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Covid Clinical Trial Consent Forms Were ‘Ridiculous’ Legal Tomes (1)

April 28, 2021, 3:02 PMUpdated: April 28, 2021, 4:26 PM

Somebody needs an editor. Volunteers in Covid-19 vaccine clinical trials waded through paperwork that was longer and more complex than necessary and included ancillary information, according to a study published Wednesday.

An evaluation of informed consent documents from vaccine trials by Pfizer Inc., Moderna Inc., Johnson & Johnson and AstraZeneca, found these forms averaged more than 21 pages long and took about 35 minutes to read. The documents also required at least a high school reading comprehension level, even though multiple federal guidelines recommend a reading comprehension level of eighth grade or below.

The findings indicate pharma researchers continue to fall short of making the informed consent process easy for study volunteers. The goal is to make sure participants understand what will be done to them, how the research study is constructed, and that there may be risks or discomforts associated with the treatment. But the documents explaining these things cause eyes to glaze over even in high-stakes, high-profile studies and despite a major rewrite of federal rules that aimed to improve this process.

“Informed consent documents are really bad. And it’s not hard to improve them. But it does require a mindset, which is, ‘We’re going to try to make it as short as possible, as simple as possible,’” the study’s co-author Ezekiel J. Emanuel, a bioethicist and vice provost for global initiatives the University of Pennsylvania, said in an interview.

Informed consent is a critical component in protecting volunteers who sign up for studies. The documents must meet standards outlined in the Common Rule (45 C.F.R 46), which is designed to protect people who volunteer to be research subjects from undue harm. These agreements have morphed over the years into legal documents that research ethicists generally agree are far too long with too much jargon.

Irrelevant Material

For the Covid-19 vaccine studies, Emanuel and research coordinator Connor Boyle found irrelevant material in the privacy sections of all four consent forms. They also said people writing the forms may have prioritized the company’s legal protections over making sure the potential subjects actually understood what the studies were about and the risks and benefits of participating.

The authors sharpened their red pencils and wrote revised forms that cut the reading time in half. “We show that you could substantially reduced by two thirds, these informed consent documents, and make them much clearer, simpler, without any loss of content,” Emanuel said.

“The whole introduction is totally ridiculous,” he said, including a description of the origins of the virus in Wuhan, China. “Why is that at all relevant to whether I’m going to sign up for a vaccine trial?”

Emanuel initiated the Common Rule rewrite when he was a White House adviser during the Obama administration.

That overhaul aimed to improve the informed consent process. It included a requirement that key information must appear at the top of the form. But the Common Rule applies only to federally funded research so it’s unlikely that these vaccine studies had to follow it. The companies are subject to Food and Drug Administration’s regulations, which haven’t incorporated these changes yet.

Those revisions to the Common Rule also make the length of the rest of the form “less important than it used to be,” according to Jerry A. Menikoff, director of the Office for Human Research Protections at the Department of Health and Human Services.

“This ‘key information’ section provides the information most likely to help people understand the reasons why they might or might not want to participate in that research study,” Menikoff said.

“Of course, using simpler, clearer language in consent forms continues to be an important goal,” he added.

While the OHRP hasn’t issued specific guidance on how to meet the key information criteria, Menikoff pointed to examples provided to an HHS advisory panel on how to write this section. They can be found at Regulations.gov by searching: Document IDs: HHS-OPHS-2020-0003-0007 and HHS-OPHS-2020-0003-0008, he said.

Editing Skills

“I really don’t think it’s a regulatory problem,” Emanuel said. “I think it’s a practice problem” that requires empowering someone with solid editing skills.

Elisa A. Hurley, executive director of Public Responsibility in Medicine and Research, noted that the findings represent documents for just four studies, even though they are big trials involving more than 100,000 participants altogether.

It’s also unclear what transpired during the consenting process. There could have been visual aids with a robust conversation with question-and-answer period and an assessment of whether the prospective volunteer understood the study.

“It’s disappointing, but I wouldn’t want to paint one broad brush, which is like nobody’s working on this, or nobody’s getting any better at this. I think there are places that are,” Hurley said.

Some data suggest the length of the forms doesn’t impact comprehension too much, she added.

“That’s not an excuse for writing really long and incomprehensible forms,” Hurley said. “But it’s to say that I think the science of what good consent looks like has been going on for a while, and I’m not sure we have totally conclusive evidence about what it is.”

The findings appear in JAMA Network Open, which is part of the Journal of the American Medical Association network.

(Updated with comment from the HHS's Office for Human Research Protections in the 11th through 14th paragraphs.)

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloombergindustry.com

To contact the editor responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com

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