Development of an Online Research Ethics Training Resource
Specific to South African Health Law and Guidance
A Ukzn-Mepi Funded Project
Nivedhna Singh
and Douglas Wassenaar
Discipline of Psychology, University of KwaZulu-Natal, Pietermaritzburg, South Africa
Keywords: e-Learning, Capacity Building, Research Ethics.
Abstract: This paper describes the development of an online learning course aimed at building capacity in the field of
research ethics. E-Learning is a popular tool to train large numbers of students and professionals across the
world. This learning tool has been adapted to different fields and disciplines. In developing countries, there
is a need to improve research ethics capacity. Generic and specific research ethics modules are being used to
build capacity in Africa through various online websites. This paper describes the development of a South
African online module for the Training and Resources in Research Ethics Evaluation (TRREE) website.
1 INTRODUCTION
This paper describes the development, aims and
objectives of an online research ethics training
module designed to familiarise researchers,
members of research ethics committees and other
stakeholders with applicable South African health
law and research ethics guidance. This work was an
integral component of a UKZN-based Medical
Education Partnership Initiative (MEPI) grant from
the US National Institutes of Health Fogarty
International Centre to build sustainable medical
education capacity in South Africa.
It is not known when e-learning emerged but e-
learning has become a popular and powerful training
technique both internationally and locally in South
Africa. E-learning in this digital age, is a popular
medium for the acquisition of knowledge and
sharing of information from any area or location in
the world. Globally, many tertiary institutions utilise
e-learning as a common learning technique for
training and capacity building in various disciplines.
Online learning and distance learning are thought to
be synonymous with e-learning but many see these
two terms as different and separate but inter-related
(Moore et al. 2011). Although not all distance
education involves e-learning, e-learning is a
common form of distance learning (Moore et al.
2011).
There is no consensus amongst academics about
the definition and essential characteristics of e-
learning, but authors (Ellis 2004) and (Nicholis
2003) suggest that e-learning can be defined as
“being accessible using technological tools that are
web-based, web-distributed, or web-capable. The
belief that e-learning not only covers content and
instructional methods delivered by CD-ROM, the
Internet or an Intranet but also includes audio- and
videotape, satellite broadcast and interactive TV”
(Benson et al. 2002) and (Clark 2002 cited in
Moore et al. 2011: 130). Despite a lack of consensus
on its characteristics, e-learning can be identified as
applications, programs, objects, and websites that
ultimately provide a means to improve capacity and
learning.
As technology evolved and improves, e-learning
has become increasingly beneficial to individuals
across the world and especially to those who reside
in remote locations (Aggarwal et al. 2011). Distance
learning, in the form of e-learning enables teaching
and learning to take place in areas that are
geographically distant and where infrastructure is
underdeveloped (Silverman et al. 2013), either as a
stand-alone resource or to supplement other capacity
building formats and activities. Furthermore online
learning is thought to be more attractive than
traditional face-to-face training because it is
available to a greater audience, is more cost
effective, time-effective, scalable and sometimes an
efficient tool (Aggarwal et al. 2011 and Fordis, King
& Ballantyne (2005) cited in Williams et al. 2013).
E-learning is cost effective in areas where
503
Singh N. and Wassenaar D..
Development of an Online Research Ethics Training Resource Specific to South African Health Law and Guidance - A Ukzn-Mepi Funded Project.
DOI: 10.5220/0004955405030507
In Proceedings of the 6th International Conference on Computer Supported Education (CSEDU-2014), pages 503-507
ISBN: 978-989-758-020-8
Copyright
c
2014 SCITEPRESS (Science and Technology Publications, Lda.)
teaching and learning are under-resourced or not
readily available in terms of teaching skills,
experience and local facilities. In a study conducted
by Aggarwal et al. 2011, Indian subjects were
randomly assigned into two groups, in the first group
students attended a 3.5 day onsite training on
biostatistics and 3.5 week online course. In the
second arm students attended a 3.5 onsite in
research ethics and completed a 3.5 week online
biostatistics course. The findings suggest that online
training is as effective as onsite training. We
further argue that e-learning might also be more
sustainable as technology evolves and improves;
content can be easily upgraded, edited and revised
which facilitates better learning and improved
knowledge.
Developers and providers of e-learning
workshops from three continents met recently to
discuss standards for introductory courses in human
participant research ethics (Williams et al. 2013).
Proceedings of this workshop highlight the
importance of aims and standards of online training,
and the importance of clear descriptions of these
standards (Williams et al. 2013). It is argued that
standards are important when developing online
programmes and that they should be specifically
tailored for the target audience. Williams et al.
(2013) suggest that standards ensure that there is
some uniformity across programmes in terms of
quality of information provided to target audiences.
