What are four key areas to teach in informed consent?

Step 1: Make sure it's clear

Based on a survey of research participants, the office of research compliance and quality improvement at Cedars-Sinai Medical Center in Los Angeles, CA, has come up with these four key areas to demonstrate informed consent.

These four areas can be taught to IRB staff through the use of "good" and "bad" mock IC scenarios. Here they are:

1. Distinguish standard of care from research participation.

"This needs to be made very clear to research subjects," says Rebecca Flores Stella, CIP, manager for operations and education in the office of research compliance and quality improvement at Cedars-Sinai Medical Center in Los Angeles, CA.

Researchers need to do a better job of explaining the purpose of a study, she says.

In a mock informed consent scenario, the principal investigator should talk with the subject about what a phase I study means and what could be expected, Stella explains.

"You should talk about how this is the first time the investigational product is used in humans, and talk about the unknown nature of this product," she says.

In a bad IC scenario, the investigator might say, "You've used up all your options. This is pretty much all that's left for you," she adds.

2. Make sure the study's purpose is clearly communicated.

An IC scenario might have an investigator discussing how the subject's tissue sample will assist with research that might lead to an innovative treatment for a particular disease. The investigator would clearly explain how the study's purpose is to collect data for use later.

"Give the subject a better picture of the overall purpose of research," Stella advises.

In the bad IC scenario, the investigator might say, "If you give me your tissue, we'll find a new treatment for your disease," she adds.

3. Answer all logistical questions clearly.

Research participants often want to know the details of their participation in a study, including these questions:

  • How long will the appointments be?
  • Where do I park?
  • How many study visits will I have to make?

In a good scenario, the investigator will clearly answer these questions within the informed consent document and then also address them when meeting with the potential subject.

"The investigator will say, 'You'll have 22 appointments and six will be very detailed and long — up to four hours long,'" Stella says.

In a bad IC scenario, a study might entail 22 study visits, which would be a burden for most research participants. But instead of being straightforward with potential subjects, the study coordinator might say, "You'll come in and have a regular office visit, and that'll be that."

4. Clear up any confusion about who pays the bill.

"This is a huge issue," Stella notes.

The investigator could say to a patient, "These are the things we'd do with you as a patient, regardless of whether you're in the study," she says. "And these are the things that will be repeated or done additionally for the research so they won't be billed to you."