The cornerstone of Good Clinical Practice is protection of the patient – and this includes their right to appreciate just what they are letting themselves in for by taking part in a clinical trial.
Informed consent is one of the most important stages of any clinical trial – a fact thrown into sharp relief by the recent deaths of 254 Indian women from a control group in a trial of cervical cancer screening methods.
Those who died were deliberately given no screening so they would provide a baseline figure for unscreened populations. Given the indisputable benefits of screening, it seems extremely unlikely that any would have volunteered to forgo it had they been fully informed – thus the US-funded trial was deemed to have clearly been in breach of GCP & FDA informed consent rules.
However, informed consent is not always a straightforward thing to obtain. An explanation of the ins and outs of a trial and its risks may be totally clear to one participant but utterly baffling to another.
Key to good informed consent is matching the way the information is relayed to the participant – as Canadian philosopher Marshall McLuhan once said, “The medium is the message.”
What is an Informed Consent Form?
The main source of information to subjects considering taking part in clinical trials is the Informed Consent Form (ICF). An ICF is a document that requires a participant’s signature upon participating in a clinical research study. The document gives detailed information about the study the participant is considering, and ensures the health care provider has given complete information, including the risks and benefits of the study.
Clinical research is a complex subject and touches on difficult science. It is easy for researchers unwittingly to pepper the ICF with scientific terms and jargon – but this must be avoided at all costs.
Trials involving children, adults with impaired mental function e.g. Alzheimer’s, or those with little or no grasp of English are a challenge. Sometimes the best way forward is to have more than one ICF – each tailored to the audience. For example, one aimed at six-year-olds may have pictures in a cartoon format accompanied by an adult version for the parent(s).
There are a number of tools that the researcher can use to help them write simpler forms. Using Microsoft Word, for example, one can aim for a Flesch Reading Ease score of >60. (Here’s how you can test your document’s readability and find the Flesh Reading Ease.)
What information do you need to include in an Informed Consent Form?
1. What the trial is for and how it will be run
The participant must appreciate the trial is for research purposes, what its aims are, the nature of the treatments and the probability for random assignment to each one, the trial procedure (especially any invasive procedures), and which aspects are experimental. They must understand how long their participation is likely to last, roughly how many other subjects are involved, and the circumstances under which their participation (or the trial in its entirety) may be terminated.
2. The risks and potential benefits
They must grasp the reasonably foreseeable risks or inconveniences and the reasonably expected benefits (including any expenses or payment for taking part), plus any compensation or treatment available in case something goes wrong.
3. Responsibilities and confidentiality
Participants must understand their responsibilities as well as those of the staff running the trial. They must appreciate that their identity will remain confidential except that the monitors, the auditors, the IRB/IEC, and the regulatory authorities will be granted direct access to their original medical records for verification of clinical trial procedures. The participant will be informed in a timely manner if further information comes to light that may affect them. They must be told who to contact for further information regarding the trial and the rights of trial subjects, as well as in the event of a trial-related injury.
4. The voluntary nature or participation
Participants must understand that their participation is completely voluntary. They have the right to refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which they are otherwise entitled.
5. Additional information
The US FDA requires certain additional pieces of information depending upon the trial. These include: a statement that the particular treatment or procedure may involve currently unforeseeable risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), additional costs to the subject that may result from participation in the research, and the consequences of a subject’s decision to withdraw from the research.
The FDA also requires that the following statement be provided to each clinical trial subject: “A description of this clinical trial will be available on [http://www.clinicaltrials.gov/], as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
The full list of FDA ICF requirements can be found by following this link.
The IRB/IEC will pay particular scrutiny to the form as it is the main way to ensure and later prove that consent is freely given.
To learn more about how to simplify and improve your informed consent forms, watch our free, on-demand webinar, “Making Your Consent Forms Readable: The Why and the How.”