Nurses: Research Integrity in Clinical Trials

University Of Minnesota Twin Cities, Minneapolis MN

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by the applicant): Research integrity is, appropriately, a national priority. However in discussions of clinical trials, research ethics focuses nearly exclusively on the perspective of Principal Investigators. Yet nurses are key in implementing clinical trials, that is, they perform much of the day-to-day work. While the ethical issues pertaining to physician-researchers are well documented, there is virtually no research on the ethical concerns and challenges confronting nurses working in clinical trials. There is some evidence indicating that their perspective differs from that of physician-researchers at least in certain circumstances. Also, the complexity of clinical trials suggests that the ethical concerns encountered by nurses might vary by disease being studied, type of trial, site of trial, source of funding, and other variables. In order to move towards a more complete knowledge of the ethical issues arising in research, it is crucial that we know more about the ethical concerns and challenges of nurses who implement Clinical trials and the institutional and other factors influencing these concerns and challenges. Assurance of research integrity requires that policies and guidelines be based on such an adequate understanding of the concerns and challenges faced in the work of Clinical trials. The specific aims of this research are to: 1) identify and describe the ethical and professional concerns encountered by nurses during their work in Clinical trials; 2) identify and compare the institutional and other conditions that influence the nurses' ethical/professional concerns; 3) describe the process nurses use in making ethical decisions within clinical trials; 4) identify sources of guidance/resolution for difficulties that clinical trials nurses have used to promote research integrity. Eight focus groups of nurses working in four disease-related Clinical trials will be conducted in two regions of the country. The four diseases are addictions/mental health, breast cancer, Parkinson's Disease, and cardiovascular disease. This study hypothesizes that Clinical trials investigating these four diseases will be associated with different ethical challenges and institutional factors. The sample will consist of 8 to 10 nurses per focus group with two focus groups for each disease. Demographic data including education level, specific training in ethics, and previous experience in Clinical trials work will be collected. Consensual qualitative analysis will be the primary method used for analyzing focus group data. This data will serve as a basis for future research, with two long-term goals for the research program. The first will be to evaluate the adequacy of existing policy and guidance for the research involving human participants, which has been developed without an understanding of the concerns confronting nurses in their work in Clinical trials. The second will be to reconsider the dominant understanding of the ethics of research, which conceives of moral decision-making as the application of abstract, impartial moral rules and tends to ignore the moral importance of context, such as the institutional and other factors we propose to investigate.