Better consent forms

March 12, 2020 2:42 PM

I'm a researcher who does clinical trials for PTSD treatments. In general, I'm trying to make the materials I give to participants more engaging, useful, visually pleasing, and accessible; meaning, not just the standard walls of text full of PhD-level research-speak. Right now, I'm trying to apply this concept to consent forms for a study of people age 14+, but am struggling because of how much information needs to be there for ethical reasons. I'm looking for examples of medical/research consent forms, that do this while thoroughly covering the important ethical bases, or suggestions from your experience of how to make consent forms better.

Note that I have a really intensive translation service for this project, so the forms can be translated to 80+ languages on the spot, and can be read aloud for people who cannot read. There are also special consent procedures for teenagers. But I'm aiming to make the most broadly accessible consent form possible aside from these special considerations.

posted by quiet coyote to Science & Nature (7 answers total)

Best answer: There's a key concept in accessibility for written materials that's (unsurprisingly) called "plain language." There are (U.S.) federal government guidelines for plain language that might be useful to you.

Also, accessibility.digital.gov has some resources on ease of interpretation for graphic elements as well more on plain language.
posted by mandolin conspiracy at 3:02 PM on March 12, 2020

Best answer: I do not do clinical research, but I do write consent form for public health research - mostly low and very low-risk surveys and interviews. We recently had a suggestion to put our consent information into a table - and along with shortening the sentences to more like bullet points, this helped us get our consent information down to one, not-too-dense page.

E.g.

Purpose of the Study | [Short text]
-
Funders | [Granting Agency]
-
Time Commitment | 15-20 minutes
-
Benefits | [helping better understand blah, blah, blah]
-
Risks | [for us minimal, maybe higher for you]

(only in a table format).

I don't know why we didn't think of it years ago - it's much more user friendly than the more text heavy forms we've used in the past.

Also, we don't have this consent on its own - it comes along with a "intro page" for the online survey which is relatively short and in lay-language. We've also traditionally bolded the most important parts of our consent - e.g. Your participation is voluntary, You can skip any question you wish, etc.

(You can me-mail me for more details if you are interested.)
posted by jb at 3:33 PM on March 12, 2020 [2 favorites]

Can you use infographics in any way to make it more accessible to visual learners? Like I'm imagining pie charts, those little bathroom sign type stick figures, stuff you might see at the reception/triage desk in an ER where lots of different languages are used.

(If that's not clear enough or you want help brainstorming visual ideas for your specific information, feel free to me-mail me!)
posted by carlypennylane at 6:04 PM on March 12, 2020

Best answer: Sage Bionetworks has a toolkit that may be of use to you, and some other open source resources can be found by poking around their website.

I’m an HRPP professional and will follow this thread with interest, and try to add more useful suggestions in the morning.

Cheers!
posted by mds35 at 8:41 PM on March 12, 2020

Response by poster: I made the table suggested by jb and then I remembered I usually do this kind of thing in Canva so made something in there, and then checked it against the plain language guidance linked by mandolin conspiracy. Then I reviewed the Sage Bionetworks toolkit linked by mds35 and was reminded to check readability, and got it down to 8th grade Flesch-Kincaid level. Check it out (deidentified version)! I'm thinking this will serve as an intro/summary page for the dense consent form that meets the requirements of my IRB and funder.
posted by quiet coyote at 10:14 PM on March 12, 2020 [3 favorites]

That's a great looking consent information sheet!

I don't think this is relevant for your population (younger), but if you're ever working with older people or people with vision issues, you may wish to avoid the light on dark text, and instead go for a relatively high contrast dark on light text. I've also had feedback from participants that serif fonts can sometimes be easier to read than sans serif.
posted by jb at 8:33 AM on March 13, 2020

I'm a medical writer, and this is exactly the type of thing that I do. I am also a PTSD survivor. Without the medical interventions I received to get me on the road to recovery from PTSD, I would not be here right now. If you would like me to consult for you, I will do so for free. Send me a message. I hold a PhD in Pharmacology, for what it's worth.
posted by sickinthehead at 4:43 PM on March 13, 2020 [1 favorite]