research paper about quality assurance

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• Published: 19 December 2011

Quality assurance of qualitative research: a review of the discourse

• Joanna Reynolds 1 ,
• James Kizito 2 ,
• Nkoli Ezumah 3 ,
• Peter Mangesho 4 ,
• Elizabeth Allen 5 &
• Clare Chandler 1  

Health Research Policy and Systems volume  9 , Article number:  43 ( 2011 ) Cite this article

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Increasing demand for qualitative research within global health has emerged alongside increasing demand for demonstration of quality of research, in line with the evidence-based model of medicine. In quantitative health sciences research, in particular clinical trials, there exist clear and widely-recognised guidelines for conducting quality assurance of research. However, no comparable guidelines exist for qualitative research and although there are long-standing debates on what constitutes 'quality' in qualitative research, the concept of 'quality assurance' has not been explored widely. In acknowledgement of this gap, we sought to review discourses around quality assurance of qualitative research, as a first step towards developing guidance.

A range of databases, journals and grey literature sources were searched, and papers were included if they explicitly addressed quality assurance within a qualitative paradigm. A meta-narrative approach was used to review and synthesise the literature.

Among the 37 papers included in the review, two dominant narratives were interpreted from the literature, reflecting contrasting approaches to quality assurance. The first focuses on demonstrating quality within research outputs; the second focuses on principles for quality practice throughout the research process. The second narrative appears to offer an approach to quality assurance that befits the values of qualitative research, emphasising the need to consider quality throughout the research process.

Conclusions

The paper identifies the strengths of the approaches represented in each narrative and recommend these are brought together in the development of a flexible framework to help qualitative researchers to define, apply and demonstrate principles of quality in their research.

Peer Review reports

The global health movement is increasingly calling for qualitative research to accompany its projects and programmes [ 1 ]. This demand, and the funding that goes with it, has led to critical debates among qualitative researchers, particularly over their role as applied or theoretical researchers [ 2 ]. An additional challenge emanating from this demand is to justify research findings and methodological rigour in terms that are meaningful and useful to global public health practitioners. A key area that has grown in quantitative health research has been in quality assurance activities, following the social movement towards evidence-based medicine and global public health [ 3 ]. Through the eyes of this movement, the quality of research affects not only the trajectory of academic disciplines but also local and global health policies. Clinical trials researchers and managers have led much of health research into an era of structured standardised procedures that demarcate and assure quality [ 4 , 5 ].

By contrast, disciplines using qualitative research methods have, to date, engaged far less frequently with quality assurance as a concept or set of procedures, and no standardised guidance for assuring quality exists. The lack of a unified approach to assuring quality can prove unhelpful for the qualitative researcher [ 6 , 7 ], particularly when working in the global health arena, where research needs both to withstand external scrutiny and provide confidence in interpretation of results by internal collaborators Furthermore, past and existing debates on what constitutes 'good' qualitative research have tended to be centred firmly within social science disciplines such as sociology or anthropology, and as such, their language and content may prove difficult to penetrate for the qualitative researcher operating within a multi-disciplinary, and largely positivist, global health environment.

The authors and colleagues within the ACT Consortium [ 8 ] conduct qualitative research that is mostly rooted in anthropology and sociology, to explore the use of antimalarial medicines and intervention trials around antimalarial drug use, within the global health field. Through this work, within the context of clinical trials following Good Clinical Practice (GCP) guidelines [ 4 ], we have identified a number of challenges relating to the demands for evidence of quality and for quality assurance of qualitative research. The quality assurance procedures available for quantitative research, such as GCP training and auditing, are rooted in a positivist epistemology and are not easily translated to the reflexive, subjective nature of qualitative research and the interpretivist-constructionist epistemological position held by many social scientists, including the authors. Experiences of spatial distance between collaborators and those working in remote study field sites have also raised questions around how best to ensure that a qualitative research study is being conducted to high quality standards when the day-to-day research activity is unobservable by collaborators.

In response to the perceived need for the authors' qualitative studies to maintain and demonstrate quality in research processes and outcomes, we sought to identify existing guidance for quality assurance of qualitative research. In the absence of an established unified approach encapsulated in guidance format, we saw the need to review literature addressing the concept and practice of quality assurance of qualitative research, as a precursor to developing suitable guidance.

In this paper, we examine how quality assurance has been conceptualised and defined within qualitative paradigms. The specific objectives of the review were to, firstly, identify literature that expressly addresses the concept of quality assurance of qualitative research, and secondly, to identify common narratives across the existing discourses of quality assurance.

Search strategy

Keywords were identified from a preliminary review of methodological papers and textbooks on qualitative research, reflecting the concepts of 'quality assurance' and 'qualitative research', and all their relevant synonyms. The pool of keywords was augmented and refined iteratively as the search progressed and as the nature of the body of literature became apparent. Five electronic databases-Academic Search Complete, CINAHL Plus, IBSS, Medline and Web of Science-were searched systematically between October and December 2010, using combinations of the following keywords: "quality assurance", "quality assess*", "quality control*", "quality monitor*", "quality manage*, "audit*", "quality", "valid*", "rigo*r", "trustworth*", "legitima*", "authentic*", "strength", "power", "reliabil*", "accura*","thorough*", "credibil*", "fidelity", "authorit*", "integrity", "value", "worth*", "good*", "excellen*", "qualitative AND (research OR inquiry OR approach* OR method* OR paradigm OR epistemolog* OR study). Grey literature was also searched for using Google, and the key phrases "quality assurance" AND "qualitative research".

Several relevant journals- International Journal of Qualitative Methods, International Journal of Social Research Methodology and Social Science and Medicine - were hand searched for applicable papers using the same keywords. Finally, additional literature, in particular books and book chapters, was identified through snowballing techniques, both backwards by following references of eligible papers and forwards through citation chasing. At the point where no new references were identified from the above techniques, the decision was made to curtail the search and begin reviewing, reflecting the practical and time implications of adopting further search strategies.

Inclusion and exclusion criteria

Inclusion criteria were identified prior to the search, to include:

Methodological discussion papers, books or book chapters addressing qualitative research with explicit focus on issues of assuring quality.

Guidance or training documents (in 'grey literature') addressing quality assurance in qualitative research.

Excluded were:

Publications primarily addressing critical appraisal or evaluation of qualitative research for decision-making, reviews or publication. These topics were considered to be distinct from the activity of quality assurance which occurs before writing up and publication.

Publications focusing only on one or more specific qualitative methods or methodological approaches, for example grounded theory or focus groups; focusing on a single stage of the research process only, for example, data collection; or primarily addressing mixed methods of qualitative and quantitative research. It was agreed by the authors that these method-specific papers would not help inform narratives about the discourse of quality assurance, but may become useful at a later date when developing detailed guidance.

Publications not in the English language.

