Trial Participants: Informed Consent, GCP, Patient Involvement

2. How Are Clinical Trial Participants Protected?

During the design and before a clinical trial can start, there are several elements that ensure the protection of participants:

Scientific review:

A Clinical Trial Application for the investigational medicinal product (IMP), has to be submitted to the national competent authority of the member state in which the sponsor plans to conduct the clinical trial. They review the documents to ensure the clinical trial is scientifically sound, and the foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial participant.

They also:
  • Assess whether the methods to collect data are appropriate.
  • Determine whether the most suitable participants are planned to be included.
  • Review if the people running the trial are suitably qualified.
  • Some review processes also ask for input from patients on the proposed trial design.
Institutional review – Ethics review

A Research Ethics Committee (REC) is there to safeguard the rights, safety, and well-being of all participants in a clinical trial. Its positive opinion is required before a clinical trial can start.

The REC specifically evaluates:
  1. The relevance of the clinical trial and the trial design.

  2. Whether the evaluation of the anticipated benefits and risks is satisfactory and whether the conclusions are justified.

  3. The protocol.

  4. The suitability of the investigator and supporting staff; (e) the investigator's brochure.

  5. The quality of the facilities.

  6. The adequacy and completeness of the written information to be given and the procedure to be followed for the purpose of obtaining informed consent and the justification for the research on persons incapable of giving informed consent.

  7. The provision for indemnity or compensation in the event of injury or death attributable to a clinical trial.

  8. Any insurance or indemnity to cover the liability of the investigator and sponsor.

  9. The amounts and, where appropriate, the arrangements for rewarding or compensating investigators and trial participants and the relevant aspects of any agreement between the sponsor and the site.

  10. The arrangements for the recruitment of participants:
  • Special attention is paid to trials that may include vulnerable participants,
  • The REC also assures that there is no coercion or undue influence on the trial participants, and
  • Conducts reviews of each ongoing trial at intervals appropriate to the degree of risk to human participants.
Clinical trial guidelines pertaining to the approval of a clinical trial

The Clinical Trials Directive and Regulation harmonises the rules in the EU for the approval of a clinical trial conducted in a member state. As regards NCAs, the details are set out in the Commission Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1) (here).

With regards to Ethics Committees: Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use (here).

These guidance:
  • Provide public assurance that the rights, safety and well-being of trial participants are protected.
  • Establishes principles for the written informed consent documentation:
the documentation needs to be written in a non-technical language and should be understandable to the patient or the patient’s representative.