Improving the informed consent process--a booklet on participants' rights in medical research

Abstract

Aim: This paper describes the process undertaken to develop and validate a booklet that informs participants of their rights in clinical studies. A booklet coupled with a shorter study-specific informed consent form may improve informed consent.

Methods: A booklet was developed in simple clear language, based on information contained in currently used audited informed consent forms and good clinical practice guidelines. 159 people from a broad range of backgrounds with expertise or interest in the consent process were asked to review the booklet and complete a survey. The booklet was modified based on feedback received from 59 respondents.

Results: Feedback was used to improve the booklet and ensure it complied with guidelines, was legally accurate and sensitive to tanga te whenua (Māori/indigenous people). The booklet was easier to read and comprehend compared to equivalent information contained in currently used informed consent forms.

Conclusions: A broad consultation and revisions improved the booklet and suggested it would be well received if introduced in New Zealand together with shorter study-specific informed consent forms.