79C3C34C52B45572883A05D425EB0F82
National Health Research Act
http://www.parliament.gov.zm/sites/default/files/documents/acts/Health%20%20Research%20%20Act%202013.pdf
http://leaux.net/URLS/ConvertAPI Text Files/28AB8CD4FF2A3CD373B6A55E47CC8F58.en.txt
Examining the file media/Synopses/28AB8CD4FF2A3CD373B6A55E47CC8F58.html:
This file was generated: 2020-12-01 09:21:02
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.(None): (6) The Authority shall not consent to a health research under paragraph (b) of subsection (5), in circumstances where—
p.(None): (a) the objectives of the health research or experimentation may also be achieved if it is conducted on an adult;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the minor’s condition, disease or disorder to such an extent that shall result in significant benefit to the minor;
p.(None): (c) the reasons for the consent to the health research or experimentation by the parent or guardian of the
p.(None): minor and, if applicable, the minor, are contrary to social norms and public policy;
p.(None): (d) the health research or experimentation poses a significant risk to the health of the minor; or
p.(None): (e) there is some risk to the health or well being of the minor and the potential benefit of the health research
p.(None): or experimentation does not significantly outweigh that risk.
p.(None): (7) Health research involving special groups such as prisoners, pregnant women, persons with mental disabilities, or
p.(None): workers in a hierarchical system shall be conducted—
p.(None): (a) in such manner and on such terms and conditions as may be prescribed;
p.(None): (b) with the consent of the Authority, on recommendations from a committee of relevant experts established by the
p.(None): Minister; and
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 33
p.(None):
p.(None):
p.(None): (c) if the person is capable of understanding, with the written consent of the person, after the person has been
p.(None): informed of the objectives of the health research or experimentation and any possible potential
p.(None): risks and benefits on the person’s health.
p.(None): (8) The Authority shall not consent to health research under paragraph (b) of subsection (7) in circumstances
p.(None): where—
p.(None): (a) the objectives of the health research or experimentation may also be achieved if conducted on the general
p.(None): population;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the special group’s condition, disease or disorder to such an extent as shall result in significant benefit to
p.(None): their health or well being;
p.(None): (c) the reasons for the consent to the health research or experimentation are contrary to social norms and public
p.(None): policy;
...
Political / Indigenous
Searching for indicator indigenous:
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p.(None): prescribed under the Medicines and Allied Substances Act, 2013.
p.(None): (4) A clinical trial on human beings shall only be conducted—
p.(None): (a) in the prescribed manner;
p.(None): (b) if the researcher is in possession of a letter of approval issued by the relevant research ethics committee;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 37
p.(None):
p.(None):
p.(None): (c) if the researcher has a clinical trial certificate issued by the Zambia Medicines Regulatory Authority;
p.(None): (d) has ethical approval granted by the Board;
p.(None): (e) in accordance with Part V; and
p.(None): (f) with proven evidence of being in possession of a no fault insurance for all research participants.
p.(None): PART VIII
p.(None): RESEARCH IN TRADITIONAL, COMPLEMENTARY AND ALTERNATIVE MEDICINE
p.(None): 55. (1) The Minister, in consultation with the Authority shall—
p.(None): (a) make regulations for facilitating health research in traditional, complementary and alternative medicine in Zambia;
p.(None): (b) ensure wide dissemination of information on traditional, complementary and alternative medicine;
p.(None): (c) foster collaborative research between and among traditional and conventional health researchers and
p.(None): research institutions; and
p.(None): (d) ensure that nothing in the execution of this Act prevents traditional health practitioners from individually
p.(None): or collectively protecting their intellectual property rights and indigenous knowledge relating to the processing of
p.(None): their medicinal preparations or final products.
p.(None): PART VIX INTELLECTUAL PROPERTY RIGHTS
p.(None): 56. (1) Any intellectual property rights arising from, or connected with, health research undertaken under
p.(None): this Act shall be protected under the relevant laws and a health researcher or research institutions shall be
p.(None): entitled to the full dissemination of information and benefits of the health research.
p.(None): (2) Notwithstanding subsection (1), a research institution or a health researcher shall patent and hold rights of all
p.(None): innovations and inventions that are products of dedicated and original scientific research under the relevant laws
p.(None): relating to registration of intellectual property rights.
p.(None):
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p.(None):
p.(None):
p.(None): Research in traditional, complementary and alternative medicine
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None): Intellectual property rights
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p.(None): 38 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Entry by inspectors or other authorised
p.(None): persons
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Political / criminal
Searching for indicator criminal:
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p.(None): accordance with this Act;
p.(None): (d) shares samples collected from human participants with other health researchers or research institutions without
p.(None): first obtaining the relevant approvals under this Act;
p.(None): (e) shares samples collected from human participants without an approved material transfer agreement, as provided under
p.(None): this Act;
p.(None): (f) shares samples collected prospectively from human participants with other health researchers or research
p.(None): institutions without the informed consent of the donors of the samples to do so;
p.(None): (g) fails to submit prescribed mandatory reports to a health research ethics committee and the Board;
p.(None): (h) fails to uphold privacy and confidentiality of participants’ information;
p.(None): (i) deviates from an approved research protocol;
p.(None): (j) fails to report deviations from an approved research protocol to the relevant health research ethics
p.(None): committee or the Board;
p.(None): (k) fabricates, falsifies or knowingly plagiarises data; or
p.(None): (l) forges approvals or other relevant documents under this Act.
p.(None): (2) A health researcher who contravenes subsection (1) and who is found guilty by a health research ethics
p.(None): committee or the Board is liable to a fine not exceeding four hundred thousand penalty units or shall be banned
p.(None): from conducting health research for a minimum of five years.
p.(None): (3) Notwithstanding subsection (2), a health researcher who commits a criminal offence is liable to prosecution.
p.(None): (4) The Minister shall, in consultation with the Authority, by statutory instrument, issue regulations for dealing with
p.(None): misconduct by health researchers and procedures for their discipline.
p.(None): 21. (1) A health researcher or research institution whose interests are affected by an action or decision of a
p.(None): health research
p.(None):
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p.(None):
p.(None): Complaints
p.(None):
p.(None):
p.(None): 22 No. 2 of 2013] National Health Research
p.(None):
p.(None): ethics committee may lodge a complaint with the Board and request an investigation concerning the action or decision of
p.(None): the health research ethics committee, on one or more of the grounds set out in subsection (2).
p.(None): (2) A health researcher or research institution, referred to in subsection (1), may lodge a complaint on any of
p.(None): the following grounds:
p.(None): (a) that the action or decision breached the rules of natural justice;
p.(None): (b) that the action or decision was induced or affected by fraud;
...
Health / Drug Usage
Searching for indicator substance:
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p.(None): authorised or required by this Act to be given, made or issued by, or to, the Minister, the Authority, the Council,
p.(None): Board, Director or health research ethics committee shall be in writing.
p.(None): (2) A direction, notice, consent, approval, demand or other document which the Authority is authorised or
p.(None): required by or under this Act to give, make or issue may be signed on behalf of the Authority by—
p.(None): (a) the Director or Secretary; or
p.(None): (b) an officer of the Authority authorised by the Director, in writing, to sign documents of the particular kind or to
p.(None): sign the particular document.
p.(None): 61. (1) A person who commits an offence under this Act shall, if no other penalty is specified or prescribed
p.(None): in respect of the offence, be liable, upon conviction, to a fine not exceeding three hundred thousand penalty units
p.(None): or to imprisonment for a term not exceeding three years, or to both.
p.(None): (2) In addition to the penalties, specified under subsection (1), any contravention of this Act or any regulations made
p.(None): under this Act shall be a ground for terminating a research protocol, licence or any permission or approval given under
p.(None): this Act.
p.(None): (3) Where a person is convicted of an offence under this Act any research material or substance relating to the
p.(None): research shall be forfeited to the State.
p.(None): 62. Where an offence under this Act is committed by a body corporate or an unincorporate body, every director or
p.(None): manager of the corporate or unincorporate body is liable, upon conviction, as if the director or manager had
p.(None): personally committed the offence, unless the director or manager proves to the satisfaction of the court that the act
p.(None): constituting the offence was done without the
p.(None):
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p.(None): Authentication of documents
p.(None):
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p.(None): General penalties for offences
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p.(None):
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p.(None): Offences by body corporate or an unincorporate body
p.(None):
p.(None):
p.(None): 40 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
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p.(None): Regulations
p.(None):
p.(None):
p.(None):
p.(None): Transitional provisions
p.(None): knowledge, consent or connivance of the director or manager or that the director or manager took reasonable steps to
p.(None): prevent the commission of the offence.
p.(None): 63. The Minister may, in consultation with the Authority, by statutory instrument, make regulations for the better
p.(None): carrying out of the provisions of this Act.
...
Health / Mentally Disabled
Searching for indicator mentally:
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p.(None): (a) all clinical trials involving medicines, vaccines or other biological products, new therapeutic regimes, as well as
p.(None): invasive diagnostic procedures;
p.(None): (b) multi-center and multi-national collaborative health research;
p.(None): (c) health research which is fully or partially initiated, financed and wholly or partly carried out by external donors
p.(None): or international agencies;
p.(None): (d) health research which is carried out by an international agency or agencies with bilateral or multi-lateral
p.(None): collaboration or agreements with the Government; and
p.(None): (e) health research proposals that meet the health research ethics guidelines.
p.(None): (4) The Board may delegate any of its functions to an accredited health research ethics committee.
p.(None): 15. (1) A member of the Board shall hold office for a period of three years from the date of appointment and is
p.(None): eligible for re- appointment for one further term of three years.
p.(None): (2) A member may resign upon giving one month’s notice, in writing, to the Council.
p.(None): (3) The office of member becomes vacant —
p.(None): (a) upon the member’s death;
p.(None): (b) if the member is absent, without reasonable excuse, from three consecutive meetings of the Board of which the
p.(None): member had notice without the prior approval of the Board;
p.(None): (c) on ceasing to be a representative of the organisation or association which recommended the member;
p.(None): (d) if the member is found guilty of professional misconduct by the relevant professional association or statutory
p.(None): body;
p.(None): (e) if the member is convicted of an offence involving fraud or dishonesty;
p.(None): (f) if the member becomes mentally or physically incapable of performing the duties of a member; or
p.(None): (g) if the member is declared bankrupt.
p.(None):
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p.(None):
p.(None):
p.(None): Tenure of office and vacancy of Board
p.(None):
p.(None):
p.(None): 20 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Proceedings of Board
p.(None):
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p.(None): Research protocol
p.(None):
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p.(None): Health research ethics committees
p.(None):
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p.(None): Functions and procedures of health research ethics committee
p.(None):
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p.(None):
p.(None):
p.(None): Misconduct by
p.(None): health researchers
p.(None): (4) The Council may fill a vacancy on the Board by appointing another person to replace the member who vacates office
p.(None): for the remainder of the term.
p.(None): 16. (1) The Board shall regulate its own procedures at meetings.
p.(None): (2) The quorum at any meeting of the Board shall be eight members.
p.(None): (3) The disciplinary proceedings of the Board shall be as prescribed.
p.(None): 17. All proposals for health research under this Act shall be reviewed by the Board or any other accredited
...
p.(None): 2. (1) A member of the Council shall, subject to the other provisions of this Schedule, hold office for a
p.(None): term of three years and may be re-appointed for a further term of three years.
p.(None): (2) Upon the expiration of the term for which a member is appointed, the member shall continue to hold
p.(None): office until another member is appointed, but in no case shall any extension of the period exceed three months.
p.(None): (3) The office of a member becomes vacant—
p.(None): (a) upon the member’s death;
p.(None): (b) if the member is adjudged bankrupt;
p.(None): (c) if the member is absent, without reasonable excuse, from three consecutive meetings of the Authority of which the
p.(None): member had notice, without the prior approval of the Authority;
p.(None): (d) upon the expiry of one month’s notice of the member’s intention to resign, given by the member, in writing, to the
p.(None): Minister;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None): Seal of
p.(None): Authority
p.(None):
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p.(None):
p.(None): Tenure of office
p.(None): and vacancy of
p.(None): member
p.(None):
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p.(None): 42 No. 2 of 2013] National Health Research
p.(None):
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p.(None): Filling of casual vacancy
p.(None):
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p.(None):
p.(None): Proceedings of
p.(None): Council
p.(None): (e) if the member becomes mentally or physically incapable of performing duties as a member; or
p.(None): (f) if the member is convicted of an offence under this Act or any other law.
p.(None): 3. The Minister may, where the office of a member becomes vacant before the expiry of the term of office,
p.(None): appoint another member in place of the member who vacates office, but that member shall hold office only for the
p.(None): unexpired part of the term.
p.(None): 4. (1) Subject to this Act, the Council may regulate its own procedure.
p.(None): (2) The Council shall meet for the transaction of business at least once in every three months at such places and times
p.(None): as the Chairperson may determine.
p.(None): (3) The Chairperson may, upon giving notice of not less than fourteen days, call a meeting of the Council and shall
p.(None): call a special meeting to be held within fourteen days of receipt of a written request to the Chairperson by at least
p.(None): five members of the Council.
p.(None): (4) If the urgency of any particular matter does not permit the giving of such notice as is required under subparagraph
p.(None): (3), a special meeting may be called by the Chairperson, upon giving a shorter notice.
p.(None): (5) Seven members of the Council shall form a quorum at any meeting of the Council.
p.(None): (6) There shall preside at any meeting of the Council—
p.(None): (a) the Chairperson; and
p.(None): (b) in the absence of the Chairperson, the Vice Chairperson, and in the absence of the Chairperson and the Vice
p.(None): Chairperson, such member as the members present may elect for the purpose of that meeting.
p.(None): (7) A decision of the Council on any question shall be by a majority of the members present and voting at the meeting
...
Searching for indicator disability:
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p.(None): “ research institution ” means an organisation, whether public or private, including a university, which undertakes
p.(None): health research;
p.(None): “ research protocol ” means a research proposal for health research approved by the Board in accordance with section
p.(None): seventeen;
p.(None): “ Secretary ” means the Secretary to the Council appointed under section twelve;
p.(None): “ site ” means a place approved by the Board for the conduct of health research;
p.(None): “ social norm ” means a pattern of behaviour in a particular group or community or culture accepted as normal in that
p.(None): group or community;
p.(None): “ therapeutic cloning ” means a procedure for producing tissues or organs from genetically identical cells that
p.(None): originate from undifferentiated stem cells for purposes of repairing or replacing damaged tissues;
p.(None): “ traditional, complementary and alternative medicines ” means the total combination of knowledge and practices,
p.(None): whether explicable or not, used in diagnosing, preventing or eliminating physical, mental or social diseases and which
p.(None): may rely exclusively on past experience and observation handed down from generation to generation, verbally or in
p.(None): writing;
p.(None): “ traditional health practitioner ” means a person recognised by a community in which that person lives as competent to
p.(None): provide health care, using vegetable, animal or mineral substances and other methods based on social, cultural and
p.(None): religious background and knowledge, attitudes and beliefs that are prevalent in the community regarding the physical,
p.(None): mental and social well being of a person, including the causes of disease and disability;
p.(None):
p.(None):
p.(None): 12 No. 2 of 2013] National Health Research
p.(None):
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p.(None): Application and scope
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p.(None): Establishment of
p.(None): National Health Research Authority
p.(None):
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p.(None):
p.(None):
p.(None): Functions of Authority
p.(None): “ Trust Account ” means the Health Research Trust Account established under section forty-one;
p.(None): “ vertebrate animal ” means a bird, fish, reptile, amphibian or mammal, other than a human being, which is a member of
p.(None): the phylum vertebrates, or a bee, butterfly and any other insect used in the production of animal products, and
p.(None): includes the carcass of an animal; and
p.(None): “ Vice-Chairperson ” means the person elected Vice- Chairperson of the Council under section seven.
p.(None): 3. (1) Notwithstanding any other law, this Act applies to all health research conducted in Zambia, biological
p.(None): material and the use of personal health data.
p.(None): (2) Notwithstanding subsection (1), this Act applies to health research undertaken outside Zambia under the direction
p.(None): of a person or body established in Zambia.
p.(None): PART II
p.(None): THE NATIONAL HEALTH RESEARCH AUTHORITY
p.(None): 4. (1) There is hereby established the National Health Research Authority which shall be a body corporate
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p.(None): inform the Authority of the intention to move from a site prior to re-locating.
p.(None): 7. (1) The Authority shall be governed by a Council.
p.(None): (2) The Council shall consist of the following part-time members who shall be appointed by the Minister:
p.(None): (a) one representative each recommended by the Ministries responsible for—
p.(None): (i) science, technology and vocational training;
p.(None): (ii) finance;
p.(None): (iii) justice;
p.(None): (iv) defence;
p.(None):
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p.(None): National Health Research [ No. 2 of 2013 15
p.(None):
p.(None):
p.(None): (v) health;
p.(None): (vi) community development;
p.(None): (vii) education; and
p.(None): (viii) livestock and fisheries development;
p.(None): (b) one representative each recommended by—
p.(None): (i) a research and development institution;
p.(None): (ii) a higher education institution; and
p.(None): (iii) a civil society organisation concerned with matters of health;
p.(None): (c) a traditional health practitioner;
p.(None): (d) a renowned health researcher; and
p.(None): (e) two other persons.
p.(None): (3) A person shall not be appointed as a member of the Council if the person —
p.(None): (a) is an undischarged bankrupt;
p.(None): (b) has been convicted of an offence related to health research under this Act or any other written law;
p.(None): (c) has been convicted of an offence involving fraud or dishonesty;
p.(None): (d) is an employee of the Authority;
p.(None): (e) has a mental disability that makes the person incapable of performing the functions of a member; or
p.(None): (f) is not resident in Zambia.
p.(None): (4) The Minister shall, when appointing the members of the Council, ensure equitable gender representation and
p.(None): that at least a third of the members have health research experience.
p.(None): (5) The Minister shall appoint the Chairperson of the Council from among the members of the Council.
p.(None): (6) The Vice-Chairperson of the Council shall be elected by the members from amongst themselves.
p.(None): 8. (1) Except as otherwise provided under this Act, the Council shall exercise the following functions and powers of
p.(None): the Authority:
p.(None): (a) set, review and enforce ethical standards and human and animal research ethical guidelines, including ethical
p.(None): standards and guidelines for clinical trials;
p.(None):
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p.(None): Exercise of functions and powers of
p.(None): Authority
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p.(None): 16 No. 2 of 2013] National Health Research
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p.(None): (d) institute such disciplinary action, as may be prescribed, against any health researcher or research
p.(None): institution found to be in violation of any ethical standards or guidelines set for conducting of health
p.(None): research;
p.(None): (e) act as an appeals body from decisions of the health research ethics committees;
p.(None): (f) adjudicate complaints about the functioning of health research ethics committees and hear any
p.(None): complaint by a health researcher regarding a health research ethics committee;
p.(None): (g) notify any violation of professional conduct to the appropriate professional association or statutory body;
p.(None): (h) create awareness among health research reviewers, decision and policy makers and the community on the basic
p.(None): principles of health research ethics;
p.(None): (i) promote training in health research ethics and support the formation of health research ethics committees;
p.(None): (j)audit health research ethics committees; and
p.(None): (k) review research proposals and research protocols in order to ensure that health research conducted by a research
p.(None): institution or health researcher promotes health, contributes to the prevention of communicable or non-
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 19
p.(None):
p.(None):
p.(None): communicable diseases or disability or results in cures for communicable or non-communicable diseases and is in
p.(None): accordance with health research ethics.
p.(None): (3) The Board shall give ethical approval for—
p.(None): (a) all clinical trials involving medicines, vaccines or other biological products, new therapeutic regimes, as well as
p.(None): invasive diagnostic procedures;
p.(None): (b) multi-center and multi-national collaborative health research;
p.(None): (c) health research which is fully or partially initiated, financed and wholly or partly carried out by external donors
p.(None): or international agencies;
p.(None): (d) health research which is carried out by an international agency or agencies with bilateral or multi-lateral
p.(None): collaboration or agreements with the Government; and
p.(None): (e) health research proposals that meet the health research ethics guidelines.
p.(None): (4) The Board may delegate any of its functions to an accredited health research ethics committee.
p.(None): 15. (1) A member of the Board shall hold office for a period of three years from the date of appointment and is
p.(None): eligible for re- appointment for one further term of three years.
p.(None): (2) A member may resign upon giving one month’s notice, in writing, to the Council.
p.(None): (3) The office of member becomes vacant —
p.(None): (a) upon the member’s death;
p.(None): (b) if the member is absent, without reasonable excuse, from three consecutive meetings of the Board of which the
p.(None): member had notice without the prior approval of the Board;
p.(None): (c) on ceasing to be a representative of the organisation or association which recommended the member;
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. of 2013
p.(None): “ health researcher ” means an individual who undertakes health research;
p.(None): “ human participant ” means any living person who consents to participate in a health research activity or a body of a
p.(None): deceased person or part of a body of a deceased person as provided in the Human Tissue Act;
p.(None): “ human research guidelines ” means guidelines for the conduct of health research involving human participants
p.(None): issued under section thirty-six;
p.(None): “ inspector ” means a person appointed by the Authority as an inspector for the purposes of this Act;
p.(None): “ national health research strategic plan ” means a national plan that prioritises health research as provided
p.(None): under section thirty-one;
p.(None): “ intellectual property rights ” means an exclusive right granted to inventors and owners of works that are the result
p.(None): of human intellectual creativity;
p.(None): “ interim regulatory requirements ” means a regulatory framework issued under section thirty-eight;
p.(None): “ legal guardian ” means a person lawfully vested with the power, and charged with the obligation, of taking care of
p.(None): and managing the property and rights of a person who, because of age, understanding or self control, is incapable of
p.(None): administering that person’s own affairs;
p.(None): “ material transfer agreement ” means a written contract between the provider and recipient of research material as
p.(None): prescribed under section fifty-three;
p.(None): “ medicine ” has the meaning assigned to it in the Medicines and Allied Substances Act, 2013;
p.(None): “ member ” means a member of the Council;
p.(None): “ minor ” means a person below the age of eighteen years; “ private health establishment ” means a health establishment
p.(None): that is not owned or controlled by the Government;
p.(None): “ public health establishment ” means a health establishment that is owned or controlled by the Government;
p.(None): “ public policy ” means the objectives relating to the health, morals and well being of the citizens approved by
p.(None): Cabinet as part of the national health programme;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 11
p.(None):
p.(None): “ regulatory framework ” means any statute dealing with, or impacting on, health research, or regulations,
p.(None): rules, regulatory requirements, guidelines or practice directives relating to, or impacting on, health research,
p.(None): made in accordance with this Act;
p.(None): “ reproductive cloning ” means the genetic duplication of an existing organism especially by transferring the nucleus
p.(None): of a somatic cell of the organism into an enucleated oocyte;
p.(None): “ research institution ” means an organisation, whether public or private, including a university, which undertakes
p.(None): health research;
p.(None): “ research protocol ” means a research proposal for health research approved by the Board in accordance with section
p.(None): seventeen;
...
p.(None): 7. (1) The Authority shall be governed by a Council.
p.(None): (2) The Council shall consist of the following part-time members who shall be appointed by the Minister:
p.(None): (a) one representative each recommended by the Ministries responsible for—
p.(None): (i) science, technology and vocational training;
p.(None): (ii) finance;
p.(None): (iii) justice;
p.(None): (iv) defence;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 15
p.(None):
p.(None):
p.(None): (v) health;
p.(None): (vi) community development;
p.(None): (vii) education; and
p.(None): (viii) livestock and fisheries development;
p.(None): (b) one representative each recommended by—
p.(None): (i) a research and development institution;
p.(None): (ii) a higher education institution; and
p.(None): (iii) a civil society organisation concerned with matters of health;
p.(None): (c) a traditional health practitioner;
p.(None): (d) a renowned health researcher; and
p.(None): (e) two other persons.
p.(None): (3) A person shall not be appointed as a member of the Council if the person —
p.(None): (a) is an undischarged bankrupt;
p.(None): (b) has been convicted of an offence related to health research under this Act or any other written law;
p.(None): (c) has been convicted of an offence involving fraud or dishonesty;
p.(None): (d) is an employee of the Authority;
p.(None): (e) has a mental disability that makes the person incapable of performing the functions of a member; or
p.(None): (f) is not resident in Zambia.
p.(None): (4) The Minister shall, when appointing the members of the Council, ensure equitable gender representation and
p.(None): that at least a third of the members have health research experience.
p.(None): (5) The Minister shall appoint the Chairperson of the Council from among the members of the Council.
p.(None): (6) The Vice-Chairperson of the Council shall be elected by the members from amongst themselves.
p.(None): 8. (1) Except as otherwise provided under this Act, the Council shall exercise the following functions and powers of
p.(None): the Authority:
p.(None): (a) set, review and enforce ethical standards and human and animal research ethical guidelines, including ethical
p.(None): standards and guidelines for clinical trials;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Exercise of functions and powers of
p.(None): Authority
p.(None):
p.(None):
p.(None): 16 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): invasive diagnostic procedures;
p.(None): (b) multi-center and multi-national collaborative health research;
p.(None): (c) health research which is fully or partially initiated, financed and wholly or partly carried out by external donors
p.(None): or international agencies;
p.(None): (d) health research which is carried out by an international agency or agencies with bilateral or multi-lateral
p.(None): collaboration or agreements with the Government; and
p.(None): (e) health research proposals that meet the health research ethics guidelines.
