12. What do we know about the Consent Process?
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Consent: An Ongoing Process
Often in cancer clinical trials, people are first approached about trials soon after
diagnosis, at a time when they maybe vulnerable and not thinking as clearly as they
would normally. They maybe completely new to the health system and unfamiliar with
it, or experts who work in the system daily. They may wish for different amounts of
information and involvement in treatment decision-making. People coming through the
clinic doors maybe completely unaware of clinical trials or they maybe actively seeking
one. In most instances the initial approach about participation in clinical trials will be
made by the patient’s treating clinician. They will discuss the trial as a treatment option
during the consultation. After the consultation, the patient is likely to meet a clinical
research nurse or data manager who will also discuss the trial in more detail with the
patient, going through the written information about the trial with them too. Sometimes
patients may want to make a decision immediately, but it is common for clinicians and
research staff to encourage patients to take some time to think about the study and
discuss it with their family and friends.
Value
We know that in general patients place the greatest value on information derived from
the doctor. They see the doctors as the expert with their best interests at heart.
Verbal Consent
The information health professionals discuss with patients during consultations
contributes to their decision-making about treatment and follow-up after a cancer
diagnosis. At the time of diagnosis or change in disease status, patients are likely to be
feeling shocked or distressed. Their capacity to assimilate new information maybe
reduced. Their recall of information is likely to be low, and they maybe in an
environment or situation that is very new to them. Consequently, information provided
more than once, and possibly by more than one person, may help them to process
information. It is important that they have time to think about treatment options and to
discuss it with family and friends. This can help ensure patients understand the
treatment options they need to decide on. The discussion between patients and health
professionals is individual and confidential. The type and amount of information
provided by health professionals during consultations is not monitored. Consent to
clinical trials – the focus of consent becomes the written information provided,
however, it is important to remember that the Patient Information Sheets are only one
part of consent process. In an Australian study done in 1995, the researchers found that
only 80% of people participating in a clinical trial reported reading the information
sheet at all. The impact of information provided to patients about clinical trials on their
decisions to participate and other psychological or disease outcomes is unclear.
Gaining Consent Isn’t Easy
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Discussing trials and obtaining consent to participate is not easy. It is a complex and
nuanced discussion. Individual patients commonly find it difficult to understand
treatment options, have difficulty understanding medical research and making informed
decisions about treatment. Health professionals on the other hand find it difficult to
present treatment options clearly and without expressing their personal preference for
specific treatments. Consequently, they need to be conscious of their own biases and
monitor their own behaviour to avoid coercing patients. Sometimes it is easier to avoid
involvement in clinical trials completely.
Why Is It Hard?
Both patient and doctor factors contribute to the difficulty of obtaining consent.
Patients are often unfamiliar with the language or words used, the concepts that are
discussed and the methods or approaches to medical decision-making. They maybe
feeling vulnerable and emotional. They may also be in the role of patient conforming to
social expectations of their role and that of the health professional. It is unrealistic to
expect that patients will feel comfortable gathering information in reaching a decision
without that support. There are a range of ways doctors can enable participation.
Patient Misunderstanding
Sometimes patient misunderstanding can make clinical trial discussions even more
complex. For example, many people in the general community believe that
experimental treatments, or clinical trials, are only done when no other treatment
options exist. Offering them participation in a clinical trial may lead them to believe
their disease must be worse than they thought. Or as many patients believe their doctor
has their best interests at heart, when offered a clinical trial, they may think that the
doctor will make sure they get the best treatment. They are trusting their health
professional to do the best for them. But this type of thinking reflects a lack of
understanding about how treatment allocations are made, that is they do not understand
randomisation.
Why Is It Hard 2?
For health professionals, they have the sense that patients want expert guidance,
wanting the doctor to make the decisions about treatment as they are the expect rather
than the patient. Many have concerns about discussing medical uncertainty, or clinical
equipoise, which refers to a genuine uncertainty that one treatment is better over
another. Health professionals maybe uncomfortable with the concept of randomisation,
finding it difficult to explain to patients. They have worries about coercing patients to
participate in clinical trials and most health professionals have not been trained in
collaborative decision-making and how to go about it.
Gaining Consent
Identify the clinical trial concepts patients may find difficult
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Identify clinical trial concepts health professionals may find difficult
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