Trial Participants: Informed Consent, GCP, Patient Involvement

Both the informed consent discussion and the written informed consent form, and any other written information to be provided to patients, should include explanations according to the Guideline for Good Clinical Practice.

The guideline should include explanations of the following:

• The trial involves research.
  
• Purpose of the trial.
  
• Trial treatments and probability for random assignment to each treatment.
  
• Procedures (including invasive) to be followed in the trial.
  
• Participant’s responsibilities.
  
• What aspects are experimental.
  
• Reasonably foreseeable risks or inconveniences to the participant.
  
• Whether there are expected benefits for the participant or there is no intended clinical benefit.
  
• Alternative treatments, and their important potential benefits and risks.
  
• Compensation or treatment available in the event of trial-related injury.
  
• Anticipated payment, if any, for the participating patient.
  
• Anticipated expenses, if any, for the participating patient.
  

Additionally participants must be informed of:

• The participation in the trial is voluntary and the person may refuse to participate or withdraw from the trial at any time, without penalty or loss of benefits to which the person is otherwise entitled.
  
• That the monitor(s), the auditor(s), the REC, and the regulatory authority(ies) will be granted direct access to the participant’s original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the participant or the participant’s legally acceptable representative is authorising such access.
  
• That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws or regulations, will not be made publicly available. If the results of the trial are published, the participant’s identity will remain confidential.
  
• The participant or the participant’s legal representative will be informed when information relevant to the participant’s willingness to continue participation in the trial becomes available.
• Contact details to obtain further information regarding the participant’s rights, and whom to contact in the event of trial-related injury.
• Foreseeable circumstances or reasons for which the participation in the trial may be terminated.
  

The expected duration of the participation in the trial and the approximate number of participants involved.