NATIONAL HEALTH RESEARCH ACT, 2013: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION
National Health Research (Material Transfer) Regulations
National Health Research (Bio banking) Regulations
National Health Research (Registration and Accreditation) Regulations
NATIONAL HEALTH RESEARCH (MATERIAL TRANSFER) REGULATIONS
[Section 63]
Arrangement of Regulations
Regulation
3. Application for transfer of biological materials for research purposes
4. Application for transfer of biological materials for quality assurance
5. Material transfer agreement
6. Rights of parties to material transfer agreement
SI 92 of 2018.
These Regulations may be cited as the National Health Research (Material Transfer) Regulations, 2018.
In these Regulations, unless the context otherwise requires-
"Authority" has the meaning assigned to the word in the Act;
"benefit" means a financial, health or other advantage or profit gained from research;
"biological material" has the meaning assigned to the word in the Act;
"clinical trial" has the meaning assigned to the word in the Act;
"material transfer agreement" has the meaning assigned to the word in the Act; and
"standard operating procedure" means a written instruction intended to document how to perform a routine activity.
3. Application for transfer of biological materials for research purposes
(1) A person who wishes to transfer a biological material for research purposes shall apply to the Authority for approval in Form I set out in the First Schedule, on payment of the prescribed fee.
(2) The Authority shall consider the application for transfer of biological materials for research purposes within 90 days of the date of receipt of the application.
(3) The Authority shall, where it approves an application for the transfer of biological materials for research purposes, inform the applicant within seven days of approval of the application in Form II set out in the First Schedule.
(4) The Authority shall, where it rejects an application for transfer of biological materials for research purposes, notify the applicant in Form III set out in the Schedule within seven days of the decision.
4. Application for transfer of biological materials for quality assurance
(1) Where an application for transfer of biological materials is required for quality assurance, the application shall be accompanied by the following-
(a) standard operating procedures for the planned tests;
(b) a statement of agreement between the two laboratories; and
(c) a plan for scheduled shipments of quality assurance samples.
(2) The Authority shall consider the application for transfer of biological materials for quality assurance within 30 days from the date of receipt of the application.
(3) The Authority may determine the number of shipments for each approval for quality assurance samples.
(4) Each shipment shall bear the seal of the Authority.
(5) The Authority shall, where it approves an application for transfer of biological materials for quality assurance purposes, notify the applicant in Form II set out in the First Schedule within seven days of the decision.
(6) The Authority shall, where it rejects an application for transfer of biological materials for quality assurance purposes, notify the applicant in Form III set out in the First Schedule within seven days of the decision.
5. Material transfer agreement
(1) A person who intends to import or export biological materials for research purposes shall fill out a material transfer agreement in Form IV set out in the First Schedule.
(2) The parties to a material transfer agreement shall ensure that confidentiality is maintained by withholding identities of participants.
(3) Where a material transfer agreement has been terminated, the parties shall destroy the samples unless the analysis is one which cannot be abandoned.
(4) The Authority shall require a publication to acknowledge the source of the material.
6. Rights of parties to material transfer agreement
(1) The material transfer agreement shall include terms relating to-
(a) intellectual property rights;
(b) rights to authorship;
(c) benefits to the health researcher, community or individual where applicable; and
(d) access to data generated from the study.
(2) Despite sub-regulation (1) an agreement made on intellectual property rights, rights to authorship, sharing benefits and access to data shall not be inconsistent with any other written law.
The fees set out in the Second Schedule are payable for the matters specified in that Schedule.
