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Initiated in 2017 after extensive community engagement, the Last Gift program enrolls altruistic volunteers willing to donate their cells and tissues at the end of life to allow studies on HIV reservoir dynamics across anatomical sites. As the Last Gift team received tissue requests outside the scope of HIV cure research, we noticed the absence of guiding frameworks to help prioritize the use of altruistically donated human biological materials. In this commentary, we present a proposed framework for prioritizing the use of donated human biological materials within and outside the end-of-life (EOL) HIV cure research context, using the Last Gift study as an example. First, we discuss regulatory and policy considerations, and highlight key ethical values to guide prioritization decisions. Second, we present our prioritization framework and share some of our experiences prioritizing requests for donated human biological materials within and outside EOL HIV cure research.

Initiated in 2017 after extensive community engagement, the Last Gift program enrolls altruistic volunteers willing to donate their cells and tissues at the end of life to allow studies on HIV reservoir dynamics across anatomical sites. As the Last Gift team received tissue requests outside the scope of HIV cure research, we noticed the absence of guiding frameworks to help prioritize the use of altruistically donated human biological materials. In this commentary, we present a proposed framework for prioritizing the use of donated human biological materials within and outside the end-of-life (EOL) HIV cure research context, using the Last Gift study as an example. First, we discuss regulatory and policy considerations, and highlight key ethical values to guide prioritization decisions. Second, we present our prioritization framework and share some of our experiences prioritizing requests for donated human biological materials within and outside EOL HIV cure research.

The National Biobank of the National Health Laboratory Service (NHLS) is a national treasure established to serve as support infrastructure for the provision of high quality human biological materials for research purposes and it represents the first of its kind in South Africa. This article aims to demonstrate the alignment of the NHLS Biobank to international best practices and guidelines with reference to the 13 sections of the International Society of Biological and Environmental Repositories (ISBER) Best Practices for Repositories (4th ed.). The NHLS Biobank has implemented procedures and management strategies that are technical best practices covering the lifecycle of biobanking (collection, processing, storage and dissemination of human biological materials) while having respect for ethical and regulatory processes, upholding the interest of the donors. ISBER best practices are invaluable sources of guidance and benchmarking on the guiding principles has enabled the NHLS Biobank to develop into an entity with infrastructure and operational activities that support its short-term and long-term objectives that are set out in the business plan.

Abstract Background Human biological materials are usually stored for possible future use in research because they preserve valuable biological information, save time and resources, which would have been spent on collection of fresh samples. However, use of these materials may pose ethical challenges such as unauthorized disclosure of genetic information, which can result in dire consequences for individuals or communities including discrimination, stigma, and psychological harm; has biosecurity implications; and loss of control or ownership of samples or data. To understand these problems better, we evaluated the extent to which tuberculosis (TB) clinical research protocols that were used to collect and store biological materials for future use conform to the requirements stated in the Uganda national guidelines for research involving humans as participants. Methods This was a retrospective review of TB clinical research projects approved by the Uganda National Council for Science and Technology (UNCST) from 2011 to 2015, to examine whether they fulfilled the requirements for ethical collection and use of human materials. Data were abstracted through review of the project protocols using a template developed based on the informed consent and the Materials Transfer Agreement (MTA) requirements in the national guidelines. Results Out of 55 research protocols reviewed, most of the protocols 83.6% had been used to collect the stored samples (sputum, blood and sometimes urine), 28% had a section on specimen collection and 24% mentioned ownership of the biological materials. With respect to review of the consent forms used in the studies that stored materials for future use, only 9% of the protocols had a separate consent form for storage of materials, 4.5% of the consent forms explained the risks, 11.4% explained the purpose of the study while 6.8% mentioned the place of storage for the collected materials. Conclusion Many of the studies reviewed did not meet the requirements for collection and storage of biological materials contained in the national guidelines, which indicates a need to additional training on this topic.

Background: Human biological materials are usually stored for possible future use in research because they preserve valuable biological information, save time and resources, which would have been spent on collection of fresh samples. However, use of these materials may pose ethical challenges such as unauthorized disclosure of genetic information, which can result in dire consequences for individuals or communities including discrimination, stigma, and psychological harm; has biosecurity implications; and loss of control or ownership of samples or data. To understand these problems better, we evaluated the extent to which tuberculosis (TB) clinical research protocols that were used to collect and store biological materials for future use conform to the requirements stated in the Uganda national guidelines for research involving humans as participants.Methods: This was a retrospective review of TB clinical research projects approved by the Uganda National Council for Science and Technology (UNCST) from 2011 to 2015, to examine whether they fulfilled the requirements for ethical collection and use of human materials. Data were abstracted through review of the project protocols using a template developed based on the informed consent and the Materials Transfer Agreement (MTA) requirements in the national guidelines.Results: Out of 55 research protocols reviewed, most of the protocols 83.6% had been used to collect the stored samples (sputum, blood and sometimes urine), 28% had a section on specimen collection and 24% mentioned ownership of the biological materials. With respect to review of the consent forms used in the studies that stored materials for future use, only 9% of the protocols had a separate consent form for storage of materials, 4.5% of the consent forms explained the risks, 11.4% explained the purpose of the study while 6.8% mentioned the place of storage for the collected materials.Conclusion: Many of the studies reviewed did not meet the requirements for collection and storage of biological materials contained in the national guidelines, which indicates a need to additional training on this topic. [ABSTRACT FROM AUTHOR]

