Concise without compromise: clinical trial consent forms need reader-friendly revamp
The report, recently published in the open-access journal PLOS ONE by Christine Grady from the NIH Clinical Center, US, and her colleagues, found that brevity does not beget a clear understanding of study information.
“We are always looking for ways to improve the informed consent process, and especially understanding of study information among research participants,” Christine Grady from the NIH Clinical Center and study author told Outsourcing-Pharma.com.
Recently, as a substudy of a randomized trial of when to start antiretroviral treatment in HIV infection, Grady explained researchers randomized sites that enrolled more than 4,000 participants to receive either a standard consent form or a more concise, simpler form.
The researchers then measured participant understanding of randomization and overall study information, as well as satisfaction with the consent process as a whole.
“We found no significant difference in understanding, in satisfaction, or in voluntariness between those participants who received a standard form and those who received a concise form,” said Grady.
However, some factors were associated with better understanding, such as education and mailing consent information before the consent visit.
“Moving forward, we suggest consent forms should be more concise and written at a lower reading level, so that they are user-friendly and easier to read and review,” said Grady. “More concise does not compromise understanding.”
While the researchers note the study only examined one type of concise document in a single trial, it is the largest test of its kind to date – and supports continued efforts to improve the informed consent process.
