The new Common Rule puts forth a reasonable person standard for informed consent (IC). IC forms should provide information that a reasonable person would like to have and that would help an informed person make a decision on whether to participate in a study.
The reasonable person standard comes from tort law and criminal law about negligence, says Rebecca Dresser, JD, professor of law emerita at Washington University in St. Louis. Dresser also is the author of the book Silent Partners: Human Subjects and Research Ethics, published in 2016 by Oxford University Press.
“When you’re thinking about whether somebody harmed somebody else — not intentionally — should they have been aware it was risky?” she explains. “In law, you’re supposed to judge that — when should a reasonable person have known that driving in this way was risky and there was a possibility of hurting someone? So a reasonable driver wouldn’t have done this.”
Traditionally, the judgment is made by the jury, peers of the defendant. In the research world, there are no juries — only IRBs to assess ethical considerations.
“How are we supposed to know what reasonable people should know?” Dresser says. “Most direct comparison comes from law on informed consent in medicine.”
Most cases involving lawsuits and medical or research issues do not go to trial. They are settled after lawyers on each side and a judge sit down and decide on a reasonable way to settle the claims, she says.
“They make implicit judgments on whether the standard was met, based on their own intuition,” Dresser says.
One way for IRBs and researchers to determine whether informed consent meets the reasonable person standard is to ask themselves these questions of the informed consent document: “What is it you wish you had known, and what is it you didn’t really need to know?” she says.
The informed consent should be designed based on those questions, and IRBs can assist.
Another way to improve informed consent according to the reasonable person standard is to seek empirical evidence of what people want to know when they read an informed consent, Dresser says.
“Members of the public can give you some information, but you can get better information from people who have actually been in research,” she says. “They can say, ‘I went through this cancer study, and this is what I wish I had known.’”
Focus groups and surveys of former research participants can help obtain useful information.
“Don’t ask them whether they want to be in a study or not,” Dresser says. “Ask them about what they would want to know, every facet of research, because we need to know about their perspective.”
The same strategy of seeking input from research participants also can be used when creating broad consent related to studies using biospecimens.
“Give them background information about the signs and ways and information about how biospecimens can be used in research,” Dresser says. “Even if you just say it’s for cancer research, there are different variations in that.”
For instance, some potential research participants will not want their samples used in reproductive research where they are creating embryos, she says.
“With both general informed consent and broad consent, there is room for more targeted research to survey what we have now and what we don’t have a lot of information on — so let’s do surveys, interviews, and focus groups,” Dresser says.
“Some people say about this new Common Rule provision that maybe this is an opportunity to remind ourselves that this is what we’re supposed to be doing,” she says. “We’re not targeting research to doctors and researchers, we’re targeting it to people who don’t have that background. So where can we find out more about what kind of data we need to help us get better at this?”
Here are some of the questions non-research people might want to know:
• Will the study’s findings be used by a for-profit company or by a not-for-profit organization?
• Will someone tell me if the study changes, and how will they contact me?
• Who could I call if I see something in the study that I do not like?
There is qualitative data. The drawback is that the various research studies about informed consent have not been comprehensively reviewed. “People do these wonderful studies and publish them, and then that’s it,” Dresser says. “No one is saying, ‘OK, let’s do a mega study on everything we’ve found out and put it in digestible form so IRBs and researchers can use it. That’s the missing step.”
The bottom line is that IRBs might decide under the new Common Rule that they need to do more than what they previously did to apply the reasonable person standard.
“People on the IRB are thinking of what they would want to know or what the people they know want to know,” Dresser says.
“IRBs have been trying to use the reasonable person standard, and it’s been speculative and informal rather than evidence-based.”