Authors : Jadesola Lokulo-Sodipe, Oluwatoyin Akintola, Clement Adebamowo
This module was realized with support of Fogarty International Center and West African Bioethics
LEGAL BASIS FOR RESEARCH ETHICS GOVERNANCE IN NIGERIA
Introduction
Ethics is a theoretical framework for the analysis of human conduct
(and there are philosophical, sociological and other theoretical
frameworks). It is the general term covering several different ways of
examining and understanding the moral life.
Ethics can be divided into two main types, namely, Normative Ethics
which is a branch of ethics that investigates the set of questions that
arise when we think about the question, ‘how we ought to act morally?’
It examines standards for the rightness and wrongness of actions. It is
also known as Prescriptive ethics; and Non-normative ethics which has
the objective of establishing what factually or conceptually the case is
and what ethically
ought to be the case or what is ethically
valuable. It is an analysis of the meaning of the terms used in moral
discourse. Non – normative ethics can further be divided into
Descriptive ethics, which is the factual investigation of moral belief,
and conducts. It uses scientific techniques to study how people reason
and act; and Meta-ethics which involves analysis of the language,
concepts and methods of reasoning in normative ethics.
Law can be described as a system of rules a society sets to maintain order and protect
harm
to persons and property. Law is a set of rules established by a
governing authority to institute and maintain orderly co-existence.
The law establishes restrictions and requirements for behaviour and
represents a general consensus of what is or is not ethical.
Consequently, law acts as a guide for solving research ethics problems.
Laws are created through legislations which are called
statutory laws, or by judges in court cases which are called
case laws. Statutory
laws comprises of written laws enacted by either a state legislature or
national assembly. Statutory laws are either civil or criminal. Case
law comprises of decisions of the various courts. These decisions
determine the outcome of individual court cases by providing precedents
to be followed in the interpretation of statutory laws and the
Constitution.
This module compiles the laws governing research ethics in Nigeria.
The objective is to provide an overview of the various laws regulating
research in Nigeria with a view to compiling and codifying them.
Secondly, the module is aimed at increasing knowledge in respect of the
laws relating to management and conduct of ethics in research.
Thirdly, it will be a resource for stakeholders in research and
development. Lastly, it is hoped that it will strengthen research ethics
evaluation capacities.
This module involves a research into the various laws applicable to
research ethics. It is a literature research. This will involve an
examination of legal literature in Nigeria, legal and policy instruments
that are relevant to research ethics. References will also be made to
relevant case law.
The module collates laws governing various aspects of research ethics
such as ethics review criteria, oversight for ethics review, criteria
for selecting research participants, issues relating to
conflict of interest, privacy,
risk-
benefit ratio, compensation and
informed consent process.
The Nigerian Legal System
The Federal Republic of Nigeria (FRN) is a Constitutional Republic.
At independence, Nigeria consisted of three regions, namely, the
Northern Region, the Eastern Region and the Western Region. Presently,
Nigeria is made up of 36 states and a federal capital territory (FCT),
located in Abuja. These states are, as a matter of convenience and
political expediency grouped into 6 geopolitical zones of North East,
North West, North Central, South East, South West, and South South. This
grouping has however not been accorded any constitutional recognition.
There are close to 400 linguistic groups in Nigeria, but the 3 major
languages are Hausa, Igbo and Yoruba, while English is the official
language.
The Nigerian Legal System (NLS) is based on the English Common Law
and legal tradition by virtue of colonization and the attendant
incidence of reception of English law through the process of legal
transplant. English law has a tremendous influence on the Nigerian legal
system, and it forms a substantial part of Nigerian law. Section 45 (1)
of the Interpretation Act provides that,
the common law of England
and the doctrines of equity and the statutes of general application
which were in force in England on 1st January, 1900 are applicable in
Nigeria, only in so far as local jurisdiction and circumstances shall
permit.
Consequently, legal issues evolving from common law in England and
codes of conduct of the medical profession and professional ethics as a
whole, such as confidentiality, consent, maleficence,
beneficence, duty of care are applicable in Nigeria even though they have not been legislated upon.
Sources of Nigerian Law
The sources of Nigerian Law are as follows:
The Constitution
The Nigerian Constitution is a Federal one. A federal constitution is
one which provides for division of powers between the constituents of
the Federal Government.
The Nigerian Constitution is supreme. Constitutional supremacy
relates to the supremacy of authority of the constitution over other
laws. Section 1(1) provides, “
this Constitution and its provisions
shall have binding force on all authorities and persons throughout the
Federal Republic of Nigeria”. In addition to this, Section 1(3) provides, “
if
any other law is inconsistent with the provisions of this Constitution,
this Constitution shall prevail and that other law shall to the extent
of the inconsistency be void. The current Constitution is the 1999 Constitution. It came into operations on 29th May, 1999.
