Ethical principles underpinning high quality research
In 1999 I published a paper in which I described and explored the seven ethical principles that should underpin the planning and conduct of high quality clinical research. In the intervening years I have repeatedly used these ethical principles as the basis for teaching ‘research ethics’ to many undergraduate, postgraduate and doctoral students and to others undertaking research training. These ethical principles have also provided me with a framework to guide the many hundreds of ethical reviews I have undertaken.
Anyone who has attended the Clinfield courses on ‘applying for an ethical opinion in the NHS’ or ‘informed consent’ will be familiar with these ethical principles and how they might be applied in the research setting by clinical research nurses and other researchers. The seven ethical principles are:
- Respect for autonomy
Whilst there is clearly considerable overlap between these ethical principles, it can also be useful for researchers to consider each principle in isolation. Examination of these ethical principles can help researchers to ensure they have addressed the full spectrum of ethical issues that might impact on the conduct of their research.
The first ethical principle is ‘beneficence’, which is the principle dictating that clinical research should be associated with the potential to benefit patients. This may seem an obvious objective for researchers but, as an NHS research ethics committee (REC) Chair, I know that researchers sometimes struggle to demonstrate how their research might benefit patients, either those being invited to participate in their research or future patients. That benefit can be interpreted in the widest possible sense and need not always be a direct benefit to the patients participating in the research. It is more common and perfectly acceptable for clinical research to offer greater potential benefit to future patients.
Researchers need to convince RECs that the potential benefits of a proposed research project are at least equal to any harm that might be caused. Researchers will always have a more challenging time before the reviewing REC if possible risks appear to outweigh the possible benefits. This can be further complicated because the beneficence of any action can be extremely personal and may differ between individuals. So an intervention that might benefit one person might be less beneficial to someone else.
In addition to demonstrating the potential benefit of a research project to the reviewing REC, demonstrating the potential benefit of a research project can be an important part of the process of recruiting individuals into research projects. For example, participant information sheets usually begin with a section about why the research is being conducted and what the researchers hope to achieve through the research. If someone believes there to be value in a research project they will be more likely participate in that research, even if the benefit is not directly to them.
Once a researcher has established the beneficence of a research project they need to balance this against the possible harm that might result from participating in a research project. My next blog will consider non-maleficence.