ethics in a literature review

• Research article
• Open access
• Published: 03 October 2016

Current state of ethics literature synthesis: a systematic review of reviews

• Marcel Mertz 1 , 2 ,
• Hannes Kahrass 1 &
• Daniel Strech 1  

BMC Medicine volume  14 , Article number:  152 ( 2016 ) Cite this article

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Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed.

A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature.

We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information.

Conclusions

While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.

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Decision making in clinical care, public health, biomedical research, and other fields is strongly based on “external” knowledge (e.g., knowledge from clinical trials, health services research, or economic studies). Non-systematic retrieval and appraisal of external information, however, risks several types of bias and therefore diminishes the quality and accountability of decisions. Systematic reviews (SRs) aim to identify and process information from published material in a systematic, transparent, and reproducible manner. Their ultimate goals are to guarantee comprehensiveness and to reduce systematic errors (bias) in the identification and processing of relevant information, and they are therefore conducive to good evidence-based decision making.

Decision making in medicine, research, and health policy often explicitly or implicitly includes normative ethical considerations. For example, should trial participants be granted access to trial drugs after the end of the study? When health professionals and parents disagree about the appropriate course of medical treatment for a child, under what circumstances is the health professional ethically justified in overriding the parents’ wishes? What are ethical arguments for and against sham interventions? Is it allowable to store biological samples and DNA of minors for non-therapeutic research? When is public health surveillance ethical?

Since the rise of scholarly conduct in “applied” ethical analysis in the 1960s and the establishment of institutes for medical ethics, corresponding peer-reviewed journals, conferences, etc., it seems to be unquestioned that normative ethical input in medical and health policy decision making is a professional enterprise that can be more or less appropriate, of high or low quality, etc. However, it is also known that scholars can come to contrasting but equally well-argued conclusions on what is normatively right or wrong, or more or less appropriate [ 1 – 3 ].

Against this background it is surprising that modern standards for evidence-based decision making in clinical care and public health still rely on eminence-based input alone regarding normative ethical information, even though review methodology has been increasingly used in various disciplines and fields.

Scientific communities such as the Cochrane Collaboration, the Campbell Collaboration, and institutions such as the Institute of Medicine (IOM) or the National Institute for Health and Care Excellence (NICE) provide detailed guidance for review methodologies in different fields [ 4 – 6 ]. While these guidelines cover qualitative as well as quantitative research, they do not explicitly mention whether or how current methodological standards apply to normative ethical literature (“normative literature” for short). Similarly, manuals for evidence-based guideline development do not explain how to include ethical issues in a systematic and transparent manner [ 7 ]. Recent methodological debate demonstrated the need of knowledge synthesis methods that are specified for particular types of information [ 8 ]. But here again, normative ethical information was not acknowledged explicitly.

The ethics literature includes empirical and normative studies on morally challenging topics. Normative literature aims to evaluate or prescribe policies, (moral) reasons, and decisions for or against particular (moral) judgements and policies. Most often, this type of literature can also be described as “argument-based” or “reason-based” literature [ 9 , 10 ]. The “source material” of ethics research includes (ethical) theory, intuitions, common sense, and scientifically produced empirical data.

Despite the neglect of reviews on normative literature by manuals for the development of clinical guidelines and health technology assessment (HTA), and despite any explicit guidance on methodological particularities, such reviews of normative literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed [ 10 – 13 ].

This study aimed to identify trends in the quantity of published systematic and semi-systematic reviews of normative ethical or “mixed” (empirical and normative ethical) literature, the academic affiliations of corresponding authors, and other review characteristics. The study further particularly assessed how these reviews report on their methods for (1) search, (2) selection, (3) analysis, and (4) synthesis of ethics literature.

The review was based on two PubMed searches (15 April 2015, 27 April 2015), with additional searches in PhilPapers (29 April 2015) and Google Scholar (30 April 2015). For PubMed , two search strings were used. The first one was composed for screening purposes, and the second one used a refined search string. See Table  1 and the flowchart in Fig.  1 .

Preferred reporting items for systematic reviews and meta-analyses (PRISMA) flowchart

It proved to be impossible to search directly and solely for reviews of normative literature, as such a distinction is not established or standardized yet in databases (e.g., no standardized key words refer to this kind of review). Therefore, the search had to be intentionally broad in order to capture any review done related to topics of medical ethics or bioethics, even if this included reviews that solely analyzed and synthesized empirical literature.

We have not used a language restriction for the search in order to assess the overall amount of identifiable reviews.

For the purpose of this meta-review on a still little-standardized review area we decided to apply rather sensitive and not too restrictive selection criteria. We selected all reviews that explicitly or implicitly indicated their objective to analyze and present ethics literature in a systematic manner. To be included, reviews had to be explicitly concerned with normative ethical considerations of medical topics; e.g., they had to pose an ethical question or determine ethical challenges. It was not deemed sufficient for the results of a review to be able to be regarded as “ethically relevant.” Furthermore, reviews should have an identifiable description of at least some methodological elements describing a reproducible literature search (e.g., search terms, databases used, or inclusion/exclusion criteria). See Table  2 . We labeled such reviews as semi-systematic reviews . Only those reviews that explicitly or implicitly reported on search, selection, analysis, and synthesis were labeled as (full) systematic reviews . Finally, we only included reviews written in English, German, or French.

Articles were selected first according to their title or abstract, and later by full text screening. See Table  2 . All reviews for empirical, normative, and “mixed” literature were included at this stage. The in-depth analysis and corresponding data presented in this paper focused on the normative and mixed literature, because methodological particularities, especially concerning analysis and synthesis, have been much less widely discussed for normative and conceptual literature than for empirical research.

The selection was initially done by one researcher (MM). Then, a second researcher (HK) checked all the selection results (inclusion and exclusion) for consistency with the selection criteria. Discrepancies were discussed and successfully overcome via consensus-seeking discussions.

Because we aimed to assess the current state of the art of reviews of normative ethical literature, we did not exclude reviews that did not fulfill all PRISMA criteria. Depicting the state of art must also include reviews of “relatively bad” reporting quality. Also, it is possible that certain reviews demonstrate a fair reporting of analysis and synthesis of normative information but are not able to fulfill some basic PRISMA criteria. Excluding such reviews would deprive our review of important insights about how reviews of normative information are analyzing and synthesizing information. Nevertheless, we present slightly adapted PRISMA ratings as part of our results.

Apart from the reporting quality, it would also be impossible to assess the methodological quality of the included reviews because of the lack of specific quality assessment tools for reviews of normative ethics literature.

We determined the academic fields of the journals that published included reviews based on how they were classified by the Journal Citation Reports ( JCR ) Science Edition 2014 and JCR Social Science Edition 2014 . Where no entry was available, the journal was categorized as “not found”.

We further categorized the affiliation of all authors. (Table  4 lists the different categories used.) For this purpose, we considered the affiliation of all first authors. We took the lowest identifiable organizational unit if several organizational units/levels were mentioned. If the last author had a differing affiliation, this affiliation was also considered. Finally, if additional authors of a review had further differing affiliations, these were also considered. Therefore, the amount of authors considered regarding affiliations is not equal to the total amount of authors.

The method of qualitative content analysis (QCA) [ 14 , 15 ] was employed to analyze the literature in detail, i.e., to identify and categorize the methods used for search, selection, analysis, and synthesis, and the information given about methodology (e.g., stating aims, discussing limitations, providing a flowchart). In applying this method, we used a combined deductive and inductive strategy for building up categories [ 14 ]. This was done iteratively by two researchers (MM, HK).

The qualitatively analyzed content of the reviews was synthesized into descriptive statistics assessing how often the description of methods corresponded to established (and slightly adapted) criteria of the PRISMA guideline [ 16 ] (See Table  6 ).

From the initially identified 1393 references we finally included 160 reviews covering three types of ethics reviews: (1) empirical ethics ( n  = 76), (2) normative ethics ( n  = 51), and (3) mixed literature ( n  = 33). For the above-described reasons we further excluded the 76 reviews of empirical ethics literature from the in-depth analysis. See the flowchart in Fig.  1 . The following results therefore represent the remaining 84 reviews of normative or mixed literature. Additional file 1 : Tables S1–S3 present all references for the three types of ethics reviews.

Languages, publication dates, and self-labeling

Of all 84 reviews, 98 % ( n  = 82) were in English, one in French, and one in German. The earliest reviews were published in 1997. Of the 84 reviews, 82 % were published in the last ten years. See Fig.  2 . In total, 31 (37 %) labeled themselves as “systematic review” or used the term “systematic” in labelings such as “systematic literature review” or “systematic survey.”

Publication dates of the reviews

Journals: academic fields and titles

The academic fields most prominent were Nursing ( n  = 17, 15 %), Medical Ethics and Ethics ( n  = 10 + 2 = 12, 11 %), Public, Environmental, and Occupational Health ( n  = 8, 7 %), and Genetics and Heredity ( n  = 8, 7 %). See Table  3 . Note that a journal can be classified in two or more fields.

The journal that published the most reviews was Nursing Ethics ( n  = 7, 8 %), followed by Journal of Medical Ethics ( n  = 4, 5 %), BMC Medical Ethics ( n  = 4, 5 %), Journal of Advanced Nursing ( n  = 4, 5 %), and European Journal of Human Genetics ( n  = 4, 5 %). However, roughly 70 % ( n  = 59) of all finally included reviews ( n  = 84) were found in journals that only appeared once in our review. See Table  3 .

Authors: number, country of origin, and affiliations

The greatest number of reviews were authored by two authors ( n  = 26, 31 %), followed by three ( n  = 18, 21 %) and four authors ( n  = 16, 19 %) with an arithmetic mean of 3.45. See Table  4 .

Twenty reviews (24 %) were written by authors from the USA, 10 (12 %) from the UK, 10 (12 %) from Belgium, 8 (10 %) from Germany, and 6 (8 %) from the Netherlands. The remaining 30 reviews were written by authors from 18 other countries. See Table  4 .

We analyzed the affiliation of 205 authors with different affiliations. The greatest number, namely 60 (30 %), were affiliated to Bioethics institutions, 51 (25 %) to institutions related to medicine, 23 (11 %) to Nursing and Allied Health Practitioners (AHP)-related institutions, 18 (9 %) to Health Sciences institutions, and 7 (3 %) were affiliated to Philosophy and the Humanities. See Table  4 .

Standards/guidelines and limitations

Twenty (24 %) of the 84 reviews stated that they used an established/published review methodology (see Table  5 ). Only the approach of McCullough et al. and Garrard were mentioned more than once ( n  = 9, 45 %, n = 2, 10 %). Ten reviews (12 %) stated that they took guidance from established reporting standards or guidelines (whether general or specific to SRs). The only standard mentioned more than once was PRISMA, with 8 entries. Thirty-three reviews (39 %) reported on limitations.

