Vidar Enebakk (Directors)
Bjørn Hvinden (Chair)
Kjersti Fjørtoft
Anne Gjelsvik
Marit Anne Hauan
Ingegerd Holand
Ove Jakobsen
Lynn Nygaard
Hilde Pape
Erling Sandmo
Einar Spurkeland
Knut Martin Tande
Elin Thuen
Arne Tostensen
Lisbeth Øyum
Helene Ingierd /
Espen Gamlund /
Hallvard Fossheim (Directors)
Anne-Hilde Nagel (Chair)
Alexander Cappelen
Hallvard J. Fossheim
Arne Grønningsæter
Kristian Berg Harpviken
Marit Anne Hauan
Stig André Haugen
Hilde Pape
Jone Salomonsen
Cecilie Elisabeth Schjatvet
Anne-Julie Semb
Arne Tostensen
Hilde W. Nagell /
Helene Ingierd (Directors)
Ragnvald Kalleberg (Chair)
Asta Balto
Alexander Cappelen
Anne-Hilde Nagel
Hanne Signe Nymoen
Helge Rønning
Jone Salomonsen
Per Schreiner
Anne Julie Semb
Ann Helen Skjelbred
Ole Peter Askheim
Bjarte Vandvik
Hilde W. Nagell (Director)
Ragnvald Kalleberg (Chair)
Elisabeth Backe-Hansen
Hanne Inger Bjurstrøm
Ida Blom
Aksel Hatland
Trond Herland
Heidi von Weltzien Høivik
Paul Leer-Salvesen
Raino Malnes
Audhild Schanche
Ann Helene B. Skjelbred
Jan Tøssebro
Finn Mølmen /
Hilde W. Nagell / Micheline Egge Grung (Directors)
Fredrik Engelstad (Chair)
Bente Gullveig Alver
Ida Blom
Elisabeth Backe-Hansen
Hanne Inger Bjurstrøm
Aksel Hatland
Trond Herland
Heidi von Weltzien Høivik
Wenche Håland
Paul Leer-Salvesen
Raino Malnes
Dag Elgesem (Director)
Fredrik Engelstad (Chair)
Bente Gullveig Alver
Elisabeth Backe-Hansen
Aksel Hatland
Kari Helliesen
Trond Herland
Heidi von Weltzien Høivik
Wenche Håland
Yngvar Løken
Halvor Moxnes
Pål Repstad
Sølvi Sogner
Andreas Føllesdal /
Dag Elgesem (Directors)
Fredrik Engelstad (Chair)
Bente Gullveig Alver
Ivar Asheim
Kirsti Coward
Victor Hellern
Kari Helliesen
Wenche Håland
Tore Lindholm
Yngvar Løken
Halvor Moxnes
Pål Repstad
Sølvi Sogner
Andreas Føllesdal (Director)
1 . See the attachment for more on NESH and the guidelines.
2 . ‘The ethos of science’ was formulated by Robert K. Merton in 1942; see also Knut Erik Tranøy (1986), Vitenskapen – samfunnsmakt og livsform .
3 . The three fundamental principles were formulated in the Belmont report (1979).
4 . UN (1948), The Declaration of Human Rights , article 27 (1).
5 . The Norwegian Constitution § 100; Universitets- og høgskoleloven § 1–5.
6 . The Research Ethics Act § 1.
7 . The Research Ethics Act § 4.
8 . The Research Ethics Act § 5.
9 . The Research Ethics Act § 6.
10 . UNESCO (2017), Recommendation on Science and Scientific Researchers ; Ministerial Conference on the European Research Area (2020), Bonn Declaration on Freedom of Scientific Research .
11 . Universitets- og høgskoleloven § 1–5.
12 . The Norwegian Constitution § 100.
13 . See also forvaltningsloven § 6.
14 . See also the Vancouver recommendations by the International Committee of Medical Journal Editors (ICMJE), and other relevant resources by the Committee on Publication Ethics (COPE).
15 . A possible demand concerning the legal basis for the processing of personal data applies indepen- dently of the research ethical demand for consent to participate in research.
16 . See personvernforordningen (GDPR) art. 4 no. 11 og art. 7 no. 1 for demands for legal consent.
17 . UN’s Convention on the Rights of the Child, article 3 on the best interests of the child. Also, see the Norwegian Constitution § 104, point two.
18 . UN’s Convention on the Rights of the Child, article 12 on the right to be heard. Also, see the Nor- wegian Constitution § 104, point one.
19 . Legally, children cannot, as a main rule, consent to sharing personal information. Therefore, consi- dering other grounds for data processing apart from consent may be necessary, for instance that the research is in the general interest of the public, see personvernforordningen (GDPR) art. 6 og 9.
20 . Within medical and health research children between the ages of 12 and 16 may in some cases provide their own consent to participate, provided that the project has been approved by a regional committee (REK). See The Ministry of Health and Care Services (Helse og omsorgsdepartementet) (2017), Forskrift om barn mellom 12 og 16 år sin rett til selv å samtykke i medisinsk og helsefaglig forskning .
21 . For more on these concepts, see NESH (2018), A Guide to Internet Research Ethics .
22 . See personvernforordningen (GDPR) art. 6 point 1 letter e and art. 9 and also personopplysningsloven § 9.
23 . «Pseudonymization» is also a legal concept, see GDPR art. 4 point 5 and art. 89 point 1.
24 . Forvaltningsloven § 13 e.
25 . The Penal Code § 196.
26 . Barnevernloven § 6–4.
27 . Personvernlovverket; arkivlova.
28 . UN (2007). Declaration on the Rights of Indigenous Peoples .
29 . Cultural objects that are also pieces of art demand particular consideration, as they are sources, original artifacts and intellectual property; see kulturminneloven.
30 . Nasjonalt utvalg for vurdering av forskning på menneskelige levninger (2018), Forskningsetisk veileder for forskning på menneskelige levninger ; (2018), Veileder ved funn av menneskelig levninger .
31 . International Council of Museums (2017), ICOM Code of Ethics for Museums .
32 . See also offentleglova on how access to public data may be limited by concerns for confidentiality of personal information, overarching national interests or security concerns.
33 . Universitets- og høgskoleloven § 1–5; The Research Ethics Act § 1.
34 . The Research Ethics Act § 5 b.
35 . ALLEA (2017), European Code of Conduct for Research Integrity , point 2.6. Collaborative Working.
36 . Veileder for brukermedvirkning i helseforskning i spesialisthelsetjenesten, May 2018.
37 . For more information about publication ethics, see Committee on Publication Ethics (COPE).
38 . The Norwegian Constitution § 100 ‘The authorities of the state shall create conditions that facilitate open and enlightened public discourse.’
39 . Universitets- og høyskoleloven § 1–1 c; § 1–3 c and e.
40 . Aune-utvalget (NOU 2020: 3), Ny lov om universiteter og høgskoler , ch. 15 Akademisk frihet.
41 . Arne Næss (1975), En del elementære logiske emner . 11th. ed., ch. 7.
