In Kenya, access to biological and genetic resources and associated knowledge is governed by various multilateral environmental agreements (MEAs) including but not limited to the Convention of Biological Diversity (CBD), Nagoya Protocol, International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), Convention on International Trade on Endangered Species (CITES) and World Intellectual Property Organization Treaties (WIPO) among others, as wells as being subject to domestic legislation.
Below are the steps required for obtaining research permits for accessing biological and genetic resources and associated knowledge in Kenya.
- Researchers seeking to work on traditional knowledge and wildlife (e.g. plants, microorganisms, arthropods, insects, fish, large and small mammals), their habitats (e.g.
landscape, marine, inland waters, soil and water), associated genetic derivatives, etc., MUST apply for a WRTI permit. - The first step is to fill the FORM RPC 1A and send it to the Permits office at WRTI using the
email, permits@wrti.go.ke - The following documents should be submitted together with the filled Form RPC-1A
- A valid copy of a personal identification document (National ID/ Passport biodata page)
- Support letter from your academic/work/institution
- Recommendation from your host/attached institution in Kenya (Researchers seeking affiliation with Mpala must submit a research proposal using this template.
- A comprehensive research project proposal, approved and signed by the applicant institution/funding institution.
- Grant Award Letter (original, not altered)
- Curriculum Vitae of the applicant
- Ethical Review Compliance (IACUCs) report (where applicable)
Note: more documents/information may be requested depending on nature of research
- On receiving your application, WRTI will check for the appropriateness of your work. WITHIN
60 days, they will: approve your research, request that you amend your proposal, or decline your research. - As you wait for WRTI approval it is important to identify your stakeholders. They are institutions that will assist you in implementing your work, and are also those that would be impacted by your work. These are legal entities with a mandate on the collaborations/roles you seek.
- It is important to learn about the Prior Informed Consent and the Mutually Agreed Terms
(PIC/MAT) process and engage your institution’s legal office and outline some of the standard clauses in the documents. - On approval of your proposal by WRTI, you will be required to develop the PIC/MAT in line
with the Convention of Biological Diversity and protocols (e.g. Cartagena and Nagoya). This is a
negotiation process on the access benefits sharing between the providers and the users of the
biological resources. - Once the PIC and MAT have been signed by all the stakeholders, the researcher sends it back to the WRTI Permits office. If satisfactory, a one-year permit is issued.
- The researcher should then proceed and apply for the Nacosti Permits. Here are the requirements.
- After obtaining both the WRTI and Nacosti Permits, the researcher should proceed and apply for
the NEMA access permit and fill out the CBD and ABS Regulations 2006. - Once a Nema Access Permit is granted, researchers planning to capture wildlife can now apply
for a capture permit. - Researchers planning to export their samples to laboratories outside Kenya need to apply for an
Export Permit and Material Transfer Agreement.
To assist on research permit matters or if you have questions pertaining to the research permit application processes, contact the Chief Research Officer, Dr. Nina Wambiji at nina.wambiji@mpala.org
What is access?
Access means obtaining, possessing, and using genetic resources conserved, whether derived products and, where applicable, intangible components, for purposes of research, bio-prospecting, conservation, industrial application or commercial use as defined in the laws of
Kenya.
This includes observation and use of data collected by other persons, apart from published/secondary data sources.
Who is Principal Investigator?
Principal Investigator (PI) means the person responsible for the scientific and technical conduct of the project activities. A PI shall possess expertise in the area of research (s)he seeks permit and shall be the authority to admit new investigators working under the program.
What is prior informed consent (PIC)?
Prior informed consent refers to the permission given by the providing national authority and where possible in collaboration with county governments and local communities in the form of a signed agreement with legal authority prior to accessing genetic resources, in line with an appropriate national legal and institutional framework on access to biological diversity, biological resources, or associated knowledge.
Do I need to develop both the MAT and the PIC?
Yes. These are separate instruments and both need to be developed.
What part of my research funds should I declare to WRTI, if grant supports sites outside Kenya?
Declare the entire amount of funds granted even if only part of the funds will be used in Kenya.
As a principal investigator does my WRTI permit cover my student’s projects?
No. A WRTI permit is issued to individual researchers and students will need to have their own application for permits.
As a principal investigator does my PIC/MAT cover my students’ projects?
The PIC/MAT will cover only the students accessing the biological resources you are permitted under your PIC/MAT and proposals with objectives that contribute to your focus area.
At what point should I engage my institution’s legal team?
It is always recommended to involve your institution’s legal team before you start drafting the PIC/MAT and educate them on their role.
Is there a common clause in the PIC that legal offices have difficulties with?
Yes. On administration of royalties there is a standard clause that must be included in every PIC. It reads, “In the event of royalties generated from IP, copyright will attract 15% to the Providers, while other forms of IP including patents among others will attract minimum royalties of 10% to the Providers. Detailed modalities on IP management are outlined in the MAT.”
Can I sign the PIC/MAT on behalf of my institution?
No. Only the person legally mandated by the institution can sign the PIC/MAT.
Does Mpala provide assistance in the development of the PIC/MAT?
Yes. Mpala works closely with the WRTI team, through the Research Liaison and Chief Research Officer. Guidance on this process and linkages to relevant stakeholders can be provided.