The use of human biological materials (HBMs) involves a number of issues from both an ethical and a legal point of view. In recent decades, the purposes for which this material has been used have increased. The development of therapeutic products has led to the configuration of a market in which products have acquired an economic value. As soon as the private sector crosses the threshold of access to the use of human cells and tissues, a conflict may arise between the altruistic principles motivating the act of donation and the profit-making objectives. When donated material emerges from the public management setting and becomes a source of profit, the instrument of informed consent may not adequately protect the dignity of the donors. In the era of medical biotechnology revolution, any use of the donated material must be justified and consistent with the values motivating the act of donation. [ABSTRACT FROM AUTHOR]

In recent decades, there has been a revision of the role of institutional review boards with the intention of protecting human subjects from harm and exploitation in research. Informed consent aims to protect the subject by explaining all of the benefits and risks associated with a specific research project. To date, there has not been a review published analyzing issues of informed consent in research in the field of genetic/Omics in subjects with chronic pain, and the current review aims to fill that gap in the ethical aspects of such investigation. Despite the extensive discussion on ethical challenges unique to the field of genetic/Omics, this is the first attempt at addressing ethical challenges regarding Informed Consent Forms for pain research as the primary focus. We see this contribution as an important one, for while ethical issues are too often ignored in pain research in general, the numerous arising ethical issues that are unique to pain genetic/Omics suggest that researchers in the field need to pay even greater attention to the rights of subjects/patients. This article presents the work of the Ethic Committee of the Pain-Omics Group (), a consortium of 11 centers that is running the Pain-Omics project funded by the European Community in the 7th Framework Program theme ( HEALTH.2013.2.2.1-5-Understanding and controlling pain). The Ethic Committee is composed of 1 member of each group of the consortium as well as key opinion leaders in the field of ethics and pain more generally. [ABSTRACT FROM AUTHOR]

With biobank research on the increase and the history of exploitation in Africa, it has become necessary to manage the transfer of human tissues across national boundaries. There are many accepted templates of Material Transfer Agreements (MTAs) that currently exist internationally. However, these templates do not address the specific concerns of South Africa and even of Africa as a continent. This article will examine three significantly important ethico-legal concepts that were deliberated and carefully adapted by a South African Institution to suit the transfer of Human Biological Materials (HBMs) and associated data for biobank research, namely: informed consent; benefit sharing arrangements; and ownership together with intellectual property rights in human tissues. The discussion includes an analysis of current practice; the ethico-legal challenges in the South African/African context; the decisions made with regard to how the related ethico-legal challenges were addressed in the MTA; and justifications for implementing these decisions. The processes considered could be of benefit to other developing world countries who consider it necessary to manage the transfer of HBMs across national boundaries. [ABSTRACT FROM AUTHOR]

Human Biological Materials ( HBMs) are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee ( REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators ( PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent ( IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits ( EPs) and Material Transfer Agreements ( MTAs) were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. [ABSTRACT FROM AUTHOR]

Introduction: The use of modern advances in medicine to investigate crimes has caused a number of problems that require scientific reflection. In particular, today there are quite acute questions: medical intervention without the person’s consent; forced sampling of human biological materials; clinical methods, the use of which in the biological samples taking will not be regarded as violation of international standards of human rights protection; the correlation of the need for the formation of DNA profile databases and the right of the person to non-disclosure of medical information. The aim: The aim of this work is to identify and analyze the key points of the European Court of Human Rights (hereinafter referred to as the ECHR) regarding the peculiarities of retention and use of human biological material samples in the investigation of crimes, and the retention of such materials after the completion of the investigation and trial., Material and Methods: In the preparation of the article, scientific works, the provisions of international normative acts regulating the use of human biological materials as well as the practice of the ECHR concerning the use of human biological materials in the investigation of crimes were used (8 decisions were analyzed in which the ECHR concerned the use of biological samples or related issues). In the research process to achieve the goal, a complex of general scientific and special methods of cognition was used, in particular, the comparative legal method, the system and structural method, the method of generalization, the method of analysis and synthesis, etc., Review: The positions of the ECHR concerning the following were distinguished and generalized: a) the criteria for the permissibility of compulsory medical intervention for taking of human biological material within the framework of the crime investigation; b) the possibilities of spreading the right not to incriminate oneself on the compulsory taking of human biological materials samples; c) the retention features of cell samples and DNA information in the context of respect for the right to non-interference in the person’s private life., Conclusions: Obtaining and using the human material for the investigation of crimes are not a violation of the European Convention on Human Rights (hereinafter – the Convention), subject to the requirements stated in the practice of the ECHR.