Many in the research world admit that informed consent forms are too long. Yet, it’s difficult to find agreement on what should be shortened or cut.

One new study has an answer that might appeal to most people who work in human research protection: eliminate repetition.1

“One of the main findings from our study is that consent forms are highly repetitious. The same information is presented over and over again,” says Amy Corneli, PhD, MPH, an assistant professor at the Duke Clinical Research Institute at Duke University School of Medicine in Durham, NC.

Stakeholders were asked to evaluate various informed consent forms. The forms ranged from 16 to 21 pages with 429 to 523 sentences. In each, study procedures was the longest content area, and risks and confidentiality was second.1

When investigators sought input on how to shorten the forms, they heard that people wanted the repetition reduced. Respondents also said the forms were too detailed and laborious.1

The investigators developed the following three main strategies:

1. Group study procedures by frequency. “Right now, in consent forms, investigators often list each study procedure that happens at every study visit,” Corneli says.

So if blood is drawn at weeks 1, 4, 8, 12, 16, then they’ll list “we will draw X amount of blood” five times.

“For informed decision-making, it likely doesn’t matter whether something will be done at week eight or 12,” Corneli says. “Potential participants likely just want to know that they’ll have blood drawn and how often it will be done.”

For instance, the informed consent form could read, “At most or at all of these study visits, we will…” and then list items, such as ask questions about the participant’s health, draw blood, collect a urine sample, etc. It also could describe what might happen at some of the visits.1

Since some research participants will want to plan their visits and know whether and when they’ll have invasive procedures, the informed consent can include this detailed information in a diagram. “The left side can have all study procedures, and columns can be for each week’s visit,” Corneli says.

This doesn’t have to be part of the informed consent form, but a table they can have as a reference.

2. Use appendices (if allowed). The study explored the use of appendices to provide participants with information that was not critical for informed decision-making, but which would be nice to know.

Tables, diagrams, and charts — such as the idea of a chart that outlines procedures at each visit — could be part of an appendix, Corneli says.

“We explored whether people would be accepting of putting detailed information in appendices, and, overall, they were supportive,” she adds.

However, the revised Common Rule does not support appendices in the informed consent document, Corneli notes.

Key information must be at the beginning of the informed consent document, and detailed information follows that information, she says.

Even if implementation of the revised Common Rule results in a ban on appendices in informed consent, IRBs and study sites still could include tables and charts as separate information.

“Make it clear it’s not new information,” Corneli suggests.

Instead, the tables and charts could provide additional details on the same topic to help participants prepare and plan for their visits, but not to aid them in their decision-making process about study participation, she adds.

3. Eliminate duplicate side effects. This strategy is to list side effects once, instead of listing them under each medication included in a trial.

“List all the side effects of each study medication, and remove those listed twice so participants are not distracted by listing the same side effect over and over,” Corneli suggests.

An informed consent form could read, “You will be randomly assigned one of these study drugs. Here are all of the possible side effects,” she says.

This strategy made a surprising difference in the word count in the study medication section of one informed consent form, cutting it from 944 words to 622 words. Also, the change was approved by most respondents, who said it made the side effects simpler and easier to understand.1

These three strategies were approved by greater than 90% of stakeholder respondents in the study.1

Researchers mainly looked for ways to shorten the informed consent form without removing information that some IRBs and sites would find necessary. The solution was to focus on repetition.

“Removing repetition to shorten consent forms is easier than saying, ‘This information is not needed,’” she notes. “There’s a strong consensus for these three strategies, and there’s a really high consensus to reduce the length of consent forms.”

REFERENCE

  1. Corneli A, Namey E, Mueller MP, et al. Evidence-based strategies for shortening informed consent forms in clinical research. JERHRE. 2017;12(1):14-25.