Consent Document

Consent document, consent form, whatever you call it—just the mention can send anyone involved in research into a diatribe. Most of those are not glowing praise. Whether you are at a site, a sponsor, an institution, an IRB or a consultant, it’s always a hot topic.
And well it should be, as it is a physical manifestation of the tenuous link between research and the subject. Without that link (or at least an appreciation for when it is not important), we have no research. If that link is corrupt, of course it taints everything. It is really unsurprising that each stakeholder of the complex enterprise we call research would have a vested interest in it. With so much riding on it, there is no wonder why it is in such shape.
Each of those stakeholders has a different use, a different perspective for that poor creature we call the consent document. Legal subtleties, complex and layered medical information, complicated procedures, esoteric risk and benefit percentage calculations and more are stitched together in a gerrymander Frankenstein’s monster. And after creating it, we chase it with pitchforks and torches.
There is evidence that its original, noble intent, to provide information to help the subject make a decision, is not even valid any more. At least today, most people make their decision to be in a study before ever being presented with, much less reading or signing, the consent document. For those that have not made their decision, the document is last, if even on the list of factors in subjects’ decision-making processes. Their underlying personality, their relationship with their doctor, their perspectives on research in general, the availability of treatment options and so on all are more important.
Again, are we surprised? No, not really. Those soft factors, while underappreciated, are fairly well documented with our current understanding of the psychology of human decision making. But well beyond that, we live in the information age. The current role of actual documents is much different than it was 10, much less 30 years ago. “Sign here” has become a one-click reflex instead of the rare and significant ceremony it once was. More and more every day, we are moving away from where we were. Think of yourself—how do you make decisions? If you wanted more information on something, would you a) ask your friend b) google it or c) look it up in a book, the manual that came with it, the agreement you think you remember signing etc. You might do all three: but if you did, you would get 15 answers on-line in 1/10th the time, and would value your friend’s opinion more. You can insert “doctor” for friend, if you want.
As you can see, I have my own pitchfork and torch. However, the problem is not the monster we have created, but the fact that we have created a monster. The link is still as important as it ever was, and stakeholder’s interests are as valid as they ever were. The great new is that most if not all stakeholders agree that a change is needed. There are a lot of really great discussions about and ideas being generated on how to improve the consent document, each with valid points. It’s a very exciting time, and I encourage you to join the conversation.
by Currien MacDonald, MD
Medical Director