The advancement and understanding of medical knowledge and disease requires valuable material which includes stored samples and their linked clinical data [1-4[. However, several questions are raised for organizations, laboratories, and researchers keeping these samples and for Research and Ethics committee members regarding the use of “residual” or stored samples and linked data.

These questions include:

• Do the tissue samples and linked medical records used for research pose any risks to the individual?
• Who owns the data and samples that are stored in the repository? Who is responsible for taking decisions on their use?
• Is it feasible to obtain informed consent from the contributor of the samples for research?
• Can the tissue samples be transferred along with linked data to institutions that wish to conduct research on these samples?

There are social, legal, and ethical implications of research involving biological tissue samples and linked data regarding patient confidentiality, informed consent, patient autonomy, data sharing and benefit sharing among communities [5-7].

Research participants have shown in different studies, varying attitudes towards sharing and storage of biological tissue samples for future research. Some participants in these studies have shown no concern to conduct future studies on stored biological tissue samples whilst others believed it is unethical to conduct future studies on these samples [8-9].

In Sub-Saharan Africa there is support in collaborative research for the sharing of biological tissue samples reported in some studies, however other studies have reported a reluctance to share any tissue samples [10-11]. Concerns have been raised about the lack of any mechanism in place to protect the interests of local investigators and the interests of sample donors [12-13].

The National Guidelines for Research Involving Humans as Research Participants (2014) are national guidelines in Uganda that provide the necessary guidance on the transfer, storage, and acquisition of biological tissue samples. These guidelines clearly state that prior to export it should be demonstrated that in-country capacity is inadequate or nonexistent. Clearance from the Uganda National Council for Science and Technology is mandatory and a Material Transfer Agreement and export permit must be in place prior to the export of any biological tissue samples.

However, it is important to understand that there are ethical differences between research with stored samples with linked medical data and other types of research. These differences include the following:

• At the time of sample collection, the purpose of research is not known in many circumstances in stored sample research. There is very often a time lag between the storage/use of the samples for research and the collection of the samples. It may not have been envisaged that specific consent would be needed [13]. There is also a difference between the extended or secondary use of the biological tissue samples and linked data for research and the purpose of primary collection and storage which are usually for diagnostic purposes [7,14-15].
• The degree of non-involvement versus ‘involvement’ is another difference. Doubts are raised about the possible need to protect participants and whether the participant is involved during the research as there is no direct contact with the individual in research on stored biological tissue samples [16]. The nomenclature of the individual tends to reflect the perspective of the researcher from literature analysis. “Source” is impersonal, “donor” shows one-way altruism, “participant” reflects on exaggerated involvement, and “contributor” respects and acknowledges the biological tissue material and the person [15,17].
• Due to possible violations in privacy and confidentiality, there is a socioeconomic impact and possible risk of psychological harm. However, as there is no direct contact, there is no direct physical harm to the individual [7,14,18]. There is the potential of doing harm (maleficence) if the test results are not clinically significant and no intervention is considered.
• Pooling of data resulting in larger sample sizes may be needed to achieve the potential expected outcome. The storage facility is virtual as databases are more commonly electronic and hence are easily transferable [13,19]. It is seen to be necessary to make use and “exploit” the data/samples by transferring the biological tissue samples to other research locations [20]. To manage resources and sustain the facility of storage a collaboration between multiple sites and partners may occur. This may take place many years after the original biological tissue sample collection and would not have been envisaged when the consent form was initially written up. Compared to the primary site of storage and collection where the relationship with the contributor was based on credibility and trust, the motives of the new sites may be entirely different [21-24].
• Genetic studies – In Sub-Saharan Africa there has been an exponential increase in biobanking and genomic research under the H3Africa initiative. The collection of biological materials and collection of DNA from 22 African countries is managed by a biorepository programme under the auspices of the H3Africa consortium. The biological specimens are stired in regional biorepositories in Uganda, South Africa and Nigeria (H3 Africa). In Uganda, new concepts such as genetic confidentiality and genetic privacy give rise to complexities with this type of research [7,25,26]. Can the researcher anonymize genetic samples? Can the identity of the genetic material ever be removed? The genetic results may have implications not only on the donor of the tissue samples but also on family members [26-28]. If family members are at risk of disease, should the disclosure of the findings be mandatory? Could there be any compromise of the autonomy of the individual? [28,29].
• Commercialization: There are many levels of exploitation of biological tissue samples as in the case of ‘Mo cell line’ which resulted from cancerous spleen cells from John Moore and the ‘Hela cell line’ from the cervical tumour cells of Henrietta Lacks [30,31]. The questions of whose rights need to be protected, who should share the benefits, and who the owner of the material is are areas that make this research different from other researchers [25,27,30,32].
• Responsibility for databases, stored data, accountability, and access to stored samples-The owner of responsibility for safeguarding his/her interests varies however the donor is the ultimate “owner” of the data and sample. In Uganda, there is no centralized biobank, so the responsibility lies in the Department of Pathology of the respective hospitals, academic institutions, and private laboratories. Responsibility also lies with the medical records departments of the institutions and the principal investigator/co-investigators on the research project. Therefore, issues are raised on the systems of accountability of the timeframe of the research projects and issues related to the governance of the research and storage facilities [2,19,29].
• In Uganda, and generally, in Sub-Saharan Africa, the idea of research on biological tissue samples has not entered public consciousness, and there is a low level of health literacy and an inability of the public to distinguish between treatment and research [33].

