Ethical Issues of Qualitative Research

This chapter explores ethics in qualitative research. It outlines the broad ethical principles that underpin good research and the aspects of ethical practice that qualitative researchers are especially likely to need to consider when designing, conducting, and disseminating their research. The chapter explains ways of thinking about research ethics, beginning with some overarching philosophical principles, before moving on to discuss situational and relational aspects of ethical research practice. Formal codes of ethics, and practice guidelines developed by professional bodies and institutions, highlight three core concerns that researchers working with human subjects should attend to, namely: informed consent, confidentiality, and anonymity. The chapter also outlines how these apply to qualitative research. It also explores ethics associated with doing research. Although the requirements of research ethical review processes described in the chapter can help the researcher avoid many ethical issues in advance, ethical questions and dilemmas can arise during the conduct of a project.

The purpose of this paper is discussing the main issues in conceptualizing reliability and validity between qualitative and quantitative research approaches. The researcher examined the arguments about validity and reliability in inquiry methodology and identified three main debates primarily in qualitative research. The first one was about qualitative inquirers’ limited emphasis on the data collection process to increase the robustness of their research efforts. Most of the strategies in qualitative research (e.g. peer debriefing, member check, audit trail) are used after completing the data collection procedures. Another important discussion in social inquiry was about what valid research means in qualitative paradigm. There are various interpretations of what validity is in qualitative research. This is due to epistemological grounds of qualitative research. Qualitative research does not accept a single truth. Reality is not fixed in qualitative research. It is concerned with cooperation of the multiple constructed realities to reach the contextual truth. The third debate reported in the literature was the discussion about reliability in qualitative research. It is evident that replication of any qualitative methods will not release the same results due to changing contextual conditions. Even though reliability has a long history in inquiry methodology discussions, some qualitative inquirers claim that reliability is not an appropriate concept for qualitative inquiry.

Ethical Issues in Qualitative Research

The global medical and nursing research community has increasingly embraced qualitative research approaches, recognizing the additional benefits they provide to the investigation process. Qualitative research explores the intricate details of human behavior, attitudes, and experiences, emphasizing the exploration of nuances and context. Ensuring trustworthiness is crucial in establishing the credibility and reliability of qualitative findings. This includes elements such as credibility, transferability, dependability, and confirmability. Several papers have discussed concerns regarding the rigor of qualitative health services research and have provided guidelines and checklists for publishing and conducting qualitative research. The key criteria for ensuring the quality of qualitative research include credibility, achieved through extended involvement, persistent observation, and triangulation; transferability, achieved through comprehensive and detailed explanations; dependability, achieved through rigorous documentation and the creation of an audit trail; and confirmability, achieved through peer debriefing, member checking, and reflexive journaling. Establishing reliability in qualitative research is crucial for influencing future research paths and advancing cumulative knowledge. Trustworthy qualitative research findings are also important for informing policy decisions and improving the provision of services in various fields. While qualitative research has limitations, such as subjectivity and resource constraints, the methodical application of measures to ensure trustworthiness greatly enhances the precision and reliability of qualitative research. These measures also encourage transparency and critical evaluation by the scholarly community.

In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community.

Ethical issues in research are especially important when working with confined populations such as prisoners. One method that has been proposed to assist the decision‐making process is the use of a risk/benefit model. The informed estimation of the probable risks and potential benefits of any given research project should be used to determine the ethical justifiability of conducting the research. The present article enumerates the variables relevant to a risk/benefit analysis when conducting research in a prison setting. Also, the risks of undue influence and the limits of confidentiality will be discussed. Finally, the appropriate use of informed consent will be discussed as a safeguard against these risks.

Chapters 4 and 5 have already illustrated a range of methodological difficulties in studies with children of different ages. In particular, the use of different de-contextualised tests and tasks was highlighted as a potential risk in research. Methodological challenges are closely linked to ethical issues in child research and this chapter will aim to highlight some common difficulties and possible solutions.