Reported methods for search, selection, analysis, and synthesis

Table  6 presents detailed data on how often the reviews were transparent about methodological criteria for search, selection, analysis, and synthesis. Table  6 also highlights how these criteria match with reporting items mentioned in PRISMA. Most reviews reported, for example, on what databases (93 %), search terms (91 %), or inclusion/exclusion criteria (81 %) they used. Overall, only 1 % and 8 % did not fulfill any criteria related to search and selection, respectively. However, only a minority reported on other essential details such as the procedure for information extraction (37 %) and information synthesis (18 %). In fact, 31 % did not fulfill any criteria related to the reporting of analysis methods. For example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information.

A comprehensive qualitative analysis and comparison of all applied methods for search, selection, analysis, and synthesis is beyond the scope of this paper and is to be published elsewhere. The applied methods for search and selection of relevant normative literature are largely comparable with standard “systematic review” methodology. Methods for analysis and synthesis of normative information, however, are of substantial differences. In the following, therefore, we highlight some core findings with regard to the reported analysis and synthesis.

Regarding extraction and analysis of normative information, the most sought types of information were ethical issues, topics, or dilemmas ( n  = 27), arguments or reasons ( n  = 14), and ethical principles, values, or norms ( n  = 13) (multiple responses possible). Among the procedures for extracting information we broadly distinguished between “coding and categorizing” ( n  = 9), “collecting” ( n  = 7), or “close reading” ( n  = 6). See Table  7 for more detailed explanations and case examples.

Regarding synthesis, we could broadly distinguish between qualitative methods ( n  = 44), quantitative methods ( n  = 5), and narrative/hermeneutical methods ( n  = 3). In most cases, qualitative analyses aimed to develop overarching normative issues, reasons, or principles that allowed summarizing the more detailed normative information. To do this, a variety of deductively and inductively developed category systems with main and subcategories were employed. Quantitative analyses aimed, for example, to quantify the distribution of qualitatively assessed topics. See Table  8 for more detailed explanations and case examples.

Thirty-eight (45 %) of the included reviews ( n  = 84) reported on at least some aspects of all four domains of the methodology (search, selection, analysis, and synthesis).

Most reviews reported on the essential elements for search and selection methods (e.g., databases, search terms, inclusion/exclusion) except for flowcharts (reported by only 29 %). However, reporting was much less explicit for analysis and synthesis methods. Almost one third of all reviews did not report on any essential element of the analysis methods (what information to extract and how). For example, only 25 % of reviews on normative literature reported on the kind of ethical approach/theory needed to identify relevant normative information. Only 45 % of reviews reported on all methods and could therefore be labeled as (full) systematic reviews, implying that most reviews we found are rather semi-systematic. Somehow in line with the aforementioned neglect of important method reporting is the fact that only 39 % of reviews discussed their limitations.

A limitation of our review is that we only searched the databases PubMed, PhilPapers, and Google Scholar . We restricted our search to these three databases mainly because of experiences from former systematic reviews of normative information demonstrating that most of the literature can be found in PubMed and Google Scholar , and that searching other ethics-specific databases did not add a substantial proportion of references [ 17 ]. In our review, 86 % of all included reviews were found by PubMed searches alone. Furthermore, all languages other than English, German, or French were excluded, but this only resulted in the exclusion of three reviews.

Our results demonstrate that most elements of searching and selecting normative literature reflect the widely accepted PRISMA recommendations. However, appropriate elements for the analysis and synthesis of normative literature are less standardized. Further meta-research and conceptual analysis are needed to inform the development of minimal standards for the analysis and synthesis of normative literature. The quality assessment of normative literature might be one of the most controversial topics in this regard [ 10 ]. The required degree of transparency for all steps of information processing in analyzing and synthesizing normative information will be another controversial topic, because strong requirements in this regard might result in excessive workloads for review authors [ 18 ].

Nevertheless, our review demonstrates that analysis and synthesis methods can be described and justified with regard to the specific review objectives. This demands that the following elements for analysis and synthesis should be clarified prior to each review of normative information and should be reported with the dissemination of results: (1) normative information unit (e.g., ethical issues, ethical reasons, ethical norms, etc.), (2) ethical approach (e.g., a specific ethical theory) and the technical procedure used to identify and extract the relevant normative information units, (3) method for synthesizing normative information (e.g., category building). See Tables  7 and 8 . Researchers should also be aware that these three steps are interrelated; i.e., that using a specific ethical approach will lead to a specific way of identifying normative information units, or, vice versa, that the set of normative information units identified will depend on the ethical approach (e.g., a deontological ethical theory would identify some issues as “ethical issues,” which a consequentialist ethical theory would not).

Thus, future clarification is also needed for the personal competencies and skills necessary to realize a valid and informative review of normative information. Based on our personal experiences with reviews of normative information, it is also important to clarify the expectations and needs of the intended readership. In particular, the choice of synthesis methods for normative information might differ substantially if the review group aims to inform either expert discourse in bioethics or policy decision making in guideline or HTA development. Stakeholder orientation, therefore, is another issue that should be clarified prior to conducting ethics reviews.

This is the first study, to our knowledge, to analyze the state of systematic and semi-systematic reviews of normative literature on medical topics. We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. The reference lists for all included reviews (Additional file  1 : Tables S1–S3) provide a rich source for those interested in medical ethics and those wanting to conduct (systematic) reviews of normative literature themselves.

Further research as well as interdisciplinary discussion and consent are needed to define detailed best practice recommendations for the respective steps of a review of normative information. Experts from different fields such as bioethics, HTA and guideline development, as well as health care professionals and patient representatives, should work together to further develop the methodology of (systematic) reviews of normative ethical information to support evidence-based health care.

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Acknowledgements

We would like to thank our student assistant Nadine Komeinda for her help in retrieving and electronically archiving the full text versions of the articles we found, and our student assistant Christopher Schürmann for his help in analyzing review characteristics.

Authors’ contributions

MM wrote the main draft of the paper (all sections), devised search algorithms and conducted the search, worked out most of the methods employed, and revised and finalized the manuscript. HK assisted in devising the search algorithms, cross-checked selection, was one of two researchers analyzing and synthesizing the material, and contributed to writing the manuscript. DS originated the idea of conducting a systematic review about reviews of normative ethical literature on medical topics, gave input to the review design, acted as third (“control”) researcher in the analysis procedure, and revised the manuscript. All authors read and approved the final manuscript.

Competing interests

Financial competing interests: There are none to declare. Non-financial competing interests: In three reviews finally included in this review DS was one of the authors. In one review MM and HK were co-authors.

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Marcel Mertz, Hannes Kahrass & Daniel Strech

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Additional file

Additional file 1: table s1..

Reviews (English/German/French): empirical literature. Table S2 : Reviews (English/German/French): normative literature. Table S3 : Reviews (English/German/French): mixed literature. (DOCX 56 kb)

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Mertz, M., Kahrass, H. & Strech, D. Current state of ethics literature synthesis: a systematic review of reviews. BMC Med 14 , 152 (2016). https://doi.org/10.1186/s12916-016-0688-1

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A scoping review of the literature featuring research ethics and research integrity cases

• Anna Catharina Vieira Armond   ORCID: orcid.org/0000-0002-7121-5354 1 ,
• Bert Gordijn 2 ,
• Jonathan Lewis 2 ,
• Mohammad Hosseini 2 ,
• János Kristóf Bodnár 1 ,
• Soren Holm 3 , 4 &
• Péter Kakuk 5  

BMC Medical Ethics volume  22 , Article number:  50 ( 2021 ) Cite this article

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The areas of Research Ethics (RE) and Research Integrity (RI) are rapidly evolving. Cases of research misconduct, other transgressions related to RE and RI, and forms of ethically questionable behaviors have been frequently published. The objective of this scoping review was to collect RE and RI cases, analyze their main characteristics, and discuss how these cases are represented in the scientific literature.

The search included cases involving a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework. A search was conducted in PubMed, Web of Science, SCOPUS, JSTOR, Ovid, and Science Direct in March 2018, without language or date restriction. Data relating to the articles and the cases were extracted from case descriptions.

A total of 14,719 records were identified, and 388 items were included in the qualitative synthesis. The papers contained 500 case descriptions. After applying the eligibility criteria, 238 cases were included in the analysis. In the case analysis, fabrication and falsification were the most frequently tagged violations (44.9%). The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation (15.7%), followed by patient safety issues (11.1%) and plagiarism (6.9%). 80.8% of cases were from the Medical and Health Sciences, 11.5% from the Natural Sciences, 4.3% from Social Sciences, 2.1% from Engineering and Technology, and 1.3% from Humanities. Paper retraction was the most prevalent sanction (45.4%), followed by exclusion from funding applications (35.5%).

Conclusions

Case descriptions found in academic journals are dominated by discussions regarding prominent cases and are mainly published in the news section of journals. Our results show that there is an overrepresentation of biomedical research cases over other scientific fields compared to its proportion in scientific publications. The cases mostly involve fabrication, falsification, and patient safety issues. This finding could have a significant impact on the academic representation of misbehaviors. The predominance of fabrication and falsification cases might diverge the attention of the academic community from relevant but less visible violations, and from recently emerging forms of misbehaviors.

Peer Review reports

There has been an increase in academic interest in research ethics (RE) and research integrity (RI) over the past decade. This is due, among other reasons, to the changing research environment with new and complex technologies, increased pressure to publish, greater competition in grant applications, increased university-industry collaborative programs, and growth in international collaborations [ 1 ]. In addition, part of the academic interest in RE and RI is due to highly publicized cases of misconduct [ 2 ].

There is a growing body of published RE and RI cases, which may contribute to public attitudes regarding both science and scientists [ 3 ]. Different approaches have been used in order to analyze RE and RI cases. Studies focusing on ORI files (Office of Research Integrity) [ 2 ], retracted papers [ 4 ], quantitative surveys [ 5 ], data audits [ 6 ], and media coverage [ 3 ] have been conducted to understand the context, causes, and consequences of these cases.

Analyses of RE and RI cases often influence policies on responsible conduct of research [ 1 ]. Moreover, details about cases facilitate a broader understanding of issues related to RE and RI and can drive interventions to address them. Currently, there are no comprehensive studies that have collected and evaluated the RE and RI cases available in the academic literature. This review has been developed by members of the EnTIRE consortium to generate information on the cases that will be made available on the Embassy of Good Science platform ( www.embassy.science ). Two separate analyses have been conducted. The first analysis uses identified research articles to explore how the literature presents cases of RE and RI, in relation to the year of publication, country, article genre, and violation involved. The second analysis uses the cases extracted from the literature in order to characterize the cases and analyze them concerning the violations involved, sanctions, and field of science.