The objective of this review is to bring together researchers in Uganda and East Africa who deal with stored biological tissue samples in Pathology Departments for research purposes and REC members who have a role to protect patients interests and to understand the challenges faced by this type of research and offer suggestions how to address these issues in an effective way.

In Uganda and the rest of Sub-Saharan Africa, there has been a sharp increase in genomic and genetic research and this provides great opportunities for the well-being and health of the population and for scientific advancement [34,35]. Between developing low-income countries and developed high-income countries there is inequity, particularly in biobanking and tissue sample storage, technological gaps in laboratory analysis, and the future use of samples. This review study examines the perceptions of local genomic and genetic researchers towards biological tissue collection and future use in international collaborative research.

Local researchers in Uganda have the following concerns in collaborative research involving biological tissue samples:

• Sharing benefits and sharing data, transfer of biological tissue samples, and intellectual property matters.
• When using the donor’s stored biological tissue samples and data, the requirement to obtain consent for research and whether a waiver of consent is necessary.
• Retrieval and storage of biological tissue samples and clinical records, including quality issues, duration of storage permitted, and the conditions of storage.

The second and third concerns are raised mainly by pathologists who deal with biological tissue samples for diagnosis and research. The first and second concerns are mainly expressed by REC members who need to grant approval for the research project. The concerns of local researchers in Uganda involving collaborative research mainly fall into the first category. Given the limited capacity in developing low-income countries, local researchers generally understand the need to generate new knowledge however there are many concerns that centre around biological tissue sample collection, storage, and transfer. The need for capacity building in developing low-income countries has been acknowledged widely in the local research community.

Biological tissue samples collection and storage for future use of samples in research

The process of sample collection and storage for future use in research has been acknowledged by many local researchers as not only important to advance and generate knowledge but also to build infrastructure to improve laboratory services in Uganda. When a certain number of samples cannot be collected in real-time the storage of these biological tissue samples is considered an opportunity to counteract limited resources in developing low-income countries. Therefore, this cohort of samples may be used in situations of difficulty in obtaining the tissues in real-time. Biological tissue sample storage is time-saving and cost-effective and may provide the necessary data. The disadvantages of these stored tissue samples are that the quality of the tissue may not be similar to those collected in real-time as the tissue may undergo enzymatic degradation with time reducing the quantity and quality of DNA for genetic and genomic research. In order to limit the transfer of biological tissue samples out of the country, if limited capacity is available, DNA may be extracted and exported instead of a whole tissue block. This strategy may limit the quantity of biological tissues exported out of the country.

Cultural context of storage of biological tissue samples

There is a need for local researchers to be sensitive to the cultural context from where the samples were collected. It should be noted that it was not socially acceptable for communities to accept all types of biological tissues to be collected, especially in the case where the future purpose is unknown. In Uganda, local researchers are aware that it is considered taboo to collect certain body parts such as hair and nails [36].

