A review of informed consent forms for major Covid-19 vaccine trials found the documents to be far too long and complex for most trial recruits to easily understand, averaging more than 8,000 words, or around 30 pages.
The quality improvement evaluation of phase III randomized trials involving the AstraZeneca, Johnson & Johnson, Moderna, and Pfizer vaccines—which collectively enrolled more than 100,000 people—found that the informed consent documents did not follow federal guidance calling for information to be conveyed in a manner that is easily understandable by the average study participant.
The findings highlight longstanding issues with written informed consent, and researcher Ezekiel Emanuel, MD, PhD, of the University of Pennsylvania Perelman School of Medicine, and colleagues, called for reforms that would “eliminate verbose and irrelevant material.”
The study was published online April 28 in JAMA Network Open.
“These forms are just written badly. There is just so much unnecessary information in them,” Emanuel said.
He told BreakingMED that it would take the average person around 35 minutes to read one of the written consent forms reviewed in the study. All four of the documents were written at a 10th grade or higher reading level, despite the fact that federal guidance recommends clinical trial informed consent forms not exceed a grade 6 reading level.
When the researchers wrote their own informed consent document covering the same relevant topics addressed in the reviewed documents, their version ended up being less than 3,000 words written at a 7th-8th grade reading level.
“It is certainly possible to make these forms less complex and more understandable, but researchers have to commit to doing it,” Emanuel said. “The hope is that the research advocacy community—the patient groups out there—will demand better.”
He said the research team decided to examine the Covid-19 vaccine phase III studies because they represented some of the most high-profile clinical trials conducted within the last 5 decades.
The four informed consent documents had a mean word count of 8,333 (7,821-9,340) words, and the mean time to read them was 35 (32.6-38.9) minutes, at a reading speed of 240 words per minute.
All of the documents exceeded a grade 9 reading complexity level and scored lower than 60 in the formal reading ease metric (Flesch Reading Ease Score). Just one of the four documents addressed whether participants in the placebo group would be given the opportunity to receive the active vaccine.
The researchers provided examples of how the complex and unnecessary language could be dramatically simplified.
The study purpose was stated as follows in one of the documents:
- “Coronaviruses are a large family of viruses that cause illness ranging from the common cold to more severe disease, such as Middle eastern respiratory syndrome and SARS-CoV. Coronaviruses are zoonotic, meaning they are transmitted between animals and people. An outbreak of Covid-19 caused by the 2019 novel coronavirus SARS-CoV-2 began in Wuhan, Hubei Province China in December 2019 and has spread throughout China and to over 200 other countries and territories, including the United States. There is currently no vaccine that has been shown to be effective against SARS-CoV-2. Therefore, there is an urgent public health need for rapid development of novel interventions to prevent the spread of this disease. This study is testing mRNA-1273 study vaccine at a dose of 100 μg. The main purpose of this study is to understand if mRNA-1273 can prevent Covid-19 and to understand the safety of the mRNA study vaccine.”
Emanuel and colleagues noted that the study’s purpose could easily have been simplified to the single sentence:
- “This study will test a vaccine against the virus that causes Covid-19.”
Likewise, the language addressing risk in the document noted that:
- “As in all research studies, the Covid-19 vaccines may involve risks that might be expected based on results from studies of similar vaccines, as well as risks that are currently unknown.”
The researchers rewrote the risk statement to read:
- “This vaccine may cause currently unknown risks.”
“Why do we need to go back to Wuhan and spend hundreds of words explaining where the virus was first found? That’s just nonsense,” Emanuel told BreakingMED.
In commentary published with the study, Stefan C. Grant, MD, of Wake Forest Baptist Comprehensive Cancer Center, Winston Salem, North Carolina, wrote that the study by Emanuel and colleagues “should be recognized as a wake-up call to sponsors, investigators, institutional review boards and regulators to reevaluate how consent forms are drafted, reviewed and used, along with reappraisal of the entire consenting process.”
“After decades of largely fruitless effort, an acknowledgement of the seemingly insurmountable challenge of drafting sufficiently detailed but easily readable and not overly lengthy documents would allow the re-imagining of the entire consenting process,” Grant wrote, adding that key changes could include “placing even greater emphasis on the discussion component of the consent process while deemphasizing the role of the consent form, a greater use of multimedia and other technology, more formal scripting of consenting discussions, mandatory documentation of confirmation of adequate comprehension by study participants, and even regulatory reform.”
“Such an appraisal and revision to the process would be neither simple nor without cost, but if history is any guide, failure to act is likely to lead to having the exact same conversation a decade from now,” Grant concluded.
- A review of informed consent forms for major Covid-19 vaccine trials found the documents to be far too long and complex for most trial recruits to easily understand, averaging more than 8,000 words, or around 30 pages.
- Researchers found that the informed consent documents did not follow federal guidance calling for information to be conveyed in a manner that is easily understandable by the average study participant.
Salynn Boyles, Contributing Writer, BreakingMED™
Funding for this study was provided by the Colton Family Foundation. Emanuel reported receiving personal fees from the Center for Neurodegenerative Disease Research, Genentech Oncology, Council of Insurance Agents and Brokers, America’s Health InsurancePlans, Montefiore Physician Leadership Academy, RAND Corporation, and others. Grant reported having equity in and serving as General Counsel of TheraBionic.
Cat ID: 190
Topic ID: 79,190,502,728,932,730,933,190,926,192,927,151,587,928,925,934
