Let's Change Informed Consent and Make it Work

Since the Belmont report by USHEW in 1979, the practice of informing the research candidate about what will be happening to them in a clinical trial and gaining their freely given consent has focused on the presentation of a written document to the patient or research candidate with discussion by the principal investigator of the study or the physician conducting the research. As Verheggen and his co-authors report in a review of 25 clinical trials, this method does not insure that patients understand what will happen, the risks involved or their alternate medical options.

As a result of the patient's lack of understanding about the clinical trial, clinical research takes longer and is more expensive as candidates refuse to enroll or dropout after being enrolled in the study. For the pharmaceutical and medical device industries, candidate dropout and refusal increase trial cost and delay the development of effective therapies. Much of this may result from the use of a purely text approach to presentation of information.

Many consent documents are written at a high literacy level. However, the National Assessment of Adult Literacy reports that over 93 million US adults are functioning with basic or below basic literacy skills, indicating that many simply have no idea what is being proposed for them. With the increase in easily available web-based interactive media, a consent document for a clinical trials can become an information and educational tool that will truly inform the candidate and decrease research participants lack of understanding about the goals of research what it can and can not do for them and how they will be involved.

The use of an electronic document opens up the door to increased candidate understanding. Audio tracks in one or several languages can be added, thus increasing understanding for those candidates reading at a lover level than that of the document. Media elements can be easily embedded for education, knowledge assessment, and explanatory purposes.

For the research organization, real time documentation of candidate use of the consent document, through web tools that track time and date use of the consent document, can provide assurance that the candidate did indeed hear and see the information. Embedded interactive quizzes provide feedback on candidate understanding of their involvement in the clinical trial.

Although the vast majority of clinical trials use paper based consents, the rapidly increasing use of mobile media by all segments of the population suggests that a turn to media for consenting will provide a boost to clinical trials by increasing understanding and decreasing costs.

Citations

Verheggen F, Jonkers R, Kok G. Patients perceptions on informed consent and the quality of information disclosure in clinical trials. Pt Ed & Couns 1995; 29:137-53.

Belmont Report http://ohsr.od.nih.gov/guidelines/belmont.html

National Assessment of Adult Literacy http://nces.ed.gov/naal/