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.
{mprestriction ids="2,3,5"}
The fees set out in the Second Schedule are payable for the matters specified therein.
[Regulations 3, 4, 5, 6, 7, 9, 10, 11, 12, 15 and 16]
Form I
[Regulations 3(2) and 7(1)]
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THE NATIONAL HEALTH RESEARCH AUTHORITY |
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The National Health Research Act |
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The National Health Research (Bio-banking) Regulations, 2020 |
Form II
[Regulation 3(5)]
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THE NATIONAL HEALTH RESEARCH AUTHORITY |
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The National Health Research Act |
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(Act No. 2 of 2013) |
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The National Health Research (Bio banking) Regulations, 2020 |
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NOTICE OF GRANT OF BIO BANK LICENCE |
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To: .......................................................................................................................................... |
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In the matter of ......................................................................................................................... |
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You are notified that your application for designation as a bio bank has been approved pending the issuance of the licence. |
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Dated this ............... day of ....................... 20....... |
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Signed: |
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.............................. |
Form III
[Regulation 4]
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THE NATIONAL HEALTH RESEARCH AUTHORITY |
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The National Health Research Act |
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(Act No. 2 of 2013) |
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The National Health Research (Bio banking) Regulations, 2020 |
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REQUEST FOR ADDITIONAL INFORMATION |
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To ........................................................................................................................................... |
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In the matter of ........................................................................................................................ |
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You are hereby requested to provide the following information: |
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(a) ................................................................................................................................ |
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................................................................................................................................ |
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Dated this ............... day of ......................, 20....... |
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Signed: |
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.............................. |
Form IV
[Regulation 5(2)]
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THE NATIONAL HEALTH RESEARCH AUTHORITY |
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The National Health Research Act |
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(Act No. 2 of 2013) |
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The National Health Research (Bio banking) Regulations, 2020 |
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NOTICE OF REJECTION OF APPLICATION TO BE LICENSED AS BIO BANK |
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To ........................................................................................................................................... |
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ln the matter of ......................................................................................................................... |
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You are notified that your application for .................................................................................... |
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has been rejected on the following grounds: ............................................................................... |
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............................................................................................................................................... |
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Dated this ............... day of ........................, 20........ |
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Signed: |
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.............................. |
Form V
[Regulation 6(1)]
Licence No. ................
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THE NATIONAL HEALTH RESEARCH AUTHORITY |
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The National Health Research Act |
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(Act No. 2 of 2013) |
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The National Health Research (Bio banking) Regulations, 2020 |
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LICENCE |
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............................................................................................................................................... |
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has been granted a licence to operate a bio bank on the conditions specified overleaf |
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............................................................................................................................. for the period |
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.......................................................... to ...................................................... |
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Dated this ............ day of ......................., 20....... |
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Signed: |
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............................................. |
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Overleaf |
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(a) This licence is not transferrable in any way. |
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(b) The licensee is expected to adhere to guidelines, Regulations and the provisions of the Act. |
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(c) Failure to adhere to guidelines, Regulations and the Act, may lead to the revocation of this licence. |
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(d) In the event that the licence is revoked, you are expected to surrender the licence to the National Health Research Authority. |
Form VI
[Regulation 9(2)]
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THE NATIONAL HEALTH RESEARCH AUTHORITY |
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The National Health Research Act |
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(Act No. 2 of 2013) |
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The National Health Research (Bio-banking) Regulations, 2020 |
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<TS:0.166667,NM,NO,0.196528,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.7875,NM,NO,0.984028,NM,NO,1.18056,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.77153,NM,NO,1.96875,NM,NO>APPLICATION FOR AMENDMENT OF LICENCE |
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Please complete in block letter |
Shaded fields for official use only |
Tel: +260-1-220177 |
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Fax: 260-1-225270 |
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Email: info@zda.org.zm |
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Website: https.//www.zda.org.zm |
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Information Required |
Information Provided |
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PARTICULARS OF APPLICANT |
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1. |
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(a) |
Name |
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(b) |
Profession |
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(c) |
Qualification |
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PARTICULARS OF HEALTH FACILITY |
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2. |
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(a) |
Name of health facility |
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(b) |
Certificate of Registration No. |
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3. |
Type of entity |
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4. |
Business premises |
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(a) |
Physical address |
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(b) |
Plot No. |
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(c) |
Street |
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(d) |
Postal address |
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(e) |
Telephone No. |
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(f) |
Fax No. |
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(g) |
Mobile No. |
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(h) |
Email address |
|||
|
(i) |
Village |
|||
|
(j) |
Town |
|||
|
(k) |
District |
|||
5.
