NATIONAL HEALTH RESEARCH ACT

PART I
PRELIMINARY

   1.   Short title

   2.   Interpretation

   3.   Application and scope

PART II
THE NATIONAL HEALTH RESEARCH AUTHORITY

   4.   Establishment of the National Health Research Authority

   5.   Functions of Authority

   6.   Powers of Authority

   7.   Council of Authority

   8.   Exercise of functions and powers of Authority

   9.   Committees of Council

   10.   Delegation of functions

   11.   Director

   12.   Secretary, inspectors and other staff of Authority

PART III
THE NATIONAL HEALTH RESEARCH ETHICS SYSTEM

   13.   National Health Research Ethics Board

   14.   Functions of Board

   15.   Tenure of office and vacancy of Board

   16.   Proceedings of Board

   17.   Research protocol

   18.   Health research ethics committees

   19.   Functions and procedures of health research ethics committee

   20.   Misconduct by health researchers

   21.   Complaints

   22.   Immunity from liability or penalty

   23.   Reports by Board

   24.   Staff of Board

   25.   Disclosure of interest by members of Board

   26.   Protection of personal information

   27.   Immunity of member of Board or committee

   28.   Annual report of Board

   29.   Appeals

   30.   Jurisdiction over offences committed outside Zambia

PART IV
REGULATORY FRAMEWORK FOR HEALTH RESEARCH

   31.   Priority areas for health research

   32.   Dissemination of health research information

   33.   Access to, and deposition of, health research databases

   34.   Monitoring and evaluation

   35.   Partnerships in health research

   36.   Human research guidelines

   37.   Consultation about regulatory framework

   38.   Interim regulatory requirements

   39.   Revocation of regulatory frameworks

   40.   Procedures for making submissions

   41.   Health Research Trust Account

   42.   Credit of amounts to Trust Account

   43.   Purposes of Trust Account

   44.   Accounting for gifts and bequests

PART V
HEALTH RESEARCH ON, OR EXPERIMENTATION WITH HUMAN PARTICIPANTS AND ANIMAL SUBJECTS

   45.   Health research on, or experimentation with, human participants or animal subjects

   46.   Prohibition of reproductive cloning of human beings

   47.   Prohibition of removal of tissue, organs, blood, blood products or gametes from living persons for research purposes

PART VI
BIOLOGICAL MATERIALS FOR HEALTH RESEARCH

   48.   Purposes of collection of biological materials

   49.   Storage of biological materials

   50.   Exportation and importation of biological materials

   51.   Designation of institution as bio-bank

   52.   Searches at ports of entry, exit and sites

   53.   Ownership of biological materials and material transfer agreement

PART VII
CLINICAL TRIALS

   54.   Clinical trials

PART VIII
RESEARCH IN TRADITIONAL, COMPLEMENTARY AND ALTERNATIVE MEDICINE

   55.   Research in traditional, complementary and alternative medicine

PART IX
INTELLECTUAL PROPERTY RIGHTS

   56.   Intellectual property rights

PART X
GENERAL PROVISIONS

   57.   Entry by inspectors or other authorised persons

   58.   Duty to provide information to inspector

   59.   Service of Notice

   60.   Authentication of documents

   61.   General penalties for offences

   62.   Offences by body corporation or an unincorporate body

   63.   Regulations

   64.   Transitional provisions

      SCHEDULE

AN ACT

to establish the National Health Research Authority and provide for its functions and powers; establish the National Health Research Ethics Board and provide for its functions and powers; provide a regulatory framework for the development, regulation, financing and coordination of health research and ensure the development of consistent health research standards and guidelines for ethically sound health research; provide for the establishment of health research ethics committees and the regulation and management of research institutions, health researchers and health establishments involved in or undertaking research; provide for the regulation of biological material for health research; provide for ethical approval for the conduct of clinical trials; provide for the use of traditional, complementary and alternative medicines in health research; provide for data management and intellectual property rights in health research; provide for the designation of bio banks; and provide for matters connected with, or incidental to, the foregoing.

[Date of Commencement: 22 March 2013]

Act 2 of 2013.

PART I
PRELIMINARY

1.   Short title

This Act may be cited as the National Health Research Act 2013.