42 . See researchethics.no.
43 . St. medl. nr. 28 (1988–1989). Om forskning , s. 70–73.
44 . Hovedkomiteen for norsk forskning (1981), Forskning og etisk ansvar . Ledet av Knut Erik Tranøy.
45 . Norges allmennvitenskapelige forskningsråd (1979), Forskningsetikk og personopplysninger .
46 . Singapore Statement (2010); Montreal Statement (2013).
47 . ALLEA (2017), Europeiske retningslinjer for forskningsintegritet , Norwegian in 2019.
48 . The Research Ethics Act § 3.
49 . The Health Research Act.
50 . The Research Ethics Act § 7.
51 . Kulturminneloven.
52 . The Health Research Act § 10.
53 . WMA Declaration of Helsinki.
54 . The Research Ethics Act § 5.
55 . Personvernlovverket.
(3 reviews)
Matt DeCarlo, La Salle University
Cory Cummings, Nazareth University
Kate Agnelli, Virginia Commonwealth University
Copyright Year: 2021
ISBN 13: 9781949373219
Publisher: Open Social Work Education
Language: English
Conditions of use.
Learn more about reviews.
Reviewed by Erin Boyce, Full Time Faculty, Metropolitan State University of Denver on 6/3/24
This book provides a strong comprehensive overview of each step in the research & evaluation process for students, clearly outlining each step with clarity and direction. read more
Comprehensiveness rating: 5 see less
This book provides a strong comprehensive overview of each step in the research & evaluation process for students, clearly outlining each step with clarity and direction.
Content Accuracy rating: 5
Content in this text is accurate, needing no clarification or added information, and is presented in an unbiased manner.
Relevance/Longevity rating: 5
The relevance of this text is it's greatest strength. It is one of the strongtest research texts I've encountered, and while change always comes this text will survive new iterations of research, only needing minimal and straightforward updates.
Clarity rating: 5
As a research text, this is extremely user friendly. It is easy to read, direct, and does not interfere with student understanding. Students come away with a good understanding of the concepts from this text, and many continue to use it beyond the classroom.
Consistency rating: 5
This text is consistent with research methods and frameworks and stands alone among social work research texts as the most accessbile due to it's status as an OER and as a social work textbook.
Modularity rating: 5
This text is easily divisible into smaller readings, it works great for courses in which assignments are scaffolded to move students through the research process.
Organization/Structure/Flow rating: 5
This text is organized to walk the student through the research process from start to finish, and is easily adjusted for different teaching styles.
Interface rating: 5
This text has no significant interface issues, the readings, links, and images are easily accessbile and are presented in a way that does not interfere with student learning.
Grammatical Errors rating: 5
This text is well edited and formatted.
Cultural Relevance rating: 5
This text is culturally relevant, addresses issues of cultural relevance to social work, and highlights the role of social work values within the realm of social work research.
This is one of the best research texts I've encounted in over a decade of teaching. It is so easily digested and presents information in a direct and understandable way, and is one of the best texts for those teaching graduate level research for social workers. It is an inclusive text that honors the multiple levels of knowledge that our students come to us with, which helps sets it apart. And, the committment throughout the text to social work values and ethics is critical for todays social worker.
Reviewed by Laura Montero, Full-time Lecturer and Course Lead, Metropolitan State University of Denver on 12/23/23
Graduate Research Methods in Social Work by DeCarlo, et al., is a comprehensive and well-structured guide that serves as an invaluable resource for graduate students delving into the intricate world of social work research. The book is divided... read more
Comprehensiveness rating: 4 see less
Graduate Research Methods in Social Work by DeCarlo, et al., is a comprehensive and well-structured guide that serves as an invaluable resource for graduate students delving into the intricate world of social work research. The book is divided into five distinct parts, each carefully curated to provide a step-by-step approach to mastering research methods in the field. Topics covered include an intro to basic research concepts, conceptualization, quantitative & qualitative approaches, as well as research in practice. At 800+ pages, however, the text could be received by students as a bit overwhelming.
Content appears consistent and reliable when compared to similar textbooks in this topic.
The book's well-structured content begins with fundamental concepts, such as the scientific method and evidence-based practice, guiding readers through the initiation of research projects with attention to ethical considerations. It seamlessly transitions to detailed explorations of both quantitative and qualitative methods, covering topics like sampling, measurement, survey design, and various qualitative data collection approaches. Throughout, the authors emphasize ethical responsibilities, cultural respectfulness, and critical thinking. These are crucial concepts we cover in social work and I was pleased to see these being integrated throughout.
The level of the language used is appropriate for graduate-level study.
Book appears to be consistent in the tone and terminology used.
Modularity rating: 4
The images and videos included, help to break up large text blocks.
Topics covered are well-organized and comprehensive. I appreciate the thorough preamble the authors include to situate the role of the social worker within a research context.
Interface rating: 4
When downloaded as a pdf, the book does not begin until page 30+ so it may be a bit difficult to scroll so long for students in order to access the content for which they are searching. Also, making the Table of Contents clickable, would help in navigating this very long textbook.
I did not find any grammatical errors or typos in the pages reviewed.
I appreciate the efforts made to integrate diverse perspectives, voices, and images into the text. The discussion around ethics and cultural considerations in research was nuanced and comprehensive as well.
Overall, the content of the book aligns with established principles of social work research, providing accurate and up-to-date information in a format that is accessible to graduate students and educators in the field.
Reviewed by Elisa Maroney, Professor, Western Oregon University on 1/2/22
With well over 800 pages, this text is beyond comprehensive! read more
With well over 800 pages, this text is beyond comprehensive!
I perused the entire text, but my focus was on "Part 4: Using qualitative methods." This section seems accurate.
As mentioned above, my primary focus was on the qualitative methods section. This section is relevant to the students I teach in interpreting studies (not a social sciences discipline).
This book is well-written and clear.
Navigating this text is easy, because the formatting is consistent
My favorite part of this text is that I can be easily customized, so that I can use the sections on qualitative methods.
The text is well-organized and easy to find and link to related sections in the book.
There are no distracting or confusing features. The book is long; being able to customize makes it easier to navigate.
I did not notice grammatical errors.
The authors offer resources for Afrocentricity for social work practice (among others, including those related to Feminist and Queer methodologies). These are relevant to the field of interpreting studies.
I look forward to adopting this text in my qualitative methods course for graduate students in interpreting studies.
About the book.
We designed our book to help graduate social work students through every step of the research process, from conceptualization to dissemination. Our textbook centers cultural humility, information literacy, pragmatism, and an equal emphasis on quantitative and qualitative methods. It includes extensive content on literature reviews, cultural bias and respectfulness, and qualitative methods, in contrast to traditionally used commercial textbooks in social work research.
Our author team spans across academic, public, and nonprofit social work research. We love research, and we endeavored through our book to make research more engaging, less painful, and easier to understand. Our textbook exercises direct students to apply content as they are reading the book to an original research project. By breaking it down step-by-step, writing in approachable language, as well as using stories from our life, practice, and research experience, our textbook helps professors overcome students’ research methods anxiety and antipathy.