[Regulations 3, 4 and 5]
FORM I
[Regulation 3(1)]
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The National Health Research Authority |
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The National Health Research Authority Act |
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National Health Research (Material Transfer) Regulations, 2018 |
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APPLICATION FOR MATERIAL TRANSFER |
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Please write in BLOCK LETTERS |
Shaded fields for official use only |
Application No. |
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Date/Time |
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PART I |
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Information Required |
Information Provided |
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A. DETAILS OF HEAD OF INSTITUTION (PROVIDER SCIENTIST) |
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Title (Tick ["] where applicable) |
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(a) Surname: |
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(b) Forename(s): |
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(c) Qualification(s): |
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(d) Email: |
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(e) Phone number: |
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(f) Name of institution: |
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(g) Registration number: |
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(h) Physical address: |
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(i) Postal address: |
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(j) Official phone number: |
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(k) Fax: |
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(l) Signature: |
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(m) Date: |
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B. DETAILS OF LOCAL PRINCIPAL INVESTIGATOR (PROVIDER SCIENTIST) |
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Title (Tick ["] where applicable) |
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(a) Surname: |
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(b) Forename(s): |
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(c) Qualification(s): |
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(d) Email: |
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(e) Phone: |
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(f) Title of study: |
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(g) Name of institution: |
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(h) Registration number: |
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(i) Physical address: |
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(j) Postal address: |
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(k) Phone number: |
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(l) Fax: |
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(m) Signature: |
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(n) Date: |
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1. Material to be transferred |
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2. Purpose of export or import |
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3. Name of study site(s) |
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PART II |
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A. DETAILS OF HEAD OF INSTITUTION (RECIPIENT SCIENTIST) |
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Title (Tick ["] where applicable) |
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(a) Surname: |
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(b) Forename(s): |
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(c) Qualification(s): |
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(d) Email: |
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(e) Phone number: |
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(f) Name of Organisation/Laboratory |
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(g) Physical Address: |
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(h) City: |
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(i) Country: |
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(j) Website: |
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(k) Signature: |
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Attachments |
Attached Yes/No |
Comment |
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Research protocol (including budget, questionnaires, consent form, timelines, curriculum vitae) |
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Letter of approval from the REC |
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Letter of authority to conduct research |
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Material transfer agreement signed by both parties |
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Proof of payment of prescribed fee |
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I certify that the recipient organisation has accepted and signed a copy of the material transfer agreement and shall not outsource the biological material to another organisation/laboratory without written approval of the Authority. I have read and understood the conditions outlined in this Agreement and I agree to abide by them in the receipt and use of the biological material. |
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Signature: |
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Date: |
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B. DETAILS OF RECIPIENT SCIENTIST |
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Title (Tick ["] where applicable) |
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(a) Surname: |
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(b) Forename(s): |
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(c) Qualification(s): |
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(d) Email: |
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(e) Phone number: |
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(f) Title of study: |
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(g) Signature: |
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(h) Date: |
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(i) Name of Organisation/Laboratory |
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(j) Physical address: |
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(k) City: |
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(l) Country: |
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(m) Email: |
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(n) Website: |
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I certify that the recipient organisation has accepted and signed a copy of the material transfer agreement and shall not outsource the biological material to another organisation/laboratory without written approval of the Authority. I have read and understood the conditions outlined in this Agreement and I agree to abide by them in the receipt and use of the biological material. |
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Signature: |
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Date: |
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FOR OFFICIAL USE ONLY |
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Status: Tick [ |
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Recommended |
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Not Recommended |
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Deferred |
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BOARD VICE-CHAIRPERSON: ................................................................................................ |
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Signature: .............................................................................................................................. |
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Date: ..................................................................................................................................... |
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BOARD CHAIRPERSON: ........................................................................................................ |
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Signature: .............................................................................................................................. |
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Date: ..................................................................................................................................... |
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Approved |
] Comments
Not approved FORM II
[Regulations 3(3) and 4(5)]
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The National Health Research Authority |
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The National Health Research Authority Act |
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National Health Research (Material Transfer) Regulations, 2018 |
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NOTICE OF APPROVAL TO TRANSFER BIOLOGICAL MATERIALS FOR RESEARCH/QUALITY ASSURANCE PURPOSES |
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1. Here insert the full names and address of the applicant |
To (1) ................................................................................................. |
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.......................................................................................................... |
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.......................................................................................................... |
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2. Here insert the reference No. of the application |
IN THE MATTER OF (2) ........................................................................ |
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You are notifed that your application for material transfer has been approved on the following conditions: |
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(a) approval is not transferrable in any way; |
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(b) there is adherence to the provisions of the National Health Research Act No. 2 of 2013, Council Guidelines and other regulations; and |
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(c) failure to adhere to Council Guidelines and the National Health Research Act No. 2 of 2013 and other regulations shall result in the revocation of this approval. |
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Dated this ............. day of ...................... 20........ |
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Signed: ................ |
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FORM III
[Regulations 3(4) and 4(6)]
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The National Health Research Authority |
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The National Health Research Authority Act |
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National Health Research (Material Transfer) Regulations, 2018 |
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NOTICE OF APPROVAL TO TRANSFER BIOLOGICAL MATERIALS |
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1. Here insert the full names and address of the applicant |
To (1) ................................................................................................. |
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2. Here insert the reference No. of the application |
IN THE MATTER OF (2) ........................................................................ |
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You are notified that your application to transfer biological materials for research/quality assurance purposes has been rejected on the following grounds: |
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(a) ....................................................... |
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(b) ....................................................... |
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(c) ....................................................... |
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Dated this ............ day of ...................... 20........ |
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............... |
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FORM IV
[Regulation 5]
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The National Health Research Authority |
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The National Health Research Authority Act |
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National Health Research (Material Transfer) Regulations, 2018 |
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MATERIAL TRANSFER AGREEMENT |
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This AGREEMENT made this .................. day of ......................................., Two Thousand and ................................... BETWEEN ...................................... of .......................................... in ..................... (country and city) (hereinafter called "the exporter/importer") of the one party, and .......... of .............. (country and city) (hereinafter called "the exporter/importer") of the other party WHEREBY IT IS AGREED that the exporter/importer shall transfer biological materials mentioned in the accompanying application form to the importer/exporter for purposes of ............ upon the stated terms and conditions as set out in the schedule attached hereto. |
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IN WITNESS whereof the parties or their duly authorised agents have set their hands this day and year first before written. |
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SIGNED by: .....................) |
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in the presence of: ..................) |
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WITNESS |
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Name: ...............................) |
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Physical address: .........................) |
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Occupation: .............................) |
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SIGNED by: ...................) |
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in the presence of ................) |
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WITNESS |
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Name: .............................................. |
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Physical address: ......................................... |
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Occupation: ........................................... |
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CONDITIONS |
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1. These biological materials are transferred subject to the National Health Research Authority general conditions so far as the same are not inconsistent with or varied by these special conditions. |
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GENERAL CONDITIONS |
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2. The parties shall state the following- |
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(a) exported or imported research materials shall be used only for the purpose indicated in the research protocol; |
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(b) the biological materials shall not be transferred to a third party without written permission from the Authority; |
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(c) intellectual property rights and patents; |
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(d) rights to authorship; |
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(e) rights of ownership of the biological materials; |
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(f) benefits to the health researcher, community or individual(s) where applicable; |
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(g) access to data generated from the study; |
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(h) shipping of biological materials; |
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(i) disposal of biological materials; and |
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(j) termination of the agreement. |
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SPECIAL CONDITIONS |
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The parties may agree to any other conditions in addition to the above conditions. |
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Please return a filled in copy of this Agreement to: The National Health Research Authority, P. O. Box 30075, LUSAKA. |
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The purpose of this agreement is to provide a record of the biological material transfer, to memorialise the agreement between the provider scientist and the recipient scientist to abide by all terms and conditions of the Material Transfer Agreement and to certify that the recipient organisation has accepted and signed a copy of the Material Transfer Agreement. All materials collected from Zambia shall remain the property of the Government of the Republic of Zambia. For any commercial product derived from the exported materials, the person from whom the samples were collected shall receive royalties. The recipient agrees to acknowledge the source of the material in any publications reporting use of it. The recipient agrees to use the material in compliance with statutes and regulations. |
[Regulation 7]
PRESCRIBED FEES
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No. |
Item |
Fee Units |
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1. |
Application to transfer biological materials (students) |
3,400 |
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2. |
Application to transfer biological materials (locally funded protocol) |
8,350 |
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3. |
Application to transfer biological materials (internationally funded protocol) |
16,700 |
NATIONAL HEALTH RESEARCH (BIO BANKING) REGULATIONS
[Sections 49, 51 and 63]
Arrangement of Regulations
Regulation
4. Request for additional information
7. Application for renewal of licence
8. Designation not transferable
11. Suspension or revocation of licence
12. Revocation of licence to operate bio bank
14. Failure to maintain biological material integrity
17. Transfer of biological materials
SI 24 of 2020.