2.   Interpretation

In this Act, unless the context otherwise requires—

"accreditation" means a process of certification of competence in health research;

"animal subject" means an animal which is used for health research or clinical trial;

"Authority" means the National Health Research Authority established under section 4;

"Board" means the National Health Research Ethics Board constituted under section 13;

"bio-bank" means a collection of biological materials and the associated data and information which is stored in an organised system;

"biological materials" means organs and parts of organs, cells and tissue, sub cellular structures and cell products, blood, saliva, sputum, gametes (sperm and ova), embryos and foetal tissue, waste, including urine, feaces, sweat, hair, epithelial scales, nail clippings, placenta and cell lines from human or animal tissue;

"blood product" means any product derived or produced from blood, including circulating progenitor cells, bone marrow progenitor cells and umbilical cord progenitor cells;

"Board Chairperson" means the person appointed as Chairperson of the Board in accordance with section 13;

"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 33;

"Chairperson" means the person appointed Chairperson of the council under section 7;

"clinical trial regulations" means regulations made under section 54;

"clinical trial" means a systematic study, involving human participants or animal subjects, that serves to answer specific questions about the safety or efficacy of a medicine, vaccine or method of prevention or treatment;

"committee" means a committee of the Council established under section 9;

"consent" means a voluntary agreement to participate in health research by a person, who is not a minor, with full understanding of the potential risks and benefits of the health research;

"Council" means the Council of the Authority constituted under section 7;

"Director” means the person appointed Director of the Authority under section 11;

"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 14 and 45;

"genetic material" means a part of a cell that carries information which can be inherited;

"health establishment" means a public or private establishment, including its facilities, buildings or other places, operated or designed to provide inpatient or outpatient treatment, diagnostic or therapeutic interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health services;

"health research" means an activity conducted which—

      (a)   contributes to knowledge of the biological, clinical, psychological or social processes in human beings or animals;

      (b)   uses scientific methods to generate information to deal with health and disease;

      (c)   improves scientific methods for provision of health services and human pathology;

      (d)   investigates causes of disease and the effects of the environment on the human body; or

      (e)   develops new applications of pharmaceuticals, medicines and health technology;

"health research ethics committee" means a committee registered and accredited by the Board under section 18;

"health researcher" means an individual who undertakes health research;

"human participant" means any living person who consents to participate in a health research activity or a body of a deceased person or part of a body of a deceased person as provided in the Human Tissue Act;

"human research guidelines" means guidelines for the conduct of health research involving human participants issued under section 36;

"inspector" means a person appointed by the Authority as an inspector for the purposes of this Act;

"national health research strategic plan" means a national plan that prioritises health research as provided under section 31;

"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 38;

"legal guardian" means a person lawfully vested with the power, and charged with the obligation, of taking care of and managing the property and rights of a person who, because of age, understanding or self control, is incapable of administering that person’s own affairs;

"material transfer agreement" means a written contract between the provider and recipient of research material as prescribed under section 53;

"medicine" has the meaning assigned to it in the Medicines and Allied Substances Act 2013;

"member" means a member of the Council;

"minor" means a person below the age of 18 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;

"regulatory framework" means any statute dealing with, or impacting on, health research, or regulations, rules, regulatory requirements, guidelines or practice directives relating to, or impacting on, health research, made in accordance with this Act;

"reproductive cloning" means the genetic duplication of an existing organism especially by transferring the nucleus of a somatic cell of the organism into an enucleated oocyte;

"research institution" means an organisation, whether public or private, including a university, which undertakes health research;

"research protocol" means a research proposal for health research approved by the Board in accordance with section 17;

"Secretary" means the Secretary to the Council appointed under section 12;

"site" means a place approved by the Board for the conduct of health research;

"social norm" means a pattern of behaviour in a particular group or community or culture accepted as normal in that group or community;

"therapeutic cloning" means a procedure for producing tissues or organs from genetically identical cells that originate from undifferentiated stem cells for purposes of repairing or replacing damaged tissues;

"traditional, complementary and alternative medicines" means the total combination of knowledge and practices, whether explicable or not, used in diagnosing, preventing or eliminating physical, mental or social diseases and which may rely exclusively on past experience and observation handed down from generation to generation, verbally or in writing;

"traditional health practitioner" means a person recognised by a community in which that person lives as competent to provide health care, using vegetable, animal or mineral substances and other methods based on social, cultural and religious background and knowledge, attitudes and beliefs that are prevalent in the community regarding the physical, mental and social well being of a person, including the causes of disease and disability;

"Trust Account" means the Health Research Trust Account established under section 41;

"vertebrate animal" means a bird, fish, reptile, amphibian or mammal, other than a human being, which is a member of the phylum vertebrates, or a bee, butterfly and any other insect used in the production of animal products, and includes the carcass of an animal; and

"Vice-Chairperson" means the person elected Vice-Chairperson of the Council under section 7.

