Lack of national legislation and ethical regulations on biobanking and gaps

Although the need for national legislation on biobanking as a driving force of precision medicine development has been actively discussed by Ukrainian lawyers for the last few years, there are still no approved National regulations on biobanking. Many countries in the developing world including Arabian and Latin American countries, Africa and Eastern Europe/Central Asian countries/former Soviet republics lack national policies and governance infrastructure for biobanking27 even though these activities are ongoing. In some countries, research ethics committees (RECs) use international research ethics guidelines to review research protocols for biobanking.28 While general governance and quality assurance should be based on international standards, regulating legal and ethical issues by national guidelines aligned with local social and cultural specificities is recommended.29 There are specific features of biobanking regulations in Africa compared with the UK, the USA or Australia. Having a long history of exploitation, regulations in some African countries aim to strengthen the protection of participants and their rights. For instance, Uganda’s regulations on biobanking outline that the ownership of the sample belongs to its donor while the biobank is a custodian of the specimens and possesses a position of trust. In addition, the national template of the Material Transfer Agreement suggests the possibility of claiming ownership of new products in case of their discovery by third parties outside the country.30 However, such practice is not widely implemented. Recent studies from Africa have revealed that despite efforts at the international, regional and national levels, 20 (41 %) out of 49 sub-Saharan African countries do not have articulated national ethical principles and regulatory guidance for policymaking, reviewing and monitoring biobanking research. Among 29 African countries where ethical and regulatory guidance exists, only 17 have regulations for research using human samples, with specific recommendations on participants’ consent, sample ownership, reuse, storage and sharing.31

Gaps in national ethical and legal regulations might result in inconsistent reviews of research protocols by RECs and generate risks to biobank participants. The lack of structured ethical regulations in human research, including genetic and genomic studies in Ukraine, can compromise various ethical issues of biobanking, including the informed consent process, participants protection, samples use and sharing.

Informed consent is a key principle of research ethics in studies involving human subjects.32 Because of the unique context of biobank research, informed consent should include disclosure of the type of data to be collected, potential sample use in case of secondary research, regulation of data and sample access or sharing, and oversight mechanisms for privacy protection.33 Donors should have the right to withdraw their consent, and it should be disclosed what will happen to the biosamples and data in case of discontinuation. Finally, informed consent documents must be provided in plain language or translation in case of the international research protocol, and it must be clear that sample collection and donation are separate from healthcare.33

Despite the common requirements for informed consent in human research, there are some debates about handling the informed consent procedures governing the enrolment of participants in sample donation and their further use in future studies.34 Genomic studies approach and personalised medicine evolution have led to the development of innovative formats of the informed consent process.34 The International Society for Biological and Environmental Biorepositories (ISBER) defines several formats of informed consent,29 including specific (or traditional), broad and multi-layered (or tiered) consent, which distinguishes layers of information from minimal to more detailed at subsequent steps and offers different choices between categories of diseases or studies associated with distinct ethical, personal or societal issues. As the majority of biobank-based studies are driven by the collaboration between Ukrainian institutions and HICs-based organisations, the format of the informed consent is often dictated by the primary sponsor. This provides both pros and cons for Ukrainian biobanks and research participants. The benefit of such an approach is compliance with international regulations. On the contrary, it needs translation and approval by the local ethical committee and is sometimes taken as a formal procedure.

Besides, the dynamic consent model was suggested for biobanks based on the use of a digital platform for continuous access of donors to their consent for modification.35 However, its implementation needs modern IT solutions and communication systems.36 That seems challenging in most LMICs including Ukraine due to strict requirements for IT infrastructure and legislated electronic document flow. Due to the lack of legal regulations on biobank-related studies, most institutions in Ukraine are historically prone to use project-specific informed consent to ensure participants’ protection and compliance with institutional requirements for biomedical research. However, for the last few years, there is a trend for incorporating broad consent in biobank-based studies for expanding the range of goals to be achieved and widening opportunities for novel technologies applying to biomarkers discovery.

Anyway, the type of consent must be under applicable national, regional or local regulations and laws, as different jurisdictions may not permit the use of certain types of consent. Developing legal systems for enabling international and local biobanking is essential for regulating the voluntary participation of subjects in research and safeguarding their rights. Sample misuse or secondary use without the participant’s informed consent breaks promises, which is a violation of trust and the fundamental ethical principle of respect for autonomy. Lack of compliance with international regulations for data protection could result in inadvertent harm to research participants whose samples are stored in biobanks, which could in turn reduce participation in translational research essential for enhancing healthcare inequities in the future.37 This addresses the crucial need in arranging participants’ protection in biobanking-based studies.

Although biobank-related research is usually considered to pose minimal risks, subjects face some burdens when participating in biobank studies. These risks can be related to the procedures of sample donation (for instance, bleeding during venipuncture, local infections). Additionally, potential breaches of confidentiality are a risk of biobanking.16

