National Health Research Act, 2013
This section defines key terms and says the Act applies to health research, biological material, and personal health data in Zambia, including some research conducted outside Zambia under Zambian direction.
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This section defines key terms and says the Act applies to health research, biological material, and personal health data in Zambia, including some research conducted outside Zambia under Zambian direction. This section establishes the National Health Research Authority and gives it corporate status and powers. The Authority must regulate and oversee health research in Zambia, and it may take enforcement and inspection actions against researchers or institutions. The Authority is governed by a Council, whose members are appointed by the Minister, subject to eligibility rules and composition requirements. The Council must exercise specified Authority functions, and the Minister may give the Council directions consistent with the Act.
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Provisions of National Health Research Act, 2013
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This section defines key terms and says the Act applies to health research, biological material, and personal health data in Zambia, including some research conducted outside Zambia under Zambian direction.
2. In this Act, unless the context otherwise requires- Interpretation 8 No. of 2013] ·. ,,, ,.c National Health Research " accreditation " means a process of certification of • OJ 1 1 ,, , · .f::: ·., , /'./ comP.;e/,ence inihe'alth research; Cap. I " animal•subject "means an anima·l which is us·ed for health research or clinical trial; "Authority" means the National Health Research Authority established under sectionfour; "Board" means the National Health Research Ethics Board constituted under s".ction 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 hull)an or animal tissue; " blood product" means any product derived or produced from blood, including circulating progenitor cells, bone �arrow progenitor cells and umbilical cord progenitor cells; " Board Ch11irperson " 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 reguiations " means regulation� 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; " committcie" means a committee of the ·council established under section nine; National Health Research [·No. 2 of2013 9 : • • · • -- • •c .. " consent " means a voluntary agreement to participate in health research by a'person, ''«-ho is �ot11irtinor, with full understanding of the potential risks and,:benefits of the health research; ·td,-C)·1 ·· " 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 d,esigned to provide inpatient or outpatient treatment, diagnostic or therapeutic interventions, nursing, rehabilitative, palliative, conv�lescent, 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 scie'ntific methods to generate information to deal with he1'lth and disease; (c) improves s,cientific methods for provision of health services and human pathol?gy; (d) investigates cause� of disea�e and the effects of the environment on the human body; or {e) develops new applications of pharmaceuticals, medicines and h.ealth technology; - ' · ,· " health research ethics committee ''..means a, qommittee registered . , , ' '· and accredited by the Board' under section eighte?n; 10 No. 2 of2013] . National Health Research Cap. 306 Act No. of 2013 " 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 o� 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 i�sued under section thirty-six; " inspector " m�ans a person appointed by the Authority as �n inspe�tor for the purposes of this Act; " national health research strategic plan " means a national plan that JJrioritises 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 ag11, understanding or self control, is incapable of administering that person's own affairs; " material transfer agreement " means a written contract b_etween the provider and recipient of research material as prescribed under section fifty-three; " medicine" has the meaning assigned to it in the Medicines . an_d 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; National Health Research [ No. 2 of2013 11 " regulatory framework " means any s\atute 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 � somatic cell of the brganism 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 anci 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; " tr_aditional ,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; . 12· No. 2 of2013] National Health Research "Trust Account" means,the Health Research Trust Account established under section forty-one; "verteb;at� 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, butte�fly a�d any other insect used in the production of animal proilucts, and includes the carcass of an animal; and " Vice-Chairperson " means the person elected Vice- ' , Chairp�rson of the Council under section seven. •. Application and scope 3, (I) 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 (!), 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 Establishment of National Health Research Authority
Part
PART II
- 4 Verify source ↗
Establishment of National Health Research Authority
This section establishes the National Health Research Authority and gives it corporate status and powers.
4. (!) 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. Functions of Authority (2) Th� Schedule applies to the Authority. - 5 Verify source ↗
Functions of Authority
The Authority must regulate and oversee health research in Zambia, and it may take enforcement and inspection actions against researchers or institutions.
