Informed consent methods: an analysis of volunteer understanding
Date
2009-02-26T08:14:52Z
Authors
Jacobs, Janine
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Abstract
ABSTRACT To develop a more efficient way of informing potential clinical trial volunteers of exactly what they could expect during (and after) their participation in a clinical trial as well as the sponsor’s expectations from the volunteer. A multiple choice questionnaire, which was based on the criteria as specified by Guideline 5 of the International Conference of Harmonization (ICH), was administered to 28 Volunteers after only reading the Patient Information Leaflet/Informed Consent Document (PIL/PIL/ICD), to 21 Volunteers who had read the PIL/ICD and attended a question and answer session, to 17 Volunteers who had read the PIL/ICD and attended a presentation and 19 Volunteers who had read the PIL/ICD and attended a presentation and a question and answer session. In total, 85 Volunteers completed the questionnaire. The average calculated percentage* of volunteers who had only read the PIL/ICD was 61%, 63% for Volunteers who had read the PIL/ICD and attended a question and answer session, 73% for Volunteers who had read the PIL/ICD and attended a presentation and 68% for Volunteers who had read the PIL/ICD and attended a presentation and question and answer session. In total, the average calculated percentage was 66%. Eighty four percent of the total number of volunteers answered the question on withdrawal consequence incorrectly, 43% of Volunteers answered questions on side effects incorrectly and 100% of the Volunteers answered the question on the duration of storage of samples incorrectly. Despite increasing regulatory and ethical scrutiny, deficiencies still exist in Volunteer comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. Results indicated that any successful consent process should, at a minimum, include a visual communication mode. Concepts that are not well understood within the South-African context are withdrawal consequence, methodology such as double-blind or single blind, side effects, duration of archiving, treatment alternatives and the role of the investigator. *calculated % for each volunteer = score out of 25 x 100
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Keywords
drug trials, volunteers, consent methods