IRB: Ethics & Human Research
Readability of Consent Form Templates: A Second Look
We replicated our 2003 study that showed that IRBs’ template text for informed consent forms fell short of the IRBs’ own readability standards. In view of national attention to the issue of readability of informed consent forms for medical research studies, we hypothesized that we would see improvement in the readability of consent form template text, but that template text for HIPAA authorization forms – which became available after our previous study – would be highly complex. We also hypothesized that readability of consent form templates would be better at institutions that had been investigated by the Office for Human Research Protections (OHRP). A total of 106 Web sites of U.S. medical schools were surveyed to obtain IRBs’ readability standards and their template text for consent and HIPAA authorization forms. Data regarding OHRP investigation of possible non-compliance with research regulations was obtained from OHRP’s Web site. The reading level of consent form template text continues to remain high (10.6 reading level in 2003 vs. 9.8 in current analyses). HIPAA template text was written at a particularly high reading level. However, a recent history of OHRP investigation remains associated with medical schools providing consent form templates whose text more closely approaches their own readability standards. More than two thirds of institutions with OHRP investigations improved by at least half a grade level since 2003, while less than half without OHRP investigations improved by at least this margin. While some improvement in readability of template text was observed, IRBs commonly provide template text that falls short of their own readability standards.
Michael K. Paasche-Orlow, Frederick L. Brancati, Holly A. Taylor, Sumati Jain, Anjali Pandit, and Michael S. Wolf, “Readability of Consent Form Templates: A Second Look,” IRB: Ethics & Human Research 35, no. 4 (2013): 12-19.