Firstly, all important sections should be easily
identified; secondly, all requirements for the
programmes should be specified; lastly, an
evaluation by users of the programme should be
provided for. The meeting (Williams et al. 2013)
identified seven standards for introductory research
ethics e-learning courses. They are summarised as
follows: (a) Developer/provider qualifications:
Requires that authors’ qualifications be provided,
including a description of how the module and its
contents were developed. The authors should
provide a description of the educational principles
used and whether the module has been peer-
reviewed. (b) Learning goals: the goals of the
module should meet a specified educational gap that
exists in literature and the module should be
designed for a specific target audience. (c) Learning
objectives: Authors should provide a description of
the intended usefulness of the programme. (d)
Content: the content of the module should cover the
basic concepts and include comprehensive
background information about the topic of the
module. Important and relevant concepts and
principles should also be included. (e) Methods: the
methods should be in line with the learning
objectives. This includes details about the time
needed to complete the module, background
literature and articles referred to and language/s the
module. (f) Assessment of participants: assessment
is necessary to ensure that students have gained
knowledge and understanding from the module. (g)
Assessments of the course: learners taking the
course should be allowed to provide feedback about
the course and their learning experiences. There are
several different areas to evaluate and different
methods of obtaining responses. These standards
ensure that all modules are the same in terms of
quality and meet the needs of the target audience. A
related but different set of e-learning evaluation
standards is proposed and utilised by Silverman et
al. (2013). It is nevertheless argued that e-learning
has a growing evidence base as an effective tool for
efficiently training individuals in disciplines where
capacity is lacking and where disseminated training
is required internationally, such as is the case in
research ethics.
2 RESEARCH ETHICS
CAPACITY BUILDING
There are various learning and teaching techniques
available, viz. onsite and online training and it is
argued that online training is a useful primary or
supplementary tool for building health research
capacity. Building health research capacity is a key
driver to the development of efficient health
systems. An important aspect of building health
research capacity is ensuring that research follows
ethical guidelines. Specifically, in Africa there is a
documented need for research ethics capacity
building (Ateudjieu et al. 2010; Kirigia et al. 2005
and Milford et al. 2006). These studies found that
Research Ethics Committee (REC) members are
appointed with very little or with no ethics training
(Kirigia et al. 2005). Although there have been
major investments in international research ethics
capacity building by the US NIH Fogarty
International Centre (Millum et al. 2013) and others
(e.g. EDCTP and WHO/UNAIDS) in the past
decade, more effective and diverse techniques of
teaching and learning are needed to bridge the
remaining gaps. In order to meet this need
international organisations partnered with each other
to develop short online courses – not all of them
specifically targeting Africa. Several e-learning sites
now offer training such as Training and Resources in
Research Ethics Evaluation (TRREE) (see
http://elearning.trree.org/),Collaborative Institutional
Training Initiative (CITI) (see www.
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citiprogram.org) and the National Institutes of
Health (NIH) online training (see http://
researchethics.od.nih.gov/ ) , FHI the science of
improving lives (see http://www.fhi360.org/
sites/all/libraries/webpages/fhi-retc2/index.html) and
National Centre for Professional and Research
Ethics (see https://nationalethicscenter.org/) to name
a few, in addition to those described by Silverman et
al. (2013). Most of these sites have generic modules
provide a general overview of the requirements for
the ethical conduct of health research.
3 TRAINING AND RESOURCES
IN RESEARCH ETHICS
EVALUATION (TRREE)
3.1 Background & Format of TRREE
In 2007 a study was conducted to investigate
training needs for competent ethics review from a
list of identified African and European countries
(Ateudjieu 2010). The sample consisted of a total of
seventy four respondents from across Africa and
Europe. Participants were expected to complete a
questionnaire which requested information to be
given about their ethics training (Ateudjieu 2010). It
was found that REC and researchers mostly received
training and that majority of the participants were
trained in international institutions as opposed to
national institutions (Ateudjieu 2010). A list of
topics was identified as important information for all
researchers and REC (Ateudjieu 2010). The TRREE
e-learning site was developed based on the findings
from this research (Ateudjieu 2010). TRREE
provides basic online training on ethics and health
research regulation. It was primarily designed to
provide “online and CD-ROM training modules and
other resources in research ethics evaluation to a
diversified audience involved in research with
human participants in Africa, including research
ethics committee members, researchers, students,
institutional authorities, regulators and other
political authorities, and any other potentially
interested parties” (Ateudjieu 2010 : 90). The main
objective of TRREE is to build capacity in research
and ethics evaluation and to increase the existing
capacity in Africa and European countries. Another
major aim of TRREE is to be bilingual, to meet the
needs of individuals living in Francophone countries
(Ateudjieu 2010).TRREE is aimed at research
ethics committee members, research teams involved
in health research, health authorities, funding
agencies, universities, the general public and any
other health professionals who are interested in the
protection in the well-being of research participants.
