Why informed patient consent is vital for successful clinical trials
Informed consent is vital for any clinical trial. However, the length and complexity of consent information can lead to patients misconstruing key points and failing to understand the implications of participation. If this is the case, can we truly call it informed consent?
To improve the consent process, we need to explore potential participants’ ideas, concerns, and expectations. We need to make written materials accessible and understandable and adapt to changes in the information environment.
Informed consent should be much more than just trying to get a signature on a piece of paper. It should be a process that empowers patients while ensuring they feel supported by healthcare professionals and site staff.
The complexities of consent communication
Clinical trial consent information deals with incredibly complex topics. Depending on the phase, the trial may, or may not, have a personal clinical benefit for the patient. There may be uncertainties about the likelihood of side effects. Patients need to understand potential burdens, including increased hospital visits and tests. However, the proportion of trial participants who understand different components of informed consent varies from just over half to three quarters. The lowest levels of comprehension are around placebo (53.3%) and randomisation (52.1%). The highest is for freedom to withdraw (75.8%).
There are also emotional factors to consider. The personal values of individuals have a huge role to play in any health-related decisions. We cannot make assumptions about what risks a person is willing to accept, how they want to receive information, or their comprehension ability at a given point.
For example, in one study patients receiving a cancer diagnosis appeared to use various defences to protect them from fully engaging with the knowledge they were given. Their accounts of what they wanted to know could be affected by both the desire to protect themselves and their families from distress and the practical need for information over time. While this study looked specifically at initial oncology consultations, many of the communication challenges around distress and lack of understanding are transferrable to clinical trials.
Healthcare professionals and patients can also interpret interactions very differently. A research study I took part in, for example, found there was a misunderstanding among some doctors that patient centredness involved leaving the patient to make all the decisions. However, patients complained about this approach. They said they had no idea what to do, were not the experts, and wanted help.
The risks of poor consent comprehension
The initial risk from poor comprehension of consent materials is that patients become overwhelmed and choose not to participate in the trial at all. This could disproportionately affect those with low health literacy or who experience language barriers, potentially reducing participant diversity.
The second major risk is that participants will enrol on a trial without fully understanding the burden it may place on them, the chances of their treatment working, or even how to be compliant. This can lead to a loss of trust in healthcare professionals and site staff, lower compliance, and failure to report side effects or seek help when needed. Some patients may even decide to drop out of the trial completely, impacting data quality and quantity and threatening the potential success of the trial.
Informed consent has been an unchanging principle in the ethical principles of medical research since The Declaration of Helsinki in 1964. There has been justified outcry over historic cases like that of Henrietta Lacks. Yet, too often we are still exposing ourselves to risks and failing to meet our ethical responsibilities with consent processes that are not fit for purpose.
Improving informed consent communication
Informed clinical trial consent is ethically and legally complex. However, there are things we can do to improve the consent process and, hopefully, outcomes for both patients and the research community.
In 2022, the i-CONSENT project published a series of validated recommendations to improve the informed consent process. The idea was that informed consent should be viewed as a process which begins the moment a potential participant receives information about a study. The recommendations included:
- Adapting the informed consent process to meet the needs of participants.
- Presenting information, which may or may not be combined with new technologies.
- Using new tools to improve communication skills.
For anyone who wishes to start improving how they communicate with potential trial participants, here are some top tips:
- Start by gathering information. This should include the patient’s current level of understanding about their diagnosis, their desire for prognostic information, and how involved they want to be in the decision-making process.
- Understand the true meaning of person centredness. Provide clear and timely information and support patients to make informed decisions. This does not mean leaving the patient to make their decision alone.
- Encourage patients to ask questions. It can help to use visual aids. For example, showing patients their scan images can promote question-asking and help support information exchange.
Truly informed consent is vital for the success of clinical trials. By placing patients at the heart of consent, and strengthening our own communication skills, we can improve outcomes for not just participants, but the wider healthcare and research system.
References