EXISTING
PROPOSED AMENDMENT
REASONS FOR AMENDMENT
DECLARATION
I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief.
............................................
Name
.............................................................
Designation
............................................
Signature
.............................................................
Date
FOR OFFICIAL USE ONLY
Date of submission: .....................................................................................................................
Application Number: .....................................................................................................................
Payments Receipt Number: ........................................................................................................
Application accepted: ...................................................................................................................
Application ejected (Notify applicant)
Form VII
[Regulation 10(1)]
|
|
|
THE NATIONAL HEALTH RESEARCH AUTHORITY |
|
The National Health Research Act |
|
The National Health Research (Bio-banking) Regulations, 2020 |
|
APPLICATION FOR DUPLICATE LICENCE |
Form VIII
[Regulation 10(2)]
Licence No. ............
|
|
|
THE NATIONAL HEALTH RESEARCH AUTHORITY |
|
The National Health Research Act |
|
(Act No. 2 of 2013) |
|
The National Health Research (Bio banking) Regulations, 2020 |
|
DUPLICATE LICENCE |
|
................................................................................................................................................. |
|
has been granted a licence to operate a bio bank on the conditions specified over leaf |
|
................................................................................................................................................. |
|
for the period ....................................... to ..................................... |
|
Dated this ............. day of ........................, 20........ |
|
Signed: |
|
................................................. |
|
Overleaf |
|
(a) This licence is not transferrable in any way. |
|
(b) The licensee is expected to adhere to guidelines, Regulations and the provisions of the Act. |
|
(c) Failure to adhere to guidelines, Regulations and the Act, may lead to the revocation of this licence. |
|
(d) In the event that the licence is revoked, you are expected to surrender the licence to the National Health Research Authority. |
Form IX
[Regulation 11(3)]
|
|
|
THE NATIONAL HEALTH RESEARCH AUTHORITY |
|
The National Health Research Act |
|
(Act No. 2 of 2013) |
|
The National Health Research (Bio banking) Regulations, 2020 |
|
NOTICE OF INTENTION TO SUSPEND LICENCE |
|
To: ............................................................................................................................................................ |
|
In the matter ..................................................................................................................................... |
|
You are notified of the intention to suspend your Licence No. ................on the following grounds: |
|
.................................................................................................................................................. |
|
.................................................................................................................................................. |
|
.................................................................................................................................................. |
|
.................................................................................................................................................. |
|
You are therefore required to show cause why the license should not be suspended within .................. days. |
|
Dated this ................ day of ........................, 20....... |
|
Signed: |
|
........................................... |
Form X
[Regulation 11(5)]
|
|
|
THE NATIONAL HEALTH RESEARCH AUTHORITY |
|
The National Health Research Act |
|
(Act No. 2 of 2013) |
|
The National Health Research (Bio banking) Regulations, 2020 |
|
NOTICE OF SUSPENSION OF LICENCE |
|
To: ........................................................................... |
|
In the matter of |
|
You are notified that your Licence No. .................. is suspended for .............. days on the following grounds: |
|
................................................................................................................................................. |
|
................................................................................................................................................. |
|
................................................................................................................................................. |
|
Dated this ............... day of ......................., 20........ |
|
Signed: |
|
.......................................... |
Form XI
[Regulation 12(3)]
|
|
|
THE NATIONAL HEALTH RESEARCH AUTHORITY |
|
The National Health Research Act |
|
The National Health Research (Bio-banking) Regulations, 2020 |
|
NOTICE OF INTENTION TO REVOKE LICENCE |
|
To: ................................................................................................................................ |
|
In the matter of ....................................................... |
|
You are notified of the intention to revoke your Licence No. ..................... on the following grounds: |
|
...................................................................................................................................................... |
|
...................................................................................................................................................... |