p.(None): (4) The Board may delegate any of its functions to an accredited health research ethics committee.
p.(None): 15. (1) A member of the Board shall hold office for a period of three years from the date of appointment and is
p.(None): eligible for re- appointment for one further term of three years.
p.(None): (2) A member may resign upon giving one month’s notice, in writing, to the Council.
p.(None): (3) The office of member becomes vacant —
p.(None): (a) upon the member’s death;
p.(None): (b) if the member is absent, without reasonable excuse, from three consecutive meetings of the Board of which the
p.(None): member had notice without the prior approval of the Board;
p.(None): (c) on ceasing to be a representative of the organisation or association which recommended the member;
p.(None): (d) if the member is found guilty of professional misconduct by the relevant professional association or statutory
p.(None): body;
p.(None): (e) if the member is convicted of an offence involving fraud or dishonesty;
p.(None): (f) if the member becomes mentally or physically incapable of performing the duties of a member; or
p.(None): (g) if the member is declared bankrupt.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Tenure of office and vacancy of Board
p.(None):
p.(None):
p.(None): 20 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Proceedings of Board
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research protocol
p.(None):
p.(None):
p.(None):
p.(None): Health research ethics committees
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Functions and procedures of health research ethics committee
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Misconduct by
p.(None): health researchers
p.(None): (4) The Council may fill a vacancy on the Board by appointing another person to replace the member who vacates office
p.(None): for the remainder of the term.
p.(None): 16. (1) The Board shall regulate its own procedures at meetings.
p.(None): (2) The quorum at any meeting of the Board shall be eight members.
p.(None): (3) The disciplinary proceedings of the Board shall be as prescribed.
p.(None): 17. All proposals for health research under this Act shall be reviewed by the Board or any other accredited
...
p.(None): term of three years and may be re-appointed for a further term of three years.
p.(None): (2) Upon the expiration of the term for which a member is appointed, the member shall continue to hold
p.(None): office until another member is appointed, but in no case shall any extension of the period exceed three months.
p.(None): (3) The office of a member becomes vacant—
p.(None): (a) upon the member’s death;
p.(None): (b) if the member is adjudged bankrupt;
p.(None): (c) if the member is absent, without reasonable excuse, from three consecutive meetings of the Authority of which the
p.(None): member had notice, without the prior approval of the Authority;
p.(None): (d) upon the expiry of one month’s notice of the member’s intention to resign, given by the member, in writing, to the
p.(None): Minister;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Seal of
p.(None): Authority
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Tenure of office
p.(None): and vacancy of
p.(None): member
p.(None):
p.(None):
p.(None): 42 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Filling of casual vacancy
p.(None):
p.(None):
p.(None):
p.(None): Proceedings of
p.(None): Council
p.(None): (e) if the member becomes mentally or physically incapable of performing duties as a member; or
p.(None): (f) if the member is convicted of an offence under this Act or any other law.
p.(None): 3. The Minister may, where the office of a member becomes vacant before the expiry of the term of office,
p.(None): appoint another member in place of the member who vacates office, but that member shall hold office only for the
p.(None): unexpired part of the term.
p.(None): 4. (1) Subject to this Act, the Council may regulate its own procedure.
p.(None): (2) The Council shall meet for the transaction of business at least once in every three months at such places and times
p.(None): as the Chairperson may determine.
p.(None): (3) The Chairperson may, upon giving notice of not less than fourteen days, call a meeting of the Council and shall
p.(None): call a special meeting to be held within fourteen days of receipt of a written request to the Chairperson by at least
p.(None): five members of the Council.
p.(None): (4) If the urgency of any particular matter does not permit the giving of such notice as is required under subparagraph
p.(None): (3), a special meeting may be called by the Chairperson, upon giving a shorter notice.
p.(None): (5) Seven members of the Council shall form a quorum at any meeting of the Council.
p.(None): (6) There shall preside at any meeting of the Council—
p.(None): (a) the Chairperson; and
p.(None): (b) in the absence of the Chairperson, the Vice Chairperson, and in the absence of the Chairperson and the Vice
p.(None): Chairperson, such member as the members present may elect for the purpose of that meeting.
p.(None): (7) A decision of the Council on any question shall be by a majority of the members present and voting at the meeting
p.(None): and in the event of an equality of votes, the person presiding at the meeting shall have a casting vote in addition to
p.(None): the deliberative vote.
...
Health / Physically Disabled
Searching for indicator physically:
(return to top)
p.(None): invasive diagnostic procedures;
p.(None): (b) multi-center and multi-national collaborative health research;
p.(None): (c) health research which is fully or partially initiated, financed and wholly or partly carried out by external donors
p.(None): or international agencies;
p.(None): (d) health research which is carried out by an international agency or agencies with bilateral or multi-lateral
p.(None): collaboration or agreements with the Government; and
p.(None): (e) health research proposals that meet the health research ethics guidelines.
p.(None): (4) The Board may delegate any of its functions to an accredited health research ethics committee.
p.(None): 15. (1) A member of the Board shall hold office for a period of three years from the date of appointment and is
p.(None): eligible for re- appointment for one further term of three years.
p.(None): (2) A member may resign upon giving one month’s notice, in writing, to the Council.
p.(None): (3) The office of member becomes vacant —
p.(None): (a) upon the member’s death;
p.(None): (b) if the member is absent, without reasonable excuse, from three consecutive meetings of the Board of which the
p.(None): member had notice without the prior approval of the Board;
p.(None): (c) on ceasing to be a representative of the organisation or association which recommended the member;
p.(None): (d) if the member is found guilty of professional misconduct by the relevant professional association or statutory
p.(None): body;
p.(None): (e) if the member is convicted of an offence involving fraud or dishonesty;
p.(None): (f) if the member becomes mentally or physically incapable of performing the duties of a member; or
p.(None): (g) if the member is declared bankrupt.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Tenure of office and vacancy of Board
p.(None):
p.(None):
p.(None): 20 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Proceedings of Board
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research protocol
p.(None):
p.(None):
p.(None):
p.(None): Health research ethics committees
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Functions and procedures of health research ethics committee
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Misconduct by
p.(None): health researchers
p.(None): (4) The Council may fill a vacancy on the Board by appointing another person to replace the member who vacates office
p.(None): for the remainder of the term.
p.(None): 16. (1) The Board shall regulate its own procedures at meetings.
p.(None): (2) The quorum at any meeting of the Board shall be eight members.
p.(None): (3) The disciplinary proceedings of the Board shall be as prescribed.
p.(None): 17. All proposals for health research under this Act shall be reviewed by the Board or any other accredited
...
p.(None): term of three years and may be re-appointed for a further term of three years.
p.(None): (2) Upon the expiration of the term for which a member is appointed, the member shall continue to hold
p.(None): office until another member is appointed, but in no case shall any extension of the period exceed three months.
p.(None): (3) The office of a member becomes vacant—
p.(None): (a) upon the member’s death;
p.(None): (b) if the member is adjudged bankrupt;
p.(None): (c) if the member is absent, without reasonable excuse, from three consecutive meetings of the Authority of which the
p.(None): member had notice, without the prior approval of the Authority;
p.(None): (d) upon the expiry of one month’s notice of the member’s intention to resign, given by the member, in writing, to the
p.(None): Minister;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Seal of
p.(None): Authority
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Tenure of office
p.(None): and vacancy of
p.(None): member
p.(None):
p.(None):
p.(None): 42 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Filling of casual vacancy
p.(None):
p.(None):
p.(None):
p.(None): Proceedings of
p.(None): Council
p.(None): (e) if the member becomes mentally or physically incapable of performing duties as a member; or
p.(None): (f) if the member is convicted of an offence under this Act or any other law.
p.(None): 3. The Minister may, where the office of a member becomes vacant before the expiry of the term of office,
p.(None): appoint another member in place of the member who vacates office, but that member shall hold office only for the
p.(None): unexpired part of the term.
p.(None): 4. (1) Subject to this Act, the Council may regulate its own procedure.
p.(None): (2) The Council shall meet for the transaction of business at least once in every three months at such places and times
p.(None): as the Chairperson may determine.
p.(None): (3) The Chairperson may, upon giving notice of not less than fourteen days, call a meeting of the Council and shall
p.(None): call a special meeting to be held within fourteen days of receipt of a written request to the Chairperson by at least
p.(None): five members of the Council.
p.(None): (4) If the urgency of any particular matter does not permit the giving of such notice as is required under subparagraph
p.(None): (3), a special meeting may be called by the Chairperson, upon giving a shorter notice.
p.(None): (5) Seven members of the Council shall form a quorum at any meeting of the Council.
p.(None): (6) There shall preside at any meeting of the Council—
p.(None): (a) the Chairperson; and
p.(None): (b) in the absence of the Chairperson, the Vice Chairperson, and in the absence of the Chairperson and the Vice
p.(None): Chairperson, such member as the members present may elect for the purpose of that meeting.
p.(None): (7) A decision of the Council on any question shall be by a majority of the members present and voting at the meeting
p.(None): and in the event of an equality of votes, the person presiding at the meeting shall have a casting vote in addition to
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None): (a) the objectives of the health research or experimentation may also be achieved if it is conducted on an adult;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the minor’s condition, disease or disorder to such an extent that shall result in significant benefit to the minor;
p.(None): (c) the reasons for the consent to the health research or experimentation by the parent or guardian of the
p.(None): minor and, if applicable, the minor, are contrary to social norms and public policy;
p.(None): (d) the health research or experimentation poses a significant risk to the health of the minor; or
p.(None): (e) there is some risk to the health or well being of the minor and the potential benefit of the health research
p.(None): or experimentation does not significantly outweigh that risk.
p.(None): (7) Health research involving special groups such as prisoners, pregnant women, persons with mental disabilities, or
p.(None): workers in a hierarchical system shall be conducted—
p.(None): (a) in such manner and on such terms and conditions as may be prescribed;
p.(None): (b) with the consent of the Authority, on recommendations from a committee of relevant experts established by the
p.(None): Minister; and
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 33
p.(None):
p.(None):
p.(None): (c) if the person is capable of understanding, with the written consent of the person, after the person has been
p.(None): informed of the objectives of the health research or experimentation and any possible potential
p.(None): risks and benefits on the person’s health.
p.(None): (8) The Authority shall not consent to health research under paragraph (b) of subsection (7) in circumstances
p.(None): where—
p.(None): (a) the objectives of the health research or experimentation may also be achieved if conducted on the general
p.(None): population;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the special group’s condition, disease or disorder to such an extent as shall result in significant benefit to
p.(None): their health or well being;
p.(None): (c) the reasons for the consent to the health research or experimentation are contrary to social norms and public
p.(None): policy;
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): 10. Delegation of functions
p.(None): 11. Director
p.(None): 12. Secretary, inspectors and other staff of Authority
p.(None): PART III
p.(None): THE NATIONAL HEALTH RESEARCH ETHICS SYSTEM
p.(None): 13. National Health Research Ethics Board
p.(None): 14. Functions of Board
p.(None): 15. Tenure of office and vacancy of Board
p.(None): 16. Proceedings of Board
p.(None): 17. Research protocol
p.(None): 18. Health research ethics committees
p.(None): 19. Functions and procedures of health research ethics committee
p.(None):
p.(None):
p.(None): Single copies of this Act may be obtained from the Government Printer,
p.(None): P.O. Box 30136, 10101 Lusaka. Price K23.00
p.(None):
p.(None):
p.(None): 4 No. 2 of 2013] National Health Research
p.(None):
p.(None): 20. Misconduct by health researchers
p.(None): 21. Complaints
p.(None): 22. Immunity from liability or penalty
p.(None): 23. Reports by Board
p.(None): 24. Staff of Board
p.(None): 25. Disclosure of interest by members of Board
p.(None): 26. Protection of personal information
p.(None): 27. Immunity of member of Board or committee
p.(None): 28. Annual report of Board
p.(None): 29. Appeals
p.(None): 30. Jurisdiction over offences committed outside Zambia
p.(None): PART IV
p.(None): REGULATORY FRAMEWORK FOR HEALTH RESEARCH
p.(None): 31. Priority areas for health research
p.(None): 32. Dissemination of health research information
p.(None): 33. Access to, and deposition of, health research databases
p.(None): 34. Monitoring and evaluation
p.(None): 35. Partnerships in health research
p.(None): 36. Human research guidelines
p.(None): 37. Consultation about regulatory framework
p.(None): 38. Interim regulatory requirements
p.(None): 39. Revocation of regulatory frameworks
p.(None): 40. Procedures for making submissions
p.(None): 41. Health Research Trust Account
p.(None): 42. Credit of amounts to Trust Account
p.(None): 43. Purposes of Trust Account
p.(None): 44. Accounting for gifts and bequests
p.(None): PART V
p.(None): HEALTH RESEARCH ON, OR EXPERIMENTATION WITH HUMAN PARTICIPANTS AND ANIMAL SUBJECTS
p.(None): 45. Health research on, or experimentation with, human participants or animal subjects
p.(None): 46. Prohibition of reproductive cloning of human beings
p.(None): 47. Prohibition of removal of tissue, organs, blood, blood products or gametes from living persons for research
p.(None): purposes
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 5
p.(None):
p.(None): PART VI
p.(None): BIOLOGICAL MATERIALS FOR HEALTH RESEARCH
p.(None): 48. Purposes of collection of biological materials
p.(None): 49. Storage of biological materials
p.(None): 50. Exportation and importation of biological materials
p.(None): 51. Designation of institution as bio-bank
p.(None): 52. Searches at ports of entry, exit and sites
p.(None): 53. Ownership of biological materials and material transfer agreement
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 54. Clinical trials
p.(None): PART VII CLINICAL TRIALS
p.(None):
p.(None): PART VIII
p.(None): RSEARCH IN TRADITIONAL, COMPLEMENTARY AND ALTERNATIVE MEDICINE
p.(None): 55. Research in traditional, complementary and alternative medicine
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Immunity of member of Board or committee
p.(None): (a) takes whatever action that the Board considers appropriate; and
p.(None): (b) informs the complainant of the action that the research institution, health researcher or health establishment has
p.(None): taken and of its reasons for taking the action.
p.(None): 24. The Authority shall—
p.(None): (a) second staff to service the Board; and
p.(None): (b) provide to the Board facilities necessary for it to perform its functions and exercise its powers under this Act.
p.(None): 25. (1) Where the Board is investigating, or is to investigate, a complaint concerning an action or decision of a
p.(None): health research ethics committee and a member of the Board has, or acquires, an interest that could conflict with
p.(None): the proper performance of the member’s functions in relation to the investigation, the member shall disclose the
p.(None): interest to the Board and the member shall only take part in the investigation if the complainant and the Board agree
p.(None): that the member may so take part.
p.(None): (2) If, in relation to an investigation of a complaint by the Board—
p.(None): (a) a member discloses an interest under subsection (1); and
p.(None): (b) the complainant and the Board do not agree to the member taking part in the investigation;
p.(None): the member shall not take part in the investigation of the complaint.
p.(None): 26. (1) The Board shall not, except in the performance or exercise of its functions or powers under this
p.(None): Act, make a record of or disclose to any person any information about another person that the Board has access to in
p.(None): the performance or exercise of its functions or powers under this Act.
p.(None): (2) Except for the purposes of this Act, if the Board has possession of a document or other record or notice of a
p.(None): matter or thing as a result of its functions or powers under this Act, a court shall not require the Board to—
p.(None): (a) produce the document or other record in its possession; or
p.(None): (b) disclose the matter or thing of which it had notice.
p.(None): 27. An action or other proceeding shall not lie or be instituted against a member of the Board or a committee, or in
p.(None): respect of, any act or thing done or omitted to be done in good faith in the
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 25
p.(None):
p.(None):
p.(None):
p.(None): exercise of or performance, or purported exercise or performance of any of the powers, functions or duties conferred
p.(None): under this Act.
p.(None): 28. The Board shall, as soon as practicable after the end of each financial year, give the Authority a written
p.(None): report of the Board’s activities during that year.
p.(None): 29. (1) A person who is aggrieved with the decision of the Board may, within fourteen days of service of the
p.(None): decision, appeal to the Council and thereafter may appeal to a court of competent jurisdiction.
p.(None): (2) A decision of the Board made under this section shall not take effect until the expiration of the time for lodging
p.(None): an appeal, the appeal is withdrawn or disposed of.
p.(None): 30. Where a health researcher has committed an offence for which the health researcher has been punished in another
p.(None): country and what the health researcher did constitutes a misconduct under this Act, that health researcher shall be
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Jurisdiction over offences committed outside Zambia
p.(None):
p.(None): PART IV
p.(None): REGULATORY FRAMEWORK FOR HEALTH RESEARCH
p.(None): 31. (1) The Authority shall identify and prioritise areas for health research and advise the Minister, who shall
p.(None): recommend the priority areas to Cabinet for approval as national health research priority areas which shall be
p.(None): incorporated in a national health research strategic plan.
p.(None): (2) The Authority shall, in identifying priorities for health research, take into consideration—
p.(None): (a) the burden of disease in the country;
p.(None): (b) the cost effectiveness of interventions aimed at reducing the burden of disease;
p.(None): (c) the availability of resources for the implementation of an intervention at the level closest to the affected
p.(None): communities;
p.(None): (d) the health needs of special groups;
p.(None): (e) the health needs of communities; and
p.(None): (f) emerging public health problems.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Priority area for health research
p.(None):
p.(None):
p.(None): 26 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Dissemination of health research information
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Access to, and deposition of, health research databases
p.(None): (3)Ahealth researcher and research institution shall align health research activities to the subsisting national health
p.(None): research strategic plan.
p.(None): (4) The Authority may allow research outside a national research strategic plan if it is in the public interest or
p.(None): public policy so requires.
p.(None): 32. (1) The Minister, in consultation with the Authority, shall prescribe mechanisms for dissemination of
p.(None): health research information as follows:
p.(None): (a) any health research conducted in Zambia shall first be disseminated locally before being disseminated outside
p.(None): Zambia; and
p.(None): (b) any person intending to publish health research information for health research undertaken in Zambia shall first
p.(None): notify the Authority, in writing, citing the research title and the ethical approval obtained from the Board.
p.(None): (2) The Authority may, for the purposes of disseminating health research information, facilitate fora or media through
p.(None): which health research information may be disseminated, timely, to a broad audience in Zambia.
p.(None): (3) A person shall not disseminate information that is identifiable without—
p.(None): (a) the written consent of the source of the information; and
p.(None): (b) approval from the responsible authority.
p.(None): (4) The Authority may, under such circumstances as it considers necessary, make exemptions in relation to the
p.(None): dissemination of information as provided under this section.
p.(None): 33. (1) The Authority has the right to access all health research databases in Zambia.
p.(None): (2) The Minister, in consultation with the Authority, shall put in place a national system for —
p.(None): (a) creating and securing health research databases;
p.(None): (b) storing and retrieving health research data; and
p.(None): (c) disseminating health research data from the national system.
p.(None): (3) The Minister may, in consultation with the Authority, by statutory instrument, make regulations for ensuring that
p.(None): databases for internally and externally funded health research are kept in a central health research repository as
p.(None): prescribed by the Minister.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 27
p.(None):
p.(None):
p.(None): (4) The Authority has the right to access databases, bio banks or any information collected by health researchers and
p.(None): research institutions.
p.(None): 34. The Authority shall —
p.(None): (a) develop monitoring and evaluation mechanisms for all health research programmes and activities;
p.(None): (b) promote training of health workers in health research methodologies and ethics, documentation, monitoring
p.(None): and evaluation; and
p.(None): (c) monitor and evaluate ongoing health research programmes and activities being undertaken in Zambia.
p.(None): 35. The Minister may, in consultation with the Authority —
p.(None): (a) establish mechanisms for involving communities in health research;
p.(None): (b) facilitate the establishment of a consultative forum for wide dissemination of national health research priority
p.(None): areas and outputs; and
p.(None): (c) make regulations for the protection of interests of stakeholders and the sharing of risks, benefits
p.(None): and outputs in health research programmes and activities.
p.(None): 36. (1) Without limiting any of the matters on which the Council may issue guidelines under this Act, the Council
p.(None): shall issue guidelines on the conduct of human research.
p.(None): (2) The Council shall issue guidelines on the conduct of human research in collaboration with the Board.
p.(None): 37. (1) The Minister, in consultation with the Authority, shall, before issuing any proposed regulatory framework,
p.(None): consult with relevant stakeholders in accordance with this section, except that this section shall not apply—
p.(None): (a) to a statutory instrument; or
...
Social / Age
Searching for indicator age:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 306
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. of 2013
p.(None): “ health researcher ” means an individual who undertakes health research;
p.(None): “ human participant ” means any living person who consents to participate in a health research activity or a body of a
p.(None): deceased person or part of a body of a deceased person as provided in the Human Tissue Act;
p.(None): “ human research guidelines ” means guidelines for the conduct of health research involving human participants
p.(None): issued under section thirty-six;
p.(None): “ inspector ” means a person appointed by the Authority as an inspector for the purposes of this Act;
p.(None): “ national health research strategic plan ” means a national plan that prioritises health research as provided
p.(None): under section thirty-one;
p.(None): “ intellectual property rights ” means an exclusive right granted to inventors and owners of works that are the result
p.(None): of human intellectual creativity;
p.(None): “ interim regulatory requirements ” means a regulatory framework issued under section thirty-eight;
p.(None): “ legal guardian ” means a person lawfully vested with the power, and charged with the obligation, of taking care of
p.(None): and managing the property and rights of a person who, because of age, understanding or self control, is incapable of
p.(None): administering that person’s own affairs;
p.(None): “ material transfer agreement ” means a written contract between the provider and recipient of research material as
p.(None): prescribed under section fifty-three;
p.(None): “ medicine ” has the meaning assigned to it in the Medicines and Allied Substances Act, 2013;
p.(None): “ member ” means a member of the Council;
p.(None): “ minor ” means a person below the age of eighteen years; “ private health establishment ” means a health establishment
p.(None): that is not owned or controlled by the Government;
p.(None): “ public health establishment ” means a health establishment that is owned or controlled by the Government;
p.(None): “ public policy ” means the objectives relating to the health, morals and well being of the citizens approved by
p.(None): Cabinet as part of the national health programme;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 11
p.(None):
p.(None): “ regulatory framework ” means any statute dealing with, or impacting on, health research, or regulations,
p.(None): rules, regulatory requirements, guidelines or practice directives relating to, or impacting on, health research,
p.(None): made in accordance with this Act;
p.(None): “ reproductive cloning ” means the genetic duplication of an existing organism especially by transferring the nucleus
p.(None): of a somatic cell of the organism into an enucleated oocyte;
p.(None): “ research institution ” means an organisation, whether public or private, including a university, which undertakes
p.(None): health research;
p.(None): “ research protocol ” means a research proposal for health research approved by the Board in accordance with section
p.(None): seventeen;
p.(None): “ Secretary ” means the Secretary to the Council appointed under section twelve;
p.(None): “ site ” means a place approved by the Board for the conduct of health research;
p.(None): “ social norm ” means a pattern of behaviour in a particular group or community or culture accepted as normal in that
p.(None): group or community;
p.(None): “ therapeutic cloning ” means a procedure for producing tissues or organs from genetically identical cells that
p.(None): originate from undifferentiated stem cells for purposes of repairing or replacing damaged tissues;
...