If you decide to adopt our resource, we ask that you complete this short Adopter’s Survey that helps us keep track of our community impact. You can also contact [email protected] for a student workbook, homework assignments, slideshows, a draft bank of quiz questions, and a course calendar.
Matt DeCarlo , PhD, MSW is an assistant professor in the Department of Social Work at La Salle University. He is the co-founder of Open Social Work (formerly Open Social Work Education), a collaborative project focusing on open education, open science, and open access in social work and higher education. His first open textbook, Scientific Inquiry in Social Work, was the first developed for social work education, and is now in use in over 60 campuses, mostly in the United States. He is a former OER Research Fellow with the OpenEd Group. Prior to his work in OER, Dr. DeCarlo received his PhD from Virginia Commonwealth University and has published on disability policy.
Cory Cummings , Ph.D., LCSW is an assistant professor in the Department of Social Work at Nazareth University. He has practice experience in community mental health, including clinical practice and administration. In addition, Dr. Cummings has volunteered at safety net mental health services agencies and provided support services for individuals and families affected by HIV. In his current position, Dr. Cummings teaches in the BSW program and MSW programs; specifically in the Clinical Practice with Children and Families concentration. Courses that he teaches include research, social work practice, and clinical field seminar. His scholarship focuses on promoting health equity for individuals experiencing symptoms of severe mental illness and improving opportunities to increase quality of life. Dr. Cummings received his PhD from Virginia Commonwealth University.
Kate Agnelli , MSW, is an adjunct professor at VCU’s School of Social Work, teaching masters-level classes on research methods, public policy, and social justice. She also works as a senior legislative analyst with the Joint Legislative Audit and Review Commission (JLARC), a policy research organization reporting to the Virginia General Assembly. Before working for JLARC, Ms. Agnelli worked for several years in government and nonprofit research and program evaluation. In addition, she has several publications in peer-reviewed journals, has presented at national social work conferences, and has served as a reviewer for Social Work Education. She received her MSW from Virginia Commonwealth University.
BMC Medical Ethics volume 22 , Article number: 135 ( 2021 ) Cite this article
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Despite its ubiquity in academic research, the phrase ‘ethical challenge(s)’ appears to lack an agreed definition. A lack of a definition risks introducing confusion or avoidable bias. Conceptual clarity is a key component of research, both theoretical and empirical. Using a rapid review methodology, we sought to review definitions of ‘ethical challenge(s)’ and closely related terms as used in current healthcare research literature.
Rapid review to identify peer-reviewed reports examining ‘ethical challenge(s)’ in any context, extracting data on definitions of ‘ethical challenge(s)’ in use, and synonymous use of closely related terms in the general manuscript text. Data were analysed using content analysis. Four databases (MEDLINE, Philosopher’s Index, EMBASE, CINAHL) were searched from April 2016 to April 2021.
393 records were screened, with 72 studies eligible and included: 53 empirical studies, 17 structured reviews and 2 review protocols. 12/72 (17%) contained an explicit definition of ‘ethical challenge(s), two of which were shared, resulting in 11 unique definitions. Within these 11 definitions, four approaches were identified: definition through concepts; reference to moral conflict, moral uncertainty or difficult choices; definition by participants; and challenges linked to emotional or moral distress. Each definition contained one or more of these approaches, but none contained all four. 68/72 (94%) included studies used terms closely related to synonymously refer to ‘ethical challenge(s)’ within their manuscript text, with 32 different terms identified and between one and eight different terms mentioned per study.
Only 12/72 studies contained an explicit definition of ‘ethical challenge(s)’, with significant variety in scope and complexity. This variation risks confusion and biasing data analysis and results, reducing confidence in research findings. Further work on establishing acceptable definitional content is needed to inform future bioethics research.
Peer Review reports
Methodological rigour within research is a cornerstone in the production of high-quality findings and recommendations. Across the range of empirical methodologies, a broad collection of protocol development tools, methodology guidelines, and reporting guidelines have been developed and evidence of their use is increasingly required by journals [ 1 , 2 , 3 , 4 , 5 , 6 ]. Within both empirical bioethics and descriptive ethics, there has been an accompanying increase in the acknowledgment of the importance of methodological rigour in the empirical elements, including within the recent consensus statement on quality standards in empirical bioethics research by Ives et al. [ 7 , 8 , 9 ]. Aligned with this aim for rigour, definitional clarity of key terms used within a research project is a component of research quality [ 10 , 11 ]. Improving the quality of empirical bioethics is also itself an ethical imperative [ 9 ].
We recently conducted a systematic review examining ‘ethical challenges’ as reported by specialist palliative care practitioners [ 12 ]. Our review, alongside our initial scoping search findings and reading of the literature, suggested that, although many authors use the term ‘ethical challenge(s)’ in empirical ethics research, there appeared to be no commonly described or accepted definition. Furthermore, papers retrieved rarely defined ‘ethical challenge(s)’ explicitly , which has also been noted by other researchers examining other topic areas [ 13 , 14 , 15 ]. Our review further suggested that authors frequently use terms closely related to ‘ethical challenge(s)’—such as ‘moral dilemmas’ or ‘ethical issues’—interchangeably with ‘ethical challenge(s)’ throughout manuscripts, rather than staying with the original term. Research shows that non-philosophers may understand these related terms in heterogeneous ways which may additionally affect understanding of texts across different readerships [ 16 , 17 ].
Without a clear definition of an ethical challenge, each researcher must use individual judgement to ascertain whether they have identified an instance of one within their dataset. This potentially generates an unnecessary source of bias, particularly if multiple researchers are involved in data collection, extraction, or analysis. This risks generating misleading ethical analyses, evaluations, or recommendations. Additionally, and more broadly, if primary studies do not define the term, then work based on these—such as systematic reviews of individual studies or those undertaking secondary data analysis—may unknowingly compare different phenomena without a mechanism for mitigating the effects this introduces.
In the hope of prompting a debate on this topic, we therefore undertook a rapid review, which aimed to explore existing definitions of “ethical challenge(s)” and the use of other closely related terms within recent empirical healthcare ethics literature.
We conducted a rapid review examining the usage of the term ‘ethical challenge(s)’ over the last 5 years in published research articles, in order to identify and summarise if, and how, the term was defined. As a secondary aim, we examined authors’ uses of closely related alternative terms within the included article texts separate to their use within any explicit definitions that may be present.
Rapid reviews use abridged systematic review methodology to understand the evidence base on a particular topic in a time and resource efficient manner [ 18 , 19 , 20 , 21 , 22 ]. Comparative reviews of topics in which both a rapid review and a systematic review had been undertaken demonstrated that the overall conclusions were similar, although rapid reviews were less likely to contain social and economic data, and systematic reviews contained more detailed recommendations [ 18 , 19 , 20 , 23 , 24 ]. The Cochrane Rapid Review Methods Group has recently released interim methodological guidelines for undertaking rapid reviews [ 6 ], advising authors to describe where their protocol deviates from a systematic review and detail any biases that these deviations may introduce [ 18 , 19 , 21 ]. We have followed the Cochrane recommended methodology [ 6 ]. A rapid review reporting guideline is currently under development [ 25 ] and this review is therefore reported based on the PRISMA 2020 statement for systematic reviews, with justifications provided where our approach deviated [ 26 ].
