Effective Date: July 2026 · Last reviewed: July 2026

Purpose and Scope

This policy governs all laboratory research conducted outside the United States, with particular reference to our long-term programme in Kenya’s Mara River ecosystem. It applies to every laboratory member who collects, receives, transports, analyses, or publishes on material or data originating outside the United States, and to every collaborator working with us under that programme.

The United States is not a Party to the Nagoya Protocol. The obligations described below bind this laboratory through Kenyan domestic law, through the terms of our own permits and agreements, and through University of Florida and sponsor policy. NEMA administers them. That does not mean there is no US exposure: the Lacey Act makes it a US offence to import wildlife taken, possessed, or exported in violation of foreign law, so treat Kenyan permitting as carrying US consequences and route questions to UF RISC. Kenya has been a Party to the Convention on Biological Diversity since 24 October 1994 and to the Nagoya Protocol since 12 October 2014.10,11,12

Kenya’s access and benefit-sharing regulations

Kenya’s operative instrument is the Environmental Management and Co-ordination (Access to Biological Resources and Benefit Sharing) (No. 2) Regulations, 2025, Legal Notice No. 68 of 2025, in force since 24 March 2025 and administered by the National Environment Management Authority (NEMA) as Competent National Authority. Legal Notice 68 replaced Legal Notice 19 of 2025, which came into force on 7 February 2025 and was revoked on 24 March 2025 by regulation 29 of Legal Notice 68. Confirm the instrument currently in force with NEMA and UF RISC before relying on any citation, including a citation on this page.1,2,8

  • All access requires a permit, including non-commercial academic access. Applications under regulation 11 must be supported by evidence of Prior Informed Consent and Mutually Agreed Terms, a research clearance certificate, localities specified by GPS coordinates, and a Material Transfer Agreement where applicable.1
  • The access permit runs for one year, is not transferable, and is renewable once for one further year (regulation 17). A multi-year research agreement does not substitute for the permit cycle. Permit expiry dates are tracked by the Principal Investigator and reviewed each January.1
  • No biological resource may leave Kenya without an executed Material Transfer Agreement in the form of the Sixth Schedule, filed with the Authority. The exporter must declare the resource at the port of departure and produce a copy of the MTA. Breach is an offence under regulation 27, and regulation 28 applies the section 144 penalty where the Regulations prescribe no specific one.1
  • Deposition is a permit condition. Duplicates and holotypes of collected genetic resources must be deposited with the Authority and other relevant stakeholders, and on export a holotype must be deposited with the entity granting the MTA or with a depository gazetted by the Authority.1
  • Kenyan citizens must be guaranteed reasonable access to collected biological resources, whether those resources are held in Kenya or abroad. This is a standing condition on every access permit and it is a continuing obligation on material held in Gainesville. Section “Access to Held Material” below operationalises it.1

CITES may apply to some taxa collected under this programme. CITES Appendices were amended at CoP20 in Samarkand, with those amendments entering into effect on 5 March 2026. Members should also check the current text of Resolution Conf. 12.3 (Rev.), which governs simplified procedures for biological samples, against the CoP20 outcomes. Any pre-2026 CITES guidance in a laboratory protocol should be treated as stale. Before exporting material from any listed taxon, confirm requirements directly with the Kenya CITES Management Authority and with UF Research Integrity, Security and Compliance.16

Our specimens are deposited at the National Museums of Kenya, the national repository under the National Museums and Heritage Act. Confirm with NEMA that NMK appears on its approved depository list for the purposes of regulation 21(5), since the ABS regulations designate depositories separately.1,7

Research licensing and wildlife permits

Research licensing through the National Commission for Science, Technology and Innovation (NACOSTI) operates separately from ABS permitting, under the Science, Technology and Innovation Act No. 28 of 2013 and the Research Licensing Regulations 2014. Licences run one year. Non-Kenyan researchers must hold affiliation with a Kenyan host institution, itself valid one year, and renewal requires a progress report lodged at least 30 days before expiry. The County Director of Education, County Commissioner, and County Governor must be notified before fieldwork begins, and a final report must be deposited with the Commission within one year of completion.3,4

