Researchers’ perspectives on the use of material transfer agreements in biobanking research; a case of Uganda

Abstract

Background

The increase in sharing of human biological materials and associated data in collaborative research underpins the need for robust regulatory frameworks. This study explored researchers’ perspectives on the use of material transfer agreements in biobanking research.

Methods

A qualitative descriptive study was conducted among researchers at two research institutions in Uganda. Fourteen researchers were purposively selected to participate in key informant interviews. Data were analysed using thematic analysis. NVivo 12 software was used to organize the data.

Results

Four themes were generated from the data: the importance of material transfer agreements, facilitators of successful development and execution of material transfer agreements, negotiating power dynamics between institutions in drafting of material transfer agreements, and barriers and challenges to the drafting and execution of material transfer agreements. Material transfer agreements were considered legal documents that describe the obligations of each party during the execution of the study. Researchers felt that robust ethical and legal frameworks, having multi-disciplinary teams and transparency were key to the successful development and execution of material transfer agreements. Researchers mentioned power dynamics, limited understanding and experiences with material transfer agreement processes, protracted bureaucratic approval processes, and differences in policies and laws across different jurisdictions as challenges to the drafting and execution of material transfer agreements.

Conclusion

The material transfer agreement is key to ensuring fairness in collaborative research, and the processes to ensure fairness in the drafting and execution of the material transfer agreement require empowerment of partners in resource-limited settings through effective regulatory frameworks and legal support to negotiate better.

Clinical trial number

not applicable.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12910-026-01462-y.

Introduction

A Material Transfer Agreement (MTA) is a type of legally enforceable contract employed by research institutions and companies to set the terms under which their materials and associated data may be obtained and used by others [1]. These agreements provide a mechanism to protect the interests of the owners of discoveries and inventions, while promoting data and material sharing in collaborative research. The purpose of an MTA is to facilitate the exchange of human biological materials (HBM) and associated data between researchers/institutions, as well as to safeguard the interests of research participants, researchers and their institutions. Conventionally, an MTA typically sets out the uses of the material, the quantity of the material, terms and conditions under which the material may be used, third-party transfers, benefit-sharing mechanisms, intellectual property rights and other legal and/or regulatory policies or guidelines that need to be considered [2].

In the past decades, sub-Saharan Africa has experienced tremendous growth in research involving the transfer of HBM to high-income countries (HICs) [3], including commercial entities [4]. Studying African genetic data is particularly important and desirable due to the greater genetic diversity found in African populations, which makes Africa a rich environment for research, attracting international collaborations [5], given the high disease burden and epidemics such as HIV/AIDS and TB on the continent [6, 7]. Therefore, the collection, storage, and transfer of biological materials are essential for medical research and innovation [8, 9].

The sharing of HBM and associated data raises several legal and ethical issues among collaborating parties [10], including ownership and custodianship of samples, informed consent and benefit sharing [8], loss of control over samples once transferred, local researchers’ inability to track exported samples, and lack of recognition for their authorship in future work using those samples [11]. These concerns are further escalated by the potential for commercialization of the derivatives from the HBM [5].

African HBM have been in demand internationally with a unidirectional move of biomaterials out of the continent, because of funding and influence from institutions in high-income countries [7, 12]. This unidirectional transfer raises concerns about the exploitation of low-resource countries [13, 14], ensuring fairness and equity in access to and the ability to utilize these samples for scientists from both high-income and low-income countries [15]. It also raises questions about participants’ understanding and consent to the sharing and potential commercialization of their data [5].

The MTAs are commonly used to facilitate the exchange of materials [9]. All samples to be stored in the Biobank should be accompanied by an MTA between the custodian institution and the Biobank [16]. Parties to an MTA include universities, specialised research organizations, and commercial companies [17].

Previous findings show how African researchers have expressed interest in achieving equitable partnerships through actively being involved in the decision-making process relating to the use of samples and decisions relating to publications and property rights, instead of being looked at as hired workers or data collectors [12]. It is therefore essential that a carefully drafted MTA, which incorporates the ethical and legal aspects that the transfer of HBM raises.