Prospective review protocol registration on the PROSPERO database is the current gold standard, but, at the time of writing, PROSPERO does not accept records for rapid reviews [ 27 ]. The protocol was therefore not published in advance.
The inclusion and exclusion criteria are summarised in Table 1 . We used Strech et al.’s Methodology, Issues, Participants (MIP) structure for our eligibility criteria, which is recommended for systematic reviews in ‘empirical bioethics’ [ 28 ]. The criteria reflect three assumptions. First, that the inclusion of ‘ethical challenge(s)’ in the title would increase the likelihood that this was the authors’ preferred term for the concept under investigation, and therefore increase the probability of a definition being provided. Second, that studies aiming to describe empirical data and identify ethical challenges in real-world contexts are most likely to contain a definition to guide researchers in identifying these challenges as they collect and analyse data. Third, that structured reviews of studies of ethical challenges are likely to include a definition to allow researchers to reliably recognise an ethical challenge in retrieved records. We used a 5-year timeframe as a date restriction. This reflected a balance between adequately covering recent use of the term and time and resource restrictions of the rapid review.
The search strategy was as follows:
‘ethical challenge’.ti OR ‘ethical challenges’.ti.
We searched Medline (Ovid interface), Philosopher’s Index (OVID interface), EMBASE (OVID interface), and CINAHL (Cumulative Index to Nursing and Allied Health Literature, EBSCO interface) for studies indexed over a five-year period between April 2016 and April 2021. These resources cover the breadth of healthcare research. Including Philosopher’s Index increased coverage of the bioethics literature. We did not search the grey literature [ 6 ]. The search strategy was tested by successfully retrieving three sentinel studies known to the research team.
Retrieved studies were imported into Endnote X9.2 [ 29 ]. Records unavailable through institutional subscriptions were requested from corresponding authors. If unavailable 14 days after the request, the record was excluded. A random sample of 20% of records were dual screened at the title/abstract level by GS/MD. After discussion, the remainder were screened by GS. At full-text screening, a further 20% were dual screened by GS/MD and, again after discussion, the remaining studies were screened by GS.
Data extraction was undertaken using a pre-piloted form, with the first 5 records dually extracted by GS and MD. Data from the remaining included studies was then extracted by GS, with correctness and completeness checked by MD. We collected data on date of publication, authors, journal, country (for primary studies), methodology, definition of ‘ethical challenge(s)’ (present (yes/no)) and (where offered) the definition provided, and any closely related terms used, with counts of all terms used in each article. For closely related terms, data was extracted from the authors’ text, but not from direct quotations from qualitative research. Where definitions of ‘ethical challenge(s)’ were offered and/or related terms were identified, these were categorised and counted following the principles of summative content analysis [ 30 ]. Summative content analysis combines both the quantitative counting of specific content or words/terms with latent content analysis to identify and categorise their meanings. We identified keywords (‘ethical challenge(s)’ and closely related terms) deployed by the authors of the included papers, both prior to and during data analysis, and analysed the retrieved definitions. This approach allowed for exploration of both the content of definitions and development of insights into the use of related terms.
The focus of the rapid review was the definition of the term ‘ethical challenge(s)’ within retrieved records. We therefore did not undertake quality assessment for the included studies and reviews.
831 records were retrieved, reduced to 393 after de-duplication. 238 records were excluded after reviewing the title and/or abstract. 157 records were identified for full text screening, with 3 unavailable [ 31 , 32 , 33 ]. 82 records were excluded at full text stage and 72 records were included for analysis. See Fig. 1 for the PRISMA flowchart.
PRISMA flow diagram of record identification
Of the 72 included records, 53 were empirical studies [ 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 ], 10 non-systematic reviews [ 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 ], 7 systematic reviews [ 12 , 13 , 14 , 97 , 98 , 99 , 100 ], 1 systematic review protocol [ 101 ], and 1 non-systematic review protocol [ 102 ]. Of the 53 empirical studies, 42 (79%) were qualitative studies [ 34 , 35 , 36 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 47 , 48 , 50 , 51 , 52 , 54 , 55 , 56 , 57 , 58 , 60 , 62 , 63 , 64 , 65 , 66 , 67 , 69 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 79 , 80 , 81 , 83 , 84 , 85 , 86 ], 6 (12%) used a mixed methods approach [ 45 , 46 , 53 , 59 , 61 , 68 ], and 5 (10%) were quantitative [ 37 , 49 , 70 , 78 , 82 ]. 7/56 empirical studies, all qualitative interview studies, recruited participants internationally with no specific location stated [ 40 , 54 , 55 , 58 , 60 , 63 , 73 ]. Of the remaining studies, all but one were single-country studies: Botswana [ 75 ], Canada [ 41 , 65 ], China [ 57 ], Denmark [ 39 , 43 ], Dominican Republic [ 44 ], Germany [ 51 , 84 ], India [ 61 ], Iran [ 38 , 46 , 49 , 68 , 70 , 71 , 72 , 78 , 82 , 98 ], Italy [ 45 ], Mexico [ 87 ], the Netherlands [ 76 ], New Zealand [ 47 ], Norway [ 42 , 52 , 56 , 64 , 80 , 81 , 83 ], Saudi Arabia [ 34 , 35 , 36 , 37 ], Tanzania [ 69 , 74 ], Uganda [ 67 ], UK [ 86 ], and USA [ 50 , 53 , 59 , 62 , 66 , 77 , 79 , 85 , 85 ]. The remaining study was undertaken in both Sierra Leone and the UK [ 48 ]. See Table 2 for a summary.
12/72 (17%) of retrieved studies offered an explicit definition for ‘ethical challenge(s)’ [ 12 , 13 , 14 , 48 , 50 , 56 , 57 , 66 , 69 , 81 , 98 , 101 ]. Definitions were more likely to be found in more recent publications, with 4/12 included studies published in 2016–2018 [ 14 , 48 , 56 , 81 ], and 8/12 published in 2019–2021 [ 12 , 13 , 50 , 57 , 66 , 69 , 98 , 101 ]. The included study locations were evenly distributed, matching the overall pattern of retrieved studies, with studies from high- [ 48 , 50 , 56 , 66 , 81 ], middle- [ 57 , 98 ], and low-income settings [ 48 , 69 ]. The identified studies included eight qualitative studies [ 48 , 50 , 56 , 57 , 66 , 69 , 81 , 98 ], 3 systematic reviews [ 12 , 13 , 14 ], and 1 systematic review protocol [ 101 ]. Two of these records were the systematic review protocol and the report from our group, which accordingly contained the same definition [ 12 , 101 ], leaving 11 unique definitions. Definitions of ‘ethical challenge(s)’ identified in included studies are provided in Table 3 . Additionally, 68/72 (94%) reports used closely related terms synonymously in place of ‘ethical challenge(s)’ throughout their manuscript text, with between 1 and 8 different terms used within each report, and 32 different terms were identified. This occurred in both those reports that contained a definition and those that did not. See Table 4 for terms and frequencies.