Review methodology

A meta-narrative approach was chosen for the reviewing and synthesis of the literature. This is a systematic method developed by Greenhalgh et al [ 9 ] to make sense of complex, conflicting and diverse sources of literature, interpreting the over-arching narratives across different research traditions and paradigms [ 9 , 10 ]. Within the meta-narrative approach, literature is mapped in terms of its paradigmatic and philosophical underpinnings, critically appraised and then synthesised by constructing narrative accounts of the contributions made by each perspective to the different dimensions of the topic [ 9 ]. Due to the discursive nature of the literature sought, representing different debates and philosophical traditions, the meta-narrative approach was deemed most appropriate for review and synthesis. A process of evaluating papers according to predefined quality criteria and using methods to minimise bias, as in traditional, Cochrane-style systematic reviewing, was not considered suitable or feasible to achieve the objectives.

Each paper was read twice by JR, summarised and analysed to determine the paper's academic tradition, the debates around quality assurance in qualitative research identified and discussed, the definition(s) used for 'quality' and the values underpinning this, and recommended methods or strategies for assuring quality in qualitative research. At the outset of the review, the authors attempted to identify the epistemological position of each paper and to use as a category by which to interpret conceptualisations of quality assurance. However, it emerged that fewer than half of the publications explicitly presented their epistemology; consequently, epistemological position was not used in the analytical approach to this review, but rather as contextual information for a paper, where present.

Following the appraisal of each paper individually, the literature was then grouped by academic disciplines, by epistemological position (where evident) and by recommendations. This grouping enabled the authors to identify narratives across the literature, and to interpret these in association with the research question. The narratives were developed thematically, following the same process used when conducting thematic analysis of qualitative data. First, the authors identified key idea units in each of the papers, then considered and grouped these ideas into broader cross-cutting themes and constructs. These themes, together with consideration of the epistemologies of the papers, were then used to develop overarching narratives emerging from the reviewed literature.

Search results

The above search strategy yielded 93 papers, of which 37 fulfilled the inclusion and exclusion criteria on reading the abstracts or introductory passages. Of the 56 papers rejected, 26 were papers specifically focused on the critical evaluation or appraisal of qualitative research for decision-making, reviews or publication. The majority of the others were rejected for focusing solely on guidance for a specific qualitative method or single stage of the research process, such as data analysis. Dates of publication ranged from 1994 to 2010. This relatively short and recent timeframe can perhaps be attributed in part to the recent history of publishing qualitative research within the health sciences. It was not until the mid-1990s that leading medical publications such as the British Medical Journal began including qualitative studies [ 11 , 12 ], reflecting an increasing acknowledgement of the value of qualitative research within the predominant evidence-based medicine model [ 13 , 14 ]. Within evidence-based medicine, the emphasis on assessment of quality of research is strong, and as such, may account for the timeframe in which consideration of assuring quality of qualitative research emerged.

Among the 37 papers accepted for inclusion in the review, a majority, 19, were from the fields of health, medical or nursing research [ 6 , 15 – 32 ]. 11 papers represented social science in broad terms, but most commonly from a largely sociological perspective [ 33 – 43 ]. Three papers came from education [ 44 – 46 ], two from communication studies [ 47 , 48 ] and one each from family planning [ 49 ] and social policy [ 50 ]. In terms of the types of literature sourced, there were 27 methodological discussion papers, 3 papers containing methodological discussion with one case study, two editorials, two methodology books, two guidance documents and one paper reporting primary research.

Appraisal of literature

Epistemological positions.

In only 10 publications were the authors' epistemological positions clearly identifiable, either explicitly stated or implied in their argument. Of these publications, five represented a postpositivist-realist position [ 16 , 24 , 39 , 44 , 47 ], and five represented an interpretive-constructionist position [ 17 , 21 , 25 , 34 , 38 ]; see Table 1 for further explanation of the authors' use of these terms. Many of the remaining publications appeared to reflect a postpositivist position due to the way in which authors distinguished qualitative research from positivist, quantitative research, and due to the frequent use of terminology derived from Lincoln and Guba's influential postpositivist criteria for quality [ 51 ].

Two strong narratives across the body of literature were interpreted through the review process, plus one other minor narrative.

Narrative 1: quality as assessment of output

A majority of the publications reviewed (n = 22) demonstrated, explicitly or implicitly, an evaluative perspective of quality assurance, linked to assessment of quality by the presence of certain indicators in the research output [ 15 , 16 , 18 – 22 , 24 , 26 , 27 , 30 , 32 , 36 , 39 , 40 , 42 , 44 , 45 , 47 – 50 ]. These publications were characterized by a 'post-hoc' approach whereby quality assurance was framed in terms of demonstrating that particular standards or criteria have been met in the research process. The publications in this narrative typically offered or referred to sets of criteria for research quality, listing specific methods or techniques deemed to be indicators of quality, and the documenting of which in the research output would be assurance of quality [ 15 , 18 – 20 , 24 , 26 , 32 , 39 , 42 , 47 , 48 , 50 ].

Theoretical perspectives of quality

Many of the authors addressing quality of qualitative research from the output perspective drew upon recent debates that juxtapose qualitative and quantitative research in efforts to increase its credibility as an epistemology. Several of the earlier publications from the 1990s discussed the context of an apparent lack of confidence in quality of qualitative research, particularly against the rising prominence of the evidence-based model within health and medical disciplines [ 16 , 19 , 27 ]. This contextual background links into the debate raised in a number of the publications around whether qualitative research should be judged by the same constructs and criteria of quality as quantitative research.

Many publications engaged directly with the discourse of the post-positivist movement of the mid-1980s and early 1990s to develop criteria of quality unique to qualitative research, recognizing that criteria rooted in the positivist tradition were inappropriate for qualitative work [ 18 , 20 , 24 , 26 , 39 , 44 , 47 , 49 , 50 ]. The post-positivist criteria developed by Lincoln and Guba [ 51 ], based around the construct of 'trustworthiness', were referenced frequently and appeared to be the basis upon which a number of authors made their recommendations for improving quality of qualitative research [ 18 , 26 , 39 , 47 , 50 ]. A number of publications explicitly drew on a post-positivist epistemology in their approach to quality of qualitative research, emphasising the need to ensure research presents a 'valid' and 'credible' account of the social reality [ 16 , 18 , 24 , 39 , 44 , 47 ]. In addition, a multitude of other, often rather abstract, constructs denoting quality were identified across the literature contributing to this narrative, including: 'rigour', 'validity', 'credibility', 'reliability', 'accuracy', 'relevance', 'transferability' 'representativeness', 'dependability' and more.

Methods of quality assurance

Checklists of quality criteria, or markers of 'best practice', were common within this output-focused narrative [ 15 , 16 , 19 , 20 , 24 , 32 , 39 , 42 , 47 , 48 ], with arguments for their value centring on a perceived need for standardised methods by which to determine quality in qualitative research [ 20 , 42 , 50 ]. Typically, these checklists comprised specific techniques and methods, the presence of which in qualitative research, was deemed to be an indicator of quality. Among the publications that did not proffer checklists by which to determine quality, methodological techniques signalling quality were also prominent among the authors' recommendations [ 26 , 40 , 44 , 49 ].