Of the e-learning courses described above,
TRREE is unique as comprises two main sections:
one section provides a growing number of country-
specific modules outlining each country’s specific
health law and research ethics related law and
guidance, in addition to a growing list of modules
covering specific topics in health research ethics,
such as informed consent and ethical issues in HIV
prevention research.
The topic-specific e-learning modules are
certificate-generating web-based learning
programmes. Participants are required to read the
basic and linked supplementary learning material
and answer questions based on the material they
have covered. Upon completion of the e-learning
modules students are graded and successful
participants receive a certificate if they attain over
70% correct. The national supplements are country
specific e-learning modules where local experts in
the field of research ethics present an overview of
relevant legal and ethical guidelines that inform the
practical application of research. Most TRREE
national supplements are not certificate-bearing but
the modules on Nigeria and South Africa includes a
quiz into the module which tests students’
knowledge and generates a certificate if the 70%
threshold is met. TRREE learning material and
resources are available in different languages based
on where the module was written and who are the
beneficiaries or intended audience. For example, the
module written for Cameroon is available in English
and French whereas the Swiss module is available in
French and German. TRREE requires low
bandwidth to enable participation from users in
countries with poor internet accessibility, is free of
charge to all users and requires the students to create
an online account which is stored on the database.
An active email account is needed for account
confirmation and password recovery. TRREE
maintains a consistent link with its users and informs
them when new modules are available and when
modules have been updated. TRREE also provides
tools and resources such as a bibliography and a
glossary. A record is kept of how many students
registered and completed all modules and these
statistics are used to evaluate the module and its
effectiveness.
3.2 Design
All TRREE modules follow a specific template
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designed to standardise legal and ethical sub-
headings in all the country-specific modules to
facilitate ease of comparison and structured
coverage. The country-specific modules also cover a
standard range of subheadings which provide
supplementary literature such as health law and
other ethical guidelines on research for each
particular setting. The module development process
itself requires experts in health law and research
ethics to collaborate, facilitating national and
international capacity development. As all TRREE
modules are available online free of charge an
infinite number of users can benefit from the
module. Students are required to obtain a pass
mark/ grade of 70% in order to pass the module. The
certificate is also acknowledged by Swiss
organisations such as the FMH (Swiss Medical
Association) and FPH (Swiss Association of
Pharmacists). TRREE is a user-friendly learning
site and the support team can be easily contacted by
email if problems occur.
3.3 South African National Module
As in most countries, the ethical conduct of health
research requires familiarity with and compliance
with several laws and guidance documents,
including the South African Health Act, the South
African research ethics guidance (2004), South
African Good Clinical Practice Guidelines (2006)
and ethical guidelines on the conduct of HIV
vaccine trials (MRC 2003). It was felt that UKZN
MEPI resources would be well used if a dedicated
South African TRREE module could ensure that all
researchers working in South Africa, in addition to
members of the over 35 registered RECs in South
Africa, could have access to a module covering the
essential requirements of the national laws and
guiding documents in an easily accessible online
format such as provided by the TRREE platform.
The first draft of the South African module was
written in 2011. The module underwent several
external reviews by three experts in research ethics
and South African health law. In 2012, the South
African authors decided to include a quiz to the
national supplement which is certificate-generating
and allows individuals to use the module as
documenting proof of introductory-level research
ethics training for the South African setting. The
module and quiz was accepted in September 2013
for final programming and the module has been
uploaded and is now available on the TRREE
website. We are beginning to collect user statistics
and user feedback. It is envisaged that this South
African MEPI-sponsored TRREE module will
become compulsory for all ethics applications to the
UKZN Biomedical Research Ethics Committee and
it is likely that other major South African health
research institutions will follow suit.
4 CONCLUSIONS
E-learning is a very useful evidence-based method
of preliminary or supplementary training and
building capacity in the field of health research
ethics. It has become especially useful in the African
continent where a lack of capacity has been
identified. The advantages of online training sites
are that they can easily be updated and edited; they
are available to an infinite number of users at
relatively low cost and are readily available for
asynchronous use. The lack of capacity in the field
of research ethics continues to decrease as more and
more training institutions commit to online learning
(Silverman et al. 2013). In a digital age, international
funders and training organisations can be seen
utilising the internet and online mediums to train a
greater number of individuals cost-effectively and
we are yet to see further evolution and upgrades to
online training in the field of research ethics and
other disciplines.
ACKNOWLEDGEMENTS
We would like to acknowledge the following people:
The MEPI PI, Prof Umesh Lalloo, members of the
MEPI management team, Dr Sandy Pillay, Dr
Nisha-Nadesan Reddy.
We would like to also thank the TRREE team,
Prof Dominique Sprumont, Dr Joanna Bourke-
Martignoni.
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