Social / Police Officer
Searching for indicator officer:
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p.(None): (f) establish and approve conditions of service of the staff of the Authority;
p.(None): (g) make recommendations to the Minister for amendments to this Act or issuance of regulations under this Act; and
p.(None): (h) perform any other function conferred or imposed on the Council by or under this Act.
p.(None): (2) The Minister may give to the Council general or specific directions, consistent with this Act, relating to the
p.(None): discharge of the functions of the Authority and the Council shall give effect to those directions.
p.(None): 9. (1) The Council may, for purposes of performing the functions of the Authority, establish such committees
p.(None): as it considers necessary for the effective exercise of the functions of the Authority.
p.(None): (2) The Council may appoint, as members of a committee, persons who are or are not members of the Council, except that
p.(None): at least one member of the Council shall be a member of a committee.
p.(None): (3) A person serving as a member of a committee shall hold office for such period as the Council may determine.
p.(None): (4) Subject to any specific or general direction of the Council, a committee may regulate its own procedure.
p.(None): 10. The Council may, by direction, in writing, and subject to such terms and conditions as it considers necessary,
p.(None): delegate to the Director, any member or any committee any of the functions of the Authority.
p.(None): 11. (1) The Council shall appoint, on such terms and conditions as it may determine, a Director who shall be the
p.(None): chief executive officer of the Authority.
p.(None): (2) The Director shall be responsible, under the general direction of the Council, for—
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 17
p.(None):
p.(None):
p.(None): (a) the management and administration of the affairs of the Authority;
p.(None): (b) the implementation of the decisions of the Council; and
p.(None): (c) any other function assigned or delegated to the Director by the Council or by or under this Act.
p.(None): (3) The Director shall attend meetings of the Council and may address those meetings but shall not vote on any matter.
p.(None): (4) The person presiding at any meeting of the Council may request the Director to withdraw from the meeting.
p.(None): 12. (1) The Council may appoint, on such terms and conditions as it may determine, the Secretary, inspectors and
p.(None): such other staff as may be necessary for the performance of the functions of the Authority.
p.(None): (2) The Council shall provide an inspector with a certificate of appointment, in the prescribed form, which shall be
p.(None): prima facie evidence of the inspector’s appointment.
p.(None): PART III
p.(None): THE NATIONAL HEALTH RESEARCH ETHICS SYSTEM
p.(None): 13. (1) There is established the National Health Research Ethics Board which shall consist of one
p.(None): representative from each of the following disciplines and sectors:
p.(None): (a) law;
p.(None): (b) pharmacology;
p.(None): (c) pharmacy;
p.(None): (d) theology;
p.(None): (e) biostatistics;
p.(None): (f) epidemiology;
p.(None): (g) public health;
p.(None): (h) biomedical science;
...
p.(None): (a) receive biological materials for storage purposes;
p.(None): (b) store biological material remnants for a period not exceeding ten years, unless the Authority approves a
p.(None): longer period of time for special reasons; and
p.(None): (c) dispose of biological materials that are due for disposal following prescribed bio-hazard waste guidelines.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Purposes of collection of biological materials
p.(None): Storage of biological materials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. 12
p.(None): of 2011
p.(None): Act No. 24
p.(None): of 2009
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Exportation and importation of biological materials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Designation of
p.(None): institution as bio-bank
p.(None):
p.(None):
p.(None): 36 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None): Searches at ports of entry, exit and sites Cap. 295
p.(None): Act No. 16
p.(None): of 2005
p.(None): Act No. 18
p.(None): of 2010
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Ownership of biological materials and material transfer agreement
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Clinical trials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. of 2013
p.(None): 52. (1) An officer authorised under the Public Health Act, Ionising Radiation Protection Act, 2005, and
p.(None): Immigration and Deportation Act, 2010, and any other relevant law enforcement officer may conduct a search, at any
p.(None): reasonable time, at any site, port of entry and port of exit.
p.(None): (2) Any biological material that is found to have been transferred without the necessary approvals and supporting
p.(None): documentation, as required under this Act, shall be confiscated and the person transferring the biological
p.(None): material commits an offence and is liable to the general penalty.
p.(None): 53. (1) The Minister shall, in consultation with the Authority, prescribe and specify the requirements and contents
p.(None): of a material transfer agreement and shall provide for the terms and conditions regarding—
p.(None): (a) ownership of the material, including any of its derivatives and modifications; and
p.(None): (b) intellectual property rights, publication rights, the various uses of the material, including reproduction
p.(None): and replication, confidentiality of information and transfer to third parties and liabilities.
p.(None): PART VII CLINICAL TRIALS
p.(None): 54. (1) The Minister, in consultation with the Authority, shall make regulations for the conduct of clinical trials
p.(None): in Zambia.
p.(None): (2) The Minister may constitute a special expert review panel on matters of public interest, public policy or
p.(None): national security concerning the conduct of clinical trials.
p.(None): (3) A medicine to be used in a clinical trial shall be approved by the Zambia Medicines and Regulatory Authority as
p.(None): prescribed under the Medicines and Allied Substances Act, 2013.
p.(None): (4) A clinical trial on human beings shall only be conducted—
p.(None): (a) in the prescribed manner;
...
p.(None): case may be, to enter on to the site or premises.
p.(None): (4) A person exercising any power under this section shall do so with reasonable care and in such a manner as to cause
p.(None): as little damage as possible.
p.(None): 58. (1) A health researcher or research institution and any employee or agent of a health researcher or
p.(None): research institution shall, on demand by an inspector—
p.(None): (a) avail to the inspector such information as is within their knowledge in all matters relating to any inspection or
p.(None): investigation done under this Act; and
p.(None): (b) produce for inspection, any research protocol, licence, material transfer agreement or other document or record, as
p.(None): the case may be, relating to the health research being undertaken on the site or any matter that is the cause for the
p.(None): inspection or investigation.
p.(None): (2) A person who contravenes subsection (1) commits an offence and is liable, upon conviction, to the general penalty
p.(None): provided under this Act.
p.(None): 59. (1) Any notice required to be served under this Act shall be served—
p.(None): (a) by delivering it personally to the person required to be served or, if the person is absent or cannot be found
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 39
p.(None):
p.(None):
p.(None): (i) by leaving it at the person’s usual or last known place of abode in Zambia; or
p.(None): (ii) by registered post, addressed to the person’s usual or last known address in Zambia; or
p.(None): (b) in the case of a notice required to be served on a company or other corporate body, by delivering it to its
p.(None): principal officer, leaving it at the office with an employee or sending it through registered post.
p.(None): 60. (1) Any direction, notice, consent, approval, permission, demand, objection, application or other thing
p.(None): authorised or required by this Act to be given, made or issued by, or to, the Minister, the Authority, the Council,
p.(None): Board, Director or health research ethics committee shall be in writing.
p.(None): (2) A direction, notice, consent, approval, demand or other document which the Authority is authorised or
p.(None): required by or under this Act to give, make or issue may be signed on behalf of the Authority by—
p.(None): (a) the Director or Secretary; or
p.(None): (b) an officer of the Authority authorised by the Director, in writing, to sign documents of the particular kind or to
p.(None): sign the particular document.
p.(None): 61. (1) A person who commits an offence under this Act shall, if no other penalty is specified or prescribed
p.(None): in respect of the offence, be liable, upon conviction, to a fine not exceeding three hundred thousand penalty units
p.(None): or to imprisonment for a term not exceeding three years, or to both.
p.(None): (2) In addition to the penalties, specified under subsection (1), any contravention of this Act or any regulations made
p.(None): under this Act shall be a ground for terminating a research protocol, licence or any permission or approval given under
p.(None): this Act.
p.(None): (3) Where a person is convicted of an offence under this Act any research material or substance relating to the
p.(None): research shall be forfeited to the State.
p.(None): 62. Where an offence under this Act is committed by a body corporate or an unincorporate body, every director or
p.(None): manager of the corporate or unincorporate body is liable, upon conviction, as if the director or manager had
p.(None): personally committed the offence, unless the director or manager proves to the satisfaction of the court that the act
p.(None): constituting the offence was done without the
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Authentication of documents
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Social / Property Ownership
Searching for indicator property:
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p.(None): 34. Monitoring and evaluation
p.(None): 35. Partnerships in health research
p.(None): 36. Human research guidelines
p.(None): 37. Consultation about regulatory framework
p.(None): 38. Interim regulatory requirements
p.(None): 39. Revocation of regulatory frameworks
p.(None): 40. Procedures for making submissions
p.(None): 41. Health Research Trust Account
p.(None): 42. Credit of amounts to Trust Account
p.(None): 43. Purposes of Trust Account
p.(None): 44. Accounting for gifts and bequests
p.(None): PART V
p.(None): HEALTH RESEARCH ON, OR EXPERIMENTATION WITH HUMAN PARTICIPANTS AND ANIMAL SUBJECTS
p.(None): 45. Health research on, or experimentation with, human participants or animal subjects
p.(None): 46. Prohibition of reproductive cloning of human beings
p.(None): 47. Prohibition of removal of tissue, organs, blood, blood products or gametes from living persons for research
p.(None): purposes
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 5
p.(None):
p.(None): PART VI
p.(None): BIOLOGICAL MATERIALS FOR HEALTH RESEARCH
p.(None): 48. Purposes of collection of biological materials
p.(None): 49. Storage of biological materials
p.(None): 50. Exportation and importation of biological materials
p.(None): 51. Designation of institution as bio-bank
p.(None): 52. Searches at ports of entry, exit and sites
p.(None): 53. Ownership of biological materials and material transfer agreement
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 54. Clinical trials
p.(None): PART VII CLINICAL TRIALS
p.(None):
p.(None): PART VIII
p.(None): RSEARCH IN TRADITIONAL, COMPLEMENTARY AND ALTERNATIVE MEDICINE
p.(None): 55. Research in traditional, complementary and alternative medicine
p.(None): PART IX INTELLECTUAL PROPERTY RIGHTS
p.(None): 56. Intellectual property rights
p.(None): PART X GENERAL PROVISIONS
p.(None): 57. Entry by inspectors or other authorised persons
p.(None): 58. Duty to provide information to inspector
p.(None): 59. Service of Notice
p.(None): 60. Authentication of documents
p.(None): 61. General penalties for offences
p.(None): 62. Offences by body corporation or an unincorporate body
p.(None): 63. Regulations
p.(None): 64. Transitional provisions Schedule
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 7
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): GOVERNMENT OF ZAMBIA
p.(None):
p.(None): ACT
p.(None): No. 2 of 2013
p.(None):
p.(None):
p.(None): Date of Assent: 21/03/13
p.(None): An Act to establish the National Health Research Authority and provide for its functions and powers; establish the
p.(None): National Health Research Ethics Board and provide for its functions and powers; provide a regulatory framework for the
p.(None): development, regulation, financing and coordination of health research and ensure the development of consistent health
p.(None): research standards and guidelines for ethically sound health research; provide for the establishment of health research
p.(None): ethics committees and the regulation and management of research institutions, health researchers and health
p.(None): establishments involved in or undertaking research; provide for the regulation of biological material for health
p.(None): research; provide for ethical approval for the conduct of clinical trials; provide for the use of traditional,
p.(None): complementary and alternative medicines in health research; provide for data management and intellectual
p.(None): property rights in health research; provide for the designation of bio banks; and provide for matters connected
p.(None): with, or incidental to, the foregoing.
p.(None): [22nd March, 2013 ENACTED by the Parliament of Zambia.
p.(None): PART I PRELIMINARY
p.(None): 1. This Act may be cited as the National Health Research Act, 2013.
p.(None): 2. In this Act, unless the context otherwise requires—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Enactment
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Short title
p.(None):
p.(None):
p.(None): Interpretation
p.(None):
p.(None):
p.(None): 8 No. of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 1
p.(None): “ accreditation ” means a process of certification of competence in health research;
p.(None): “ animal subject ” means an animal which is used for health research or clinical trial;
p.(None): “ Authority ” means the National Health Research Authority established under section four;
p.(None): “ Board ” means the National Health Research Ethics Board constituted under section thirteen;
p.(None): “ bio-bank ” means a collection of biological materials and the associated data and information which is stored in an
p.(None): organised system;
...
p.(None): (d) investigates causes of disease and the effects of the environment on the human body; or
p.(None): (e) develops new applications of pharmaceuticals, medicines and health technology;
p.(None): “ health research ethics committee ” means a committee registered and accredited by the Board under section eighteen;
p.(None):
p.(None):
p.(None): 10 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 306
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. of 2013
p.(None): “ health researcher ” means an individual who undertakes health research;
p.(None): “ human participant ” means any living person who consents to participate in a health research activity or a body of a
p.(None): deceased person or part of a body of a deceased person as provided in the Human Tissue Act;
p.(None): “ human research guidelines ” means guidelines for the conduct of health research involving human participants
p.(None): issued under section thirty-six;
p.(None): “ inspector ” means a person appointed by the Authority as an inspector for the purposes of this Act;
p.(None): “ national health research strategic plan ” means a national plan that prioritises health research as provided
p.(None): under section thirty-one;
p.(None): “ intellectual property rights ” means an exclusive right granted to inventors and owners of works that are the result
p.(None): of human intellectual creativity;
p.(None): “ interim regulatory requirements ” means a regulatory framework issued under section thirty-eight;
p.(None): “ legal guardian ” means a person lawfully vested with the power, and charged with the obligation, of taking care of
p.(None): and managing the property and rights of a person who, because of age, understanding or self control, is incapable of
p.(None): administering that person’s own affairs;
p.(None): “ material transfer agreement ” means a written contract between the provider and recipient of research material as
p.(None): prescribed under section fifty-three;
p.(None): “ medicine ” has the meaning assigned to it in the Medicines and Allied Substances Act, 2013;
p.(None): “ member ” means a member of the Council;
p.(None): “ minor ” means a person below the age of eighteen years; “ private health establishment ” means a health establishment
p.(None): that is not owned or controlled by the Government;
p.(None): “ public health establishment ” means a health establishment that is owned or controlled by the Government;
p.(None): “ public policy ” means the objectives relating to the health, morals and well being of the citizens approved by
p.(None): Cabinet as part of the national health programme;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 11
p.(None):
p.(None): “ regulatory framework ” means any statute dealing with, or impacting on, health research, or regulations,
p.(None): rules, regulatory requirements, guidelines or practice directives relating to, or impacting on, health research,
p.(None): made in accordance with this Act;
p.(None): “ reproductive cloning ” means the genetic duplication of an existing organism especially by transferring the nucleus
p.(None): of a somatic cell of the organism into an enucleated oocyte;
p.(None): “ research institution ” means an organisation, whether public or private, including a university, which undertakes
...
p.(None):
p.(None):
p.(None): Searches at ports of entry, exit and sites Cap. 295
p.(None): Act No. 16
p.(None): of 2005
p.(None): Act No. 18
p.(None): of 2010
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Ownership of biological materials and material transfer agreement
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Clinical trials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. of 2013
p.(None): 52. (1) An officer authorised under the Public Health Act, Ionising Radiation Protection Act, 2005, and
p.(None): Immigration and Deportation Act, 2010, and any other relevant law enforcement officer may conduct a search, at any
p.(None): reasonable time, at any site, port of entry and port of exit.
p.(None): (2) Any biological material that is found to have been transferred without the necessary approvals and supporting
p.(None): documentation, as required under this Act, shall be confiscated and the person transferring the biological
p.(None): material commits an offence and is liable to the general penalty.
p.(None): 53. (1) The Minister shall, in consultation with the Authority, prescribe and specify the requirements and contents
p.(None): of a material transfer agreement and shall provide for the terms and conditions regarding—
p.(None): (a) ownership of the material, including any of its derivatives and modifications; and
p.(None): (b) intellectual property rights, publication rights, the various uses of the material, including reproduction
p.(None): and replication, confidentiality of information and transfer to third parties and liabilities.
p.(None): PART VII CLINICAL TRIALS
p.(None): 54. (1) The Minister, in consultation with the Authority, shall make regulations for the conduct of clinical trials
p.(None): in Zambia.
p.(None): (2) The Minister may constitute a special expert review panel on matters of public interest, public policy or
p.(None): national security concerning the conduct of clinical trials.
p.(None): (3) A medicine to be used in a clinical trial shall be approved by the Zambia Medicines and Regulatory Authority as
p.(None): prescribed under the Medicines and Allied Substances Act, 2013.
p.(None): (4) A clinical trial on human beings shall only be conducted—
p.(None): (a) in the prescribed manner;
p.(None): (b) if the researcher is in possession of a letter of approval issued by the relevant research ethics committee;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 37
p.(None):
p.(None):
p.(None): (c) if the researcher has a clinical trial certificate issued by the Zambia Medicines Regulatory Authority;
p.(None): (d) has ethical approval granted by the Board;
p.(None): (e) in accordance with Part V; and
p.(None): (f) with proven evidence of being in possession of a no fault insurance for all research participants.
p.(None): PART VIII
p.(None): RESEARCH IN TRADITIONAL, COMPLEMENTARY AND ALTERNATIVE MEDICINE
p.(None): 55. (1) The Minister, in consultation with the Authority shall—
p.(None): (a) make regulations for facilitating health research in traditional, complementary and alternative medicine in Zambia;
p.(None): (b) ensure wide dissemination of information on traditional, complementary and alternative medicine;
p.(None): (c) foster collaborative research between and among traditional and conventional health researchers and
p.(None): research institutions; and
p.(None): (d) ensure that nothing in the execution of this Act prevents traditional health practitioners from individually
p.(None): or collectively protecting their intellectual property rights and indigenous knowledge relating to the processing of
p.(None): their medicinal preparations or final products.
p.(None): PART VIX INTELLECTUAL PROPERTY RIGHTS
p.(None): 56. (1) Any intellectual property rights arising from, or connected with, health research undertaken under
p.(None): this Act shall be protected under the relevant laws and a health researcher or research institutions shall be
p.(None): entitled to the full dissemination of information and benefits of the health research.
p.(None): (2) Notwithstanding subsection (1), a research institution or a health researcher shall patent and hold rights of all
p.(None): innovations and inventions that are products of dedicated and original scientific research under the relevant laws
p.(None): relating to registration of intellectual property rights.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research in traditional, complementary and alternative medicine
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Intellectual property rights
p.(None):
p.(None):
p.(None): 38 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Entry by inspectors or other authorised
p.(None): persons
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Duty to provide information to inspector
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Service of notice
p.(None): PART X GENERAL PROVISIONS
p.(None): 57. (1) An inspector, agent of the Authority or any person authorised by the Authority for the purpose, may
p.(None): at any reasonable time, enter on to any site and inspect the site, after giving reasonable notice to a health
p.(None): researcher or person responsible for a research institution, for the purpose of ensuring compliance with this Act.
p.(None): (2) Notwithstanding subsection (1), an inspector may enter a site or premises for purposes of this Act, with
p.(None): warrant, if the inspector has reasonable grounds to believe that a provision of this Act or of any other regulatory
p.(None): framework has been or is about to be contravened or the site or premises are used or are being used for the commission
p.(None): of an offence.
p.(None): (3) If so requested by a health researcher or person responsible for a research institution, an inspector, agent of
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p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Complaints
p.(None):
p.(None):
p.(None): 22 No. 2 of 2013] National Health Research
p.(None):
p.(None): ethics committee may lodge a complaint with the Board and request an investigation concerning the action or decision of
p.(None): the health research ethics committee, on one or more of the grounds set out in subsection (2).
p.(None): (2) A health researcher or research institution, referred to in subsection (1), may lodge a complaint on any of
p.(None): the following grounds:
p.(None): (a) that the action or decision breached the rules of natural justice;
p.(None): (b) that the action or decision was induced or affected by fraud;
p.(None): (c) that there was no evidence or other material to justify the action or decision;
p.(None): (d) that an irrelevant consideration was taken into account in relation to the action;
p.(None): (e) that a relevant consideration was not taken into account in relation to the action or decision;
p.(None): (f) that in the course of the decision making process, a discretionary power was exercised for a purpose
p.(None): other than the purpose for which the power was conferred;
p.(None): (g) that the action or decision involved the exercise of a discretionary power in bad faith;
p.(None): (h) that, in the course of the decision making process, a personal discretionary power was exercised at
p.(None): the direction of another person;
p.(None): (i) that the decision involved the exercise of a discretionary power in accordance with a rule or policy without regard
p.(None): to the merits of the particular case; or
p.(None): (j) that the exercise of the power was done in a way that constituted an abuse of the power.
p.(None): (3) A complaint shall—
p.(None): (a) be in writing;
p.(None): (b) be signed by the complainant;
p.(None): (c) describe the action complained about;
p.(None): (d) specify the nature of, and grounds for, the complaint; and
p.(None): (e) be lodged with the Board.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 23
p.(None):
p.(None):
p.(None): (4) The Board shall investigate a complaint concerning an action or decision of a health research ethics committee if a
p.(None): complaint is lodged with it or on its own initiative.
p.(None): (5) The Board may decide not to investigate a complaint lodged under this section or decide to discontinue an
p.(None): investigation if it—
p.(None): (a) is satisfied that the complainant became aware of the matter constituting a ground for the complaint more
p.(None): than twelve months before making the complaint to the Board; or
p.(None): (b) has reasonable grounds for believing that —
p.(None): (i) the complaint is frivolous or vexatious or is not made in good faith; or
p.(None): (ii) the investigation or any further investigation of the action is not justified in all the circumstances.
p.(None): (6) The Board shall, if it decides not to investigate a complaint or to discontinue an investigation, give the
p.(None): complainant written notice of the decision, which shall include the reasons for the decision.
p.(None): (7) The Minister shall prescribe the manner, form and process for investigating, hearing and deciding on complaints by
p.(None): the Board.
p.(None): 22. A person who is requested by the Board or a health research ethics committee to—
p.(None): (a) provide information, documents or other records; or
p.(None): (b) answer a question;
p.(None): to assist the Board or a health research ethics committee in its investigation on a matter shall not be subject to any
p.(None): liability or penalty under this Act or any other written law.
p.(None): 23. (1) The Board shall make a report to the Council where, upon investigating a complaint concerning an action or
p.(None): decision of a health research ethics committee, it determines that the action was based on one of the grounds set out
p.(None): in section twenty.
p.(None): (2) A copy of the report of the Board shall be submitted to the Minister and the person responsible for, or board of,
p.(None): the relevant research institution, health researcher or health establishment and to the complainant.
p.(None): (3) The Council shall ensure, having regard to the recommendations made in the report of the Board,
p.(None): that the relevant research institution, health researcher or health establishment—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): health research ethics committee and a member of the Board has, or acquires, an interest that could conflict with
p.(None): the proper performance of the member’s functions in relation to the investigation, the member shall disclose the
p.(None): interest to the Board and the member shall only take part in the investigation if the complainant and the Board agree
p.(None): that the member may so take part.
p.(None): (2) If, in relation to an investigation of a complaint by the Board—
p.(None): (a) a member discloses an interest under subsection (1); and
p.(None): (b) the complainant and the Board do not agree to the member taking part in the investigation;
p.(None): the member shall not take part in the investigation of the complaint.
p.(None): 26. (1) The Board shall not, except in the performance or exercise of its functions or powers under this
p.(None): Act, make a record of or disclose to any person any information about another person that the Board has access to in
p.(None): the performance or exercise of its functions or powers under this Act.
p.(None): (2) Except for the purposes of this Act, if the Board has possession of a document or other record or notice of a
p.(None): matter or thing as a result of its functions or powers under this Act, a court shall not require the Board to—
p.(None): (a) produce the document or other record in its possession; or
p.(None): (b) disclose the matter or thing of which it had notice.
p.(None): 27. An action or other proceeding shall not lie or be instituted against a member of the Board or a committee, or in
p.(None): respect of, any act or thing done or omitted to be done in good faith in the
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 25
p.(None):
p.(None):
p.(None):
p.(None): exercise of or performance, or purported exercise or performance of any of the powers, functions or duties conferred
p.(None): under this Act.
p.(None): 28. The Board shall, as soon as practicable after the end of each financial year, give the Authority a written
p.(None): report of the Board’s activities during that year.
p.(None): 29. (1) A person who is aggrieved with the decision of the Board may, within fourteen days of service of the
p.(None): decision, appeal to the Council and thereafter may appeal to a court of competent jurisdiction.
p.(None): (2) A decision of the Board made under this section shall not take effect until the expiration of the time for lodging
p.(None): an appeal, the appeal is withdrawn or disposed of.
p.(None): 30. Where a health researcher has committed an offence for which the health researcher has been punished in another
p.(None): country and what the health researcher did constitutes a misconduct under this Act, that health researcher shall be
p.(None): banned, by the Council on the recommendation of the Board, from conducting health research in Zambia.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Annual report of Board
p.(None):
p.(None): Appeals
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Jurisdiction over offences committed outside Zambia
p.(None):
p.(None): PART IV
p.(None): REGULATORY FRAMEWORK FOR HEALTH RESEARCH
p.(None): 31. (1) The Authority shall identify and prioritise areas for health research and advise the Minister, who shall
...
p.(None): (2) A person who contravenes subparagraph (1) commits an offence and is liable, upon conviction, to a fine not
p.(None): exceeding three hundred thousand penalty units or to imprisonment for a period not exceeding two years, or to both.
p.(None): (3) A person who, having any information which to the knowledge of that person has been published or disclosed in
p.(None): contravention of subparagraph (1), unlawfully publishes or communicates the information to any other person,
p.(None): commits an offence and is liable,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Allowances for
p.(None): members
p.(None):
p.(None): Disclosure of
p.(None): interest
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of publication or disclosure of information to unauthorised persons
p.(None):
p.(None):
p.(None): 44 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Immunity
p.(None): upon conviction, to a fine not exceeding three hundred thousand penalty units or to imprisonment for a period not
p.(None): exceeding two years, or to both.
p.(None): 8. An action or other proceeding shall not lie or be instituted against a member of the Council, the Board or a
p.(None): committee of the Board for, or in respect of, any act or thing done or omitted to be done in good faith in the exercise
p.(None): or performance of, or purported exercise or performance of, any of the powers, functions or duties conferred under this
p.(None): Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Funds of Authority
p.(None): PART II FINANCIAL PROVISIONS
p.(None): 9. (1) The funds of the Authority shall consist of such moneys as may—
p.(None): (a) be appropriated to the Authority by Parliament for the purposes of the Authority;
p.(None): (b) be paid to the Authority by way of fees, charges, grants or donations; and
p.(None): (c) otherwise vest in or accrue to the Authority.
