Trial Participants' Rights and Obligations

Participants' Rights
Participants have rights and they are protected under law when participating in clinical trials. The European Commission Directive and Regulation establish that ’Human dignity and right to the integrity of the person are recognized in the Charter of Fundamental Rights of the European Union’. The Charter requires that any intervention in the field of biology and medicine cannot be performed without the free and informed consent of the person concerned.

The informed consent process is one of the key aspects of protecting research participants. It is designed to respect the autonomy of individuals and to protect their freedom of choice. It is imperative that the decision to volunteer for a study is individual and free from undue influences that might persuade a person to consent to greater than reasonable risk.

Prior to study enrolment, the participant has a right to fair information in order to be able to understand all the possible benefits and risks and burdens involved with participating in the clinical trial, the purpose and the overall plan for the trial: the methods used, the location and time required. The participant (patient or healthy volunteer) has the right to know everything that is going to happen in a study. As participating in a clinical trial may imply the imposition of unknown risks (a new medicine with unknown side-effects) and burdens (extra tests and procedures) in comparison to the standard of care, a full disclosure and understanding of all the implications of research participation is essential. This right is accompanied by the possibility to ask any questions and express all concerns about the participation in the study.

In practice, the informed consent is a process where a member of the research team explains, in clear and understandable language, all the aspects of the trial(s), and where the potential participant receives information both verbally and in writing. The potential participant has the right to refuse to take part in research and, if a decision to take part is made, the participant can decline participation or withdraw from the clinical trial at any time and for any reason without prejudice or loss of future treatment.

During the trial, the participants have both rights and protections to make sure their privacy and the confidentiality of their data are maintained. The informed consent process does not end once the form is signed. If new benefits, risks, or side effects are discovered during a study, the researchers must inform the study participants. There are also post-trial obligations for the sponsor regarding the appropriate follow-up with study participants. For example, study participants have the right to claim continued access to beneficial treatment at the end of clinical trials (expanded access/compassionate use).

Participants' 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...’ [1]. This range of positive obligations is relevant for the case of the research participant:

  1. 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.

  2. 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.

  3. 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.