
Docent Mari Kangasniemi, Ph.D.
Department of Nursing Science University of Eastern Finland KUOPIO
FINLAND
Reviewers: Docent Tarja Pölkki, Ph.D.
University of Oulu Oulu
FINLAND
Professor Marja Kaunonen, Ph.D.
Faculty of Social Science University of Tampere TAMPERE
FINLAND
Opponent: Professor Helvi Kyngäs, Ph.D.
Department of Nursing Science and Health Administration University of Oulu
OULU FINLAND
Nurmi, Sanna-Maria
Ethically conducted clinical research in hospitals: Views of the stakeholders University of Eastern Finland, Faculty of Health Sciences
Publications of the University of Eastern Finland. Dissertations in Health Sciences Number 486. 2018, 74 p.
ISBN (print): 978-952-61-2903-7 ISBN (PDF): 978-952-61-2904-4 ISSN (print): 1798-5706 ISSN (PDF): 1798-5706 ISSN-L: 1798-5706
ABSTRACT
Ethics is an integral part of clinical research involving human subjects as research participants. Clinical research is an increasingly collaborative action enabling ethical research. However, little attention has been paid to ethical aspects of the clinical research conducted in the hospitals. This study was carried out to describe ethically conducted clinical research in hospitals from the perspective of nurse leaders and administrative staff including principal investigators, administrative managers, and elected officials and via a synthesis of previous studies.
The study comprised three sub-studies. The first was a two-phase qualitative one focusing on the ethical aspects of clinical research from the standpoint of nurse leaders (n=10) and administrative staff (n=31). This sub-study was conducted in two phases. Data were collected via semi-structured face-to-face interviews, firstly with nurse leaders in autumn 2012 and then with administrative staff in summer–autumn 2014. Both phases utilised inductive content analysis. Sub-study two involved secondary supra-analysis of the pre-existing interview data (n=41). This was focused on collaborative partnership and social value of clinical research, and other ethical requirements presented in the Ethical Framework for Clinical Research (Emanuel et al., 2000, 2004; Emanuel and Wendler, 2008).The data analysis took the form of deductive-inductive content analysis aided by NVivo software. The third sub-study was an integrative literature review focusing on the topical aspects of privacy in clinical research. From PubMed, CINAHL and Scopus database searches, empirical and theoretical papers (n=16) published in 2012–2017 were subjected to the constant comparison analysis method (Whittemore and Knafls, 2005).
Nurse leaders and administrative staff considered human subjects’ autonomy a central yet threatened ethical principle in clinical research practice at hospitals. In addition, collaborative partnership was identified as a cornerstone for ethical clinical research. Ways to foster collaboration among stakeholders, such as supporting mutual respect and equality, shared goals, and clearly defined roles and responsibilities, emerged also. While the social value of clinical research was considered an important precondition for ethical clinical research and the multidimensional social value of clinical research was described, the results indicate also that this multidimensional value remained partly unidentified in society. Achieving greater social value for clinical research was found to require greater transparency, setting of research priorities, shared responsibility for the dissemination and use of the findings, and stronger community awareness of the ethical aspects of clinical research. Moreover, an integrative literature review identified that human subjects’ privacy is increasingly related to topical ethical aspects of clinical research in light of changing research practice. Six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymising data, collaboration among stakeholders, complexity of regulation, and ethics-related tension between social benefits and privacy.
Perspectives of nurse leaders and administrative staff were shown to form an essential element for understanding the multifaceted picture of ethically conducted clinical research in hospitals. Accordingly, their views should be considered in the planning and implementation of clinical research in hospitals, in order to ensure ethically conducted research.
National Library of Medicine Classification: W 20.55.E7; W 20.55.H9; WB 60
Medical Subject Headings: Ethics, Research; Biomedical Research/ethics; Attitude of Health Personnel;
Perception; Privacy; Nurse Administrators
Nurmi, Sanna-Maria
Ethically conducted clinical research in hospitals: Views of the stakeholders University of Eastern Finland, Faculty of Health Sciences
Publications of the University of Eastern Finland. Dissertations in Health Sciences Number 486. 2018, 74 p.
ISBN (print): 978-952-61-2903-7 ISBN (PDF): 978-952-61-2904-4 ISSN (print): 1798-5706 ISSN (PDF): 1798-5706 ISSN-L: 1798-5706
ABSTRACT
Ethics is an integral part of clinical research involving human subjects as research participants. Clinical research is an increasingly collaborative action enabling ethical research. However, little attention has been paid to ethical aspects of the clinical research conducted in the hospitals. This study was carried out to describe ethically conducted clinical research in hospitals from the perspective of nurse leaders and administrative staff including principal investigators, administrative managers, and elected officials and via a synthesis of previous studies.
The study comprised three sub-studies. The first was a two-phase qualitative one focusing on the ethical aspects of clinical research from the standpoint of nurse leaders (n=10) and administrative staff (n=31). This sub-study was conducted in two phases. Data were collected via semi-structured face-to-face interviews, firstly with nurse leaders in autumn 2012 and then with administrative staff in summer–autumn 2014. Both phases utilised inductive content analysis. Sub-study two involved secondary supra-analysis of the pre-existing interview data (n=41). This was focused on collaborative partnership and social value of clinical research, and other ethical requirements presented in the Ethical Framework for Clinical Research (Emanuel et al., 2000, 2004; Emanuel and Wendler, 2008).The data analysis took the form of deductive-inductive content analysis aided by NVivo software. The third sub-study was an integrative literature review focusing on the topical aspects of privacy in clinical research. From PubMed, CINAHL and Scopus database searches, empirical and theoretical papers (n=16) published in 2012–2017 were subjected to the constant comparison analysis method (Whittemore and Knafls, 2005).
Nurse leaders and administrative staff considered human subjects’ autonomy a central yet threatened ethical principle in clinical research practice at hospitals. In addition, collaborative partnership was identified as a cornerstone for ethical clinical research. Ways to foster collaboration among stakeholders, such as supporting mutual respect and equality, shared goals, and clearly defined roles and responsibilities, emerged also. While the social value of clinical research was considered an important precondition for ethical clinical research and the multidimensional social value of clinical research was described, the results indicate also that this multidimensional value remained partly unidentified in society. Achieving greater social value for clinical research was found to require greater transparency, setting of research priorities, shared responsibility for the dissemination and use of the findings, and stronger community awareness of the ethical aspects of clinical research. Moreover, an integrative literature review identified that human subjects’ privacy is increasingly related to topical ethical aspects of clinical research in light of changing research practice. Six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymising data, collaboration among stakeholders, complexity of regulation, and ethics-related tension between social benefits and privacy.
