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Objectives: To explore the federal regulations governing clinical trials and human subject protection, the importance of research participant's informed consent, and the role the oncology clinical research nurse has within the clinical trial setting., Data Sources: Peer-reviewed journal articles, internet, book chapters, white papers., Conclusion: Federal regulations mandate the conduct of a clinical research trial, human research participant protection, and the informed consent process., Implications for Nursing Practice: The oncology nurse supports the autonomy and safe conduct of the human research participant during a clinical research trial and provides education and support through the informed consent process., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Intensive-care unit (ICU) nurses have an important role in the recruitment of patients for scientific research and in the performance of clinical research., Aim: A study was conducted to examine ICU nurses' perceptions of ethics-related aspects of ICU-based research. The study focused on nurse attitudes and knowledge related to clinical research, with special emphasis on perceptions of the informed-consent process in ICU research., Method: The study applied a descriptive qualitative approach, involving semi-structured group interviews and theme-based inductive content analysis. Subjects were ICU nurses (n = 28) at a university hospital ICU who had experience with research protocols applied in that unit., Findings: The nurses had mainly positive perceptions of clinical studies. They found research beneficial for future patients and for society. The nurses considered the information given to them about the studies inadequate. They were concerned about the fact that the consent for research is almost always obtained at the beginning of the ICU care, when patients and relatives are still in the crisis period. This limits the possibility of understanding and assimilating the information provided on the study., Conclusions: The role of ICU nurses in clinical studies should be more prominent and taken into account in the planning of ICU studies., (© 2019 Nordic College of Caring Science.)

This article explores perspectives on qualitative research and the variety of views concerning rigour in the research process. Evaluating and ensuring the quality of research are essential considerations for practitioners who are appraising evidence to inform their practice or research. Several criteria and principles for evaluating quality in qualitative research are presented, recognising that their application in practice is influenced by the qualitative methodology used. The article examines a range of techniques that a qualitative researcher can use to promote rigour and apply it to practice.

There is considerable interest in the various ethical problems associated with undertaking health and social science research. Participants in such research are often considered vulnerable because of their health status, social position, or dependence on others for health and welfare services. Researchers and ethics committees pay scrupulous attention to the identification and amelioration of risks to participants. Rarely are the benefits to participants of engaging in research highlighted or drawn to the attention of potential participants. Such potential benefits need to be considered by researchers and reviewers when considering the balance of benefits and harms associated with research projects. In this paper, we particularly consider the psychotherapeutic benefits of participation in research., (© 2012 The Authors; International Journal of Mental Health Nursing © 2012 Australian College of Mental Health Nurses Inc.)

Experimental studies potentially produce scientific evidence. To achieve this goal, it is necessary to pay particular attention to three elements essential for the validity of the study: randomisation, manipulation and control.

Care is based on ethics, a non-corporatist form of ethics. For the caregiver, clinical refers to the patient and not a profession, a sine qua non condition of not losing sight of the meaning of care. Human nature incites us to escape the formal aspect, but can we necessarily make the informal exclusive to nursing?

Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as an early 'rite of passage' in the category of 'labouring the doctorate'. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of 'medicalized' research ethics is further explored including its meaning for nursing or midwifery research.

Research on the palliative care needs of heart failure patients is scant and requires development to provide a sound evidence base for improved care; but there are distinct practical and ethical challenges in conducting research with this population. This paper presents an integrative review of the literature that aims to describe these challenges and discuss potential strategies by which they may be addressed. It is recognised that heart failure is a volatile condition making identification of the end of the life phase difficult. This leads to an array of other issues; firstly clinical teams tend to use this as a rationale for their failure to discuss palliative care issues with patients and families, making identification of the population difficult and research related communication challenging. Symptom volatility also creates methodological problems for researchers in deciding patients' eligibility, securing user involvement and contributes to sample attrition in research. There are also substantial ethical challenges for researchers in terms of gaining access and ensuring patient autonomy in this population. Acknowledgement of these issues and discussion of strategies by which they can be addressed has the potential to augment clinical research, develop practice and ultimately produce the much needed improvements in patient care required for those with advanced heart failure.