In a study conducted among researchers and research ethics committee members in Uganda, respondents raised concerns about a need for researchers and institutions in LMICs to be empowered to negotiate better MTAs in international collaborative research, because poorly negotiated MTAs hampered local capacity building [18]. Furthermore, there is limited literature on researchers’ perspectives on the use of MTAs and biobanking research in Uganda. Exploring researchers’ perspectives can help identify the gaps, challenges, and practices that influence ethical compliance, governance, and the responsible sharing of biological samples. This could contribute to strengthening national regulatory frameworks in Uganda, where biobanking governance is still evolving to foster equitable collaboration in biobank research.

Methods

A qualitative descriptive approach was employed. The qualitative description approach provides rich insights from the participants’ perspective, providing factual responses to questions about how people feel about a phenomenon [19], in this case, researchers’ perspectives on the use of MTAs in biobanking research, particularly the importance of MTAs, facilitators of successful drafting and execution of MTAs, negotiating power dynamics between institutions in drafting of MTAs, and barriers and challenges that arise.

Study setting

The study was conducted at two institutions that conduct collaborative research on Mulago Hospital Hill and have several active research studies on HIV and TB involving biobanking.

Study population

The study population comprised 14 researchers, who included 7 principal investigators, and administrative staff (1 research manager, 2 research directors, 2 signing or authorization officials or Executive Directors of the institutions, and 2 laboratory managers). Most of the respondents had a master’s level of education and were aged 41–50 years, as shown in Table 1. Respondents were selected purposively based on their experience and roles in the drafting, review, negotiating, and execution of MTAs at their respective research institutions. Data were collected till saturation, that is, until no new ideas were being generated from additional interviews or discussion [20].

Table 1.

Respondent socio-demographics

Characteristic	Frequency
Age (years)
30–40	01
41–50	09
< 50	04
Gender
Male	02
Female	12
Level of Education
Degree	01
Masters	12
PhD	01
Designation
Principal Investigator	07
Research Manager	01
Research director	02
Laboratory manager	02
Executive director	02

Data collection

Fourteen key informant interviews were conducted between May and June 2023. Potential participants were contacted via phone or email, briefed about the study, and an appointment was requested at a convenient time to participate in the key informant interview. Face to face interviews were conducted in English by RN and HB, using a semi-structured interview guide that was developed based on the aim of the study and a scholarly review of literature [6, 21–24]. The interview guide was pre-tested on two bioethics graduate fellows and some adjustments were made to ensure clarity. All interviews were audio recorded with the permission of the respondents, alongside detailed notes taken as backup for the interviews. On average, interviews lasted between 30 and 45 minutes. Participants were recruited up to the point at which no new ideas were being generated from additional interviews.

Data management and analysis

Audio recordings were transcribed verbatim by trained transcribers, independent of the study team for subsequent analysis. Two coders used an inductive approach to code data. Three transcripts were manually reviewed and coded to develop the initial set of codes. This was then followed by a detailed thematic analysis to develop a draft of the coding framework. Transcripts were imported into NVivo version 12 software to support data analysis using a coding framework that was iteratively revised. There was flexibility to accommodate new emerging themes as coding evolved. To ensure credibility of the analysis, transcripts were coded independently, compared and discussed. A code book was developed, and the revised codes were grouped into categories, and themes were identified. Illustrative quotes for each emergent theme were selected for results narration.

Ethical considerations

Ethical approval was obtained from the Makerere University School of Biomedical Sciences Research Ethics Committee (reference number: SBS-2022-269), and administrative clearance from the institution heads. Participation in the study was voluntary. Written informed consent was sought from each participant before conducting the interview. Confidentiality of participants was maintained through the use of identification numbers. Data was kept securely, and all recordings and transcripts were de-identified, assigned special codes, and stored on a password-protected computer.

Results

Four themes were identified from the data, and these included (1) importance of MTAs, (2) facilitators of successful development and execution of MTAs, (3) negotiating power dynamics between institutions in drafting of MTAs, and (4) barriers and challenges to the drafting and execution of MTAs (see Table 2).

Table 2.