This scoping review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and PRISMA Extension for Scoping Reviews (PRISMA-ScR). The full protocol was pre-registered and it is available at https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5bde92120&appId=PPGMS .

Eligibility

Articles with non-fictional case(s) involving a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework, were included. Cases unrelated to scientific activities, research institutions, academic or industrial research and publication were excluded. Articles that did not contain a substantial description of the case were also excluded.

A normative framework consists of explicit rules, formulated in laws, regulations, codes, and guidelines, as well as implicit rules, which structure local research practices and influence the application of explicitly formulated rules. Therefore, if a case involves a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework, then it does so on the basis of explicit and/or implicit rules governing RE and RI practice.

Search strategy

A search was conducted in PubMed, Web of Science, SCOPUS, JSTOR, Ovid, and Science Direct in March 2018, without any language or date restrictions. Two parallel searches were performed with two sets of medical subject heading (MeSH) terms, one for RE and another for RI. The parallel searches generated two sets of data thereby enabling us to analyze and further investigate the overlaps in, differences in, and evolution of, the representation of RE and RI cases in the academic literature. The terms used in the first search were: (("research ethics") AND (violation OR unethical OR misconduct)). The terms used in the parallel search were: (("research integrity") AND (violation OR unethical OR misconduct)). The search strategy’s validity was tested in a pilot search, in which different keyword combinations and search strings were used, and the abstracts of the first hundred hits in each database were read (Additional file 1 ).

After searching the databases with these two search strings, the titles and abstracts of extracted items were read by three contributors independently (ACVA, PK, and KB). Articles that could potentially meet the inclusion criteria were identified. After independent reading, the three contributors compared their results to determine which studies were to be included in the next stage. In case of a disagreement, items were reassessed in order to reach a consensus. Subsequently, qualified items were read in full.

Data extraction

Data extraction processes were divided by three assessors (ACVA, PK and KB). Each list of extracted data generated by one assessor was cross-checked by the other two. In case of any inconsistencies, the case was reassessed to reach a consensus. The following categories were employed to analyze the data of each extracted item (where available): (I) author(s); (II) title; (III) year of publication; (IV) country (according to the first author's affiliation); (V) article genre; (VI) year of the case; (VII) country in which the case took place; (VIII) institution(s) and person(s) involved; (IX) field of science (FOS-OECD classification)[ 7 ]; (X) types of violation (see below); (XI) case description; and (XII) consequences for persons or institutions involved in the case.

Two sets of data were created after the data extraction process. One set was used for the analysis of articles and their representation in the literature, and the other set was created for the analysis of cases. In the set for the analysis of articles, all eligible items, including duplicate cases (cases found in more than one paper, e.g. Hwang case, Baltimore case) were included. The aim was to understand the historical aspects of violations reported in the literature as well as the paper genre in which cases are described and discussed. For this set, the variables of the year of publication (III); country (IV); article genre (V); and types of violation (X) were analyzed.

For the analysis of cases, all duplicated cases and cases that did not contain enough information about particularities to differentiate them from others (e.g. names of the people or institutions involved, country, date) were excluded. In this set, prominent cases (i.e. those found in more than one paper) were listed only once, generating a set containing solely unique cases. These additional exclusion criteria were applied to avoid multiple representations of cases. For the analysis of cases, the variables: (VI) year of the case; (VII) country in which the case took place; (VIII) institution(s) and person(s) involved; (IX) field of science (FOS-OECD classification); (X) types of violation; (XI) case details; and (XII) consequences for persons or institutions involved in the case were considered.

Article genre classification

We used ten categories to capture the differences in genre. We included a case description in a “news” genre if a case was published in the news section of a scientific journal or newspaper. Although we have not developed a search strategy for newspaper articles, some of them (e.g. New York Times) are indexed in scientific databases such as Pubmed. The same method was used to allocate case descriptions to “editorial”, “commentary”, “misconduct notice”, “retraction notice”, “review”, “letter” or “book review”. We applied the “case analysis” genre if a case description included a normative analysis of the case. The “educational” genre was used when a case description was incorporated to illustrate RE and RI guidelines or institutional policies.

Categorization of violations

For the extraction process, we used the articles’ own terminology when describing violations/ethical issues involved in the event (e.g. plagiarism, falsification, ghost authorship, conflict of interest, etc.) to tag each article. In case the terminology was incompatible with the case description, other categories were added to the original terminology for the same case. Subsequently, the resulting list of terms was standardized using the list of major and minor misbehaviors developed by Bouter and colleagues [ 8 ]. This list consists of 60 items classified into four categories: Study design, data collection, reporting, and collaboration issues. (Additional file 2 ).

Systematic search

A total of 11,641 records were identified through the RE search and 3078 in the RI search. The results of the parallel searches were combined and the duplicates removed. The remaining 10,556 records were screened, and at this stage, 9750 items were excluded because they did not fulfill the inclusion criteria. 806 items were selected for full-text reading. Subsequently, 388 articles were included in the qualitative synthesis (Fig.  1 ).

Flow diagram

Of the 388 articles, 157 were only identified via the RE search, 87 exclusively via the RI search, and 144 were identified via both search strategies. The eligible articles contained 500 case descriptions, which were used for the analysis of the publications articles analysis. 256 case descriptions discussed the same 50 cases. The Hwang case was the most frequently described case, discussed in 27 articles. Furthermore, the top 10 most described cases were found in 132 articles (Table 1 ).

For the analysis of cases, 206 (41.2% of the case descriptions) duplicates were excluded, and 56 (11.2%) cases were excluded for not providing enough information to distinguish them from other cases, resulting in 238 eligible cases.

Analysis of the articles

The categories used to classify the violations include those that pertain to the different kinds of scientific misconduct (falsification, fabrication, plagiarism), detrimental research practices (authorship issues, duplication, peer-review, errors in experimental design, and mentoring), and “other misconduct” (according to the definitions from the National Academies of Sciences and Medicine, [ 1 ]). Each case could involve more than one type of violation. The majority of cases presented more than one violation or ethical issue, with a mean of 1.56 violations per case. Figure  2 presents the frequency of each violation tagged to the articles. Falsification and fabrication were the most frequently tagged violations. The violations accounted respectively for 29.1% and 30.0% of the number of taggings (n = 780), and they were involved in 46.8% and 45.4% of the articles (n = 500 case descriptions). Problems with informed consent represented 9.1% of the number of taggings and 14% of the articles, followed by patient safety (6.7% and 10.4%) and plagiarism (5.4% and 8.4%). Detrimental research practices, such as authorship issues, duplication, peer-review, errors in experimental design, mentoring, and self-citation were mentioned cumulatively in 7.0% of the articles.

Tagged violations from the article analysis

Analysis of the cases

Figure  3 presents the frequency and percentage of each violation found in the cases. Each case could include more than one item from the list. The 238 cases were tagged 305 times, with a mean of 1.28 items per case. Fabrication and falsification were the most frequently tagged violations (44.9%), involved in 57.7% of the cases (n = 238). The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation (15.7%) and involved in 20.2% of the cases. Patient safety issues were the third most frequently tagged violations (11.1%), involved in 14.3% of the cases, followed by plagiarism (6.9% and 8.8%). The list of major and minor misbehaviors [ 8 ] classifies the items into study design, data collection, reporting, and collaboration issues. Our results show that 56.0% of the tagged violations involved issues in reporting, 16.4% in data collection, 15.1% involved collaboration issues, and 12.5% in the study design. The items in the original list that were not listed in the results were not involved in any case collected.

Major and minor misbehavior items from the analysis of cases

Article genre

The articles were mostly classified into “news” (33.0%), followed by “case analysis” (20.9%), “editorial” (12.1%), “commentary” (10.8%), “misconduct notice” (10.3%), “retraction notice” (6.4%), “letter” (3.6%), “educational paper” (1.3%), “review” (1%), and “book review” (0.3%) (Fig.  4 ). The articles classified into “news” and “case analysis” included predominantly prominent cases. Items classified into “news” often explored all the investigation findings step by step for the associated cases as the case progressed through investigations, and this might explain its high prevalence. The case analyses included mainly normative assessments of prominent cases. The misconduct and retraction notices included the largest number of unique cases, although a relatively large portion of the retraction and misconduct records could not be included because of insufficient case details. The articles classified into “editorial”, “commentary” and “letter” also included unique cases.

Article genre of included articles

Article analysis

The dates of the eligible articles range from 1983 to 2018 with notable peaks between 1990 and 1996, most probably associated with the Gallo [ 9 ] and Imanishi-Kari cases [ 10 ], and around 2005 with the Hwang [ 11 ], Wakefield [ 12 ], and CNEP trial cases [ 13 ] (Fig.  5 ). The trend line shows an increase in the number of articles over the years.

Frequency of articles according to the year of publication

Case analysis

The dates of included cases range from 1798 to 2016. Two cases occurred before 1910, one in 1798 and the other in 1845. Figure  6 shows the number of cases per year from 1910. An increase in the curve started in the early 1980s, reaching the highest frequency in 2004 with 13 cases.

Frequency of cases per year

Geographical distribution

The first analysis concerned the authors’ affiliation and the corresponding author’s address. Where the article contained more than one country in the affiliation list, only the first author’s location was considered. Eighty-one articles were excluded because the authors’ affiliations were not available, and 307 articles were included in the analysis. The articles originated from 26 different countries (Additional file 3 ). Most of the articles emanated from the USA and the UK (61.9% and 14.3% of articles, respectively), followed by Canada (4.9%), Australia (3.3%), China (1.6%), Japan (1.6%), Korea (1.3%), and New Zealand (1.3%). Some of the most discussed cases occurred in the USA; the Imanishi-Kari, Gallo, and Schön cases [ 9 , 10 ]. Intensely discussed cases are also associated with Canada (Fisher/Poisson and Olivieri cases), the UK (Wakefield and CNEP trial cases), South Korea (Hwang case), and Japan (RIKEN case) [ 12 , 14 ]. In terms of percentages, North America and Europe stand out in the number of articles (Fig.  7 ).

Percentage of articles and cases by continent

The case analysis involved the location where the case took place, taking into account the institutions involved in the case. For cases involving more than one country, all the countries were considered. Three cases were excluded from the analysis due to insufficient information. In the case analysis, 40 countries were involved in 235 different cases (Additional file 4 ). Our findings show that most of the reported cases occurred in the USA and the United Kingdom (59.6% and 9.8% of cases, respectively). In addition, a number of cases occurred in Canada (6.0%), Japan (5.5%), China (2.1%), and Germany (2.1%). In terms of percentages, North America and Europe stand out in the number of cases (Fig.  7 ). To enable comparison, we have additionally collected the number of published documents according to country distribution, available on SCImago Journal & Country Rank [ 16 ]. The numbers correspond to the documents published from 1996 to 2019. The USA occupies the first place in the number of documents, with 21.9%, followed by China (11.1%), UK (6.3%), Germany (5.5%), and Japan (4.9%).

