Object

Title: Optimization of Informed Consent Forms for clinical trials participants

Abstract:

An Informed Consent Form documents participants’ acceptance of participation in a clinical trial. The aim of the research was to examine how the current format of informed consent forms impacts readability of the documents and patient understanding of the critical elements. Subsequent to that analysis, improvements to the format were proposed for implementation by ethics committees, regulatory authorities, and sponsor companies that prepare clinical trials. The research consisted of 3 parts. Part 1 of the research analyzed the length of the informed consent forms and their growth over time, the use of visual aids in the forms, and how these factors varied based on the intended reader of the document. Part 2 of the research involved 9 ethics committees in Poland. EC members were asked to grade the importance of ICF elements and to ask about EC members’ opinions regarding currently used ICFs. The aim of Part 3 of the research was to conduct a readability assessment comparing a standard version ICF and a modified (shortened and illustrated) and to propose solution optimizing the design of the informed consent forms. Based on the information retention observed in this study, significant improvements in readability and design are needed for informed con-sent forms to fulfill their intended purpose. Patient representation in the ethical review process is advisable, and it is recommended that standards for readability assessments of ICFs be developed that can be applied consistently on a global scale given the international nature of clinical research today.

Place of publishing:

Kraków

Level of degree:

2 - studia doktoranckie

Degree discipline:

farmacja

Degree grantor:

Uniwersytet Jagielloński. Collegium Medicum. Wydział Farmaceutyczny.

Promoter:

Agnieszka Skowron

Date issued:

2019

Format:

application/pdf

Identifier:

oai:dl.cm-uj.krakow.pl:4340

Call number:

ZB-130880

Access rights:

nieograniczony

Location of original object:

Biblioteka Medyczna Uniwersytetu Jagiellońskiego- Collegium Medicum

Object collections:

Last modified:

Nov 16, 2020

In our library since:

Jun 22, 2020

Number of object content hits:

14

All available object's versions:

http://dl.cm-uj.krakow.pl:8080/publication/4341

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ZB-130880 Nov 16, 2020
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