Themes and subthemes

Theme	Subtheme
1. The importance of MTAs	• Legal document
2. Facilitators of successful development and execution of MTAs	• Regulatory frameworks • Multidisciplinary team effort
3. Negotiating power dynamics between institutions in drafting of MTAs	• Creating a common ground with collaborating parties • Community involvement through Community Advisory Boards and obtaining informed consent
4. Barriers and challenges to the development and implementation of MTAs	• Power dynamics between collaborating partners • Limited capacity and lack of experience among researchers • Protracted bureaucratic approval process • Difference in regulatory frameworks across different jurisdictions

Theme 1: The importance of MTAs

All respondents clearly appreciated the importance of MTAs in research involving the transfer or sharing of HBM. Most respondents perceived an MTA as a legally binding contract that governs the transfer of biological materials between collaborating institutions and ensures that shared samples are used for the rightful purposes as stipulated therein. They also indicated that MTAs are important in defining the responsibilities and expectations of each party.

“MTAs help in clarifying the obligations and restrictions of the collaborating entities and ensuring that the collected samples are used to perform activities only related to the study at the time as mentioned in the protocol.” (KII 11).

“It [MTA] is really a contract between the parties. So, in there, they have to clearly mention the nature, the quantity and the purpose of that material.” (KII 06).

In addition, two principal investigators mentioned that MTAs help them clearly define the laws that will govern the use of the HBM and how the benefits may be fairly shared between the parties.

“And within these material transfer agreements, the different laws that will govern this whole exchange of the specimen from one part of the world where the investigator is, to the other side, that is actually going to run the different analyses on the specimens that have been collected”. (KII 04)

“The other importance is to clearly mention the benefits of both parties in terms of intellectual property, in case there are going to be any publications or economic gain from these samples”. (KII 02)

This finding implies that all the negotiations done and legally binding restrictions relating to the use of samples are aimed at ensuring that both parties gain amicably from the transfer and analysis conducted on samples, irrespective of where the analysis is done.

Theme 2: Facilitators of successful development and execution of MTAs

Regulatory frameworks

Respondents noted that the successful development and execution of MTAs should be governed by robust ethical and legal frameworks. Material transfer agreements should be reviewed by a research ethics committee (REC) and the Uganda National Council for Science and Technology (UNCST). Respondents posited that review and approval of MTAs by research regulators ensures responsible sharing of HBM and guides local institutions on what to include in these documents.

“We have quite a good support from UNCST when we are developing the MTAs. They usually guide you, and if there is missing information, they let you know. So, we have learnt to make sure that the MTAs are in line with what UNCST requires”. (KII 13).

“They've [UNCST guidelines] also provided a clear template on what we expect as a country in terms of designing or developing a material transfer agreement, [like] what should the key elements be in an MTA”. (KII 06)

Multidisciplinary team effort

Respondents opined that successful MTA development and implementation requires a multidisciplinary approach involving several personnel within the local institution, including the Executive Director, principal investigator, legal personnel, the Research Director, laboratory personnel, and other stakeholders. They contended that this is necessary for due diligence, ensuring that the MTAs follow national laws, and that the interests of the local institution are catered for.

“At our institution, we also share with the legal team to see if they have any input, and whether they have any concerns”. (KII 10).

One respondent mentioned that it was desirable for institutions to have a dedicated team of experienced individuals to review and negotiate MTAs and other collaborative agreements.

“Other factors are also having a team on site that takes their time to read in detail, what this transfer agreement means, especially if the PI is also not so sure. So, it’s a team activity together with the legal team of the institution”. (KII 08).

Another respondent emphasized that it should also be a team of experienced and knowledgeable individuals that reviews MTAs to ensure that all elements stipulated in the national ethics guidelines are included.

“In our institution, we have had a team I work with to make sure we draft the right material transfer agreements. So once this is drafted, we look at the different elements that abide or that pertain to a material transfer agreement. And once it’s drafted, it is shared with PI and the research or regulatory team to make sure that the language is correct. And where we feel comfortable, we then go ahead and share with sponsors” .(KII 06).

All respondents unanimously called for honesty, transparency and equity on both sides during the development and implementation of MTAs. They pointed out that it is imperative for institutions to have good negotiating skills and front their interests during MTA negotiations.