We evaluate the use of data obtained by illicit means against a broad set of ethical and legal issues. Our analysis covers both the direct collection, and secondary uses of, data obtained via illicit means such as exploiting a vulnerability, or unauthorized disclosure. We extract ethical principles from existing advice and guidance and analyse how they have been applied within more than 20 recent peer reviewed papers that deal with illicitly obtained datasets. We find that existing advice and guidance does not address all of the problems that researchers have faced and explain how the papers tackle ethical issues inconsistently, and sometimes not at all. Our analysis reveals not only a lack of application of safeguards but also that legitimate ethical justifications for research are being overlooked. In many cases positive benefits, as well as potential harms, remain entirely unidentified. Few papers record explicit Research Ethics Board (REB) approval for the activity that is described and the justifications given for exemption suggest deficiencies in the REB process.

Ethical conduct of research involving humans has gained relevance and importance over the years with the expansion of research beyond boundaries of traditional medical and clinical research into a multiplicity of disciplines with human participation. Human research is regarded as research conducted on or with or about people, or their tissues or cells or data obtained from them. Historically, it is stated that the Greek Philosopher Aristotle (384-322 BCE) was probably the first to discuss principles of ethics ‘by studying and offering criteria to assess human behaviour’. It is believed that he taught a course of ethics at the Lyceum during his mature years which was based on the many treatises he wrote on the subject. Increased attention to ethics in human research started after the Second World War following the judgment of the International Military Tribunal which also included 10 principles of permissible medical experiments which have since then been referred to as the Nuremburg Code (1949). Later discussions by the World Medical Assembly of the Code led to the adoption of the Helsinki Declaration (1964) which has been revised many times since then. The Council for International Organizations of Medical Sciences (CIOMS) which in association with the World Health Organizations (WHO) undertook its work on ethics in biomedical research in late 1970s. It has published an updated version with a wider scope of coverage titled ‘International Ethical Guidelines for Health-Related Research Involving Humans’ (2016). Close cooperation with World Medical Assembly has ensured that the guidelines are closely aligned to the Helsinki Declaration. Traditionally, ethics has received much attention both in clinical practice and in health research. Faculties of Medicine were the first to establish ethics review boards and ethics review committees in Sri Lanka to undertake review of research proposals with human participation for ethical aspects and issues and granting approval. The primary aim is to safeguard the interests and right of participants of research and prevent their exploitation. There is no doubt about the value of health research and the benefits it has brought and will continue to bring to ensure health, wellbeing, safety and quality of life of people. Most research on human participants is simple, observational, descriptive and non-invasive and the ethical issues though may be minimal, still needs explicit attention and review by an ethics review board before approval. The more complex research where human participants are subject to ‘experimentation’ or ‘interventions’ has many ethical issues that need to assessed by recognized ethics review committees with experience and capability to do so. If a new drug, a new vaccine, medicinal product, device, or equipment not already in use by people is to be tested on humans before being granted approval for use in day-to-day life by the appropriate authority, the researcher should adopt recommended procedures, regulations and registration mechanism prescribed. In Sri Lanka any interventional research requires applying and obtaining approval of ethics review committees that have been gazetted under the National Medicines Regulatory Authority (NMRA) as being approved by name to undertake ethics review. The interventional research should also be registered with the Sri Lanka Clinical Trials Registry. Both these need to be submitted to the Clinical Trials Evaluation Committee of the NMRA in order to be evaluated prior to being granted approval and registration. These approvals and registrations are also requested by peer reviewed high impact journals to consider such research manuscripts for publication. There are certain values which provides the framework for principles guiding formulation of research proposals and ethics of research. These include and are not limited to respect, integrity, justice, beneficence and research merit. It is implicit in research that badly designed, conduced, analysed and reported research is unethical. Clinical Centre researchers at National Institute of Health of USA have enunciated seven principles to guide the conduct of ethical research. These are social and clinical value, scientific validity, fair subject selection, favourable risk benefit ratio, independent review, informed consent, respect for potential and enrolled subjects. Given the importance of scientific merit and integrity of research, good research practice needs much attention both by researchers and research institutions. In order to meet these needs the National Health Research Council and the Education, Training and Research Unit of the Ministry of Health have taken steps to publish, ‘The Code of Conduct on Health Research in Sri Lanka’ (2018) (available at http://www.health.gov.lk/moh_final/english/public/elfinder/files/publications/2018/TheCodeofConduct.pdf). The Code covers aspects of: formulation of research proposals; management of research data and primary materials; collaborative research; conflict of interest; supervision of research; peer review, and dissemination of research findings, publication and responsible authorship. With the expansion of research on human participation into may other sciences such as branches of engineering, computing, bio technology, genetics, artificial intelligence, machine learning, nano technology and others, the ethical issues of human research have reached a new dimension. It has to be emphasized that whatever the branch of science or discipline, if the research requires human participants, then approval of an ethics review committee is a must. Thus, it behoves on research institutes, universities, and faculties to establish ethics review committees beyond the traditional practice of having ethics review committees in medical faculties. It is necessary that members of such a committee, functions within the set terms of references, standard operating procedures, ensure confidentiality and also have appropriate training in ethics of research, approval processes and documentation. In Sri Lanka too universities have gone one step ahead to establish ethics review committees at university level to facilitate research on humans in disciplines other than health and medical practice. Time has come when universities and research institutions take steps to develop codes of conduct on research, conduct courses on such practices and ethics of research for all researchers in order to safeguard the interests and safety of both researchers and participants of research.