5. (I) The functions of the Auth9rity are to- (a) regulate the conduct ofresearch 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; ' ' National Health Research . ' [ .No. 2 of 2013. 13 (j) identify and recommend to the Minister national health research priorities for il)corporation ii) national health research strategic plans; (g) advise the Minister on the application and implementation of national health research strategic phms; (h) foster partnerships in product development and commercialisation of innovations in h�alth research; . (lj hanrionise, nehvork and promote public-private partnerships in health research; (j) register a�d accredit research institutions and health research�r�; (k) investigaie reports of professional misconduct relating to health research and report the misconduct to the relevant . professional association or statutory body; (I) 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; 14 No; 2 of 2013] National Health Research Powers of Authority (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 !}pproved by the Board for the.c<;>nduct of health research, including databases and bio banks; (e) confiscate, impoun'd and destroy, where necessary, biological materials obtained by any person in contravention: of any provision of this Act; (I) require any health researcher or research institution to submit such _inforl1)ation an·d records as may be nec'essary 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 ofa health research activity to inform the Authority ofthe. intention to move from a site prior to re-locating, Council of Authority - 7 Verify source ↗
Council of Authority
The Authority is governed by a Council, whose members are appointed by the Minister, subject to eligibility rules and composition requirements.
7. (I) 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; National Health Research [ No. 2·of2013 • 15 (v) health; (vi) comnmnity 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 \raditional he,alth practition.er; (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 res�arch ' 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 inember; or (I) 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 Verify source ↗
Exercise of functions and powers of Authority
The Council must exercise specified Authority functions, and the Minister may give the Council directions consistent with the Act.
8. ' (I) 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; Exercise of functions and powers of Authority 16 No. 2 of2013f National Health Research (b) determine policy matters in health �esearch; (c) review the policy ind strategic plan 'of the Authority and oversee the implementation and efficient operation of the policy and functions of the Authority; (d) approve the an_nual budget and plans of the Authority; (e) monitor and-evaluate the performance of the Authority against budgets �nd plans; (I) establish and approve conditions of service of the staff of · theAuthority; (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 C9uncil byor 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. Committees of Council - 9 Verify source ↗
Committees of Council
The Council may set up committees, appoint committee members, and committee members must serve for the period the Council तयmins?
9. ( I ) 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 ofa committee. (3) A person serving as a member cif 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 Verify source ↗
The Council may, by direction, in writing, and subject to
The Council may delegate any functions of the Authority to the Director, any member, or any committee, by written direction and on terms and conditions it considers necessary.
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 o_r any committee any of the functions of the Authority. - 11 Verify source ↗
, (I) The Council shall appoint, on such terms and conditions
The Council appoints a Director, who manages the Authority and attends Council meetings, but cannot vote.
11. , (I) The Council shall appoint, on such terms and conditions as it may determine, a Director who shall be the chief executive ' 1 officer of the Authority . . . (2)'.fhe Director shall be responsible, under the general direction of the Council, for- Delegation of functions Director National Health Research [ No. 2 of2013 17 (a) the management and, administration of the affairs. of the Authority; · (1,),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 add.ress 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 . . f - 12 Verify source ↗
Secretary, inspectors and other staff of AuthGrity
The Council may appoint the Secretary, inspectors, and other necessary staff, and must give an inspector a certificate of appointment in the prescribed form.
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. Secretary, inspectors and other staff of Authority National Health Research Ethics Board (2) The Council shall provide an inspector with a certificate of appointment, in the prescribed form, which shall be prima facie evide�ce of the inspector's appointment. PART III. THE NATIONAL HEALTH RESEARCH ETHICS SYSTEM - 9 Verify source ↗
Committees of Council
The Authority may receive and use money, charge fees, borrow and invest funds, but some actions need the Minister’s approval; certain health-research donations and grants must go into the Trust Account.
