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Scientific medical research involving human samples often leads to improved diagnosis, the discovery of treatment modalities, or the identification of possible risk factors for many diseases. Some findings, including incidental findings, may be important to donors, and some may require intervention. This study aimed to explore the perspectives of health care professionals in their use of stored biological samples for biomedical research regarding the concept of the research results and the challenges of informing donors regarding the results. This qualitative study involved 19 medical researchers doing research with stored biological samples and biobanks. The data were gathered during face-to-face interviews in English using a semistructured interview technique. The participants provided rich and illuminating experiences, framed in the following themes: the professional duty of researchers to return the research results and the right of donors to know; factors affecting informing donors of results (e.g., severity of disease; impact of the provided information; reliability of the research results; and donor approval); challenges to physically returning the results; and the nature of the informed consent, as well as the elements required in the informed consent documentation. Although the majority of researchers agree on the importance of returning research results, some have contradictory views such as that returning research results is not the researcher's responsibility. The study results also support the view that a number of elements should be included in the informed consent, such as the intention of informing the donors of the results as well as the benefits and risks.

Achieving a balance between giving access to information and respecting donors' confidentiality is a crucial issue for any biobank, with its large number of samples and associated information. Despite the existence of much empirical literature on confidentiality, there are too few surveys in the Middle East about the topic, particularly in the Saudi context. A survey was conducted of 200 respondents at King Abdulaziz Medical City in Riyadh, Saudi Arabia, among 5 groups of equal size, comprised of researchers, physicians, medical students, donors and laypersons, respectively. The majority of participants agreed that confidentiality is an important issue and that it is well protected in the Saudi biobank. All 5 groups showed different attitudes toward disclosing information to various third parties. They were in favor of allowing treating physicians, and to a certain extent family members, to have access to medical and genetic results from research. No significant differences were found between views on medical and genetic confidentiality. The majority of respondents agreed that confidentiality might be breached in cases with specific justified reasons. Even considering differences in religion, culture and other factors, the results of the study were consistent with those reported in the literature and research conducted in other countries. We therefore place emphasis on the importance of protecting and promoting patient/donor confidentiality and privacy., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

The growth of research biobanks has created many new ethical challenges worldwide. This article outlines and discusses key issues in the governance of Saudi Biobank, a newly established national biobank in Saudi Arabia launched in 2014. The Saudi Biobank project includes human biological samples from participants aged 10-70 years and aims to conduct an extensive study on the influence of genes, environment and lifestyle in common diseases. We examined the strengths and weaknesses of Saudi Biobank's governance as well as the similarities and differences with 4 other biobanks (in the United Kingdom, Iceland, Estonia and Canada). Three different ethical issues are discussed in detail: confidentiality, informed consent and children's participation in research. We evaluated these issues in relation to international ethical guidelines and Islamic law. The insights gained may be useful in developing national biobanking regulations in other Islamic countries, particularly in countries of the Eastern Mediterranean Region.

Background: Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents., Methods: Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization-Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others., Results: This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics., Conclusions: Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines.

Protecting confidentiality is an essential value in all human relationships, no less in medical practice and research.(1) Doctor-patient and researcher-participant relationships are built on trust and on the understanding those patients' secrets will not be disclosed.(2) However, this confidentiality can be breached in some situations where it is necessary to meet a strong conflicting duty.(3) Confidentiality, in a general sense, has received much interest in Islamic resources including the Qur'an, Sunnah and juristic writings. However, medical and research confidentiality have not been explored deeply. There are few fatwas about the issue, despite an increased effort by both individuals and Islamic medical organizations to use these institutional fatwas in their research. Infringements on confidentiality make up a significant portion of institutional fatwas, yet they have never been thoroughly investigated. Moreover, the efforts of organizations and authors in this regard still require further exploration, especially on the issue of research confidentiality. In this article, we explore medical and research confidentiality and potential conflicts with this practice as a result of fatwas released by international, regional, and national Islamic Sunni juristic councils. We discuss how these fatwas affect research and publication by Muslim doctors, researchers, and Islamic medical organizations. We argue that more specialized fatwas are needed to clarify Islamic juristic views about medical and research confidentiality, especially the circumstances in which infringements on this confidentiality are justified., (© 2012 Blackwell Publishing Ltd.)