“A clear understanding of the terms and conditions of the MTA between the collaborators or partners. Once the MTA has that level of transparency, usually the partners will really have no major challenges in implementing it”. (KII 13).

“One factor that I would really think about is good negotiation skills that both [parties] will be able to negotiate and come to a compromise very fast”. (KII 03).

This implies that negotiations towards development of equitable MTAs in biobank research is not always straightforward but dynamic, involving an interplay of multidisciplinary teams on either side, but most importantly, the ability for each party to push for its interests through better and transparent negotiations. In addition, the regulatory framework involving RECs and UNCST helps to review and assess if the key elements of MTAs are included so that local institutions front their interests and play their role as custodians of participants’ samples.

Theme 3: Negotiating power dynamics between institutions in the drafting of MTAs

Creating a common ground with collaborating parties

Respondents noted that negotiations differ depending on the kind of research and analysis to be conducted on the samples and the reasons for shipment of the samples.

“MTAs are very diverse, so it is not a script, which is like one fits all because one, it depends on the nature of your study protocol, the nature of analysis that you want to do and the reasons why you must transfer what you must transfer”. (K11 01).

They pointed out that before negotiation, there should be a common ground regarding the purpose of the collaborating partnership concerning what has to be done regarding the transfer of samples and laws concerning the sample sharing.

“There is need to understand and either parties need to understand what they need and aspects to do with the laws governing the samples that are being shipped. If both parties really understand that aspect, then I think that amicable agreement is not a challenge. But if one wants to supersede the other, then that’s where the challenge comes in”. (KII 12).

Before negotiation, respondents noted that prior assessments are done to ensure both parties have the capacity to collaborate effectively. It goes back to the study protocol and the nature of analysis to be conducted on the samples, and then assess the technical capacity of the institution or university where the biomaterials are to be transferred.

“You have to assess technical competence. So, we assess their technical competence, but they also assess our technical competence, because it is not a one-way. It is two-way. Did we have the capacity to collect the specimens that we said we would collect, to store them, to transport them at the temperatures at which we are supposed to transport them? So, it is two-way; where there are partnerships, both have to assess. They assess our capacity, we assess their capacity. We assess each other’s qualifications”. (KII 01).

Respondents noted that at the outset of drafting the MTAs, the provider and recipient institutions have templates that outline the various areas that should be included in an MTA. However, they eventually have to ensure that the drafted MTA aligns with the UNCST guidelines

“For our site, we are fortunate that we do have a template which can [can be] into place with different negotiations between the sponsors, and different regulatory authorities”. (KII 04).

“Usually, we share with the sponsor, or if the sponsors have their own template, they also share a template, but again, the regulatory team goes ahead to make sure that whatever template you used is well aligned to the National Council guidelines”. (KII 02).

Respondents indicated that the MTA negotiation process is dynamic and iterative, with several rounds of sharing of drafts until all parties reach a consensus. The local institutions also rely on the UNCST standardized MTA template to protect their interests.

“Ultimately during the [MTA] review process, both sides or parties do mention their critical areas of interest pertaining to them, and the tendency is that they are all subject to negotiation, but also with the mind that there are certain requirements that the local regulatory bodies are also interested in that need to be taken care of”. (KII 10).

Community involvement through community advisory boards and obtaining informed consent

Respondents found Community Advisory Boards (CABs) key in representing participant communities and articulating their interests, concerns and expectations during the transfer of samples.

“When we are trying to develop the material transfer agreement, it is a good idea that these people (CAB members) are involved, because they are the people who talk to the participants in the community, and they bridge that gap between the communities and the researchers”. (KII 11).

Consequently, the content, scope, and limitations of participant consent greatly influence how collaborating institutions negotiate and draft material transfer agreements. Consent serves as both an ethical boundary and a means of negotiation leverage.

“But I think their [participants’] involvement could be from the angle of probably getting their opinion on things to do with sample use, whether use is restricted to the actual study at the moment, or they can open it up to any other research or related research”. (KII 10).

