Empirical Studies on Aspects of IRB/REC Functioning
Journal of Empirical Research on
Assessment of the Operational Human Research Ethics2022, Vol. 17(1-2) 114–128
© The Author(s) 2021
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Ethics Committees in Ghana DOI: 10.1177/15562646211051189journals.sagepub.com/home/jre
Samuel Asiedu Owusu1 , Grace Addison2, Barbara Redman3,
Lisa Kearns4, Paul Amuna5, and Amos Laar6
Abstract
There were eighteen Research Ethics Committees (RECs) operating in Ghana as of December 2019 but no empirical
assessment of their operational characteristics had been conducted. We assessed the characteristics of Ghanaian RECs
using an existing Self-Assessment Tool for RECs in Developing Countries. We present results from nine RECs that par-
ticipated in this nation-wide assessment. Our results indicate that the RECs are generally adherent to the recommendations
in the Tool including being composed of members with diverse expertise. They also reviewed and approved research pro-
tocols as well as had access to some limited funding for their activities. There is no national policy on research human pro-
tections or an ethics authority to regulate the activities of the RECs. We recommend the establishment of this authority in
Ghana while encouraging institutions to sustain efforts aimed at making their RECs operate independently.
Keywords
Research Ethics Committees, operational, characteristics, ghana
Introduction RECs. They identified availability of infrastructure, infor-
mation on processing of proposals (hard copies or elec-
Research Ethics Committees (RECs) or Institutional Review tronic), membership (with fair gender representation) and
Boards (IRBs), herein referred to as RECs, have been estab- administrative staff as well as capacity building require-
lished by some international, national, institutional, local or ments for members as key characteristics of functional
private entities to oversee ethical conduct of both human RECs. Thus, the RECs require some basic administrative
and animal proposed research studies. The establishment infrastructure such as office furniture, computers and their
of these RECs forms part of efforts to minimize or eliminate accessories, internet connectivity and data storage facilities
research wrongdoings while improving research quality, for both soft and hard copies of documents. Similarly, the
robust scientific research methodology, active engagement RECs, based on the United States Common Rule (45 CFR
and respect for research participants and their communities 46), are to be composed of members who are sufficiently
as well as enhancing the protection of research subjects. The qualified or professionally competent with diversified
RECs, as described by Barrett, “are intended to oversee the members that embraces race, gender and cultural back-
entire scope of one or more medical research studies includ- grounds as well as being sensitive to issues such as commu-
ing protecting the rights and welfare of human research sub- nity attitudes as a means of promoting respect for its advice
jects” (2019, p. 11), while Emanuel et al., also described
them as individuals who are unaffiliated with the research
1
but review “the design of the research trial, its proposed Directorate of Research, Innovation and Consultancy, University of Cape
subject population and risk-benefit ratio” (2000, p. 2703). Coast, Cape Coast, Ghana2Department of Philosophy and Classics, University of Ghana, Legon-
With the goal of balancing the needs of society for advance- Accra
ment in science against the rights of the human subject, 3Division of Medical Ethics, Department of Population Health, New York
RECs consider the potential risks and benefits of the University Grossman School of Medicine, USA
4
research to the community within which the research will Division of Medical Ethics, Department of Population Health, New York
be conducted, thereby ensuring that the research protocols University Grossman School of Medicine, USA5School of Public Health, University of Health and Allied Sciences, Ho-
conform to internationally and locally accepted ethical Ghana
standards. RECs therefore play an integral and critical role 6Department of Population, Family and Reproductive Health, University of
in advancing the conduct of ethical research. Ghana, Legon-Accra
The study conducted by Mokgatla et al. (2018) to map Corresponding Author:
the RECs in Africa listed some key attributes of functional Email: sowusu@ucc.edu.gh
Owusu et al. 115
and counsel and safeguarding the rights and welfare of mission of creating a networking platform for its members
research participants (Department of Health & Human through activities such as conferences, workshops or semi-
Services, 2018). nars as well as sensitization of the members and the
In applying the Self-Assessment Tool earlier developed Ghanaian public on issues that relate to adherence of high
by Sleem et al. (2010) to assess the operational characteris- ethical research standards or advancing the conduct of
tics of RECs in low- and middle-income countries, ethical research (GHAAREC, 2015; Laar et al., 2020). It
Silverman and his associates (2015) indicated, among must be noted, however, that membership of the
others, that the necessary conditions that could sustain the Association is purely voluntary.
establishment of an ethical culture include transparency Most studies conducted on RECs in Africa have largely
such as availability of conflict of interest policies, appoint- focused on capacity development and training of their
ment policies for the chair and members, and open commu- members due to the fact that most of the RECs are still in
nication and interaction with the local community, research their infancy (Bain et al., 2019). Indeed, there have been
participants, investigators and other stakeholders. They few studies that have examined the operating procedures,
further provided conditions such as accountability (includ- strengths and challenges of RECs on the African continent
ing appropriate monitoring and review) and integrity (con- (Sleem et al., 2010). Silverman et al. (2015) have asserted
sisting of membership diversity, requirement of ethics that many low-and middle-income developing countries
training for investigators, legitimizing the authority of have established and strengthened RECs in response to
RECs and safeguarding the independence of RECs from increased clinical research involving human participants.
