Susan,

The guidelines say that you should not assume literacy at all.  When  
you are obtaining informed consent, you give a copy of the consent  
form to the individual, and then verbally go over each part of the  
form with the potential subject.  Because you do this with each  
subject, there is no presumption of reading ability or stigma in the  
process.  The only time when you might ask the potential subject to  
read is when one of your selection criteria involves reading a  
particular size of text as a measure of visual accuity or language  
skill, in which case you can ask the person to read a particular  
sentence aloud, which might be impossible because of poor vision or  
poor literacy.

Denis Anson, MS, OTR
Director of Research and Development
Assistive Technology Research Institute

On Apr 18, 2008, at 9:34 AM, Susan J. Slade wrote:

>

> Dear Colleagues,

>

> Participation of individual subjects in a research study requires  

> informed

> consent.  How have others handled literacy for informed consent with

> individual subjects?  What reading level is your informed consent  

> written

> at?  Do you use pictures to aid in literacy?

>

> Susan Slade

> Director

> Medical Home Unit

> 219 ESP Corning Tower

> New York State Department of Health

> Albany, NY 12237-0618

> phone:  (518) 474-2001

> fax:       (518) 474-3914

>

>

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