“Most of our research is collaborative. You want to make sure that the sample is used for the purpose it’s meant to be used for, because usually in the consent we also specify your sample will be used for ABCD and whatever. So, in the material transfer agreement, actually, there’s a section where we are required to state what the samples are going to be used for. It has to be clear, such that the recipient is also aware”. (KII 03).

Theme 4: Barriers and challenges in the development and implementation of MTAs

Respondents highlighted several perceived barriers and challenges to the development and implementation of MTAs.

Power dynamics between collaborating partners

Some respondents stated that the successful development and execution of MTAs is hampered by power dynamics between low and middle-income countries (LMICs) and high-income country institutions. They opined that most MTAs tend to favour the western collaborators who have the funds to finance the research, which exposes LMIC researchers to exploitation.

“The power balance is not tilted in favor of the local principal investigator from a low-income country. Taking samples to a more advanced setting that is probably funding or has access to the funders, that dynamic may not be in favour of the institution in a low-resource setting”. (KII 07).

One respondent pointed out that oftentimes, LMIC institutions must capitulate to the demands of their collaborators for fear of losing funding opportunities.

“The receiving party [recipient of the samples] will want their terms. So, the low resourced countries end up dancing on the tunes of the other [party]”. (KII 02).

Limited capacity and experience among researchers

Lack of awareness and poor understanding of MTA processes was also cited as a major barrier to MTA development and implementation. One participant opined that many researchers have no experience, lack negotiating skills, and may not appreciate the intricacies associated with negotiating an MTA, or may overlook some key important aspects, as illustrated in these quotes,

“The challenge would be in terms of the individuals who develop these agreements not being able to appreciate scope, implications, and the consequences of what this whole process entails—because if they do not appreciate that, there are chances that they may not pay attention to all the details. …”. (KII 08).

Protracted bureaucratic approval process

Some respondents cited the prolonged MTA approval process as a barrier. Participants expressed frustration due to institutional bureaucracy and delays caused by regulatory approval processes. They indicated that delays slow down the research implementation and negatively impact international collaborative research.

“I think the [regulatory] layers are delaying research and making it harder. You can have a project that takes a whole year to get approval. The MTA also takes so long, another six months. Even though it’s good for us to be cautious, we don’t want to delay the research. Other people will do it and we lose the benefit to us as investigators, and also our participants”. (KII 09).

Difference in regulatory frameworks across different jurisdictions

Furthermore, some respondents felt that scientists have limited understanding of the ethical and regulatory frameworks that govern sample export. They opined that this, coupled with varying institutional policies and regulations across borders has made MTA development and implementation difficult.

“Then, the other issue is that these samples are being transferred to another institution that probably has a different kind of protocol that manages [the samples]—for which you also have no representation at those sites. So, you kind of rely on the trust element within the whole flow”. (KII 09)

“The regulations, the state regulations in both countries if the guidelines in both the countries are not favourable to one party then that would also hinder the quick development of the material transfer agreement”. (KII 11).

Discussion

This study explored researchers’ perspectives on the use of MTAs in biobanking research.

Material transfer agreements were considered legal documents that facilitate the transfer of HBM between institutions, and ensure that samples are used for their intended purpose. Robust ethical and legal frameworks and having multi-disciplinary teams were perceived as key in the successful development and execution of MTAs. Several challenges to MTA drafting and execution were identified.

Our findings suggest that an MTA is a legally enforceable agreement that spells out the intended use of the samples and the responsibilities of the provider and recipient institution, and also clarifies access and ownership of data and aspects relating to publication. All these aspects are discussed prior to collection and shipment of samples by all parties involved. An MTA also ensures that the interests of research participants, researchers and their institutions are protected [25]. The MTAs also limit the use of materials by third parties and also outline dispute resolution mechanisms, legal jurisdiction, the duration of the relationship, and conditions for its termination, including the return or destruction of the materials [23]. They are key in resolving ownership and benefit sharing conflicts in case of any commercial products [10].