This paper offers guidance for novice nurse researchers on the ethical and methodological challenges of conducting health research in high school settings. Over the course of two studies in UK high schools with students aged 11-16 years, the authors encountered common ethical and methodological challenges. This article draws on these studies to build a critique of approaches to health research in school settings. Issues of consent and assent, confidentiality and participation can highlight tensions between the expectations of schools and health researchers. In this context, feasible research designs raise complex ethical and methodological questions. Ethical and methodological norms for health research may not be suitable for high school settings. Successful school-based health research designs may need to be flexible and responsive to the social environment of schools.

Aim: The objective of this paper is to identify and explore some of the ethical and professional issues facing the clinical researcher-practitioner and to discuss how these were addressed in one particular study., Background: The author's experience of undertaking ethnographic research in the organisation in which she works as a nurse consultant highlighted a number of ethical and professional dilemmas. This paper discusses how some of these issues, particularly relating to informed consent, confidentiality, practice concerns and exploitation were addressed., Data Sources: Doctoral research (DMedSCi) with Sheffield University., Discussion: This paper discusses the ethical and professional dilemmas and some of the advantages associated with the researcher-practitioner role., Conclusion: This paper identifies and discusses the need to: Remember who the research is about and whom it should benefit. Include a wide research team. Acknowledge the researcher's responsibility towards the participants. Identify and act on problems as they arise. IMPLICATION FOR RESEARCH/PRACTICE: The need to keep the participant as the focus of the research, to involve a wide research team and to reflect constantly on the process.

Service-learning is a valued strategy for educating health professionals. Linking service-learning with community-based participatory research (CBPR) engages students with community stakeholders and faculty in a collaborative process to bring about social change and improved health. The purpose of this paper is to describe a strategy for involving interprofessional students in ongoing faculty CBPR in an underserved community. The process includes the design and implementation of a course that combines weekly seminars with field experiences in the targeted community, emphasizing community assessment, and working with community members to find solutions to health problems. Nursing, public health, and medical students were recruited to the initial course, and offered the opportunity to meet objectives of required components of their disciplinary curriculum. Community members became actively involved in educating students while working to solve identified health problems. Important principles of CBPR--trust, collaboration, excellence in science, and ethics--are emphasized throughout the initiative. This course is now a regular offering for interprofessional students, providing valuable learning experiences for students, faculty, and the community. Ongoing faculty CBPR continues a trusting community-academic relationship and gives the community a voice in the solution for health problems., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Magnet hospitals were surveyed to determine the processes used to promote the integrity of nursing research conducted in clinical settings. Results indicated that four central processes, institutional review board review, nursing research council review, nursing research mentorship, and reliance on personal and professional values, were used to educate, monitor, and oversee the integrity of research conducted by bedside nurse scientists. Staff development educators are challenged to provide instruction regarding the process of nursing research and all elements of scientific integrity. Research is needed to test the effectiveness of the processes identified in this investigation in promoting the quality and integrity of nursing research conducted in clinical settings.

Background: Most reports of scientific misconduct have been focused on principal investigators and other scientists (e.g., biostatisticians) involved in the research enterprise. However, by virtue of their position, research coordinators are often closest to the research field where much of misconduct occurs., Objective: The purpose of this study was to describe research coordinators' experiences with scientific misconduct in their clinical environment., Design: The descriptive design was embedded in a larger cross-sectional national survey. A total of 266 respondents, predominately registered nurses, who answered "yes" to having firsthand knowledge of scientific misconduct in the past year, provided open-ended question responses., Methods: Content analysis was conducted by the research team, ensuring agreement of core categories and subcategories of misconduct., Findings: Research coordinators most commonly learned about misconduct via firsthand witness of the event, with the principal investigator being the person most commonly identified as the responsible party. Five major categories of misconduct were identified: protocol violations, consent violations, fabrication, falsification, and financial conflict of interest. In 70% of cases, the misconduct was reported. In most instances where misconduct was reported, some action was taken. However, in approximately 14% of cases, no action or investigation ensued; in 6.5% of cases, the coordinator was fired or he or she resigned., Conclusions: This study demonstrates the need to expand definitions of scientific misconduct beyond fabrication, falsification, and plagiarism to include other practices. The importance of the ethical climate in the institution in ensuring a safe environment to report and an environment where evidence is reviewed cannot be overlooked.