Field of science

The cases were classified according to the field of science. Four cases (1.7%) could not be classified due to insufficient information. Where information was available, 80.8% of cases were from the Medical and Health Sciences, 11.5% from the Natural Sciences, 4.3% from Social Sciences, 2.1% from Engineering and Technology, and 1.3% from Humanities (Fig.  8 ). Additionally, we have retrieved the number of published documents according to scientific field distribution, available on SCImago [ 16 ]. Of the total number of scientific publications, 41.5% are related to natural sciences, 22% to engineering, 25.1% to health and medical sciences, 7.8% to social sciences, 1.9% to agricultural sciences, and 1.7% to the humanities.

Field of science from the analysis of cases

This variable aimed to collect information on possible consequences and sanctions imposed by funding agencies, scientific journals and/or institutions. 97 cases could not be classified due to insufficient information. 141 cases were included. Each case could potentially include more than one outcome. Most of cases (45.4%) involved paper retraction, followed by exclusion from funding applications (35.5%). (Table 2 ).

RE and RI cases have been increasingly discussed publicly, affecting public attitudes towards scientists and raising awareness about ethical issues, violations, and their wider consequences [ 5 ]. Different approaches have been applied in order to quantify and address research misbehaviors [ 5 , 17 , 18 , 19 ]. However, most cases are investigated confidentially and the findings remain undisclosed even after the investigation [ 19 , 20 ]. Therefore, the study aimed to collect the RE and RI cases available in the scientific literature, understand how the cases are discussed, and identify the potential of case descriptions to raise awareness on RE and RI.

We collected and analyzed 500 detailed case descriptions from 388 articles and our results show that they mostly relate to extensively discussed and notorious cases. Approximately half of all included cases was mentioned in at least two different articles, and the top ten most commonly mentioned cases were discussed in 132 articles.

The prominence of certain cases in the literature, based on the number of duplicated cases we found (e.g. Hwang case), can be explained by the type of article in which cases are discussed and the type of violation involved in the case. In the article genre analysis, 33% of the cases were described in the news section of scientific publications. Our findings show that almost all article genres discuss those cases that are new and in vogue. Once the case appears in the public domain, it is intensely discussed in the media and by scientists, and some prominent cases have been discussed for more than 20 years (Table 1 ). Misconduct and retraction notices were exceptions in the article genre analysis, as they presented mostly unique cases. The misconduct notices were mainly found on the NIH repository, which is indexed in the searched databases. Some federal funding agencies like NIH usually publicize investigation findings associated with the research they fund. The results derived from the NIH repository also explains the large proportion of articles from the US (61.9%). However, in some cases, only a few details are provided about the case. For cases that have not received federal funding and have not been reported to federal authorities, the investigation is conducted by local institutions. In such instances, the reporting of findings depends on each institution’s policy and willingness to disclose information [ 21 ]. The other exception involves retraction notices. Despite the existence of ethical guidelines [ 22 ], there is no uniform and a common approach to how a journal should report a retraction. The Retraction Watch website suggests two lists of information that should be included in a retraction notice to satisfy the minimum and optimum requirements [ 22 , 23 ]. As well as disclosing the reason for the retraction and information regarding the retraction process, optimal notices should include: (I) the date when the journal was first alerted to potential problems; (II) details regarding institutional investigations and associated outcomes; (III) the effects on other papers published by the same authors; (IV) statements about more recent replications only if and when these have been validated by a third party; (V) details regarding the journal’s sanctions; and (VI) details regarding any lawsuits that have been filed regarding the case. The lack of transparency and information in retraction notices was also noted in studies that collected and evaluated retractions [ 24 ]. According to Resnik and Dinse [ 25 ], retractions notices related to cases of misconduct tend to avoid naming the specific violation involved in the case. This study found that only 32.8% of the notices identify the actual problem, such as fabrication, falsification, and plagiarism, and 58.8% reported the case as replication failure, loss of data, or error. Potential explanations for euphemisms and vague claims in retraction notices authored by editors could pertain to the possibility of legal actions from the authors, honest or self-reported errors, and lack of resources to conduct thorough investigations. In addition, the lack of transparency can also be explained by the conflicts of interests of the article’s author(s), since the notices are often written by the authors of the retracted article.

The analysis of violations/ethical issues shows the dominance of fabrication and falsification cases and explains the high prevalence of prominent cases. Non-adherence to laws and regulations (REC approval, informed consent, and data protection) was the second most prevalent issue, followed by patient safety, plagiarism, and conflicts of interest. The prevalence of the five most tagged violations in the case analysis was higher than the prevalence found in the analysis of articles that involved the same violations. The only exceptions are fabrication and falsification cases, which represented 45% of the tagged violations in the analysis of cases, and 59.1% in the article analysis. This disproportion shows a predilection for the publication of discussions related to fabrication and falsification when compared to other serious violations. Complex cases involving these types of violations make good headlines and this follows a custom pattern of writing about cases that catch the public and media’s attention [ 26 ]. The way cases of RE and RI violations are explored in the literature gives a sense that only a few scientists are “the bad apples” and they are usually discovered, investigated, and sanctioned accordingly. This implies that the integrity of science, in general, remains relatively untouched by these violations. However, studies on misconduct determinants show that scientific misconduct is a systemic problem, which involves not only individual factors, but structural and institutional factors as well, and that a combined effort is necessary to change this scenario [ 27 , 28 ].

Analysis of cases

A notable increase in RE and RI cases occurred in the 1990s, with a gradual increase until approximately 2006. This result is in agreement with studies that evaluated paper retractions [ 24 , 29 ]. Although our study did not focus only on retractions, the trend is similar. This increase in cases should not be attributed only to the increase in the number of publications, since studies that evaluated retractions show that the percentage of retraction due to fraud has increased almost ten times since 1975, compared to the total number of articles. Our results also show a gradual reduction in the number of cases from 2011 and a greater drop in 2015. However, this reduction should be considered cautiously because many investigations take years to complete and have their findings disclosed. ORI has shown that from 2001 to 2010 the investigation of their cases took an average of 20.48 months with a maximum investigation time of more than 9 years [ 24 ].

The countries from which most cases were reported were the USA (59.6%), the UK (9.8%), Canada (6.0%), Japan (5.5%), and China (2.1%). When analyzed by continent, the highest percentage of cases took place in North America, followed by Europe, Asia, Oceania, Latin America, and Africa. The predominance of cases from the USA is predictable, since the country publishes more scientific articles than any other country, with 21.8% of the total documents, according to SCImago [ 16 ]. However, the same interpretation does not apply to China, which occupies the second position in the ranking, with 11.2%. These differences in the geographical distribution were also found in a study that collected published research on research integrity [ 30 ]. The results found by Aubert Bonn and Pinxten (2019) show that studies in the United States accounted for more than half of the sample collected, and although China is one of the leaders in scientific publications, it represented only 0.7% of the sample. Our findings can also be explained by the search strategy that included only keywords in English. Since the majority of RE and RI cases are investigated and have their findings locally disclosed, the employment of English keywords and terms in the search strategy is a limitation. Moreover, our findings do not allow us to draw inferences regarding the incidence or prevalence of misconduct around the world. Instead, it shows where there is a culture of publicly disclosing information and openly discussing RE and RI cases in English documents.

Scientific field analysis

The results show that 80.8% of reported cases occurred in the medical and health sciences whilst only 1.3% occurred in the humanities. This disciplinary difference has also been observed in studies on research integrity climates. A study conducted by Haven and colleagues, [ 28 ] associated seven subscales of research climate with the disciplinary field. The subscales included: (1) Responsible Conduct of Research (RCR) resources, (2) regulatory quality, (3) integrity norms, (4) integrity socialization, (5) supervisor/supervisee relations, (6) (lack of) integrity inhibitors, and (7) expectations. The results, based on the seven subscale scores, show that researchers from the humanities and social sciences have the lowest perception of the RI climate. By contrast, the natural sciences expressed the highest perception of the RI climate, followed by the biomedical sciences. There are also significant differences in the depth and extent of the regulatory environments of different disciplines (e.g. the existence of laws, codes of conduct, policies, relevant ethics committees, or authorities). These findings corroborate our results, as those areas of science most familiar with RI tend to explore the subject further, and, consequently, are more likely to publish case details. Although the volume of published research in each research area also influences the number of cases, the predominance of medical and health sciences cases is not aligned with the trends regarding the volume of published research. According to SCImago Journal & Country Rank [ 16 ], natural sciences occupy the first place in the number of publications (41,5%), followed by the medical and health sciences (25,1%), engineering (22%), social sciences (7,8%), and the humanities (1,7%). Moreover, biomedical journals are overrepresented in the top scientific journals by IF ranking, and these journals usually have clear policies for research misconduct. High-impact journals are more likely to have higher visibility and scrutiny, and consequently, more likely to have been the subject of misconduct investigations. Additionally, the most well-known general medical journals, including NEJM, The Lancet, and the BMJ, employ journalists to write their news sections. Since these journals have the resources to produce extensive news sections, it is, therefore, more likely that medical cases will be discussed.

Violations analysis

In the analysis of violations, the cases were categorized into major and minor misbehaviors. Most cases involved data fabrication and falsification, followed by cases involving non-adherence to laws and regulations, patient safety, plagiarism, and conflicts of interest. When classified by categories, 12.5% of the tagged violations involved issues in the study design, 16.4% in data collection, 56.0% in reporting, and 15.1% involved collaboration issues. Approximately 80% of the tagged violations involved serious research misbehaviors, based on the ranking of research misbehaviors proposed by Bouter and colleagues. However, as demonstrated in a meta-analysis by Fanelli (2009), most self-declared cases involve questionable research practices. In the meta-analysis, 33.7% of scientists admitted questionable research practices, and 72% admitted when asked about the behavior of colleagues. This finding contrasts with an admission rate of 1.97% and 14.12% for cases involving fabrication, falsification, and plagiarism. However, Fanelli’s meta-analysis does not include data about research misbehaviors in its wider sense but focuses on behaviors that bias research results (i.e. fabrication and falsification, intentional non-publication of results, biased methodology, misleading reporting). In our study, the majority of cases involved FFP (66.4%). Overrepresentation of some types of violations, and underrepresentation of others, might lead to misguided efforts, as cases that receive intense publicity eventually influence policies relating to scientific misconduct and RI [ 20 ].

