Informed Consent Isn't Broken — But It's Barely Working
By Dan Schell, Chief Editor, Clinical Leader
When I interviewed former FDA Commissioner Dr. Robert Califf, I told him I wanted to do something slightly different than the usual post-interview follow-up. Rather than just quoting him and moving on, I asked if I could point readers directly to the Substack essays (Should I call these essays? Articles? Nah, let’s stick with essays.) he’s been writing on informed consent in clinical trials and summarize them without giving away the full gist of each piece. Surprisingly (since he really didn’t know me or Clinical Leader prior to our interview), he agreed, which I was super psyched about!
Thus, what follows is my intentionally high-level take on Dr. Califf’s three-part series on ICFs. Think of it as a guided orientation, not a substitute. These essays are opinionated, thoughtful, and clearly written for people who live and breathe clinical research (and who are willing to question some of its most entrenched assumptions).
Califf makes the case that informed consent has slowly drifted away from its original purpose. What was meant to be a meaningful exchange between people has, in many trials, become a legally defensible transaction — one that often protects institutions better than it serves patients.
It’s interesting; he doesn’t sound like some former regulatory official scolding from afar. Instead, he really comes across as someone who has been in the room too many times, watched the same failures repeat themselves, and finally decided to speak up. (I’m sure it helps that he is retired and has no one to tell him what he can or cannot say.)
When Consent Becomes a Checkbox
Like I mentioned, Califf is steadfast in his belief that the ICF is both a legal requirement and an ethical obligation, yet in practice, he says, it often fulfills neither role particularly well. Consent forms have grown so long and dense that most participants cannot reasonably absorb them, let alone use them to make an “informed” decision.
This is not because researchers don’t care about participants. It is because the consent process has been overtaken by institutional fear. Over time, legal language, liability protection, and worst-case hypotheticals have crowded out clarity. As Califf puts it, the operating assumption has become simple: If it is written down and signed, it must be fine. Understanding is implied, not verified.
We Don’t Want To Talk About Uncertainty
In the second essay, Califf zeroes in on what he sees as one of the most underappreciated barriers to effective consent: the healthcare system’s discomfort with uncertainty. Clinicians are trained to project confidence, even when evidence is incomplete. Institutions market certainty as a competitive advantage. But clinical research exists precisely because we do not know which interventions work best, for whom, and under what conditions.
Technology Can Help … If We Let It
The third essay makes the case that many of the tools needed to improve informed consent already exist. Digital platforms, asynchronous learning, adaptive content, and AI-enabled interfaces could all make consent more understandable, more personal, and less dependent on a single, time-pressured conversation. But the informed consent process — or dare I say, experience — will not improve through better templates alone. It requires a cultural shift that prioritizes participant autonomy, accepts uncertainty as an honest starting point, and values communication as much as documentation.
And guess what … culture shifts suck (that should be a t-shirt). So, like everything in clinical research, improving this status quo is not going to happen fast or easily.
If this topic matters to you, I strongly encourage you to read his full Substack posts (links below) and even contribute to his Substack. I’ll also be posting summaries for some of his other clinical-research focused Substack essays, so stay tuned.
Dr. Califf’s Substack: