Exportation and Importation of Human Biological Samples.

KEMRI collaborates with numerous research scientists, research organizations, and academic institutions across the world. Many a times local scientists or collaborating scientists from other countries request for exportation or storage of human biological samples for research purposes. This document highlights the processing and approval of exportation and importation of human biological samples at KEMRI as well as the execution of Material Transfer Agreements (MTAs). The common concerns arising from transfer of human biological samples have also been documented.

1. Exportation of Human Biological Samples

Prior to the exportation of human biological samples, scientists are required to obtain the authority from the Director General, KEMRI. Request for approval and authorization of shipment of human biological samples begins with the participant and ends with the DG, KEMRI who serves as the custodian of all samples on behalf of the Republic of Kenya. The following diagram illustrates the linear process of authorization of exportation of human biological samples at KEMRI:

A complete application for the exportation of human biological samples includes:

1. A duly signed explanatory cover letter.
2. One duly completed and signed SERU Form for Exportation of HBS.
3. One copy of the latest SERU approval letter for the study.
4. One copy of the latest PPB approval letter for all clinical trials.
5. One copy of the latest NACOSTI research license.
6. One copy of the Approved Consent Documents
7. The section (s) of the approved protocol which justifies the need for shipment of samples.
8. Approved Material Transfer Agreement

2. Importation of Human Biological Samples

No human biological materials may be brought into Kenya by an individual or groups of individuals working in or with the Institute, without the permission and approval of the Director General, KEMRI, on the advice of the SERU and the Office of Health, Safety and Environment, and any other relevant institutions. The following diagram illustrates the linear process of authorization of importation of human biological samples to KEMRI:

A complete application for the importation of human biological samples includes:

1. A duly signed explanatory cover letter
2. One duly completed and signed SERU Form for Importation of HBS.
3. One copy of the latest IRB approval letter and other clearances for the study from the country sending samples to Kenya.
4. One copy of the approved protocol which justifies the need for shipment of samples to Kenya.

3. Execution of Material Transfer Agreements
   Material Transfer Agreements (MTAs) are administered between KEMRI and the collaborating Institution, and not between persons associated with the institutions. No request for exportation of human biological samples shall be processed without a prior MTA between the recipient and the provider of the samples.
   A complete application for the processing and signing of MTA includes:
   • A duly signed explanatory cover letter
   • One duly completed and signed MTA form.
   • One copy of the latest SERU approval letter for the study.
   • One copy of the latest PPB approval letter for all clinical trials.
   • One copy of the latest NACOSTI research license.
   • One copy of the Approved Consent Documents
   • The section (s) of the approved protocol which justifies the need for shipment of samples.

The following diagram illustrate the sequential nature of MTA approval and execution at KEMRI:

Common concerns raised during processing and approval of MTAs, exportation, and importation of Human Biological Samples.

1. The list of samples to be shipped is not provided
2. The type of test to be conducted outside the country has not been provided.
3. The test to be conducted outside the country can be done locally.
4. The justification for sample shipment is not provided or inadequately provided.
5. The duration of sample storage has not been provided.
6. Justification for storage of samples outside the country not provided or inadequately provided.
7. The approved consent document does not indicate that samples will be shipped, or the destination and purpose of shipment is not clearly described to the participant.
8. The approved protocol does not indicate that samples will be shipped, or the destination and purpose of shipment not clearly provided.
9. The specific country of sample destination not mentioned in the ICF nor the protocol.

Downloads:
https://www.kemri.go.ke/scientific-ethics-review-unitseru/#1570444831277-7af7b258-130b

A. Form for Exportation of Human Biological Samples
B. Form for Importation of Human Biological Samples
C. Template for Materials Transfer Agreement (MTA)