Sanctions analysis

The five most prevalent outcomes were paper retraction, followed by exclusion from funding applications, exclusion from service or position, dismissal and suspension, and paper correction. This result is similar to that found by Redman and Merz [ 31 ], who collected data from misconduct cases provided by the ORI. Moreover, their results show that fabrication and falsification cases are 8.8 times more likely than others to receive funding exclusions. Such cases also received, on average, 0.6 more sanctions per case. Punishments for misconduct remain under discussion, ranging from the criminalization of more serious forms of misconduct [ 32 ] to social punishments, such as those recently introduced by China [ 33 ]. The most common sanction identified by our analysis—paper retraction—is consistent with the most prevalent types of violation, that is, falsification and fabrication.

Publicizing scientific misconduct

The lack of publicly available summaries of misconduct investigations makes it difficult to share experiences and evaluate the effectiveness of policies and training programs. Publicizing scientific misconduct can have serious consequences and creates a stigma around those involved in the case. For instance, publicized allegations can damage the reputation of the accused even when they are later exonerated [ 21 ]. Thus, for published cases, it is the responsibility of the authors and editors to determine whether the name(s) of those involved should be disclosed. On the one hand, it is envisaged that disclosing the name(s) of those involved will encourage others in the community to foster good standards. On the other hand, it is suggested that someone who has made a mistake should have the right to a chance to defend his/her reputation. Regardless of whether a person's name is left out or disclosed, case reports have an important educational function and can help guide RE- and RI-related policies [ 34 ]. A recent paper published by Gunsalus [ 35 ] proposes a three-part approach to strengthen transparency in misconduct investigations. The first part consists of a checklist [ 36 ]. The second suggests that an external peer reviewer should be involved in investigative reporting. The third part calls for the publication of the peer reviewer’s findings.

Limitations

One of the possible limitations of our study may be our search strategy. Although we have conducted pilot searches and sensitivity tests to reach the most feasible and precise search strategy, we cannot exclude the possibility of having missed important cases. Furthermore, the use of English keywords was another limitation of our search. Since most investigations are performed locally and published in local repositories, our search only allowed us to access cases from English-speaking countries or discussed in academic publications written in English. Additionally, it is important to note that the published cases are not representative of all instances of misconduct, since most of them are never discovered, and when discovered, not all are fully investigated or have their findings published. It is also important to note that the lack of information from the extracted case descriptions is a limitation that affects the interpretation of our results. In our review, only 25 retraction notices contained sufficient information that allowed us to include them in our analysis in conformance with the inclusion criteria. Although our search strategy was not focused specifically on retraction and misconduct notices, we believe that if sufficiently detailed information was available in such notices, the search strategy would have identified them.

Case descriptions found in academic journals are dominated by discussions regarding prominent cases and are mainly published in the news section of journals. Our results show that there is an overrepresentation of biomedical research cases over other scientific fields when compared with the volume of publications produced by each field. Moreover, published cases mostly involve fabrication, falsification, and patient safety issues. This finding could have a significant impact on the academic representation of ethical issues for RE and RI. The predominance of fabrication and falsification cases might diverge the attention of the academic community from relevant but less visible violations and ethical issues, and recently emerging forms of misbehaviors.

Availability of data and materials

This review has been developed by members of the EnTIRE project in order to generate information on the cases that will be made available on the Embassy of Good Science platform ( www.embassy.science ). The dataset supporting the conclusions of this article is available in the Open Science Framework (OSF) repository in https://osf.io/3xatj/?view_only=313a0477ab554b7489ee52d3046398b9 .

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Acknowledgements

The authors wish to thank the EnTIRE research group. The EnTIRE project (Mapping Normative Frameworks for Ethics and Integrity of Research) aims to create an online platform that makes RE+RI information easily accessible to the research community. The EnTIRE Consortium is composed by VU Medical Center, Amsterdam, gesinn. It Gmbh & Co Kg, KU Leuven, University of Split School of Medicine, Dublin City University, Central European University, University of Oslo, University of Manchester, European Network of Research Ethics Committees.

EnTIRE project (Mapping Normative Frameworks for Ethics and Integrity of Research) has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement N 741782. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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All authors (ACVA, BG, JL, MH, JKB, SH and PK) developed the idea for the article. ACVA, PK, JKB performed the literature search and data analysis, ACVA and PK produced the draft, and all authors critically revised it. All authors have read and approved the manuscript.

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Supplementary Information

Additional file 1.

. Pilot search and search strategy.

Additional file 2

. List of Major and minor misbehavior items (Developed by Bouter LM, Tijdink J, Axelsen N, Martinson BC, ter Riet G. Ranking major and minor research misbehaviors: results from a survey among participants of four World Conferences on Research Integrity. Research integrity and peer review. 2016;1(1):17. https://doi.org/10.1186/s41073-016-0024-5 ).

Additional file 3

. Table containing the number and percentage of countries included in the analysis of articles.

Additional file 4

. Table containing the number and percentage of countries included in the analysis of the cases.

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Armond, A.C.V., Gordijn, B., Lewis, J. et al. A scoping review of the literature featuring research ethics and research integrity cases. BMC Med Ethics 22 , 50 (2021). https://doi.org/10.1186/s12910-021-00620-8

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• Research ethics
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• Scientific misconduct

BMC Medical Ethics

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Ethics in systematic reviews

Affiliation.

• 1 Dental Faculty, Paul Sabatier University, Department of Epidemiology, Public Health, Prevention and Legislation, Toulouse University Hospital, Toulouse, France. [email protected]
• PMID: 20952493
• DOI: 10.1136/jme.2010.039941

Since its introduction by the Nuremberg Code and the Declaration of Helsinki, the place held by ethics in biomedical research has been continuously increasing in importance. The past 30 years have also seen exponential growth in the number of biomedical articles published. A systematic review of the literature is the scientific way of synthesising a plethora of information, by exhaustively searching out and objectively analysing the studies dealing with a given issue. However, the question of ethics in systematic reviews is rarely touched upon. This could lead to some drawbacks, as systematic reviews may contain studies with ethical insufficiencies, may be a possible way to publish unethical research and may also be prone to conflict of interest. Finally, informed consent given for an original study is not necessarily still valid at the systematic review level. There is no doubt that routine ethical assessment in systematic reviews would help to improve the ethical and methodological quality of studies in general. However, ethical issues change so much with time and location, and are so broad in scope and in context that it appears illusory to search for a universal, internationally accepted standard for ethical assessment in systematic reviews. Some simple suggestions could nevertheless be drawn from the present reflection and are discussed in the paper.

• Biomedical Research / ethics*
• Ethics, Research*
• Informed Consent / ethics
• Review Literature as Topic*

• Open access
• Published: 24 May 2020

A systematic literature review of the ethics of conducting research in the humanitarian setting

• William Bruno   ORCID: orcid.org/0000-0001-9429-6874 1 &
• Rohini J. Haar 2  

Conflict and Health volume  14 , Article number:  27 ( 2020 ) Cite this article

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Research around humanitarian crises, aid delivery, and the impact of these crises on health and well-being has expanded dramatically. Ethical issues around these topics have recently received more attention. We conducted a systematic literature review to synthesize the lessons learned regarding the ethics of research in humanitarian crises.

We conducted a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines to identify articles regarding the ethics of research in humanitarian contexts between January 1, 1997 and September 1, 2019. We analyzed the articles to extract key themes and develop an agenda for future research.

We identified 52 articles that matched our inclusion criteria. We categorized the article data into five categories of analysis: 32 were expert statements, 18 were case studies, 11 contained original research, eight were literature reviews and three were book chapters. All included articles were published in English. Using a step-wise qualitative analysis, we identified 10 major themes that encompassed these concepts and points. These major themes were: ethics review process (21 articles, [40.38%]); community engagement (15 articles [28.85%]); the dual imperative , or necessity that research be both academically sound and policy driven, clinical trials in the humanitarian setting (13 articles for each, [25.0%)]; informed consent (10 articles [19.23%]); cultural considerations (6 articles, [11.54%]); risks to researchers (5 articles, [9.62%]); child participation (4 articles [7.69%]); and finally mental health , and data ownership (2 articles for each [3.85%]).

Conclusions

Interest in the ethics of studying humanitarian crises has been dramatically increasing in recent years. While key concepts within all research settings such as beneficence, justice and respect for persons are crucially relevant, there are considerations unique to the humanitarian context. The particular vulnerabilities of conflict-affected populations, the contextual challenges of working in humanitarian settings, and the need for ensuring strong community engagement at all levels make this area of research particularly challenging. Humanitarian crises are prevalent throughout the globe, and studying them with the utmost ethical forethought is critical to maintaining sound research principles and ethical standards.

Defined as both natural and man-made disasters, along with both acute and chronic conflicts, humanitarian crises threaten the lives and livelihoods of over 131 million people in the world today [ 1 ]. With more than 68.5 million people currently displaced, 25.4 million of whom are refugees outside their country of origin, the global community is witnessing urgent humanitarian issues that are crossing borders and impacting even those states and communities once thought immune [ 2 , 3 ]. Humanitarian aid is the impartial, independent and neutral delivery of services to populations in immediate danger [ 4 ]. Since the end of World War II, the humanitarian aid sector (in the form of health services, water and sanitation services, nutritional goods and security) has grown tremendously [ 5 ].

With expansion in humanitarian aid delivery and the deepening awareness that humanitarian crises can destroy health systems and have long-term impacts on public health, ensuring that the services provided are effective and acceptable is crucial. Following several highly publicized failures of the humanitarian community, veteran humanitarians from across the spectrum of governmental and non-governmental organizations have attempted to improve humanitarian response [ 6 ]. Initiatives such as the Sphere Project and others aimed to create minimum standards and evidence-based protocols for the delivery of five core components of humanitarian response—water supply and sanitation, nutrition, food aid, shelter and site planning and health services [ 7 ]. Over the past several decades, a key component of the assessment process has been conducting formal monitoring, evaluation and research on humanitarian aid delivery. Studies ranging from randomized control trials to population surveys and qualitative assessments evaluating the full spectrum of humanitarian aid delivery have burgeoned [ 8 ].

Parallel to the increase in professionalization of humanitarian aid, the public health community has been grappling with how to ensure that research on vulnerable populations is conducted ethically and with a focus on the rights and best interests of the community. Spurred by a backlash to unchecked human experimentation carried out through the twentieth century during World War II and the decades afterwards, there is more recognition of the critical importance of considering research ethics, particularly when studying vulnerable populations [ 9 ].