p.(None): (2) The Authority may—
p.(None): (a) accept moneys by way of grants, gifts, bequests or donations from any source in Zambia and subject to the
p.(None): prior approval of the Minister, in writing, from any source outside Zambia;
p.(None): (b) subject to the approval of the Minister, raise by way of loans or otherwise, such moneys as it may require for the
p.(None): discharge of its functions; and
p.(None): (c) in accordance with the regulations made under this Act, charge fees for services provided by the Authority.
p.(None): (3) There shall be paid from the funds of the Authority—
p.(None): (a) salaries, allowances, loans, gratuities and pensions of staff of the Authority, and other payments for the
p.(None): recruitment and retention of staff;
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No.18 of 2010
p.(None):
p.(None):
p.(None): 34 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of reproductive cloning of human beings
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of removal of tissue, organs, blood, blood products or gametes from living persons for research
p.(None): purposes
p.(None): (b) the principles and standards applicable to the conduct of health research on animal subjects; and
p.(None): (c) any other matters necessary for the proper conduct of health research on animal subjects in accordance with
p.(None): the provisions of this Act.
p.(None): 46. (1) A person shall not —
p.(None): (a) manipulate any genetic material, including the genetic material of humans for the purpose of cloning a human being;
p.(None): or
p.(None): (b) engage in any activity, including nuclear transfer or embryo splitting, gametes, zygotes or embryos for the purpose
p.(None): of reproductive cloning of a human being.
p.(None): (2) A person shall not export or import human zygotes or embryos without the prior written approval of the Minister.
p.(None): (3) A person who contravenes a provision of this section or who fails to comply with this section commits an offence
p.(None): and is liable, upon conviction, to a fine not exceeding four hundred thousand penalty units or to imprisonment for a
p.(None): period not exceeding five years, or to both.
p.(None): (4) The Minister may, in consultation with the Authority, if it is consistent with this Act and any other written law,
p.(None): and upon such terms and conditions as the Minister may consider necessary, by notice in the Gazette, exempt any person
p.(None): or category of persons from any or all of the provisions of this section.
p.(None): 47. (1) A person shall not remove any tissue, organ, blood, blood product or gametes from a living person for health
p.(None): research purposes unless it is done with the written consent of the person from whom the tissue, organ, blood, blood
p.(None): product or gametes are removed in accordance with this Act, the regulatory framework or as is otherwise prescribed.
p.(None): (2) A person shall not withdraw blood, blood products, tissue or gametes from a living person for any unspecified
p.(None): future health research activity or unspecified storage.
p.(None): (3) A person shall not remove any tissue or organ which is not replaceable by natural processes from a minor.
p.(None): (4) A person shall not sell or cause another person to sell that person’s tissue, organ, blood, blood product or
p.(None): gametes from a living body for any purposes including health research.
p.(None): (5) A person who contravenes this section commits an offence and is liable, upon conviction, to a fine not exceeding
p.(None): four million penalty units or to imprisonment for a period not exceeding seven years or to both.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 35
p.(None):
p.(None):
p.(None): PART VI
p.(None): BIOLOGICAL MATERIALS FOR HEALTH RESEARCH
p.(None): 48. Notwithstanding any other law, biological material for health research shall only be collected for the purposes
p.(None): for which it is indicated in the research protocol.
p.(None): 49. (1) The Minister shall designate specific research institutions and sites as bio-banks in accordance with
p.(None): section fifty- one, and grant a licence, in the prescribed manner, to research institution, site or health
p.(None): establishment which are able to provide storage services.
p.(None): (2) A bio-bank shall comply with the provisions of the Environmental Management Act, 2011, and the Health
p.(None): Professions Act, 2009.
p.(None): (3) A person, other than the holder of a licence granted in accordance with subsection (1), who keeps
p.(None): biological materials commits an offence and is liable, upon conviction, to a fine not exceeding two million penalty
p.(None): units or to imprisonment for a term not exceeding four years, or to both.
p.(None): 50. (1) A person shall not export or import biological materials without the prior written approval of the Authority
p.(None): as provided under subsection (2).
p.(None): (2) The Authority may, on the recommendation of the Board, permit the export or import of biological materials if all
p.(None): the prescribed elements of a material transfer agreement are met.
p.(None): (3) A person who contravenes this section commits an offence and is liable, upon conviction, to a fine not exceeding
p.(None): two million penalty units or to imprisonment for a period not exceeding four years, or to both.
p.(None): 51. (1) The Minister may, by notice in the Gazette, designate any research institution, site or health establishment
p.(None): as a bio-bank.
p.(None): (2) A research institution, site or health establishment designated as a bio-bank under subsection (1), may
p.(None): (a) receive biological materials for storage purposes;
p.(None): (b) store biological material remnants for a period not exceeding ten years, unless the Authority approves a
p.(None): longer period of time for special reasons; and
p.(None): (c) dispose of biological materials that are due for disposal following prescribed bio-hazard waste guidelines.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Purposes of collection of biological materials
p.(None): Storage of biological materials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. 12
p.(None): of 2011
p.(None): Act No. 24
p.(None): of 2009
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Exportation and importation of biological materials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Designation of
p.(None): institution as bio-bank
p.(None):
p.(None):
p.(None): 36 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None): Searches at ports of entry, exit and sites Cap. 295
p.(None): Act No. 16
p.(None): of 2005
p.(None): Act No. 18
p.(None): of 2010
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Ownership of biological materials and material transfer agreement
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): researcher or person responsible for a research institution, for the purpose of ensuring compliance with this Act.
p.(None): (2) Notwithstanding subsection (1), an inspector may enter a site or premises for purposes of this Act, with
p.(None): warrant, if the inspector has reasonable grounds to believe that a provision of this Act or of any other regulatory
p.(None): framework has been or is about to be contravened or the site or premises are used or are being used for the commission
p.(None): of an offence.
p.(None): (3) If so requested by a health researcher or person responsible for a research institution, an inspector, agent of
p.(None): the Authority or a person authorised by the Authority shall produce evidence of the authorisation or permission, as the
p.(None): case may be, to enter on to the site or premises.
p.(None): (4) A person exercising any power under this section shall do so with reasonable care and in such a manner as to cause
p.(None): as little damage as possible.
p.(None): 58. (1) A health researcher or research institution and any employee or agent of a health researcher or
p.(None): research institution shall, on demand by an inspector—
p.(None): (a) avail to the inspector such information as is within their knowledge in all matters relating to any inspection or
p.(None): investigation done under this Act; and
p.(None): (b) produce for inspection, any research protocol, licence, material transfer agreement or other document or record, as
p.(None): the case may be, relating to the health research being undertaken on the site or any matter that is the cause for the
p.(None): inspection or investigation.
p.(None): (2) A person who contravenes subsection (1) commits an offence and is liable, upon conviction, to the general penalty
p.(None): provided under this Act.
p.(None): 59. (1) Any notice required to be served under this Act shall be served—
p.(None): (a) by delivering it personally to the person required to be served or, if the person is absent or cannot be found
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 39
p.(None):
p.(None):
p.(None): (i) by leaving it at the person’s usual or last known place of abode in Zambia; or
p.(None): (ii) by registered post, addressed to the person’s usual or last known address in Zambia; or
p.(None): (b) in the case of a notice required to be served on a company or other corporate body, by delivering it to its
p.(None): principal officer, leaving it at the office with an employee or sending it through registered post.
p.(None): 60. (1) Any direction, notice, consent, approval, permission, demand, objection, application or other thing
p.(None): authorised or required by this Act to be given, made or issued by, or to, the Minister, the Authority, the Council,
p.(None): Board, Director or health research ethics committee shall be in writing.
p.(None): (2) A direction, notice, consent, approval, demand or other document which the Authority is authorised or
p.(None): required by or under this Act to give, make or issue may be signed on behalf of the Authority by—
p.(None): (a) the Director or Secretary; or
p.(None): (b) an officer of the Authority authorised by the Director, in writing, to sign documents of the particular kind or to
p.(None): sign the particular document.
p.(None): 61. (1) A person who commits an offence under this Act shall, if no other penalty is specified or prescribed
p.(None): in respect of the offence, be liable, upon conviction, to a fine not exceeding three hundred thousand penalty units
p.(None): or to imprisonment for a term not exceeding three years, or to both.
p.(None): (2) In addition to the penalties, specified under subsection (1), any contravention of this Act or any regulations made
p.(None): under this Act shall be a ground for terminating a research protocol, licence or any permission or approval given under
p.(None): this Act.
p.(None): (3) Where a person is convicted of an offence under this Act any research material or substance relating to the
p.(None): research shall be forfeited to the State.
p.(None): 62. Where an offence under this Act is committed by a body corporate or an unincorporate body, every director or
p.(None): manager of the corporate or unincorporate body is liable, upon conviction, as if the director or manager had
p.(None): personally committed the offence, unless the director or manager proves to the satisfaction of the court that the act
p.(None): constituting the offence was done without the
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Authentication of documents
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): General penalties for offences
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Offences by body corporate or an unincorporate body
p.(None):
p.(None):
p.(None): 40 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Regulations
p.(None):
p.(None):
p.(None):
p.(None): Transitional provisions
p.(None): knowledge, consent or connivance of the director or manager or that the director or manager took reasonable steps to
p.(None): prevent the commission of the offence.
p.(None): 63. The Minister may, in consultation with the Authority, by statutory instrument, make regulations for the better
p.(None): carrying out of the provisions of this Act.
p.(None): 64. (1) The National Health Research Advisory Committee established by the Ministry responsible for health shall
p.(None): cease to exist three months after the constitution of the Authority.
p.(None): (2) Any health research related rights, liabilities, legal proceedings or obligations of the National Health Research
...
p.(None): 6. (1) If a member or any person is present at a meeting of the Council or any committee of the Council at which any
p.(None): matter is the subject of consideration and in which matter the member or that person or the member’s or that
p.(None): person’s relative is directly or indirectly interested, in a private capacity, is the subject of
p.(None): consideration, the member or person shall, as soon as is practicable, after the commencement of the meeting, declare
p.(None): such interest and shall not, unless the Council or the committee otherwise directs, take part in any consideration or
p.(None): discussion of, or vote on, any question touching that matter.
p.(None): (2) A declaration of interest made under this paragraph shall be recorded in the minutes of the meeting at which it is
p.(None): made.
p.(None): (3) In this paragraph, “ relative ” in relation to a person means—
p.(None): (a) a parent, son, daughter, brother, sister, niece, uncle, aunt, grandparent or cousin of that person or that person’s
p.(None): spouse; and
p.(None): (b) a spouse of that person.
p.(None): 7. (1) A person shall not, without the consent, in writing, given by, or on behalf of, the Authority, publish
p.(None): or disclose to any unauthorised person, otherwise than in the course of duties of that person, the contents of any
p.(None): document, communication or information whatsoever, which relates to or which has come to the knowledge of that person
p.(None): in the course of that person’s duties under this Act.
p.(None): (2) A person who contravenes subparagraph (1) commits an offence and is liable, upon conviction, to a fine not
p.(None): exceeding three hundred thousand penalty units or to imprisonment for a period not exceeding two years, or to both.
p.(None): (3) A person who, having any information which to the knowledge of that person has been published or disclosed in
p.(None): contravention of subparagraph (1), unlawfully publishes or communicates the information to any other person,
p.(None): commits an offence and is liable,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Allowances for
p.(None): members
p.(None):
p.(None): Disclosure of
p.(None): interest
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of publication or disclosure of information to unauthorised persons
p.(None):
p.(None):
p.(None): 44 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Immunity
p.(None): upon conviction, to a fine not exceeding three hundred thousand penalty units or to imprisonment for a period not
p.(None): exceeding two years, or to both.
p.(None): 8. An action or other proceeding shall not lie or be instituted against a member of the Council, the Board or a
p.(None): committee of the Board for, or in respect of, any act or thing done or omitted to be done in good faith in the exercise
p.(None): or performance of, or purported exercise or performance of, any of the powers, functions or duties conferred under this
p.(None): Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Funds of Authority
p.(None): PART II FINANCIAL PROVISIONS
p.(None): 9. (1) The funds of the Authority shall consist of such moneys as may—
p.(None): (a) be appropriated to the Authority by Parliament for the purposes of the Authority;
p.(None): (b) be paid to the Authority by way of fees, charges, grants or donations; and
p.(None): (c) otherwise vest in or accrue to the Authority.
p.(None): (2) The Authority may—
p.(None): (a) accept moneys by way of grants, gifts, bequests or donations from any source in Zambia and subject to the
p.(None): prior approval of the Minister, in writing, from any source outside Zambia;
p.(None): (b) subject to the approval of the Minister, raise by way of loans or otherwise, such moneys as it may require for the
p.(None): discharge of its functions; and
...
Searching for indicator religious:
(return to top)
p.(None): made in accordance with this Act;
p.(None): “ reproductive cloning ” means the genetic duplication of an existing organism especially by transferring the nucleus
p.(None): of a somatic cell of the organism into an enucleated oocyte;
p.(None): “ research institution ” means an organisation, whether public or private, including a university, which undertakes
p.(None): health research;
p.(None): “ research protocol ” means a research proposal for health research approved by the Board in accordance with section
p.(None): seventeen;
p.(None): “ Secretary ” means the Secretary to the Council appointed under section twelve;
p.(None): “ site ” means a place approved by the Board for the conduct of health research;
p.(None): “ social norm ” means a pattern of behaviour in a particular group or community or culture accepted as normal in that
p.(None): group or community;
p.(None): “ therapeutic cloning ” means a procedure for producing tissues or organs from genetically identical cells that
p.(None): originate from undifferentiated stem cells for purposes of repairing or replacing damaged tissues;
p.(None): “ traditional, complementary and alternative medicines ” means the total combination of knowledge and practices,
p.(None): whether explicable or not, used in diagnosing, preventing or eliminating physical, mental or social diseases and which
p.(None): may rely exclusively on past experience and observation handed down from generation to generation, verbally or in
p.(None): writing;
p.(None): “ traditional health practitioner ” means a person recognised by a community in which that person lives as competent to
p.(None): provide health care, using vegetable, animal or mineral substances and other methods based on social, cultural and
p.(None): religious background and knowledge, attitudes and beliefs that are prevalent in the community regarding the physical,
p.(None): mental and social well being of a person, including the causes of disease and disability;
p.(None):
p.(None):
p.(None): 12 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Application and scope
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Establishment of
p.(None): National Health Research Authority
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Functions of Authority
p.(None): “ Trust Account ” means the Health Research Trust Account established under section forty-one;
p.(None): “ vertebrate animal ” means a bird, fish, reptile, amphibian or mammal, other than a human being, which is a member of
p.(None): the phylum vertebrates, or a bee, butterfly and any other insect used in the production of animal products, and
p.(None): includes the carcass of an animal; and
p.(None): “ Vice-Chairperson ” means the person elected Vice- Chairperson of the Council under section seven.
p.(None): 3. (1) Notwithstanding any other law, this Act applies to all health research conducted in Zambia, biological
p.(None): material and the use of personal health data.
p.(None): (2) Notwithstanding subsection (1), this Act applies to health research undertaken outside Zambia under the direction
p.(None): of a person or body established in Zambia.
p.(None): PART II
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.(None):
p.(None): ethics committee may lodge a complaint with the Board and request an investigation concerning the action or decision of
p.(None): the health research ethics committee, on one or more of the grounds set out in subsection (2).
p.(None): (2) A health researcher or research institution, referred to in subsection (1), may lodge a complaint on any of
p.(None): the following grounds:
p.(None): (a) that the action or decision breached the rules of natural justice;
p.(None): (b) that the action or decision was induced or affected by fraud;
p.(None): (c) that there was no evidence or other material to justify the action or decision;
p.(None): (d) that an irrelevant consideration was taken into account in relation to the action;
p.(None): (e) that a relevant consideration was not taken into account in relation to the action or decision;
p.(None): (f) that in the course of the decision making process, a discretionary power was exercised for a purpose
p.(None): other than the purpose for which the power was conferred;
p.(None): (g) that the action or decision involved the exercise of a discretionary power in bad faith;
p.(None): (h) that, in the course of the decision making process, a personal discretionary power was exercised at
p.(None): the direction of another person;
p.(None): (i) that the decision involved the exercise of a discretionary power in accordance with a rule or policy without regard
p.(None): to the merits of the particular case; or
p.(None): (j) that the exercise of the power was done in a way that constituted an abuse of the power.
p.(None): (3) A complaint shall—
p.(None): (a) be in writing;
p.(None): (b) be signed by the complainant;
p.(None): (c) describe the action complained about;
p.(None): (d) specify the nature of, and grounds for, the complaint; and
p.(None): (e) be lodged with the Board.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 23
p.(None):
p.(None):
p.(None): (4) The Board shall investigate a complaint concerning an action or decision of a health research ethics committee if a
p.(None): complaint is lodged with it or on its own initiative.
p.(None): (5) The Board may decide not to investigate a complaint lodged under this section or decide to discontinue an
p.(None): investigation if it—
p.(None): (a) is satisfied that the complainant became aware of the matter constituting a ground for the complaint more
p.(None): than twelve months before making the complaint to the Board; or
p.(None): (b) has reasonable grounds for believing that —
p.(None): (i) the complaint is frivolous or vexatious or is not made in good faith; or
p.(None): (ii) the investigation or any further investigation of the action is not justified in all the circumstances.
p.(None): (6) The Board shall, if it decides not to investigate a complaint or to discontinue an investigation, give the
p.(None): complainant written notice of the decision, which shall include the reasons for the decision.
p.(None): (7) The Minister shall prescribe the manner, form and process for investigating, hearing and deciding on complaints by
p.(None): the Board.
p.(None): 22. A person who is requested by the Board or a health research ethics committee to—
p.(None): (a) provide information, documents or other records; or
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): (a) the objectives of the health research or experimentation may also be achieved if it is conducted on an adult;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the minor’s condition, disease or disorder to such an extent that shall result in significant benefit to the minor;
p.(None): (c) the reasons for the consent to the health research or experimentation by the parent or guardian of the
p.(None): minor and, if applicable, the minor, are contrary to social norms and public policy;
p.(None): (d) the health research or experimentation poses a significant risk to the health of the minor; or
p.(None): (e) there is some risk to the health or well being of the minor and the potential benefit of the health research
p.(None): or experimentation does not significantly outweigh that risk.
p.(None): (7) Health research involving special groups such as prisoners, pregnant women, persons with mental disabilities, or
p.(None): workers in a hierarchical system shall be conducted—
p.(None): (a) in such manner and on such terms and conditions as may be prescribed;
p.(None): (b) with the consent of the Authority, on recommendations from a committee of relevant experts established by the
p.(None): Minister; and
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 33
p.(None):
p.(None):
p.(None): (c) if the person is capable of understanding, with the written consent of the person, after the person has been
p.(None): informed of the objectives of the health research or experimentation and any possible potential
p.(None): risks and benefits on the person’s health.
p.(None): (8) The Authority shall not consent to health research under paragraph (b) of subsection (7) in circumstances
p.(None): where—
p.(None): (a) the objectives of the health research or experimentation may also be achieved if conducted on the general
p.(None): population;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the special group’s condition, disease or disorder to such an extent as shall result in significant benefit to
p.(None): their health or well being;
p.(None): (c) the reasons for the consent to the health research or experimentation are contrary to social norms and public
p.(None): policy;
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): organised system;
p.(None): “ biological materials ” means organs and parts of organs, cells and tissue, sub cellular structures and cell products,
p.(None): blood, saliva, sputum, gametes (sperm and ova), embryos and foetal tissue, waste, including urine, feaces,
p.(None): sweat, hair, epithelial scales, nail clippings, placenta and cell lines from human or animal tissue;
p.(None): “ blood product ” means any product derived or produced from blood, including circulating progenitor cells, bone
p.(None): marrow progenitor cells and umbilical cord progenitor cells;
p.(None): “ Board Chairperson ” means the person appointed as Chairperson of the Board in accordance with section
p.(None): thirteen;
p.(None): “ Cabinet ” has the meaning assigned to it in the Constitution;
p.(None): “ central health research repository ” means the central health research repository as prescribed by the Minister under
p.(None): section thirty-three;
p.(None): “ Chairperson ” means the person appointed Chairperson of the Council under section seven;
p.(None): “ clinical trial regulations ” means regulations made under section fifty-four;
p.(None): “clinical trial ” means a systematic study, involving human participants or animal subjects, that serves to
p.(None): answer specific questions about the safety or efficacy of a medicine, vaccine or method of prevention or treatment;
p.(None): “ committee ” means a committee of the Council established under section nine;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 9
p.(None):
p.(None): “ consent ” means a voluntary agreement to participate in health research by a person, who is not a minor, with full
p.(None): understanding of the potential risks and benefits of the health research;
p.(None): “ Council ” means the Council of the Authority constituted under subsection seven;
p.(None): “ Director ” means the person appointed Director of the Authority under section eleven;
p.(None): “ embryo ” means a human offspring in the first eight weeks from conception or animal offspring in the first trimester,
p.(None): the gestation or incubation period for the relevant species as the case may be;
p.(None): “ ethical approval ” means approved by the Board for the conduct, in Zambia, of research on human participants or
p.(None): animal subjects in accordance with sections fourteen and forty-five;
p.(None): “ genetic material ” means a part of a cell that carries information which can be inherited;
p.(None): “ health establishment ” means a public or private establishment, including its facilities, buildings or other
p.(None): places, operated or designed to provide inpatient or outpatient treatment, diagnostic or therapeutic
p.(None): interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health services;
p.(None): “ health research ” means an activity conducted which—
p.(None): (a) contributes to knowledge of the biological, clinical, psychological or social processes in human beings or animals;
p.(None): (b) uses scientific methods to generate information to deal with health and disease;
p.(None): (c) improves scientific methods for provision of health services and human pathology;
p.(None): (d) investigates causes of disease and the effects of the environment on the human body; or
...
p.(None): deceased person or part of a body of a deceased person as provided in the Human Tissue Act;
p.(None): “ human research guidelines ” means guidelines for the conduct of health research involving human participants
p.(None): issued under section thirty-six;
p.(None): “ inspector ” means a person appointed by the Authority as an inspector for the purposes of this Act;
p.(None): “ national health research strategic plan ” means a national plan that prioritises health research as provided
p.(None): under section thirty-one;
p.(None): “ intellectual property rights ” means an exclusive right granted to inventors and owners of works that are the result
p.(None): of human intellectual creativity;
p.(None): “ interim regulatory requirements ” means a regulatory framework issued under section thirty-eight;
p.(None): “ legal guardian ” means a person lawfully vested with the power, and charged with the obligation, of taking care of
p.(None): and managing the property and rights of a person who, because of age, understanding or self control, is incapable of
p.(None): administering that person’s own affairs;
p.(None): “ material transfer agreement ” means a written contract between the provider and recipient of research material as
p.(None): prescribed under section fifty-three;
p.(None): “ medicine ” has the meaning assigned to it in the Medicines and Allied Substances Act, 2013;
p.(None): “ member ” means a member of the Council;
p.(None): “ minor ” means a person below the age of eighteen years; “ private health establishment ” means a health establishment
p.(None): that is not owned or controlled by the Government;
p.(None): “ public health establishment ” means a health establishment that is owned or controlled by the Government;
p.(None): “ public policy ” means the objectives relating to the health, morals and well being of the citizens approved by
p.(None): Cabinet as part of the national health programme;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 11
p.(None):
p.(None): “ regulatory framework ” means any statute dealing with, or impacting on, health research, or regulations,
p.(None): rules, regulatory requirements, guidelines or practice directives relating to, or impacting on, health research,
p.(None): made in accordance with this Act;
p.(None): “ reproductive cloning ” means the genetic duplication of an existing organism especially by transferring the nucleus
p.(None): of a somatic cell of the organism into an enucleated oocyte;
p.(None): “ research institution ” means an organisation, whether public or private, including a university, which undertakes
p.(None): health research;
p.(None): “ research protocol ” means a research proposal for health research approved by the Board in accordance with section
p.(None): seventeen;
p.(None): “ Secretary ” means the Secretary to the Council appointed under section twelve;
p.(None): “ site ” means a place approved by the Board for the conduct of health research;
p.(None): “ social norm ” means a pattern of behaviour in a particular group or community or culture accepted as normal in that
p.(None): group or community;
p.(None): “ therapeutic cloning ” means a procedure for producing tissues or organs from genetically identical cells that
...
p.(None): 34. The Authority shall —
p.(None): (a) develop monitoring and evaluation mechanisms for all health research programmes and activities;
p.(None): (b) promote training of health workers in health research methodologies and ethics, documentation, monitoring
p.(None): and evaluation; and
p.(None): (c) monitor and evaluate ongoing health research programmes and activities being undertaken in Zambia.
p.(None): 35. The Minister may, in consultation with the Authority —
p.(None): (a) establish mechanisms for involving communities in health research;
p.(None): (b) facilitate the establishment of a consultative forum for wide dissemination of national health research priority
p.(None): areas and outputs; and
p.(None): (c) make regulations for the protection of interests of stakeholders and the sharing of risks, benefits
p.(None): and outputs in health research programmes and activities.