9. as may- 1 (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;J 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 \ National Health Research [ No. of 2013 45 (c) any other expenses1 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 ofits functions. - 10 Verify source ↗
The financial year of the Authority shall be the period of ,Accounts
The Authority’s financial year runs for 12 months and ends on 31 December each year.
10. The financial year of the Authority shall be the period of ,Accounts and audit twelve months ending on 3 1st December of each year. I \. - 11 Verify source ↗
Section 11
The Authority must keep proper financial books and records, submit an activity report to the Minister within 90 days after the financial year ends, and its accounts must be audited by the Auditor General.
11. (I) The Authority shall cause to be kept proper books of Financial accounts and other records relating to its accounts. years (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 Verify source ↗
Secretary, inspectors and other staff of AuthGrity
The Authority must submit an annual report to the Minister within 90 days after the financial year ends, and the Minister must table it before the National Assembly within 7 days after the first sitting following receipt.
12. (1) As soon as practicable, but not later than ninety days Annual report 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 financiaj_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 (I), lay the report before the National Assembly. I 46 •
Part
PART III.
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This section establishes the National Health Research Ethics Board and sets out how its members, Chairperson, and Vice-Chairperson are chosen.
13. · ( I ) There is established the Nationa\ Health _Research Ethics Bqard which shall consist of one representative from each ofthe following disciplines and sectors: , ' (a) law; (1,) pharmacology; (c) pharmacy; (d) theology; (e) biostatistics; (f) epidemiology; (g) public health; (h) biomedical science; (i) veterinary medicine; 0) traditional medicine; (k) nursing; (I) socfal 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. 18 No. 2 of 2013) National Health Research (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
The Board must regulate health research ethics, oversee compliance, register and accredit researchers and ethics committees, handle complaints and appeals, and give ethical approval for specified research activities.
14. (I) 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 etliics as provided- in the regulatory framework and ethics guidelines. Functions of Board (2) Notwithstanding the generality of s·ubsection (I), the 'Board shall- ' · ' (a) regulate.the conduct of research and mon.itor and evaluate all health research; (b) register and accredit health researchers and health research: ethics committees; (c) regulate and monitor the 9onduct of health research and health research ethic·s committees; (d) institute such disciplinary action, as inay be prescribed, agai�st any health researcher or research institution found to be in vfolatii:m · of any ethical standards or guidelines set for conducting of liealth research; (e) act as an appeals body from decisions of the health research ethics committees; (j) 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; _ (i) audit health research ethics committees; and (k) review research proposals and research protocols in order to ensure that health re.search conducted by a_re�earch institution or health researcher promotes health, contributes to the prevention of communicable or non- f I I I j National Health Research [ No. 2 of 2013 19 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
Board members serve a three-year term from appointment and may be reappointed once; they may resign with one month’s written notice to the Council, and vacancies arise in specified cases.
15. (I) A member of the Board shall lfold 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. Tenure of office and vacancy of Board (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; (j) if the member becomes mentally or physically incapable of performing the duties of a member; or (g) if the member is declared bankrupt. l ' I ; I I l 20 No. 2 of2013] National Health Research ( 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. Proceedings of Board - 16
The Board must regulate its own meeting procedures, and meetings need a quorum of eight members.
16. (I) The Board shall regulate its own procedures at meetings. (2) The quorum at ati.y meeting of the Board shall be eight members. (3) The disciplinary proceedings of the Board shall be as prescribed. Research protocol - 17
All health research proposals under this Act must be reviewed and approved by the Board, or reviewed by another accredited health research ethics committee if 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. Health research ethics committees - 18
Research institutions and health establishments doing health research must form ethics committees, and the Minister must make regulations for accrediting health researchers and research institutions.
18. (I) 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· b y the respective research i nstitution a n d 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 Verify source ↗
THE NATIONAL HEALTH RESEARCH ETHICS SYSTEM
A health research ethics committee must comply with the Act, regulate its own meeting procedure, and has functions and powers as prescribed.
