Related Experiment Video
Updated: May 16, 2026

Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
Improving the informed consent process--a booklet on participants' rights in medical research
Jocelyne R Benatar1, Philip McKibbin, Ralph A H Stewart
1Cardiovascular Research Unit, Greenlane Cardiovascular Service, Auckland City Hospital, Auckland 1030, New Zealand. Jocelyne.Benatar@adhb.govt.nz
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.
Related Concept Videos
Nurses' Legal Responsibilities I
The legal responsibilities of a nurse regarding informed consent include the following:
Ethics in Research
Nursing Ethical Principles II
Consider the following scenario, which illustrates how these principles are applied in the care of Mr. John, a fifty-year-old teacher diagnosed with metastatic liver cancer.
Initially, Mr. John's cancer...
Bioavailability Study Design: Healthy Subjects Versus Patients
Blinding
Blind Procedures