Those records that offered explicit definitions used four approaches: (1) definition through concepts [ 12 , 57 , 66 ]; (2) reference to moral conflict, moral uncertainty or difficult choices [ 13 , 14 , 48 , 57 , 69 , 98 ]; (3) definition by study participants [ 12 , 48 , 50 , 56 ]; or (4) challenges as linked to their ability to generate emotional or moral distress within healthcare practitioners [ 14 , 14 , 66 , 81 ]. Each definition was associated with one or more of the identified elements, although none covered all four approaches. We describe these approaches below.
This approach involves primarily defining ‘ethical challenge(s)’ in terms of related concepts. All three definitions using this approach defined ‘ethical challenge(s)’ as a summative collection of related concepts, including ‘ethical dilemmas’, ‘moral dilemmas’, ‘moral challenges’, ‘ethical issues’, and ‘ethical conflicts’ [ 12 , 57 , 66 ], for example:
‘The expression “ethical challenges” mainly refers to ethical dilemmas and ethical conflicts as well as other scenarios where difficult choices have to be made’ [ 57 ] p34
Only one went on to define the other concepts they utilised, ‘ethical dilemmas’ and ‘ethical conflicts’:
‘Ethical dilemmas are described as situations that cannot be solved; decisions made between two options may be morally plausible but are equally problematic due to the circumstances. Ethical conflicts, on the contrary, arise when one is aware of the necessity of proper actions but he or she may have trouble exercising these actions because of certain internal or external factors.’ [ 57 ] p34
This approach anchors an ethical challenge to the requirement for an agent to make a (difficult) choice in a situation where moral principles conflict, or there is moral uncertainty as to the ‘right’ way forward.
‘In this context, ethical challenge refers to the situation whereby every alternative is morally wrong and still one has to make a choice’ [ 69 ] p676 ‘An ethical challenge occurs when one does not know how to behave and act in the best way…’ [ 14 ] p93
Four of the definitions involved research participants themselves defining something as an ‘ethical challenge’ [ 12 , 48 , 50 , 56 ], with three studies explicitly stating that participants would lead this definitional work [ 48 , 50 , 56 ]. Draper & Jenkins offer a starting definition, adopted from Schwartz et al. [ 103 ] with which to prime participants, while Forbes and Phillips [ 50 ] and Jakobsen and Sørlie [ 56 ] left the definition fully with their participants (Table 3 ). Finally, Schofield et al. proposed a very broad definition (Table 3 ), alongside the specific statement that either participants or researchers could nominate something as an ‘ethical challenge’ [ 12 ].
This final approach was to tie ethical challenges to situations where participants feel ‘discomfort’, emotional distress or more specifically moral distress or moral residue [ 14 , 66 , 81 ]. Larkin et al. are clear that this distress must be tied to moral causes, but Hem et al. and Storaker et al. also refer more broadly to ‘discomfort’ [ 14 ] and ‘emotional stress’ [ 81 ] respectively. For example:
‘In this article, ethical challenges refer to values that entail emotional and moral stress in healthcare personnel.’ [ 81 ] p557
To the authors’ knowledge, this is the first rapid review to examine the use of the term ‘ethical challenge(s)’ in empirical healthcare research literature. Notably, only 12/72 (17%) of included studies published in the last 5 years contained a definition for ‘ethical challenge(s)’, despite this being the focus of the research being reported. The definitions identified were found in qualitative studies and systematic reviews and were evenly distributed geographically across high-, middle- and low-income settings. Definitions contained one or more of the identified approaches, although none contained elements from all four. Taken together, these findings suggest that a clear definition of ‘ethical challenge(s)’, and consistent use thereof, is currently lacking.
The four approaches indicate the diverse approaches to understanding ‘ethical challenge(s)’. Approaches 1 and 2 explore the concept from opposite viewpoints, with approach 1 looking from the conceptual perspective, through terms such as ‘dilemmas’ and ‘conflict’, and approach 2 from a participant perspective, specifically in those situations in which someone is trying to make a decision in circumstances where the preferred option is not possible or when they perceive there to be clash in values they feel are important. Within the concept-led definitions (approach 1), the use of a plurality of terms highlights a potential risk of bias, as different readers may interpret these differently. For example, some terms, such as ‘moral dilemma’, have relatively well understood specific meanings for some readers, particularly those with philosophical training [ 104 , 105 , 106 ]. The presence in the literature of specific and multiple meanings for some related terms highlights the importance of empirical studies providing a definition of these additional terms alongside their primary definition for ‘ethical challenge(s)’. This is more likely to be relevant where an a priori definition is used, but may be relevant to any prompting text for studies using a participant-led process, as in the study by Draper and Jenkins [ 48 ]. This clarity is important for both readers and future researchers who may undertake a secondary analysis of the data.
Approach 3 involves facilitating participants to nominate something as an ethical challenge [ 12 , 48 , 50 , 56 ]. This speaks to an important question about who, in a research context, is permitted to define or describe the object of interest, in this case ‘ethical challenge(s)’. Restricting the identification of ‘ethical challenge(s)’ to researchers alone may introduce bias by excluding input from those without bioethical ‘expertise’, but with important lived experience of the context under investigation. There is evidence that although clinicians can be sensitive to major ethical dilemmas, they can be less sensitive to small everyday ethical elements in clinical practice, and that ethical awareness varies between individuals [ 107 , 108 ]. Additionally, there is evidence in healthcare ethics research that patients and carers identify ethical challenges in situations that healthcare workers do not [ 109 ]. Therefore, relying entirely on a particular stakeholders’ perspectives (such as clinicians’) may risk missing important ethical challenges present in a scenario (assuming, of course, that we can settle what counts as an ‘ethical challenge(s)’).
In Approach 4, ethical challenges were linked to situations in which participants felt discomfort [ 14 ], emotional stress [ 81 ], moral distress or moral residue [ 66 ]. These concepts are themselves defined in quite varied ways (see, for example, definitions of ‘moral distress’ in a systematic review by Morley et al. [ 110 ]), potentially leading to additional conceptual confusion. Identifying triggers for moral distress is important, as high levels of moral distress are known to have negative impacts on work environments and lead to increased levels of compassion fatigue, increased staff turnover rates and poorer patient outcomes [ 110 , 111 , 112 ]. However, it is also possible that the requirement that, to be identified as an ethical challenge, the situation must invoke stress or distress might result in the under-identification of ethical challenges. We anticipate that many practitioners will daily manage multiple low-level ethical challenges, many of which will not generate moral distress or leave a moral residue. As such, the presence of moral distress may not be sufficient or even necessary in order to label a moral event an ‘ethical challenge’. However, the relationship between ‘ethical challenge(s)’ and moral distress is complex, and some might argue that the latter has an important relationship to the former. For example, moral distress, as conceived by Jameton and others [ 110 , 113 , 114 ], is linked to the after-effects of having to handle ethical challenge(s), so some researchers might view the generation of moral distress as relevant to identifying ethical challenges.