A wide range of techniques were referenced across the literature in this narrative as indicators of quality, but common to most publications were recommendations for the use of triangulation, member (or participant) validation of findings, peer review of findings, deviant or negative case analysis and multiple coders of data. Often these techniques were presented in the publications with little explanation of their theoretical underpinnings or in what circumstances they would be appropriate. Furthermore, there was little discussion within the narrative of the quality of these techniques themselves, and how to ensure they are conducted well.

Recognition of limitations

Two of the more recent papers in this review highlight debates of a more fundamental challenge around defining quality, linked to the challenges in defining the qualitative approach itself [ 26 , 32 ]. These papers, and others, reflect upon the plethora of different terminology and methods used in discourse around quality in qualitative research, as well as the numerous different checklists and criteria available to evaluate quality [ 20 , 32 , 40 , 42 ]. Some critique is offered of the inflexibility of fixed lists of criteria by which to determine quality, with authors emphasizing that standards, and the corresponding techniques by which to achieve them, should be selected in accordance with the epistemological position underpinning each research study [ 18 , 20 , 22 , 30 , 32 , 45 ]. However, in much of the literature there is little guidance around how to determine which constructs of quality are most applicable, and how to select the appropriate techniques for its demonstration.

Narrative 2: assuring quality of process

The second narrative identified was less prominent than the first, with fewer publications addressing the assurance of quality in terms of the research process (n = 13). Among these, several explicitly stated the need to consider how to assure quality through the research process, rather than merely evaluating it at output stage [ 6 , 17 , 31 , 33 , 34 , 37 , 38 , 43 ]. The other papers addressed aspects of good qualitative research or researcher that could be considered process rather than output-oriented, without explicitly defining them as quality assurance methods [ 23 , 25 , 35 , 41 , 46 ]. These included process-based methods such as recommending the use of field diaries for on-going self-reflection [ 25 ], and researcher-centred attributes such as an 'underlying methodological awareness' [ 46 ].

Conceptualisations of quality within the literature contributing to this narrative appeared most commonly to reflect a fundamental, internal set of values or principles indicative of the qualitative approach, rather than theoretical constructs such as 'validity' more traditionally linked to the positivist paradigm. These were often presented as principles to be understood and upheld by the research teams throughout the research process, from designing a study, through data collection to analysis and interpretation [ 17 , 31 , 34 , 37 , 38 ]. Six common principles were identified across the narrative: reflexivity of the researcher's position, assumptions and practice; transparency of decisions made and assumptions held; comprehensiveness of approach to the research question; responsibility towards decision-making acknowledged by the researcher; upholding good ethical practice throughout the research; and a systematic approach to designing, conducting and analyzing a study.

Of the four papers in this narrative which explicitly presented an epistemological position, all represented an interpretive/constructionist approach to qualitative research. These principles reflected the prevailing argument in this narrative that unthinking application of techniques or rules of method does not guarantee quality, but rather an understanding of and engagement with the values unique to qualitative paradigms are crucial for conducting quality research [ 6 , 25 , 31 ].

Critique of output-based approach

Within this process-focused narrative emerged a strong theme of critique of the approach to evaluating quality of qualitative research by the research output [ 6 , 17 , 25 , 31 , 33 , 35 , 37 , 38 , 43 , 46 ]. The principle argument underpinning this theme was that judging quality of research by its output does not help assure or manage quality in the process that leads up to it, but rather, the discussion of what constitutes quality should be maintained throughout the research [ 43 , 46 ]. Furthermore, several papers explicitly criticised the use of set criteria or standards against which to determine the quality of qualitative research [ 6 , 34 , 37 , 46 ], arguing that checklists are inappropriate as they may fail to accommodate the subjectivity and creativity of qualitative inquiry. As such, many studies may appear lacking or of poor quality against such criteria [ 46 ].

A number of authors within this narrative argued that checklists can promote the 'uncritical' use of techniques considered indicative of quality research, such as triangulation. Meeting specific criteria may not be a true indication of the quality of the activities or decisions made in the research process [ 37 , 43 ] and methodological techniques become relied upon as "technical fixes" [ 6 ] which do not automatically lead to good research practice or findings. Authors argued that the promotion of such checklists of may result in diminished researcher responsibility for their role in assuring quality throughout the research process [ 6 , 25 , 35 , 38 ], leading to a lack of methodological awareness, responsiveness and accountability [ 38 ].

Assuring quality of the research process

A number of activities were identified across this narrative to be used along the course of qualitative research to improve or assure its quality. They included the researcher conducting an audit or decision trail to document all decisions and interpretations made at each stage of the research [ 25 , 33 , 37 ]; on-going dynamic discussion of quality issues among the research team [ 46 ]; and developing reflexive field diaries in which researchers can explore and capture their own assumptions and biases [ 17 ]. Beyond these specific suggestions, however, were only broader, more conceptual recommendations without detailed guidance on exactly how they could be enacted. These included encouraging researchers to embrace their responsibility for decision making [ 38 ], understanding and applying a broad understanding of the rationale and assumptions behind qualitative research [ 6 ], and ensuring that the 'attitude' with which research is conducted, as well as the methods, are appropriate [ 37 ].

Although specific recommendations to assure quality were not present in all papers contributing to this narrative, there were some commonalities across each publication in the form of the principles or values that the authors identified as underpinning good quality qualitative research. Some of the publications made explicit reference to principles of good practice that should be appreciated and followed to help assure good quality qualitative research, including transparency, comprehensiveness, reflexivity, ethical practice and being systematic [ 6 , 25 , 35 , 37 ]. Across the other publications in this narrative, these principles emerged from definitions or constructs of quality [ 34 ], from recommendations of strategies to improve the research process [ 17 , 31 , 38 , 43 ], or through critiques of the output-focused approach to evaluating quality [ 33 ].

Minor narrative

Two papers did not contribute coherently to either of the two major narratives, but were similar in their approach towards addressing quality of qualitative research [ 28 , 29 ]. Both were methodological discussion papers which engaged with recent and ongoing debates around quality of qualitative research. The authors drew upon the plurality of views of quality within qualitative research, and linked it to the qualitative struggle to demonstrate credibility alongside quantitative research [ 29 ], and the contested nature of qualitative research itself [ 28 ].