3.   Application and scope

   (1) Notwithstanding any other law, this Act applies to all health research conducted in Zambia, biological material and the use of personal health data.

   (2) Notwithstanding subsection (1), this Act applies to health research undertaken outside Zambia under the direction of a person or body established in Zambia.

PART II
THE NATIONAL HEALTH RESEARCH AUTHORITY

4.   Establishment of the National Health Research Authority

   (1) There is hereby established the National Health Research Authority which shall be a body corporate with perpetual succession and a common seal, capable of suing and of being sued in its corporate name, and with powers, subject to the provisions of this Act, to do all such acts and things as a body corporate may, by law, do or perform.

   (2) The Schedule applies to the Authority.

5.   Functions of Authority

   (1) The functions of the Authority are to—

      (a)   regulate the conduct of research and monitor and evaluate all health research in Zambia;

      (b)   facilitate research and development in health research and provide oversight and coordination of health research;

      (c)   develop mechanisms for setting national health research priorities and strategies in accordance with the needs of Zambia;

      (d)   promote the translation of health research outcomes into policy;

      (e)   advise the Minister on all matters related to health research;

      (f)   identify and recommend to the Minister national health research priorities for incorporation in national health research strategic plans;

      (g)   advise the Minister on the application and implementation of national health research strategic plans;

      (h)   foster partnerships in product development and commercialisation of innovations in health research;

      (i)   harmonise, network and promote public-private partnerships in health research;

      (j)   register and accredit research institutions and health researchers;

      (k)   investigate reports of professional misconduct relating to health research and report the misconduct to the relevant professional association or statutory body;

      (l)   facilitate the development of health research capacity of individuals, institutions and systems by building quality human resources which are capable of responding to the essential research and health demands of Zambia;

      (m)   mobilise and disburse resources for health research;

      (n)   advocate for health research within society, and in the public and the private sectors;

      (o)   recommend to law enforcement authorities the prosecution of health researchers and research institutions that contravene this Act;

      (p)   collaborate with health researchers and research institutions outside Zambia;

      (q)   promote multi-disciplinary and inter-sectoral research collaboration in a bid to establish essential health research which is consistent with the national health research strategic plan; and

      (r)   do all such things as are connected with, or incidental to, the functions of the Authority under this Act.

   (2) The Authority shall, in performing its functions under this Act—

      (a)   develop and review accreditation guidelines for health researchers and research institutions;

      (b)   maintain a database of research undertaken and facilitate the dissemination of research results;

      (c)   establish and maintain a central health research repository; and

      (d)   maintain a profile of non-complying health researchers and research institutions.

6.   Powers of Authority

The Authority may—

      (a)   withdraw the accreditation of a health researcher or research institution;

      (b)   ban health researchers and research institutions from carrying out research in Zambia;

      (c)   stop an ongoing health research activity;

      (d)   inspect any institution or site approved by the Board for the conduct of health research, including databases and bio banks;

      (e)   confiscate, impound and destroy, where necessary, biological materials obtained by any person in contravention of any provision of this Act;

      (f)   require any health researcher or research institution to submit such information and records as may be necessary to enable the Authority to monitor the performance or activities of the health researcher or research institution;

      (g)   consider any matter relating to health research and make representations on those matters to the Minister; and

      (h)   require any health researcher who, or research institution which, is in control of a health research activity to inform the Authority of the intention to move from a site prior to re-locating.

7.   Council of Authority

   (1) The Authority shall be governed by a Council.

   (2) The Council shall consist of the following part-time members who shall be appointed by the Minister—

      (a)   one representative each recommended by the Ministries responsible for—

      (i)   science, technology and vocational training;

      (ii)    finance;

      (iii)   justice;

      (iv)   defence;

      (v)   health;

      (vi)   community development;

      (vii)   education; and

      (viii)   livestock and fisheries development;

      (b)   one representative each recommended by—

      (i)   a research and development institution;

      (ii)   a higher education institution; and

      (iii)   a civil society organisation concerned with matters of health;

      (c)   a traditional health practitioner;

      (d)   a renowned health researcher; and

      (e)   two other persons.

   (3) A person shall not be appointed as a member of the Council if the person —

      (a)   is an undischarged bankrupt;

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