Wildlife-related sampling triggers a third and independent regime. Under the Wildlife Conservation and Management Act 2013, section 59(1), no research on the wildlife sector may be conducted without a permit from the Wildlife Research and Training Institute; section 22(1)(b) requires the written approval of the Cabinet Secretary, given on the advice of Kenya Wildlife Service, to export wildlife resources for bio-prospecting or any other research. The Act defines “wildlife” to include microorganisms and defines “specimen” to include material taken for research, so the scope of this regime is not a determination this laboratory makes. Obtain a written scope determination from WRTI and KWS before any sampling campaign and route it through UF Research Integrity, Security and Compliance. Where any part of the work is characterised as bio-prospecting, KWS is a joint partner on behalf of the people of Kenya under section 22(6).5,6

What the Kenyan Affiliation Obligates You to Disclose

Holding a NACOSTI-mandated affiliation with a Kenyan host institution creates a foreign institutional affiliation, and in-kind support from that host (bench space, vehicles, staff time) is foreign support. Both may be disclosable on NSF Senior Personnel Documents and NIH Other Support. Disclosure determinations are made by UF Sponsored Programs and the UF research security office, not by this laboratory. Before any proposal submission, and at onboarding, members confirm their disclosures with UF Sponsored Programs and the UF research security office.

Digital Sequence Information

Kenya regulates digital sequence information derived from its biological resources. Regulation 4(1)(e) of Legal Notice 68 applies the regulations to “any digital sequence information relating to Kenya biological resources,” and regulation 2 defines that term as biological data associated with or derived from genetic resources, including nucleotide sequences and epigenetic, protein, and metabolite data. There is no separate DSI procedure; DSI flows through the same access permit, PIC, MAT, and benefit-sharing machinery as physical material. Depositing Mara-derived sequence in a public archive is therefore a regulated act.1

At the international level, COP16 Decision 16/2, adopted at Cali on 1 November 2024, established a multilateral mechanism and the Cali Fund. Two points:

  1. Public research and academic institutions are expressly not expected to make monetary contributions to the Cali Fund, which is operational and administered through the CBD Secretariat, UNEP and UNDP.15 Monetary contributions are expected from large commercial entities in listed sectors that exceed at least two of three thresholds. This laboratory has no payment obligation.13,14
  2. The absence of a payment obligation does not exempt us from anything else. All users of DSI, academic included, should share non-monetary benefits fairly and equitably, and the multilateral mechanism operates without prejudice to national ABS measures. Kenya’s regulations bind us regardless of the Cali Fund exemption.13,1

Accordingly, for every sequence submission derived from non-US material, laboratory members must record country of origin in the submission metadata, retain the permit and MTA references in the project record, and disclose any access-derived restriction in the relevant sponsor data management plan. Database governance under Decision 16/2 is expected to be consistent with the FAIR, CARE, and TRUST principles.13,20,24

Access to Held Material

To operationalise the permit condition guaranteeing Kenyan citizens reasonable access to collected resources, the laboratory maintains the following:

  1. A current inventory of Kenyan-origin material held in Gainesville, with collection locality, permit reference, and MTA reference.
  2. A documented request pathway by which Kenyan researchers and institutions may request access to that material or to derived sequence data. Requests are acknowledged promptly and routed to UF.
  3. Laboratory support for such requests, on terms mirroring the H3Africa model: access provided in collaboration with the requesting researcher, structured to build capability, with attribution required in resulting outputs. Transfers of University-held material and data are executed by UF through a Material Transfer Agreement and are subject to UF and export-control review; this laboratory routes requests promptly but does not control the outcome or the timeline. H3Africa is a human genomics framework and does not govern our material, but we adopt its sample-sovereignty norm voluntarily.25,26