|
...................................................................................................................................................... |
|
You are therefore required to show cause why the licence should not be revoked within .............. days. |
|
Dated this ......... day of ....., 20.. |
|
Signed: |
|
........... |
Form XII
[Regulation 12(5)]
|
|
|
THE NATIONAL HEALTH RESEARCH AUTHORITY |
|
The National Health Research Act |
|
The National Health Research (Bio-banking) Regulations, 2020 |
|
NOTICE OF REVOCATION OF LICENCE |
|
To: ............................................................................................................................. |
|
In the matter of .................................................... |
|
You are notified that your Licence No. ............ is revoked on the following grounds: |
|
................................................................................................................................................... |
|
................................................................................................................................................... |
|
................................................................................................................................................... |
|
Dated this ........ day of ....., 20.. |
|
Signed: |
|
............. |
Form XIII
[Regulation 15(1)]
|
|
|
THE NATIONAL HEALTH RESEARCH AUTHORITY |
|
The National Health Research Act |
|
The National Health Research (Bio-banking) Regulations, 2020 |
|
APPLICATION FOR DUPLICATE LICENCE |
Form XIV
[Regulation 16(1)]
|
|
|
THE NATIONAL HEALTH RESEARCH AUTHORITY |
|
The National Health Research Act |
|
The National Health Research (Bio-banking) Regulations, 2020 |
[Regulations 3(1), 7(1), 9(2), 10(1), 13, 15(1), 16(1) and 18]
PRESCRIBED FEES
|
S/No. |
Description |
Local |
Foreign |
||
|
Public |
Private not for |
Private for |
|||
|
1. |
Application for bio-bank licence |
111,556 |
122,711 |
167,334 |
334,668 |
|
2. |
Inspection fee |
53,800 |
53,800 |
53,800 |
53,800 |
|
3. |
Re-inspection fee |
33,400 |
33,400 |
33,400 |
33,400 |
|
4. |
Application for renewal of bio-bank licence |
20,000 |
22,000 |
33,333 |
66,666 |
|
5. |
Restoration of suspended or revoked licence |
223,112 |
245,422 |
334,668 |
669,336 |
|
6. |
Duplicate licence |
3,340 |
3,340 |
3,340 |
3,340 |
|
7. |
Amendment of licence |
5,010 |
5,010 |
5,010 |
5,010 |
|
8. |
Relocation of bio-bank |
53,800 |
53,800 |
53,800 |
53,800 |
|
9. |
Closure of bio-bank |
53,800 |
53,800 |
53,800 |
53,800 |
NATIONAL HEALTH RESEARCH (REGISTRATION AND ACCREDITATION) REGULATIONS
[Sections 18(3), 19 and 63]
Arrangement of Regulations
Regulation
3. Application for registration of health research ethics committee
4. Certificate of registration
5. Suspension, cancellation of registration
6. Restoration of certificate of registration
7. Application for accreditation or renewal of accreditation
8. Certificate of accreditation
9. Display of certificate of accreditation
10. Revocation of certificate of accreditation
11. Restoration of accreditation certificate
12. Duplicate certificate of accreditation or registration
13. Prohibition of transfer of certificate of registration or accreditation
14. Levels of accreditation for health research ethics committee
15. Functions of health research ethics committee
SI 25 of 2020.
These Regulations may be cited as the National Health Research (Registration and Accreditation) Regulations, 2020.
In these Regulations, unless the context otherwise requires-
"certificate of accreditation" means a certificate of accreditation issued under regulation 8; and
"certificate of registration" means the certificate of registration issued under regulation 4.
3. Application for registration of health research ethics committee
(1) A research institution or health establishment at which health research is conducted shall apply to the Board for the registration of a health research ethics committee in Form I set out in the First Schedule on payment of the fee set out in the Second Schedule.
(2) The Board may, within 30 days of receipt of an application under sub-regulation (1), grant or reject the application.
(3) The Board shall, where it rejects an application, inform the applicant in Form II set out in the First Schedule.
4. Certificate of registration
(1) The Board shall, where it approves an application for registration, issue an applicant with a certificate of registration in Form III set out in the First Schedule.
(2) A certificate of registration shall remain valid unless suspended or cancelled under these Regulations.
5. Suspension, cancellation of registration
(1) The Board may suspend or cancel a certificate of registration of a health research ethics committee if the certificate of the health research ethics committee-
(a) obtained the certificate of registration by fraud, negligence, misrepresentation, or concealment of a material fact;
(b) is found guilty of misconduct under the written Act;
(c) contravenes the Act or any other relevant written law; or
(d) is disqualified based on circumstances arising against the health research ethics committee.
(2) The Board shall before suspending or cancelling the certificate of registration of a health research ethics committee, give notice to the holder of the certificate of registration to show cause within a specified period why the certificate of registration should not be suspended, cancelled or revoked in Form IV set out in the First Schedule.
(3) The Board shall suspend or cancel a certificate of registration if the health research ethics committee fails to take remedial measures during the period specified by the Board in Form V set out in the Schedule.
