Medical Writing Writing for Patients Participant information – an ethics committee view

Volume 29, Issue 4 - Writing for Patients

Participant information – an ethics committee view


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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Editorial - Writing for Patients
Editorials - Passing the Torch: The Sequel/Filling Big Shoes
Foreword: Writing for Patients, Foreword from the EMA
President's Message
Promoting equity in understanding: A cross-organisational plain language glossary for clinical research
Medical abbreviations with multiple meanings: A prescription for disaster
Writing for patients: When and how?
Lay summaries for Phase 1 trials in healthy volunteers
Participant information – an ethics committee view
Establishing a patient publication steering committee: A case study with insights for medical writers
Translation: A transcultural activity
Writing for the internet
Social Media: A tool that can benefit public health?
Partnering with patient associations: Engaging medical writers to support health literacy for patients
Pharmaceutical clinical trials transparency and privacy
News from the EMA
Medical Devices
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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