Two protocols that were developed to address risks related to emotional distress in an ongoing, qualitative, community-based study of adolescent dating violence are presented. The first protocol is for use in telephone screening to identify individuals at high risk of adverse emotional reactions. The second protocol guides interviewer's responses to emotional distress expressed by participants during in-depth research interviews. The study is briefly described, and the process used to develop the protocols is discussed. The process of developing the protocols caused the authors to reconsider some previously held assumptions about human subject protections in research on sensitive topics.

In the past decade, the introduction of electronic monitoring systems for monitoring medication adherence has contributed to the dialog about what works and what does not work in monitoring adherence. The purpose of this article is to describe the use of the Medication Event Monitoring System (MEMS) in a study of patients receiving isoniazid for latent tuberculosis infection. Three case examples from the study illustrate the data that are obtained from the electronic device compared to self-reports and point to the disparities that may occur in electronic monitoring. The strengths and limitations of using the MEMS and ethical issues in utilizing this technology are discussed. Nurses need to be aware of these challenges when using electronic measuring devices to monitor medication adherence in clinical nursing practice and research.

This research series is aimed at clinicians who wish to develop research skills, or who have a particular clinical problem that they think could be addressed through research. The series aims to provide insight into the decisions that researchers make in the course of their work, and to also provide a foundation for decisions that nurses may make in applying the findings of a study to practice in their own Unit or Department. The series emphasises the practical issues encountered when undertaking research in critical care settings; readers are encouraged to source research methodology textbooks for more detailed guidance on specific aspects of the research process.

This is a qualitative study aimed developing an investigative care practice of HIV-positive pregnant woman based on Rosemarie Parse's theory. The study was carried out at a Maternity Ward in Florianópolis, Santa Catarina, Brazil. Its target population included four HIV-positive pregnant women under pre-natal care. The theoretical foundation was applied to the nursing process, taking into account three dimensions: clarifying meaning, synchronizing rhythm, and mobilizing transcendence. Data were collected using interviews and patient observation. The results reveal an innovative method of providing care to HIV-positive pregnant women holistically, thereby, promoting their evolution as human beings.

To improve outcomes for patients with many serious clinical problems, multifactorial research approaches by nurse scientists, including the use of animal models, are necessary. Animal models serve as analogies for clinical problems seen in humans and must meet certain criteria, including validity and reliability, to be useful in moving research efforts forward. This article describes research considerations in the development of rodent models. As the standard of diabetes care evolves to emphasize intensive insulin therapy, rates of severe hypoglycemia are increasing among patients with type 1 and type 2 diabetes mellitus. A consequence of this change in clinical practice is an increase in rates of two hypoglycemia-related diabetes complications: hypoglycemia-associated autonomic failure (HAAF) and resulting hypoglycemia unawareness. Work on an animal model of HAAF is in an early developmental stage, with several labs reporting different approaches to model this complication of type 1 diabetes mellitus. This emerging model serves as an example illustrating how evaluation of validity and reliability is critically important at each stage of developing and testing animal models to support inquiry into human disease.

Aims: This paper reviews placebo and placebo effects and their measurement and application to nursing. Ethical and methodological issues are also discussed. Implications for nursing and recommendations for future study are offered., Background: Placebos have been used for decades in clinical trials but discussion about conceptual, methodological and ethical issues has been comparatively scarce., Conclusion: It is concluded that true placebo effects are difficult to measure and control and the use of credible placebo is sometimes impractical in clinical nursing research. This leads to the increased use of usual care as a control by researchers. However, more information should be reported in studies that use this approach, including the specification of usual care, its monitoring and patient adherence., Relevance to Clinical Practice: Where its use is considered ethical, safe and feasible, a placebo arm should be included in studies of efficacy to distinguish between active and inactive treatment.