Although our review revealed these four approaches, the wider literature indicates there may be alternative approaches available. For example, other potential approaches would define ethical challenges as events that interact with moral principles, such as autonomy, beneficence, non-maleficence or justice, as proposed by Beauchamp and Childress [ 115 ], or as events in which those principles clash, for example as used by Klingler et al. in their research focusing on ethical issues in health surveillance [ 116 ]. However, these approaches were not seen amongst our included papers.
Returning to our included papers, the high rates of use of closely related terms within included manuscript texts may add to difficulties in understanding the exact object of interest if these terms are being used as synonyms for ‘ethical challenge(s)’. This may be particularly the case if terms used include those such as ‘moral dilemma’, which (as shown above) will have specific meanings for some readers. Interchangeable, undefined usage of these terms by study authors within study texts risks further exacerbating the problems caused by a lack of definitional clarity.
This rapid review is the first systematic attempt to describe the definitions of ‘ethical challenge(s)’ available within the recent published literature.
There are, however, five limitations to note. First, the review only includes results from the past 5 years, which inevitably means that older publications, which may have contained further definitions of ‘ethical challenge(s)’, were excluded. The focus on the previous 5 years does, however, allow for an assessment of the term’s use(s) within a reasonable period of time and was felt to be appropriate given the aims and resources available to this project.
Second, our three assumptions listed in the methodology section may have excluded some records that contained a relevant definition. However, these assumptions, and the resulting focus on two search terms, allowed for a balance between retrieved record numbers and team resources.
Third, the four databases searched were chosen for their focus on the healthcare ethics literature; we may therefore may have missed relevant usage in other fields or disciplines. Similarly, we did not search the grey literature, which might have excluded relevant research.
Fourth, for resource reasons, the assessment as to whether a related term was being used interchangeably in the text was undertaken by a single researcher (GS). This subjective assessment risks miscalculating both the number of interchangeable terms identified and the frequency counts.
Finally, we did not review the theoretical literature for conceptual definitions of ‘ethical challenge(s)’, hence the definitions we identified might not match completely conceptual understandings of the term. However, our review shows how the term is currently being used in the research literature. Indeed, if there are strong conceptual definitions within the theoretical literature, then it is clear that they are currently not reaching the researchers whose work was identified by our review.
This review is the first, to our knowledge, to identify and describe definitions (and uses) of the widely-utilised concept of ‘ethical challenge(s)’ within healthcare research. Only 17% (12/72) of retrieved papers presented an explicit definition of ‘ethical challenge(s)’ before beginning to investigate this concept in context. The definitions found contained one or more of four identified approaches, with significant cross-reference to related terms and concepts which themselves have variation in their accepted meanings. We recommend that researchers define the phenomenon of interest—in this case, ‘ethical challenge(s)’—to help ensure clarity. This should either be a priori, or, if using an approach that includes participant participation in the generation of the definition, reporting their final working definition a posteriori. The choice of definition should be justified, including the decision as to whether to include participants in this process. Additionally, if a definition references other conceptual terms, then consideration should be given to defining these as well.
The results of this rapid review suggest that a common conceptual understanding of the term ‘ethical challenge(s)’ is lacking within empirical bioethical research and that there is a need for researchers in this area to consider what conceptual formulations might be most useful. Again, failure to use definitions of crucial research concepts within empirical bioethics research potentially generates confusion and avoidable bias within research outputs, risking misleading ethical analyses, evaluations, and resulting recommendations. We therefore hope this review will help stimulate debate amongst empirical bioethics researchers on possible definitional content for such a commonly used term and prompt further discussion and research. Additionally, given the central role of patient and public partnership and involvement in research, further thought should be given to who should be involved in nominating something as a challenge worthy of study.
Following on from this work, there would be value in conducting an empirical bioethical project combining a full systematic review of definitions of ‘ethical challenge(s)’ (and related terms) integrated with an exploration of the conceptual literature to generate recommendations for approaches towards the content of potential definitions, perhaps related to the identified approaches above. Such a project could also ask authors who currently use the term ‘ethical challenge(s)’ in their research how they conceptualise this. Furthermore, work to better understand the benefits of including study participants in the definition process is also important. Finally, whilst researchers should justify whatever approach they choose to take, there may be merit in examining whether anything is lost if studies lack a robust or agreed definition, or whether doing so affords a flexibility and openness that allows for a broader range of ethical challenges to be identified.
All data is presented in this manuscript.
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GS is supported by a Wellcome Trust Research Award for Health Professionals (208129/Z/17/Z). LES is funded by a Career Development Fellowship from the National Institute for Health Research. RH is part-funded by the Wellcome Trust (209841/Z/17/Z) and the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. He serves on various local, regional, and national ethics committees and related groups. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research, the Department of Health, or any of the other organisations with and for whom the authors work.
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GS, MD and RH conceived of the idea for the review; LES, GS, MD and RH designed the review protocol; GS and MD conducted the literature searching, screening, data extraction and led on data interpretation but all authors were involved; GS led on drafting the manuscript; all authors critically revised the manuscript for content and approved the version to be published. All authors read and approved the final manuscript.
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Schofield, G., Dittborn, M., Selman, L.E. et al. Defining ethical challenge(s) in healthcare research: a rapid review. BMC Med Ethics 22 , 135 (2021). https://doi.org/10.1186/s12910-021-00700-9
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Adopted by the 18 th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29 th WMA General Assembly, Tokyo, Japan, October 1975 35 th WMA General Assembly, Venice, Italy, October 1983 41 st WMA General Assembly, Hong Kong, September 1989 48 th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52 nd WMA General Assembly, Edinburgh, Scotland, October 2000 53 rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added) 55 th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 59 th WMA General Assembly, Seoul, Republic of Korea, October 2008 64 th WMA General Assembly, Fortaleza, Brazil, October 2013
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.
3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”
4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include studies involving human subjects.
6. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.
8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
10. Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
11. Medical research should be conducted in a manner that minimises possible harm to the environment.
12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.
13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
15. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.
16. In medical practice and in medical research, most interventions involve risks and burdens.
Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.
Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
18. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.
19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically considered protection.
20. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.
21. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
22. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.
The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.
In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.
23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.
The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.
24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.
26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
All medical research subjects should be given the option of being informed about the general outcome and results of the study.
27. When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.
28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.
31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.
32. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.
33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention
and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option.
34. In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.
35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.
Archived versions.
Wma declaration of venice on end of life medical care, wma international code of medical ethics.
Published: 22 December 2023 Contributors: Amanda McGrath, Alexandra Jonker
Corporate social responsibility (CSR) is the idea that businesses should operate according to principles and policies that make a positive impact on society and the environment.
