Consent Builder relies on plain language templates

Key is use of sections, clear statements

The University of California at Berkeley’s Consent Builder application relies on the simplified language and template structure previously developed by the institution’s IRB office.

“We had to do a complete overhaul of informed consent guidelines and create more specific tools and resources,” says Louise Tipton, EdM, CIP, IRB administrator in the office for the protection of human subjects.

“We’ve had to emphasize that consent was not just a form,” she adds. “It’s a process of putting all of these elements together to have a completely informed individual who makes this decision.”

A standard sample consent form created by UC Berkeley’s IRB incorporates the elements of informed consent required by federal regulations on human research (45 CFR 46.116) and includes these sections:

  • introduction;
  • purpose;
  • procedures;
  • benefits;
  • risks/discomforts;
  • alternatives (if appropriate);
  • confidentiality;
  • compensation/payment;
  • rights of the subject;
  • questions;
  • signed consent.

The language in each section is kept simple and direct. Under “risks/discomforts” for instance, the information is presented in bullet points. An interview consent might say, “Some of the research questions may make you uncomfortable or upset. You are free to decline to answer any questions you don’t wish to, or to stop the interview at any time.”

Under the procedures section, a bullet point might explain a DNA testing procedure this way: “You will be asked for a cheek swab to sample cells for DNA testing. This involves briefly wiping the inside of your cheek with a cotton swab.”

The application resulted from several years of work at UC Berkeley’s IRB. The organization inherited a program called Consent Writer from a sister institution and adapted it by incorporating informed consent guidelines, biomedical and social-behavioral consent templates and sample forms, and using standard and recommended language for consent documents.

“Improving the overall informed consent process was a big milestone we needed to meet,” Tipton says.

Custom-built consent forms

The UC Berkeley Consent Builder features screens that ask the researcher a series of questions. The answers are used to generate an informed consent document that reads as clearly and concisely as the informed consent template in hard copy format.

One screen about the study purpose asks these questions:

  • What is the purpose of this research?
  • Briefly describe what the study is designed to discover or establish.

Another screen addresses inclusion criteria. It asks, “Why is the individual being asked to take part in this study?”

In other parts of the application, a researcher is asked to describe benefits of the study. If the researcher has not checked the “direct benefit” box in a previous screen, this screen will show standard language for a study that has no individual benefit to the subject, but does anticipate general benefits, such as benefits to others, society, and/or scientific knowledge: “No direct benefit to you is expected from participating in this study. However, we hope that the information gained from the study will help...” Researchers can add to and edit those words before clicking on “save and continue.”

The application also allows the user to go back and make changes to any screen along the way. The last screen of the Consent Builder asks if the user would like to generate a Word-format consent form now. This form will take all the answers that have been entered and present them as statements, along with appropriate standard language, in the generated form. If the answer is “yes,” a consent form in Word is created. The researcher then can save this form and do further editing as needed before submitting it as part of a protocol for IRB review.

In the year since Consent Builder was implemented, it has worked well, Tipton notes.

“In that time, there have been only a few occasions when someone has had problems accessing it, and the IT team fixed it right away,” she says. “And feedback to our staff analysts in the office and at our educational outreach sessions has been very positive. The result was worth the time and care we took to test it out and to make sure both the technical and content aspects were fine.”

However, the Consent Builder application will not be used with studies involving minors because of the more extensive requirement differences, Tipton notes.

“So if people are doing research with children, we refer them to our specific guidelines and sample forms for such studies,” she explains.

The Consent Builder application will be improved as users provide more feedback, she adds.

“There are still some improvements that need to be made, but it’s been a healthy system so far and has been helpful to our research community,” Tipton says. “We just hope that continues to be true.”