Developing a research study
There are further specific guidelines that affect different stages of the lifecycle of a research project. For this reason, ethics should be considered from the initial conception of the research questions. Ethical research questions will focus on problems that have the potential to benefit the participants being studied. For some studies, this benefit may be clearly identifiable, such as studies examining the effectiveness of an intervention for a target patient group, where, if benefits are found, there may be a rationale for scaling up the intervention to reach more people. However, for other studies the benefit may not be as immediate. For example, a research study looking at how different parameters of music affect heart rate variability will not immediately lead to patient or public benefit, but the information derived from that study could have a significant effect in the future, such as in the choice of music to help patients relax in stressful situations like hospital waiting areas. Therefore, both basic and applied research can have potential benefits, and identifying what these benefits might be and when they are likely to occur is an important part of deciding whether a research question is ethical. However, if there is no clear impact from undertaking a research study, for example because the question is too obscure or specific and thus not likely to have any real-world implications, it may be questioned whether it is ethical to spend money on the study or to put participants through involvement in the research.
Related to this selection of an ethical research question is a consideration of any potential conflicts of interest. A research study naturally combines the individual agendas of researchers, who have areas of research in which they want to develop and become known; funders, who have strategic priorities for how their money is spent; and sponsors, who want to prioritize support for studies which are in line with their own strategies. Balancing these different agendas is important to ensure a study remains ethical. If any one of these three parties becomes too dominant, a study could be at risk of bias. For example, if a funder wants to test whether their new music software is capable of reducing stress hormones in people with anxiety disorder, it is important for the researcher to be allowed enough autonomy to design an objective research study, as well as to analyse the data appropriately, avoiding misleading presentation of results. It is also important that participants are aware of the individual interest of the funder in the study. As another example, it is important to ensure that the arts intervention being proposed for a research project is truly suitable for the target participant group, rather than merely being the one promoted by the arts organization involved. Preliminary evaluations, focus groups, and pilot projects undertaken as part of consultancy processes (outlined in Chapters 5 and 6) can be of help in confirming that the intervention is suitable for those involved. Although many of these issues will arise at later stages of the project, being aware of the potential for conflicts of interest is important at the start of a study so that appropriate agreements can be drawn up regarding the roles of the different parties.
The American Medical Association discusses potential conflicts of interest and ways to minimize and mitigate them as part of its Code of Medical Ethics available at www.ama-assn.org.
Finally, ownership of data and any potential intellectual property arising from a project should be clarified at the outset of a study. Personal agreements, such as Brunswick Agreements, can be developed between institutions to ensure that all parties are in agreement about arrangements once data are collected.
Brunswick Agreements were developed by the Brunswick Group to facilitate collaborative research between two universities or similar not-for-profit organizations. More information can be found on the Association of Research Managers and Administrators website www.arma.ac.uk.