p.(None): 36. (1) Without limiting any of the matters on which the Council may issue guidelines under this Act, the Council
p.(None): shall issue guidelines on the conduct of human research.
p.(None): (2) The Council shall issue guidelines on the conduct of human research in collaboration with the Board.
p.(None): 37. (1) The Minister, in consultation with the Authority, shall, before issuing any proposed regulatory framework,
p.(None): consult with relevant stakeholders in accordance with this section, except that this section shall not apply—
p.(None): (a) to a statutory instrument; or
p.(None): (b) if the proposed regulatory framework is urgent or is of minor significance, as the Minister may determine.
p.(None): (2) If the Minister, in consultation with the Authority, intends to issue any regulatory framework, the Minister shall
p.(None): publish a notice, in the Gazette or in a daily newspaper of general circulation in Zambia—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Monitoring and evaluation
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Partnerships in health research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Human research guidelines
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Consultation about regulatory framework
p.(None):
p.(None):
p.(None): 28 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Interim regulatory requirements
p.(None): (a) stating the intention to issue the regulatory framework; and
p.(None): (b) inviting persons or bodies to make submissions relating to the proposed regulatory framework in accordance with the
p.(None): procedures, and within the period, specified in the notice.
p.(None): (3) As soon as practicable after the end of the period specified under paragraph (b) of subsection (2), the Minister,
p.(None): in consultation with the Authority, shall, having regard to any submissions received pursuant to the invitation
p.(None): referred to in that paragraph—
p.(None): (a) prepare a draft of the regulatory framework and publish a notice, in the Gazette and in a daily newspaper of
p.(None): general circulation in Zambia—
p.(None): (i) containing a summary of the provisions of the draft regulatory framework;
p.(None): (ii) stating where copies of the draft regulatory framework may be obtained; and
p.(None): (iii) inviting persons or bodies to make submissions relating to the draft regulatory framework in accordance with the
p.(None): procedures, and within the period, specified in the notice; or
p.(None): (b) publish a notice, in the Gazette and in a daily newspaper of general circulation in Zambia, stating that it no
p.(None): longer proposes to issue the regulatory framework.
p.(None): (4) The Minister, in consultation with the Authority, shall take into account any submissions received pursuant to the
p.(None): invitation referred to in subparagraph (iii) of paragraph (a) of subsection (3) before issuing the proposed regulatory
p.(None): framework.
p.(None): 38. (1) The Minister, in consultation with the Authority, may make interim regulatory requirements and issue the
p.(None): requirements without following the procedure provided in section thirty-seven if a matter —
p.(None): (a) would ordinarily be the subject of a regulatory framework;
p.(None): (b) needs, for any reason or circumstance, to be dealt with urgently; and
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 29
p.(None): (c) raises issues that are of minor significance;
p.(None): and shall publish a notice, in the Gazette or a daily newspaper of general circulation in Zambia, stating the reasons
p.(None): for not following the procedures provided under section thirty-seven.
p.(None): (2) Notwithstanding subsection (1), the Minister, in consultation with theAuthority, shall, within thirty days of the
p.(None): issue of an interim regulatory requirement, publish a notice in the manner and form prescribed—
p.(None): (a) setting out the reasons for issuing the interim regulatory requirement and a summary of the interim
p.(None): regulatory requirement; and
p.(None): (b) inviting persons or bodies to make submissions to the Minister on the interim regulatory requirement, within the
p.(None): period specified in the notice.
p.(None): (3) If the Minister fails, within forty-five days after the end of the period specified in subsection (2), to
p.(None): comply with the procedures provided for in subsection (2), any interim regulatory requirement shall be revoked on the
p.(None): forty-fifth day.
p.(None):
p.(None): 39. The Minister, in consultation with the Authority, may, without undertaking consultation, revoke any regulatory
p.(None): framework or interim regulatory requirements.
p.(None): 40. The Authority shall develop and publish procedures to assist persons or bodies to make submissions under this
p.(None): Part.
p.(None): 41. (1) There shall be established a Health Research Trust Account.
p.(None): (2) The Trust Account shall be opened as a special account, in a
p.(None): commercialbank,forthepurposesofthePublicFinanceAct,2004.
p.(None): (3) If interest is received by the Authority from the investment of an amount standing to the credit of the
...
p.(None):
p.(None):
p.(None): experimentation and any possible potential risks or benefits on that person’s health;
p.(None): (c) in the case of a deceased person, with written consent as provided in the Human Tissue Act;
p.(None): (d) if it does not threaten national security;
p.(None): (e) if it does not violate social and cultural norms; and
p.(None): (f) in Zambia, with ethical approval by the Board or accredited health research ethics committee in accordance
p.(None): with this Act.
p.(None): (2) Research involving human participants shall embrace all the following basic pillars of health research ethics:
p.(None): (a) respect of persons (autonomy);
p.(None): (b) benefit to the research participants (beneficence); and
p.(None): (c) equal distribution of risks and benefits (justice).
p.(None): (3) The following elements shall be adhered to in conducting health research on human participants:
p.(None): (a) social or scientific value;
p.(None): (b) scientific validity;
p.(None): (c) fair selection of participants;
p.(None): (d) favourable risk benefit ratio;
p.(None): (e) informed consent;
p.(None): (f) respect of participants;
p.(None): (g) confidentiality;
p.(None): (h) protection of interests of stakeholders;
p.(None): (i) good clinical and laboratory practice; and
p.(None): (j) independent review.
p.(None): (4) Health research on a minor for therapeutic purposes shall be conducted—
p.(None): (a) if it is in the best interest of the minor;
p.(None): (b) in such manner and on such conditions as may be prescribed in a regulatory framework;
p.(None): (c) with the consent of the parent or legal guardian of the minor; and
p.(None): (d) if the minor is capable of understanding the nature and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 306
p.(None):
p.(None):
p.(None): 32 No. 2 of 2013] National Health Research
p.(None):
p.(None): the potential risks and benefits of the health research, with the consent of the minor.
p.(None): (5) Health research on a minor for non therapeutic purposes shall be conducted —
p.(None): (a) in such manner and on such conditions as may be prescribed;
p.(None): (b) with the consent of the Authority;
p.(None): (c) with the consent of the parent or legal guardian of the minor; and
p.(None): (d) if the minor is capable of understanding the nature and potential risks and benefits of the health research, the
p.(None): consent of the minor.
p.(None): (6) The Authority shall not consent to a health research under paragraph (b) of subsection (5), in circumstances where—
p.(None): (a) the objectives of the health research or experimentation may also be achieved if it is conducted on an adult;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the minor’s condition, disease or disorder to such an extent that shall result in significant benefit to the minor;
p.(None): (c) the reasons for the consent to the health research or experimentation by the parent or guardian of the
p.(None): minor and, if applicable, the minor, are contrary to social norms and public policy;
p.(None): (d) the health research or experimentation poses a significant risk to the health of the minor; or
p.(None): (e) there is some risk to the health or well being of the minor and the potential benefit of the health research
p.(None): or experimentation does not significantly outweigh that risk.
p.(None): (7) Health research involving special groups such as prisoners, pregnant women, persons with mental disabilities, or
p.(None): workers in a hierarchical system shall be conducted—
p.(None): (a) in such manner and on such terms and conditions as may be prescribed;
p.(None): (b) with the consent of the Authority, on recommendations from a committee of relevant experts established by the
p.(None): Minister; and
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 33
p.(None):
p.(None):
p.(None): (c) if the person is capable of understanding, with the written consent of the person, after the person has been
p.(None): informed of the objectives of the health research or experimentation and any possible potential
p.(None): risks and benefits on the person’s health.
p.(None): (8) The Authority shall not consent to health research under paragraph (b) of subsection (7) in circumstances
p.(None): where—
p.(None): (a) the objectives of the health research or experimentation may also be achieved if conducted on the general
p.(None): population;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
...
p.(None): or
p.(None): (b) engage in any activity, including nuclear transfer or embryo splitting, gametes, zygotes or embryos for the purpose
p.(None): of reproductive cloning of a human being.
p.(None): (2) A person shall not export or import human zygotes or embryos without the prior written approval of the Minister.
p.(None): (3) A person who contravenes a provision of this section or who fails to comply with this section commits an offence
p.(None): and is liable, upon conviction, to a fine not exceeding four hundred thousand penalty units or to imprisonment for a
p.(None): period not exceeding five years, or to both.
p.(None): (4) The Minister may, in consultation with the Authority, if it is consistent with this Act and any other written law,
p.(None): and upon such terms and conditions as the Minister may consider necessary, by notice in the Gazette, exempt any person
p.(None): or category of persons from any or all of the provisions of this section.
p.(None): 47. (1) A person shall not remove any tissue, organ, blood, blood product or gametes from a living person for health
p.(None): research purposes unless it is done with the written consent of the person from whom the tissue, organ, blood, blood
p.(None): product or gametes are removed in accordance with this Act, the regulatory framework or as is otherwise prescribed.
p.(None): (2) A person shall not withdraw blood, blood products, tissue or gametes from a living person for any unspecified
p.(None): future health research activity or unspecified storage.
p.(None): (3) A person shall not remove any tissue or organ which is not replaceable by natural processes from a minor.
p.(None): (4) A person shall not sell or cause another person to sell that person’s tissue, organ, blood, blood product or
p.(None): gametes from a living body for any purposes including health research.
p.(None): (5) A person who contravenes this section commits an offence and is liable, upon conviction, to a fine not exceeding
p.(None): four million penalty units or to imprisonment for a period not exceeding seven years or to both.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 35
p.(None):
p.(None):
p.(None): PART VI
p.(None): BIOLOGICAL MATERIALS FOR HEALTH RESEARCH
p.(None): 48. Notwithstanding any other law, biological material for health research shall only be collected for the purposes
p.(None): for which it is indicated in the research protocol.
p.(None): 49. (1) The Minister shall designate specific research institutions and sites as bio-banks in accordance with
p.(None): section fifty- one, and grant a licence, in the prescribed manner, to research institution, site or health
p.(None): establishment which are able to provide storage services.
p.(None): (2) A bio-bank shall comply with the provisions of the Environmental Management Act, 2011, and the Health
p.(None): Professions Act, 2009.
p.(None): (3) A person, other than the holder of a licence granted in accordance with subsection (1), who keeps
p.(None): biological materials commits an offence and is liable, upon conviction, to a fine not exceeding two million penalty
p.(None): units or to imprisonment for a term not exceeding four years, or to both.
p.(None): 50. (1) A person shall not export or import biological materials without the prior written approval of the Authority
...
Social / education
Searching for indicator education:
(return to top)
p.(None): (c) stop an ongoing health research activity;
p.(None): (d) inspect any institution or site approved by the Board for the conduct of health research, including databases and
p.(None): bio banks;
p.(None): (e) confiscate, impound and destroy, where necessary, biological materials obtained by any person in
p.(None): contravention of any provision of this Act;
p.(None): (f) require any health researcher or research institution to submit such information and records as may
p.(None): be necessary to enable the Authority to monitor the performance or activities of the health researcher or
p.(None): research institution;
p.(None): (g) consider any matter relating to health research and make representations on those matters to the Minister; and
p.(None): (h) require any health researcher who, or research institution which, is in control of a health research activity to
p.(None): inform the Authority of the intention to move from a site prior to re-locating.
p.(None): 7. (1) The Authority shall be governed by a Council.
p.(None): (2) The Council shall consist of the following part-time members who shall be appointed by the Minister:
p.(None): (a) one representative each recommended by the Ministries responsible for—
p.(None): (i) science, technology and vocational training;
p.(None): (ii) finance;
p.(None): (iii) justice;
p.(None): (iv) defence;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 15
p.(None):
p.(None):
p.(None): (v) health;
p.(None): (vi) community development;
p.(None): (vii) education; and
p.(None): (viii) livestock and fisheries development;
p.(None): (b) one representative each recommended by—
p.(None): (i) a research and development institution;
p.(None): (ii) a higher education institution; and
p.(None): (iii) a civil society organisation concerned with matters of health;
p.(None): (c) a traditional health practitioner;
p.(None): (d) a renowned health researcher; and
p.(None): (e) two other persons.
p.(None): (3) A person shall not be appointed as a member of the Council if the person —
p.(None): (a) is an undischarged bankrupt;
p.(None): (b) has been convicted of an offence related to health research under this Act or any other written law;
p.(None): (c) has been convicted of an offence involving fraud or dishonesty;
p.(None): (d) is an employee of the Authority;
p.(None): (e) has a mental disability that makes the person incapable of performing the functions of a member; or
p.(None): (f) is not resident in Zambia.
p.(None): (4) The Minister shall, when appointing the members of the Council, ensure equitable gender representation and
p.(None): that at least a third of the members have health research experience.
p.(None): (5) The Minister shall appoint the Chairperson of the Council from among the members of the Council.
p.(None): (6) The Vice-Chairperson of the Council shall be elected by the members from amongst themselves.
p.(None): 8. (1) Except as otherwise provided under this Act, the Council shall exercise the following functions and powers of
p.(None): the Authority:
p.(None): (a) set, review and enforce ethical standards and human and animal research ethical guidelines, including ethical
p.(None): standards and guidelines for clinical trials;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): “ blood product ” means any product derived or produced from blood, including circulating progenitor cells, bone
p.(None): marrow progenitor cells and umbilical cord progenitor cells;
p.(None): “ Board Chairperson ” means the person appointed as Chairperson of the Board in accordance with section
p.(None): thirteen;
p.(None): “ Cabinet ” has the meaning assigned to it in the Constitution;
p.(None): “ central health research repository ” means the central health research repository as prescribed by the Minister under
p.(None): section thirty-three;
p.(None): “ Chairperson ” means the person appointed Chairperson of the Council under section seven;
p.(None): “ clinical trial regulations ” means regulations made under section fifty-four;
p.(None): “clinical trial ” means a systematic study, involving human participants or animal subjects, that serves to
p.(None): answer specific questions about the safety or efficacy of a medicine, vaccine or method of prevention or treatment;
p.(None): “ committee ” means a committee of the Council established under section nine;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 9
p.(None):
p.(None): “ consent ” means a voluntary agreement to participate in health research by a person, who is not a minor, with full
p.(None): understanding of the potential risks and benefits of the health research;
p.(None): “ Council ” means the Council of the Authority constituted under subsection seven;
p.(None): “ Director ” means the person appointed Director of the Authority under section eleven;
p.(None): “ embryo ” means a human offspring in the first eight weeks from conception or animal offspring in the first trimester,
p.(None): the gestation or incubation period for the relevant species as the case may be;
p.(None): “ ethical approval ” means approved by the Board for the conduct, in Zambia, of research on human participants or
p.(None): animal subjects in accordance with sections fourteen and forty-five;
p.(None): “ genetic material ” means a part of a cell that carries information which can be inherited;
p.(None): “ health establishment ” means a public or private establishment, including its facilities, buildings or other
p.(None): places, operated or designed to provide inpatient or outpatient treatment, diagnostic or therapeutic
p.(None): interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health services;
p.(None): “ health research ” means an activity conducted which—
p.(None): (a) contributes to knowledge of the biological, clinical, psychological or social processes in human beings or animals;
p.(None): (b) uses scientific methods to generate information to deal with health and disease;
p.(None): (c) improves scientific methods for provision of health services and human pathology;
p.(None): (d) investigates causes of disease and the effects of the environment on the human body; or
p.(None): (e) develops new applications of pharmaceuticals, medicines and health technology;
p.(None): “ health research ethics committee ” means a committee registered and accredited by the Board under section eighteen;
p.(None):
p.(None):
p.(None): 10 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 306
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): provide for—
p.(None): (a) the methods, circumstances, conditions and procedures under which health research may be conducted on animal
p.(None): subjects;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No.18 of 2010
p.(None):
p.(None):
p.(None): 34 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of reproductive cloning of human beings
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of removal of tissue, organs, blood, blood products or gametes from living persons for research
p.(None): purposes
p.(None): (b) the principles and standards applicable to the conduct of health research on animal subjects; and
p.(None): (c) any other matters necessary for the proper conduct of health research on animal subjects in accordance with
p.(None): the provisions of this Act.
p.(None): 46. (1) A person shall not —
p.(None): (a) manipulate any genetic material, including the genetic material of humans for the purpose of cloning a human being;
p.(None): or
p.(None): (b) engage in any activity, including nuclear transfer or embryo splitting, gametes, zygotes or embryos for the purpose
p.(None): of reproductive cloning of a human being.
p.(None): (2) A person shall not export or import human zygotes or embryos without the prior written approval of the Minister.
p.(None): (3) A person who contravenes a provision of this section or who fails to comply with this section commits an offence
p.(None): and is liable, upon conviction, to a fine not exceeding four hundred thousand penalty units or to imprisonment for a
p.(None): period not exceeding five years, or to both.
p.(None): (4) The Minister may, in consultation with the Authority, if it is consistent with this Act and any other written law,
p.(None): and upon such terms and conditions as the Minister may consider necessary, by notice in the Gazette, exempt any person
p.(None): or category of persons from any or all of the provisions of this section.
p.(None): 47. (1) A person shall not remove any tissue, organ, blood, blood product or gametes from a living person for health
p.(None): research purposes unless it is done with the written consent of the person from whom the tissue, organ, blood, blood
p.(None): product or gametes are removed in accordance with this Act, the regulatory framework or as is otherwise prescribed.
p.(None): (2) A person shall not withdraw blood, blood products, tissue or gametes from a living person for any unspecified
p.(None): future health research activity or unspecified storage.
p.(None): (3) A person shall not remove any tissue or organ which is not replaceable by natural processes from a minor.
p.(None): (4) A person shall not sell or cause another person to sell that person’s tissue, organ, blood, blood product or
...
Social / gender
Searching for indicator gender:
(return to top)
p.(None): (a) one representative each recommended by the Ministries responsible for—
p.(None): (i) science, technology and vocational training;
p.(None): (ii) finance;
p.(None): (iii) justice;
p.(None): (iv) defence;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 15
p.(None):
p.(None):
p.(None): (v) health;
p.(None): (vi) community development;
p.(None): (vii) education; and
p.(None): (viii) livestock and fisheries development;
p.(None): (b) one representative each recommended by—
p.(None): (i) a research and development institution;
p.(None): (ii) a higher education institution; and
p.(None): (iii) a civil society organisation concerned with matters of health;
p.(None): (c) a traditional health practitioner;
p.(None): (d) a renowned health researcher; and
p.(None): (e) two other persons.
p.(None): (3) A person shall not be appointed as a member of the Council if the person —
p.(None): (a) is an undischarged bankrupt;
p.(None): (b) has been convicted of an offence related to health research under this Act or any other written law;
p.(None): (c) has been convicted of an offence involving fraud or dishonesty;
p.(None): (d) is an employee of the Authority;
p.(None): (e) has a mental disability that makes the person incapable of performing the functions of a member; or
p.(None): (f) is not resident in Zambia.
p.(None): (4) The Minister shall, when appointing the members of the Council, ensure equitable gender representation and
p.(None): that at least a third of the members have health research experience.
p.(None): (5) The Minister shall appoint the Chairperson of the Council from among the members of the Council.
p.(None): (6) The Vice-Chairperson of the Council shall be elected by the members from amongst themselves.
p.(None): 8. (1) Except as otherwise provided under this Act, the Council shall exercise the following functions and powers of
p.(None): the Authority:
p.(None): (a) set, review and enforce ethical standards and human and animal research ethical guidelines, including ethical
p.(None): standards and guidelines for clinical trials;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Exercise of functions and powers of
p.(None): Authority
p.(None):
p.(None):
p.(None): 16 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Committees of
p.(None): Council
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): (f) in Zambia, with ethical approval by the Board or accredited health research ethics committee in accordance
p.(None): with this Act.
p.(None): (2) Research involving human participants shall embrace all the following basic pillars of health research ethics:
p.(None): (a) respect of persons (autonomy);
p.(None): (b) benefit to the research participants (beneficence); and
p.(None): (c) equal distribution of risks and benefits (justice).
p.(None): (3) The following elements shall be adhered to in conducting health research on human participants:
p.(None): (a) social or scientific value;
p.(None): (b) scientific validity;
p.(None): (c) fair selection of participants;
p.(None): (d) favourable risk benefit ratio;
p.(None): (e) informed consent;
p.(None): (f) respect of participants;
p.(None): (g) confidentiality;
p.(None): (h) protection of interests of stakeholders;
p.(None): (i) good clinical and laboratory practice; and
p.(None): (j) independent review.
p.(None): (4) Health research on a minor for therapeutic purposes shall be conducted—
p.(None): (a) if it is in the best interest of the minor;
p.(None): (b) in such manner and on such conditions as may be prescribed in a regulatory framework;
p.(None): (c) with the consent of the parent or legal guardian of the minor; and
p.(None): (d) if the minor is capable of understanding the nature and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 306
p.(None):
p.(None):
p.(None): 32 No. 2 of 2013] National Health Research
p.(None):
p.(None): the potential risks and benefits of the health research, with the consent of the minor.
p.(None): (5) Health research on a minor for non therapeutic purposes shall be conducted —
p.(None): (a) in such manner and on such conditions as may be prescribed;
p.(None): (b) with the consent of the Authority;
p.(None): (c) with the consent of the parent or legal guardian of the minor; and
p.(None): (d) if the minor is capable of understanding the nature and potential risks and benefits of the health research, the
p.(None): consent of the minor.
p.(None): (6) The Authority shall not consent to a health research under paragraph (b) of subsection (5), in circumstances where—
p.(None): (a) the objectives of the health research or experimentation may also be achieved if it is conducted on an adult;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the minor’s condition, disease or disorder to such an extent that shall result in significant benefit to the minor;
p.(None): (c) the reasons for the consent to the health research or experimentation by the parent or guardian of the
p.(None): minor and, if applicable, the minor, are contrary to social norms and public policy;
p.(None): (d) the health research or experimentation poses a significant risk to the health of the minor; or
p.(None): (e) there is some risk to the health or well being of the minor and the potential benefit of the health research
p.(None): or experimentation does not significantly outweigh that risk.
p.(None): (7) Health research involving special groups such as prisoners, pregnant women, persons with mental disabilities, or
p.(None): workers in a hierarchical system shall be conducted—
p.(None): (a) in such manner and on such terms and conditions as may be prescribed;
p.(None): (b) with the consent of the Authority, on recommendations from a committee of relevant experts established by the
p.(None): Minister; and
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 33
p.(None):
p.(None):
p.(None): (c) if the person is capable of understanding, with the written consent of the person, after the person has been
p.(None): informed of the objectives of the health research or experimentation and any possible potential
...
p.(None): deliberations of the meeting of the Council but such person or representative shall not have any vote.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 43
p.(None):
p.(None):
p.(None): (9) The validity of any proceedings, act or decision of the Council shall not be affected by any vacancy in the
p.(None): membership of the Council or by any defect in the appointment of any member or by reason that any person not
p.(None): entitled to do so took part in the proceedings.
p.(None): 5. The members of the Council, the Board or any committee shall be paid such allowances as the Council may, with the
p.(None): approval of the Minister, determine.
p.(None): 6. (1) If a member or any person is present at a meeting of the Council or any committee of the Council at which any
p.(None): matter is the subject of consideration and in which matter the member or that person or the member’s or that
p.(None): person’s relative is directly or indirectly interested, in a private capacity, is the subject of
p.(None): consideration, the member or person shall, as soon as is practicable, after the commencement of the meeting, declare
p.(None): such interest and shall not, unless the Council or the committee otherwise directs, take part in any consideration or
p.(None): discussion of, or vote on, any question touching that matter.
p.(None): (2) A declaration of interest made under this paragraph shall be recorded in the minutes of the meeting at which it is
p.(None): made.
p.(None): (3) In this paragraph, “ relative ” in relation to a person means—
p.(None): (a) a parent, son, daughter, brother, sister, niece, uncle, aunt, grandparent or cousin of that person or that person’s
p.(None): spouse; and
p.(None): (b) a spouse of that person.
p.(None): 7. (1) A person shall not, without the consent, in writing, given by, or on behalf of, the Authority, publish
p.(None): or disclose to any unauthorised person, otherwise than in the course of duties of that person, the contents of any
p.(None): document, communication or information whatsoever, which relates to or which has come to the knowledge of that person
p.(None): in the course of that person’s duties under this Act.
p.(None): (2) A person who contravenes subparagraph (1) commits an offence and is liable, upon conviction, to a fine not
p.(None): exceeding three hundred thousand penalty units or to imprisonment for a period not exceeding two years, or to both.
p.(None): (3) A person who, having any information which to the knowledge of that person has been published or disclosed in
p.(None): contravention of subparagraph (1), unlawfully publishes or communicates the information to any other person,
p.(None): commits an offence and is liable,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Allowances for
p.(None): members
p.(None):
p.(None): Disclosure of
p.(None): interest
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of publication or disclosure of information to unauthorised persons
p.(None):
p.(None):
p.(None): 44 No. 2 of 2013] National Health Research
p.(None):
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): unexpired part of the term.
p.(None): 4. (1) Subject to this Act, the Council may regulate its own procedure.
