Medical Writing Vaccines and Immunotherapies Lay writing: Strategies for improving assent forms
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Volume 27, Issue 1 - Vaccines and Immunotherapies

Lay writing: Strategies for improving assent forms

Abstract

Writing for lay audiences is recognised as a  difficult task for medical writers, whose  specialised knowledge can often hinder  effective lay communication. This task is even  more challenging when preparing clinical trial  information for a paediatric population.  Involving advisory groups in the development  of clinical trial materials improves their  quality and ensures that they are fit for  purpose. This article describes how medical  writers can build successful partnerships with  advisory groups in developing assent forms  for children being approached to participate  in clinical trials.

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References

  1. World Medical Association Declaration of Helsinki. JAMA. 2013;310(20):2191–4.
  2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Clinical Investigation of Medicinal Products in the Pediatric Population (E11). 2000.
  3. US Department of Health and Human Services. Code of Federal Regulations, Title 21 (Food and Drugs) Food and Drug Administration, Part 46 – Protection of Human Subjects, Subpart D, Section 46.408. Accessed 26 July 2016.
  4. Giesbertz N, Bredenoord A, van Delden J. Clarifying assent in pediatric research. Eur J Hum Genet. 2013;22(2):266–9.
  5. Lepola P, Needham A, Mendum J, Sallabank P, Neubauer D, de Wildt S. Informed consent for paediatric clinical trials in Europe: Table 1. Arch Dis Child. 2016;101(11):1017–25.
  6. Calderón JL, Morales LS, Liu H, Hays RD. Variation in the readability of items within surveys. Am J Med Qual. 2006;21(1):49–56.
  7. National Institute of Adult Continuing Education. Readability: how to produce clear written materials for a range of readers. Leicester: NIACE; 2009.
  8. National Institute for Health Research. Medicines for Children Research Network. Guidance document for researchers designing patient information leaflets. Available from: http://www.hra-decisiontools.org.uk/consent/docs/MRCN%20YPAG%20-%20Guidance%20for%20Researchers%20designing%20Patient%20Information%20Leaflets.pdf
  9. INVOLVE. Involving children and young people in research: top tips for researchers. Eastleigh: INVOLVE; 2016.
  10. INVOLVE. Briefing notes for researchers: involving the public in NHS, public health and social care research. Eastleigh: INVOLVE; 2012.

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Articles

Vaccines and immunotherapies
President's Column
A history of EMWA
EMWA News
An introduction to vaccines and immunotherapies
Immuno-oncology: Harnessing our immune system to fight cancer
Changing methods to assess targeted therapies in oncology
HIV vaccine clinical trials: An overview
Allergen immunotherapy in the European regulatory environment
Pharmacovigilance for vaccines and immunotherapies
Addressing vaccine hesitancy in writing
Results of the 2017 EMWA salary survey
Lay writing: Strategies for improving assent forms
The perils of the unknown: Missing data in clinical studies
Medical writing in China: Trends and opportunities
PhD student: A medical writer in the making!
News from the EMA
Medical Communications
Journal Watch
In the Bookstores
The Webscout
Lingua Franca and Beyond
Teaching Medical Writing
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Entering medical communications as a non-native English speaker
Out on Our Own

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