Templates could build better informed consent

Interactive tool is praised by users

Years of improvements to the informed consent process and many hours of developing tools and templates to assist IRBs and investigators in fine tuning informed consent documents have helped pave the way for Consent Builder.

Created by IRB experts, Consent Builder is the next generation of template documents, says Becky Armstrong, DVM, PhD, director of the office for protection of research subjects, University of California at Berkeley.

“The informed consent process is the point of contact between researchers and their subjects, and it’s where IRBs can have a fair amount of impact,” Armstrong says.

Launched a year ago, the Consent Builder application has been popular among researchers, especially those starting out, she notes.

“I received one comment from a graduate student who said, ‘Thank you — I would never have been able to write a consent form without it!’” Armstrong says.

The Consent Builder application is available to all investigators who work with UC Berkeley through a password-protected website. The software is not being copyrighted, so other institutions and IRBs can access it at a public site at http://ucb-rac.github.com/consent-builder/, she adds.

Building a simpler IC process

The IRB made a goal of developing better guidance documents and templates for investigators. About nine years ago, the IRB provided minimal information on its website about informed consent, including instructions to principal investigators (PIs) and a checklist, Armstrong says.

“We started by putting together general informed consent guidance and built from there,” says Louise Tipton, EdM, CIP, IRB administrator for the office for protection of human subjects at UC Berkeley.

Tipton led teams to develop guidance and templates for biomedical and social-behavioral studies. The guidance came to include sample consent forms for various types of research.

“We want to have a user-friendly website, and we try to provide all the materials researchers might need to answer their questions,” Armstrong says.

These efforts to promote a better informed consent process eventually led to developing the Consent Builder online tool.

Consent Builder is a user-friendly, interactive application that aims to improve the consistency, completeness, and readability of human research consent forms. The researcher moves through a series of screens, answering questions about the study and completing text boxes as instructed. Answers to questions help direct the next questions, skipping irrelevant ones. The researcher can then download the created consent form in Word. The Word document includes IRB standard language and formatting, and can be edited further if needed before submission.

UC Berkeley adapted the Consent Builder application from one that had been created a decade earlier at UC Irvine, Armstrong notes.

“UC Irvine had developed it in the early 2000s; then, as part of the National Institute of Health’s funding program to encourage human research protection programs to develop materials, share things, collaborate, and make the whole IRB world better, UC Riverside got Consent Builder from Irvine, and we got it from UC Riverside,” she explains.

After a long hiatus where the project was on backburner status, Tipton was assigned to work as the content source for Consent Builder, coordinating with two expert information technology (IT) programmers in the department.

“We had just gone through a major transition of moving our whole application to an electronic system ... so this was a good time to update the consent tools as well as get some staff resources for the project,” Tipton explains.

Initially, everyone hoped they could make minor adjustments to the application and then roll it out.

“It turned out there was quite a bit of reworking that had to take place on both sides,” Tipton notes.

“We had been working on it for five months when the programmers said, ‘The software is pretty archaic. We can keep working around that, but if you want this to be robust and flexible enough to allow for changes and adaptations in the future, then we should basically start over and rebuild it,’” she recalls.

“It made sense for the long term, so we agreed,” Armstrong says.

Keeping it “clean and simple”

On the content side, one important element was to have the investigator walk through the application and complete the fields; the program would adapt these answers, add standard language, and produce an informed consent document that could be further edited and adapted as needed, Tipton says.

The templates tended to be very long, so the goal for Consent Builder was to achieve simplicity and brevity as much as possible, she adds.

“The Consent Builder application goal was to have it clean and simple: You answer a series of questions after choosing biomed or social-behavioral or both for your type of research,” Tipton says. “Consent Builder was a very lengthy project; it went through a lot of adjustments and restructuring to try and reach that goal of simplicity.”

Even so, as Armstrong points out, the program has its limitations.

“It follows the flow of how we have written our templates,” she explains.

The informed consent templates and sample forms were created five years ago, and although they have been updated and improved along the way, they may be due for further refinement, Tipton says.

“We’ve tried to work on the language to make it simpler and more toward our goal of having a consent form that is at an eighth-grade reading level,” Armstrong says. “But we have to be realistic and not try to redo the entire system in the course of creating this one tool; so it’s similar to the templates we have, but with improvements in terms of readability and clarity.”

“In an ideal world with lots of staff time and resources, we’d update our templates to be more like Consent Builder,” Armstrong says.

For now, though, Consent Builder seems to be providing a valuable addition to the researcher’s toolkit, showing the way for future improvements to the consent process for investigators and subjects alike, Tipton says.