Nursing literature is replete with discussions about the ethics of research interviews. These largely involve questions of method, and how careful study design and data collection technique can render studies more ethical. Analysis, the perennial black box of the research process, is rarely discussed as an ethical practice. In this paper, I introduce the idea that analysis itself is an ethical practice. Specifically, I argue that political discourse analysis of research interviews is an ethical practice. I use examples from my own research in a prison control unit to illustrate what this might look like, and what is at stake.

Increased consumer participation, clinical governance, accreditation, and occupational health and safety requirements have contributed to considerable changes in the demands placed upon mental health staff, and many are now expected to undertake or participate in research. However, many staff have not received formal training in research design and methodology, and the multitude of policies, procedures, and committees, designed to protect research participants, can seem like insurmountable barriers to clinicians new to the field. In response to this, a guide was developed based on self-directed learning principles, to compliment other resource material and promote effective research work. It was considered important to clarify some of the issues surrounding research development, ethics, and scholarly integrity, and to educate staff as to the appropriate approval processes, which must be followed before embarking on research work. This paper seeks to describe the process of developing a guide for novice researchers, its key characteristics, and its implications for practice. The guide 'Undertaking research: a guide for the beginner' described in this paper, provides a helpful resource that can be readily adapted and developed for a variety of workplaces and professional backgrounds. It is a strategy intended to encourage research and ongoing education and narrow the research-practice gap while placing minimum demand upon existing organizational infrastructure.

In this article, a novice nurse researcher relates her personal experience of encountering a challenging situation while taking consent from the parents of a critically ill child. This critical incident raises issues for the researcher of ensuring validity of the consent process and ensuring recruitment of an unbiased sample when issues of language and culture could impede communication. The process of reflection allowed the novice researcher to gain greater insight into her responsibilities as a research nurse in relation to recruiting patients and to reflect on how she would integrate this into her future practice, thus enhancing her confidence in her role.

Background: Researchers have ethical and professional obligations to produce research of a high standard. The constituents of quality in research appear to differ between authors, leaving readers unsure about which pathway to follow. This can reflect inadequate consideration of the theoretical framework guiding the study. Many papers fail to consider the theoretical underpinnings of the methodology chosen and the link between these and the methods employed. These need to be accessible to readers in order to assess the trustworthiness of the research., Aim: This paper discusses the development of trustworthiness in hermeneutic phenomenological research., Discussion: Referring to a study on lived experience of Chronic Fatigue Syndrome/myalgic encephalitis, I describe the decision trail and discuss the strengths and limitations of the choices made throughout the study., Conclusion: The methodology focused my approach more fully on the importance of recognizing the influences that I brought to the study and the impact of these in generating the data. It highlighted the fact that the process of setting out my horizon can never be complete, the importance of analysing the data at a macro and micro level, acknowledging the evolution of the data over time, and ensuring that analysis does not move beyond the data and out of the hermeneutic circle. In seeking to make the decision trail clear to others, researchers must distill the philosophical principles of the methodology and set these out in a way that is accessible and open to scrutiny.

The experience of being critically ill and being a patient in a critical care unit has attracted considerable research interest in recent years. Evidence of this is apparent in the increasing development of critical care follow-up services in many of our hospitals in the United Kingdom. However, actually conducting research this area can be fraught with difficulties and problems. Research participants may be extremely vulnerable during their recovery, making the methodological considerations crucial, in any study, which aims to explore the experiences of survivors. This paper explores some of the difficulties the researcher can face when researching this area.

The aim of this paper is to examine the way in which nurses manage patients who are unable to consent to nursing care procedures. This paper reports on a qualitative study using focus groups and critical incidents collected through in-depth interviews to explore the way in which nurses obtain consent prior to nursing care procedures. The finding indicate that nurses are uneasy about administering care to a patient who cannot consent. When complicating factors are present this unease is exacerbated and sometimes the appropriate delivery of care is withheld.

In the past, nurses often found themselves pressured within complex social interactions in the research environment that often overshadowed their advocacy role for the patient (Davis, 1989). With the recent emphasis on enforcing adequate protections for participants in research, nurses need to feel free to act as sentient beings with a conscience and a strong commitment to their patients. It is only through this advocacy role that scientific misconduct can be reduced and research integrity upheld.