19. (I) 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 Verify source ↗
Misconduct by health researchers
Health researchers commit misconduct if they do any of the listed prohibited acts, such as lacking approvals or consent, failing to report, or falsifying data. Penalties can include a fine or a ban, and criminal offences may lead to prosecution.
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 i nvolves human participants or potentially affects humans without first obtaining ethical approval under this Act or other approvals required under any other written law; Functions and procedures of health research ethics committee Misconduct by health researchers National Health Research [ No. 2 of2013 21 • (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 withput an approved material transfer agreement, as provided under this Act; (f) shares samples collected prospecth:ely from human participants with other health researchers o� 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 (I) forges approvals or other relevant documents under this Act. (2) A health researcher who contravenes subsection. (!) 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 Verify source ↗
Complaints
Affected health researchers or research institutions may complain to the Board about a health research ethics committee decision and ask for an investigation.
21. ( I ) A health researcher or research institution whose Complaints interests are affected by an action or decision of a health research I l 22 No. 2 of 2013] National Health Research 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 ( I ), 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 d�cision 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 takell'into account in relation to the action or decision; (j) 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. National Health Research [ No. 2 of2013 23 ( 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, ifit decides not to investigate a complaint or to discontinue an i,nvestigation, 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 Verify source ↗
23. Reports by Board
A person asked by the Board or a health research ethics committee to provide information, records, or answers for an investigation is exempt from liability or penalty under this Act or any other written law.
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. Immunity from liability or penalty - 23 Verify source ↗
Reports by Board
The Board must report to the Council after investigating certain complaints, send copies of the report to specified people, and the Council must ensure the relevant research body takes the action the Board considers appropriate and tells the complainant what was done and why.
23. (I) 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. Reports by Board (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 regafd to the recommendations made in .the report of the Board, that the relevant research institution, health researcher or health establishment- 24 No. 2 of2013] National Health Research (a) takes whate_yer 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. Staff of Board - 24 Verify source ↗
25. Disclosure of interest by members of Board
The Authority must second staff to service the Board and provide facilities the Board needs to do its work under the Act.
24. The Authority shall- (a) second staff to service the Board; and Disclosure of interest by members of Board Protection of personal information (b) provide to the Board facilities necessary for it to perform its functions and exercise its powers under this Act. - 25 Verify source ↗
Disclosure of interest by members of Board
A Board member with a conflicting interest must disclose it and may take part in the investigation only if the complainant and the Board agree.
25. (I) Where the Board is investigating, or is to investigate, a complaint concerning af\ 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 sha.11 only take part in the investigation ifthe 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 Verify source ↗
Protection of personal information
The Board must not record or disclose certain personal information, and courts must not require the Board to produce or disclose related records or notices, except in the specified Act-related cases.
26. (!) 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 exerdse 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 ncitice. Immunity of member of Board or committee - 27 Verify source ↗
28. Annual report of Board
No action or other proceeding may be brought against Board or committee members for acts or omissions done in good faith under the Act.
27. An action or other proceeding shall noi 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 • National,Health Research [ No. 2 of2013 25 Annual" report of Board Appeals Jurisdiction over offences committed outside Zambia Priority area for health research exercise of or performance, or puf ported exe;cise or performance ofany of the powers, functions or duties conferred under this Act. - 28 Verify source ↗
Annual report of Board
The Board must give the Authority a written report of its activities each financial year, as soon as practicable after year-end.
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 Verify source ↗
Appeals
A person aggrieved by a Board decision may appeal to the Council within 14 days of service, and then may appeal to a court of competent jurisdiction.
29. ( I ) 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 Verify source ↗
Jurisdiction over offences committed outside Zambia
A health researcher who has been punished for an offence in another country and whose conduct counts as misconduct under this Act may be banned from doing health research in Zambia by the Council on the Board’s recommendation.