(4) Where the certificate of registration of a health research ethics committee is suspended or cancelled-
(a) holder of a certificate of registration shall cease research activities;
(b) the Board shall transfer research protocols under the review of a health research ethics committee to another accredited health research ethics committee;
(c) the Board shall transfer research materials of the health researcher or research institution; and
(d) the certificate of registration of the health research ethics committee shall be surrendered to the Authority and the registration shall be cancelled.
6. Restoration of certificate of registration
A suspended or cancelled certificate may be restored if the Board is satisfied with the remedial measures taken by the health research ethics committee, on payment of the fee set out in the Second Schedule.
7. Application for accreditation or renewal of accreditation
(1) A health researcher, research institution or health research ethics committee shall apply to the Authority for accreditation or renewal of accreditation in Form VI set out in the First Schedule on payment of the fee set out in the Second Schedule.
(2) The Board shall, within thirty days of receipt of the application under sub-regulation (1) grant or reject an application for accreditation or renewal of accreditation.
(3) The Board shall, where it grants an application for accreditation or renewal of accreditation, notify the applicant in Form VII set out in the First Schedule.
(4) The Board shall, where it rejects an application for accreditation or renewal of accreditation, notify the applicant in Form VIII set out in the First Schedule.
8. Certificate of accreditation
The Board shall issue a certificate of accreditation in Form IX set out in the First Schedule.
9. Display of certificate of accreditation
A health researcher, research institution or health research ethics committee shall display the certificate of accreditation in a conspicuous place at their respective registered place of business or office.
10. Revocation of certificate of accreditation
(1) <PN:"Highlighter 3">The Minister shall revoke the certificate of accreditation of a health researcher, research institution or health research ethics committee if the health researcher, research institution or health research ethics committee-
(a) contravenes the provisions of the Act or any other relevant written law or breaches the conditions of the accreditation;
(b) fails to take corrective measures following the suspension of the certificate of accreditation within a specified period;
(c) changes location of its place of business or office without authorisation; or
(d) obtained the certificate of registration by fraud, negligence, misrepresentation, or concealment of a material fact.
(2) The Minister shall, before revoking a certificate of accreditation, give notice to the health researcher, research institution or health research ethics committee of the intention to revoke the certificate and request the health researcher, health research ethics committee or research institution, to show cause, within a specified period, why the certificate should not be revoked.
11. Restoration of accreditation certificate
(1) The Minister may restore a suspended or cancelled certificate of accreditation if the Minister is satisfied with the remedial measures taken by a health researcher, research institution, or health research ethics committee.
(2) A health researcher, research institution or health research ethics committee may apply for the restoration of a suspended or revoked certificate of accreditation in Form VI set out in the First Schedule on payment of the fee set out in the Second Schedule.
12. Duplicate certificate of accreditation or registration
(1) A health researcher, research institution or health research ethics committee whose certificate of registration or accreditation is destroyed or lost may apply to the Board for a duplicate certificate in Form X set out in the First Schedule on payment of the fee set out in the Second Schedule.
(2) The Board may, within thirty days of receipt of an application under this regulation, issue a duplicate certificate of accreditation or registration in Form XI or XII set out in the First Schedule, respectively.
13. Prohibition of transfer of certificate of registration or accreditation
A certificate of registration or accreditation issued under these Regulations is non-transferable to a third party.
14. Levels of accreditation for health research ethics committee
(1) A certificate of accreditation for a health research ethics committee shall be issued according to the following levels-
(a) level one, for a health research ethics committee which reviews research protocols that have minimum risks to research participants;
(b) level two, for a health research ethics committee which reviews all types of research protocols except clinical and vaccine trials; and
(c) level three, for a health research ethics committee which reviews all types of research protocols, including clinical and vaccine trials.
(2) A health research ethics committee shall comply with the guidelines issued by the Authority for each level of accreditation.
(3) The certificate of accreditation shall state the level of accreditation granted to a health research ethics committee.
(4) A health research ethics committee shall not approve a research protocol that is beyond the level of accreditation permitted by the Board.
(5) The Board shall revoke the certificate of accreditation of a health research ethics committee that does not comply with sub-regulation (4).
15. Functions of health research ethics committee
The functions of a health research ethics committee are to-
(a) promote the rights, dignity and welfare of research participants;
(b) ensure that a certificate of accreditation is adhered to;
(c) review, approve or disapprove research protocols;
(d) maintain records of approved research protocols;
(e) monitor the conduct of research by a health researcher, research institution or health research ethics committee;
(f) submit annual reports to the Board; and
(g) perform other functions conferred on a health research ethics committee under the Act.
(1) The Director shall keep and maintain a Register of persons registered and accredited under these Regulations.
