Many ethicists feel that patient autonomy may be the pre-eminent ethical principle. The tangible expression of patient autonomy in clinical research is the process of informed consent. There are several key components to adequate informed consent.
Firstly, the patient must have a level of decision making capacity necessary to make a meaningful choice. This includes a patient’s ability to understand the information disclosed, appreciate the potential risks and benefits of participation, engage in a reasoning process to include alternatives, and express a choice.
A second and related component of informed consent is that the potential patient must be provided, in language they understand, all the information necessary to make a decision whether or not to participate. This seemingly simple requirement represents one of the most challenging current issues in clinical trials for patients with autoimmune diseases. For example, in the USA, a common guideline is that informed consent documents must be understandable to someone who has completed eight years of primary school education only. However, the science and technology enabling novel therapeutics have become increasingly complex. For psoriasis and psoriatic arthritis, current clinical trials target such diverse components of the immune system as costimulatory molecules, subsets of immunocompetent cells, and inflammatory mediators, using monoclonal antibodies, soluble receptor conjugates, and other novel biological agents. In the future, both the range of targets as well as the treating agents may become even more complex. Providing relevant understandable information to potential study patients will likewise become more challenging. Similarly, the intricacy of adverse events potentially associated with newer therapeutic agents has increased substantially. In the case of TNF inhibitors, there is currently disagreement among experts in the field about the actual risks of these agents as regards certain malignancies, infections, and neurological and cardiovascular sequelae. Therefore, providing accurate information to patients on this topic is complicated. In psoriasis and psoriatic arthritis, the situation is made even more tenuous not only by potential differences in the conditions, which could result in disparate efficacy or safety of a given agent, but also by dissimilarities in the standard of care for these conditions. In the case of methotrexate, for example, dermatologists and rheumatologists have traditionally disagreed in their consideration of the safety of this agent, which has resulted in dissimilar recommendations for optimal dosage, monitoring, and use.
The third key component of informed consent is that it must be given free of coercive influences, which may be subtle. For example, in some countries, TNF inhibitors have not been generally available outside of participation in clinical trials. If patients do not otherwise have access to newer medications, could the potential for receiving them in a research study be considered coercive? If so, does the promise of continued open label therapy with the agent after the study mollify this consideration? Even in countries where newer drugs are available, because of their costs or because of regulations, access may not be universal. For patients without insurance coverage, clinical trials afford them a means to receive such treatments, which may be a coercive influence to enrol.