30. Where a health researcher has committed an offence for which the heaith 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 N REGULATORY FRAMEWORK FOR HEALTH RESEARCH
Part
PART N
- 31 Verify source ↗
Priority areas for health research
The Authority must identify and prioritise health research areas, advise the Minister, and the Minister must recommend priority areas to Cabinet. Health researchers and research institutions must align their activities with the national health research strategic plan, unless the Authority allows research outside it for public interest or public policy reasons.
31. ( I ) 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 ofresources 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. 26 No. 2 of 2013] National Health Research Dissemination of health reseaI'ch information Access to, and deposition of, health research databases (3)Ahealth researcher and research institution shall align health research activities to the subsisting national health research strategic plan. ( 4) TheAuthotity may allow research outside a national research strategic plan if it is in the public interest or public policy so requires. - 32 Verify source ↗
Dissemination of health research information
Rules on sharing health research information: local dissemination first, notice to the Authority before publishing, and no dissemination of identifiable information without consent and approval.
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 Verify source ↗
Access to, and deposition of, health research databases
The Authority may access health research databases and related data, while the Minister must set up a national system for managing that data and may make regulations for a central repository.
33. ( 1 ) The Authority has the rightto 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. National Health Research [ No. 2 of 2013 27 ( 4) The Authority has the right to access databases, bio banks or any information collected by health researchers and research institutions. - 34 Verify source ↗
Monitoring and evaluation
The Authority must set up monitoring and evaluation mechanisms, train health workers on research methods and ethics, and monitor ongoing health research programmes in Zambia.
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. Monitoring and evaluation - 35 Verify source ↗
The Minister may, in consultation with the Authority
The Minister may, after consulting the Authority, set up community involvement mechanisms, help create a consultative forum, and make regulations for health research programmes and activities.
35. The Minister may, in consultation with the Authority- (a} establish mechanisms for involving communities in health Partnerships in health research 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 Verify source ↗
Human research guidelines
The Council must issue guidelines on the conduct of human research.
36. (!) 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. Human research guidelines (2) The Council shall issue guidelines on the conduct of human research in collaboration with the Board. - 37 Verify source ↗
(!) The Minister, in consultation with the Authority, shall,
Before issuing a proposed regulatory framework, the Minister must consult stakeholders, publish notices, and consider submissions, with exceptions for statutory instruments and urgent or minor proposals.
37. (!) 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- Consultation about regulatory framework (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- 28 No. 2 of2013) National Health Research (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 circ?lation 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. Interim regulatory requirements - 38 Verify source ↗
39. Revocation ofregulatory frameworks
The Minister may issue interim regulatory requirements without the usual section 37 procedure if the matter is urgent, minor, and would normally be covered by a regulatory framework, but must publish notices and seek submissions on them.
38. ( I ) 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 National Health Research I No. 2 of 2013 29 (c) raises issues that are of minor significance; and shall publish a notice, in the Gazette or a daily newspaper ofgeneralcirculationinZ.ambia, statingthereasonsfornotfollowing 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 sununary of the interim regulatory requirement; and (b) inviting person; 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 Verify source ↗
Revocation ofregulatory frameworks
The Minister may revoke any regulatory framework or interim regulatory requirements, and the text says this can be done without undertaking consultation.
39. The Minister, in consultation with the Authority, may, without undertaking consultation, revoke any regulatory framework or interim regulatory requirements. Revocation of regulatory frameworks - 40 Verify source ↗
Procedures for making submissions
The Authority must develop and publish procedures to help people or bodies make submissions under this Part.
40. The Authority shall develop and publish procedures to assist persons or bodies to make. submissions under this Part. - 41 Verify source ↗
Heahh Res�arch Trust Acc;unt
A Health Research Trust Account must be established and opened as a special account in a commercial bank. Any interest earned on money credited to the account must be credited back to the Trust Account.