These Regulations may be cited as National Health Research (Bio banking) Regulations, 2020.
In these Regulations, unless the context otherwise requires-
"biological material integrity" means the unimpaired and unmarred condition of biological material;
"designation" means designation of a research institution, site or health establishment as a bio bank and designate shall be construed accordingly;
"licence" means a licence issued under regulation 6;
"licensee" means a holder of a licence issued under regulation 6;
"standard operating procedure" means a written instruction specifying the manner of consistently performing a complex routine activity; and
"Zambia Environmental Management Agency" means the Zambia Environmental Management Agency established by the Environmental Management Act, 2011.
(1) A research institution, site or health establishment that is designated as a bio bank under section 51 of the Act shall apply to the Minister for a licence to store biological material in Form I set out in the First Schedule on payment of the fee set out in the Second Schedule.
(2) The Minister shall, within 30 days of receipt of the application refer the application to the Authority for consideration.
(3) The Authority shall, within 90 days of receipt of the application from the Minister, recommend to the Minister to grant or reject the application.
(4) The Minister shall, within 30 days of receipt of the recommendation of the Authority, notify the applicant of the Minister's decision.
(5) The Minister shall, where the Minister approves the bio bank application, inform the applicant in Form II set out in the First Schedule.
4. Request for additional information
The Authority may request an applicant to submit additional information in relation to an application in Form III set out in the First Schedule.
(1) The Minister shall reject an application for a licence if the-
(a) applicant fails to comply with any condition precedent for the grant of the licence; or
(b) applicant was earlier issued with a licence under these Regulations which was revoked by the Minister within a period of five years preceding the date of the application.
(2) The Minister shall, where the Minister rejects an application under sub-regulation (1), inform the applicant within 30 days of the decision in Form IV set out in the First Schedule.
(1) The Minister shall issue a licence to a designated research institution, site or health establishment in Form V set out in the First Schedule.
(2) A licence shall be valid for three years.
7. Application for renewal of licence
(1) A licensee who intends to renew a licence shall apply to the Minister, 90 days before the expiry of the licence, in Form I set out in the First Schedule, on payment of the fee set out in the Second Schedule.
(2) The Minister shall, within 30 days of receipt of the application for the renewal of a licence, refer the application to the Authority for consideration.
(3) The Authority shall, within 90 days of the receipt of the application from the Minister, recommend to the Minister the renewal of a licence if the applicant meets the requirements of the Act.
(4) The Minister shall, where the Minister renews a licence, issue a new licence to the applicant.
(5) A licence that is not renewed by the Minister lapses on the date of its expiry.
8. Designation not transferable
A designation is not transferable to any other person.
(1) The Minister may amend a licence where-
(a) the name of the research institution, site or health establishment of the licence changes; or
(b) the location of the bio bank changes.
(2) A licensee may apply to the Minister to amend a licence in Form VI set out in the First Schedule on payment of the fee set out in the Second Schedule.
(3) The Minister shall, within 30 days of receipt of the application for amendment of the licence, notify the applicant of the decision.
(4) The Minister shall, where the licence is amended, issue the applicant with a new licence for the remaining validity period of the initial licence.