institutional pressures and other biases). Finally, they Nonetheless, empirical research studies that have been con-
asserted that availability of an adequate budget to support ducted to assess the operational characteristics of RECs in
the required financial and human resources as well as com- Ghana remain insufficient. There are some questions that
pliance with national laws and guidance are required for are yet to be comprehensively answered or empirically doc-
effective functioning of RECs. umented especially as they relate to the operational charac-
The first two RECs in Ghana were set up in 2000 teristics of RECs in Ghana. For instance, how should the
(GHAAREC, 2015) and at the end of 2019 there were eigh- various training initiatives be contextualized when informa-
teen RECs that were operational in the country. Ghana cur- tion on the real operational challenges of RECs in Ghana is
rently has no National Ethics Committee, Authority or not known? Further, are the RECs in Ghana operating with
Commission that oversees or regulates the activities of the approved and functional SOPs? Are the RECs composed of
various RECs. The RECs operate independently of one the requisite membership with expertise in research ethics?
another and have their own operational guidelines or struc- And do the RECs have the basic infrastructure and adequate
tures based on some existing international recommendations funding to support the implementation of their activities?
such as the US Common Rule or research ethical principles This study is an effort to fill this gap. It was modelled on
set forth in the Belmont Report, Council for International a previous study conducted to assess the operational charac-
Organization of Medical Sciences (CIOMS), the World teristics of RECs in low-and middle-income countries by
Medical Association’s Declaration of Helsinki and the Silverman and his colleagues (2015). The current study
Nuremberg Code. For instance, each REC develops and was, among other specific objectives, conducted to deter-
approves its own Standard Operating Procedures (SOP) mine the preparedness of RECs in Ghana to advance the
which specify their research protocol review processes, conduct of ethical research in the country. Besides serving
administrative structures and operations, membership com- as a baseline study for future evaluations, it was also
position, training activities and funding sources. They may intended to assess the RECs’ operational activities, chal-
respectively formulate other operational guiding documents lenges and support needed to guide interventions that
such as conflict of interest and research misconduct policies could be rolled out to strengthen their activities.
as well as research protocol application manuals or guide-
lines to aid their prospective clients. There are also no sep-
arate national entities that conduct follow-up monitoring of Method
approved research protocols or review research misconduct Study Design
or other research breaches such as conflicts of interest like
those in some countries including the US. Instead, this This was a cross-sectional study that used both quantitative
falls within the purview of the various RECs in Ghana and qualitative methods to assess the operational character-
whose primary mandate is to have oversight responsibility istics of RECs in Ghana. This research approach permits
over human research studies to ensure that they are con- quantitative and qualitative data gathering concurrently.
ducted soundly, both scientifically and ethically. The quantitative and qualitative strands were weighted
The Ghana Association of Administrators of Research equally in this study (Terrell, 2012). The data was integrated
Ethics Committees (GHAAREC) comprises all the during the analysis and interpretation stages to determine
Administrators of existing RECs in Ghana with the confirmation, corroboration or divergence of responses.
116 Journal of Empirical Research on Human Research Ethics 17(1-2)
The primary data from the RECs consisted of their for the interview sessions. This was intended to facilitate
responses to a survey questionnaire and interview guide. the process and avoid undue delays or missed appointments.
The questionnaire was deployed by means of a simple
Population and Sample Hypertext Transfer Protocol (HTTP) through an email link
to enable easy accessibility and completion. The software
Records available at the Secretariat of GHAAREC indicate is very flexible and enables the respondents to save their
that eighteen RECs were operational in Ghana as of incomplete responses as drafts. Respondents were required
December 2019. Adopting a census approach, we invited all to click a “submit” button that automatically forwarded the
eighteen RECs to participate in this assessment. The primary data to a central server being managed by the authors.
target respondents were the chairpersons or their authorised Two RECs (one university- and the other hospital-based)
representatives. Nine of the eighteen RECs agreed to partici- were purposefully selected to participate in a qualitative
pate, representing a 50% response rate (quantitative analysis component of the study. Our assumption was that one of
is rather based on responses from eight RECs while the 9th them would have been playing a lead role in reviewing
REC opted for just a qualitative session). national research protocols, while the other was a relatively
new REC. The qualitative data from these RECs provided
Instruments in-depth perspectives on the history, key milestones and
challenges in the functions or operations of RECs in the
Two main instruments were developed to facilitate primary country and shed light on some of the quantitative responses
data collection: a survey questionnaire and an in-depth inter- provided by the surveyed RECs. The in-depth interviews
view guide. The instruments were designed to determine were conducted by phone and in-person. The responses
levels of institutional commitment (authority of the appoint- were tape-recorded. The entire data collection phase of the
ing person, dedicated funding, auditing processes), avail- study lasted for four months (November 2020 to February
ability and operationalization of policies and procedures 2021). Eight completed questionnaires and two in-depth
of their activities, membership composition (experience, interview transcripts were generated from this study.
