Informed Consent Clinical Trial
Official title:
Informed Consent and Clinical Trials: a Survey on the Patient's Level of Understanding
To understand the patients' meaning of the informed consent process in clinical trials.
Objective of the study is:
- to assess, in a cohort of subjects included in clinical trials, whether the information
and the informed Consent Forms conveyed to the patients have been understood
- to assess whether the choice to participate in a clinical trial is informed and aware
Patient information and the Informed Consent Form (ICF) represent a focal point for an
informed and aware participation in clinical research. As required by the Declaration of
Helsinki no medical experimentation, including research on identifiable human material, can
be undertaken without the subject has previously been informed about many issues, including
goals, methods, anticipated benefits, possible risks and discomforts, commitment required
and the possibility of withdrawing from the study at any time without explanation. All this
information is essential to guarantee that the decision to enter a clinical trial is free,
well informed and aware. Only when patients have collected and understood all the
information needed, they are able to give their agreement to participate at the study and
sign the ICF.
An interesting element that identifies a deficit of understanding is the so-called
"therapeutic misconception". This term expresses the erroneous beliefs in which could incur
a participant to a study, on the therapeutic value of the experimental therapy. Recent
studies in the literature shows that a high percentage of patients agree to participate in
order to derive a personal benefit. This view contrasts with the main objective of the
clinical trial that has its own purpose just in obtaining new knowledge. While it is
understandable that a person would expect a personal benefit is equally important that he
would base his hopes on a solid rationale (i.e. expected benefits). Many other things, if
not carefully understood, can lead to the "therapeutic misconception", including the concept
of randomization, the risks related to the study, the time required to release his own
informed consent, the reason for which has been asked to participate. Even the
misunderstanding of just one of these elements may raise false hopes able to impact heavily
on the final decision.
During the Ethical Committee meetings of the Azienda USL di Bologna (local health authority)
all these points have been often discussed through the process of the RCT approval. For this
reason the Ethical Committee decided to carry out a survey aimed to better understand the
value and the meaning of ICF.
Initially, it has been conducted a literature review of studies, with particular attention
to on those published from 2006 up to date. The common objective of these studies was to
assess the understanding of the ICF by patients who were asked to participate in clinical
trials (research Medline, keywords: informed consent, comprehension, clinical trials). These
studies were in general survey conducted through interviews or questionnaires.
These studies have been conducted in cardiology, oncology, surgery, or treatment of pain.
The studies were phase I, II, III or IV. In general, the results from these studies raise
doubts on about the understanding of some important elements of the ICF. These doubts have
emerged also from an Italian experience reported in on a thesis of Master's Degree in
Economics and Management of Health Services. More in details, two studies have investigated
the understanding of the informed consent, with particular attention to the issue of the
"therapeutic misconception": in the study "Joffe", although 90% of participants were
satisfied with the process of informed consent, many of them would not have been able to
recognize non-standard cares of experimental treatments (74%), the potential additional
risks related from the trial (69%), and the scientific uncertainty of the benefits of
experimental therapy (70%). In the study "Bergenmar", even though 80% of the subjects feels
that they have understood the important elements of the research, it seems that 65% do not
recognize the experimental nature (not standard) of treatment, the 80% are not aware of the
potential additional risks, and 75% are not aware about the fact that the experimental
treatment is not scientifically proven to be the best treatment available. More significant
factors emerged from the literature review, for example a high percentage of patients (67%)
who did not live the process of informed consent as an important step to decide whether to
participate to the trial. A study of 21 patients revealed that many had recognized as the
main objective of the research the increasing of knowledge for the benefit of future
patients, but only for a few of them this altruistic motivation was an important element in
the final decision to participate.
The study promoted by the Ethical Committee of Azienda USL Bologna is observational,
prospective and cross sectional. An ad hoc questionnaire has been developed on the basis of
the literature available and through the discussion among Ethical Committee members, where
also lay people are represented. The questionnaire has been discussed with the clinicians
promoting clinical trials and tested with a group of patients enrolled in clinical trial.
The self-administered questionnaire in 20 items long.
The questionnaire will be proposed to a cohort of subjects who have signed the ICF for a
participation in an interventional clinical trial, not earlyer than 30 days have passed
since the ICF signature.
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Observational Model: Cohort, Time Perspective: Prospective
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