p.(None): (2) The Council shall meet for the transaction of business at least once in every three months at such places and times
p.(None): as the Chairperson may determine.
p.(None): (3) The Chairperson may, upon giving notice of not less than fourteen days, call a meeting of the Council and shall
p.(None): call a special meeting to be held within fourteen days of receipt of a written request to the Chairperson by at least
p.(None): five members of the Council.
p.(None): (4) If the urgency of any particular matter does not permit the giving of such notice as is required under subparagraph
p.(None): (3), a special meeting may be called by the Chairperson, upon giving a shorter notice.
p.(None): (5) Seven members of the Council shall form a quorum at any meeting of the Council.
p.(None): (6) There shall preside at any meeting of the Council—
p.(None): (a) the Chairperson; and
p.(None): (b) in the absence of the Chairperson, the Vice Chairperson, and in the absence of the Chairperson and the Vice
p.(None): Chairperson, such member as the members present may elect for the purpose of that meeting.
p.(None): (7) A decision of the Council on any question shall be by a majority of the members present and voting at the meeting
p.(None): and in the event of an equality of votes, the person presiding at the meeting shall have a casting vote in addition to
p.(None): the deliberative vote.
p.(None): (8) The Council may invite any person, including any representative of the Council or any health
p.(None): research ethics committee, whose presence is in its opinion desirable, to attend and to participate in the
p.(None): deliberations of the meeting of the Council but such person or representative shall not have any vote.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 43
p.(None):
p.(None):
p.(None): (9) The validity of any proceedings, act or decision of the Council shall not be affected by any vacancy in the
p.(None): membership of the Council or by any defect in the appointment of any member or by reason that any person not
p.(None): entitled to do so took part in the proceedings.
p.(None): 5. The members of the Council, the Board or any committee shall be paid such allowances as the Council may, with the
p.(None): approval of the Minister, determine.
p.(None): 6. (1) If a member or any person is present at a meeting of the Council or any committee of the Council at which any
p.(None): matter is the subject of consideration and in which matter the member or that person or the member’s or that
p.(None): person’s relative is directly or indirectly interested, in a private capacity, is the subject of
p.(None): consideration, the member or person shall, as soon as is practicable, after the commencement of the meeting, declare
p.(None): such interest and shall not, unless the Council or the committee otherwise directs, take part in any consideration or
p.(None): discussion of, or vote on, any question touching that matter.
p.(None): (2) A declaration of interest made under this paragraph shall be recorded in the minutes of the meeting at which it is
p.(None): made.
p.(None): (3) In this paragraph, “ relative ” in relation to a person means—
p.(None): (a) a parent, son, daughter, brother, sister, niece, uncle, aunt, grandparent or cousin of that person or that person’s
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.(None): shall not be dealt with except in accordance with this Act, the condition and the obligations of the trustees as set
p.(None): out in a Trust to be established by the Minister for the purposes of this Act.
p.(None): (2) There shall be kept separate accounts of each sum of money standing to the credit of the Trust Account that
p.(None): represents an amount given as a gift or bequest for specific health research.
p.(None): PART V
p.(None): HEALTH RESEARCH ON, OR EXPERIMENTATION WITH HUMAN PARTICIPANTS AND ANIMAL SUBJECTS
p.(None): 45. (1) Health research or experiments on a human participant shall be conducted—
p.(None): (a) in the prescribed manner consistent with this Act;
p.(None): (b) with the written consent of the person, after the person has been informed of the objectives of the research or
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 31
p.(None):
p.(None):
p.(None): experimentation and any possible potential risks or benefits on that person’s health;
p.(None): (c) in the case of a deceased person, with written consent as provided in the Human Tissue Act;
p.(None): (d) if it does not threaten national security;
p.(None): (e) if it does not violate social and cultural norms; and
p.(None): (f) in Zambia, with ethical approval by the Board or accredited health research ethics committee in accordance
p.(None): with this Act.
p.(None): (2) Research involving human participants shall embrace all the following basic pillars of health research ethics:
p.(None): (a) respect of persons (autonomy);
p.(None): (b) benefit to the research participants (beneficence); and
p.(None): (c) equal distribution of risks and benefits (justice).
p.(None): (3) The following elements shall be adhered to in conducting health research on human participants:
p.(None): (a) social or scientific value;
p.(None): (b) scientific validity;
p.(None): (c) fair selection of participants;
p.(None): (d) favourable risk benefit ratio;
p.(None): (e) informed consent;
p.(None): (f) respect of participants;
p.(None): (g) confidentiality;
p.(None): (h) protection of interests of stakeholders;
p.(None): (i) good clinical and laboratory practice; and
p.(None): (j) independent review.
p.(None): (4) Health research on a minor for therapeutic purposes shall be conducted—
p.(None): (a) if it is in the best interest of the minor;
p.(None): (b) in such manner and on such conditions as may be prescribed in a regulatory framework;
p.(None): (c) with the consent of the parent or legal guardian of the minor; and
p.(None): (d) if the minor is capable of understanding the nature and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 306
p.(None):
p.(None):
p.(None): 32 No. 2 of 2013] National Health Research
p.(None):
...
General/Other / Manipulable
Searching for indicator manipulate:
(return to top)
p.(None): experimentation with, animal subjects.
p.(None): (12) Notwithstanding the generality of subsection (11), regulations made by the Minister under that subsection may
p.(None): provide for—
p.(None): (a) the methods, circumstances, conditions and procedures under which health research may be conducted on animal
p.(None): subjects;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No.18 of 2010
p.(None):
p.(None):
p.(None): 34 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of reproductive cloning of human beings
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of removal of tissue, organs, blood, blood products or gametes from living persons for research
p.(None): purposes
p.(None): (b) the principles and standards applicable to the conduct of health research on animal subjects; and
p.(None): (c) any other matters necessary for the proper conduct of health research on animal subjects in accordance with
p.(None): the provisions of this Act.
p.(None): 46. (1) A person shall not —
p.(None): (a) manipulate any genetic material, including the genetic material of humans for the purpose of cloning a human being;
p.(None): or
p.(None): (b) engage in any activity, including nuclear transfer or embryo splitting, gametes, zygotes or embryos for the purpose
p.(None): of reproductive cloning of a human being.
p.(None): (2) A person shall not export or import human zygotes or embryos without the prior written approval of the Minister.
p.(None): (3) A person who contravenes a provision of this section or who fails to comply with this section commits an offence
p.(None): and is liable, upon conviction, to a fine not exceeding four hundred thousand penalty units or to imprisonment for a
p.(None): period not exceeding five years, or to both.
p.(None): (4) The Minister may, in consultation with the Authority, if it is consistent with this Act and any other written law,
p.(None): and upon such terms and conditions as the Minister may consider necessary, by notice in the Gazette, exempt any person
p.(None): or category of persons from any or all of the provisions of this section.
p.(None): 47. (1) A person shall not remove any tissue, organ, blood, blood product or gametes from a living person for health
p.(None): research purposes unless it is done with the written consent of the person from whom the tissue, organ, blood, blood
p.(None): product or gametes are removed in accordance with this Act, the regulatory framework or as is otherwise prescribed.
p.(None): (2) A person shall not withdraw blood, blood products, tissue or gametes from a living person for any unspecified
p.(None): future health research activity or unspecified storage.
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.(None): Professions Act, 2009.
p.(None): (3) A person, other than the holder of a licence granted in accordance with subsection (1), who keeps
p.(None): biological materials commits an offence and is liable, upon conviction, to a fine not exceeding two million penalty
p.(None): units or to imprisonment for a term not exceeding four years, or to both.
p.(None): 50. (1) A person shall not export or import biological materials without the prior written approval of the Authority
p.(None): as provided under subsection (2).
p.(None): (2) The Authority may, on the recommendation of the Board, permit the export or import of biological materials if all
p.(None): the prescribed elements of a material transfer agreement are met.
p.(None): (3) A person who contravenes this section commits an offence and is liable, upon conviction, to a fine not exceeding
p.(None): two million penalty units or to imprisonment for a period not exceeding four years, or to both.
p.(None): 51. (1) The Minister may, by notice in the Gazette, designate any research institution, site or health establishment
p.(None): as a bio-bank.
p.(None): (2) A research institution, site or health establishment designated as a bio-bank under subsection (1), may
p.(None): (a) receive biological materials for storage purposes;
p.(None): (b) store biological material remnants for a period not exceeding ten years, unless the Authority approves a
p.(None): longer period of time for special reasons; and
p.(None): (c) dispose of biological materials that are due for disposal following prescribed bio-hazard waste guidelines.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Purposes of collection of biological materials
p.(None): Storage of biological materials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. 12
p.(None): of 2011
p.(None): Act No. 24
p.(None): of 2009
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Exportation and importation of biological materials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Designation of
p.(None): institution as bio-bank
p.(None):
p.(None):
p.(None): 36 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None): Searches at ports of entry, exit and sites Cap. 295
p.(None): Act No. 16
p.(None): of 2005
p.(None): Act No. 18
p.(None): of 2010
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Ownership of biological materials and material transfer agreement
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Clinical trials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. of 2013
p.(None): 52. (1) An officer authorised under the Public Health Act, Ionising Radiation Protection Act, 2005, and
p.(None): Immigration and Deportation Act, 2010, and any other relevant law enforcement officer may conduct a search, at any
p.(None): reasonable time, at any site, port of entry and port of exit.
p.(None): (2) Any biological material that is found to have been transferred without the necessary approvals and supporting
...
General/Other / Other Country
Searching for indicator another country:
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General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 3
p.(None):
p.(None): THE NATIONAL HEALTH RESEARCH ACT, 2013
p.(None): ARRANGEMENT OF SECTIONS
p.(None):
p.(None): Section
p.(None):
p.(None):
p.(None):
p.(None): 1. Short title
p.(None): 2. Interpretation
p.(None):
p.(None): PART I PRELIMINARY
p.(None): 3. Application and scope
p.(None): PART II
p.(None): THE NATIONAL HEALTH RESEARCH AUTHORITY
p.(None): 4. Establishment of National Health Research Authority
p.(None): 5. Functions of Authority
p.(None): 6. Powers of Authority
p.(None): 7. Council of Authority
p.(None): 8. Exercise of functions and powers of Authority
p.(None): 9. Committees of Council
p.(None): 10. Delegation of functions
p.(None): 11. Director
p.(None): 12. Secretary, inspectors and other staff of Authority
p.(None): PART III
p.(None): THE NATIONAL HEALTH RESEARCH ETHICS SYSTEM
p.(None): 13. National Health Research Ethics Board
p.(None): 14. Functions of Board
p.(None): 15. Tenure of office and vacancy of Board
p.(None): 16. Proceedings of Board
p.(None): 17. Research protocol
p.(None): 18. Health research ethics committees
p.(None): 19. Functions and procedures of health research ethics committee
p.(None):
p.(None):
p.(None): Single copies of this Act may be obtained from the Government Printer,
p.(None): P.O. Box 30136, 10101 Lusaka. Price K23.00
p.(None):
p.(None):
p.(None): 4 No. 2 of 2013] National Health Research
p.(None):
p.(None): 20. Misconduct by health researchers
p.(None): 21. Complaints
p.(None): 22. Immunity from liability or penalty
p.(None): 23. Reports by Board
p.(None): 24. Staff of Board
p.(None): 25. Disclosure of interest by members of Board
p.(None): 26. Protection of personal information
p.(None): 27. Immunity of member of Board or committee
p.(None): 28. Annual report of Board
p.(None): 29. Appeals
p.(None): 30. Jurisdiction over offences committed outside Zambia
p.(None): PART IV
p.(None): REGULATORY FRAMEWORK FOR HEALTH RESEARCH
p.(None): 31. Priority areas for health research
p.(None): 32. Dissemination of health research information
p.(None): 33. Access to, and deposition of, health research databases
p.(None): 34. Monitoring and evaluation
p.(None): 35. Partnerships in health research
p.(None): 36. Human research guidelines
...
p.(None): National Health Research [ No. 2 of 2013 5
p.(None):
p.(None): PART VI
p.(None): BIOLOGICAL MATERIALS FOR HEALTH RESEARCH
p.(None): 48. Purposes of collection of biological materials
p.(None): 49. Storage of biological materials
p.(None): 50. Exportation and importation of biological materials
p.(None): 51. Designation of institution as bio-bank
p.(None): 52. Searches at ports of entry, exit and sites
p.(None): 53. Ownership of biological materials and material transfer agreement
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 54. Clinical trials
p.(None): PART VII CLINICAL TRIALS
p.(None):
p.(None): PART VIII
p.(None): RSEARCH IN TRADITIONAL, COMPLEMENTARY AND ALTERNATIVE MEDICINE
p.(None): 55. Research in traditional, complementary and alternative medicine
p.(None): PART IX INTELLECTUAL PROPERTY RIGHTS
p.(None): 56. Intellectual property rights
p.(None): PART X GENERAL PROVISIONS
p.(None): 57. Entry by inspectors or other authorised persons
p.(None): 58. Duty to provide information to inspector
p.(None): 59. Service of Notice
p.(None): 60. Authentication of documents
p.(None): 61. General penalties for offences
p.(None): 62. Offences by body corporation or an unincorporate body
p.(None): 63. Regulations
p.(None): 64. Transitional provisions Schedule
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 7
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): GOVERNMENT OF ZAMBIA
p.(None):
p.(None): ACT
p.(None): No. 2 of 2013
p.(None):
p.(None):
p.(None): Date of Assent: 21/03/13
p.(None): An Act to establish the National Health Research Authority and provide for its functions and powers; establish the
p.(None): National Health Research Ethics Board and provide for its functions and powers; provide a regulatory framework for the
p.(None): development, regulation, financing and coordination of health research and ensure the development of consistent health
p.(None): research standards and guidelines for ethically sound health research; provide for the establishment of health research
p.(None): ethics committees and the regulation and management of research institutions, health researchers and health
p.(None): establishments involved in or undertaking research; provide for the regulation of biological material for health
p.(None): research; provide for ethical approval for the conduct of clinical trials; provide for the use of traditional,
p.(None): complementary and alternative medicines in health research; provide for data management and intellectual
p.(None): property rights in health research; provide for the designation of bio banks; and provide for matters connected
p.(None): with, or incidental to, the foregoing.
p.(None): [22nd March, 2013 ENACTED by the Parliament of Zambia.
p.(None): PART I PRELIMINARY
p.(None): 1. This Act may be cited as the National Health Research Act, 2013.
p.(None): 2. In this Act, unless the context otherwise requires—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Enactment
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Short title
p.(None):
p.(None):
p.(None): Interpretation
p.(None):
p.(None):
p.(None): 8 No. of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 1
p.(None): “ accreditation ” means a process of certification of competence in health research;
p.(None): “ animal subject ” means an animal which is used for health research or clinical trial;
p.(None): “ Authority ” means the National Health Research Authority established under section four;
p.(None): “ Board ” means the National Health Research Ethics Board constituted under section thirteen;
p.(None): “ bio-bank ” means a collection of biological materials and the associated data and information which is stored in an
p.(None): organised system;
p.(None): “ biological materials ” means organs and parts of organs, cells and tissue, sub cellular structures and cell products,
p.(None): blood, saliva, sputum, gametes (sperm and ova), embryos and foetal tissue, waste, including urine, feaces,
p.(None): sweat, hair, epithelial scales, nail clippings, placenta and cell lines from human or animal tissue;
p.(None): “ blood product ” means any product derived or produced from blood, including circulating progenitor cells, bone
p.(None): marrow progenitor cells and umbilical cord progenitor cells;
p.(None): “ Board Chairperson ” means the person appointed as Chairperson of the Board in accordance with section
p.(None): thirteen;
p.(None): “ Cabinet ” has the meaning assigned to it in the Constitution;
p.(None): “ central health research repository ” means the central health research repository as prescribed by the Minister under
p.(None): section thirty-three;
p.(None): “ Chairperson ” means the person appointed Chairperson of the Council under section seven;
p.(None): “ clinical trial regulations ” means regulations made under section fifty-four;
p.(None): “clinical trial ” means a systematic study, involving human participants or animal subjects, that serves to
p.(None): answer specific questions about the safety or efficacy of a medicine, vaccine or method of prevention or treatment;
p.(None): “ committee ” means a committee of the Council established under section nine;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 9
p.(None):
p.(None): “ consent ” means a voluntary agreement to participate in health research by a person, who is not a minor, with full
p.(None): understanding of the potential risks and benefits of the health research;
p.(None): “ Council ” means the Council of the Authority constituted under subsection seven;
p.(None): “ Director ” means the person appointed Director of the Authority under section eleven;
p.(None): “ embryo ” means a human offspring in the first eight weeks from conception or animal offspring in the first trimester,
p.(None): the gestation or incubation period for the relevant species as the case may be;
p.(None): “ ethical approval ” means approved by the Board for the conduct, in Zambia, of research on human participants or
p.(None): animal subjects in accordance with sections fourteen and forty-five;
p.(None): “ genetic material ” means a part of a cell that carries information which can be inherited;
p.(None): “ health establishment ” means a public or private establishment, including its facilities, buildings or other
p.(None): places, operated or designed to provide inpatient or outpatient treatment, diagnostic or therapeutic
p.(None): interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health services;
p.(None): “ health research ” means an activity conducted which—
p.(None): (a) contributes to knowledge of the biological, clinical, psychological or social processes in human beings or animals;
p.(None): (b) uses scientific methods to generate information to deal with health and disease;
p.(None): (c) improves scientific methods for provision of health services and human pathology;
p.(None): (d) investigates causes of disease and the effects of the environment on the human body; or
p.(None): (e) develops new applications of pharmaceuticals, medicines and health technology;
p.(None): “ health research ethics committee ” means a committee registered and accredited by the Board under section eighteen;
p.(None):
p.(None):
p.(None): 10 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 306
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. of 2013
p.(None): “ health researcher ” means an individual who undertakes health research;
p.(None): “ human participant ” means any living person who consents to participate in a health research activity or a body of a
p.(None): deceased person or part of a body of a deceased person as provided in the Human Tissue Act;
p.(None): “ human research guidelines ” means guidelines for the conduct of health research involving human participants
p.(None): issued under section thirty-six;
p.(None): “ inspector ” means a person appointed by the Authority as an inspector for the purposes of this Act;
p.(None): “ national health research strategic plan ” means a national plan that prioritises health research as provided
p.(None): under section thirty-one;
p.(None): “ intellectual property rights ” means an exclusive right granted to inventors and owners of works that are the result
p.(None): of human intellectual creativity;
p.(None): “ interim regulatory requirements ” means a regulatory framework issued under section thirty-eight;
p.(None): “ legal guardian ” means a person lawfully vested with the power, and charged with the obligation, of taking care of
p.(None): and managing the property and rights of a person who, because of age, understanding or self control, is incapable of
p.(None): administering that person’s own affairs;
p.(None): “ material transfer agreement ” means a written contract between the provider and recipient of research material as
p.(None): prescribed under section fifty-three;
p.(None): “ medicine ” has the meaning assigned to it in the Medicines and Allied Substances Act, 2013;
p.(None): “ member ” means a member of the Council;
p.(None): “ minor ” means a person below the age of eighteen years; “ private health establishment ” means a health establishment
p.(None): that is not owned or controlled by the Government;
p.(None): “ public health establishment ” means a health establishment that is owned or controlled by the Government;
p.(None): “ public policy ” means the objectives relating to the health, morals and well being of the citizens approved by
...
p.(None): group or community;
p.(None): “ therapeutic cloning ” means a procedure for producing tissues or organs from genetically identical cells that
p.(None): originate from undifferentiated stem cells for purposes of repairing or replacing damaged tissues;
p.(None): “ traditional, complementary and alternative medicines ” means the total combination of knowledge and practices,
p.(None): whether explicable or not, used in diagnosing, preventing or eliminating physical, mental or social diseases and which
p.(None): may rely exclusively on past experience and observation handed down from generation to generation, verbally or in
p.(None): writing;
p.(None): “ traditional health practitioner ” means a person recognised by a community in which that person lives as competent to
p.(None): provide health care, using vegetable, animal or mineral substances and other methods based on social, cultural and
p.(None): religious background and knowledge, attitudes and beliefs that are prevalent in the community regarding the physical,
p.(None): mental and social well being of a person, including the causes of disease and disability;
p.(None):
p.(None):
p.(None): 12 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Application and scope
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Establishment of
p.(None): National Health Research Authority
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Functions of Authority
p.(None): “ Trust Account ” means the Health Research Trust Account established under section forty-one;
p.(None): “ vertebrate animal ” means a bird, fish, reptile, amphibian or mammal, other than a human being, which is a member of
p.(None): the phylum vertebrates, or a bee, butterfly and any other insect used in the production of animal products, and
p.(None): includes the carcass of an animal; and
p.(None): “ Vice-Chairperson ” means the person elected Vice- Chairperson of the Council under section seven.
p.(None): 3. (1) Notwithstanding any other law, this Act applies to all health research conducted in Zambia, biological
p.(None): material and the use of personal health data.
p.(None): (2) Notwithstanding subsection (1), this Act applies to health research undertaken outside Zambia under the direction
p.(None): of a person or body established in Zambia.
p.(None): PART II
p.(None): THE NATIONAL HEALTH RESEARCH AUTHORITY
p.(None): 4. (1) There is hereby established the National Health Research Authority which shall be a body corporate
p.(None): with perpetual succession and a common seal, capable of suing and of being sued in its corporate name, and with
p.(None): powers, subject to the provisions of this Act, to do all such acts and things as a body corporate may, by law, do or
p.(None): perform.
p.(None): (2) The Schedule applies to the Authority.
p.(None): 5. (1) The functions of the Authority are to—
p.(None): (a) regulate the conduct of research and monitor and evaluate all health research in Zambia;
p.(None): (b) facilitate research and development in health research and provide oversight and coordination of health
p.(None): research;
p.(None): (c) develop mechanisms for setting national health research priorities and strategies in accordance with the needs of
p.(None): Zambia;
p.(None): (d) promote the translation of health research outcomes into policy;
p.(None): (e) advise the Minister on all matters related to health research;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 13
p.(None): (f) identify and recommend to the Minister national health research priorities for incorporation in national health
p.(None): research strategic plans;
p.(None): (g) advise the Minister on the application and implementation of national health research strategic plans;
p.(None): (h) foster partnerships in product development and commercialisation of innovations in health research;
p.(None): (i) harmonise, network and promote public-private partnerships in health research;
p.(None): (j) register and accredit research institutions and health researchers;
p.(None): (k) investigate reports of professional misconduct relating to health research and report the misconduct to the
p.(None): relevant professional association or statutory body;
p.(None): (l) facilitate the development of health research capacity of individuals, institutions and systems by building
p.(None): quality human resources which are capable of responding to the essential research and health demands of Zambia;
p.(None): (m) mobilise and disburse resources for health research;
p.(None): (n) advocate for health research within society, and in the public and the private sectors;
p.(None): (o) recommend to law enforcement authorities the prosecution of health researchers and research institutions that
p.(None): contravene this Act;
p.(None): (p) collaborate with health researchers and research institutions outside Zambia;
p.(None): (q) promote multi-disciplinary and inter-sectoral research collaboration in a bid to establish essential health
p.(None): research which is consistent with the national health research strategic plan; and
p.(None): (r) do all such things as are connected with, or incidental to, the functions of the Authority under this Act.
p.(None): (2) The Authority shall, in performing its functions under this Act—
p.(None): (a) develop and review accreditation guidelines for health researchers and research institutions;
p.(None): (b) maintain a database of research undertaken and facilitate the dissemination of research results;
p.(None):
p.(None):
p.(None): 14 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Powers of Authority
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Council of Authority
p.(None): (c) establish and maintain a central health research repository; and
p.(None): (d) maintain a profile of non-complying health researchers and research institutions.
p.(None): 6. The Authority may—
p.(None): (a) withdraw the accreditation of a health researcher or research institution;
p.(None): (b) ban health researchers and research institutions from carrying out research in Zambia;
p.(None): (c) stop an ongoing health research activity;
p.(None): (d) inspect any institution or site approved by the Board for the conduct of health research, including databases and
p.(None): bio banks;
p.(None): (e) confiscate, impound and destroy, where necessary, biological materials obtained by any person in
p.(None): contravention of any provision of this Act;
p.(None): (f) require any health researcher or research institution to submit such information and records as may
p.(None): be necessary to enable the Authority to monitor the performance or activities of the health researcher or
p.(None): research institution;
p.(None): (g) consider any matter relating to health research and make representations on those matters to the Minister; and
p.(None): (h) require any health researcher who, or research institution which, is in control of a health research activity to
p.(None): inform the Authority of the intention to move from a site prior to re-locating.
p.(None): 7. (1) The Authority shall be governed by a Council.
