More Than 2,000 Consent Forms Posted Publicly
Creators of federally funded studies have been mandated to post informed consent documents on ClinicalTrials.gov ever since the revised Common Rule requirements became effective in January 2019. However, it was unclear how many or what kind of consent forms were posted — and who was posting the forms. A group of investigators set out to answer these rudimentary questions.1
“We wanted to put together a baseline analysis to get a sense of the types of sponsors that are posting consent forms, and for what types of studies the consent forms are being posted,” explains Sarah White, MPH, executive director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard.
White and colleagues analyzed data downloaded from ClinicalTrials.gov, noting the percentage of trials with a posted consent form by funder type. There were consent forms posted for nearly 2,100 trials from 600 mostly non-industry sponsors (as of July 2021). More than half those trials did not list funding by a federal agency. Some were initiated before the form-posting requirements went into effect. “This suggests that the consent forms were probably posted voluntarily,” White suggests.
In some cases, researchers might have posted consent forms not because it was federally required, but because the IRB required them to. “When there is a federal requirement, sometimes IRBs apply that across the board,” White notes.
White and colleagues intend to go further and assess other aspects of the posted consent forms. “But before we get into that, we thought it was probably a good idea to put data out there on who is posting the consents,” White explains.
Posted consent forms can be useful to researchers. “In the spirit of transparency, posting the consent form is terrific,” White shares.
Since consent forms are available publicly for anyone to view, it is extra motivation for investigators to be sure consent forms present information clearly.
“It’s one thing to meet the requirements in the Common Rule; it’s another to make sure participants understand the information,” White says.
Since the consent forms are in the public forum, it is possible the documents could be analyzed — or even criticized. “Someone could go in and assess, ‘Did the investigator draft, and did the IRB approve, a consent form that is missing some of the required elements in the federal regulations?’” White offers.
Just as people have used data from ClinicalTrials.gov to learn if all researchers have reported their results, the same is true of publicly posted consent forms.
“Researchers could run a readability scan of the posted consent forms and determine that the posted consent form was written at a reading level way higher than most people can understand,” White says.
For investigators, making all the terminology comprehensible to laypeople is a persistent challenge. “For a word like ‘randomization,’ it’s hard to put terms like that into plain language,” White notes.
Researchers also could scrutinize the eligibility criteria in the study. They might notice a subgroup of the population the researchers were trying to recruit spoke a language into which the consent forms were not translated. “There’s a tremendous benefit to having the consent forms out there,” White says. “On the flip side, people can go in and criticize them.”
- Tse T, White S, Gelinas L, et al. Characterization of informed consent forms posted on ClinicalTrials.gov. JAMA Netw Open 2021;4:e2135146.
Creators of federally funded studies have been mandated to post informed consent documents on ClinicalTrials.gov ever since the revised Common Rule requirements became effective in January 2019. However, it was unclear how many or what kind of consent forms were posted — and who was posting the forms. A group of investigators set out to answer these rudimentary questions.
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