Stem cells have the ability to produce a large number of specialised cells or tissue by regeneration and differentiation. The cells that regenerate could be known to cure disease or injury. As a result, they are distinguished from other cell types by their ability to replicate themselves. Stem cells offer the potential to develop cell-based therapies. Such type of research could lead to novel and improved treatments for a variety of disorders, including diabetes, spinal cord injuries, Alzheimer's, Parkinson's, and heart disease. Stem cell treatment, also characterized as regenerative medicine, induce the repair mechanism of damaged, diseased, or injured tissue using stem cells and their derivatives. Early-stage embryos are used to obtain human embryonic stem cells. Because human embryonic stem cells are harvested from human embryos, there have been various concerns raised the moral and ethical issues in embryonic stem cell research. On the other hand, reprogramming of somatic cells to make induced pluripotent stem cells, avoids the moral and ethical issues that come with embryonic stem cell research. In human stem cell research in addition to moral issues, informed consent to donate materials, critical downstream research, premature clinical trials and oversight all issues occur. To ensure that stem cell research is carried out in an ethically acceptable way, these ethical and policy issues must be discussed along with scientific challenges. This article examines these challenges and how they are addressed in India are explained.

An increasing volume of qualitative research and articles about qualitative methods has been published recently in medical journals. However, compared with the extensive debate in social sciences literature, there has been little consideration in medical journals of the ethical issues surrounding qualitative research. A possible explanation for this lack of discussion is that it is assumed commonly that qualitative research is unlikely to cause significant harm to participants. There are no agreed guidelines for judging the ethics of qualitative research proposals and there is some evidence that medical research ethics committees have difficulty making these judgements. Our aim was to consider the ethical issues which arise when planning and carrying out qualitative research into health and health care, and to offer a framework within which health services researchers can consider these issues. Four potential risks to research participants are discussed: anxiety and distress; exploitation; misrepresentation; and identification of the participant in published papers, by themselves or others. Recommended strategies for reducing the risk of harm include ensuring scientific soundness, organizing follow-up care where appropriate, considering obtaining consent as a process, ensuring confidentiality and taking a reflexive stance towards analysis. While recognizing the reservations held about strict ethical guidelines for qualitative research, we argue for further debate of these issues so that the health services research community can move towards the adoption of agreed standards of good practice. In addition, we suggest that empirical research is desirable in order to quantify the actual risks to participants in qualitative studies.

Preface. Acknowledgements. Part I: Overview of the Research Process. 1. Introduction to Research in Nutrition and Health. 2. Research Problem and Literature Review. 3. Framing a Research Problem: Hypotheses, Purposes, Objectives, and Questions. 4. Writing Method Sections. 5. Ethical Issues in Research and Scholarship. Part II: Statistical and Measurement Concepts in Research. 6. Statistical Concepts. 7. Relationships Among Variables. 8. Differences Among Groups. 9. Nonparametric Statistics. 10. Measuring Research Variables. Part III: Various Types of Research. 11. Experimental and Quasi-Experimental Research. 12. Descriptive Research and Qualitative Research. Part IV: Writing the Research Proposal and Results. 13. Results, Discussion, and Abstract. 14. Publications. 15. Writing the Research Proposal. Part V: Using Computers in Research. 16. Using Computers. Appendix: A. Statistical Tables. Subject Index.