Perspectives of nurse leaders and administrative staff were shown to form an essential element for understanding the multifaceted picture of ethically conducted clinical research in hospitals. Accordingly, their views should be considered in the planning and implementation of clinical research in hospitals, in order to ensure ethically conducted research.
National Library of Medicine Classification: W 20.55.E7; W 20.55.H9; WB 60
Medical Subject Headings: Ethics, Research; Biomedical Research/ethics; Attitude of Health Personnel;
Perception; Privacy; Nurse Administrators
Nurmi, Sanna-Maria
Eettisesti toteutettu kliininen tutkimus sairaalassa: eri viiteryhmien näkökulma Itä-Suomen yliopisto, terveystieteiden tiedekunta
Publications of the University of Eastern Finland. Dissertations in Health Sciences Numero 486. 2018. 74s.
ISBN (print): 978-952-61-2903-7 ISBN (PDF): 978-952-61-2904-4 ISSN (print): 1798-5706 ISSN (PDF): 1798-5706 ISSN-L: 1798-5706
TIIVISTELMÄ
Etiikka on perustana kliinisen tutkimuksen toteuttamisessa, joka edellyttää yhä enemmän eri viiteryhmien välistä yhteistyötä. Aikaisempaa tutkimustietoa kliinisen tutkimuksen eettisistä näkökohdista sairaaloissa on vähän. Tämän tutkimuksen tarkoituksena oli kuvata eettisesti toteutettua kliinistä tutkimusta sairaalassa hoitotyön johtajien, hallinnollisen ja tutkimuksesta vastaavan henkilöstön näkökulmasta (sisältäen tutkimusryhmien johtajia, hallinnollisia esimiehiä sekä sairaanhoitopiirin hallituksen jäseniä) sekä perustuen aikaisempaan tutkimustietoon.
Tutkimus koostuu kolmesta osatutkimuksesta. Ensimmäinen osatutkimus toteutettiin kahdessa vaiheessa ja se kohdentui hoitotyön johtajien (n=10) sekä hallinnollisen ja tutkimuksesta vastaavan henkilöstön (n=31) käsityksiin kliinisen tutkimuksen eettisistä näkökohdista. Aineistonkeruumenetelmänä oli puolistrukturoitu yksilöhaastattelu.
Hoitotyön johtajien haastattelut toteutettiin syksyllä 2012 ja hallinnollisten sekä tutkimuksesta vastaavan henkilöstön haastattelut kesällä ja syksyllä 2014. Aineistot analysoitiin induktiivisella sisällönanalyysillä. Toisen osatutkimuksen menetelmänä oli haastatteluaineiston (n=41) sekundaarianalyysi. Tutkimus kohdentui kahteen eettiseen edellytykseen, yhteistyökumppanuuteen ja sosiaaliseen arvoon, jotka on esitetty kliinisen tutkimuksen eettisessä viitekehyksessä sekä muihin viitekehyksessä esitettyihin eettisiin edellytyksiin (Emanuel ym. 2000, 2004, 2008). Aineiston analyysi oli deduktiivis- induktiivinen sisällönanalyysi, jossa hyödynnettiin Nvivo-tietokoneavusteista analyysiohjelmaa. Kolmas osatutkimus oli integroitu kirjallisuuskatsaus, joka kohdentui tutkimukseen osallistuvan henkilön yksityisyyteen. Aineiston hankinta toteutettiin PubMed, CINAHL ja Scopus tietokannoista ja haku rajattiin koskemaan vuosia 2012–2017.
Hakuprosessissa valitut empiiriset ja teoreettiset (n=16) artikkelit analysoitiin soveltamalla jatkuvan vertailun analyysiä (Whittemore ja Knafls, 2005).
Hoitotyön johtajat sekä hallinnollinen ja tutkimuksesta vastaava henkilöstö kuvasivat tutkittavan autonomian kunnioittamisen keskeisenä kliinisen tutkimuksen eettisenä periaatteena. Tutkittavan autonomian todettiin kuitenkin olevan myös uhattuna sairaalassa toteutettavassa kliinisessä tutkimuksessa. Yhteistyökumppanuus kuvattiin eettisesti toteutetun kliinisen tutkimuksen kulmakivenä. Lisäksi tulokset osoittivat keinoja edistää yhteistyötä eri viiteryhmien välillä, kuten keskinäinen kunnioitus ja tasa-arvo toimijoiden välillä, yhteisten tavoitteiden sekä selkeiden vastuiden ja roolien määrittely tutkimusprosessiin osallistuvien viiteryhmien välillä. Sosiaalista arvoa pidettiin tärkeänä edellytyksenä eettisesti kestävälle kliiniselle tutkimukselle. Sosiaalinen arvo kuvattiin moniuloitteisena, joskin vielä osin tunnistamattomana eettisenä edellytyksenä yhteiskunnassa. Tulosten mukaan kliinisen tutkimuksen sosiaalisen arvon edistäminen edellytti tutkimuksen läpinäkyvyyden lisäämistä, tutkimusprioriteettien asettamista, jaettua vastuuta tutkimustulosten jakamisessa ja hyödyntämisessä, sekä kansalaisten vahvempaa ymmärrystä kliinisen tutkimuksen eettisistä näkökohdista. Integroivan kirjallisuuskatsauksen perusteella tutkittavan yksityisyys tunnistettiin yhä keskeisemmäksi eettiseksi näkökohdaksi muuttuvassa tutkimuskäytännössä. Lisäksi tunnistettiin kuusi ajankohtaista teemaa: terveystiedon muuttuva luonne, tiedon jakaminen, anonymisoinnin haasteet, viiteryhmien välinen yhteistyö edellytyksenä tutkittavan yksityisyyden turvaamiselle, säätelyn kompleksisuus ja eettinen jännite yksilön yksityisyyden turvaamisen ja yhteiskunnallisen hyödyn välillä.