(2) The Director shall enter the details and particulars relating to-
(a) registered health researchers, research institutions and health research ethics committees;
(b) the holders of certificates of registration and accreditation, and person whose certificates have been cancelled;
(c) the applications rejected and the reasons for the rejection; and
(d) any other information that the Authority may determine.
(3) The Register shall be kept in the custody of the Director at the offices of the Authority and shall be open for inspection by members of the public during normal office hours on payment of the fee set out in the Second Schedule.
(4) The Director may, on an application by any person, issue to the person a certified extract from the Register of a copy of a certificate of registration or accreditation, on payment of the fee set out in the Second Schedule.
The fees set out in the Second Schedule are payable for the matters specified therein.<PN:"American English and Spell Error">
[Regulations 3, 4, 5, 7, 8 and 12]
Form I
[Regulation 3 (1))
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
APPLICATION FOR REGISTRATION
|
1. APPLICATION DETAILS |
|
|
PART A: Research Institution |
|
|
Name of Ethics Committee |
|
|
Institutional affiliation |
|
|
Physical address |
|
|
Postal address |
|
|
Phone |
|
|
Fax |
|
|
|
|
|
Level applied for |
|
|
Chairperson |
Title (Tick [ |
|
Surname: |
|
|
Forename(s): |
|
|
Phone: |
|
|
Email: |
|
|
Address: |
|
|
Administrator |
Title (Tick [ |
|
Surname: |
|
|
Forename(s): |
|
|
Phone: |
|
|
Email: |
|
|
Address: |
|
|
Type of Certificate (Registration/Accreditation): |
|
|
Certificate No |
|
|
Affidavit (Attach) |
] where applicable)
Dr |
A2. Supporting documents |
||
|
Document |
Attached |
Comment |
|
Registration Certificate |
||
|
List of the members of research ethics committee |
||
|
Composition of research ethics committee as provided for in attachment 1 |
||
|
Curriculum vitae of members of the research ethics committee |
||
|
Evidence of ethics training, undertaken within the last three years |
||
|
Signed statement of commitment by the head of institution to conduct health research in accordance with the National Health Research Act No. 2 of 2013 |
||
|
Declarations of conflict of interest |
||
|
Standard operating procedures |
||
|
Protocol and consent forms template |
||
|
Fee structure |
|
A3. Type of research to be reviewed |
|
|
Biomedical research |
|
|
Social research |
|
|
Other (Specific) |
|
B1. Health establishment |
|
|
Name of institution Type of institution |
Public |
|
Registration number (e.g. PACRA, HPCZ etc.) |
|
|
Physical address |
|
|
Postal address |
|
|
Phone |
|
|
Fax |
|
|
|
|
|
Type of Certificate (Registration/Accreditation) |
|
|
Certificate No. |
|
|
Affidavit (Attach) |
|
B2. Supporting documents for Research Institution |
||
|
Document |
Attached |
Comment |
|
Registration Certificate |
||
|
Composition of research ethics committee as provided for in attachment |
||
|
Curriculum vitae of members of the research ethics committee |
||
|
Evidence of ethics training, undertaken within the last three years |
||
|
Signed statement of commitment by the head of institution to conduct health research in accordance with the National Health Research Act No. 2 of 2013 |
||
|
Declarations of conflict of interest |
||
|
Curriculum vitae of research staff |
||
|
Standard operating procedures |
||
|
Protocol and consent forms template |
||
|
Fee Structure |
|
2. DECLARATION AND SIGNATURE |
|
I ............................................................... declare that the information provided in this application and attachments contained therein, are true to the best of my knowledge. Further, I acknowledge that submission of false information shall render the application void, and may result in a fine or being banned from conducting research in Zambia. |
|
Details of person signing the application |
|
(a) Name:............................................................................................................................... |
|
(b) Designation:...................................................................................................................... |
|
(c) Signature:......................................................................................................................... |
|
(d) Date: ............../............./............. (dd/mm/yyyy) |
|
FOR OFFICIAL USE ONLY |
|
Date of receipt of application: |
|
Registration number: |
|
Completeness of application: YES |
|
General comments |
|
....................................................................................................................................................... |
|
....................................................................................................................................................... |
|
Name of reviewer ......................................................................................................................... |
|
Signature ...................................................................................................................................... |
|
Date .............................................................................................................................................. |
Payment receipt number: |
Attachment 1: Composition of Research Ethics Committee |
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
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Profession |
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Institutional affiliation |
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Qualification(s) |
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Physical address |
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Phone |
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Form II
[Regulation 3 =(3)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
NOTICE OF REJECTION OF REGISTRATION
|
To ............................................................................................................................................... |
|
In the matter of .............................................................................................................................. |
|
You are notified that your application for.............................................................................. has been |
|
rejected on the following grounds: .................................................................................................... |
|
...................................................................................................................................................... |
|
...................................................................................................................................................... |
