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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Raquel Billiones

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Evguenia Alechine

Jonathan Pitt

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Victoria White

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Alicia Waltman

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Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

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Nicole Bezuidenhout 

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Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Morris

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk