Delivering informed consent old school style
Keep these elements in mind when using print
As informed consent documents continue to get longer and more complex, be prepared to challenge old ways of thinking — even when using print. "Simple formatting issues we take for granted need to be challenged," says Matthew Baker, president and CEO, Compass IRB, LLC, Mesa, AZ. "Determining whether these elements are adding benefit or taking space is a critical issue in keeping informed consent documents from becoming needlessly lengthy."
Baker presented several formatting suggestions at the 44th Annual Drug Information Association meeting in Boston, MA, to consider in developing an informed consent document:1
1. Headers and footers: "Too often there's just way too much information in the headers and footers," Baker says. "We understand that version control is very important, but how you format this information might save a couple of pages. And it may be something you can work out internally so as not to confuse the subjects if they're presented with, say, version 6."
2. Bullets: Bullets can be a real space eater. White space can be good, but try to balance that benefit to what it will do to the length of your document.
3. Margins and spacing: Again, there's a fine line to walk when it comes to margins and spacing. Creating a shorter document with serious readability concerns is not going to add benefit.
4. Section breaks: "Our IRB and editors always ask us not to put in section breaks," notes Baker. "They're so hard to format and we know that these documents are going to be changed and adjusted."
5. Signature lines and subject initials: "Be careful and assess what is really needed," advises Baker. "Sometimes I think we see forms that have been cut and pasted together without thinking about the requirements of the protocol and the informed consent. Think about who is going to be signing the document. If a parent, witness, or surrogate is needed, then it should be there. If not, it's just taking up space.
"We see much the same thing with subject initials. Initials can be positive, but if a subject misses page 26," cautions Baker, "there's the potential that this will create even more documentation."
Reference
- Radical ideas for transforming the informed consent process. Presented at the 44th Annual Meeting of the Drug Information Association; Boston, MA; June 26, 2008.
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