Writing readable consent forms: how useful is the advice given by IRBs?

Institutional review boards (IRBs) often provide researchers with advice about how to write readable consent forms (CFs) for human subjects research. This work reports on the type, amount, and accuracy of advice given on 30 IRB Web sites. Our findings suggest that this advice, while well-intended, is often weak or uneven in one or more of these areas. This study provides insight into the assumptions that one type of bureaucratic body holds about how to construct readable prose and into how it communicates those assumptions to subject-matter experts. It also demonstrates one mechanism through which (sometimes faulty) assumptions about writing are perpetuated and legitimatized.

[1]  R. Schwartz,et al.  Comprehension and recall of the informational content of the informed consent document : an evaluation of 168 patients in a controlled clinical trial , 1994 .

[2]  E. J. Mayeaux,et al.  Parent comprehension of polio vaccine information pamphlets. , 1996, Pediatrics.

[3]  Michael K Paasche-Orlow,et al.  Readability standards for informed-consent forms as compared with actual readability. , 2003, The New England journal of medicine.

[4]  E. B. Coleman.  The comprehensibility of several grammatical transformations. , 1964 .

[5]  R. M. Cooper,et al.  Readability of informed consent forms. , 1991, American journal of hospital pharmacy.

[6]  T M Grundner,et al.  On the readability of surgical consent forms. , 1980, The New England journal of medicine.

[7]  H. H. Clark,et al.  What's new? Acquiring New information as a process in comprehension , 1974 .

[8]  J. Ogloff,et al.  Are research participants truly informed? Readability of informed consent forms used in research. , 1991, Ethics & behavior.

[9]  H. H. Clark,et al.  Semantic Distinctions and Memory for Complex Sentences , 1968, The Quarterly journal of experimental psychology.

[10]  Kathryn Bock,et al.  Syntactic effects of information availability in sentence production , 1980 .

[11]  Mark Hochhauser.  Some overlooked aspects of consent form readability. , 1997, IRB.

[12]  T. M. Grunder.  Two formulas for determining the readability of subject consent forms. , 1978, The American psychologist.

[13]  E. B. Coleman,et al.  Learning of prose written in four grammatical transformations. , 1965, The Journal of applied psychology.

[14]  A. Goldstein,et al.  Consent form readability in university-sponsored research. , 1996, The Journal of family practice.

[15]  Michel Hupet,et al.  The given-new contract and the constructive aspect of memory for ideas* , 1977 .

[16]  S. Piantadosi,et al.  Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? , 1994, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[17]  Meade Cd,et al.  Consent forms: how to determine and improve their readability. , 1992 .

[18]  Veda R. Charrow,et al.  Making Legal Language Understandable: A Psycholinguistic Study of Jury Instructions , 1979 .

[19]  Kathryn Bock,et al.  The effect of a pragmatic presupposition on syntactic structure in question answering , 1977 .

[20]  F. E. Freeberg,et al.  Informed consent documents: increasing comprehension by reducing reading level. , 1990, IRB.

[21]  Jan H. Spyridakis,et al.  The Influence of Semantics and Syntax on what Readers Remember , 1999 .

[22]  J. Fodor,et al.  Some syntactic determinants of sentential complexity , 1967 .

[23]  B. Jolly,et al.  Simplification of emergency department discharge instructions improves patient comprehension. , 1995, Annals of emergency medicine.