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