Hoitotyön johtajien ja hallinnollisen ja tutkimuksesta vastaavan henkilöstön näkemysten huomioon ottaminen kliinisen tutkimuksen suunnittelussa ja toteuttamisessa on tärkeää, jotta voidaan turvata eettisesti kestävän kliinisen tutkimuksen toteuttaminen.
Luokitus: W 20.55.E7; W 20.55.H9; WB 60
Yleinen Suomalainen asiasanasto:tutkimusetiikka; kliiniset kokeet; mielipiteet; johtajat
Nurmi, Sanna-Maria
Eettisesti toteutettu kliininen tutkimus sairaalassa: eri viiteryhmien näkökulma Itä-Suomen yliopisto, terveystieteiden tiedekunta
Publications of the University of Eastern Finland. Dissertations in Health Sciences Numero 486. 2018. 74s.
ISBN (print): 978-952-61-2903-7 ISBN (PDF): 978-952-61-2904-4 ISSN (print): 1798-5706 ISSN (PDF): 1798-5706 ISSN-L: 1798-5706
TIIVISTELMÄ
Etiikka on perustana kliinisen tutkimuksen toteuttamisessa, joka edellyttää yhä enemmän eri viiteryhmien välistä yhteistyötä. Aikaisempaa tutkimustietoa kliinisen tutkimuksen eettisistä näkökohdista sairaaloissa on vähän. Tämän tutkimuksen tarkoituksena oli kuvata eettisesti toteutettua kliinistä tutkimusta sairaalassa hoitotyön johtajien, hallinnollisen ja tutkimuksesta vastaavan henkilöstön näkökulmasta (sisältäen tutkimusryhmien johtajia, hallinnollisia esimiehiä sekä sairaanhoitopiirin hallituksen jäseniä) sekä perustuen aikaisempaan tutkimustietoon.
Tutkimus koostuu kolmesta osatutkimuksesta. Ensimmäinen osatutkimus toteutettiin kahdessa vaiheessa ja se kohdentui hoitotyön johtajien (n=10) sekä hallinnollisen ja tutkimuksesta vastaavan henkilöstön (n=31) käsityksiin kliinisen tutkimuksen eettisistä näkökohdista. Aineistonkeruumenetelmänä oli puolistrukturoitu yksilöhaastattelu.
Hoitotyön johtajien haastattelut toteutettiin syksyllä 2012 ja hallinnollisten sekä tutkimuksesta vastaavan henkilöstön haastattelut kesällä ja syksyllä 2014. Aineistot analysoitiin induktiivisella sisällönanalyysillä. Toisen osatutkimuksen menetelmänä oli haastatteluaineiston (n=41) sekundaarianalyysi. Tutkimus kohdentui kahteen eettiseen edellytykseen, yhteistyökumppanuuteen ja sosiaaliseen arvoon, jotka on esitetty kliinisen tutkimuksen eettisessä viitekehyksessä sekä muihin viitekehyksessä esitettyihin eettisiin edellytyksiin (Emanuel ym. 2000, 2004, 2008). Aineiston analyysi oli deduktiivis- induktiivinen sisällönanalyysi, jossa hyödynnettiin Nvivo-tietokoneavusteista analyysiohjelmaa. Kolmas osatutkimus oli integroitu kirjallisuuskatsaus, joka kohdentui tutkimukseen osallistuvan henkilön yksityisyyteen. Aineiston hankinta toteutettiin PubMed, CINAHL ja Scopus tietokannoista ja haku rajattiin koskemaan vuosia 2012–2017.
Hakuprosessissa valitut empiiriset ja teoreettiset (n=16) artikkelit analysoitiin soveltamalla jatkuvan vertailun analyysiä (Whittemore ja Knafls, 2005).
Hoitotyön johtajat sekä hallinnollinen ja tutkimuksesta vastaava henkilöstö kuvasivat tutkittavan autonomian kunnioittamisen keskeisenä kliinisen tutkimuksen eettisenä periaatteena. Tutkittavan autonomian todettiin kuitenkin olevan myös uhattuna sairaalassa toteutettavassa kliinisessä tutkimuksessa. Yhteistyökumppanuus kuvattiin eettisesti toteutetun kliinisen tutkimuksen kulmakivenä. Lisäksi tulokset osoittivat keinoja edistää yhteistyötä eri viiteryhmien välillä, kuten keskinäinen kunnioitus ja tasa-arvo toimijoiden välillä, yhteisten tavoitteiden sekä selkeiden vastuiden ja roolien määrittely tutkimusprosessiin osallistuvien viiteryhmien välillä. Sosiaalista arvoa pidettiin tärkeänä edellytyksenä eettisesti kestävälle kliiniselle tutkimukselle. Sosiaalinen arvo kuvattiin moniuloitteisena, joskin vielä osin tunnistamattomana eettisenä edellytyksenä yhteiskunnassa. Tulosten mukaan kliinisen tutkimuksen sosiaalisen arvon edistäminen edellytti tutkimuksen läpinäkyvyyden lisäämistä, tutkimusprioriteettien asettamista, jaettua vastuuta tutkimustulosten jakamisessa ja hyödyntämisessä, sekä kansalaisten vahvempaa ymmärrystä kliinisen tutkimuksen eettisistä näkökohdista. Integroivan kirjallisuuskatsauksen perusteella tutkittavan yksityisyys tunnistettiin yhä keskeisemmäksi eettiseksi näkökohdaksi muuttuvassa tutkimuskäytännössä. Lisäksi tunnistettiin kuusi ajankohtaista teemaa: terveystiedon muuttuva luonne, tiedon jakaminen, anonymisoinnin haasteet, viiteryhmien välinen yhteistyö edellytyksenä tutkittavan yksityisyyden turvaamiselle, säätelyn kompleksisuus ja eettinen jännite yksilön yksityisyyden turvaamisen ja yhteiskunnallisen hyödyn välillä.
Hoitotyön johtajien ja hallinnollisen ja tutkimuksesta vastaavan henkilöstön näkemysten huomioon ottaminen kliinisen tutkimuksen suunnittelussa ja toteuttamisessa on tärkeää, jotta voidaan turvata eettisesti kestävän kliinisen tutkimuksen toteuttaminen.
Luokitus: W 20.55.E7; W 20.55.H9; WB 60
Yleinen Suomalainen asiasanasto:tutkimusetiikka; kliiniset kokeet; mielipiteet; johtajat
“ It is the time you have wasted for your rose that makes your rose so important.”