Through CSR, companies make decisions driven by financial gain and profitability, and the impact of their actions on their communities and the world at large. CSR goes beyond legal obligations: by voluntarily adopting ethical, sustainable and responsible business practices, companies seek to deliver benefits to consumers, shareholders, employees and society.
Learn about the processes used to manage environmental performance data and the steps required to account for greenhouse gas (GHG) emissions.
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Often, a company’s business model and practices are built around financial goals. However, CSR programs encourage business leaders to consider corporate citizenship or the larger impact of the business on society when making decisions. Corporate social responsibility helps companies ensure that their operations are ethical, safe and delivering positive impact wherever possible. Through CSR initiatives, companies work to limit environmental impact, contribute to solving societal problems (such as poverty and inequality) and ensure their brand identity reflects their values.
The theory of the “ triple bottom line ” can help organizations as they pursue corporate social responsibility. As a financial framework, the triple bottom line refers to the idea that a company’s business model should revolve around the three P’s: people, planet and profit. By maximizing all three, a company aims to make a positive impact on the world and remove barriers to growth.
Corporate social responsibility initiatives generally fall into four categories: environmental, ethical, philanthropic and economic. Each type of CSR contributes to a company’s overall CSR strategy.
More companies are assessing their overall environmental impact and engaging in CSR efforts that aim to protect natural resources and minimize any contribution to climate change. CSR encourages sustainability in business through eco-friendly practices, such as by reducing energy consumption, using renewable resources and minimizing waste.
Environmental responsibility hinges on eliminating negative impacts of business operations (primarily through limiting pollution-causing activities) as well as offsetting them through actions such as planting trees and engaging in programs that support biodiversity.
CSR initiatives often focus on social impact and human rights concerns, such as ensuring fair wages, safe working conditions and proper treatment of employees and suppliers. They also encourage accountability both internally and externally. Ethical CSR may include abiding by fair labor practices, ending workplace discrimination and ensuring supply chain transparency.
CSR practices include donating money, resources or time to positive causes and organizations, such as local and national charities, educational programs, disaster relief and more. Businesses who adopt philanthropic CSR engage with the communities where they operate, offering support through volunteer work, sponsoring local events, making contributions to local nonprofits or supporting skills training programs.
Corporate social responsibility involves ensuring that money is not a company’s sole motivator. To demonstrate this, companies enact policies and procedures to make sure their choices align with values, even if the alternatives may save money or boost profitability. Economic CSR also includes efforts to support the economic development and growth of the communities in which a business operates—for example, supporting job training and job creation efforts and forging local partnerships.
The benefits of CSR include:
CSR can have a positive impact on an organization’s brand identity as well as its bottom line. Some CSR efforts, such as improving energy efficiency, can reduce operating costs and might lead to savings in the end. Consumers increasingly prefer brands that share their values, and CSR policies offer ways for organizations to demonstrate those values, building trust and loyalty to fuel a competitive advantage.
CSR can also help attract top talent and drive employee engagement and retention, as more workers seek employers whose values align with their own. Additionally, a proactive approach to ethical and social issues has the potential to prevent legal problems, fines and reputational damage.
CSR initiatives can help people become more responsible consumers, making it easier for them to access products and services that align with their values and educating them on issues of sustainability and ethical consumption. It can encourage companies to prioritize and invest in testing, quality control and safety measures. CSR can also minimize the likelihood of defective or harmful products reaching consumers.
CSR can have a positive impact on the overall health of the planet, as it encourages environmental responsibility and sustainable practices. CSR initiatives can help companies reduce their greenhouse gas emissions or pursue net-zero emissions goals that are key to slowing climate change. They might also help conserve natural resources, reduce pollution and limit disruption of ecosystems. Additionally, a focus on CSR can support investment in research and development of eco-friendly products and practices.
Corporate social responsibility can help support local communities and address societal issues, such as poverty, inequality and environmental concerns. CSR initiatives can fuel economic growth by creating jobs. They can also shape public opinion as companies leading the way inspire others to follow suit, creating a positive ripple effect. A focus on ethical behavior at the corporate level reinforces a broader norm of ethical behavior across other parts of society.
Consumers are increasingly seeking products and services from socially responsible companies. Meanwhile, many investors are prioritizing companies whose values are clear and aligned with their own. To meet these demands, businesses are integrating CSR into their operations. In addition, global expansion and the increasingly interconnected nature of supply chains pushes companies to comply with a growing web of regulatory environments and to better confront the impact of their business on communities around the world.
With increased awareness of environmental issues, labor practices and ethical concerns, combined with better research and communication, CSR is now more central to business strategies. Some companies even have dedicated CSR departments.
Examples of CSR include:
Corporate social responsibility is the overall ethos that drives a company to adopt policies and practices that support sustainability, societal and other ethical ends. Environmental, social and governance (ESG) is about the ways in which their impact is measured or quantified. While both CSR and ESG are about reflecting the company’s values, CSR is typically seen as more of an internal framework, while ESG frameworks are often used externally as a way of demonstrating real-world impact.
Because the parameters of corporate social responsibility are continually evolving, there is no single standard by which CSR initiatives are measured or governed. Companies that embrace CSR are guided by local and international laws, including environmental regulations, labor rules and consumer protection standards.
Some efforts are also held to industry-specific standards; for example, the Global Reporting Initiative (GRI) provides reporting standards for sustainability. Organizations like the United Nations have introduced global guidance, such as the Sustainable Development Goals (SDGs), which encourage businesses to adopt sustainable practices.
Many companies that embrace CSR will also engage in CSR reporting , through which they document performance of non-financial metrics and provide transparency on social and environmental impact. CSR reporting is typically voluntary; however, some jurisdictions mandate that large organizations disclose social and environmental performance, so that investors and consumers can assess CSR efforts.
Some organizations have designated corporate social responsibility teams that oversee a company's CSR activities. People on these teams plan and run the social and environmental programs that align with the company's values and goals. They work with company leadership to devise the overall CSR strategy and engage stakeholders, including employees, customers, investors and community partners, to help them succeed. They also typically track and report on their progress by using metrics and other methods of assessment, deal with compliance and regulatory issues and manage communication about the company’s CSR efforts both internally and externally.
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CSR reporting is the practice of reporting an organization’s performance of non-financial metrics, providing transparency on the organization’s impact on society and the environment.
Net zero is the point at which greenhouse gases emitted into the atmosphere are balanced by an equivalent amount removed from the atmosphere.
The goal of the CRSD is to provide transparency that will help stakeholders better evaluate EU companies’ sustainability performance as well as the related business impacts and risks.
The triple bottom line (TBL) is a sustainability framework that revolves around the three P’s: people, planet and profit.
Sustainability in business refers to a company's strategy and actions to eliminate the adverse environmental and social impacts caused by business operations.
Decarbonization is a method of climate change mitigation that reduces greenhouse gas (GHG) emissions, as well as removes them from the atmosphere.
