A Policy of Informed Consent for Biobanking in Tropical Disease Research Projects, Using the Delphi Technique: Principles for Good Practice

Abstract

A policy of informed consent was developed to standardize guidelines for biobanking in tropical disease research projects. A four-rounds Policy Delphi was carried out with a panel of clinical trials and policymaking experts who are currently working in clinical research, and are part of the Mahidol-Oxford Tropical Medicine Research Unit (MORU), n=30. A master policy narrative was derived through the consensus results. Thematic content was analyzed using NVIVO 10 software in round one. Descriptive statistics were used to evaluate levels of agreement, including the mean, the percentage of agreement, and the interquartile deviation (IQD) in round two. Consensus was established in round two if the mean rating was 3.5, the level of consensus by percentage of agreement among experts who agree or strongly agree was equal to or more than 70%, and IQD was equal to or less than 1.00. The response rates were used in the analytical process in rounds three and four to confirm maximum validity of the results of the Delphi method for improved confirmation of consensual decision-making. From the results, a policy of informed consent for biobanking in tropical disease research was developed, and a consent form and patient information sheet for biobanking studies were designed. These tools will reduce the burden placed on research staff responsible for the projects and the biobank, while at the same time maximize the protection of clinical trial participants through principles of good practice for affiliates MORU.