Antoine de Saint-Exupéry, The Little Prince
“ It is the time you have wasted for your rose that makes your rose so important.”
Antoine de Saint-Exupéry, The Little Prince
Acknowledgements
This dissertation was conducted at the Department of Nursing Science for the Faculty of Health Sciences at the University of Eastern Finland. During this scientific journey, I have enjoyed the support, inspiration and encouragement of many people. It gives me great pleasure to express my deep sense of gratitude to all of you, who have made this possible.
I am beyond grateful to my principal supervisor Professor Anna-Maija Pietilä for believing in me and guiding me through this process. I have been extremely lucky to have had a supervisor who cares so much about me and my work, who has always had time for me and all my questions and who has always been genuinely present. You have taught me a lot about science and ethics, but above all you have taught me about life and how to meet each and every person with an air of appreciation. It has been a real privilege to have had you as my supervisor and a mentor.
I am deeply grateful to my second supervisor Docent Arja Halkoaho. Your work has served as an inspiration for this study and your contextual expertise in clinical research ethics has been extremely valuable to me. You have always encouraged me to apply more critical thinking and deeper reflection. It has helped me so much in my development as a researcher. Thank you ever so much for all those valuable discussions together.
I express my sincere thank you to my third supervisor Docent Mari Kangasniemi. You are the best teacher I have ever known, because you always really listen to your students and value their opinions. I have admired your scientific work since the day we met. It was you, who first introduced me to research ethics. You have given me such valuable methodological advice, helped me better understand multidimensional ethical aspect of research and supported me during the moments I have been close to giving up. Working with you has been a real joy and honour.
Moreover, I would like to express my sincere thanks to Professor Kai Kaarniranta, Professor Heikki Kröger and Docent Esko Vanninen for their valuable contribution in defining the research topic at the beginning of this research process.
I wish to express my profound gratitude to the reviewers of the dissertation, Docent Tarja Pölkki and Professor Marja Kaunonen. Their careful reviews and constructive comments and criticism have helped me improve the last version of the dissertation. I would also like to sincerely thank Professor Helvi Kyngäs for accepting to act as my opponent.
I want to express my warm thanks to the personnel and the colleagues of the Department of Nursing Science for their support. Especially, I would like to express my gratitude to PhD Anja Terkamo-Moisio, for all the important advice you have given me! I am also deeply thankful for the participants who have taken part in this study and shared their views and experiences with me.
This study was financially supported by the Northern-Savo Hospital District, OLVI Foundation, The Finnish Work Environment Foundation, the Finnish Cultural Foundation (North Savo Regional Fund) and the Department of Nursing Science, University of Eastern Finland. I owe a debt of gratitude to all of them for their valuable support, which made this study possible.
My lovely friends! I am so privileged to have you all in my life. This work would not have been possible without you and thus I would like to express my warmest gratitude to all of you! Niina you are like my big sister – my role model. You have always been there for me and I can trust you whatever happens. Such a friendship is a very valuable gift! Without your support in my toughest moments, I probably would not have reached the finish line with this project. Elisa, PhD, I am sure that all our adventures and tent trips in our youth has led us to this path. So, thanks for your long-lasting friendship Ninni! Assi, together we have shared our joys and sorrows. I am pleased that certain events in our youth have led to
Acknowledgements
This dissertation was conducted at the Department of Nursing Science for the Faculty of Health Sciences at the University of Eastern Finland. During this scientific journey, I have enjoyed the support, inspiration and encouragement of many people. It gives me great pleasure to express my deep sense of gratitude to all of you, who have made this possible.
I am beyond grateful to my principal supervisor Professor Anna-Maija Pietilä for believing in me and guiding me through this process. I have been extremely lucky to have had a supervisor who cares so much about me and my work, who has always had time for me and all my questions and who has always been genuinely present. You have taught me a lot about science and ethics, but above all you have taught me about life and how to meet each and every person with an air of appreciation. It has been a real privilege to have had you as my supervisor and a mentor.
I am deeply grateful to my second supervisor Docent Arja Halkoaho. Your work has served as an inspiration for this study and your contextual expertise in clinical research ethics has been extremely valuable to me. You have always encouraged me to apply more critical thinking and deeper reflection. It has helped me so much in my development as a researcher. Thank you ever so much for all those valuable discussions together.
I express my sincere thank you to my third supervisor Docent Mari Kangasniemi. You are the best teacher I have ever known, because you always really listen to your students and value their opinions. I have admired your scientific work since the day we met. It was you, who first introduced me to research ethics. You have given me such valuable methodological advice, helped me better understand multidimensional ethical aspect of research and supported me during the moments I have been close to giving up. Working with you has been a real joy and honour.
Moreover, I would like to express my sincere thanks to Professor Kai Kaarniranta, Professor Heikki Kröger and Docent Esko Vanninen for their valuable contribution in defining the research topic at the beginning of this research process.
I wish to express my profound gratitude to the reviewers of the dissertation, Docent Tarja Pölkki and Professor Marja Kaunonen. Their careful reviews and constructive comments and criticism have helped me improve the last version of the dissertation. I would also like to sincerely thank Professor Helvi Kyngäs for accepting to act as my opponent.
I want to express my warm thanks to the personnel and the colleagues of the Department of Nursing Science for their support. Especially, I would like to express my gratitude to PhD Anja Terkamo-Moisio, for all the important advice you have given me! I am also deeply thankful for the participants who have taken part in this study and shared their views and experiences with me.
This study was financially supported by the Northern-Savo Hospital District, OLVI Foundation, The Finnish Work Environment Foundation, the Finnish Cultural Foundation (North Savo Regional Fund) and the Department of Nursing Science, University of Eastern Finland. I owe a debt of gratitude to all of them for their valuable support, which made this study possible.
My lovely friends! I am so privileged to have you all in my life. This work would not have been possible without you and thus I would like to express my warmest gratitude to all of you! Niina you are like my big sister – my role model. You have always been there for me and I can trust you whatever happens. Such a friendship is a very valuable gift! Without your support in my toughest moments, I probably would not have reached the finish line with this project. Elisa, PhD, I am sure that all our adventures and tent trips in our youth has led us to this path. So, thanks for your long-lasting friendship Ninni! Assi, together we have shared our joys and sorrows. I am pleased that certain events in our youth have led to
this precious friendship. You are an amazingly talented chef and the world-famous parties you have thrown have helped me to relax. Darling, there would not be a party without you!