By virtue of section 13(2)(b), the security and welfare of the people
is the primary purpose of the government. Sections 15-21 set out the
various ways in ensuring that this purpose is fulfilled without
violating the fundamental rights of the citizens which are set out in
Chapter 4 of the Constitution. These rights include, the right to life,
right to dignity of persons, right to personal liberty, right to fair
hearing, right to private and family life, right to freedom of thought,
conscience and religion, right to freedom of expression and the press,
right to peaceful assembly and association, right to freedom of
movement, right to freedom from discrimination and the right to acquire
and own immovable property anywhere in Nigeria.
Legislation
The Constitution regulates the distribution of legislative business
between the National Assembly which has power to make laws for the
Federation and the House of Assembly of each state of the federation.
The current legislation in force at the Federal level is largely
contained in the Laws of the Federation of Nigeria 2004 (LFN). Laws made
subsequently are found in the annual volumes of the laws of the FRN.
Federal laws enacted under the military regime known as Decrees and
state laws known as Edicts form the bulk of primary legislations.
English Law
This consists of:
- The received English Law comprising of the following, the common
law, the doctrine of equity, statutes of general application in force in
England on January 1, 1900, Statutes and subsidiary legislation on
specified matters, and
- English law (statutes) made before 1st October, 1960 and extending
to Nigeria which are not yet repealed. Laws made by the local colonial
legislature are treated as part of the Nigerian legislation.
Despite the influence of English law, the Nigerian legal system is very complex because of legal pluralism.
Legal pluralism is the existence of multiple legal systems within one
geographic area. It occurs when different laws govern different groups
within a country or where, to an extent, the legal systems of the
indigenous population have been given some recognition. Legal pluralism
is prevalent in former colonies, where the law of a former colonial
authority may exist alongside traditional legal systems. This is evident
in the Nigerian Legal system where the customary law exists side by
side with the inherited English Legal System.
Customary Law
This emanated from the usage and practices of the people. The
traditional classification of customary law is into the following
categories:
- Ethnic/ Non – Muslim: is the indigenous law that applies to the
members of the different ethnic groups. Nigeria is made up of several
ethnic groups each with its own variety of customary law. Ethnic
Customary law is unwritten, uncertain and difficult to ascertain.
Ethnic Customary law is enforced in customary courts. These courts are
at the lowest rung of the hierarchy of courts and in most cases are
presided over by non- legally trained personnel.
- Muslim Law / Sharia: In the southern part of the country, Muslim/
Islamic law, where it exists, is integrated into and has always been
treated as an aspect of the customary law. Islamic law has however been
in use in the Northern part of the country since 1959.
Islamic/Sharia/Muslim Law is written with clearly defined and
articulated principles. It is based on the Islamic religion and was
introduced in Nigeria as a consequence of a successful process of
Islamization. It is based on the Holy Koran and the teachings of the
Prophet Mohammad. The Muslim laws, also known as the Sharia are found in
the Holy Koran and the Hadith (teachings of the Prophet Mohammad).
Judicial Precedent
This is “an earlier happening, decision, etc, taken as an example or
rule for what comes up later. The doctrine of precedent is founded on
the objective of law that ensures that like cases are decided alike. The
operation of the doctrine is tied to the hierarchy of the courts. A
court is bound by the decisions of any court above it in the hierarchy
and usually by a court of co-ordinate or equivalent jurisdiction. The
Supreme Court is the highest court of the land. The Court of Appeal is
the penultimate court to entertain appeals from the High Courts, which
are the trial courts of general jurisdiction. The Court of Appeal and
all lower courts are bound by the decision of the Supreme Court.
The judicial precedent does not apply to certain courts like the customary/area courts and the sharia courts.
The Federal and State courts are not in two parallel lines. It is
only to a limited extent that it may be asserted that each state has its
own legal system.
International Law
Nigeria is a member of the United Nations, the Commonwealth of Nations, African Union and many others.
Although Nigeria is a signatory to various international conventions
and covenants, these are not enforceable in Nigeria unless they are
enacted into law by the National Assembly.
Government Bodies
The system of Government in the FRN is modelled after the American
presidential system with three arms of government, namely, the
legislature, the executive and the judiciary. This is known as
‘Separation of powers’. The legislature makes the law, the executive
implements the law, while the judiciary interprets the law.
Legislature
Section 4 (1) of the Constitution provides that the legislative
powers of the country shall be vested in the National Assembly. By
virtue of sub section (2), the National Assembly has powers to make laws
for the peace, order and good government of the federation, to the
exclusion of the state House of Assembly. It follows law making
procedures as specified in sections 58 and 59 of the 1999 Constitution.
It is bicameral and is made up of the Senate and the House of
Representatives. The powers of the National Assembly to legislate refer
to:
- Any matter included in the Exclusive Legislative list, to the exclusion of the State House of Assembly.