Few populations are as vulnerable to the potential adverse ethical challenges of research as those experiencing a humanitarian crisis [ 10 ]. Faced with weak government protections, disrupted health systems, insecure living conditions, and unreliable food and unsafe water, disaster-affected populations can be particularly at risk of inadequate consent processes and coercion. Furthermore, humanitarian emergencies require timely evaluation and management, making traditional ethics review—typically a protracted process—impractical [ 11 , 12 , 13 ]. These unique challenges, along with underdeveloped oversight and regulatory bodies of host countries and international mechanisms, make ethics considerations a crucial but difficult task in humanitarian research [ 14 , 15 ].

Despite increasing interest and an expanding literature base, there has been limited formal synthesis of the existing published data around the ethical issues of research in the humanitarian setting. We conducted a systematic review to (1) identify ethical issues surrounding research in humanitarian settings, (2) assess how these issues are managed in these unique circumstances and (3) develop an agenda for major issues that will require further discourse.

We conducted a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines [ 16 ]. The PRISMA checklist has been provided as Supplementary Table  1 . Articles relevant to research ethics in the humanitarian setting were identified and analyzed. We chose to limit the search to articles published after January 1, 1997, when the initiation of the Sphere project marked a paradigm shift in how humanitarian aid was envisioned and carried out. This allows for review of nearly 25 years of literature, therefore spanning a wide swath of potential ethical research. We used the Sphere project dates because it included explicit language highlighting the need for evidence-based practices, which would require significant augmentation in research efforts to provide such an evidence base [ 7 ]. Our search included articles published as late as September 1, 2019, when this study was first undertaken.

Search strategy

We searched PubMed and Scopus for articles with significant discussion of the ethical issues of humanitarian research ethics. After a qualitative assessment of relevant keywords, we identified all pertinent articles based on the following terminology categories (articles could be in any language): (1) humanitarian settings (terms such as humanitarian, global health, disaster, emergency and/or conflict), (2) ethics (terms such as ethic(s), bioethics, human rights and/or rights) and (3) research type (terms such as research, program evaluation, monitoring and evaluation and/or investigation). The full search strategy and MeSH terms can be found in the Appendix . The initial search results of 1459 articles underwent a title and abstract review followed by a full text review by two different authors (WB and RH) (Fig.  1 ). A priori inclusion criteria included the 22-year timeframe mentioned above and selected for articles with robust discussion of ethical issues in the context of conducting research in humanitarian settings. Any article deemed by both reviewers to contain only a superficial mention of ethical issues and to not substantively (1) discuss ethics or (2) focus on research (3) in the context of humanitarian settings was excluded from the final analysis. Ethics was defined broadly as engagement with specific research ethics, as well as human rights issues, and other non-formal discussions of right versus wrong and other moral concepts. Research was defined as discussions including any types of data collection including quantitative and qualitative, as well as data collection for monitoring and evaluation for other programmatic and academic purposes. Humanitarian settings included diverse contexts including conflict and post-conflict states, post-natural disaster settings and refugee camps that requires specific interventions to prevent large scale suffering of the populations. Two authors (WB and RH) reviewed the final list of articles meeting the inclusion criteria.

Stages of Systematic Literature Review Utilizing PRISMA Guidelines

Analytical methods

We used a modified meta-ethnographic approach to inductively identify key concepts and synthesize the major themes [ 17 ]. We chose the meta-ethnographic approach as it has been shown useful in other systematic reviews of qualitative health literature in that it utilizes an inductive approach that can account for differences in methodology and focus, and has the potential to provide a higher level of analysis and generate new research questions [ 18 , 19 , 20 ]. We conducted three steps of analysis: (1) Identifying original concepts and ideas from each paper that related to cross-cutting themes; (2) synthesizing these ideas into cross-cutting themes; and (3) identifying major themes. These steps are outlined in Table  2 . Original concepts were topics discussed in each paper, which the authors felt had some relevance to this paper’s focus on humanitarian research ethics. Cross-cutting themes were key concepts that were identified in at least two different articles. We assessed how the cross-cutting themes may fall into broader overarching ideas and coded these into related non-mutually exclusive groups we termed major themes. The synthesis process of extracting these major themes was one of reciprocal translation and constant comparison of concepts across studies. The process elucidated tensions and areas for future research within each major theme, as shown in Table 2 . Any disagreements on the analysis were resolved with discussion and consensus.

This research, based on previously published literature, did not meet criteria for Institutional Review Board approval.

Of the 1459 unique articles resulting from our search terms, 52 matched our inclusion criteria (Table 1 : List of Included Articles). The articles took the shape of five non-mutually exclusive categories of analysis: 32 were expert statements, 18 were case studies, 11 contained original research, eight were literature reviews and three were book chapters. All included articles were published in English. Thirty-four of the 52 (65.38%) articles were published in 2015 or later, ten between 2007 and 2014, and eight were published in the 1997–2006 decade (Fig.  2 ). Of the 52 articles included for final analysis, 23 were published by international teams (meaning that they were comprised of members from at least two different countries), 12 were from the United States, six from the United Kingdom, three from Canada, two each form Ireland, Trinidad and Tobago, and Switzerland, and one each from Australia and India.

Included articles by publication date

Thematic analysis

The step-wise analysis is presented in Table 2 . First order analysis of the articles meeting our final inclusion criteria revealed ideas and issues within the context of ethics related research in humanitarian settings. In the second phase of the analysis, qualitative review of the reports identified cross-cutting themes between the papers, and 10 major themes that encompassed these concepts and points. These major themes in descending order of prevalence were ethics review process (21 articles, [40.38%]); community engagement (15 articles [28.85%]); the dual imperative , or necessity that research be both academically sound and policy driven and clinical trials in the humanitarian setting (13 articles for each, [25.0%]); informed consent (10 articles [19.23%]); cultural considerations (6 articles, [11.54%]); risks to researchers (5 articles, [9.62%]); child participation (4 articles [7.69%]), and finally mental health , and data ownership (2 articles for each [3.85%]).

Ethical review

Discussion of the ethical review process was the most commonly identified theme, with 21 articles having a substantive focus on this [ 11 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 ]. Independent ethics review prior to the start of a study is a core component of research ethics. Tansey et al. conducted a survey of ethics review board members with experience in reviewing research ethics in disaster settings. Their results suggest a general feeling that research in this setting is not only of particularly high social value, making it a desirable pursuit, but also necessitates a higher level of justification due to the inherent vulnerability of the research subjects [ 33 ]. There is also general agreement that the innate fluidity and urgency of humanitarian situations make swift and efficient ethics review of paramount importance [ 11 , 25 , 29 ]. Hunt et al. report, “where research is launched in response to a sudden-onset disaster such as an earthquake or hurricane, researchers may need to initiate their protocols quickly in order to answer research questions pertinent to the acute phase of the disaster response” [ 11 ]. However, as mentioned above, the particular vulnerability of the subjects being studied leads many research ethics committees to automatically identify humanitarian research as requiring “the highest level of stringency”. On the other hand, framing research as “needs assessments” and/or “monitoring and evaluation,” which is often done in evaluating aid needs and programs, may act to sideline rigorous ethical review and jeopardize the well-being of the recipient population [ 11 ]. This contradiction of values makes ethical review of humanitarian research particularly challenging.

Authors suggested strategies to mitigate the inherent challenges of ethics review in this setting [ 25 ]. For example, Hunt et al. suggest pre-approved research protocol templates which can be quickly customized for use in individual emergencies [ 11 ]. Eckenwiler et al. propose what they refer to as ‘real-time responsiveness,’ which is an iterative strategy of constant dialogue between ethics reviewers and researchers while studies are being conducted [ 24 ]. Given the potential for misstep in an expedited initial ethics review, Chiumento et al. describe the utility of a post-research ethical audit. The authors explain how this could help to evaluate “procedural ethics against in-practice realities”, which could help inform future studies [ 21 ]. Ethical analysis after data collection may also offer the added benefit of offering lessons on the review and practice process to the reviewers and researchers.

Our results highlighted the particular case of how the humanitarian aid agency Médecins Sans Frontières’ (MSF), who conducts substantial research in humanitarian settings, has devised an independent Ethics Review Board (ERB). The ERB utilizes several of the strategies mentioned above such as pre-approved protocols, engaging in ongoing dialogue between researchers and the ERB and conducting post-research evaluations [ 29 , 31 ]. Saxena et al. reported on a joint panel conducted by the WHO and the African Coalition for Epidemic Research, Response and Training. The authors outline the group’s recommendations for “rapid and sound ethics review”, which includes “preparing national ethics committees for outbreak response; pre-crisis review of potential protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries” [ 32 ]. Indeed, as Mezinska et al. point out in their systematic review of ethical guidelines, most of the analyzed documents included in their report did “not attempt to give researchers and other stakeholders a comprehensive overview of how to proceed ethically in all types of research and in all types of disasters”, which the authors see as problematic given that “disaster research is unavoidably context and time sensitive, making generalized guidance less applicable” [ 35 ].

Community engagement

Substantive involvement of the community being studied was identified as an imperative for researchers and a major theme of discussion in 15 articles [ 21 , 22 , 30 , 32 , 33 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 ]. It was generally agreed that active participation is necessary in order to fulfill the ethical requisite that research be of use to the community being studied (also known as beneficence) [ 22 , 48 , 50 ]. As Chiumento et al. identified in their systematic review of mental health literature, the right to participate in research can be viewed as a basic right in and of itself, insofar as it relates to other rights such as self-determination and autonomy [ 22 ]. One important strategy described was involving local community health and government officials in an effort to maximize community support [ 43 ]. More practically speaking, this effort can help limit potential for a community’s misunderstanding of research, which can jeopardize a project’s legitimacy and undermine its acceptance [ 46 ]. Early involvement of community actors, potentially via consultation during study protocol design or community meetings, was suggested [ 21 , 42 ].

The discussions within the articles suggest that community involvement also involves strengthening local institutions, effectively improving their ability to conduct their own research [ 21 , 22 ]. Despite being recognized as an important component of ethical research, it was generally agreed that there is a critical shortage of local capacity to carry out studies, particularly in post-conflict zones where formal institutions are often eroded [ 45 , 47 ]. In their study on the research capacity of Somaliland, Boyce et al. identified potential harms of a “dominance of authors from [High-Income Countries]” [ 45 ]. They explain that, for example, the unrelatability between researcher and subject could lead to a reduced relevance of the research question.

Despite the agreement for “a set of practices that help researchers establish and maintain relationships with the stakeholders to a research program”, Tansey et al. discuss some of the inherent challenges in community participation. Particularly when conducting disaster research, the practicality of including locals can be difficult when “you don’t know when the disaster is going to hit. .. so it would be hard to set up community approvals and engagement beforehand” [ 33 ]. Furthermore, lack of adequately trained researchers and poor local infrastructure are perennial problems [ 45 ]. While ethically desirable, partnering with the local community may, in many circumstances, often prove practically prohibitive.

