Medical Writing Writing for Patients Participant information – an ethics committee view
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Volume 29, Issue 4 - Writing for Patients

Participant information – an ethics committee view

Abstract

The participant information sheet (PIS) is one of the documents that promote most discussion and concern for research ethics committees (REC). This article looks at ways to ensure the PIS meets their requirements based on the specific experience of a REC member. General problems include the fact that the PIS is too long, too complex, and written from the researcher’s perspective rather than the participant’s perspective. In addition, certain details are often lacking or unclear, the wording needs to be appropriate for the specific country and the benefit/risk balance should not be skewed in any way. Finally, every PIS should be proofread and tested on someone unconnected with the study. Following the advice given in this article will minimise requests for changes to the submitted PIS.

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Participant information – an ethics committee view
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Regulatory Matters
In the Bookstores
Good Writing Practice
My First Medical Writing
Getting Your Foot in the Door
Out on Our Own

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