"I don't have the energy to read it. This is fine."
As a member of an Oncology Research Ethics Board, I have just slogged through another 30-plus-page consent form intended for patients being considered for a cancer-related clinical trial. And this doesn't include the optional tissue consent.
I read this particular consent form three times, and I still didn't get it, though I consider myself of average intelligence. I finally grabbed a super tall triple espresso and drew a table to clarify what would happen when with each drug, and which part applied to which patient cohort. As I was doing so, I found myself questioning the value of the document as an informed consent. I would love to see a study on this -- perhaps a post-consent assessment of whether patients really understand what the study was about.
After reading numerous pages that undoubtedly were written at the eighth-grade level, I can't imagine patients would understand the purpose of this convoluted multi-arm trial. Part of the problem, I think, is that 30-page consent forms have become the norm, so we no longer question the user friendliness of an informed consent. Another part of the problem is the complexity of trial design these days. Consider the individual who doesn't read very well or very much. For this individual, the burden of reading through 30-plus pages of medical lingo would be exhausting at best and impossible at worst.
To cover any possible lack of understanding, one section of every consent includes the following statement: "Please ask your Doctor if there is anything in this consent you don't understand." What if you don't understand most of it, or even all of it? Would the embarrassment of not understanding what the heck these people are talking about prevent you from asking these questions? When all other options are gone, would the fear of being denied treatment through a clinical trial prevent you from asking about it? Given the option of participating in a trial and perhaps even being cured, would you stop to ask questions about what you don't understand? Or would you trust the doctor and just go for it?
My suspicion is that patients would just go for it, due to a fear of being embarrassed, a fear of being excluded, or blind trust that someone else understands. One patient once told me, "My chemo brain doesn't retain any information after the first few pages. I'm sure the doctor knows what she's doing."
What do we do about this? We all know it is important to provide comprehensive information to patients considering participating in trials, but 30 pages? I would propose a few things:
- Stop complicating things. Trial design has morphed into a melting pot of methodologies. I remember the good old days, when a phase 1 study was a phase 1 study. You completed the trial, looked at the data, and then designed phase 2. Now we have all manner of trial designs melted into one. Phase 1/2 trials are the norm, and phase 2/2b or 2/3 are becoming more common. Whether this is to reduce costs or save time, I don't know, but I long to see the clean, crisp design of phase 1 followed by phase 2 followed by phase 3 again. This way, patients would be handed a consent form covering only the part of the study in which they are participating. They wouldn't need to wade through the ifs, ands, or buts of a multi-phase trial, 75 percent of which doesn't apply to them anyway.
- Don't try to study too much at once. Combining multiple agents with multiple designs and various sets of inclusion/exclusion criteria is a recipe for confusion -- not just for the patient, but also for the staff involved in the research.
- Go back to basics. Start with a simple overview of the purpose of the study and what it means in the context of that one patient group only -- in plain, eighth-grade language. Perhaps even find a few eighth-grade volunteers to check it out.
I know that research and development is costly. Nevertheless, if we truly want patients and families to understand what we, the researchers, are asking them to commit to and why, then we need to deconstruct some of the complexities that have become the norm in the name of time and money.