The publications also shared critique of existing discourse around quality of qualitative research, but without presentation of alternative ways to assure it. Both papers critiqued the output-focused approach, conceptualising quality in terms of the demonstration of particular technical methods. However, neither paper offers a clear interpretation of the process of quality assurance; when and how it should be conducted, and what it should seek to achieve. One paper synthesised other literature and described abstract principles of qualitative research that indicate quality, but it was not clear whether these were principles were intended as guidance for the research process or standards against which to evaluate the output. Similarly, the second paper argues that quality cannot be assured by predetermined techniques, but does not offer more constructive guidance. Perhaps it can be said that these two papers encapsulate the difficulties that have been faced within the qualitative research field with defining quality and articulating appropriate ways to assure that it reflects the principles of the qualitative approach, which itself is contested.

Synthesis of the two major narratives

The key features of the two major narratives emerging from the review, assuring quality by output and assuring quality by process, have been captured in Table 2 . This table details the perspectives held by each approach, the context in which the narratives are situated, how quality is conceptualised, and examples from the literature of recommended ways in which to assure quality.

The literature reviewed showed a lack of consensus between qualitative research approaches about how to assure quality of research. This reflects past and on-going debates among qualitative researchers about how to define quality, and even the nature of qualitative research itself. The two main narratives that emerged from the reviewed literature reflected differing approaches to quality assurance and, underpinning these differing conceptualisations of quality in qualitative research.

Among the literature that directly discusses quality assurance in qualitative research, the most dominant narrative detected was that of an output-oriented approach. Within this narrative, quality is conceptualised in relation to theoretical constructs such as validity or rigour, derived from the positivist paradigm, and is demonstrated by the inclusion of certain recommended methodological techniques. By contrast, the second, process-oriented narrative presented conceptualisations of quality that were linked to principles or values considered inherent to the qualitative approach, to be understood and enacted throughout the research process. A third, minor narrative offered critique of current and recent discourses on assuring quality of qualitative research but did not appear to offer alternative ways by which to conceptualise or conduct quality assurance.

Strengths of the output-oriented approach for assuring quality of qualitative studies include the acceptability and credibility of this approach within the dominant positivist environment where decision-making is based on 'objective' criteria of quality [ 11 ]. Checklists equip those unfamiliar with qualitative research with the means to assess its quality [ 6 ]. In this way, qualitative research can become more widely accessible, accepted and integrated into decision-making. This has been demonstrated in the increasing presence of qualitative studies in leading medical research journals [ 11 , 12 ]. However, as argued by those contributing to the second narrative in this review, the following of check-lists does not equate with understanding of and commitment to the theoretical underpinnings of qualitative paradigms or what constitutes quality within the approach. The privileging of guidelines as a mechanism to demonstrate quality can mislead inexperienced qualitative researchers as to what constitutes good qualitative research. This runs the risk of reducing qualitative research to a limited set of methods, requiring little theoretical expertise [ 52 ] and diverting attention away from the analytic content of research unique to the qualitative approach [ 14 ]. Ultimately, one can argue that a solely output-oriented approach risks the values of qualitative research becoming skewed towards the demands of the positivist paradigm without retaining quality in the substance of the research process.

By contrast, strengths of the process-oriented approach include the ability of the researcher to address the quality of their research in relation to the core principles or values of qualitative research (see Table 2 ). For example, previous assumptions that incorporating participant-observation methods over an extended period of time in 'the field' constituted 'good' anthropology and an indicator of quality have been challenged on the basis that fieldwork as a method should not be conducted uncritically [ 53 ], without acknowledgement of other important steps, including exploring variability and contradiction [ 54 ], and being explicit about methodological choices made and the theoretical reasons behind them [ 55 ]. The core principles identified in this narrative also represent continuous, researcher-led activities, rather than externally-determined indicators such as validity, or end-points. Reflexivity, for example, is an active, iterative process [ 56 ], described as ' an attitude of attending systematically to the context of knowledge construction... at every step of the research process' [p484, 23]. As such, this approach emphasises the need to consider quality throughout the whole course of research, and locates the responsibility for enacting good qualitative research practice firmly in the lap of the researcher(s).

The question remains, however, as to how researchers can demonstrate to others that core principles have guided their research process. The paucity of guidelines among those advocating a process-oriented approach suggests these are either not possible or not desirable to disseminate. Guidelines, by their largely fixed nature, could be considered incompatible with flexible, pluralistic, qualitative research. Awareness and understanding of the fundamental principles of qualitative research (such as those six identified in this review) could be considered sufficient to ensure that researchers conduct the whole research process to a high standard. Indeed, it could be argued that this type of approach has been promoted within qualitative research fields beyond the health sciences for several decades, since debates around how to do 'good' qualitative research emerged publically [ 41 , 43 , 51 ]. However, the premises of this approach are challenged by increasing scrutiny over the accuracy and ethics of the generation of information through scientific activity [ 57 , 58 ]. Previous critiques of a post-hoc evaluation approach to quality, in favour of procedural mechanisms to ensure good research [ 43 ], have not responded to the demand in some research contexts, particularly in global health, for externally demonstrable quality assurance procedures.

The authors propose, therefore, that some form of guidelines may be possible and desirable, although in a less structured format than those representing a more positivistic paradigm and based on researcher-led principles of good practice rather than externally-determined constructs of quality such as validity. However, first it is important to acknowledge some of the limitations of our search and interpretations.

Limitations

The number of papers included in the review was relatively low. The search was limited to publications explicitly focused on 'quality assurance', and the inclusion criteria may have excluded relevant literature that uses different terminologies, particularly as this concept has not commonly been used within qualitative methods literature. As has been demonstrated in the narratives identified, approaches to quality assurance are linked closely to conceptualisations of quality, about which there is a much larger body of literature than was reviewed for this paper. The possibility of these publications being missed, along with other hard-to-find and grey literature, has implications for the robustness of the narratives identified.

This limitation is perhaps most evident in the lack of literature in this review identified from the field of anthropology. Debates around concepts such as validity and what constitutes 'knowledge' from research have long been of interest to anthropologists [ 55 ], but the absence of these in the publications which met the inclusion criteria raises questions about the search strategy used. Although the search strategy was revised iteratively during the search process to capture variations of quality assurance, anthropological references did not emerge. The choice was made not to pursue the search further for practical and time-related reasons, but also as we felt that limiting the review to quality assurance as originally described would be useful for understanding the literature that a researcher would likely encounter when exploring quality assurance of qualitative research. The lack of clear anthropological voice in this literature reflects the paucity of engagement with the theoretical basis of this discipline in the health sciences, unlike other social sciences such as sociology [ 52 ]. As such, anthropology's contributions to debates on qualitative research methods within health and medical research have been somewhat overlooked [ 59 ].

Hence, this review presents only a part of the discourse of assuring quality of qualitative research, but it does reflect the part that has dominated the fields of health and medical research. Although this review leaves some unanswered questions about defining and assuring quality across different qualitative disciplines, we believe it gives a valuable insight into the types of narratives a typical researcher would begin to engage with if coming from a global health research perspective.

