Developing a policy of informed consent for biobanking in tropical disease research projects, using Delphi technique : principles for good practice

Abstract

The policy of informed consent for biobanking were developed for a standardize guidelines in biobanking. This study is divided into two major phases, the first objective to explore the attitudes and understanding of clinical trial participants to biobanking, subsequently using these results to identify and develop a content of inform consent of biobanking as a policy to improve the quality and standardize for affiliates of Mahidol-Oxford Tropical Medicine Research Unit (MORU); Bangkok in Thailand. The instrument is oriented toward clinical participant attitude, understanding and agreement of experts to determine the policy for future study related to informed consent of biobanking. Phase one using qualitative research methodology, clinical trial participants (N=24) who were already enrolled to clinical research studies at the Hospital for Tropical Diseases were given an information sheet explaining biobanking. An in-depth interview was then conducted along with a demographic questionnaire. The results were analyzed using NVIVO 10 software. From the results, fifty four percent felt they had a clearer understanding of biobanking after reading the brochure. All the respondents were willing to donate a blood sample to a biobank. In conclusions, this study suggests that researchers should provide both written and oral information during enrollment for biobanking studies, giving time for participants to better understand the purpose of biobanking studies prior to signing a consent form. Phase two, four round Policy Delphi techniques was conducted using participants who are expert in clinical trial, policy maker position and currently working in clinical research, based in network of Mahidol-Oxford Tropical Medicine Research Unit (N=30). The master policy narratives was derived through these consensus results. Thematic content analysis was used to analyze the data by 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. The percentage of response rate were used in the analytical process in round three and round four. From the results, policy of informed consent for biobanking in Tropical disease research project were developed along with designing of consent form and patient information sheet for biobanking study. The tools will reduce the burden placed on research staff responsible for the generic projects and biobank, at the same time, maximize the protection of clinical trial participants and for principle for good practice in affiliates of MORU in Thailand.