Trial Participants' Rights and Obligations
What are the obligations of a participant whether they are a patient or healthy volunteer, when agreeing to take part in research? Before answering this question, it should be clear on which grounds participants have obligations.
Participant obligations are not like professional obligations. The supporters of the view that patients have obligations ground their claim in the common good and common need. For example, according to Evans, a list of ten duties could be enumerated;
like for example: ’the duty to uphold his own health, the duty to protect the health of others, the duty of truthfulness, the duty of compliance, the duty to seek and access healthcare responsibly, the duty to participate in research, the duty of
recovery or maintenance etc...’ . This range of positive obligations is relevant for the case of the research participant:
- Participant's adherence: Patient adherence can be an issue in clinical research. It can apply to several different facets of clinical trials, like adherence to trial procedures, study visit compliance, adherence to medications and
reporting of adverse events. The impact of a poor medication adherence by research participants may have detrimental effects on a trial, calling into question the scientific validity of the results.
- Participant's health: It is a generally accepted obligation to maintain one’s own health. Whilst enrolled in a trial, participants should take special care to further minimise risks to their health.
- Truthfulness: By informing doctors of symptoms, research participants are asked to report any adverse events in order to protect themselves and others. Study participants should also inform doctors of any other important factor that
can impact the study results (such as the use of other medicines or substances that could interact with the investigational product). In general, any action which could undermine the integrity of the trial, should be avoided.
There is no doubt that the notion of participant’s obligations or responsibilities is debatable; and especially when participants take risks during research. There is a temptation to counter this with discussion regarding the duties of the sponsor against
a system of duties for the participants. Responsible behaviour of the research participant should be promoted.
One reason is that the concept of generalisation of clinical trial results for the entire population of patients implies that patient behaviours inside and outside of a trial should be as identical as possible. It is in the interest of patient organisations to make sure that the actual diversity of the patient population is reflected in clinical trials.