Jenni you have maintained my physical and mental well-being during these years. You have been a wonderful and understandable friend, even though I have not always been able to offer you the same kind of friendship during these busy days. I hope our friendship lasts forever! Miisku my dear cousin. You have offered me lots of priceless advice and deep discussions, which have made me a better person and helped me carry on with my study. I am sorry that I cannot express my gratitude to all my great friends in this acknowledgement, even though every one of you would earn praises page after page. From the bottom of my heart, I would also like to express my gratitude to Kerli, Veera, Jonde, Eija, Elisa, and Johanna. You are all precious to me!
Words are not enough to thank my family. I owe my sincere gratitude to my mom and dad. You have supported me with great love in each and every step of my life. I know I have not always been the easiest child to raise, but I hope you can now be proud of your achievement. Daddy, I made it! My sisters Minttu and Anniina: You are the greatest gift I will ever know. There has been so much happiness and love in all those unforgettable moments we have spent together. Minttu, the old soul sister of mine, you have always supported and encouraged me to listen to my heart and follow my chosen path confidently.
Where ever you go on your travels, you are in my heart. Thank you also for all the English lessons. Anniina, my little forest fairy, you have the most beautiful heart I have ever known. I am so proud and happy to be your big sister. Last but not least, Piippola deserves a special bone for all her unconditional support.
Kim, I think you have had some hard times with me, but yet you have been by my side, supporting and helping me carry on. Your unquestioning belief in me, has meant so much to me. We have a great journey ahead and I am happy and privileged to travel that path with you.
Turku, 3.9.2018 With great gratitude, Sanna-Maria Nurmi
List of the original publications
This dissertation is based on the following original publications:
I Nurmi S-M, Pietilä A-M, Kangasniemi M & Halkoaho A. Nurse leaders’
perceptions of the ethical recruitment of study subjects in clinical research. Journal of Nursing Management 23: 1020-1028, 2015.
II Nurmi S-M, Kangasniemi M, Halkoaho A & Pietilä A-M. What enables ethically conducted clinical research in hospitals: Views of administrative staff. Clinical Ethics 11: 166-175, 2016.
III Nurmi S-M, Halkoaho A, Kangasniemi M & Pietilä A-M. Collaborative partnership and the social value of clinical research: a qualitative secondary analysis. BMC Medical Ethics 18:57, 2017.
IV Nurmi S-M, Kangasniemi M, Halkoaho A, & Pietilä A-M. Privacy of clinical research subjects: An integrative literature review. Accepted for Publication in the Journal of Empirical Research on Human Research Ethics, 2018.
These publications were adapted with the permission of the copyright-owners.
The summary also contains supplementary material.
this precious friendship. You are an amazingly talented chef and the world-famous parties you have thrown have helped me to relax. Darling, there would not be a party without you!
Jenni you have maintained my physical and mental well-being during these years. You have been a wonderful and understandable friend, even though I have not always been able to offer you the same kind of friendship during these busy days. I hope our friendship lasts forever! Miisku my dear cousin. You have offered me lots of priceless advice and deep discussions, which have made me a better person and helped me carry on with my study. I am sorry that I cannot express my gratitude to all my great friends in this acknowledgement, even though every one of you would earn praises page after page. From the bottom of my heart, I would also like to express my gratitude to Kerli, Veera, Jonde, Eija, Elisa, and Johanna. You are all precious to me!
Words are not enough to thank my family. I owe my sincere gratitude to my mom and dad. You have supported me with great love in each and every step of my life. I know I have not always been the easiest child to raise, but I hope you can now be proud of your achievement. Daddy, I made it! My sisters Minttu and Anniina: You are the greatest gift I will ever know. There has been so much happiness and love in all those unforgettable moments we have spent together. Minttu, the old soul sister of mine, you have always supported and encouraged me to listen to my heart and follow my chosen path confidently.
Where ever you go on your travels, you are in my heart. Thank you also for all the English lessons. Anniina, my little forest fairy, you have the most beautiful heart I have ever known. I am so proud and happy to be your big sister. Last but not least, Piippola deserves a special bone for all her unconditional support.
Kim, I think you have had some hard times with me, but yet you have been by my side, supporting and helping me carry on. Your unquestioning belief in me, has meant so much to me. We have a great journey ahead and I am happy and privileged to travel that path with you.
Turku, 3.9.2018 With great gratitude, Sanna-Maria Nurmi
List of the original publications
This dissertation is based on the following original publications:
I Nurmi S-M, Pietilä A-M, Kangasniemi M & Halkoaho A. Nurse leaders’
perceptions of the ethical recruitment of study subjects in clinical research. Journal of Nursing Management 23: 1020-1028, 2015.
II Nurmi S-M, Kangasniemi M, Halkoaho A & Pietilä A-M. What enables ethically conducted clinical research in hospitals: Views of administrative staff. Clinical Ethics 11: 166-175, 2016.
III Nurmi S-M, Halkoaho A, Kangasniemi M & Pietilä A-M. Collaborative partnership and the social value of clinical research: a qualitative secondary analysis. BMC Medical Ethics 18:57, 2017.
IV Nurmi S-M, Kangasniemi M, Halkoaho A, & Pietilä A-M. Privacy of clinical research subjects: An integrative literature review. Accepted for Publication in the Journal of Empirical Research on Human Research Ethics, 2018.
These publications were adapted with the permission of the copyright-owners.
The summary also contains supplementary material.
