Research Participants May Misunderstand Medical Consent Forms

The average research participant does not have the reading ability to fully understand informed consent documents, creating vulnerability in what is intended to protect patients from abuse, according to an Anesthesiology News report.

According to a study presented at the 2011 annual meeting of the American Society of Anesthesiologists, consent forms examined in the study were written at a grade-11 reading level, compared to the grade-8 reading level recommended by IRBs.

William Tremaine, MD, director of the Office of Human Research Protection at Mayo Clinic, told Anesthesiology News that researchers obtaining consent for studies must give participants the opportunity to ask questions and clarify confusing parts of consent documents.

He added that consent forms should only constitute part of the informed consent process for research.

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