Incorporating the patient’s perspective in ethical decision making
Ethical regulation of clinical research nearly always involves Ethical Review Committees (ERCs) composed of ‘experts’ and ‘lay representatives’ in varying proportions. However patients themselves rarely have a direct voice in the decisions these bodies make on their behalf. To answer the question if and how the patient’s perspective should be represented in the ethical regulation of clinical research it is important to understand where this need comes from.
Ethical committees have the task to balance the benefit for the patient with the perceived risk of the treatment that the patient (69) is undergoing. One would think that in order to do this, all members should have competent personal and/or professional skills to be able to make a good judgement.
However what does this competency entail?
From a professional perspective; ethical committees feel that by serving the need of the caregiver that has supplied his research proposal to the committee he is in fact actually serving the patient.
This does in reality not match the patient’s perspective of ethical committees that whilst making their decision have the (individual) patient’s interests at heart (70).
The recommendation made by the UK’s Royal College of Physicians stating that “The input of patients, and the awareness of patient’s values will need to be at the heart of the resolution of an ethical issue. Some committees may come to the conclusion that there are circumstances in which it is appropriate for a case to be reviewed by a patient or for a patient to present and to participate in the discussion” (71). Describes a process of ethical review in which patient involvement is an occasional event. It can be argued though that to be able to keep a patient’s value at heart in the ethical decision making process, patient involvement should be a requirement rather than just an option (70).
So how is the patient and or lay perspective represented in Europe?
Most of the ethical decision making processes are very complicated, and in some countries the methodology used is not transparent; these decisions are not adopted in the same way in all countries and often there is no communication or approval required by the public or patient representatives (72) .
However there does seem to be a slight increase in the number of ethics committees that are involving patient representatives in their committees (73) showing that patient involvement in ethical decision making is possible. Involvement is one thing, and actually making an impact is another. A recent survey of lay and patient representatives of ethical committees in the UK (74) showed that the majority of the surveyed participants felt that views as a lay member (44% stated that their input was based on being a patient, carers or service user) were fully taken into account in the deliberations of the Ethical review committee. Another survey, performed by PartecipaSalute (13), an Italian project to involve lay people, patient associations and scientific-medical representatives in the health debate, showed that there is a need for further discussion on the role and workings of an ethics committee in relationship to the role and value of both the professional and lay/patient input.
In conclusion; there seems to be a movement towards the consensus that lay/patient involvement is of value to the ethical decision making process in clinical research. However further discussion on how the value of the lay and or patient perspective can best be put to use in the setting of ethical committees is needed.