While including local authorities in research may seem prudent on face value, as discussed in the section on cultural considerations, these articles make clear the potential for ethical ambiguity when dealing with such actors [ 47 , 49 ]. For example, in a civil war context, researchers may hope to adhere to humanitarian principles of impartiality to ensure access to participants and safety for researchers [ 49 ]. Furthermore, as Funk et al. describe in their evaluation of the response to the Syrian conflict, remaining impartial can be impossible. One respondent explained, “You have to understand that even though we declare ourselves as a non-biased health organization with no political standing, the mere fact that we are not ‘pro-government’ makes us [perceived as] ‘the enemy’ and ‘anti-government’” [ 49 ].

The dual imperative

Thirteen articles discuss what humanitarian researchers refer to as the ‘dual imperative,’ which is the inherent tension between ensuring that research is both academically sound and practically relevant [ 28 , 41 , 53 , 55 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 71 ]. Despite the inherent challenges in humanitarian research, the general consensus is that it is justifiable insofar as it is needs-driven and not at the expense of humanitarian action [ 60 ]. However, as researchers attempt to construct sophisticated research and attract funding, there is a move toward a greater level of academic sophistication [ 59 ]. On the individual level, a member of a humanitarian response team may feel responsibilities as both service provider and researcher [ 58 , 61 ]. Wood, in her description of experiences researching conflict zones in El Salvador, describes an inevitable self-inquiry of why this research is worth pursing at the expense of a purely humanitarian medical relief mission. She concludes that her role as a researcher was justified in that a sound understanding of conflict is necessary for its abolishment. Wood does, however, concede that this conclusion may be predicated on the nature of the “relatively benign and coherent conditions” of her work. Specifically, she “did not have to make a decision whether or not to intervene to attempt to prevent or mitigate an attack on civilians.” She “did not have to decide how to leave an area under attack at short notice, retreating with one force or seeking shelter from another.” She was “never faced with direct threats [insisting] that [she] turn over material [she] had gathered” and did not have “to judge how far to press respondents about violence they had suffered or observed because of the focus of [her] research.” The implication was that had she been faced with one of these more charged situations, her resolve in the justification of research would be challenged. In fact, she ends her discussion by stating that “conditions in many civil wars simply preclude ethical field research” [ 62 ].

Another related point of contention identified in our search is a disagreement that arose between a researcher and aid agency. Due to an overtaxed and under resourced system, the Democratic Republic of Congo had engaged in rationing of AIDS medications. Rennie, a global health researcher, had intended to study the community attitudes toward this practice [ 55 ]. Feeling rationing medications to be unethical, the aid agency Médecins Sans Frontières (MSF), specifically MSF-Belgium, wrote a letter informing Rennie that they would not support his investigation [ 55 , 63 ]. They expressed concern that the research might be a form of acquiescence to the practice of drug rationing, which they see as antithetical to the humanitarian mission [ 63 ]. This tension between assessing an existing program and unintentionally bringing legitimacy to it is one of many practical conflicts in humanitarian research that requires further consideration.

Clinical trials in the humanitarian setting

Given that clinical trials are considered imperative for investigating medical interventions, many researchers advocate for these types of studies in the humanitarian setting. Thirteen articles explore the ethics of conducting clinical trials in the humanitarian setting [ 27 , 29 , 30 , 36 , 38 , 46 , 51 , 52 , 53 , 54 , 55 , 56 , 63 ]. Lanini et al. make the point that the principle of clinical equipoise should apply in the humanitarian setting as in any other, making randomized controlled trials (RCTs) the most ethical way to conduct research in this situation, using the recent Ebola outbreak and subsequent drug trials to illustrate their point [ 51 ]. With respect to Ebola, Perez et al. make the claim that, given the lethality of the disease, not including pregnant women and children (two groups often excluded from trials on grounds of inherent vulnerability) in Ebola trials is unethical [ 46 ]. This, however, presupposes a benefit to the experimental arm of a hypothetical trial, which would violate the principle of clinical equipoise and thus Lanini et al.’s justification of clinical trials outlined above [ 51 ]. Salerno et al. argue that the unique circumstances of conducting research in humanitarian settings necessitates that the researcher be less stringent in terms of study design. As the authors explain, “the recipients of experimental interventions, locations of studies, and study design should be based on the aim to learn as much as we can as fast as we can without compromising patient care or health worker safety, with active participation of local scientists, and proper consultation with communities” [ 52 ].

Again, with a focus on the recent Ebola outbreak, Calain makes an argument that insistence on RCTs, in which, by definition, one group of participants will be denied the experimental treatment, equates to a preference toward a collective interest (i.e. societal) over the individual (i.e. the patient) which could violate the basic principle of beneficence [ 53 ]. For Calain, in the face of a catastrophic illness like Ebola, randomization of interventions is seen as a “tragic choice” for humanitarian workers [ 53 ]. Furthermore, as Schopper et al. explained, there is justifiable concern that clinical trials during such an epidemic, which require significant amounts of resources and planning, would detract from the crucial work of directly caring for patients in a resource limited setting [ 29 ].

Informed consent

Like formal ethical review, informed consent is another core component of modern research ethics and was separately discussed in ten articles [ 21 , 22 , 23 , 27 , 37 , 38 , 44 , 46 , 65 , 66 ]. Our results highlight several unique considerations when contemplating informed consent in humanitarian settings. For example, Western norms of written consent might be impossible if research is carried out in a population with low literacy rates or when written consent can violate the need for complete anonymity or expeditious research [ 21 , 22 , 44 ]. Controversy surrounding traditional ideas of informed consent were highlighted by Chiumento et al. in their literature review [ 22 ]. The authors explain that despite the general consensus that informed consent was central to ethical research, there were some authors who emphasized a more informal process that considered “consent as a partnership between researchers and participants” [ 22 ]. Some authors surveyed in the study supported flexibility in informed consent by utilizing a “consent framework” that presumably ensures norms such as autonomy and capacity, but allows some latitude for the researcher to adapt to the circumstances. Germane to this point is what Black et al. describe as “dynamic consent”—where a participant’s willingness to be involved in a project is constantly reassessed [ 44 ].

Chiumento et al. explain that because of cultural norms, the typical processes of consent may be undesirable or even impossible [ 21 ]. In their case study of research conducted in a post-conflict setting in South Asia, they explain that the procurement of informed consent first required permission from gatekeepers (i.e. household males and village elders) [ 21 ]. They outline the concept of negotiated consent in which collaboration with researchers helps to distil what exactly culturally specific consent would look like and proceed with an ad-hoc consent process [ 21 ].

Our results suggest that special attention be paid to informed consent during clinical trials conducted in the humanitarian setting [ 29 , 46 , 51 ]. Particularly illustrative is the idea of informed consent for experimental therapies during the Ebola outbreak in West Africa in 2014–2015 [ 46 ]. Authors raise the question as to whether or not informed consent, free of coercion, can really be possible when potential subjects are faced with such a deadly disease [ 23 ].

The use of participatory visual methods (PVM) poses specific challenges with regard to informed consent. The methods ask researchers to encourage subjects to engage in creative forms of communication and expression, such as drama, photography, film, drawing, design, creative writing and music. The products can then be used to engage the community and answer research questions.

However, as participants are synthesizing novel content during the study, and are often encouraged to draw on traumatic experiences as inspiration for this content, fully informed consent is impossible. This is because neither participants nor investigators can completely anticipate which direction their facilitated creative endeavors might turn [ 44 , 65 ]. This type of research may require more creative or dynamic forms of consent such as frequent check-ins with participants, or “dynamic consent”, as described above.

Cultural considerations

The importance of strong appreciation, humility, and understanding of local culture was discussed to a robust degree in six articles [ 21 , 47 , 50 , 57 , 64 , 67 ]. As Black et al. explain, research can only be legitimate if it accepts the people as central actors [ 57 ]. They describe how community and cultural dynamics may be vital to ensuring that the products of research not be utilized in perverse ways [ 57 ]. The authors explain that analyzed and interpreted data on a particular population could be of strategic value to belligerents in a conflict setting [ 57 ]. This notion presents an obvious ethical challenge as it has the potential to make researchers active participants in conflict or surveillance. One may conclude that the solution is for researchers to refuse to share data with any local authorities. This, however, conflicts with what Ditton et al. refer to as a vital aspect of ethical field research, namely “the importance that the researcher has an appropriate relationship with the legitimate gatekeepers [and policy makers] of a field site” [ 47 ]. As the authors note, local authorities may have perfectly legitimate reasons for demanding cooperation and transparency from researchers. For example, in Thailand, government control of researchers might be justifiable since they espouse it as necessary to ensure that the local population is the ultimate beneficiaries of the research produced within their communities. The government, being responsible for the public’s well-being, argues that having some control over research activities is necessary for them to meet this responsibility [ 47 ].

Despite general agreement about the importance of respect for local customs, there is more ambivalence toward which, if any, customs might justifiably be ignored. Bennouna et al. in their survey of researchers explain that 15% of respondents did not believe that local attitudes should be taken into account when deciding on including children in a study, because “what if they tell us not to listen to children?” implying that local norms should not preclude children from having a right to be heard [ 67 ]. In contrast, Chiumento et al. suggest “that ethical conduct of research does not equate to importing cultural norms.” The authors continue to describe a common “ethically charged dilemma” in which consent or access to participants first requires permission from a “gatekeeper.” Cultural norms may dictate that (often male) household or community leaders are to make decisions in terms of participation and access to research, depriving some members of the community of basic “ethic and human rights norms” such as autonomy and the right to participate or refuse [ 21 ]. These points highlight an unanswered question regarding the universality of ethical principles.

Not only might respect for cultural norms be inherently ethically desirable, but it may also be important for ensuring community participation. As Mfutso-Bengo et al. explain, respect for cultural norms may be necessary “to ensure active community involvement as the community does not perceive overt threats to their way of life” [ 50 ]. Balancing fundamental ethical principles of inclusion and autonomy with cultural norms, the articles agree, requires deep cultural understanding.

Risks to researchers

Five of our included articles discuss the potential risk to researchers working in a humanitarian setting [ 21 , 23 , 49 , 68 , 69 ]. With the inherent instability of many of these contexts, Chiumento et al. summarize the wide range of potential risks to the wellbeing of researchers, stating that “threats to physical safety; risk of psychological distress; potential for accusations of improper behavior; and increased exposure to everyday risks such as infectious illnesses or accidents” must be recognized [ 21 ]. The very nature of conducting research in disaster settings exposes researchers to the potential of witnessing “human carnage and physical destructiveness” [ 23 ]. While researchers have personal decision-making responsibilities, host organizations must also acknowledge their obligations to provide security and mitigate risks while ensuring the researchers are fully informed of potential dangers [ 23 , 69 ].