Simplify the capture, consolidation, management, analysis and reporting of your environmental, social and governance (ESG) data with IBM Envizi ESG Suite.
IMAGES
VIDEO
COMMENTS
Clearly, ethical considerations inhabit each phase of the research process. Initial ethical issues are related to the auspices, funding and directions of research, in which conflicts of interest and influence may arise between funders or sponsors and the principal investigator (McLaughlin, 2011, p. 59).
The NASW Code of Ethics is a set of standards that guide the professional conduct of social workers. The 2021 update includes language that addresses the importance of professional self-care. Moreover, revisions to Cultural Competence standard provide more explicit guidance to social workers. All social workers should review the new text and ...
Social Work Ethics Resources and Research. Below is an overview of social work research related to the profession's ethical standards and values, including examples of publications that provide an overview of: Research on Ethics - examples of knowledge-building about the role and function of various ethics components.
The NASW Code of Ethics serves six purposes: The Code identifies core values on which social work's mission is based. The Code summarizes broad ethical principles that reflect the profession's core values and establishes a set of specific ethical standards that should be used to guide social work practice.
The NASW Code of Ethics is a set of standards that guide the professional conduct of social workers. The 2021 update includes language that addresses the importance of professional self-care. Revisions to Cultural Competence standard provide more explicit guidance to social workers. All social workers should review the new text and affirm their ...
This article o fers a set of practice standards for social work researchers focusing on ways that they can conduct research in a manner that promotes social justice and redresses 3/17/24, 3:02 PM ...
The Profession's Early Years. During the earliest years of social work's history, few formal ethical standards existed. The earliest known attempt to formulate a code was an experimental draft code of ethics printed in the 1920s and attributed to Mary Richmond (Pumphrey, 1959).Although several other social work organizations formulated draft codes during the profession's early years (for ...
Introduction. As research activity in social work has increased, so has attention to ethics in research. Ethical standards and practices in research guide the relationship between researcher(s) and research participant(s); guide relationships among researchers and scholars; guide how researchers relate to the organizations and communities in which their studies are conducted; and safeguard the ...
Summary. Social work researchers hold themselves to ethical standards, compatible with social work ethics, for social science and biomedical research involving human beings. This article describes (a) the general ethical principles guiding research involving human subjects; (b) mechanisms for the ethical review of studies involving human beings ...
Weve written this guidance for you to draw on when you face an ethical issue or dilemma in social research. It is intended as a basis for reflection and discussion. Like previous Social Research Association (SRA) guidance on research ethics, it does not offer rigid rules, but illustrates ethical practices to which experienced and respected social
The Belmont Report presented a summary of ethical guidelines for engaging in research that involves human subjects. The guidelines are based on three core principles: Respect for persons. This principle is founded on a conviction that "individuals should be treated as autonomous agents" (Belmont Report, 1979, p. 4).
Content Advisory. This chapter discusses or mentions the following topics: unethical research that has occurred in the past against marginalized groups in America and during the Holocaust. Joffe, S., & Miller, F. G. (2014). Ethics of cancer clinical trials in low-resource settings.
The Fourth Edition of Rafael J. Engel and Russell K. Schutt's The Practice of Research in Social Work introduces an integrated set of techniques for evaluating research and practice problems as well as conducting studies. Evidence-based practice comes alive through illustrations of actual social work research. Updated with new examples, the latest research, and expanded material on ...
Abstract. The role of research ethics committees, and research ethics issues more broadly are often not viewed in the context of the development of scientific methods and the academic community. This topic piece seeks to redress this gap. I begin with a brief outline of the changes we experience within the social sciences before exploring in ...
The aim of this article is to impose solutions to the ethical dilemmas that derive from social work research involving vulnerable children. The main concern is how to balance the protection of children while progressing their participation. Several substitute mechanisms were put in place for protecting underage children.
The SRA promotes good practice in social research, including high standards of ethics to: Protect research participants. Ensure research is high quality. Comply with legislation. Reassure funders. Maintain the good reputation of the sector. We're pleased to announce the new SRA research ethics guidance (February 2021).
We review selected aspects of current ethical guidelines pertaining to the design and conduct of social work evaluation and research studies. We contend that there are significant differences between social science research and evaluation studies, and that the uncritical application of ethical guidelines suitable for regulating social science research may hinder social workers undertaking ...
Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science. NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research: Social and clinical value. Scientific validity.
5.02 Evaluation and Research Overview Revisions to section 5 of the NASW Code of Ethics, which focuses on social workers' responsibilities to the social work profession, were limited to standard 5.02, Evaluation and Research.There are now 16 standards in this section with the inclusion of new content that specifically incorporates guidance for social workers using electronic technology in ...
For social workers, the National Association of Social Workers (NASW) Code of Ethics section 5.02 describes the responsibilities of social workers in conducting research. Summarized below, these guidelines outline that as a representative of the social work profession, it is your responsibility to conduct to conduct and use research in an ...
Revised on May 9, 2024. Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people. The goals of human research often include understanding real-life phenomena, studying effective treatments ...
no well-laid ethical guidelines are in place or practice; but more of a case to case basis. In fact, very few social research or the donor agencies in India get clearance from any ethical review board. As a matter of fact, ethical review of social research proposals and protocols are yet to be institutionalized.
Download pdf. The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH) is an independent advisory body responsible for developing national research ethics guidelines. The first edition of NESH's guidelines was published in 1993, and revised editions have been published in 1999, 2006 and 2016.
We designed our book to help graduate social work students through every step of the research process, from conceptualization to dissemination. Our textbook centers cultural humility, information literacy, pragmatism, and an equal emphasis on quantitative and qualitative methods. It includes extensive content on literature reviews, cultural bias and respectfulness, and qualitative methods, in ...
Despite its ubiquity in academic research, the phrase 'ethical challenge(s)' appears to lack an agreed definition. ... reducing confidence in research findings. Further work on establishing acceptable definitional content is needed to inform future bioethics research. ... Habek D. Guidelines for the management of the social and ethical ...
Reporting standards: Authors of reports of original research should present an accurate account of the work performed, as well as an objective discussion of its significance. Hazards and human or animal subjects: Statements of compliance are required if the work involves chemicals, procedures or equipment that have any unusual hazards inherent ...
The American Psychological Association (APA) is a scientific and professional organization that represents psychologists in the United States. APA educates the public about psychology, behavioral science and mental health; promotes psychological science and practice; fosters the education and training of psychological scientists, practitioners and educators; advocates for psychological ...
Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights. 8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
Corporate social responsibility is the overall ethos that drives a company to adopt policies and practices that support sustainability, societal and other ethical ends. Environmental, social and governance (ESG) is about the ways in which their impact is measured or quantified. While both CSR and ESG are about reflecting the company's values ...
The Model Framework covers recommended measures in the following four areas: Establish AI Strategy and Governance: Organisations should have an internal AI governance strategy, which generally comprises (i) an AI strategy, (ii) governance considerations for procuring AI solutions, and (iii) an AI governance committee (or similar body) to steer the process, including providing directions on the ...