|
Dated this .................. day of .......................... 20....... |
|
Signed: |
|
............................................................ |
Form III
[Regulation 4(1)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
CERTIFICATE OF REGISTRATION
|
This is to certify that |
|
.......................................................................................................................................................... |
|
Dated this .............................. day of ................................ 20........ |
|
Signed: |
|
............................................................ |
Form IV
[Regulation 5(2)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
NOTICE OF INTENTION TO SUSPEND/CANCEL/REVOKE CERTIFICATE OF REGISTRATION
|
(1) Here insert the full names and address of holder |
TO (1) ...................................................................................................... |
|
................................................................................................................ |
|
|
(2) Here insert the conditional authority No./ designation No. |
IN THE MATTER OF (2) .............................. you are notified that the Authority intends to *suspend/cancel/revoke your Certificate of Registration on the following grounds: |
|
(a) ............................................................................................................ |
|
|
(b) ............................................................................................................ |
|
|
(c) ............................................................................................................ |
|
|
Accordingly, you are requested to show cause why your Certificate of Registration should not be function a3(msg) { myWindow=window.open('','','width=243,height=85,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);} |
|
|
Dated this .............. day of .................... 20......... |
|
.................................................. |
|
|
|
Form V
[Regulation 5(3)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
NOTICE OF SUSPENSION, CANCELLATION OR REVOCATION OF CERTIFICATE OF REGISTRATION
|
To ............................................................................................................................................... |
|
IN THE MATTER OF...................................................................................................................... |
|
you are notified that your certificate of registration No. .................................................................... |
|
is suspended, cancelled or revoked on the following grounds: |
|
..................................................................................................................................................... |
|
..................................................................................................................................................... |
|
..................................................................................................................................................... |
|
..................................................................................................................................................... |
|
Date this ............... day of ......................... 20......... |
|
Signed: |
|
....................................................... |
Form VI
[Regulations 7(1) and 11(2)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
APPLICATION FOR ACCREDITATION, RENEWAL OR RESTORATION OF
ACCREDITATION FOR RESEARCH INSTITUTION/HEALTH
RESEARCH ETHICS COMMITTEE/RESEARCHERS
|
To be completed in triplicate |
|
1. Original to the minister |
|
2. Duplicate to the |
|
3. Triplicate to be retained by applicant |
|
[Please tick] Zambian Applicant |
|
Non-Zambian Applicant |
|
|
Type of Application: 1. Initial |
|
2. Renewal |
|
|
Level of Accreditation applied for ......................................................................................................... |
|||
|
Please write in BLOCK LETTERS |
|
3. APPLICANT DETAILS |
|
(a) Research Institutions |
|
(i) Details of Head of Institution |
|
Title (Tick [ |
Prof. |
|
Surname |
|
|
Forename(s) |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Postal address |
|
|
Phone |
|
|
Fax |
|
|
|
|
(ii) Details of Research Institution |
|
|
Name of institution |
|
|
Type of institution |
Public |
|
Registration number of Institution |
|
|
Physical address |
|
|
Postal address |
|
|
Phone |
|
|
Fax |
|
|
|
Private |
(iii) Funding and training in preceding year |
|
|
Number of grants received |
|
|
Value of grants received |
|
|
Number of publications |
|
|
Trainings |
GCP |
|
(iv) Supporting documents for Research Institution |
||
|
Document |
Attached |
Comment |
|
Covering letter |
||
|
Registration certificate |
||
|
Signed statement of commitment by the head of institution to conduct health research in accordance with the National Health Research Act No. 2 of 2013 |
||
|
Declarations of conflict of interest |
||
|
Adequate and appropriate infrastructure to conduct research |
||
|
Curriculum vitae of research staff |
|
(b) Research Ethics Committee |
|
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(i) Details of the Health Research Ethics Committee |
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Name of Ethics Committee |
|
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Institutional affiliation |
|
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Physical address |
|
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Postal address |
|
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Phone |
|
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Fax |
|
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|
|
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Level applied for |
|
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Chairperson |
Title (Tick [ |
|
Surname: |
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Forename(s): |
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Phone: |
|
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Email: |
|
|
Address: |
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Administrator |
Title (Tick [ |
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Surname: |
|
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Forename(s): |
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Phone: |
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Email: |
|
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Address: |
|
(ii) Type of Research to be reviewed |
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Biomedical research |