Biobanks for storage of biological samples

The efficient management of biological tissue samples is necessary to efficiently manage storage and use of the samples. In Uganda and the rest of Sub-Saharan Africa the potential of biobanks to store samples and corresponding data needs to be considered. Good governance is essential to fully utilize biobanks in an efficient manner. Many local researchers are of the opinion that rather than the Pathology Departments in government/private hospitals or academic institutions take decisions on stored tissue samples, this responsibility of governance is handles by biobanks. Compared to government or private hospitals, academic/research institutions which have centralized laboratory systems and repositories are best for ensuring good governance of these entities.

Ownership of biological tissue samples and linked clinical data

The ownership of data generated from the laboratory analysis on the tissue samples is decided at the commencement of a collaborative research project. This data which is used to generate new knowledge is intellectual property and is owned according to the level of financial and academic input by the researchers. Whilst many local researchers in Uganda have a poor understanding of the rightful owner of the stored samples, it should be emphasized that the biological tissue samples are owned by sample donors depending on the type of consent given. Whilst the researchers, study sponsors and regulatory bodies all have an influence in the research process it is the sample donors that own their tissues. The UNCST guidelines state that the institution storing the samples is the custodian of the samples.

Consent Process

There is a need for transparency and honesty when obtaining informed consent from study participants. In Uganda and generally in Sub-Saharan Africa, there is a need to make sure that for biological tissue sample storage for future use in research, a comprehensive informed consent process is followed by researchers. A study has shown that many research study participants do not have a clear understanding of the processes involved in biological tissue sample storage [36]. Issues of benefit sharing and ownership of samples need to be discussed during informed consent.

Export of biological tissue samples from Uganda

There need to export biological tissue samples to developed high-income countries for advanced laboratory analysis in research. This is due to the resource-poor in-country technological capacity. Researchers from developing low-income countries feel that access to advanced laboratory technology in developed high-income countries is good for the advancement of knowledge. However, it has been reported in developed high-income countries that biological tissue sample storage, limits development in human resources and local capacity building. However, to reduce the need to export biological tissue samples, the local Government needs to address the limited capacity in infrastructure and human resource capacity. It is therefore reasonable to understand the reason why many researchers feel it is unfair to the development of Uganda to continue exporting samples out of the country and deplore this long-standing practice. This has also resulted in a potential limitation in building capacity in Uganda [36].

Material Transfer Agreements (MTA) are required to transfer biological tissue samples out of the country. Local researchers following shipment, tend not to trust that the provisions of the MTA will be respected by the collaborating foreign institutions. Researchers in developing low-income countries feel that they lack the bargaining power to negotiate these agreements as the funding of the research tends to come from grants acquired from investigators in developed high-income countries. Even when the MTA is negotiated well there is a detriment to local capacity building in developing low-income countries as foreign researchers may not accept to build local infrastructure to carry out laboratory experiments locally. It should be noted that it is the mandate of the Uganda National Council for Science and Technology to review and approve MTAs and issue the export permit required for a valid export according to UNCST guidelines (2014).

Prior to approval, the principal investigator of the research project needs to prove that in-country capacity is deficient or non-existent to process the samples.

Author’s opinion

Challenges regarding sharing of biological tissue samples

Many local researchers feel a loss of control over their tissue samples as they were stored in overseas laboratories away from Uganda. The function of human biobanks for genetic research, lack a uniform regulatory system. Regarding the use of biological tissue samples, extracted DNA with linked medical data should be exported as there is considerable variation between international and national laws. Therefore, there is a perception among local researchers that international collaborators may be operating unlawfully with biological tissue samples and linked data.

Regulations governing the sharing of biological tissue sample and linked data

In international collaborative research projects local researchers agreed that good biobank governance is necessary. It has been found that many local researchers are unaware of the regulations and guidelines that govern the sharing of biological tissue samples and linked data in Uganda. Differences in regulations across international borders are impediments to data and sample sharing. Therefore common international regulations and guidelines should be in place for biobanking taking into account cultural differences between populations. There is a lack of guidelines on data sharing and biological tissue sample sharing among researchers between developed high-income countries and developing low-income countries. This leads to unfair sharing and inequity of benefits for researchers from developing low-income countries. This may reduce efforts to build capacity. The lack of data and tissue sample-sharing guidelines may be due to the inability of researchers from developing low-income countries to implement advanced laboratory analysis and hence an over-reliance on the international collaborating partners.