Contents
1 INTRODUCTION ... 1
2 REVIEW OF THE LITERATURE ... 4
2.1 Protection of human subjects in clinical research ... 4
2.1.1 The human subject’s autonomy ... 4
2.1.2 Balancing benefits and harm ... 7
2.1.3 Justice and the requirement of social value ... 8
2.2 Responsible stakeholders in clinical research ... 10
2.3 Codes of ethics and regulation guiding the conduct of clinical research ... 12
2.3.1 International codes of ethics ... 12
2.3.2 The changing European regulation landscape and its effect on national legislation ... 15
2.4 An Ethical framework for clinical research ... 19
2.5 Summary of the literature ... 22
3 AIM OF THE STUDY ... 24
4 METHODS... 25
4.1 Qualitative interview studies (Publication I & II) ... 27
4.1.1 Research environment, recruitment and participants ... 27
4.1.2 Semi-structured individual face- to -face interviews ... 27
4.1.3 Inductive content analysis ... 28
4.2 A Qualitative study with secondary analysis (Publication III and supplementary material) ... 29
4.2.1 Methods and data ... 29
4.2.2 Deductive-inductive content analysis ... 29
4.3 An Integrative review (Publication IV) ... 29
4.3.1 Methods and data collection ... 29
4.3.2 Quality assessment of selected articles ... 30
4.3.3 A constant comparison method ... 30
4.4 Ethical consideration ... 31
5 RESULTS ... 33
5.1 Realisation of human subject’s autonomy and factors enabling ethical clinical research (Publications I and II) ... 33
5.1.1 The human subject’s autonomy as a central but threatened principle ... 33
5.1.2 Factors enabling ethical conduct in clinical research ... 35
5.2 Ethical aspects of clinical research based on the ethical framework (Publication III and supplementary material) ... 37
5.2.1 Collaborative partnership as a cornerstone (Publication III) ... 37
5.2.2 The multidimensional meaning of social value (Publication III) ... 37
5.2.3 Other ethical requirements in light of the ethical framework (Supplementary material) ... 39
5.3 Topical aspects of study subjects’ privacy (Publication IV) ... 41
5.4 A summary of the findings ... 44
6 DISCUSSION ... 45
6.1 Discussion of the main findings ... 45
6.1.1 Human subjects’ autonomy and privacy in changing clinical research ... 45
6.1.2 Collaboration among stakeholders ... 48
Contents
1 INTRODUCTION ... 1
2 REVIEW OF THE LITERATURE ... 4
2.1 Protection of human subjects in clinical research ... 4
2.1.1 The human subject’s autonomy ... 4
2.1.2 Balancing benefits and harm ... 7
2.1.3 Justice and the requirement of social value ... 8
2.2 Responsible stakeholders in clinical research ... 10
2.3 Codes of ethics and regulation guiding the conduct of clinical research ... 12
2.3.1 International codes of ethics ... 12
2.3.2 The changing European regulation landscape and its effect on national legislation ... 15
2.4 An Ethical framework for clinical research ... 19
2.5 Summary of the literature ... 22
3 AIM OF THE STUDY ... 24
4 METHODS... 25
4.1 Qualitative interview studies (Publication I & II) ... 27
4.1.1 Research environment, recruitment and participants ... 27
4.1.2 Semi-structured individual face- to -face interviews ... 27
4.1.3 Inductive content analysis ... 28
4.2 A Qualitative study with secondary analysis (Publication III and supplementary material) ... 29
4.2.1 Methods and data ... 29
4.2.2 Deductive-inductive content analysis ... 29
4.3 An Integrative review (Publication IV) ... 29
4.3.1 Methods and data collection ... 29
4.3.2 Quality assessment of selected articles ... 30
4.3.3 A constant comparison method ... 30
4.4 Ethical consideration ... 31
5 RESULTS ... 33
5.1 Realisation of human subject’s autonomy and factors enabling ethical clinical research (Publications I and II) ... 33
5.1.1 The human subject’s autonomy as a central but threatened principle ... 33
5.1.2 Factors enabling ethical conduct in clinical research ... 35
5.2 Ethical aspects of clinical research based on the ethical framework (Publication III and supplementary material) ... 37
5.2.1 Collaborative partnership as a cornerstone (Publication III) ... 37
5.2.2 The multidimensional meaning of social value (Publication III) ... 37
5.2.3 Other ethical requirements in light of the ethical framework (Supplementary material) ... 39
5.3 Topical aspects of study subjects’ privacy (Publication IV) ... 41
5.4 A summary of the findings ... 44
6 DISCUSSION ... 45
6.1 Discussion of the main findings ... 45
6.1.1 Human subjects’ autonomy and privacy in changing clinical research ... 45
6.1.2 Collaboration among stakeholders ... 48
6.1.3 Tension between clinical research practice and changing regulations ... 50
6.1.4 The growing importance of social value in clinical research ... 52
6.1.4 Ethical Framework as practical tool in clinical research ... 55
6.2 Trustworthiness of the research ... 55
6.2.1 Qualitative research ... 55
6.2.2 The integrative literature review... 58
7 CONCLUSIONS ... 59
7.1 Conclusions from the main findings ... 59
7.2 Suggestions for further research ... 60
REFERENCES ... 61
ORIGINAL PUBLICATIONS (I-IV)
Abbreviations
CIOMS Council of International Organizations of Medical Sciences CINAHL Cumulative Index to Nursing and Allied Health Literature
EU European Union
GDPR General Data Protection Regulation ICH International Council for Harmonisation TENK Finnish Advisory Board on Research Integrity
UNESCO United Nations Educational, Scientific and Cultural Organization WHO World Health Organization
WMA World Medical Association
6.1.3 Tension between clinical research practice and changing regulations ... 50
6.1.4 The growing importance of social value in clinical research ... 52
6.1.4 Ethical Framework as practical tool in clinical research ... 55
6.2 Trustworthiness of the research ... 55
6.2.1 Qualitative research ... 55
6.2.2 The integrative literature review... 58
7 CONCLUSIONS ... 59
7.1 Conclusions from the main findings ... 59
7.2 Suggestions for further research ... 60
REFERENCES ... 61
ORIGINAL PUBLICATIONS (I-IV)
Abbreviations
CIOMS Council of International Organizations of Medical Sciences CINAHL Cumulative Index to Nursing and Allied Health Literature
EU European Union
GDPR General Data Protection Regulation ICH International Council for Harmonisation TENK Finnish Advisory Board on Research Integrity
UNESCO United Nations Educational, Scientific and Cultural Organization WHO World Health Organization
WMA World Medical Association
1 Introduction
Clinical research is a component of biomedical research that involves human subjects as research participants. The ultimate aim in clinical research is to produce valuable scientific knowledge for the benefit of society (Emanuel and Wendler, 2008; Levine, 2008). Furthermore, clinical research is intended to promote people’s health and well-being; to find better ways to understand, treat, and prevent diseases; and to develop new, safe, and effective treatments (Levine, 2008). Various definitions and terms have been used in efforts to define clinical research (Hemminki, Veerus, et al., 2013; Levine, 2008). For purposes of this thesis, it is understood in keeping with Finland’s Medical Research Act (488/1999), which defines medical research as research involving intervention in the integrity of a human being, human embryo, or human foetus for purposes of increasing knowledge of health; the causes, symptoms, diagnosis, treatment, and presentation of diseases; or the nature of diseases in general.
