Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 124

Prior to volunteering for a clinical trial:

 A subject should understand what clinical research is and what to expect when they volunteer to take part in a clinical trial.

 The potential volunteer should know of their rights for participating in a clinical trial. The general GCP rights are:Fully informed consent and voluntarily participate in a trial without coercionConfidentiality of their identity and health informationCompensation for trial‐related injury and for the time, effort, and expenses for their involvement in the studyMedical care for study‐related injury or intercurrent illness(es)The ability to withdraw from the study at any timeRights may be outlined in the consent form and/or in a separate document. In addition to GCP rights, sometimes rights are specifically stipulated by the institution or regional regulatory authority(ies).

 The potential volunteer should ensure that they receive a copy of the consent form that has been approved by an IRB/IEC to take with them to review before they sign the consent form. The consent form and any other subject information documents will be in a language that the potential volunteer can understand. They may review the consent documents with their family and friends and ask as many questions as they need to from the research staff at the clinic site, the IRB/IEC, or other sources to help them understand the information contained in the consent form. The subject should thoroughly understand the following, among other required elements of consent (Chapter 19 Informed Consent and Other Human Subject Protection):That the trial is investigational and no claims of safety or efficacy can be made about the investigational product unless already proven and/or approved by the appropriate regulatory authority(ies)Who is sponsoring the trial and who is the investigator and their contact informationThe procedures involved in participating in the trialWhat are the risks (side effects of all study procedures and study treatments, investigational or approved) and benefits for taking part in the trialWhat alternatives they have to participating in the trialWhom to contact in case of questions or concerns regarding study procedures, health, or rights issuesWhat happens if they experience adverse events or other harm from being in the trialIf, when, and how much they will be compensated for being in the trialThey cannot be coerced to volunteer for the trial and that their participation is completely VOLUNTARY and they may withdraw at any time