(5) The Authority shall not pay compensation that may arise in relation to the amendment of a licence.
(1) A licensee whose licence is lost, damaged or defaced, shall apply to the Minister for a duplicate licence in Form VII set out in the First Schedule on payment of the fee set out in the Second Schedule.
(2) The Minister shall, within 30 days of receipt of an application under sub-regulation (1), issue a duplicate licence in Form VIII set out in the First Schedule.
11. Suspension or revocation of licence
(1) The Minister shall suspend a licence if the licensee violates the conditions of the licence.
(2) The Minister shall, before suspending a licence, give notice to the licensee and request the licensee to show cause, within a specified period, why the licence should not be suspended.
(3) A notice of intention to suspend a licence shall be in Form IX set out in the First Schedule.
(4) The Minister shall suspend a licence if the licensee fails to take remedial measures within the period specified in the notice of intention to suspend the licence.
(5) A notice of suspension of a licence shall be in Form X set out in the First Schedule.
(6) A bio bank whose licence is suspended shall maintain the integrity of biological materials in the bio bank, but shall not receive new biological materials.
12. Revocation of licence to operate bio bank
(1) The Ministry shall revoke a licence of the licensee if that licensee-
(a) contravenes the provisions of the Act or any other relevant written law or breaches the terms and conditions of the licence;
(b) fails to take corrective measures following the suspension of the licence within the specified period;
(c) changes the location of the bio bank without authorisation; or
(d) obtained the licence by fraud, negligence of misrepresentation or consentient of a material fact.
(2) The Minister shall, before revoking a licence, give notice to the licensee of the intention to revoke the licence and request the licensee to show cause, within a specified period, why the licence should not be revoked.
(3) A notice of intention to revoke a licence shall be in Form XI set out in the First Schedule.
(4) The Minister shall revoke a licence if the licensee fails to take remedial measures during the period specified by the Minister.
(5) A notice of revocation of a licence shall be in Form XII set out in the First Schedule.
(6) A bio bank whose licence is revoked shall at its cost-
(a) transfer biological materials in its custody to another bio bank approved by the Minister in consultation with the Authority; or
(b) destroy biological materials in its custody under the supervision of the Authority on behalf of the Minister.
A suspended or revoked licence may be restored if the Minister is satisfied with the remedial measures taken by the research institution, site or health establishment, on payment of the fee set out in the Second Schedule.
14. Failure to maintain biological material integrity
(1) Where a licensee is unable to maintain the integrity of biological materials for any reason, the licensee shall apply to the Minister to transfer the biological material to another designated bio bank or destroy the biological materials under the supervision of the Authority.
(2) The Minister shall, within 30 days of receipt of the application under sub-regulation (1), authorise the transfer of the biological material on terms and conditions that the Minister may determine on the advice of the Authority.
(1) A licensee shall, where the licensee intends to change its registered office, notify the Minister 60 days before the intended change, in Form XIII set out in the First Schedule, on payment of the fee set out in the Second Schedule.
(2) The notice to change its registered office under sub-regulation (1) shall be accompanied by-
(a) an application to amend the licence;
(b) site plan of the new location including set up of equipment and materials;
(c) the manner of transportation of the biological material that shall ensure integrity of the biological material; and
(d) the approval of the site by the Zambia Environmental Management Agency or any other relevant authority.
(1) Where a licensee intends to close a bio bank, the licensee shall within 60 days before closure, notify the Authority in Form XIV set out in the First Schedule on payment of the fee set out in the Second Schedule.
(2) The notice to close a bio bank under sub-regulation (1), shall be accompanied by a-
(a) biological materials disposal plan;
(b) biological materials transfer plan where the biological materials are to be transferred to another approved bio bank; and
(c) material transfer agreement with a bio bank approved by the Authority.
17. Transfer of biological materials
A transfer of stored biological materials shall be accompanied by an approved material transfer agreement.
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