from Barb Earles


>Thanks Anne for forwarding. Interesting reading. Perhaps we can hope the

>"Plain Language in Government Communications Act" H.R. 3548 passed by

>the House April 14 and on to the Senate may have impact? The bill would

>require Federal agencies to use plain language in any new or revised

>document that explains how to obtain a benefit or service or how to pay

>taxes. This includes letters, publications, forms, notices, or

>instructions. While the bill does not specifically address the issue

>raised below, if there is such a law, it might provide more of a push

>for plain language documents into other arenas.

>

>Barb

>Barb Earles

>Director of Risk Management

>Iowa Health System - Law Department

>515-334-5043 Office

>515-205-3140 Mobile

>earlesba at ihs.org

>

>

>-----Original Message-----

>

>>Date: Tue, 22 Apr 2008 17:18:26 -0400 (EDT)

>>From: MarkH38514 at aol.com

>>Subject: [HealthLiteracy 1940] Re: Informed Consent for a Scientific

>Study

>>Sender: healthliteracy-bounces at nifl.gov

>  >To: healthliteracy at nifl.gov

>>Reply-to: The Health and Literacy Discussion List

><healthliteracy at nifl.gov>

>>

>>

>>As a long time IRB member, I find that plain language guidelines

>>have been ignored by the folks writing consent forms in the

>>pharmaceutical and medical device industry. Part of the problem is

>>that plain language recommendations are not the same as plain

>>language requirements.

>>

>>Several years ago a drug company Vice-President told me that their

>>consent form writers must strictly adhere to federal regulations in

>>order to comply with those regulations. Anything they write that

>>isn't compliant with those regulations is seen internally as being

>>non-compliant, and can create serious job problems. So, even though

>>plain language guidelines and recommendations can make consent forms

>>easier to read, such guidelines have been routinely ignored because

>>they make consent forms "non-compliant!" From this regulatory and

>>compliance perspective, plain language is seen as a compliance

>>problem not a communication solution.

>>

>>I know this doesn't make much sense, but the drug and device

>>industry obsesses over being compliant or non-compliant with federal

>>regulations. Corporate lawyers assume that their company will not

>>get into regulatory trouble if they use consent language from the

>>Federal Register--even if prospective subjects can't understand it.

>>

>>If federal agencies want consent forms to be written in plain

>>language, it would help if they would provide some "compliant"

>>examples of actual plain language consent forms and require plain

>>language consent forms. Current plain language recommendations and

>>templates have accomplished very little.

>>

>>Mark Hochhauser

>>

>>Mark Hochhauser, Ph.D.

>>Readability Consultant

>>3344 Scott Avenue North

>>Golden Valley, MN  55422-2748

>>Phone: 763-521-4672

>>Cell: 612-281-1517

>>Fax: 763-521-5069

>>email: <mailto:MarkH38514 at aol.com>MarkH38514 at aol.com

>>

>>

>>

>>

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>>

>>----------------------------------------------------

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>>Email delivered to anne.murr at drake.edu

>

>

>--

>Anne Murr, M.S., Coordinator

>Drake University Adult Literacy Center

>School of Education

>3206 University Ave.

>Des Moines, IA 50311

>anne.murr at drake.edu

>    Tel    515-271-3982

>    Fax   515-271-4544

>The MISSION OF THE ADULT LITERACY CENTER IS TO IMPROVE LITERACY,

>    resulting in enhanced self-esteem, daily living, and lifelong

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-- 
Anne Murr, M.S., Coordinator
Drake University Adult Literacy Center
School of Education
3206 University Ave.
Des Moines, IA 50311
anne.murr at drake.edu
   Tel    515-271-3982
   Fax   515-271-4544
The MISSION OF THE ADULT LITERACY CENTER IS TO IMPROVE LITERACY,
   resulting in enhanced self-esteem, daily living, and lifelong learning.