Recommendations

The narratives emerging from this literature review indicate the challenges related to approaching quality assurance from a perspective shaped by the positivist fields of evidence-based medicine, but also the lack of clear, structured guidance based on the intrinsic principles of qualitative research. We recommend that the strengths of both the output-oriented and process-oriented narratives be brought together to create guidance that reflects core principles of qualitative research but also responds to expectations of the global health field for explicitly assured quality in research. The fundamental principles characterising qualitative research, such as the six presented in Table 2 , offer the basis of an approach to assuring quality that is reflexive of and appropriate to the specific values of qualitative research.

The next step in developing guidance should focus on identifying practical and specific advice to researchers as to how to engage with these principles and demonstrate enactment of the principles at each stage of the research process while being wary of promoting unthinking use of 'technical fixes' [ 6 ]. We recommend the development of a framework that helps researchers to identify their core principles, appropriate for their epistemological and methodological approach, and ways to demonstrate that these have been upheld throughout the research process. Current generic quality assurance activities, such as the use of standard operating procedures (SOPs) and monitoring visits could be attuned to the principles of the qualitative research being undertaken through an approach that demonstrates quality without constraining the research or compromising core principles. The development of such a framework should be undertaken in a collaborative way between researchers and field teams undertaking qualitative research in practice. We propose that this framework be flexible enough to accommodate different qualitative methodologies without dictating essential activities for promoting quality. Unlike previous guidance, we propose the framework should also respond to different demands from multi-disciplinary research teams and from external, positivist, audiences for evidence of quality assurance procedures, as may be faced, for example, in the field of global health research. This review has also highlighted the challenges of accessing a broad range of literature from across different social science disciplines (in particular anthropology) when conducting searches using standard approaches adopted in the health sciences. Further consideration should be taken as to how best to encourage wider search parameters, familiarisation with different sources of literature and greater acceptance of non-traditional disciplinary perspectives within health and medical literature reviews.

Within the context of global health research, there is an increasing demand for the qualitative research field to move forwards in developing and establishing coherent mechanisms for quality assurance of qualitative research. The findings of this review have helped to clarify ways in which quality assurance has been conceptualised, and indicates a promising direction in which to take the next steps in this process. Yet, it also raises broader questions around how quality is conceptualised in relation to qualitative research, and how different qualitative disciplines and paradigms are represented in debates around the use of qualitative methods in health and medical research. We recommend the development of a flexible framework to help qualitative researchers to define, apply and demonstrate principles of quality in their research.

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The authors would like to acknowledge with gratitude the input and insights of Denise Allen in developing the discussion and recommendations of this paper, and in particular, offering an important anthropological voice. JR, JK, PM and CC have full salary support and NE and EA have partial salary support from the ACT Consortium, which is funded through a grant from the Bill & Melinda Gates Foundation to the London School of Hygiene and Tropical Medicine.

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Nkoli Ezumah

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Peter Mangesho

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JR helped with the design of the review, searched for and reviewed the literature and wrote the first draft of the manuscript. JK, NE, PM and EA contributed to the interpretation of the results and the writing the manuscript. CC conceived of the review and helped with its design, interpretation of results and writing the manuscript. All authors read and approved the final manuscript.

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Reynolds, J., Kizito, J., Ezumah, N. et al. Quality assurance of qualitative research: a review of the discourse. Health Res Policy Sys 9 , 43 (2011). https://doi.org/10.1186/1478-4505-9-43

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Quality assurance in allied healthcare education: A narrative review

Jithin k. sreedharan.

1 Department of Respiratory Care, Prince Sultan Military College of Health Sciences, Dhahran, Kingdom of Saudi Arabia

Arun Vijay Subbarayalu

2 Quality Assurance Department, Deanship of Quality and Academic Accreditation, Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia

Saad M. AlRabeeah

Manjush karthika.

3 Department of Respiratory Care, Khawarizmi International College, Abu Dhabi, UAE

5 Indian Academy of Respiratory Care, IARC, Karnataka, India

6 Srinivas Institute of Medical Sciences and Research Centre, Srinivas University, India

Madhuragauri Shevade

4 Symbiosis Center for Research and Innovation, Faculty of Health Sciences, Symbiosis International University, Pune

Musallam Abdullah Al Nasser

Abdullah s. alqahtani, introduction.

There is no standard methodology for outlining the intricacies of allied healthcare education (AHE) or its quality. The profound misconception is that quality assurance (QA) in AHE is used on a “voluntary” basis. Given the absence of statutory regulatory mechanisms such as accreditation, validation, and audit by the peripheral agencies concerning QA, adoption of QA measures in AHE is not consistent, and it results in producing a subpar allied health workforce. This paper analyzes the need to include QA measures as an essential domain in evaluating the effectiveness of allied health professional education programs.

A large database search was performed using pertinent terms, and a blueprint was developed for a meticulous literature review published between 2015 and 2021. Five hundred eighty-two articles were found and screened; a critical appraisal was performed for 22 peer-reviewed articles for relevant information.

The literature review identified the need to use academic domains such as leadership, planning, delivery, and feedback as QA criteria to evaluate the efficiency of education and training in allied health professional education programs. Instructors and facilitators for specific knowledge and skill development and a description of their roles should also be used in QA evaluation.

Resources for effective learning and teaching in the allied healthcare domain are limited. This review highlights the significant need to include a QA system in AHE, considering the pivotal role of these students in supporting humankind, now and in the future. The findings contribute to the research by providing essential insights into current trends and focusing on existing research in AHE quality.

INTRODUCTION

Allied healthcare is an umbrella term encompassing various healthcare disciplines and supportive services. The professional classification is based on specific practice areas, and it varies among different countries, governmental healthcare bodies, industries, healthcare settings, and training institutions [ 1 ]. Allied healthcare professionals (AHPs) diagnose, treat, and rehabilitate patients and conduct disease-prevention activities or healthcare education based on scientific principles and evidence-based measures [ 2 ]. The allied healthcare professions include respiratory therapy, radiology, occupational therapy, podiatry, physiotherapy, social work, medical laboratory technology, imaging technology, and other authorized professions that support quality healthcare services to individuals suffering from certain illnesses [ 1 , 2 ].

The responsibilities of AHPs include the accurate assessment of a patient’s health conditions and the provision of appropriate medication and care. However, the healthcare sector is facing specific challenges, such as failure to address growing consumerism among patients, slow adoption of information technology, workforce shortage, and discontent, which create barriers to providing adequate healthcare services to patients [ 3 ]. Standardized assessment procedures and accreditation benchmarks have been set by several international healthcare and quality organizations such as the World Healthcare Organization (WHO), Joint Commission International (JCI), and Global Alliance for Improved Nutrition (GAIN) to lessen the healthcare sector’s complexities. These organizations also emphasized the support of allied healthcare services to ensure that quality care is provided to patients. A global survey conducted by the WHO reported that approximately 30% of total health workers are AHPs [ 4 ]. Although respiratory therapy, occupational therapy, speech therapy, and physiotherapy are regarded as therapeutically oriented professions, clinical lab and imaging technology professionals are more involved in diagnostic services. The activities in allied healthcare are often interrelated and overlapped role functions are observed as well [ 5 ].