Finland is one of the Nordic welfare states, with comprehensive public health care. Hence, this country possesses significant strengths as a setting for clinical research, such as a well- functioning health-care system, a stable and homogeneous population, a consistently applied set of clinical care principles, a good health-information system with extensive registers, biobanks, and an active research environment in place in university hospitals and public hospitals (Hemminki, Veerus, et al., 2013). Conventionally, clinical research in Finland is conducted at university hospitals (Hemminki, Virtanen, et al., 2013). It forms a central part of these hospitals’ everyday work and, in fact, is also a statutory duty laid down by Finnish legislation – the staff of university hospitals are obliged to take part in the implementation of research (Health Care Act, 1326/2010).
Ethics is an integral part of clinical research involving human subjects (Mustajoki and Mustajoki, 2017; Shamoo and Resnik, 2009). Ethics in research has a ‘continuous nature’; that is, it is an issue that extends through the entire research process, from development of the research question to dissemination of the results of the study. Research ethics can be understood as a set of skills supporting both the researcher and the research community in making ethical choices in their research activities (Mustajoki and Mustajoki, 2017). According to Shamoo and Resnik (2009), the field of research ethics is a branch of applied ethics that studies the ethical problems, dilemmas, and issues that arise in the conducting of research. In clinical research, ethics encompasses questions surrounding how individuals participating in the research as human subjects can be treated fairly, and it focuses at the same time on how good scientific practice can be ensured in the research (Mustajoki and Mustajoki, 2017; Resnik, 2005; Shamoo and Resnik, 2009).
Clinical research is guided by codes of ethics (Beauchamp and Childress, 2013) defining standards for human subjects’ protection (Shamoo and Resnik, 2009). Furthermore, clinical research is regulated by international and national regulations and by national legislation (Largent, 2016), which indicates the minimum level of ethical behaviour expected (Launis, 2015). In their practice, researchers encounter complex ethical questions and issues on a daily basis, and being able to make responsible choices in these situations necessitates an understanding of the moral and social dimensions of research, an understanding that the discipline of research ethics strives to provide (Shamoo and Resnik, 2009).
Ethics has gained increased importance in clinical research for many reasons (Brall et al., 2017; Shamoo and Resnik, 2009). Firstly, clinical research is increasingly collaborative action, involving more stakeholders, from diverse professional backgrounds and working with various organisations, nationally and internationally (Blasimme et al., 2016; Brall et al., 2017;
VanWormer et al., 2012). Furthermore, increased globalisation brings opportunities for research but also forms a new and more complex research environment, in which researchers need new kinds of skills and expertise in doing high-quality, ethical research (Mustajoki and
1 Introduction
Clinical research is a component of biomedical research that involves human subjects as research participants. The ultimate aim in clinical research is to produce valuable scientific knowledge for the benefit of society (Emanuel and Wendler, 2008; Levine, 2008). Furthermore, clinical research is intended to promote people’s health and well-being; to find better ways to understand, treat, and prevent diseases; and to develop new, safe, and effective treatments (Levine, 2008). Various definitions and terms have been used in efforts to define clinical research (Hemminki, Veerus, et al., 2013; Levine, 2008). For purposes of this thesis, it is understood in keeping with Finland’s Medical Research Act (488/1999), which defines medical research as research involving intervention in the integrity of a human being, human embryo, or human foetus for purposes of increasing knowledge of health; the causes, symptoms, diagnosis, treatment, and presentation of diseases; or the nature of diseases in general.
Finland is one of the Nordic welfare states, with comprehensive public health care. Hence, this country possesses significant strengths as a setting for clinical research, such as a well- functioning health-care system, a stable and homogeneous population, a consistently applied set of clinical care principles, a good health-information system with extensive registers, biobanks, and an active research environment in place in university hospitals and public hospitals (Hemminki, Veerus, et al., 2013). Conventionally, clinical research in Finland is conducted at university hospitals (Hemminki, Virtanen, et al., 2013). It forms a central part of these hospitals’ everyday work and, in fact, is also a statutory duty laid down by Finnish legislation – the staff of university hospitals are obliged to take part in the implementation of research (Health Care Act, 1326/2010).
Ethics is an integral part of clinical research involving human subjects (Mustajoki and Mustajoki, 2017; Shamoo and Resnik, 2009). Ethics in research has a ‘continuous nature’; that is, it is an issue that extends through the entire research process, from development of the research question to dissemination of the results of the study. Research ethics can be understood as a set of skills supporting both the researcher and the research community in making ethical choices in their research activities (Mustajoki and Mustajoki, 2017). According to Shamoo and Resnik (2009), the field of research ethics is a branch of applied ethics that studies the ethical problems, dilemmas, and issues that arise in the conducting of research. In clinical research, ethics encompasses questions surrounding how individuals participating in the research as human subjects can be treated fairly, and it focuses at the same time on how good scientific practice can be ensured in the research (Mustajoki and Mustajoki, 2017; Resnik, 2005; Shamoo and Resnik, 2009).
Clinical research is guided by codes of ethics (Beauchamp and Childress, 2013) defining standards for human subjects’ protection (Shamoo and Resnik, 2009). Furthermore, clinical research is regulated by international and national regulations and by national legislation (Largent, 2016), which indicates the minimum level of ethical behaviour expected (Launis, 2015). In their practice, researchers encounter complex ethical questions and issues on a daily basis, and being able to make responsible choices in these situations necessitates an understanding of the moral and social dimensions of research, an understanding that the discipline of research ethics strives to provide (Shamoo and Resnik, 2009).
Ethics has gained increased importance in clinical research for many reasons (Brall et al., 2017; Shamoo and Resnik, 2009). Firstly, clinical research is increasingly collaborative action, involving more stakeholders, from diverse professional backgrounds and working with various organisations, nationally and internationally (Blasimme et al., 2016; Brall et al., 2017;
VanWormer et al., 2012). Furthermore, increased globalisation brings opportunities for research but also forms a new and more complex research environment, in which researchers need new kinds of skills and expertise in doing high-quality, ethical research (Mustajoki and
Mustajoki, 2017). Because of the greater demands for collaboration, there is a need to adhere more closely to standards of conduct for ethical clinical research that should foster effective collaboration in research and promote the goals of science (Shamoo and Resnik, 2009). Also, clinical research conducted with many stakeholders is more likely to have an impact on health- care practice (Abma et al., 2017) and health-sector policymaking (Emanuel and Wendler, 2008), and it may thereby increase the value of such research for society (Abma et al., 2017; Emanuel and Wendler, 2008).