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Social research |
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Other (Specify) |
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(iii) Funding and training in preceding year |
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Number of grants received |
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Value of grants received |
|
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Number of publications |
|
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Trainings |
GCP |
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(iv) Supporting documents for REC |
||
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Document |
Attached |
Comment |
|
Covering letter |
||
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Registration certificate |
||
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Signed statement of commitment by the Research Ethics Committee to conduct health research in accordance with the National Health Research Act No. 2 of 2013 |
||
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Declarations of conflict of interest |
||
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Adequate and appropriate infrastructure to conduct research |
||
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Curriculum vitae of research staff |
|
C Health Researcher |
||
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(i) Details of Health Researcher |
||
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Title (Tick [ |
Prof. |
|
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Surname |
||
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Forename(s) |
||
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Nationality |
||
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National identification number |
||
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Gender |
Male |
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Qualification(s) |
||
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Institutional affiliation |
||
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Physical address |
||
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Postal address |
||
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Phone |
||
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Fax |
||
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||
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(ii) Supporting documents for health researchers |
||
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Document |
Attached (Yes/No/NA) |
Comment |
|
Professional registration certificate |
||
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Curriculum vitae |
||
|
Evidence of ethics training, undertaken within the last three years |
||
|
Declarations of conflict of interest |
|
4. DECLARATION AND SIGNATURE |
|
I ................................................................................. declare that the information provided in this application and the attachments contained therein, are true to the best of my knowledge. Further, I acknowledge that submission of false information shall render the application void, and may result in a fine or being banned from conducting research in Zambia. |
|
Details of Person Signing the Application |
|
(a) Name:................................................................................................................................. |
|
(b) Designation: ........................................................................................................................ |
|
(c) Signature: .......................................................................................................................... |
|
(d) Date: ................./................../.................. (dd/mm/yyyy) |
|
FOR OFFICIAL USE ONLY |
||
|
For office use only |
||
|
Date of receipt of application: |
|
Payment receipt number: |
|
Registration number: |
|
Completeness of application: YES |
|
General comments |
||
|
.................................................................................................................................................. |
||
|
.................................................................................................................................................. |
||
|
Name of reviewer................................................................. |
||
|
Signature.............................................................................. |
||
|
Date...................................................................................... |
Form VII
[Regulation 7(3)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
NOTICE OF GRANT OF ACCREDITATION/RENEWAL OF ACCREDITATION
|
(1) Here insert the full names and addresses of applicant |
To (1) .................................................................................................................. |
|
(2) Here insert the reference No of the application |
IN THE MATTER OF (2) ........................................................................................ |
|
(3) Here insert the type of application |
You are hereby notified that your application for (3) ................................................... has been approved on the following conditions: |
|
(a) ....................................................................................................................... |
|
|
(b) ....................................................................................................................... |
|
|
(c) ....................................................................................................................... |
|
|
(d) ....................................................................................................................... |
|
|
(4) Signature of Secretary for the Board |
Dated this .................... day of ............................ 20.......... |
|
(4) ....................................................................................................... |
|
|
Director |
Form VIII
[Regulation 7(4)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
NOTICE OF REJECTION TO GRANT ACCREDITATION OR RENEWAL OF ACCREDITATION
|
To ................................................................................................................................................. |
|
IN THE MATTER OF....................................................................................................................... |
|
You are notified that your application for .............................................................................. has been rejected on the following grounds: |
|
.................................................................................................................................................... |