The role of any AHP is to optimize functional capacity to provide optimal healthcare services to patients, thereby improving their quality of life. In certain countries, allied healthcare services are provided by professionals who are not in the medical profession but provide care. To ensure quality healthcare is provided to a patient, the AHP adopts different roles and tasks. Quality assurance (QA) in healthcare delivery shows similar constructs to healthcare education [ 6 ]. Here, the term QA is defined as the fragment of quality management focused on providing confidence that required quality will be accomplished [ 7 ]. Further focusing on the higher education aspects, it is a combined process by which the university as an academic organization confirms that the quality of the educational process is sustained to the standards it has set itself [ 8 ]. Also, it is observed as a comprehensive term covering all the policies, processes, and actions through which the quality of higher education is sustained and improved [ 9 ]. QA in higher education is a process of developing stakeholder confidence that provision (input, processes, and outcomes) meets expectations or measures up to threshold minimum requirements [ 10 ]. In terms of QA, there are significant interrelated overlaps in both healthcare delivery and healthcare education, whereas both share the common goal of providing adequate service to the public. In healthcare education, QA is associated with upholding, improving, and comparing the essential training standards that an AHP receives in medical institutions, ensuring that those who qualify to earn their degrees and licenses from institutions are competent enough to provide healthcare services to the patients they encounter [ 11 ].

Different factors, such as grants, information, progress reviews, and others, determine the inclusion of QA in allied healthcare education (AHE). For example, strategies to enhance research capacity building for AHPs will help to evaluate and demonstrate the quality and efficiency of the healthcare services being provided [ 12 ]. Additionally, activity-specific information or decisions by policy makers also sometimes influence how QA is incorporated into healthcare delivery and the healthcare education system. For example, specific grants are awarded to continue a research process with a proven record of success in the past, thus acquiring even more valuable information and ensuring successful outcomes for the learners. Apart from this, individual research activities are also conducted by learners to enhance their learning and provide possible solutions to numerous problems identified by others [ 13 ]. Based on the above, it is witnessed that quality AHE is essential to increasing the proficiency of AHPs so they are appropriately equipped to provide quality services to their patients.

The current research examines the role of QA in AHE to gain valuable insights into the development of well-rounded professionals at the end of course tenure. The methods used and lessons learned in conducting document reviews of medical and allied health curricula, critical steps in curriculum evaluation, and so forth are assimilated to better comprehend AHPs and their contribution to the healthcare sector. This comprehensive narrative review was performed to analyze the need to include essential QA measures when evaluating the effectiveness of allied health education programs.

Search strategy

This study identified papers focusing on QA in AHE by searching online literature in databases such as Google Scholar, ProQuest, Science Direct, Scopus, and Web of Science. This search was restricted to papers published between 2015 and 2021 and written in English. The search timeline was set to begin from 2015 because the organization of International Chief Health Professions Officers (ICHPO) and by the Health and Care Professions Council (HCPC) classified allied health care professions consecutively in the year 2012 and 2014 [ 14 , 15 ]. Further, this study reviewed the reference lists of the included papers for analysis to obtain additional relevant papers.

Selection criteria

A descriptive research design was used to gain valuable facts related to methods used and lessons learned in conducting document reviews of medical and allied health curricula by introducing a curriculum evaluation system. The secondary method of data collection was data collected from secondary resources, such as experimental studies, observational studies, case studies, commentaries, concept papers, and validation studies. Original articles, review articles, and conceptual papers were selected and included in the review and the articles not matching the specific keywords, conference proceedings, abstracts, editorial materials, and book chapters were excluded. Research papers that were not published between 2015 and 2021 were also excluded from the current review, as they did not match the year selection criteria of the study. The data extraction focused on details of author and year of publication, aim and methodology, applied tools and techniques used, and findings. The researchers then extracted key findings from each study and filled them into a predesigned data extraction sheet.

The search was initiated by selecting the keywords “quality assurance,” “education,” “allied healthcare profession,” and “allied healthcare education,” which matched the current research topic. About 582 research papers, articles, scholarly papers, and journals were selected at this stage. In the next step, during the title screening process, the selected research sources were sorted and the duplicated search results removed, leaving 70 articles; of those 10 were not published within the specific period in the search criteria (between 2015 and 2021) and were removed, leaving 60 articles for further scrutiny. Next, 11 abstracts and 27 articles (including non-educational interventions, conference proceedings, book chapters, or editorial materials) were removed. Finally, 22 articles were selected and included for analysis in this study ( Figure 1 ). Data were consolidated by means of thematic analysis as study designs were heterogeneous in nature, so a meta-analysis was not feasible. The principal investigator extracted key texts and potential new lines of inquiry and interpreted the findings, thereby drawing on the combined insights of the selected articles to identify common themes that emerged from comparison across chosen research articles. The principal investigator then discussed the emerged themes ( n = 10) with other team members with a broader methodological and open disclosure issues perspective. To enhance the meticulousness of the findings and curtail researcher bias, analysis was discussed among members of the research team. While finalizing the 10 major themes, efforts were taken to conclude the findings from the extracted literature without the impact of each team member’s professional background, experiences, and prior assumptions.

Flowchart depicting the article retrieving process.

To identify the current trends in the literature about QA in AHE, this section presents the results of the organized literature review. Out of the 70 articles identified in an electronic database search, 22 articles met our eligibility and inclusion criteria ( Table 1 ) and were analyzed.

Summary of reviewed articles with details regarding quality assurance in allied healthcare education

QA is an important aspect to be considered for bringing improvements in AHE so that the standard of quality care provided by the AHPs graduating from the AHE institutions is improved [ 11 ]. The primary focus is to give quality care to the patients and adopt approaches to deliver quality service to the whole healthcare sector. By including QA in AHE, AHPs’ competency will improve, leading to high-quality healthcare services being provided [ 16 ]. A standard QA system used by all educational programs will ensure graduates of these programs are able to provide quality care to patients in their chosen field. An earlier study highlighted that the allied health educational institutions must adopt advanced technology, such as data intelligence and simulation to increase the learner’s capability to identify patient issues and provide treatment solutions against them [ 19 ]. Additionally, the allied healthcare educational institutions shall introduce generic standards by forming inter or intra-institutional steering committees, to strengthen quality regulations in the absence of statutory bodies in their respective region. Adopting different QA processes helps to increase the capabilities of the professionals and allows them to provide quality services to the patients by adopting a patient-centric approach [ 24 ].