Respondents in this study identified regulatory frameworks as important to the successful development and execution of MTAs. The UNCST guidelines require the provider organization and recipient organization to negotiate an appropriate MTA [26], and these guidelines outline clauses that have to be included in the MTA. Material transfer agreement review by RECs and UNCST ensures adequacy for compliance with national guidelines. Advice from regulatory bodies like RECs is, therefore, important, especially where researchers are not well versed with some of the aspects in the MTAs. For instance, RECs could help in reviewing MTAs to see whether there is transparency in the MTAs regarding aspects such as data sharing, authorship, and benefit sharing [27]. However, a study carried out in Uganda also reported that national ethics guidelines are not clear and do not prescribe how exactly research benefits should be shared [18]. The local guidelines also need to empower RECs by clearly defining what roles RECs have to play in the MTAs.

A multi-disciplinary team was seen as key in the development of MTAs. This is especially important because findings show that researchers generally lack the relevant legal knowledge to enter into legal agreements [4, 28]. During the development of MTA, the parties involved exchange offers and acceptances to reach a common agreement on various aspects related to the transfer of the material [29]. A team with a wide range of experience in research, legal, and regulatory aspects can ensure favourable negotiations for effective collaboration.

Respondents highlighted the need for transparency and good negotiation skills. They acknowledged that researchers in low-resource settings must negotiate effectively and collaborate fairly to achieve mutual benefits. Many ethical concerns in genomics and biobanking research between the Global South and Global North focus on equity and fairness for Sub-Saharan countries [10, 18]. Our findings imply that researchers believe MTAs can enhance their interests if terms and conditions are clearly defined. Researchers in LMICs must negotiate better, particularly in genomics, because of the potential for innovation [10, 25]. Well negotiated MTAs ensure researchers don’t lose out on any privileges accruing from commercially viable innovations.

Our findings highlight the importance of informed consent in biobanking. Respecting the autonomy is important in biobank research. If international transfer of biospecimens is anticipated at the time of collection, consent should have been given with the full knowledge of this possibility [17, 30]. The ethical implications of MTAs become most evident in the transfer of biospecimens, as consent plays a central role in such exchanges [17]. Obtaining informed consent during the development of an MTA reflects an acknowledgment of the need to balance donor protection with the advancement of research to enable effective biobank studies. Seeking consent ensures that the MTAs are ethically sound and reflect a commitment to honouring donors’ rights by ensuring that the samples are used responsibly and in accordance with their consent. All the negotiations done by the local institutions also reflect this inherent commitment to protect participants’ interests and what they agreed to when donating their samples.

Community engagement was seen as key in the process of developing MTAs. Consulting with representatives of study communities is important for research involving human biological material and associated data [10]. Researchers should make a reasonable effort to involve community stakeholders who ultimately represent the interests of people who are recruited to take part in research or other people who might be affected by the study [26]. Through community engagement, participants’ perspectives can be communicated regarding the storage, transfer, and sharing of their samples with international collaborators. These community views can then inform the terms and conditions that local institutions negotiate with foreign partners. The institution holding the samples on behalf of the donors is responsible for establishing an appropriate MTA with the recipient institution to ensure ethical and transparent use.

Power dynamics were considered as a barrier to the development of MTAs. Other studies have shown that international collaborations are associated with unequal power relations in favour of researchers and institutions from high-income countries, and this impacts on sample ownership and authorship [31]. Previous findings have also shown that researchers and research institutions from low-resource settings are not in a position to bargain favourably during MTA negotiations and that there were no supportive ethical and legal frameworks to protect the interests of local scientists and research institutions [18]. Several research institutions in Uganda have challenges with negotiating favourably when it comes to MTAs [24]. The local guidelines need to empower institutions to make better decisions because mutual respect and benefit are important to a successful global health research partnership [32].

Lack of awareness about MTA processes and knowledge gaps about MTA implications, not being familiar with the legal language or vocabulary, poor negotiation skills, and protracted bureaucratic approval processes were pointed out as barriers to the drafting and execution of MTAs in biobank research. This is similar to findings by [23]. Another study in Uganda reported challenges related to local researchers or institutions just signing MTAs drafted by collaborating institutions overseas without carefully reading through [18]. Benefits for local researchers in collaborative research can only be realized if MTAs are well negotiated [24]. There is a need to ensure that institutions have legal support to help researchers who are not well-versed with aspects of MTAs.