Secondly, clinical research always is deeply embedded in a wider social context (Shamoo and Resnik, 2009). According to Brall et al. (2017), the broader social dimension of research and the large role of research networks are quite pronounced in the field of research ethics today, instead of the focus being exclusively on the relationship between researcher and study subjects. The social context of research involves connections between researchers and the non- academic world, encompassing, for instance, makers of health policy, media entities, and the general public. The social aspect of research necessitates that researchers adopt a new kind of role besides the traditional one centred on increasing knowledge and understanding (Mustajoki and Mustajoki, 2017). With increased emphasis on social aspects of research comes a need for public support for clinical research (Wendler and Shah, 2015), which demands trust between researcher and public (Resnik, 2011). In addition, economic, political, social, and cultural values affect the scientific goals, resources, and practices related to research (Kelly and Geissler, 2011; Shamoo and Resnik, 2009). Recently there has been increased pressure and competition for research funding, due to the weak economic situation, which may affect research from an ethics angle (Mustajoki and Mustajoki, 2017; Nuffield Council on Bioethics, 2014; Tijdink et al., 2014).
Thirdly, new technology and advanced methods of science and research pose challenges in the field of research ethics (Mustajoki and Mustajoki, 2017). Among the relevant changes that are visible in the context of clinical research are the increased role of informational technology, use of big data, and employment of electronic health data for research purposes (Bélanger and Crossler, 2011; Hoffman and Podgurski, 2012; Ienca et al., 2018; Stiles and Petrila, 2011).
Research ethics is neither static nor permanent; it is dynamic in nature (Brall et al., 2017;
Emanuel and Wendler, 2008; Häyry et al., 2007), and shifts in the scientific landscape are accompanied by changes in approaches to research ethics (Brall et al., 2017; Largent, 2016).
Emanuel and Grady (2008) have recognised four paradigms of clinical research ethics, each of them expressing its own values and approach to protection of human subjects over the course of clinical research history. During World War II, the prevailing paradigm was that of researcher paternalism, wherein clinical research was seen as important for the good of society and individuals’ sacrifice was necessary for research and justified by the benefits it provided for society. This era, in which the main pillar of protection of human subjects was related to the integrity of the researcher and the researcher’s judgement, came to an end in the early 1970s, after a series of unethically conducted clinical studies came to light, creating scandals. The ensuing time of ‘regulatory protectionism’ highlighted study subjects’ protection. (Emanuel and Grady, 2008) The principles of autonomy, beneficence, non-maleficence, and justice, presented by Tom Beauchamp and James Childress, were taken up as guiding principles for ethics of clinical research (Beauchamp and Childress, 2009), and national- and international- level regulatory systems were strengthened accordingly. Informed consent and ethics review were considered to constitute the central way to protect research participants from exploitation and from risks and burdens. However, by the late 1980s, the dominant paradigm was participant access and individuals’ right to autonomy. For example, people with HIV began to demand access to trials rather than strict protection from potential exploitation, and they considered exclusion from trials to be harmful and unjust. In this view, individuals do not need to be protected by regulation; rather, it should be ensured that they are aware of their own good and their best interests, and they should be free to pursue these. In the mid-1990s, in tandem with rapid developments in fields such as genetic research and studies in developing countries, collaborative partnership became the dominant paradigm. Community engagement
and collaboration were recognised as constituting an important aspect of ensuring research’s relevance and the integrity of research practice. (Emanuel and Grady, 2008)
Now, the focus has shifted again, from the protection of study subjects and obtaining informed consent and towards social benefits and scientific integrity within the broader context of a research network and collaboration (Brall et al., 2017). The ethical principles articulated by Beauchamp and Childress (2009) are still considered to be central ones, but alternatives have been presented also. According to Lev (2011), the core values in biomedical research are solidarity, personal responsibility, autonomy, and equality. The call for a shift of focus from autonomy and individuals’ rights toward more collective responsibility and reciprocity, with a focus also on community benefits, benefit-sharing, and solidarity, has grown (Forsberg et al., 2009; IJsselmuiden et al., 2010; Prainsack and Buyx, 2013; Sutrop, 2011;
VanWormer et al., 2012). There has been greater emphasis on how clinical research can be executed such that it produces the greatest possible benefit to society through valuable research and simultaneously protects the rights and well-being of human subjects and communities (Emanuel and Wendler, 2008).
Notwithstanding the recognised importance of the broader social context of clinical research (Brall et al., 2017), little attention has been paid to the various stakeholders’ perspectives on ethical aspects of clinical research. Previous studies put the focus mainly on the viewpoint of human subjects (see for example Behrendt et al., 2011; Falagas et al., 2009; Halkoaho et al., 2010; Resnik and Ness, 2012; Tam et al., 2015), researchers (see for example Bélisle-Pipon et al., 2018; Halkoaho et al., 2011; Strüver, 2017), or clinical staff (see for example Chhoa et al., 2017;
Halkoaho, et al., 2012). However, there has been little empirical research from the perspective of the other responsible stakeholders – among them nurse leaders and administrative staff (in this study including principal investigators, administrative managers, and elected officials), both having professional responsibilities to enable and manage the conduct of clinical research in their hospitals. Awareness of their perspective is critical for gaining a holistic understanding of the ethical aspects of clinical research at their hospitals. Through empirical research, it is possible to capture nurse leaders’ and administrative staff’s actual experience of ethical aspects of clinical research and what really happens in research practice ‘on the ground’ (Sieber, 2004;
Wangmo et al., 2018). In addition, empirical research on this phenomenon has potential to guide the translation of abstract principles into workable practices and capacity to ensure that bioethicists are in touch with the real-world experiences of those affected (Wangmo et al., 2018). Accordingly, the aim of the study was to describe ethically conducted clinical research in hospitals from the perspective of nurse leaders and administrative staff including principal investigators, administrative managers, and elected officials via a synthesis of previous studies.