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) Ifinterest is received by the Authority from the investment ofanamountstandingtothecreditoftheTrustAccount, an amount equal to the interest shall be credited to the TrustAccount. Procedures for making submissions Health Research Trust Account Act No. 1 5 of2004 - 42 Verify source ↗
Credit of amounts to Trust Account
Amounts given or bequeathed for the Trust Account purposes must be credited to the Trust Account, as provided in the Schedule.
42. There shall be credited to the Trust Account amounts equal to amounts that are given or bequeathed for the purposes of the TrustAccount and as provided in the Schedule. Credit of amounts to Trust Account - 43 Verify source ↗
Purposes of Trust Account
The TrustAccount may be used to provide assistance for health research, training in health research, and any other purpose prescribed for this section.
43. (1) The purposes of the TrustAccount are- (a) to provide assistance---- Purposes of Trust Account (i) to the Departments of the Ministries responsible · for human and animal health that are engaged in health research; 30 No. 2 of 2013] National Health Research (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 ( I ) 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 Verify source ↗
Accounting for gifts and bequests
The Authority must keep separate accounts for gifts and bequests for specific health research, and it may only deal with trust-account money as allowed by the Act, the condition, and trustee obligations.
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 Accounting for gifts and bequests Act No. 15 of 2004 HEALTH RESEARCH ON, OR EXPERIMENTATION WITH HUMAN PARTICIPANTS AND ANIMAL SUBJECTS
Part
PART V
- 45 Verify source ↗
Health research on., or experimentatipn with, human
Health research on human participants must follow consent, ethics approval, and other stated conditions; minors and special groups have extra rules.
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 Health research on, or �on with., �uman part1c1pants or animal subjects National Health Research [ No. 2 of2013 31 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 (/) in Zambia, with ethical approval by the Board or accredited health research ethics committee in accordance with this Act. Cap. 306 (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 ofrisks 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; (/) 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) ifit 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 32 No. 2 of2013] National Health Research 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 ofthe Authodty; (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 resdarch under paragraph (b) of subsection (5), iri 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 ofrelevant experts established by the Minister; and National Health Research [ No. 2 of2013 33 (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 r esearch 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)thereasonsfortheconsenttothehealthresearchorexperimentation 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 oftll.e 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. (I 0) 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, 20 I 0. ( 1 1 ) The Minister may, by statutory instrument, make regulations for the conduct of health research on, or experimentation with, animal subjects. ( 12) Notwitl1standing the generality of subsection ( 1 1 ), 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; Act No. I S of2010 l f 34 No. 2 of2013] 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 (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 Verify source ↗
Prohibition ofreproductive cloning of human beings
A person must not clone or try to clone human beings using genetic material, and must not export or import human zygotes or embryos without the Minister’s prior written approval.
46. (!) 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 Verify source ↗
Prohibition ofremoval of tissue, organs, blood, blood
A person must not remove or sell certain human tissue, blood, organs, or gametes for health research without written consent, and some removals from minors or for unspecified future research/storage are also prohibited.
47. (!) 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. I National Health Research [ No. 2 of2013 35 PART VI BIOLOGICAL MATERIALS FOR HEALTH RESEARCH
Part
PART VI
- 48 Verify source ↗
Purposes ofcollection ofbiological materials
Biological material for health research may be collected only for the purposes stated in the research protocol.
48. Notwithstanding any other Jaw, biological material for health research shall only be collected for the purposes for which it is indicated in the research protocol. - 49 Verify source ↗
Storage of biological materials
The Minister may designate bio-banks and grant licences to storage-service providers. Bio-banks must comply with two listed Acts. Unlicensed persons who keep biological materials commit an offence and face fines or imprisonment.
49. { I ) The Minister shall designate specific research institutions and sites as bio-banks in accordance with sectionfifiy 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 (I), 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 Verify source ↗
Exportation and importation of biological materials
A person may not export or import biological materials unless the Authority gives prior written approval.