Our review identified that there is a paucity of literature supporting the need for QA in the AHE [ 24 ]. This reflects the need for benchmark studies on existing AHE curricula available globally, to gain valuable insights into QA in AHE and its regulations [ 12 , 37 ]. QA in AHE ensures that the best learning is available to learners to provide evidence-based quality services to their patients. By acquiring quality education from the healthcare educational organization, the AHPs will follow and implement the QA principles in their service provision attitude [ 36 ]. It includes considering patients’ experiences as the core motivating learning and service provision [ 33 ]. It also emphasizes maintaining professional integrity to acquire inter-professional learning by sharing professional experiences. Based on the review of literature, 10 major themes emerged depicting the role of QA in AHE.

1. Patient care and treatment process

AHPs must be experts in different health support systems to assist and execute their responsibilities as sterile processing technicians, anesthesia technicians and technologists, materials management personnel, and others. The AHPs can also work as support staff that would execute responsibilities related to administrative and clerical staff, surgery schedulers, environmental services personnel, and others [ 31 ]. The AHPs could provide quality patient care and treatment processes after diagnosing the symptoms [ 25 ].

2. Guidelines/model for healthcare education

As per the standards and guidelines provided by the Commission on Accreditation of Allied Healthcare Education Program, standards and protocols are to be followed in every step of the program management [ 38 ]. For instance, the sponsoring of the institute must be through an accredited agency so that supervised clinical practice can be provided, as the programs provided for healthcare education must be affiliated with a community, college, or university [ 32 ]. The personnel administration activities are to be conducted by adopting adequate management and leadership attributes [ 39 ]. The faculty must be trained in providing instruction in a didactic format to develop and enhance the student’s clinical skills. Additionally, the Clinical Preceptors must provide clinical assistance to the learners about course intricacies and to ensure there is an accurate assessment of learner capabilities [ 22 , 30 , 31 ].

3. Professional development for teaching staff in AHE

Professional development standards for teaching staff in AHE include acquiring learning, education, and training in diverse aspects such as narrative medicine initiative, organizational effectiveness, professional development series, pastoral care, nutrition, and social work [ 35 ]. Apart from this, many well-known universities are organizing review courses, conferences, and webinars to provide professional development opportunities to the teaching staff in AHE [ 16 , 17 ].

4. Quality of learning

Quality learning can be defined as a purposeful learning process in which all the aspirants and learners are provided with enriched and standard learning to enhance their skills and competencies. Quality learning describes the satisfaction of the learner with the learning procedure [ 25 ]. The AHE organizations emphasize recruiting highly skilled, talented, and experienced educators to ensure that quality learning is provided to the students [ 34 ]. It also includes providing adequate infrastructure and other essential equipment; hence, the learners can practice their theoretical concepts with practical instruments in the laboratories [ 23 , 33 ].

5. Performance indicators in QA

In allied healthcare, performance indicators in QA are associated with effectiveness, access, safety, efficiency, quality, appropriateness, cost, equity, patient experience, outcomes of care, continuity, acceptability, reporting, and others [ 12 ]. Each indicator is associated with specific customer satisfaction and experience that provides valuable information regarding QA in allied healthcare [ 30 ]. The parameters for QA may vary in different countries. For example, QA in healthcare in the Netherlands is mainly associated with national regulatory boards, healthcare insurers, and consumer expectations, whereas, in Scotland, performance indicators are mainly linked with the Quality Measurement Framework and 12 quality outcome indicators that do not have specific targets [ 21 ].

6. Service quality in healthcare

Service quality in healthcare has an essential role in differentiating between services by identifying the customers’ satisfaction levels in the hospital settings [ 22 ]. Service quality is defined as the difference between expected and received services from the customer’s perspective. Therefore, service quality occurs when the patients’ expectations are met. The service quality of the institutions offering AHE should also be periodically assessed from the students’ perspectives, thereby enhancing higher education quality [ 24 ]. Establishing a quality framework will contribute to specific AH performance assessments to advance the delivery and appropriateness of AH services [ 18 ]. This will also contribute to healthier implementation of evidence-based findings, more persistent attention to patient choices, and enhanced health outcomes [ 19 , 40 ].

7. External bodies (accreditation)

Some of the external accreditation bodies that certify the AHE include the Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM), the American Occupational Therapy Association (AOTA), the Accreditation Council for Pharmacy Education (ACPE), and Accrediting Bureau of Health Education Schools (ABHES). ACAOM offers awards to the learners, professionals, and experts who have completed their Acupuncture and Oriental Medicine training. AOTA provides accreditation to occupational therapy practices, education, and research. ACPE serves as the accrediting review committee for the organizations that offer courses belonging to the pharmacy, technician education, and medical training programs. ABHES provides specialized and institutional accreditation to the health education programs offered under U.S. Secretary of Education Programs [ 29 ].

8. Allied healthcare education

The duration of AHE programs varies from 2 to 4.5 years. Allied healthcare students are provided with education and training in various specific health-related domains such as respiratory care, palliative care, dental care, radiology, and others. By pursuing AHE, learning and expertise are acquired in research, laboratories, or health-related subjects [ 24 ]. Applying for interprofessional educational programs in AHE colleges and universities is desirable to boost the student’s comprehension of their own purpose, and the duties of other health professionals, which will persuade AHPs to play an influential role in the community [ 40 ].

9. Training for AHPs

The training for AHPs includes several stages depending on the chosen specialization and university [ 17 ]. For example, the training module that Gerthill Allied Health School offers teaches the students about Symptom Control and Disease Management. Once the learners acquire expertise in this section, they are moved to the next module section, i.e., nutrition monitoring, followed by assisting patients with activities of daily living. When the learners acquire learning in these two segments, they are provided extensive learning about care practices and techniques—age-specific training, body mechanics, and monitoring patients’ vital signs. After acquiring learning in these sections, the learners are provided training in nursing care—basic and complex care and safety practices in patient care. Finally, when learners acquire expertise in these sections, they learn about communication enhancement and basic life support [ 31 ].

10. Challenges facing AHE

The AHE institutions face significant challenges such as the lack of skilled professionals responsible for providing quality knowledge, learning, and training to the aspirants [ 23 ]. Curriculum issues are also observed as there is insufficient time for training to be allocated to every clinician’s technique and terminology. Additionally, collaboration issues are faced between the curriculum planner, expert teaching technique, and learning abilities of the allied healthcare learners. Tools and simulator issues also plague the learners because there can be gaps (if not discrepancies) between theoretical learning and practical usage. Resource shortage is another major issue faced while providing quality AHE to the aspirants [ 26 – 28 ].

LIMITATIONS

Limitations are present as grey literature, conference proceedings, book chapters, and abstracts were excluded, which means few relevant kinds of literature may have been forfeited. Furthermore, in the current review, the quality of the studies included was very modest, a handful of studies had poor descriptions of the participants and methodology and the interventions associated with the educational strategy. Some studies used very weak designs, therefore comparison amongst different groups was not possible. These inadequacies may have restricted the value of the outcomes, and henceforth the review findings should be interpreted with pensiveness. However, it is recommended to adopt a scoring system used by Qasem et al. [ 41 ] in future studies to assess the quality of the observed studies that indicate the capability of those studies to give answers to the research questions. Using this system, a score is provided based on how approximately the answers matched the research questions [ 41 ].