This article aims to reflect on scientific validation strategies in qualitative research in the light of translational theory in nursing. It is a reflection based on translational theory applied to nursing in strategies for validating qualitative studies. From this angle, validation is recognized as an adaptable construct, capable of eliciting/favoring an understanding of the subjectivity of the target audience in its relationship with the object of interest/study/research. The potential for advancing the science-profession lies in the interdisciplinary confluence of validation mechanisms, qualitative studies, the translational perspective, and nursing research. This confluence has the capacity to extend beyond theoretical and epistemological aspects. However, it is crucial to emphasize its profound, expressive, and relevant impact on the construction of scientific evidence. This impact aims to enhance the rigor and reliability of qualitative research, thereby bolstering its credibility and applicability in clinical practice.

Qualitative and mixed methods research in trials

What is Ethics? The definition of ethics revolves around the concept of morality. Ethics is defined as a set of moral principles that govern a person's actions. Or as the philosophy of morality. Or as the discipline that defines, guides, or describes what is good and bad, right and wrong.We may ask ourselves: is ethics of scientific research a science itself? Probably not. Ethics of scientific research refers to the guidelines that define or describe a responsible conduct of research. If we ask for random individuals to tell examples of violations of integrity or research ethics, the most common answers will certainly be: plagiarism and data manipulation. These are, as we all know, the most feared ethic violations that can affect the work of a researcher and can even lead to the end of his career.The issues of ethics and the integrity of research, a more recently introduced term, are in fact issues of greater finesse than these clear and indisputable violations of any system of moral and ethical values. The academic community has focused over the past two decades on many issues of ethics and integrity. Many of the world's states have set up institutions or departments exclusively responsible to study, define and judge ethical issues. In Europe, the first such institute was set up in Finland in 1996, where the first national guide on scientific integrity was drafted.At the same time, on global level, it became clear that there is a need for guidelines and statements to define and standardize, regardless of regional culture and practice, the academic research and publication activities from the point of view of integrity. Therefore, guidelines such as the Helsinki Declaration, the European Code of Conduct for Research Integrity, the Montreal Statement on Research Integrity, and the Singapore Statement on Research Integrity have been issued.In 2012, the DORA Declaration was written and signed until today by more than 14,000 researchers and over 1400 institutions. The general recommendation of this statement is: "Do not use journal-based metrics, such as Journal Impact Factors, as a substitute measure of the quality of individual research articles, to assess individual contributions, or to hiring, promoting, or funding decisions " This year, I was honored to attend at the 6th edition of The World Conference of Research Integrity, which took place in Hong Kong in early June and gathered participants from all over the world. The statement made on this occasion is titled: The Hong Kong Manifesto for Assessing Researchers: Fostering Research Integrity. It discusses one of the most current issues in research: assessing researchers and their outcomes. This manifesto proposes 5 principles accompanied by references for each and implementation suggestions. These five principles are:1. Assess researchers based on responsible practices in all aspects of the research enterprise2. Value the reporting of all research, regardless of the results and reward honest and transparent reporting3. Value the practice of open science4.Value and broad range of research activities, such as innovation, replication, synthesis, and meta-research5. Value and range of other contributions to research, such as peer review for grants and publications, and mentoring In Romania, in 2016, a number of minimal criteria for academic promotion have been proposed that have become mandatory since 2017. For the field of medicine, the minimum criteria only take into account the publishing activity from the SCIE database of the Web of Science (Clarivate Analitycs) and are based on the hirsch index, the cumulative impact factor and the total number of published articles. Thus, we can observe that in Romania, as in many other countries of the world, the minimum criteria violate both the recommendations of the DORA Declaration and the Hong Kong Manifesto, being based on quantitative metrics or metrics that are not intended for the assessment of researchers and taking into account only a small sector of a researcher's entire scientific activity.In conclusion, the latest trends in integrity research focuses on the transparency and objectivity of the process of evaluating both researchers and research. There is a global care for the objectivity of academic evaluation and promotion processes, the rational use of scientometric parameters as well as for the evaluation of the quality of research and its impact both at scientific and social levels.