Informed Consent: A Look at Multi-Media Usage and Timing

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By Beth Harper, President, Clinical Performance Partners

We had an overwhelming response to our November webinar on the topic of the art of conducting an effective informed consent discussion. As a follow up, here are answers to some of the most popular questions focused on the use of multi-media and consent timing.

Multi-Media, e-Consenting and Enhanced Consent Forms

Q: On the topic of enhanced consent forms, how have regulatory agencies & IRB’s responded to alternate formats such as newsletter/newspaper style, inclusion of pictures, etc.? Do these met with resistance or acceptance?

This is a great, but very broad question, and I can’t speak to the specific opinions of any regulatory agency or all IRB members. That said, there is a plethora of research on the need to improve patient understanding in clinical trials and a recognition from all stakeholders, I believe, that the current lengthy documents are not sufficient for enabling subject understanding. Generally speaking, in my experience and based on what has been published and presented at various industry conferences there is a growing appreciation for the various ways in which the patient education experience can be enhanced and that the organizations that are piloting different approaches are having good success.

Q: Are you seeing a trend to move towards electronic based consenting and would have concerns that it is not face-to-face?

I believe that the companies offering e-consent solutions are starting to get some traction conducting pilot projects. It is my understanding that these organizations really view the e-consenting process as a supplement to, not a replacement for, the discussion with the investigator and appropriate site personnel. Depending on the audience and when, where and how the e-consent is presented, this provides an opportunity for the patient to view a visually enhanced “storyline,” confirm their understanding at various points along the way through different types of knowledge validation questions, and also provide an opportunity for the patient to note any questions along the way. Then, when the e-consent is reviewed jointly by the prospective subject and investigator, the investigator can readily see the areas of confusion so that these sections can be reviewed in detail. Further the e-consents have different tracking and e-signature features but from a patient education perspective, the thinking is that this can help to quantify the patients’ understanding through the knowledge validation features and help to focus the live discussions on the topics of greatest concern or confusion for the patient.

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Consent Timing

Q: What if the type of disease the study is looking at does not permit multiple contacts for a consent process?  Like a stroke study where they need treatment within a few hours?

These are particularly challenging situations where having a well-orchestrated process and well-rehearsed messages really comes in to play.  Knowing who will approach the subject and family members with what type of information, what “leave behinds” and clearly articulating the critical time windows in which they have to make the decision are especially important. In my experience, these scenarios particularly require the investigator to make the initial approach to set the stage for the importance of the trial and the critical nature of a timely decision.  With all of the stress and pressure the patient and family are under, having the reassurance of the physician is often a key ingredient.  Once the physician has a sense of the mind-set of the family he or she might then be able to introduce the patient / family to the research nurse, coordinator or other members of the study team for additional information.

Q: Do you find that with a modified approach, that informed consent discussions last longer during a screening visit?

This is a hard question to answer as the patient education and consenting process really varies so much by type of study, the individuals involved and the approach.  As noted above, for acute care situations sometimes there is only “one shot” at the consent process.  In other situations, the patient education approach may need to be staged over multiple visits with just the candidate and/or including family members or other key stakeholders (e.g., a follow-up call to the personal physician).  Depending on the educational level of the subject, the actual discussions may last from 20 minutes to several hours and this may need to be broken up into smaller bite size pieces of information, supplemented with various visual aids and the like.  I am not aware of any systematic research that has actually documented what is and isn’t an appropriate amount of time to spend per se, but the meta analysis study described in the Summer 2013 issue of BMC Medical Ethics which I discussed in the webinar (http://www.biomedcentral.com/1472-6939/14/28), speaks more broadly to the value of enhanced discussions but didn’t get into the specifics of how much time this actually takes per se (or not that I am aware of).

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