Last month, we commented on the need for personal, ongoing contact in the overall informed consent process. This month, we return to the informed consent form (ICF) itself.
Of course, every ICF must explicitly contain or cover certain basic required elements of informed consent (21 CFR 50.25 and 45 CFR 46.116). Other elements are required if applicable, while still others have the status of recommendations or best practices. Aspire reviews every consent form to ensure that it includes what is required.
On a client’s request, we (actually, I, the Medical Director) will draft the ICF for a small fee. In that case, we will use a client’s preferred template, if requested, or we are happy to use a lovely template, complete and written in plain language, that was developed by my predecessor, Dr. Currien McDonald.
I like that template because it is simple. Anyone who has spent any time around clinical research knows well the ideal that ICF’s be written at an 8th-grade reading level—and also knows well how elusive that ideal is. To anyone in that group, I recommend our template. (I can’t say we’ll just send it to you—you probably need to be using our services first.)
We see many ICFs from experienced investigators or well-honed industry clinical trial departments. They are typically complete—or almost—and usually complex. Despite that, many appear to be made as readable as possible. But we still see too many ICFs that read as if they had been written by one of three groups—lawyers, bureaucrats in Brussels, or the Solenoid Robots. (The Solenoid Robots were the nerdy villains on the old Roger Ramjet cartoons when I was a kid. They were kind of like a bunch of malevolent Sheldons.)
As I mentioned in last month’s post, leaders of one session at the December 2011 meeting of Public Responsibility in Medicine and Research (PRIM&R) commented that most adults understand and follow medical instructions poorly, if at all. ICFs often look like intimidating legal contracts. Some 40 million Americans cannot read complex texts and, in one study, 60% did not understand a “standard consent form.” Media tools, “teach back” techniques, and just proceeding slowly and in simple language can help a subject navigate an ICF.
Moreover, it was said at PRIM&R that subjects want the following from consent documents:
· An up-front explanation of their role in research and their rights as a subject;
· Simple language and format; and
· Separation of the important from the unimportant. (Emphases mine in these bullets.)
We at Aspire appreciate that an ICF has already been labored over extensively before it is sent to us for review—and, in industry, that labor includes several rounds of review and efforts to comply with internal SOPs. Therefore, we do our best to avoid unnecessary editing or rewriting. But we do plead with clients to use simple organization and sentences in their ICFs, and focus on the most important things. In particular, we will ask for revisions in two cases:
1. An over-reliance on technical, medical terms (e.g., without defining or replacing them with everyday terms); and
2. A “data dump” approach to listing risks, that does not clearly identify the risks that are expected to be a) most likely and b) most serious. Believe it or not, we see some risk sections that look like unedited SAS outputs from a safety database.
Finally, there are a few edits that we will habitually make, either because they are required or they have become routine for Aspire IRB:
1. Subjects will receive a “signed and dated” copy of the ICF.
2. For FDA-regulated research, in the section listing parties with access to confidential information, the letters “FDA” or the words “Food and Drug Administration” will be in the final IRB-approved ICF.
3. We routinely edit risk-related generalizations like “As with any drug…” [e.g., allergic reaction may occur]. The issue is not ANY drug, but the STUDY drug.
4. We delete “yet” from statements like the following: “[The study drug] has not yet been approved by the FDA.”
5. We revise phrases that sound like the subject is responsible for his or her own safety, e.g., “ you may harm yourself,” e.g., if study instructions are not followed. We prefer something like, “you may be at increased risk” for adverse effects.
6. We look carefully at statements that imply or mandate subject “understanding,” preferring statements to the effect that the subject has received the information and has had sufficient opportunity to ask questions, and is aware of the voluntary nature of consent. “I understand the study” is too tall an order.
7. If a required clinicaltrials.gov statement is missing, we’ll insert the prescribed wording.
8. PLEASE don’t just cut and paste a bunch of study procedures, in third-person language, from the protocol document (“subjects will ….”). That’s not sufficient, and we’ll edit it. Speak to the subject.