Equitable Partnership Standards

Authorship. In-country collaborators who contribute to study design, implementation, data acquisition, analysis, or interpretation meet ICMJE criterion 1 and are treated as prospective co-authors, not acknowledgees. Data ownership and intellectual property are property relationships, handled through the MTA and benefit-sharing terms rather than through the author list; treating them as authorship triggers would be gift authorship under our own policy. This follows Article 4 of the TRUST Code and Rule 9 of the standing guidance on ending helicopter research, and is applied through the four ICMJE criteria in our Collaboration and Authorship Policy. Where a collaborator meets the first criterion, they must be offered the opportunity to meet criteria #2 and #3. Failure to offer that opportunity is a policy violation.17,18,21

Field staff. Field camp and research operations in Kenya are run by Soiyou Adventures, a Kenyan company. Its staff are employed by Soiyou under Kenyan law, not by this laboratory or by UF, so their pay, insurance, and employment protections are Soiyou’s to set. What this laboratory sets is the contract rate it agrees and the terms it asks for. TRUST Code Article 7 requires fair compensation of local support staff, and the contract rate is negotiated against that standard. Soiyou staff who contribute intellectually are co-authors on the same terms as anyone else; those who do not meet the criteria are named in contributor statements and credited by name in presentations.17

Agenda setting. Research questions are co-developed.18,19

Local infrastructure and capacity. We use Kenyan laboratories, institutions, and services where feasible, and every project carries an explicit capacity-building component. TRUST Code Article 20 requires a capacity-building plan. See also Rules 7 and 8 of the helicopter-research guidance.17,18

Dissemination. Results are returned to Kenyan audiences through a non-paywalled channel. Local dissemination is a project deliverable.18,22

Community rights and traditional knowledge. Where community rights or associated traditional knowledge attach to a sampling locality, Prior Informed Consent must be obtained in accordance with the customary laws, practices, protocols, and procedures of that community, per regulation 12 of Legal Notice 68. Data and metadata associated with such localities are governed by the CARE Principles for Indigenous Data Governance: Collective Benefit, Authority to Control, Responsibility, and Ethics.1,20

Local capacity and ecological restraint. We assess whether the project would deplete local staff or institutional resources and discuss the implications with local partners, per TRUST Code Article 16. Ecological harm from sampling is minimised under the ESA Code of Ethics. We abide by local written and unwritten rules of practice.17,18

Compliance Workflow

The regulatory burden on non-commercial microbial and environmental research under Nagoya-style frameworks is documented as disproportionate.23,24

Before any international sampling campaign, the Principal Investigator confirms in writing that the following are current and on file: NACOSTI research licence and Kenyan institutional affiliation; NEMA access permit under Legal Notice 68; documented PIC and MAT; WRTI permit and, where applicable, KWS authorisation; executed MTA for any material leaving Kenya; county-level notifications; and the deposition arrangement with the National Museums of Kenya. No sample leaves a field site before this confirmation exists.

Because NEMA’s published materials have lagged the current law, members must not treat the absence of a document on a regulator’s website as evidence that a requirement does not apply. Deal with the authority directly.9

Review

This policy is reviewed annually, and immediately upon any amendment to Kenyan ABS or wildlife legislation, any new CBD decision on digital sequence information, or any change in our permit or agreement status.

Policy Acknowledgment

Confirm by email, or sign a printed copy if you prefer.

Member Name (print): ___________________________________

Member Signature: ___________________________________
Date: __________________

Member Acknowledgment: All laboratory members engaged in international research must read and acknowledge understanding of this policy before their first field deployment and annually thereafter.