|
.................................................................................................................................................... |
|
Dated this ................ day of ............................ 20........ |
|
Signed: |
|
......................................................... |
Form IX
[Regulation 8]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
CERTIFICATE OF ACCREDITATION
|
This is to certify that |
|
........................................................................................................................................................ |
|
is ACCREDITED by the |
|
........................................................................................................................................................ |
|
for the period from January to December 20............. |
|
Date this .................... day of ....................... 20......... |
|
Signed: |
|
.............................................. |
Form X
[Regulation 12(1)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
APPLICATION FOR DUPLICATE CERTIFICATE OF REGISTRATION OR ACCREDITATION
1. APPLICANT DETAILS
|
PART A. Health Research Ethics Committee |
|
|
Name of Ethics Committee |
|
|
Institutional affiliation |
|
|
Physical address |
|
|
Postal address |
|
|
Phone |
|
|
Fax |
|
|
|
|
|
Level applied for |
|
|
Chairperson |
Title (Tick["˜"˜] where applicable) |
|
Surname |
|
|
Forename(s) |
|
|
Phone: |
|
|
Email: |
|
|
Address: |
|
|
Administrator |
Title (Tick [ |
|
Surname: |
|
|
Forename(s): |
|
|
Phone: |
|
|
Email: |
|
|
Address: |
|
|
Type of Certificate (Registration/Accreditation) |
|
|
Certificate No. |
|
|
Affidavit (Attach) |
|
PART B. Health Research Institution |
|
|
Name of institution |
|
|
Type of institution (Tick [ |
Public |
|
Registration number (e.g. PACRA, HPCZ etc.) |
|
|
Physical address |
|
|
Postal address |
|
|
Phone |
|
|
Fax |
|
|
|
|
|
Type of Certificate (Registration/Accreditation) |
|
|
Certificate No. |
|
|
Affidavit (Attach) |
|
PART C. Health Researcher |
|
|
Title (Tick [ |
Prof. |
|
Surname |
|
|
Forename(s) |
|
|
Nationality |
|
|
National identification number: |
|
|
Gender |
Male |
|
Qualification(s) |
|
|
Institutional affiliation |
|
|
Physical address |
|
|
Postal address |
|
|
Phone |
|
|
Fax |
|
|
|
|
|
Type of Certificate (Registration/Accreditation): |
|
|
Certificate No: |
|
|
Affidavit (Attach): |
|
2. DECLARATION AND SIGNATURE |
|
I .............................. declare that the information provided in this application and attachments contained therein, are true to the best of my knowledge. Further, I acknowledge that submission of false information shall render the application void, and may result in a fine or being banned from conducting research in Zambia. |
|
Details of person signing the application |
|
(a) Name:...................................................................................................................................... |
|
(b) Designation:.............................................................................................................................. |
|
(c) Signature: ................................................................................................................................ |
|
(d) Date: .............../............./................ (dd/mm/yyyy) |
|
FOR OFFICIAL USE ONLY |
||
|
Date of receipt of application: |
|
Payment receipt number: |
|
Registration number: |
||
|
Completeness of application: |
YES |
|
|
General comments |
||
|
.................................................................................................................................................. |
||
|
.................................................................................................................................................. |
||
|
Name of reviewer ................................................................. |
||
|
Signature .................................................... Date .......................................................... |
|
Attachment 1: Composition of Health Research Ethics Committee |
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
|
|
Name of person |
|
|
Profession |
|
|
Institutional affiliation |
|
|
Qualification(s) |
|
|
Physical address |
|
|
Phone |
|
|
|
Form XI
[Regulation 12(2)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
DUPLICATE CERTIFICATE OF ACCREDITATION
|
This is to certify that |
|
..................................................................................................................................................... |
|
is ACCREDITED by the |
|
..................................................................................................................................................... |
|
for the period from January to December 20..................... |
|
Date this .................. day of ......................... 20.......... |
|
Signed: |
|
.......................................................... |
Form XII
[Regulation 12(2)]
THE NATIONAL HEALTH RESEARCH AUTHORITY
The National Health Research Act, 2013
(Act No. 2 of 2013)
The National Health Research (Registration and Accreditation) Regulations 2020
DUPLICATE CERTIFICATE OF REGISTRATION
|
This is to certify that |
|
...................................................................................................................................................... |
|
is REGISTERED by the |
|
...................................................................................................................................................... |
|
for the period from January to December 20.................... |
|
Date this ......................... day of ......................... 20........ |
|
Signed: |
|
........................................................ |
[Regulation 17]
PRESCRIBED FEES
|
S/No. |
Description |
ZAMBIAN Application Fees (Fee Units) |
FOREIGN Application Fees (Fee Units) |
|
1. |
Application for registration as researcher |
3,400 |
6,800 |
|
2. |
Application for registration of research institution or health research ethics committee |
6,700 |
13,400 |
|
3. |
Application of accreditation of researcher |
2,500 |
5,000 |
|
4. |
Application of accreditation of research institution or health research ethics committee |
8,350 |
16,700 |
|
5. |
Application for renewal of accreditation of researcher |
1,000 |
2,000 |
|
6. |
Application for renewal of accreditation of research institution or health research ethics committee |
5,000 |
10,000 |
|
7. |
Restoration of suspended or revoked certificate |
33,500 |
67,000 |
|
8. |
Application for variation of accreditation certificate |
23,400 |
46,800 |
{/mprestriction}