Notes on Nigerian

National Code of
Health Research Ethics
Module
When a researcher who is a permanent staff in a Nigerian institution is conducting
research at a location outside the catchment area of her/his institution, it may be
necessary to find a co-investigator in an institution at the research site and obtain
ethical approval from the institution there.
In multi-site local and in international collaborative research, the ethical committee in the
locality has primary authority over ethical review of research protocols
Where consent forms are used, such consent forms must not be longer than 8 pages,
typed in double spacing, using Times New Roman Font, size 12pt
The contents of the consent form should not be beyond the reading ability of a Nigerian
Junior Secondary School graduate (that is, 9 years of formal education) so that
participants can understand and recall the contents.
The consent form is expected to contain the following essential elements in this order
(see Section F, sub-section f, p. 41 of the National Code of Health Research Ethics in
Nigeria):
Title of Research.
Names and Addresses of the Researchers and Sponsors (including telephone, fax,
e-mail, etc.)
Purpose - The reason for doing the research.
Participants - Estimated number of participants in the institution. Where this is a
multi-institutional research, the total number of participants should also be stated.
Study Procedure - What research participants should expect will happen to them when
they participate in the research.
Study Duration - The expected total duration of research – in months or years.
Duration of participation - The duration of participants' involvement. For example,
participants may be interviewed for 30 minutes and their blood samples taken; or
participants may be interviewed repeatedly over several months for some years.
Risks – The information about risks must be presented first in the consent process
before information about benefits or compensation while potential participants are still
fresh and engaged. They therefore have more opportunity to think about the risks that
may be involved consequent on their participation.
Costs to the Participants - The costs to the participants for participating in the research.
Generally, research should not cost participants anything but if participants are likely to
bear any cost, this should be explicitly stated in the consent form.
Benefits - The health benefits of participating in research are mentioned next. Where
there is no direct health benefit to participants, this should be clearly stated in the
consent form. In many epidemiological studies, the cases already have the condition of
interest. They may therefore not derive any direct health benefit from participating in the
research. However, the research may improve knowledge about the disease that will
benefit others including the controls, family members of cases, and sometimes the
cases, if the disease recurs.
Compensation - Compensation for lost wages, transport and opportunity costs are
determined by the researchers in consultation with local experts or the ethics
committee. The exact amount and modality of payment should then be stated in the
consent form.
Incentives - It is sometimes appropriate to give inducements to participants in order to
encourage their engagement in research. This inducement may become undue where
the amount of money offered is so large that participants are tempted to carry out
actions that are not in their best interest. Appropriate inducement amounts can be
determined from knowledge about local conditions and through consultation with the
ethics committee. The specific amount and modality of payment should be stated in the
consent form.
Confidentiality - The consent form should state the measures that will be used to protect
the confidentiality of research participants. Voluntariness - The consent form should
state clearly and unequivocally that participation in the research is voluntary and include
information that individuals who chose not to participate in the research will not suffer in
any way. They will continue to receive all services they require at the institutions without
any hindrance or variation.
Withdrawal - Participants may want to withdraw from the research after participating in
part or all of it. The consent form should state clearly that individuals have this right and
include information on how researchers will deal with such requests. The method of
dealing with requests for withdrawal and the completeness of withdrawal of data or
biological samples will vary with the type of research.
Research Injuries/Adverse Events – The consent form should include statements on the
action(s) to be taken in cases of injury or adverse events. In Nigeria, because health
care is an out-of-pocket expense, care for research injuries or adverse events that are
directly due to research are the full responsibility of the research team.
What Happens After Research - Increasingly, what happens to individuals or
communities when research is over is engaging the attention of ethics committees. This
is a complex matter that requires extensive dialogue between researchers, ethics
committees, and representatives of the community, the institution and other interest
groups. There is no single approach that works in all situations that may arise in
research, however, careful forethought and planning will avoid future ethical dilemma.
Conflict of Interest - The consent process should also include adequate disclosure of
any apparent or potential conflicts of interest as determined by the ethics committee
based on prevailing norms.
Inability to Sign Consent Forms - In some circumstances, it is not possible to obtain a
written consent form. This includes a situation where research participants cannot read
or are unable or unwilling to read the consent form. In such situations, acceptable
options include a witnessed thumb printing or witnessed audio recording of the consent
may be done.
• In the event that the research sponsor is the PI, then s/he must include in the
agreement the estimated cost of and sources of funds for the trial, the number of
participants, and a complete budget of the trial and the dates of payments.