Recommendations for the development of Egyptian human biobanking ethical guidelines

Ahmed Samir Abdelhafiz,Teck Chuan Voo,Calvin W L Ho

doi:10.12688/wellcomeopenres.16556.1

Abstract

Background: The development of biobanks is associated with the emergence of new ethical challenges. In Egypt, several biobanks have been established, but there are no specific local ethical guidelines to guide their work. The aim of this study is to develop recommendations for the Egyptian human biobanking ethical guidelines, which take into consideration the specific cultural and legal framework in Egypt. Methods: We searched the literature for available biobanking ethical guidelines. Six themes were the concern of search, namely; informed consent, data protection, return of results, sharing of samples and data, community engagement, and stakeholder engagement. If a document refers to another guideline, the new source is identified and the previous step is repeated. Results: Ten documents were identified, which were analyzed for the themes mentioned above. Guidelines and best practices were identified, and then compared with the published documents about ethical, legal and social issues (ELSI) related to biomedical research in Egypt to reach best recommendations. Conclusions: We have proposed, by way of recommendations, key characteristics that a national ethics framework in Egypt could have. On informed consent, the practice of broad consent may be harmonized among biobanks in Egypt. Clear policies on return of research results, training requirements and availability of genetic counseling could also be instituted through the national framework. Additionally, such a framework should facilitate community and stakeholders engagement, which is important to secure trust and build consensus on contentious issues arising from sample and data sharing across borders and commercialization, among other concerns.

Highlights

In Egypt, eight human disease based biobanks have been established over the past few years[1]
The development and growth of increasingly diverse pool of biobanks and complex biobanking practices are associated with aggravating well-recognized ethical concerns and the emergence of a range of new ethical challenges, including issues related to unfair discrimination arising from sharing of different types of samples and data[4,5]
Guidelines and best practices were identified, and compared with the published documents about ELSI related to biomedical research in Egypt to reach best recommendations

Summary

Introduction

In Egypt, eight human disease based biobanks have been established over the past few years[1]. The development and growth of increasingly diverse pool of biobanks and complex biobanking practices are associated with aggravating well-recognized ethical concerns (such as informed consent and privacy) and the emergence of a range of new ethical challenges, including issues related to unfair discrimination arising from sharing of different types of samples and data[4,5] It is not always clear which approach to consent-taking is ethically most appropriate for the type of biological material and data being collected for the purposes of primary and secondary research uses. Clear policies on return of research results, training requirements and availability of genetic counseling could be instituted through the national framework Such a framework should facilitate community and stakeholders engagement, which is important to secure trust and build consensus on contentious issues arising from sample and data sharing across borders and commercialization, among other concerns

Objectives

Methods

Results

Discussion

Conclusion