p.(None): (2) The Council shall consist of the following part-time members who shall be appointed by the Minister:
p.(None): (a) one representative each recommended by the Ministries responsible for—
p.(None): (i) science, technology and vocational training;
p.(None): (ii) finance;
p.(None): (iii) justice;
p.(None): (iv) defence;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 15
p.(None):
p.(None):
p.(None): (v) health;
p.(None): (vi) community development;
p.(None): (vii) education; and
p.(None): (viii) livestock and fisheries development;
p.(None): (b) one representative each recommended by—
p.(None): (i) a research and development institution;
p.(None): (ii) a higher education institution; and
p.(None): (iii) a civil society organisation concerned with matters of health;
p.(None): (c) a traditional health practitioner;
p.(None): (d) a renowned health researcher; and
p.(None): (e) two other persons.
p.(None): (3) A person shall not be appointed as a member of the Council if the person —
p.(None): (a) is an undischarged bankrupt;
p.(None): (b) has been convicted of an offence related to health research under this Act or any other written law;
p.(None): (c) has been convicted of an offence involving fraud or dishonesty;
p.(None): (d) is an employee of the Authority;
p.(None): (e) has a mental disability that makes the person incapable of performing the functions of a member; or
p.(None): (f) is not resident in Zambia.
p.(None): (4) The Minister shall, when appointing the members of the Council, ensure equitable gender representation and
p.(None): that at least a third of the members have health research experience.
p.(None): (5) The Minister shall appoint the Chairperson of the Council from among the members of the Council.
p.(None): (6) The Vice-Chairperson of the Council shall be elected by the members from amongst themselves.
p.(None): 8. (1) Except as otherwise provided under this Act, the Council shall exercise the following functions and powers of
p.(None): the Authority:
p.(None): (a) set, review and enforce ethical standards and human and animal research ethical guidelines, including ethical
p.(None): standards and guidelines for clinical trials;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Exercise of functions and powers of
p.(None): Authority
p.(None):
p.(None):
p.(None): 16 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Committees of
p.(None): Council
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Delegation of functions
p.(None):
p.(None):
p.(None):
p.(None): Director
p.(None):
p.(None): (b) determine policy matters in health research;
p.(None): (c) review the policy and strategic plan of the Authority and oversee the implementation and efficient operation of the
p.(None): policy and functions of the Authority;
p.(None): (d) approve the annual budget and plans of the Authority;
p.(None): (e) monitor and evaluate the performance of the Authority against budgets and plans;
p.(None): (f) establish and approve conditions of service of the staff of the Authority;
p.(None): (g) make recommendations to the Minister for amendments to this Act or issuance of regulations under this Act; and
p.(None): (h) perform any other function conferred or imposed on the Council by or under this Act.
p.(None): (2) The Minister may give to the Council general or specific directions, consistent with this Act, relating to the
p.(None): discharge of the functions of the Authority and the Council shall give effect to those directions.
p.(None): 9. (1) The Council may, for purposes of performing the functions of the Authority, establish such committees
p.(None): as it considers necessary for the effective exercise of the functions of the Authority.
p.(None): (2) The Council may appoint, as members of a committee, persons who are or are not members of the Council, except that
p.(None): at least one member of the Council shall be a member of a committee.
p.(None): (3) A person serving as a member of a committee shall hold office for such period as the Council may determine.
p.(None): (4) Subject to any specific or general direction of the Council, a committee may regulate its own procedure.
p.(None): 10. The Council may, by direction, in writing, and subject to such terms and conditions as it considers necessary,
p.(None): delegate to the Director, any member or any committee any of the functions of the Authority.
p.(None): 11. (1) The Council shall appoint, on such terms and conditions as it may determine, a Director who shall be the
p.(None): chief executive officer of the Authority.
p.(None): (2) The Director shall be responsible, under the general direction of the Council, for—
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 17
p.(None):
p.(None):
p.(None): (a) the management and administration of the affairs of the Authority;
p.(None): (b) the implementation of the decisions of the Council; and
p.(None): (c) any other function assigned or delegated to the Director by the Council or by or under this Act.
p.(None): (3) The Director shall attend meetings of the Council and may address those meetings but shall not vote on any matter.
p.(None): (4) The person presiding at any meeting of the Council may request the Director to withdraw from the meeting.
p.(None): 12. (1) The Council may appoint, on such terms and conditions as it may determine, the Secretary, inspectors and
p.(None): such other staff as may be necessary for the performance of the functions of the Authority.
p.(None): (2) The Council shall provide an inspector with a certificate of appointment, in the prescribed form, which shall be
p.(None): prima facie evidence of the inspector’s appointment.
p.(None): PART III
p.(None): THE NATIONAL HEALTH RESEARCH ETHICS SYSTEM
p.(None): 13. (1) There is established the National Health Research Ethics Board which shall consist of one
p.(None): representative from each of the following disciplines and sectors:
p.(None): (a) law;
p.(None): (b) pharmacology;
p.(None): (c) pharmacy;
p.(None): (d) theology;
p.(None): (e) biostatistics;
p.(None): (f) epidemiology;
p.(None): (g) public health;
p.(None): (h) biomedical science;
p.(None): (i) veterinary medicine;
p.(None): (j) traditional medicine;
p.(None): (k) nursing;
p.(None): (l) social science; and
p.(None): (m) clinical medicine.
p.(None): (2) The members of the Board shall be appointed by the Council and shall serve on a part-time basis.
p.(None): (3) An organisation or association that represents members in the disciplines or sectors stipulated in subsection (1)
p.(None): shall recommend a representative for appointment as a member of the Board.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Secretary, inspectors and other staff of
p.(None): Authority
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Health Research Ethics Board
p.(None):
p.(None):
p.(None): 18 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Functions of Board
p.(None): (4) The Chairperson of the Board shall be appointed by the Council from among the members of the Board.
p.(None): (5) The Vice-Chairperson of the Board shall be elected by the members from amongst themselves.
p.(None): 14. (1) The Board shall regulate ethics on human and animal research as provided by or under this Act, and oversee
p.(None): and ensure adherence to health research ethics as provided in the regulatory framework and ethics guidelines.
p.(None): (2) Notwithstanding the generality of subsection (1), the Board shall—
p.(None): (a) regulate the conduct of research and monitor and evaluate all health research;
p.(None): (b) register and accredit health researchers and health research ethics committees;
p.(None): (c) regulate and monitor the conduct of health research and health research ethics committees;
p.(None): (d) institute such disciplinary action, as may be prescribed, against any health researcher or research
p.(None): institution found to be in violation of any ethical standards or guidelines set for conducting of health
p.(None): research;
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Functions and procedures of health research ethics committee
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Misconduct by
p.(None): health researchers
p.(None): (4) The Council may fill a vacancy on the Board by appointing another person to replace the member who vacates office
p.(None): for the remainder of the term.
p.(None): 16. (1) The Board shall regulate its own procedures at meetings.
p.(None): (2) The quorum at any meeting of the Board shall be eight members.
p.(None): (3) The disciplinary proceedings of the Board shall be as prescribed.
p.(None): 17. All proposals for health research under this Act shall be reviewed by the Board or any other accredited
p.(None): health research ethics committee, as may be prescribed, and shall be approved by the Board.
p.(None): 18. (1) A research institution and health establishment, at which health research is conducted, shall constitute
p.(None): health research ethics committees, which shall be registered with, and accredited by, the Board or any other accredited
p.(None): health research ethics committee.
p.(None): (2) The members of a health research ethics committee shall be appointed by the respective research institution
p.(None): and the representation shall be consistent in discipline as provided under subsection (1) of section thirteen.
p.(None): (3) The Minister, in consultation with the Authority, shall, by statutory instrument, make regulations for
p.(None): accrediting health researchers and research institutions.
p.(None): 19. (1) A health research ethics committee shall have such functions and powers as may be prescribed.
p.(None): (2) A health research ethics committee shall comply with the provisions of this Act.
p.(None): (3) A health research ethics committee shall regulate its own procedure at meetings.
p.(None): (4) The disciplinary procedures for a health research ethics committee shall be as prescribed.
p.(None): 20. (1) A health researcher commits misconduct if the health researcher—
p.(None): (a) does not comply with a prescribed professional code of conduct;
p.(None): (b) conducts health research which involves human participants or potentially affects humans without first
p.(None): obtaining ethical approval under this Act or other approvals required under any other written law;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 21
p.(None):
p.(None):
p.(None): (c) collects samples or information from human participants without first obtaining consent from the participants in
p.(None): accordance with this Act;
p.(None): (d) shares samples collected from human participants with other health researchers or research institutions without
p.(None): first obtaining the relevant approvals under this Act;
p.(None): (e) shares samples collected from human participants without an approved material transfer agreement, as provided under
p.(None): this Act;
p.(None): (f) shares samples collected prospectively from human participants with other health researchers or research
p.(None): institutions without the informed consent of the donors of the samples to do so;
p.(None): (g) fails to submit prescribed mandatory reports to a health research ethics committee and the Board;
p.(None): (h) fails to uphold privacy and confidentiality of participants’ information;
p.(None): (i) deviates from an approved research protocol;
p.(None): (j) fails to report deviations from an approved research protocol to the relevant health research ethics
p.(None): committee or the Board;
p.(None): (k) fabricates, falsifies or knowingly plagiarises data; or
p.(None): (l) forges approvals or other relevant documents under this Act.
p.(None): (2) A health researcher who contravenes subsection (1) and who is found guilty by a health research ethics
p.(None): committee or the Board is liable to a fine not exceeding four hundred thousand penalty units or shall be banned
p.(None): from conducting health research for a minimum of five years.
p.(None): (3) Notwithstanding subsection (2), a health researcher who commits a criminal offence is liable to prosecution.
p.(None): (4) The Minister shall, in consultation with the Authority, by statutory instrument, issue regulations for dealing with
p.(None): misconduct by health researchers and procedures for their discipline.
p.(None): 21. (1) A health researcher or research institution whose interests are affected by an action or decision of a
p.(None): health research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Complaints
p.(None):
p.(None):
p.(None): 22 No. 2 of 2013] National Health Research
p.(None):
p.(None): ethics committee may lodge a complaint with the Board and request an investigation concerning the action or decision of
p.(None): the health research ethics committee, on one or more of the grounds set out in subsection (2).
p.(None): (2) A health researcher or research institution, referred to in subsection (1), may lodge a complaint on any of
p.(None): the following grounds:
p.(None): (a) that the action or decision breached the rules of natural justice;
p.(None): (b) that the action or decision was induced or affected by fraud;
p.(None): (c) that there was no evidence or other material to justify the action or decision;
p.(None): (d) that an irrelevant consideration was taken into account in relation to the action;
...
p.(None): (3) The Council shall ensure, having regard to the recommendations made in the report of the Board,
p.(None): that the relevant research institution, health researcher or health establishment—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Immunity from liability or penalty
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports by Board
p.(None):
p.(None):
p.(None): 24 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Staff of Board
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Disclosure of interest by members of Board
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Protection of personal information
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Immunity of member of Board or committee
p.(None): (a) takes whatever action that the Board considers appropriate; and
p.(None): (b) informs the complainant of the action that the research institution, health researcher or health establishment has
p.(None): taken and of its reasons for taking the action.
p.(None): 24. The Authority shall—
p.(None): (a) second staff to service the Board; and
p.(None): (b) provide to the Board facilities necessary for it to perform its functions and exercise its powers under this Act.
p.(None): 25. (1) Where the Board is investigating, or is to investigate, a complaint concerning an action or decision of a
p.(None): health research ethics committee and a member of the Board has, or acquires, an interest that could conflict with
p.(None): the proper performance of the member’s functions in relation to the investigation, the member shall disclose the
p.(None): interest to the Board and the member shall only take part in the investigation if the complainant and the Board agree
p.(None): that the member may so take part.
p.(None): (2) If, in relation to an investigation of a complaint by the Board—
p.(None): (a) a member discloses an interest under subsection (1); and
p.(None): (b) the complainant and the Board do not agree to the member taking part in the investigation;
p.(None): the member shall not take part in the investigation of the complaint.
p.(None): 26. (1) The Board shall not, except in the performance or exercise of its functions or powers under this
p.(None): Act, make a record of or disclose to any person any information about another person that the Board has access to in
p.(None): the performance or exercise of its functions or powers under this Act.
p.(None): (2) Except for the purposes of this Act, if the Board has possession of a document or other record or notice of a
p.(None): matter or thing as a result of its functions or powers under this Act, a court shall not require the Board to—
p.(None): (a) produce the document or other record in its possession; or
p.(None): (b) disclose the matter or thing of which it had notice.
p.(None): 27. An action or other proceeding shall not lie or be instituted against a member of the Board or a committee, or in
p.(None): respect of, any act or thing done or omitted to be done in good faith in the
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 25
p.(None):
p.(None):
p.(None):
p.(None): exercise of or performance, or purported exercise or performance of any of the powers, functions or duties conferred
p.(None): under this Act.
p.(None): 28. The Board shall, as soon as practicable after the end of each financial year, give the Authority a written
p.(None): report of the Board’s activities during that year.
p.(None): 29. (1) A person who is aggrieved with the decision of the Board may, within fourteen days of service of the
p.(None): decision, appeal to the Council and thereafter may appeal to a court of competent jurisdiction.
p.(None): (2) A decision of the Board made under this section shall not take effect until the expiration of the time for lodging
p.(None): an appeal, the appeal is withdrawn or disposed of.
p.(None): 30. Where a health researcher has committed an offence for which the health researcher has been punished in another
p.(None): country and what the health researcher did constitutes a misconduct under this Act, that health researcher shall be
p.(None): banned, by the Council on the recommendation of the Board, from conducting health research in Zambia.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Annual report of Board
p.(None):
p.(None): Appeals
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Jurisdiction over offences committed outside Zambia
p.(None):
p.(None): PART IV
p.(None): REGULATORY FRAMEWORK FOR HEALTH RESEARCH
p.(None): 31. (1) The Authority shall identify and prioritise areas for health research and advise the Minister, who shall
p.(None): recommend the priority areas to Cabinet for approval as national health research priority areas which shall be
p.(None): incorporated in a national health research strategic plan.
p.(None): (2) The Authority shall, in identifying priorities for health research, take into consideration—
p.(None): (a) the burden of disease in the country;
p.(None): (b) the cost effectiveness of interventions aimed at reducing the burden of disease;
p.(None): (c) the availability of resources for the implementation of an intervention at the level closest to the affected
p.(None): communities;
p.(None): (d) the health needs of special groups;
p.(None): (e) the health needs of communities; and
p.(None): (f) emerging public health problems.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Priority area for health research
p.(None):
p.(None):
p.(None): 26 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Dissemination of health research information
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Access to, and deposition of, health research databases
p.(None): (3)Ahealth researcher and research institution shall align health research activities to the subsisting national health
p.(None): research strategic plan.
p.(None): (4) The Authority may allow research outside a national research strategic plan if it is in the public interest or
p.(None): public policy so requires.
p.(None): 32. (1) The Minister, in consultation with the Authority, shall prescribe mechanisms for dissemination of
p.(None): health research information as follows:
p.(None): (a) any health research conducted in Zambia shall first be disseminated locally before being disseminated outside
p.(None): Zambia; and
p.(None): (b) any person intending to publish health research information for health research undertaken in Zambia shall first
p.(None): notify the Authority, in writing, citing the research title and the ethical approval obtained from the Board.
p.(None): (2) The Authority may, for the purposes of disseminating health research information, facilitate fora or media through
p.(None): which health research information may be disseminated, timely, to a broad audience in Zambia.
p.(None): (3) A person shall not disseminate information that is identifiable without—
p.(None): (a) the written consent of the source of the information; and
p.(None): (b) approval from the responsible authority.
p.(None): (4) The Authority may, under such circumstances as it considers necessary, make exemptions in relation to the
p.(None): dissemination of information as provided under this section.
p.(None): 33. (1) The Authority has the right to access all health research databases in Zambia.
p.(None): (2) The Minister, in consultation with the Authority, shall put in place a national system for —
p.(None): (a) creating and securing health research databases;
p.(None): (b) storing and retrieving health research data; and
p.(None): (c) disseminating health research data from the national system.
p.(None): (3) The Minister may, in consultation with the Authority, by statutory instrument, make regulations for ensuring that
p.(None): databases for internally and externally funded health research are kept in a central health research repository as
p.(None): prescribed by the Minister.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 27
p.(None):
p.(None):
p.(None): (4) The Authority has the right to access databases, bio banks or any information collected by health researchers and
p.(None): research institutions.
p.(None): 34. The Authority shall —
p.(None): (a) develop monitoring and evaluation mechanisms for all health research programmes and activities;
p.(None): (b) promote training of health workers in health research methodologies and ethics, documentation, monitoring
p.(None): and evaluation; and
p.(None): (c) monitor and evaluate ongoing health research programmes and activities being undertaken in Zambia.
p.(None): 35. The Minister may, in consultation with the Authority —
p.(None): (a) establish mechanisms for involving communities in health research;
p.(None): (b) facilitate the establishment of a consultative forum for wide dissemination of national health research priority
p.(None): areas and outputs; and
p.(None): (c) make regulations for the protection of interests of stakeholders and the sharing of risks, benefits
p.(None): and outputs in health research programmes and activities.
p.(None): 36. (1) Without limiting any of the matters on which the Council may issue guidelines under this Act, the Council
p.(None): shall issue guidelines on the conduct of human research.
p.(None): (2) The Council shall issue guidelines on the conduct of human research in collaboration with the Board.
p.(None): 37. (1) The Minister, in consultation with the Authority, shall, before issuing any proposed regulatory framework,
p.(None): consult with relevant stakeholders in accordance with this section, except that this section shall not apply—
p.(None): (a) to a statutory instrument; or
p.(None): (b) if the proposed regulatory framework is urgent or is of minor significance, as the Minister may determine.
p.(None): (2) If the Minister, in consultation with the Authority, intends to issue any regulatory framework, the Minister shall
p.(None): publish a notice, in the Gazette or in a daily newspaper of general circulation in Zambia—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Monitoring and evaluation
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Partnerships in health research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Human research guidelines
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Consultation about regulatory framework
p.(None):
p.(None):
p.(None): 28 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Interim regulatory requirements
p.(None): (a) stating the intention to issue the regulatory framework; and
p.(None): (b) inviting persons or bodies to make submissions relating to the proposed regulatory framework in accordance with the
p.(None): procedures, and within the period, specified in the notice.
p.(None): (3) As soon as practicable after the end of the period specified under paragraph (b) of subsection (2), the Minister,
p.(None): in consultation with the Authority, shall, having regard to any submissions received pursuant to the invitation
p.(None): referred to in that paragraph—
p.(None): (a) prepare a draft of the regulatory framework and publish a notice, in the Gazette and in a daily newspaper of
p.(None): general circulation in Zambia—
p.(None): (i) containing a summary of the provisions of the draft regulatory framework;
p.(None): (ii) stating where copies of the draft regulatory framework may be obtained; and
p.(None): (iii) inviting persons or bodies to make submissions relating to the draft regulatory framework in accordance with the
p.(None): procedures, and within the period, specified in the notice; or
p.(None): (b) publish a notice, in the Gazette and in a daily newspaper of general circulation in Zambia, stating that it no
p.(None): longer proposes to issue the regulatory framework.
p.(None): (4) The Minister, in consultation with the Authority, shall take into account any submissions received pursuant to the
p.(None): invitation referred to in subparagraph (iii) of paragraph (a) of subsection (3) before issuing the proposed regulatory
p.(None): framework.
p.(None): 38. (1) The Minister, in consultation with the Authority, may make interim regulatory requirements and issue the
p.(None): requirements without following the procedure provided in section thirty-seven if a matter —
p.(None): (a) would ordinarily be the subject of a regulatory framework;
p.(None): (b) needs, for any reason or circumstance, to be dealt with urgently; and
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 29
p.(None): (c) raises issues that are of minor significance;
p.(None): and shall publish a notice, in the Gazette or a daily newspaper of general circulation in Zambia, stating the reasons
p.(None): for not following the procedures provided under section thirty-seven.
p.(None): (2) Notwithstanding subsection (1), the Minister, in consultation with theAuthority, shall, within thirty days of the
p.(None): issue of an interim regulatory requirement, publish a notice in the manner and form prescribed—
p.(None): (a) setting out the reasons for issuing the interim regulatory requirement and a summary of the interim
p.(None): regulatory requirement; and
p.(None): (b) inviting persons or bodies to make submissions to the Minister on the interim regulatory requirement, within the
p.(None): period specified in the notice.
p.(None): (3) If the Minister fails, within forty-five days after the end of the period specified in subsection (2), to
p.(None): comply with the procedures provided for in subsection (2), any interim regulatory requirement shall be revoked on the
p.(None): forty-fifth day.
p.(None):
p.(None): 39. The Minister, in consultation with the Authority, may, without undertaking consultation, revoke any regulatory
p.(None): framework or interim regulatory requirements.
p.(None): 40. The Authority shall develop and publish procedures to assist persons or bodies to make submissions under this
p.(None): Part.
p.(None): 41. (1) There shall be established a Health Research Trust Account.
p.(None): (2) The Trust Account shall be opened as a special account, in a
p.(None): commercialbank,forthepurposesofthePublicFinanceAct,2004.
p.(None): (3) If interest is received by the Authority from the investment of an amount standing to the credit of the
p.(None): TrustAccount, an amount equal to the interest shall be credited to the Trust Account.
p.(None): 42. There shall be credited to the Trust Account amounts equal to amounts that are given or bequeathed for the
p.(None): purposes of the Trust Account and as provided in the Schedule.
p.(None): 43. (1) The purposes of the Trust Account are—
p.(None): (a) to provide assistance—
p.(None): (i) to the Departments of the Ministries responsible for human and animal health that are engaged in health research;
p.(None): Revocation of regulatory frameworks
p.(None):
p.(None): Procedures for making submissions
p.(None): Health Research Trust Account
p.(None):
p.(None): Act No. 15
p.(None): of 2004
p.(None):
p.(None):
p.(None):
p.(None): Credit of amounts to Trust Account
p.(None):
p.(None): Purposes of Trust Account
p.(None):
p.(None):
p.(None): 30 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Accounting for gifts and bequests Act No. 15
p.(None): of 2004
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Health research on, or experimentation with, human participants or animal subjects
p.(None): (ii) to universities for the purpose of health research;
p.(None): (iii) to research institutions and health researchers engaged in health research; and
p.(None): (iv) for the training of persons in health research; and
p.(None): (b) provide for any other purpose that is prescribed for the purpose of this section.
p.(None): (2) Any assistance provided under subsection (1) shall be provided in such cases and subject to such conditions
p.(None): as the Minister, acting on the advice of the Authority, shall determine.
p.(None): (3) Without limiting the generality of the conditions to which a grant of assistance may be made under subparagraphs
p.(None): (i) (ii) or
p.(None): (iii) of paragraph (a) of subsection (1), such assistance shall be provided if the recipient agrees to comply with the
p.(None): regulatory framework in force relating to the conduct of health research and signs a research grant.
p.(None): 44. (1) Notwithstanding the other provisions of this Act, but subject to subsection (2) and the Public Finance Act,
p.(None): 2004, any money that is—
p.(None): (a) held by the Authority on trust for the purposes of the Trust Account; or
p.(None): (b) accepted by the Authority for the purposes of the Trust Account which is subject to a condition;
p.(None): shall not be dealt with except in accordance with this Act, the condition and the obligations of the trustees as set
p.(None): out in a Trust to be established by the Minister for the purposes of this Act.
p.(None): (2) There shall be kept separate accounts of each sum of money standing to the credit of the Trust Account that
p.(None): represents an amount given as a gift or bequest for specific health research.
p.(None): PART V
p.(None): HEALTH RESEARCH ON, OR EXPERIMENTATION WITH HUMAN PARTICIPANTS AND ANIMAL SUBJECTS
p.(None): 45. (1) Health research or experiments on a human participant shall be conducted—
p.(None): (a) in the prescribed manner consistent with this Act;
p.(None): (b) with the written consent of the person, after the person has been informed of the objectives of the research or
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 31
p.(None):
p.(None):
p.(None): experimentation and any possible potential risks or benefits on that person’s health;
p.(None): (c) in the case of a deceased person, with written consent as provided in the Human Tissue Act;
p.(None): (d) if it does not threaten national security;
p.(None): (e) if it does not violate social and cultural norms; and
p.(None): (f) in Zambia, with ethical approval by the Board or accredited health research ethics committee in accordance
p.(None): with this Act.
p.(None): (2) Research involving human participants shall embrace all the following basic pillars of health research ethics:
...
p.(None): (f) respect of participants;
p.(None): (g) confidentiality;
p.(None): (h) protection of interests of stakeholders;
p.(None): (i) good clinical and laboratory practice; and
p.(None): (j) independent review.
p.(None): (4) Health research on a minor for therapeutic purposes shall be conducted—
p.(None): (a) if it is in the best interest of the minor;
p.(None): (b) in such manner and on such conditions as may be prescribed in a regulatory framework;
p.(None): (c) with the consent of the parent or legal guardian of the minor; and
p.(None): (d) if the minor is capable of understanding the nature and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Cap. 306
p.(None):
p.(None):
p.(None): 32 No. 2 of 2013] National Health Research
p.(None):
p.(None): the potential risks and benefits of the health research, with the consent of the minor.
p.(None): (5) Health research on a minor for non therapeutic purposes shall be conducted —
p.(None): (a) in such manner and on such conditions as may be prescribed;
p.(None): (b) with the consent of the Authority;
p.(None): (c) with the consent of the parent or legal guardian of the minor; and
p.(None): (d) if the minor is capable of understanding the nature and potential risks and benefits of the health research, the
p.(None): consent of the minor.
p.(None): (6) The Authority shall not consent to a health research under paragraph (b) of subsection (5), in circumstances where—
p.(None): (a) the objectives of the health research or experimentation may also be achieved if it is conducted on an adult;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the minor’s condition, disease or disorder to such an extent that shall result in significant benefit to the minor;
p.(None): (c) the reasons for the consent to the health research or experimentation by the parent or guardian of the
p.(None): minor and, if applicable, the minor, are contrary to social norms and public policy;
p.(None): (d) the health research or experimentation poses a significant risk to the health of the minor; or
p.(None): (e) there is some risk to the health or well being of the minor and the potential benefit of the health research
p.(None): or experimentation does not significantly outweigh that risk.
p.(None): (7) Health research involving special groups such as prisoners, pregnant women, persons with mental disabilities, or
p.(None): workers in a hierarchical system shall be conducted—
p.(None): (a) in such manner and on such terms and conditions as may be prescribed;
p.(None): (b) with the consent of the Authority, on recommendations from a committee of relevant experts established by the
p.(None): Minister; and
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 33
p.(None):
p.(None):
p.(None): (c) if the person is capable of understanding, with the written consent of the person, after the person has been
p.(None): informed of the objectives of the health research or experimentation and any possible potential
p.(None): risks and benefits on the person’s health.
p.(None): (8) The Authority shall not consent to health research under paragraph (b) of subsection (7) in circumstances
p.(None): where—
p.(None): (a) the objectives of the health research or experimentation may also be achieved if conducted on the general
p.(None): population;
p.(None): (b) the health research or experimentation is not likely to significantly improve scientific understanding
p.(None): of the special group’s condition, disease or disorder to such an extent as shall result in significant benefit to
p.(None): their health or well being;
p.(None): (c) the reasons for the consent to the health research or experimentation are contrary to social norms and public
p.(None): policy;
p.(None): (d) the health research or experimentation poses a significant risk to the health of the special group under
p.(None): consideration; or
p.(None): (e) there is some risk to the health or well being of the special group and the potential benefit of the health
p.(None): research or experimentation shall not significantly outweigh that risk.
p.(None): (9) Health research shall not be conducted without the inclusion of a Zambian, who resides in Zambia, on the research
p.(None): team as a principal or co-principal researcher.
p.(None): (10) A research institution that hosts foreign students or other individuals for the purposes of conducting health
p.(None): research shall ensure that the students and those other individuals comply with the Immigration and Deportation Act,
p.(None): 2010.
p.(None): (11) The Minister may, by statutory instrument, make regulations for the conduct of health research on, or
p.(None): experimentation with, animal subjects.