Based on the above facts, it is inferred that QA is one of the critical aspects to consider while providing education to AHPs. The consistent inclusion of QA in the AHE curriculum would allow all professionals to increase their abilities and guarantee that those would adopt more patient-centric approaches to providing quality service to their patients. This study examined those challenges such as the lack of adequate expertise and financial assistance faced by the AHE institutions, creating numerous issues in the adoption of QA systems within the organization. Under such circumstances, the governing, private, and public agencies must provide adequate training and financial assistance to strengthen the implementation of the QA system within AHE. It is concluded that by adopting a QA system within AHE, the competencies of the AHPs will be improved, allowing them to provide quality services to the patients as per the recognized standards and benchmarks in the healthcare industry. As a result of these higher competencies and greater confidence, AHPs everywhere will experience and enjoy enhancing their abilities to serve their patients better—diagnosing disease, developing trust, and bringing proper health to those who need it.

ACKNOWLEDGEMENTS

The authors deliver their heartful thanks to Musallam Al Nasser and Amal Somali (Program Quality Team Members, Respiratory Care Program, Prince Sultan Military College of Health Sciences, Dhahran) for sharing their valuable insights and constant motivation to prepare this article. Also, their support and editorial advice are valued while preparing the protocol for this review. Further, the authors expressed their gratitude to the Faculty and Staff of the RC program, Deanship, Vice Deanships at Prince Sultan Military College of Health Sciences for their continuous support.

DISCLOUSRES

Contributors.

The research team consists of an academician ( N = 1), AHPs ( N = 2), a quality management expert ( N = 2), and an administrator ( N = 1) belonging to the allied healthcare profession. The principal author is involved in the conceptualization of the research and carries out writing and editing tasks. Further, two co-authors are involved in identifying and collecting all the relevant literature based on the keywords chosen (MAN, MK). Then, three authors (AVS, AAQ, and SAR) screened the collected literature to ensure whether it fulfills the inclusion criteria and saved it for further analysis. The principal investigator extracted key texts and potential new lines of inquiry and interpreted the findings, thereby drawing on the combined insights of those selected articles to identify common themes that emerged from comparison across chosen research articles. Finally, the principal investigator discussed the emerged themes ( n = 10) with other team members with a broader methodological and open disclosure issues perspective. While finalizing the 10 major themes, efforts are taken to conclude the findings from the extracted literature without the impact of each team member’s professional background, experiences, and prior assumptions.

Conflict of interest

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding sources

The authors received no financial support for the research, authorship, and/or publication of this article.

Ethical approval

Not required for this article type.

Author contributions

JKS conceptualized and designed the review. JKS & AVS undertook the search, screening, data extraction, and analysis processes with support from SAR, MK, MGS, ASQ, MAN, and AAS. AVS performed the objective analysis and scrutiny. JKS wrote the first draft of the review, and all authors contributed to the writing of the final manuscript. All authors have agreed on the final version.

Quality Assurance in Research

In research contexts, quality assurance (QA) refers to strategies and policies for ensuring that data integrity, quality, and reliability are maintained at every stage of the project. This includes strategies for preventing errors from entering the datasets, taking precautions before data is collected, and establishing procedures while data is used in a study. 

Quality assurance is important for many reasons. The most obvious is that the whole point of research projects is to produce reliable data that yield rigorous and reproducible research results. There are other important factors as well. Internal Review Boards (IRBs), funding agencies, and other organizations that oversee research activity often require quality assurance procedures be implemented into project workflows to ensure that all policies are followed and that disbursed funds are going to well-organized and executed projects. There are also compliance issues in which research projects must be able to establish that data collection and analysis followed all protocols for human and animal subjects, privacy rules and regulations such as HIPAA and FERPA, and other safeguards that guarantee research projects are conducted in a responsible manner. In some instances, administrative audits are conducted to evaluate your project’s quality assurance and policy compliance. 

Having quality assurance practices in place helps your project compliance and also helps evaluating your own research and data management practices to produce the best results possible. 

Here are some steps you can take to promote quality assurance in your research:

Establishing clear data normalization protocols: Normalizing the data you record can have substantial impacts in all aspects of your research project. Normalizing means standardizing all the features and categories of data so that everyone working on the project has a clear sense for how to record it as it’s collected. Planning ahead and having clearly defined protocols for data collection before beginning the collection process means that all data that is part of the project adheres to the same standards. 

Using consistent data formats and measurement standards: Using consistent format and measurement standards is part of the normalization process, and often you can find controlled vocabularies or ontologies that will provide established structural and definitional guidelines for your data based on your discipline. This will result in consistency in your data, not only within your own project, but also for others who may want to use it later on for further analysis or evaluation. 

Rigorous data handling and analysis procedures: This is one of the most crucial components of quality assurance because data collection introduces significant opportunities for human error to undermine the integrity of data. At every stage of data collection in which a researcher records, transforms, or analyzes data, there is the potential for simple mistakes. Identifying those stages in data collection where errors are more likely to occur, and putting preventative measures in place can minimize those errors. Simple things such as establishing data and measurement formats can help, but also the tools you select for data collection can have significant impacts. 

Select data collection and storage tools that promote data consistency: Spreadsheets for instance, are notorious for making it easy for errors to occur in data collection because they offer few controls on how it’s entered. Other tools such as databases or fillable forms provide features that allow you to control how data is entered. If you have a large team of researchers collecting data from the field or in varying contexts it’s easy for inconsistencies to arise. If the tools the researchers are using require consistency, you can be more successful at maintaining data integrity at every stage of handling data.  

Metadata documenting how data was collected, recorded, and processed: Documenting how your data was handled throughout your project is good practice for a host of reasons, and it’s particularly helpful for maintaining data integrity. Making your data handling procedures explicit and formalized in the way metadata demands requires, first, that you consider these issues carefully. It also clarifies any ambiguities in your workflow so that a researcher during the project or making use of your research outputs at a later date could identify when the data is correct and where errors may have occurred.

Research staff training: Perhaps the most important thing you can do to produce consistent and reliable data is to make sure everyone working on the research project, from seasoned researchers to graduate and undergraduate project team members, have proper training in all the data collection and analysis procedures. Having everyone on the same page means that you can be confident that each person working on the project knows how their data handling tasks contribute to the overall project’s data quality goals.

Want to learn more about this topic? Check out the following resources: 

The UK Data Service provides detailed information on establishing quality assurance strategies in your research. 

DataOne provides guidance on how to craft a quality assurance plan that will allow you to “think systematically” as you put these protocols in place.

Research on Software Quality Assurance Based on Software Quality Standards and Technology Management

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