- Any matter in the concurrent legislature list set out in the 1st
column of Part II of the 2nd Schedule of the Constitution to the extent
prescribed in the 2nd Column opposite; and
- Any other matter with respect to which the National Assembly is
empowered to make laws in accordance with the provisions of the
Constitution.
Each state has its own law making organ known as the House of
Assembly. State House of Assemblies have powers to legislate on any
matter in the concurrent legislative list and any other matter with
respect to which it is empowered to make laws in accordance with the
provisions of the Constitution.
By virtue of S.4 (5), where there is inconsistency between the laws
made by the State House of Assembly and the National Assembly, the
latter prevails and the former, to the extent of the inconsistency
becomes void.
It pertinent to note that scientific and technological research, this
includes health research, falls within items on the concurrent list.
Consequently, both the National Assembly and the State House of Assembly
may make laws governing research ethics in Nigeria.
Executive
The executive power of the Federation is vested in the President by
virtue of section 5(1) of the 1999 Constitution. Such powers can be
administered directly or through the Vice President or Ministers or
officers of the government. In the states the executive power of a state
is vested in the Governor and may through the Deputy Governor or
Commissioners or other public officers.
Judiciary
By virtue of section 6(1) of the 1999 Constitution, the following
courts are established in the Federal Republic of Nigeria, Supreme
Court, Court of Appeal, Federal High Court, High Court, Abuja, High
Court of a State, the Sharia Court of Appeal of the FCT, Abuja, a Sharia
Court of Appeal of a state, the Customary Court of Appeal of the FCT,
Abuja and the Customary Court of Appeal.
The courts established by the Constitution are the only superior
courts of record in Nigeria. The Constitution empowers the National
Assembly and the House of Assembly to establish courts with subordinate
jurisdiction to the High Court. These courts are invariably inferior
courts of record notwithstanding the status of the officer presiding in
the courts.
Statutory Institutions
Apart from the arms of government set up by the Constitution, there
are institutions/ governmental bodies which are creation of statutes.
These institutions such as the National Health Research Committee, and
National Agency for Food and Drugs Administration and Control, are
allowed to make rules, regulations, directives and bylaws pursuant to
their enabling Acts and consequently are binding. These institutions are
also empowered to institute various committees as necessary in carrying
out their duties. Procedures devised for these committees have binding
effects on all parties concerned.
Sources of Law Relating to Research Ethics in Nigeria
The legal basis for research ethics in Nigeria as with all other area
of laws is created either through legislation which are called
statutory law or by opinions written by judges in court cases which is
called case law.
Statutory laws influencing research ethics in Nigeria can be found in
the Constitution; state and local government legislations; federal
enactments (regulations, codes, directives) and international treaties.
Some of these legislations have their basis in customary law and
practices.
Case law comprises of decisions of the various courts on matters brought under different heads of the common law such as
Contract
and Torts. These decisions determine the outcome of individual cases
thereby providing precedents to be followed in the interpretation of
statutory laws and the Constitution.
Research Ethics Governance Pre-2006
The pre-2006 era of research oversight in Nigeria was characterised
by formal and informal mechanisms which included regulations by the
federal government through agencies created for that purpose, review by
ethics review bodies in research institutions, self-regulatory bodies in
research institutions, and self-regulations by medical practitioners.
There were no general guidelines dealing specifically with the major
ethical concerns which arise in relation to research in developing
countries. There were no laws or general guidelines requiring that
structure or composition and functions. Be that as it may, there existed
ethics review committees which conducted reviews of research involving
humans amongst others.
At this time, clinical research involving drug trials was regulated
by the National Agency for Food and Drug Administration and Control
(NAFDAC). NAFDAC is saddled with the responsibility of ensuring drug
safety and compliance with approved specifications and quality and
regulating the importation, exportation, and manufacture of drugs. In
carrying out these functions it has powers to compile standard
specifications, guidelines and regulations for the production of drugs,
establishing and maintaining laboratories.
In exercising these powers, NAFDAC issued a set of guidelines for regulating clinical drug trials in Nigeria.
Research Ethics Governance Post-2006
The major development in research ethics in Nigeria post–2006 is the
inauguration of the National Health Research Ethics Committee (NH
REC).
In order to enhancing its functions, the committee, drew up the
National Code for Health Research Ethics, which applies to all health
research involving human participants, conducted, supported or otherwise
subject to regulation by any institution in Nigeria. The effect of this
development is that the NHREC operates at the national level, while the
Health Research Ethics Committees (HRECs) operate at the institutional
levels, reporting to the NHREC.
- 1999 Constitution 2nd Schedule, Part II, Sections 1; 4-7; 12; 13; 33-43; 235; 237; Items 20-21.
- National Code for Health Research Ethics, 2007
- Interpretation Act, Section 45(1) & (2)
- Research Institute (Establishment) Order of 29th Sept, 1977 in Scientific and Industrial Act, Cap. S3 LFN, 2004
- NAFDAC Act, Sections 1, 5, 29
- National Health Bill, Section 31