Biobanks are responsible for protecting donor privacy and confidentiality, especially in the case of samples and data sharing. Advances in molecular studies have transformed the research environment, fostering extensive data sharing nationally and internationally.22 36 Data sharing and openness provide numerous benefits in healthcare and research. In contrast, improvements in digitalisation and informational technology (IT) solutions elevate the likelihood of external parties’ access to databases. Specimens can be identifiable through big data compiled from smartphones, social media, sensors, electronic health records, etc.36 Basic regulations on access policies already exist and articulate the need for clear criteria for access decisions.29 For instance, ISBER states ‘Specimens and/or data should only be made available for ethical and scientifically appropriate research expected to contribute to scientific discovery’.29 However, many researchers ask whether current standards of data protection are adequate. In the USA, privacy in biobank-based research is protected by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule as a part of the Federal Policy for Protection of Human Subjects.38 However, there are no regulations specified in the unique context of biobank research.39 International Guidelines, including ISBER and Council for International Organisations of Medical Sciences (CIOMS), provide several protective measures. First, biobanks should follow well-documented procedures to protect participants’ privacy and confidentiality by anonymisation or de-identifying biospecimens.29 CIOMS highlights that only anonymised or coded data should be shared with researchers while other parties’ access must be limited.40 Decisions around data access depend on local arrangements for governance and practices and the global policies for biobanking and the sharing of data in biomedical studies.28 So, biobanks and investigators managing samples and data are legally and ethically obligated to protect data that are considered confidential information. The development of international consortia is the best strategy for synergy in the cooperative use of biomaterials respecting both effective sample/data use for research and the protection of the rights and interests of donors and communities.29 So, developing a comprehensive system of samples and data collection and management with proper privacy protection is essential for establishing biobanks in low-resource settings for both fostering precision medicine and participants’ rights protection with respect to basic ethical principles.

Developing National policies on the ethics of biobanking and data protection is a primary prerequisite for biobank establishment in LMICs. This is an ethical imperative for biobank legislation and evolution in Ukraine.

Limited infrastructure to ensure quality Sstandards

Progress in genetic studies has resulted in enhanced requirements for standardised collection, handling and storage of samples.16 By now, quality control has become an ethical imperative for biobank governance and operations, which is essential for reducing preanalytical variability and maintaining specimens’ integrity for further molecular studies.41 This requires the proper use of innovative technologies and state-of-the-science approaches to achieve robust and reproducible research goals.42 Such a strategy is an ethical prerequisite for building biobanks and dictates high-quality performance adherent to standards.43 The ISBER and National Cancer Institution (NCI) best practice documents, discovering the essentials of biobank operations and governance, provide detailed recommendations for standardised biobanking management across the network.44 Unfortunately, numerous research institutions in Ukraine, like in many other LMICs, demonstrate a lack of comprehensive governance structures and limited facilities for proper collection and storage space, trained staff, IT resources and limited financial and administrative support.45 Such systemic drawbacks can affect the quality of the samples and data provided which have double effects on both research and business. The lack of standardisation for biosample collection and processing is widely recognised as a crucial roadblock to genomic research at the global scale. Thus, biobank enterprises in LMICs should align with the use of state-of-the-science approaches and strict quality control. This defines the urgent need for obligatory and regular quality assurance oversight mechanisms at the national level.46

Low level of knowledge and awareness about biobanking among researchers, physicians and communities

The success of biobanking depends on stakeholder understanding and their willingness to adhere to strict legal and ethical regulations.47 Establishing a biobank requires the active participation of various stakeholders, including REC members, investigators, biobank staff and participants.45 Their level of awareness and professional competence plays an essential role in biobank establishment in LMICs.48

Although public awareness of biospecimens and biobanking has grown significantly in the last decades, studies from LMICs illuminate low literacy and profound misconceptions about biobanking, its goals and regulations.48 To our knowledge, there were no formal studies assessing the level of stakeholders’ awareness and attitude toward biobanking-related issues in Ukraine. For building trust, the experience of the Eastern Europe countries also highlights the need for public discussion of such issues as samples and data sharing, multiple use of biospecimens in future studies, informed consent in case of incompetence and the commercialisation of research.

Notably, even in developed countries, elements of informed consent unique to biobanking are poorly understood by patient participants.49 This lack of knowledge translates to limited trust in biobanks and related genomic studies, which in turn slows their progress in LMICs.50 So, disseminating knowledge on biobanking is essential for building research infrastructure and harmonising ethical, legal and quality standards. Training, focus group activities, regular webinars and teleconferences are effective tools for empowering physicians, researchers and REC members in their competence.51 From the Ukrainian perspective, despite relatively high activities in the field of biobanking, there are no academic courses to be incorporated in the programmes for educating students of medical and biotechnological specialties. Considering the role of biobanking in predictive, preventive and personalised medicine and its continuous progress worldwide, there is a need in preparing the next generations of researchers, healthcare professionals and biobanks for future multidisciplinary studies based on biosamples and data use. To develop the appropriate competencies of biobank staff, there is an urgent need in implementing new study programmes and curricula, incorporating courses, lectures and webinars on biobanking and precision medicine-related issues.52

Community distrust in science in LMICs

As the H3Africa project revealed, power asymmetries and historical exploitation have provoked a distrust in science and created barriers to conducting studies that require human tissue samples. Ukraine has a similar socio-historical context, where poor funding of science and long-term brain drain has undermined the research environment, provoking distrust in science, though there were no formal studies discovering stakeholders’ attitude to research including biobanking.

Community engagement is essential for building trust.53 Institutions and researchers worldwide have recognised the value and benefits of community engagement in the establishment of biobanks, especially in LMICs.28 Various educational activities, increased disclosure, value clarification and community discussions are essential for stakeholders’ engagement.51 The involvement of community representatives in discussions, consultations and policymaking is crucial to improve public awareness about biobanking, its goals and benefits, and to build trust in genetics and genomic medicine in LMICs.54

So, there are important differences in medical practice, knowledge and attitudes between HICs and LMICs that impact the practical realities of biobanking, and these differences are reflected in the diverse regulations across countries. Numerous research institutions in LMICs demonstrate a lack of comprehensive governance structures and limited facilities for proper collection and storage of specimens, low resources for quality assurance and IT resources, and limited financial and administrative support.45 Recognition of the diversity in regulations and acknowledgement of differences in biobanking between developed and developing countries suggests the need to understand the key barriers and articulate the set of key ethical recommendations essential for proper biobanking establishment in Ukraine.