The difference in policies and laws across different jurisdictions was perceived to affect the drafting and execution of MTAs. Whereas parties to an MTA are free to include terms negotiated between them, additional complications arise if the MTA involves exchanges of biospecimens and data between jurisdictions. Having a clause on governing laws helps to specify that the MTA is governed by the laws of a particular jurisdiction, state, or country [33]. However, when human biological materials are shipped to another country, oversight becomes complicated [22]. This can raise questions regarding how the laws and ethical guidelines that apply to the MTA are enforced [17].

Limitations and strengths

The main strength of this study was the participation of researchers with experience in drafting, negotiation and execution of MTAs. This helped us to have a multi-dimensional look at the hitherto ignored topic of discussion in Uganda. This study builds on previous studies in the Ugandan setting that looked at MTA’s compliance with regulatory requirements.

The main weakness of the study was the recruitment of researchers from only two research institutions in Uganda, as such, their responses might have been influenced or limited by their institutional affiliations. However, it was emphasized that individual responses would be anonymized. Nevertheless, their views highlight important considerations to be made when negotiating and executing MTAs to facilitate exchange of HBM for research purposes.

Regarding reflexivity, we acknowledge potential sources of bias from the moderators and respondents. As the moderators, we were aware that when interviewing individuals with prior experience in drafting, negotiating, and executing MTAs, we needed to try to remain neutral, setting aside our views and listening from the respondents’ perspective. It was, however, difficult for us to be totally objective and not relate to our experiences because of our interest in the implementation of MTAs. We tried to overcome this through protocol training and ensuring that interviews were moderated by an experienced team that was relatively unknown to the majority of the respondents. The respondents may have had different expectations that could have influenced their responses. They also could have withheld their genuine views and instead offered responses they believed were socially desirable. However, we tried to create a comfortable and friendly atmosphere, encouraged active participation and iterative discussions, and gave participants a chance to voice their opinions.

Conclusion

The MTA was regarded as a legal document that spells out responsibilities, other key clauses regarding the use of samples, and associated data. The process of drafting MTAs included obtaining written informed consent from participants, drafting, negotiating, and signing MTAs among the collaborating parties. Ethical frameworks, multidisciplinary team effort, and transparency are key facilitators, while power dynamics, limited understanding, bureaucratic delays, and differing legal and policy frameworks across jurisdictions are barriers to drafting and the successful execution of MTAs. Local research institutions need to strengthen their oversight by assigning a dedicated team to review MTAs for compliance with UNCST and other relevant guidelines. Capacity building through targeted training and mentorship can empower local researchers with the knowledge and negotiation skills required to effectively engage in MTA processes.

Future research

Obtaining views of research regulators, the community, and participant perspectives regarding MTAs could inform more effective biobanking governance through the use of MTAs.

Implications for policy

There is a need to support institutional and researcher capacity to empower local collaborators to enhance their ability for better MTA negotiations.

Abbreviations

CAB

Community Advisory Board

COIs

Conflict of Interests

H3Africa

Human Heredity and Health in Africa

HBM

Human Biological Materials

HIC

High Income Countries

KII

Key Informant Interview

LMIC

Low Middle-Income Countries

MoU

Memorandum of Understanding

MTA

Material Transfer Agreement

REC

Research Ethics Committee

UNCST

Uganda National Council for Science and Technology

Authors’ contributions

RN, IM and EM contributed to the conception of the study and study design. RN and HB collected the data. RN and EM analysed the data. RN, drafted the manuscript, EM, SN, IM and HB provided comments and made suggestions to the manuscript, which were addressed by RN. All authors read and approved the final manuscript.

Funding

Declaration.

This work was part of the master’s program and was supported by Fogarty International Center of the National Institutes of Health, through the Makerere University International Bioethics Research Training Program (NIH Grant No. 5R25TW009730-09).

Data availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

This study was reviewed and approved by the Makerere University School of Biomedical Sciences Higher Degrees and Research Ethics Committee (reference number: SBS-2022-269). The study adhered to the Declaration of Helsinki ethical principles for medical research involving human participants [34]. Written informed consent was sought from each participant before conducting the interview.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.