50. (I ) 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 ofbiological 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 Verify source ↗
Designation of institution as bio-bank
The Minister may designate a research institution, site, or health establishment as a bio-bank, and a designated bio-bank may receive, store, and dispose of biological materials under the stated limits.
51. {I) 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 (I), 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. Purposes of collection of biological materials Storage of biological materials . Act No. 1 2 of201 I Act No. 24 of 2009 Exportation and importation of biological materials Designation of institution as bio-bank 36 No. 2 of 2013] National Health Research Searches at ports of entry, exit and sites Cap. 295 Act No. 1 6 of2005 Act No. 18 of2010 Ownership of biological materials and material transfer agreement - 52 Verify source ↗
Searches at ports of entry, exit and sites
Authorized officers may search any site, port of entry, or port of exit at any reasonable time. Biological material transferred without required approvals and supporting documents may be confiscated, and the person who transferred it commits an offence and is liable to the general penalty.
52. (I) An officer authorised under the Public Health Act, Ionising Radiation Protection Act, 2005, and Immigration and Deportation Act, 20 I 0, and any other relevant Jaw 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 Verify source ↗
Ownership of biological materials and material transfer,
The Minister must consult the Authority and set the requirements and contents of material transfer agreements, including ownership, intellectual property, publication rights, uses, confidentiality, third-party transfer, and liabilities.
53. (I) 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 ofits 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 Clinical trials
Part
PART VII
- 54 Verify source ↗
Clinical trials
The Minister must make regulations for clinical trials in Zambia and may set up a special expert review panel. Medicines used in a clinical trial must be approved by the Zambia Medicines and Regulatory Authority.
54. (!) The Minister, in consultation with the Authority, shall make regulations for the conduct of clinical trials in Zambia. Act No. of 2013 (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, 20 I 3. ( 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 Jetter of approval issued by the relevant research ethics committee; National Health Research [ No. 2 of 2013 37 (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 (j) with proven evidence of being in possession of a no fault insurance for all research participants. PART VIII RESEARCH IN TRADITIONAL, COMP LEMENTARY AND ALTERNATIVE MEDICINE
Part
PART VIII
- 55 Verify source ↗
Research in traditional, complementary and alternative
The Minister must, after consulting the Authority, make regulations and take steps to support traditional, complementary and alternative medicine research and information, and to protect practitioners’ intellectual property and indigenous knowledge.
55. (I) The Minister, in consultation with the Authority shall (a) make regulations for facilitating health research in 1raditiona� complementazy and alternative medicine in Zambia; Research in traditional, complementary and alternative medicine (b) ensure wide dissemination of information on traditional, complementary and alternative medicine; {c) foster co!]aborative 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 RJGHTS Intellectual property rights
Part
PART VIX
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Intellectual property rights
Health research IP arising under the Act must be protected, and researchers or research institutions are entitled to full dissemination of information and benefits. Research institutions and health researchers must also patent and hold rights to innovations and inventions from dedicated and original scientific research.
56. ( I ) 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 (I), 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. 38 No. 2 of 2013] National Health Research PART X GENERAL PROVISIONS Entry by inspectors or other authorised persons
Part
PART X
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Entry by inspectors or either authorised persons
Inspectors, Authority agents, or authorised persons may enter and inspect sites, and inspectors may also enter with a warrant in specified cases.
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) Ifso 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. Duty to provide information to inspector - 58 Verify source ↗
Duty to provide information to inspector
Health researchers, research institutions, and their employees or agents must give an inspector information and relevant research documents on demand.
58. ( I ) 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 inspbtion 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 invesHgation. (2) A person who contravenes subsection (I) commits an offence and is liable, upon conviction, to the general penalty provided under this Act. - 59 Verify source ↗
Service of Notice
Notices required under this Act must be served personally, by leaving them at a usual or last known abode or address in Zambia, or by registered post; notices for a company or other corporate body may be delivered to the principal officer, left at the office with an employee, or sent by registered post.