It is the opinion of the author that the local infrastructure and human resource capacity should be strengthened in Uganda. This opinion is shared by other local researchers [36]. Whilst foreign funders and collaborators may invest in local infrastructure, the local Government in Uganda and other governments in Sub-Saharan African countries should invest more in local infrastructure and strengthen human resource capacity by training local researchers in carrying out advanced laboratory analysis, instead of exporting the biological tissue block samples.

This strategy will also reduce of costs of having to export the samples which in the experience of the author is often borne by the local researcher. It is also the experience of the author that in certain situations the principal investigator needs to pay for the laboratory analysis if no grant is available locally or by the international collaborators.

This review examined the personal experience of the author and other local researchers regarding the perceptions of genomic and genetic research towards the current practice of biological tissue sample collection and storage for future use in research involving international collaborations. Whilst researchers are understood on the limited capacity in developing low-income countries and the need not to prevent the generation of knowledge, there are lots of concerns about sample collection, storage, and transfer. Within developing low-income countries there is a need to build capacity. Studies from developed high-income countries have highlighted the limitations in the current practice of processing and storage of samples [38,39]. However, in developing low-income countries due to limited capacity, the importance of storage, reuse, and governance of the biological tissue samples in Sub-Saharan Africa should be emphasized. Whilst there are many guidelines that have been developed to guide international biobank research there is variation among practices in different countries which may impact tissue sample transfer and sharing. There is a need to harmonize biobanking regulations between developing low-income countries and developed high-income countries taking into account cultural and social considerations.

In biobanking research, there should be governance frameworks that encourage trust between researchers and participants and the recipient institutions where the samples are donated [40,41]. The people’s willingness to donate tissue samples and their trust in the conduct of research and handling of their biological tissue samples will determine the success of biobanking research [41]. The cultural context of the community needs to be taken into consideration when setting up biobanks. Cultural sensitivities need to be considered when consenting for biological sample storage and reuse [42]. In Sub-Saharan Africa, there are many biological tissue samples that are held sacred by some communities which consider storage as socially unacceptable [43,44]. Individual consent is emphasized in the developed world in biobanking research however, in Sub-Saharan Africa, there are many community-level factors that may influence the decision-making of a participant during the informed consent process [44-47]. Therefore in biobanking research, this poses a challenge to informed consent due to relational autonomy, spirituality, and the communitarian nature of society [48]. In genomic and genetic research in Uganda, recent studies have shown that there is inadequate understanding of consent information due to a reluctance to read the informed consent documents by the participants, inaccuracy in translating concepts and technical terminologies into local languages and a low level of genetic literacy [49]. Therefore, in our communities, researchers need to be more flexible and innovative for obtaining consent and ideally should engage the community [49-50]. In order to enhance comprehension during the informed consent process there is a need to contextualize the discussion by involving the individual and ideally participants in his/her community.

In Uganda and generally Sub-Saharan Africa there is a limited local capacity for biobanking and genetics research. Local capacity may be improved through biobanking as it is a time saving and a cost-effective way of utilizing biological tissue samples. There is generally a level of displeasure among local researchers in exporting biological tissue samples from Uganda to developing high-income countries as it reduced building local capacity and there is inequitable benefit sharing. This review serves to encourage local researchers in Uganda to engage the Government in increasing the funding necessary to increase laboratory infrastructure and strengthen human resource capacity and this has the potential of reducing the amounts of biological tissues which need to be exported from the country.

The author is thankful to the administrations of Masaka Regional Referral Hospital, Mulago National Referral Hospital, Uganda Martyrs’ Hospital Lubaga and Mengo hospitals and Department of Pathology, School of Biomedical Sciences, College of Health Sciences Makerere University in Uganda for complying with the guidelines of the Uganda National Council for Science and Technology for the authors’ PhD Colorectal Cancer Research project which included retrieval of biological tissue samples and buffy coat samples from study participants (sample donors). These biological samples were exported from the School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Uganda to the University of Edinburgh and Columbia University respectively. The content does not necessarily reflect the official views of the US National Institutes of Health and the content is the sole responsibility of the author.

Competing Interests

The author of the article declares no competing interests in the publication of this research article.

Consent For Publication

Not applicable

Ethical approval

Not applicable

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