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of reproductive cloning of human beings
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of removal of tissue, organs, blood, blood products or gametes from living persons for research
p.(None): purposes
p.(None): (b) the principles and standards applicable to the conduct of health research on animal subjects; and
p.(None): (c) any other matters necessary for the proper conduct of health research on animal subjects in accordance with
p.(None): the provisions of this Act.
p.(None): 46. (1) A person shall not —
p.(None): (a) manipulate any genetic material, including the genetic material of humans for the purpose of cloning a human being;
p.(None): or
p.(None): (b) engage in any activity, including nuclear transfer or embryo splitting, gametes, zygotes or embryos for the purpose
p.(None): of reproductive cloning of a human being.
p.(None): (2) A person shall not export or import human zygotes or embryos without the prior written approval of the Minister.
p.(None): (3) A person who contravenes a provision of this section or who fails to comply with this section commits an offence
p.(None): and is liable, upon conviction, to a fine not exceeding four hundred thousand penalty units or to imprisonment for a
p.(None): period not exceeding five years, or to both.
p.(None): (4) The Minister may, in consultation with the Authority, if it is consistent with this Act and any other written law,
p.(None): and upon such terms and conditions as the Minister may consider necessary, by notice in the Gazette, exempt any person
p.(None): or category of persons from any or all of the provisions of this section.
p.(None): 47. (1) A person shall not remove any tissue, organ, blood, blood product or gametes from a living person for health
p.(None): research purposes unless it is done with the written consent of the person from whom the tissue, organ, blood, blood
p.(None): product or gametes are removed in accordance with this Act, the regulatory framework or as is otherwise prescribed.
p.(None): (2) A person shall not withdraw blood, blood products, tissue or gametes from a living person for any unspecified
p.(None): future health research activity or unspecified storage.
p.(None): (3) A person shall not remove any tissue or organ which is not replaceable by natural processes from a minor.
p.(None): (4) A person shall not sell or cause another person to sell that person’s tissue, organ, blood, blood product or
p.(None): gametes from a living body for any purposes including health research.
p.(None): (5) A person who contravenes this section commits an offence and is liable, upon conviction, to a fine not exceeding
p.(None): four million penalty units or to imprisonment for a period not exceeding seven years or to both.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 35
p.(None):
p.(None):
p.(None): PART VI
p.(None): BIOLOGICAL MATERIALS FOR HEALTH RESEARCH
p.(None): 48. Notwithstanding any other law, biological material for health research shall only be collected for the purposes
p.(None): for which it is indicated in the research protocol.
p.(None): 49. (1) The Minister shall designate specific research institutions and sites as bio-banks in accordance with
p.(None): section fifty- one, and grant a licence, in the prescribed manner, to research institution, site or health
p.(None): establishment which are able to provide storage services.
p.(None): (2) A bio-bank shall comply with the provisions of the Environmental Management Act, 2011, and the Health
p.(None): Professions Act, 2009.
p.(None): (3) A person, other than the holder of a licence granted in accordance with subsection (1), who keeps
p.(None): biological materials commits an offence and is liable, upon conviction, to a fine not exceeding two million penalty
p.(None): units or to imprisonment for a term not exceeding four years, or to both.
p.(None): 50. (1) A person shall not export or import biological materials without the prior written approval of the Authority
p.(None): as provided under subsection (2).
p.(None): (2) The Authority may, on the recommendation of the Board, permit the export or import of biological materials if all
p.(None): the prescribed elements of a material transfer agreement are met.
p.(None): (3) A person who contravenes this section commits an offence and is liable, upon conviction, to a fine not exceeding
p.(None): two million penalty units or to imprisonment for a period not exceeding four years, or to both.
p.(None): 51. (1) The Minister may, by notice in the Gazette, designate any research institution, site or health establishment
p.(None): as a bio-bank.
p.(None): (2) A research institution, site or health establishment designated as a bio-bank under subsection (1), may
p.(None): (a) receive biological materials for storage purposes;
p.(None): (b) store biological material remnants for a period not exceeding ten years, unless the Authority approves a
p.(None): longer period of time for special reasons; and
p.(None): (c) dispose of biological materials that are due for disposal following prescribed bio-hazard waste guidelines.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Purposes of collection of biological materials
p.(None): Storage of biological materials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. 12
p.(None): of 2011
p.(None): Act No. 24
p.(None): of 2009
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Exportation and importation of biological materials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Designation of
p.(None): institution as bio-bank
p.(None):
p.(None):
p.(None): 36 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None): Searches at ports of entry, exit and sites Cap. 295
p.(None): Act No. 16
p.(None): of 2005
p.(None): Act No. 18
p.(None): of 2010
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Ownership of biological materials and material transfer agreement
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Clinical trials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Act No. of 2013
p.(None): 52. (1) An officer authorised under the Public Health Act, Ionising Radiation Protection Act, 2005, and
p.(None): Immigration and Deportation Act, 2010, and any other relevant law enforcement officer may conduct a search, at any
p.(None): reasonable time, at any site, port of entry and port of exit.
p.(None): (2) Any biological material that is found to have been transferred without the necessary approvals and supporting
p.(None): documentation, as required under this Act, shall be confiscated and the person transferring the biological
p.(None): material commits an offence and is liable to the general penalty.
p.(None): 53. (1) The Minister shall, in consultation with the Authority, prescribe and specify the requirements and contents
p.(None): of a material transfer agreement and shall provide for the terms and conditions regarding—
p.(None): (a) ownership of the material, including any of its derivatives and modifications; and
p.(None): (b) intellectual property rights, publication rights, the various uses of the material, including reproduction
p.(None): and replication, confidentiality of information and transfer to third parties and liabilities.
p.(None): PART VII CLINICAL TRIALS
p.(None): 54. (1) The Minister, in consultation with the Authority, shall make regulations for the conduct of clinical trials
p.(None): in Zambia.
p.(None): (2) The Minister may constitute a special expert review panel on matters of public interest, public policy or
p.(None): national security concerning the conduct of clinical trials.
p.(None): (3) A medicine to be used in a clinical trial shall be approved by the Zambia Medicines and Regulatory Authority as
p.(None): prescribed under the Medicines and Allied Substances Act, 2013.
p.(None): (4) A clinical trial on human beings shall only be conducted—
p.(None): (a) in the prescribed manner;
p.(None): (b) if the researcher is in possession of a letter of approval issued by the relevant research ethics committee;
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 37
p.(None):
p.(None):
p.(None): (c) if the researcher has a clinical trial certificate issued by the Zambia Medicines Regulatory Authority;
p.(None): (d) has ethical approval granted by the Board;
p.(None): (e) in accordance with Part V; and
p.(None): (f) with proven evidence of being in possession of a no fault insurance for all research participants.
p.(None): PART VIII
p.(None): RESEARCH IN TRADITIONAL, COMPLEMENTARY AND ALTERNATIVE MEDICINE
p.(None): 55. (1) The Minister, in consultation with the Authority shall—
p.(None): (a) make regulations for facilitating health research in traditional, complementary and alternative medicine in Zambia;
p.(None): (b) ensure wide dissemination of information on traditional, complementary and alternative medicine;
p.(None): (c) foster collaborative research between and among traditional and conventional health researchers and
p.(None): research institutions; and
p.(None): (d) ensure that nothing in the execution of this Act prevents traditional health practitioners from individually
p.(None): or collectively protecting their intellectual property rights and indigenous knowledge relating to the processing of
p.(None): their medicinal preparations or final products.
p.(None): PART VIX INTELLECTUAL PROPERTY RIGHTS
p.(None): 56. (1) Any intellectual property rights arising from, or connected with, health research undertaken under
p.(None): this Act shall be protected under the relevant laws and a health researcher or research institutions shall be
p.(None): entitled to the full dissemination of information and benefits of the health research.
p.(None): (2) Notwithstanding subsection (1), a research institution or a health researcher shall patent and hold rights of all
p.(None): innovations and inventions that are products of dedicated and original scientific research under the relevant laws
p.(None): relating to registration of intellectual property rights.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research in traditional, complementary and alternative medicine
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Intellectual property rights
p.(None):
p.(None):
p.(None): 38 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Entry by inspectors or other authorised
p.(None): persons
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Duty to provide information to inspector
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Service of notice
p.(None): PART X GENERAL PROVISIONS
p.(None): 57. (1) An inspector, agent of the Authority or any person authorised by the Authority for the purpose, may
p.(None): at any reasonable time, enter on to any site and inspect the site, after giving reasonable notice to a health
p.(None): researcher or person responsible for a research institution, for the purpose of ensuring compliance with this Act.
p.(None): (2) Notwithstanding subsection (1), an inspector may enter a site or premises for purposes of this Act, with
p.(None): warrant, if the inspector has reasonable grounds to believe that a provision of this Act or of any other regulatory
p.(None): framework has been or is about to be contravened or the site or premises are used or are being used for the commission
p.(None): of an offence.
p.(None): (3) If so requested by a health researcher or person responsible for a research institution, an inspector, agent of
p.(None): the Authority or a person authorised by the Authority shall produce evidence of the authorisation or permission, as the
p.(None): case may be, to enter on to the site or premises.
p.(None): (4) A person exercising any power under this section shall do so with reasonable care and in such a manner as to cause
p.(None): as little damage as possible.
p.(None): 58. (1) A health researcher or research institution and any employee or agent of a health researcher or
p.(None): research institution shall, on demand by an inspector—
p.(None): (a) avail to the inspector such information as is within their knowledge in all matters relating to any inspection or
p.(None): investigation done under this Act; and
p.(None): (b) produce for inspection, any research protocol, licence, material transfer agreement or other document or record, as
p.(None): the case may be, relating to the health research being undertaken on the site or any matter that is the cause for the
p.(None): inspection or investigation.
p.(None): (2) A person who contravenes subsection (1) commits an offence and is liable, upon conviction, to the general penalty
p.(None): provided under this Act.
p.(None): 59. (1) Any notice required to be served under this Act shall be served—
p.(None): (a) by delivering it personally to the person required to be served or, if the person is absent or cannot be found
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 39
p.(None):
p.(None):
p.(None): (i) by leaving it at the person’s usual or last known place of abode in Zambia; or
p.(None): (ii) by registered post, addressed to the person’s usual or last known address in Zambia; or
p.(None): (b) in the case of a notice required to be served on a company or other corporate body, by delivering it to its
p.(None): principal officer, leaving it at the office with an employee or sending it through registered post.
p.(None): 60. (1) Any direction, notice, consent, approval, permission, demand, objection, application or other thing
p.(None): authorised or required by this Act to be given, made or issued by, or to, the Minister, the Authority, the Council,
p.(None): Board, Director or health research ethics committee shall be in writing.
p.(None): (2) A direction, notice, consent, approval, demand or other document which the Authority is authorised or
p.(None): required by or under this Act to give, make or issue may be signed on behalf of the Authority by—
p.(None): (a) the Director or Secretary; or
p.(None): (b) an officer of the Authority authorised by the Director, in writing, to sign documents of the particular kind or to
p.(None): sign the particular document.
p.(None): 61. (1) A person who commits an offence under this Act shall, if no other penalty is specified or prescribed
p.(None): in respect of the offence, be liable, upon conviction, to a fine not exceeding three hundred thousand penalty units
p.(None): or to imprisonment for a term not exceeding three years, or to both.
p.(None): (2) In addition to the penalties, specified under subsection (1), any contravention of this Act or any regulations made
p.(None): under this Act shall be a ground for terminating a research protocol, licence or any permission or approval given under
p.(None): this Act.
p.(None): (3) Where a person is convicted of an offence under this Act any research material or substance relating to the
p.(None): research shall be forfeited to the State.
p.(None): 62. Where an offence under this Act is committed by a body corporate or an unincorporate body, every director or
p.(None): manager of the corporate or unincorporate body is liable, upon conviction, as if the director or manager had
p.(None): personally committed the offence, unless the director or manager proves to the satisfaction of the court that the act
p.(None): constituting the offence was done without the
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Authentication of documents
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): General penalties for offences
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Offences by body corporate or an unincorporate body
p.(None):
p.(None):
p.(None): 40 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Regulations
p.(None):
p.(None):
p.(None):
p.(None): Transitional provisions
p.(None): knowledge, consent or connivance of the director or manager or that the director or manager took reasonable steps to
p.(None): prevent the commission of the offence.
p.(None): 63. The Minister may, in consultation with the Authority, by statutory instrument, make regulations for the better
p.(None): carrying out of the provisions of this Act.
p.(None): 64. (1) The National Health Research Advisory Committee established by the Ministry responsible for health shall
p.(None): cease to exist three months after the constitution of the Authority.
p.(None): (2) Any health research related rights, liabilities, legal proceedings or obligations of the National Health Research
p.(None): Advisory Committee or any committee or research body established under the Ministry responsible for health which are
p.(None): transferrable shall without further assurance be transferred to the Authority.
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 41
p.(None):
p.(None):
p.(None): SCHEDULE
p.(None): (Sections 4 (2) and 42)
p.(None): THE NATIONAL HEALTH RESEARCH AUTHORITY PART 1
p.(None): ADMINISTRATION OF AUTHORITY
p.(None): 1. (1) The seal of the Authority shall be such device as may be determined by the Authority and shall be kept by the
p.(None): Secretary.
p.(None): (2) The affixing of the seal shall be authenticated by the Chairperson or the Vice-Chairperson and the
p.(None): Secretary or any other person authorised in that behalf by a resolution of the Council.
p.(None): (3) Any contract or instrument which, if entered into or executed by a person not being a body corporate, would not be
p.(None): required to be under seal, may be entered into or executed without seal on behalf of the Authority by the Secretary or
p.(None): any other person generally or specifically authorised by the Council in that behalf.
p.(None): (4) Any document purporting to be a document under the seal of the Authority or issued on behalf of the Authority shall
p.(None): be received in evidence and shall be deemed to be so executed or issued, as the case may be, without further proof,
p.(None): unless the contrary is proved.
p.(None): 2. (1) A member of the Council shall, subject to the other provisions of this Schedule, hold office for a
p.(None): term of three years and may be re-appointed for a further term of three years.
p.(None): (2) Upon the expiration of the term for which a member is appointed, the member shall continue to hold
p.(None): office until another member is appointed, but in no case shall any extension of the period exceed three months.
p.(None): (3) The office of a member becomes vacant—
p.(None): (a) upon the member’s death;
p.(None): (b) if the member is adjudged bankrupt;
p.(None): (c) if the member is absent, without reasonable excuse, from three consecutive meetings of the Authority of which the
p.(None): member had notice, without the prior approval of the Authority;
p.(None): (d) upon the expiry of one month’s notice of the member’s intention to resign, given by the member, in writing, to the
p.(None): Minister;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Seal of
p.(None): Authority
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Tenure of office
p.(None): and vacancy of
p.(None): member
p.(None):
p.(None):
p.(None): 42 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Filling of casual vacancy
p.(None):
p.(None):
p.(None):
p.(None): Proceedings of
p.(None): Council
p.(None): (e) if the member becomes mentally or physically incapable of performing duties as a member; or
p.(None): (f) if the member is convicted of an offence under this Act or any other law.
p.(None): 3. The Minister may, where the office of a member becomes vacant before the expiry of the term of office,
p.(None): appoint another member in place of the member who vacates office, but that member shall hold office only for the
p.(None): unexpired part of the term.
p.(None): 4. (1) Subject to this Act, the Council may regulate its own procedure.
p.(None): (2) The Council shall meet for the transaction of business at least once in every three months at such places and times
p.(None): as the Chairperson may determine.
p.(None): (3) The Chairperson may, upon giving notice of not less than fourteen days, call a meeting of the Council and shall
p.(None): call a special meeting to be held within fourteen days of receipt of a written request to the Chairperson by at least
p.(None): five members of the Council.
p.(None): (4) If the urgency of any particular matter does not permit the giving of such notice as is required under subparagraph
...
p.(None):
p.(None): (9) The validity of any proceedings, act or decision of the Council shall not be affected by any vacancy in the
p.(None): membership of the Council or by any defect in the appointment of any member or by reason that any person not
p.(None): entitled to do so took part in the proceedings.
p.(None): 5. The members of the Council, the Board or any committee shall be paid such allowances as the Council may, with the
p.(None): approval of the Minister, determine.
p.(None): 6. (1) If a member or any person is present at a meeting of the Council or any committee of the Council at which any
p.(None): matter is the subject of consideration and in which matter the member or that person or the member’s or that
p.(None): person’s relative is directly or indirectly interested, in a private capacity, is the subject of
p.(None): consideration, the member or person shall, as soon as is practicable, after the commencement of the meeting, declare
p.(None): such interest and shall not, unless the Council or the committee otherwise directs, take part in any consideration or
p.(None): discussion of, or vote on, any question touching that matter.
p.(None): (2) A declaration of interest made under this paragraph shall be recorded in the minutes of the meeting at which it is
p.(None): made.
p.(None): (3) In this paragraph, “ relative ” in relation to a person means—
p.(None): (a) a parent, son, daughter, brother, sister, niece, uncle, aunt, grandparent or cousin of that person or that person’s
p.(None): spouse; and
p.(None): (b) a spouse of that person.
p.(None): 7. (1) A person shall not, without the consent, in writing, given by, or on behalf of, the Authority, publish
p.(None): or disclose to any unauthorised person, otherwise than in the course of duties of that person, the contents of any
p.(None): document, communication or information whatsoever, which relates to or which has come to the knowledge of that person
p.(None): in the course of that person’s duties under this Act.
p.(None): (2) A person who contravenes subparagraph (1) commits an offence and is liable, upon conviction, to a fine not
p.(None): exceeding three hundred thousand penalty units or to imprisonment for a period not exceeding two years, or to both.
p.(None): (3) A person who, having any information which to the knowledge of that person has been published or disclosed in
p.(None): contravention of subparagraph (1), unlawfully publishes or communicates the information to any other person,
p.(None): commits an offence and is liable,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Allowances for
p.(None): members
p.(None):
p.(None): Disclosure of
p.(None): interest
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prohibition of publication or disclosure of information to unauthorised persons
p.(None):
p.(None):
p.(None): 44 No. 2 of 2013] National Health Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Immunity
p.(None): upon conviction, to a fine not exceeding three hundred thousand penalty units or to imprisonment for a period not
p.(None): exceeding two years, or to both.
p.(None): 8. An action or other proceeding shall not lie or be instituted against a member of the Council, the Board or a
p.(None): committee of the Board for, or in respect of, any act or thing done or omitted to be done in good faith in the exercise
p.(None): or performance of, or purported exercise or performance of, any of the powers, functions or duties conferred under this
p.(None): Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Funds of Authority
p.(None): PART II FINANCIAL PROVISIONS
p.(None): 9. (1) The funds of the Authority shall consist of such moneys as may—
p.(None): (a) be appropriated to the Authority by Parliament for the purposes of the Authority;
p.(None): (b) be paid to the Authority by way of fees, charges, grants or donations; and
p.(None): (c) otherwise vest in or accrue to the Authority.
p.(None): (2) The Authority may—
p.(None): (a) accept moneys by way of grants, gifts, bequests or donations from any source in Zambia and subject to the
p.(None): prior approval of the Minister, in writing, from any source outside Zambia;
p.(None): (b) subject to the approval of the Minister, raise by way of loans or otherwise, such moneys as it may require for the
p.(None): discharge of its functions; and
p.(None): (c) in accordance with the regulations made under this Act, charge fees for services provided by the Authority.
p.(None): (3) There shall be paid from the funds of the Authority—
p.(None): (a) salaries, allowances, loans, gratuities and pensions of staff of the Authority, and other payments for the
p.(None): recruitment and retention of staff;
p.(None): (b) such reasonable travelling and subsistence allowances for members, members of the Board or any committee of
p.(None): the Council, when engaged on the business of the Authority at such rates as the Minister may determine; and
p.(None):
p.(None):
p.(None): National Health Research [ No. 2 of 2013 45
p.(None):
p.(None):
p.(None):
p.(None): (c) any other expenses incurred by the Authority in the performance of its functions.
p.(None): (4) Notwithstanding subsections (1), (2) and (3) any moneys paid to the Authority as bequests and donations or grants
p.(None): for health research shall be paid into the Trust Account.
p.(None): (5) The Authority may, after the approval of the Minister, invest in such manner as it thinks fit such of its
p.(None): funds as it does not immediately require for the discharge of its functions.
p.(None): 10. The financial year of the Authority shall be the period of twelve months ending on 31st December of each year.
p.(None): 11. (1) The Authority shall cause to be kept proper books of accounts and other records relating to its accounts.
p.(None): (2) The Authority shall, within ninety days of the expiry of the financial year, submit to the Minister a report
p.(None): concerning its activities during the financial year.
p.(None): (3) The report referred to in subparagraph (2) shall include statements of income and expenditure and a
p.(None): statement of affairs or balance sheet.
p.(None): (4) The accounts of the Authority shall be audited annually or whenever necessary by the Auditor General.
p.(None): 12. (1) As soon as practicable, but not later than ninety days after the end of the financial year, the Authority
p.(None): shall submit to the Minister a report concerning its activities and the activities of the Board during the financial
p.(None): year.
p.(None): (2) The report referred to in subparagraph (1) shall include information on the financial affairs of the
p.(None): Authority and there shall be appended to the report—
p.(None): (a) an audited balance sheet;
p.(None): (b) an audited statement of income and expenditure; and
p.(None): (c) such other information as the Minister may require.
p.(None): (3) The Minister shall not later than seven days after the first sitting of the National Assembly next after receipt of
p.(None): the report referred to in subparagraph (1), lay the report before the National Assembly.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Accounts and audit
p.(None):
p.(None): Financial years
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| another country | Other Country |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| conviction | Religion |
| criminal | criminal |
| disability | Mentally Disabled |
| education | education |
| embryo | embryo |
| faith | Religion |
| gender | gender |
| hazard | Natural Hazards |
| incapable | Mentally Incapacitated |
| indigenous | Indigenous |
| manipulate | Manipulable |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| physically | Physically Disabled |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| religious | Religion |
| substance | Drug Usage |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| conviction | ['faith', 'religious'] |
| disability | ['mentally'] |
| faith | ['conviction', 'religious'] |
| mentally | ['disability'] |
| religious | ['faith', 'conviction'] |
Trigger Words
capacity
consent
cultural
ethics
justice
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input