59. ( I ) 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 Service of notice I '· j • National Health Research [ No. 2 of2013 39 (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 Verify source ↗
Authentication of documents
Certain directions, notices, approvals, applications, and similar documents under the Act must be in writing, and some Authority documents may be signed by specified officers.
60. ( I ) 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 Verify source ↗
General penalties for offences
A person convicted of an offence under the Act may face a fine, imprisonment, or both if no other penalty is set; contraventions can also trigger termination of a research protocol, licence, or other permission, and related research material may be forfeited to the State.
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 ( ! ), 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 Verify source ↗
Offences by body corporation or an unincorporate body
If a body corporate or unincorporate body commits an offence under the Act, each director or manager can be held liable on conviction unless they prove lack of knowledge, consent, connivance, or that they took reasonable steps to prevent it.
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 Authentication of documents General penalties for offences Offences by body corporate or an unincorporate body 40 No. 2 of 2013) National Health Research 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. Regulations - 63 Verify source ↗
The Minister may, in consultation with the Authority, by
The Minister may, after consulting the Authority, make regulations by statutory instrument to better carry out this Act.
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. Transitional provisions - 64 Verify source ↗
Transitional provisions
The National Health Research Advisory Committee must cease to exist three months after the Authority is constituted, and transferable health research-related rights, liabilities, proceedings, and obligations move to the Authority.
64. (!) 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. ) National Health Research [ No. 2 of2013 41 SCHEDULE (Sections 4 (2) and 42) THE N ATIONAL HEALTH RESEARCH AUTHORITY • ADMINISTRATION OF AUTHORITY PART I ( 1 ) The seal of the Authority shall be such device as may Seal of - 1. be determined by the Authority and shall be kept by the Secretary. Authority (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.
Part
PART I
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A Council member serves for three years and may be reappointed for another three years.
2. (I) 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; Tenure of office and vacancy of member 42 No. 2 of 2013] National Health Research (e) if the member becomes mentally or physically incapable of performing duties as a member; or (I) if the member is convicted of an offence under this Act or any other law. Filling o> casual vacancy - 3 Verify source ↗
Short title
If a member’s office becomes vacant before the term ends, the Minister may appoint a replacement, and the replacement serves only the remaining term.
3. The Minister may, where the office of a member becomes vacant before the exp.iry 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. ' Proceedings of Council - 4 Verify source ↗
Establishment of National Health Research Authority
This section sets the Council’s meeting procedures, including regular meetings, special meetings, quorum, voting, attendance, and allowances.
4. (!) 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 detennine. (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 he·alth 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. National Health Research [ No. 2 of2013 43 (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 ariy defect in the appointment of any member or by reason that any person not entitled to do so took part in the proceedings. ·s. The members of the Council, the Board or any committee shall be P\lid such allowances as the Council may, with the approval of the Minister, determine. - 6 Verify source ↗
Powers of Authority·
People attending a Council or committee meeting must declare a private conflict of interest promptly and generally must not join the discussion or vote on that matter.
6. (!) !fa 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 Verify source ↗
Council of Authority
A person must not disclose protected information learned in the course of duties under the Act to unauthorised people unless the Authority gives written consent or it is done in the course of duties.
7. (I) 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 (!) 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 ( I ), unlawfully publishes or communicates the information to any other person, commits an offence and is liable, Allowances for members Disclosure of interest Prohibition of publication or disclosure of information to unauthorised persons 44 No. 2 of 2013] National Health Research Immunity 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 Verify source ↗
Exercise of functions and powers of Authority
Members of the Council, the Board, or a Board committee are protected from legal action for good-faith acts or omissions done under this Act.
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 Funds of Authority (I) The funds of the Authority shall consist of such moneys
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National Health Research Act, 2013
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