Child participation

Child participation in research was discussed in four articles [ 43 , 65 , 67 , 70 ]. There was a general consensus that despite being particularly vulnerable, researchers had an ethical responsibility to include children in their studies. This action is necessary, the authors conclude, in order to ensure that children’s voices are heard and that they are not excluded from potential benefits of the research [ 67 ].

D’Amico et al. explain “researchers need to develop specific approaches that ensure children understand the benefit of participating voluntarily in research and that consent is informed and an ongoing process” [ 65 ]. The challenge, however, as the authors explain, is that through research, particularly qualitative forms such as PVM, “dangerous emotional terrain” might be breeched [ 65 ]. The implication is that it is difficult to know whether anyone can fully consent to these unforeseen emotional responses, especially children.

Data ownership

Two articles describe the unique ethical concerns surrounding data ownership when conducting research in the humanitarian setting [ 45 , 57 ]. Often, none of the researchers in question are from the communities being studied, so the potential ethical pitfalls of an abusive extractive nature of data collecting might be created [ 45 ]. The concern arises when researchers from high-income countries collect data on lower income communities and the ultimate benefits are seen in the former [ 57 ].

Mental health

Mental health research, which was discussed in two articles, has some unique features, which create special ethical issues [ 21 , 22 ]. For example, Chiumento et al. describe how community mistrust, stigma and paranoia can be particularly significant with regard to mental health, complicating mental health research [ 21 ]. There is also a particular importance for confidentiality and anonymity during mental health research given the potential for discrimination and stigmatizing behavior [ 22 ].

With the drive toward professionalization of humanitarian practice comes a need to develop a strong evidence base. While the latter half of the twentieth century has seen promising trends in favor of ethical standards for research, the unique conditions of humanitarian work and the particular vulnerabilities of the communities being studied makes exploration of humanitarian research ethics imperative. The time-sensitive nature of the work in combination with complex cultural and security dynamics makes conducting research in the humanitarian setting inherently difficult from an ethical perspective.

Efforts to better understand the nexus between research and humanitarian emergencies are expanding. Other research, including an ongoing review of ethics of humanitarian research and more focused analyses of ethics among specific crises will service to expand this knowledge base [ 72 ]. We hope that this paper, representing a broad review and meta-ethnographic analysis of ethical issues in research over more than two decades, strengthens ethical processes and decision making in the humanitarian sector.

Among the 52 articles included in the analysis, 10 major themes regarding the ethics of humanitarian research were extracted for future analysis. In our qualitative analysis of the articles, we found a general acceptance by authors that the increased vulnerabilities of crisis-affected populations lead to several unique issues. Though identified and described in our search, many of these issues have yet to be adequately resolved in a way that might be useful to further researchers. For example, with regard to respect for local cultural norms, our results highlight a unique conflict between a cultural or political demand to share research with a local authoritative body and moral or ethical apprehensions to do so [ 47 , 57 ]. Authors identified both acceptable and unacceptable reasons for an authoritative body to demand access to research [ 47 , 57 ]. The researcher must then decide whether they cooperate with authorities by sharing products of their research, and risk being complicit in less socially desirable actions, or refuse and risk access to their study population, potentially depriving them of the fruits of their work. And to the related point embodied in the disagreement between MSF-Belgium and Rennie, controversy persists as to whether cooperating with an authoritative body to study a practice in which they are engaged suggests support of that practice [ 55 , 63 ]. Further exploration of these questions is essential as the role of research on humanitarian response expands.

Our results suggest that themes of cultural considerations, community engagement and mental health research incorporate ethical dilemmas related to cultural relativism. Accepting cultural norms such as gaining a husband’s consent for his wife’s participation in a research study, or excluding children from a research project on the grounds that including them is too high risk, equates to denying some of the fundamental principles of ethical research. Therefore, researching these populations may mean conceding to certain undesirable cultural norms and rejecting others that would require the researcher to compromise ethical standards. But where should the line be drawn? What guiding principles can future researchers employ? Bennouna et al.’s survey, which revealed most researchers claimed they would, if necessary, ignore local customs and include a child’s point of view in a study might help answer the question [ 67 ]. More of this type of research needs to be done in order to identify and resolve potential conflicts of local norms and traditional research ethics.

A surprising result of our study was that some researchers held the view that certain components of traditional, modern research ethics, such as formal consent, may be applied less rigidly in the humanitarian setting [ 21 , 22 , 44 ]. For example, arguments have been made that any consent is impossible in the case of experimental treatment for Ebola victims, and the failure to meet traditional standards should not preclude one from conducting this research [ 52 ]. On the other hand, there may be certain universal ethical principles of conducting research that should never be compromised. Exactly which principles these are, if any, have yet to be elucidated.

There are further unanswered questions with regard to the involvement of local institutions. Though our results point to a general agreement about the magnanimity of significant local involvement in research, including the development of local capacity for such work the inherent challenges have yet to be addressed [ 27 , 33 ]. Humanitarian research is often conducted in places with little or no infrastructure and limited numbers of qualified researchers. Including local aid workers as researchers, solely for the inherent value of doing so, may prove costly and distract from other research mandates and aid delivery, particularly in disaster relief. As Tansey et al. put it, “while the global health research literature strongly endorses community engagement in all research, there have been few suggestions for overcoming challenges to carrying it out in the disaster setting” [ 33 ]. Future work must come to terms with this inevitable conflict of ideals.

Despite the unavoidable ethical challenges, the results of this systematic review suggest that not only is it possible to conduct research in this context, but there is an ethical obligation to do so [ 41 , 48 ]. If the global community is compelled to provide assistance in the form of humanitarian action, than those in the humanitarian field must acknowledge the responsibility to develop rational, evidence-based approaches that are, at their core, ethically responsible [ 41 ]. This impulse is reflected in our results, which demonstrate an increasing number of publications on humanitarian research ethics since the inception of the Sphere project. The growing body of literature bodes well for researchers looking to ground their future work in a strong ethical foundation.

We would like to note, however, that the vast majority of articles included in this study were from high-income and Western countries. This highlights a finding in the research itself—that community participation and involvement of researchers from the countries and regions affected by crisis is limited. Addressing this inequity should be prioritized as the field of humanitarian research ethics progresses.

It should be noted that our study has limitations. We attempted to conduct a comprehensive review of the literature with a systematic review, augmented by known grey literature, but may have missed some potentially relevant literature that did not fit the search terms and was not identified via the grey literature review. This review is based primarily on published research literature and may exclude operational or programmatic reports with valuable insights. Also, though our initial search did include book chapters via the Scopus database, and dozens of chapters have been written on the subject, relatively few were screened into our final list of included literature. The reason for this is not immediately apparent. The authors did note a relative difficulty in the searching for and screening of book chapters when compared with other types of articles. This may have lead to a preferential selection of the latter type of literature, at the expense of the former.

The selection of papers was systematic and reproducible, and the analysis of those papers relied on standard qualitative methods. While the analysis may be considered less reproducible, we utilized a standardized interpretive methodology that would reliably highlight the critical findings and points within the papers as evidenced by the strong consensus between the authors (WB and RH) on almost every inclusion and exclusion decision. Though the limited literature base makes drawing firm conclusions difficult, the consistency of issues raised between and within the articles confirms the importance of the major themes elicited in this analysis.

This study represents one of only very few attempts at a systematic review of research ethics in the humanitarian setting. We identified an increase in articles with robust ethical discussions particularly in the past few years. This promising trend could lead to further clarification and stronger ethical grounding of future research. Our data also highlight a number of unanswered questions related to fundamental conflicts that are unique to conducting research in the humanitarian setting. There is a clear need for further research and debate addressing these, and other important questions, such as: When is it appropriate to share data with local authorities? At what point should a researcher abandon a cultural relativistic point of view for an absolutist one? In a modern day humanitarian setting, what components of traditional ethics review may be anachronistic? How can researchers include local stakeholders as co-investigators when they may lack the training or infrastructure to do so? Mechanisms to translate these discussions into practical guidelines will need to be strengthened if the ideals of the Sphere Project are to be realized.

Availability of data and materials

The datasets generated and/or analyzed during the current study are available as tables in the manuscript.

Abbreviations

Ethical Review Board

Low and Middle Income Countries

Médecins Sans Frontières

Randomized Clinical Trial

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Acknowledgements

We would like to acknowledge Parveen Parmar and Len Rubenstein for support in developing the conceptual framework of this study.

There was no funding for this research.

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Department of Emergency Medicine, University of Southern California, Keck School of Medicine, Los Angeles, USA

William Bruno

Division of Epidemiology and Biostatistics, School of Public Health, Research Fellow, Human Rights Center, School of Law, University of California at Berkeley, Berkeley, USA

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WB was primarily responsible for writing the manuscript and co-coordinated study design, data analysis, and data interpretation and contributed to data collection. RH designed the study, contributed to data analysis, data interpretation, and writing. All authors have reviewed the submitted manuscript and approved the final version of the manuscript for submission.

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Search terms for systematic review of humanitarian research ethics

(Humanitarian OR “Global health”) AND (disaster OR emergency OR conflict) AND (ethic* OR bioethic* OR “human rights” OR rights) AND (research OR “program evaluation” OR “monitoring and evaluation” OR investigation) [MeSH terms].

(disaster) AND (ethic* OR bioethic* OR “human rights” OR rights) AND (research OR “program evaluation” OR “monitoring and evaluation” OR investigation) [MeSH terms]. Disaster medicine/ [MeSH]

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Bruno, W., Haar, R.J. A systematic literature review of the ethics of conducting research in the humanitarian setting. Confl Health 14 , 27 (2020). https://doi.org/10.1186/s13031-020-00282-0

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Navigating the Ethical Terrain Around the Challenges of Fake News and False Narratives: An Integrative Literature Review and a Proposed Agenda for Future Research

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• Pramukh Nanjundaswamy Vasist 1 &
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Research on fake news and false narratives is growing, and their ethical implications are increasingly garnering academic attention. This escalating crisis demands prompt consideration since its proliferation poses a significant threat to organizations and societies. As scholarly investigations garner pace in this field of inquiry, it warrants a critical appraisal of the extant body of knowledge on ethical issues related to fake news and false narratives. To this end, we analyze this growing corpus of research through an integrative review. We discuss the themes that emerge from the review, leverage key observations to establish links with business ethics, and offer propositions and a conceptual framework that serves as a basis for scholars to advance the literary space at the nexus of falsehood and business ethics. We deliberate on potential future research avenues and implications to practice.

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Vasist, P.N., Krishnan, S. Navigating the Ethical Terrain Around the Challenges of Fake News and False Narratives: An Integrative Literature Review and a Proposed Agenda for Future Research. J Bus Ethics (2024). https://doi.org/10.1007/s10551-024-05686-z

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