A clinical trial closes. Its samples and data may still have years of scientific life ahead.
Stored specimens can support new investigations. Trial datasets can help researchers answer questions beyond the original protocol. Further analysis may contribute to a diagnostic tool, a biomarker or a commercially useful discovery. By then, the agreement governing who can use those resources, and on what terms, may already be years old.
For African research institutions, this is a central governance question: does the agreement cover only the work of conducting the trial, or also the value that may emerge afterwards?
Paying a site to deliver a study does not, by itself, settle that question. Neither does adding investigators to a publication. Fair benefit sharing requires deliberate decisions about future use, decision-making authority and the distribution of benefits.
Those decisions belong at the beginning of a partnership, not after a discovery has become valuable.
Ownership is not one right
Clinical research creates value through contributions from participants, investigators, institutions, funders and sponsors, often across several countries. Recognising African contributions does not require claiming that every resulting discovery belongs exclusively to the continent. It requires being precise about the rights those contributions should support.
Sample custodianship, permission to use data, publication rights and patent ownership are different things. An institution may hold biological material without having unrestricted authority over its use. Researchers may deserve opportunities to analyse data without qualifying as inventors of a patented technology.
Patent inventorship depends on the contribution to the invention under applicable law, not simply on where a trial took place. Ownership is a separate question, shaped by law and contractual arrangements. The World Intellectual Property Organization makes this distinction explicit in its study of cross-border research collaboration (1).
That distinction strengthens the case for benefit sharing. An institution need not be a patent owner to negotiate research-use rights, licensing benefits or a share of agreed commercial returns. Equally, joint ownership is not enough if the agreement leaves unanswered who can license the invention, who pays for protection and how it will become accessible.
The practical question is broader than “Who owns the patent?” It is “Who can make decisions, use the knowledge and benefit from what follows?”
What African genomics has already tested
Human Heredity and Health in Africa (H3Africa) offers a useful example of how sharing can be governed rather than simply permitted.
A 2025 account of its Data and Biospecimen Access Committee describes the review of requests to reuse genomic resources. The committee assessed proposed uses against consent and consortium policies, sought clarification of benefits to African populations and examined collaboration with African scientists. Collaboration was a requirement for biospecimen requests and encouraged, rather than universally mandatory, for data requests (2).
One feature is particularly instructive: data were deposited in the European Genome-Phenome Archive, while access decisions remained with the H3Africa committee. Storage location and decision-making authority were not the same thing.
This does not establish that every secondary use delivered measurable benefits, nor does a genomics consortium provide a ready-made commercial trial contract. It demonstrates something narrower and valuable: international sharing can operate with a defined mechanism for scrutinising purpose, consent and expected benefit.
The lesson for clinical trials is not to reproduce every H3Africa rule. It is to ensure that someone remains accountable for what happens to research resources after their original collection.
Keeping samples within a country is not, on its own, a benefit-sharing framework. Sending them abroad need not mean surrendering all authority. The relevant safeguards are lawful transfer, clear permitted uses, oversight of onward sharing and obligations that remain meaningful after the initial study ends.
Use the right ethical and legal foundations
Benefit sharing already has a firm ethical basis. CIOMS guidance calls for research in low-resource settings to respond to local health priorities. It also calls on sponsors and researchers, working with governments and other stakeholders, to make every effort to make resulting interventions and knowledge available to the population concerned. Communities should participate in planning those arrangements (3).
Post-trial care for participants must nevertheless be distinguished from wider population access.
The 2024 Declaration of Helsinki states that sponsors and researchers must arrange post-trial provisions in advance for participants who still need an intervention identified as beneficial and reasonably safe in the trial. Exceptions require research ethics committee approval, and the arrangements must be disclosed during informed consent (4).
Making a successful product available across a country is a different undertaking. It requires planning for regulatory authorisation, affordability, procurement, supply and delivery through health services. A promise of “access” is incomplete unless these responsibilities are addressed.
Legal frameworks also need careful interpretation. The Nagoya Protocol should not be presented as a general legal basis for sharing benefits from human genomic research. The decision adopting it explicitly states that human genetic resources are not included within its framework (5). Institutions must identify the laws and requirements applicable to their particular samples, data and research activities rather than assume that one international instrument settles ownership.
Ethical standards establish expectations. Applicable law and well-drafted agreements determine how particular rights and obligations operate. Neither should be mistaken for the other.
Negotiate the future use, not just the current study
A useful starting point is to distinguish what each partner brings into a collaboration from what the collaboration may generate. Pre-existing intellectual property should be identified separately from new discoveries, with agreed rights to use each (1).
The trial agreement, material transfer agreement and data-use agreement should then be read together. A benefit promised in one document should not be undermined by restrictions in another.
For samples, the terms should address permitted research, storage, onward transfer, commercial use and the handling of unused material. They should specify when a new use requires further approval and how information about subsequent research will return to the originating institution.
For data, access should be usable in practice. That means agreeing which datasets and supporting documentation investigators can receive, when access becomes available and what analysis and publication rights accompany it. Access must remain consistent with consent, privacy protections and applicable law. Institutional interests cannot override participants’ rights.
For discoveries, the agreement should explain how inventions will be identified, ownership determined and commercial opportunities handled. Where appropriate, negotiations can include licences, milestone payments or revenue sharing. These are options to design around the research and its contributions, not automatic entitlements attached to every trial.
Not every study will produce a marketable product. A credible benefit-sharing arrangement should therefore include benefits that do not depend on commercial success, such as returning results, enabling further analysis or funding agreed research resources.
It should also distinguish institutional gains from community benefits. A university’s licensing income does not automatically improve care for the population that contributed to the research. Where community or health-system benefits are agreed, the recipients, decision process and accountability arrangements should be explicit.
Make the commitments survive the trial
The most important test comes after signature.
Each commitment needs a responsible party, a timetable, an appropriate funding arrangement and a way to check delivery. Agreements should address what happens if a study ends early, a programme is discontinued or rights are transferred to another organisation. Communities should receive understandable explanations of what has been promised, including what remains uncertain.
Research ethics committees should scrutinise participant protections and the credibility of proposed benefits within their mandates. Institutions need legal and commercial expertise to negotiate contractual rights. Funders can support that work, while research networks can share model clauses and practical experience without treating different national laws as interchangeable.
For the Africa Clinical Research Network, the governing principle is that African contributions should carry meaningful rights and responsibilities beyond study delivery. The objective is not to make collaboration harder or to cast external investment as the problem. It is to make the terms of collaboration clear enough that scientific openness and fair returns can coexist.
The question is not whether African trials should create value for the world. They should. It is whether the people and institutions that help create that value retain a meaningful say in its use, and a credible route to its benefits, long after the trial closes.
References
- World Intellectual Property Organization. Study on Patent Inventorship and Ownership Issues Arising from Collaborative Research and Cross-Border Collaboration. World Intellectual Property Organization; 2024. Report No.: SCP/36/9.
- Rebai A, Abayomi A, Andanda P, Kerr R, Herbst K, Mabuka J, et al. Responsible governance of genomics data and biospecimens in the context of broad consent: experiences of a pioneering access committee in Africa. BMJ Global Health. 2025;10(2):e016026.
- (CIOMS) CfIOoMS. International Ethical Guidelines for Health-related Research Involving Humans. Council for International Organizations of Medical Sciences (CIOMS); 2016.
- World Medical Association. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants 2024 Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki/.
- Conference of the Parties to the Convention on Biological Diversity. Decision X/1: Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization. United Nations Environment Programme; 2010. Report No.: UNEP/CBD/COP/DEC/X/1.