References

  1. Republic of Kenya. The Environmental Management and Co-ordination (Access to Biological Resources and Benefit Sharing) (No. 2) Regulations, 2025. Legal Notice No. 68 of 2025; commenced 24 March 2025. National Council for Law Reporting.
  2. Republic of Kenya. The Environmental Management and Co-ordination Act (Access to Biological Resources and Benefit Sharing) Regulations, 2025. Legal Notice No. 19 of 2025; repealed 24 March 2025. Cited only to identify the instrument no longer in force.
  3. National Commission for Science, Technology and Innovation. Guidelines on Research Licensing and Institutional Affiliation (PDF). December 2019.
  4. National Commission for Science, Technology and Innovation. Application for a Research License: Application Guidelines. NACOSTI Research Information Management System.
  5. Republic of Kenya. Wildlife Conservation and Management Act, No. 47 of 2013. Consolidated as at 31 December 2022. See sections 3, 22 and 59.
  6. Wildlife Research and Training Institute. Research Permitting System. Republic of Kenya.
  7. Republic of Kenya. National Museums and Heritage Act, No. 6 of 2006 (Cap. 216). See sections 4(a), 5(1)(f) and 17.
  8. Kenya National Clearing-House Mechanism. Access and Benefit Sharing. Kenya Biodiversity.
  9. National Environment Management Authority. Biodiversity Regulations. Republic of Kenya. Cited as evidence that published regulator materials lag the current law.
  10. Secretariat of the Convention on Biological Diversity. Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization (PDF). United Nations Environment Programme, Montreal, 2011. See Articles 5(1) and 6(1).
  11. Secretariat of the Convention on Biological Diversity. Parties to the Nagoya Protocol. Protocol entered into force 12 October 2014.
  12. Convention on Biological Diversity. Kenya Country Profile. Party to the CBD since 24 October 1994; Party to the Nagoya Protocol since 12 October 2014.
  13. Conference of the Parties to the Convention on Biological Diversity. Decision 16/2: Digital sequence information on genetic resources (PDF). CBD/COP/DEC/16/2, sixteenth meeting, Cali, Colombia; adopted 1 November 2024. See Annex paragraphs 6, 9, 10 and 26.
  14. Secretariat of the Convention on Biological Diversity, UNEP and UNDP. Guide for Databases: The Multilateral Mechanism for the Fair and Equitable Sharing of Benefits from the Use of DSI, and the Cali Fund (PDF). 2025, preliminary version.
  15. Convention on Biological Diversity. Cali Fund.
  16. U.S. Fish and Wildlife Service, Office of Law Enforcement. Notice to the Wildlife Import/Export Community: CITES CoP20 Amendments to Appendices I and II (PDF). Public Bulletin PB 26-001, 13 January 2026. CoP20 amendments entered into effect 5 March 2026.
  17. TRUST Project. The TRUST Code: A Global Code of Conduct for Equitable Research Partnerships. 2018. DOI: 10.48508/GCC/2018.05. Adopted by the European Commission in August 2018. See Articles 4, 5, 7, 16 and 20.
  18. Haelewaters D, Hofmann TA, Romero-Olivares AL. Ten simple rules for Global North researchers to stop perpetuating helicopter research in the Global South. PLOS Computational Biology. 2021;17(8):e1009277.
  19. Trisos CH, Auerbach J, Katti M. Decoloniality and anti-oppressive practices for a more ethical ecology. Nature Ecology & Evolution. 2021;5(9):1205-1212.
  20. Carroll SR, Garba I, Figueroa-Rodríguez OL, Holbrook J, Lovett R, Materechera S, Parsons M, Raseroka K, Rodriguez-Lonebear D, Rowe R, Sara R, Walker JD, Anderson J, Hudson M. The CARE Principles for Indigenous Data Governance. Data Science Journal. 2020;19(1):43.
  21. Horn L, Alba S, Gopalakrishna G, Kleinert S, Kombe F, Lavery JV, Visagie RG. The Cape Town Statement on fairness, equity and diversity in research. Nature. 2023;615(7954):790-793.
  22. Stefanoudis PV, Licuanan WY, Morrison TH, Talma S, Veitayaki J, Woodall LC. Turning the tide of parachute science. Current Biology. 2021;31(4):R184-R185.
  23. Overmann J, Scholz AH. Microbiological Research Under the Nagoya Protocol: Facts and Fiction. Trends in Microbiology. 2017;25(2):85-88.
  24. Muñoz-García M, DSI Scientific Network, Scholz AH, et al. Navigating COP16's digital sequence information outcomes: What researchers need to do in practice. Patterns. 2025;6(3):101208.
  25. H3Africa Consortium. H3Africa Data and Biospecimen Access Committee Guidelines (PDF). Updated April 2020.
  26. The H3Africa Consortium. Enabling the genomic revolution in Africa. Science. 2014;344(6190):1346-1348.