gender, diversity), legitimacy (operating within tenure or
expired tenure) and training activities implemented. Other Data Analysis
operational activities of the RECs that were captured by
the instruments included ethical clearance application pro- The quantitative and qualitative data collected were cleaned,
cesses, post-protocol review mechanisms, feedback pro- processed and analysed to provide evidence-based descrip-
cesses to research investigators and participants as well as tions of the operational characteristics of the RECs in Ghana.
administrative structures (availability of administrators, The quantitative data submitted by the respondents was
support staff, office equipment). received in the central server in a Microsoft Excel format.
The questionnaire used to elicit quantitative data was The data was then converted into an SPSS format (version
configured electronically using Kobotoolbox software, 20) for analysis. The quantitative data was then analysed
developed by the Harvard Humanitarian Initiative open- using descriptive statistics such as frequencies, percentages,
source system platform (https://ee.humanitarianresponse. and cross-tabulations.We did not conduct inferential statistical
info/x/30ARCcdL). This software was adopted due to its tests due to the relatively low number of the RECs that partic-
simple coding systems and several deployment modes that ipated in the assessment. The findings from this study should
work well with or without internet. This was also in line not be generalized for the entire RECs in Ghana but must be
with our intention to minimize data gathering errors, contextualized based on the relatively small number of the
reduce the turnaround time for data entry and provide real sample size and the diversity of the RECs.
time data collection updates as well as adhere to social dis- The authors transcribed the qualitative interviews and
tancing protocol due to the COVID-19 pandemic. The inter- thoroughly read the details to identify common themes to
view guide was used to gather qualitative data and generally aid in the analysis based on the principle of grounded
contained open ended questions that were used to gather theory, in which theory emerges from the data (Strauss,
detailed responses on the activities, experiences, achieve- 1987). The framework analysis, often called the thematic
ments, challenges and recommendations from the RECs. analysis framework, was adopted to analyze the qualitative
data. Salient quotes were identified and used to complement
Methods of Data Collection the quantitative analysis that was done. We collectively per-
formed all the above data collection activities through daily
We first liaised with the Secretariat of GHAAREC to obtain in-brief sessions to review the data collection processes to
contact information for the various RECs in Ghana. The ensure that we were progressing according to schedule
primary data collection was preceded by an advance notice and plan for the next activities. The in-briefs were used to
to all the RECs informing them of the assessment, their review the responses received for the day to assess their
respective roles, duration of the assessment and schedule completeness.
Owusu et al. 117
Ethical Issues 37MH-IRB/NF/IPN/419/2020 and GHS-ERC014/07/20)
who deemed the study to be ethical to conduct.
The study was evaluated by two randomly selected RECs in
Ghana for review and approval (reference numbers
Results
Table 1. Background Characteristics of RECs.
Background Characteristics
Frequency
Responses (N= 8) % Nature of REC and Approved Research Protocols. Six of the
eight RECs that provided the quantitative data were
Ownership status university-or research-based institutions, while the remain-
Hospital-based 2 25.0 der were situated within hospitals. The main clientele of
university/research Institute 6 75.0
the RECs were students, faculty members, health, humani-
Years of operations
Between 2-5 years 1 12.5 ties and international development partners. It is instructive
More than 5 years 7 87.5 to note that the majority of the RECs surveyed (87.5%) had
Reasons for establishment been operational for more than five years with half of them
Incessant request from main clients 2 25.0 indicating that the strategic focus of their institutions led to
To meet a funded project requirement 2 25.0 their establishment. Similarly, the need to meet require-
Due to institutional strategic focus 4 50.0 ment(s) of a funded project informed the establishment of
Average protocols approved in 2019 two RECs while incessant requests from prospective clien-
Students tele prompted the establishment of the other committees
1-500 6 75.0 (Table 1). Another factor that was ascertained during the
>501 2 25.0 key informant interviews was the issue of institutional
Faculty/Lecturers control or regulation of the activities of researchers who
None 2 25.0 use their facilities or materials for research purposes. The
1-20 2 25.0 issue of a funded project is further elaborated upon by one
21-40 3 37.5 of the key informants:
41-50 1 12.5
Health professional Our REC was not established out of a recorded research mis-
None 2 25.0 conduct or impropriety but we received a National Institute of
1-20 7 87.5 Health funding to conduct research in the country. The
21-40 1 12.5 research protocol had to be ethically reviewed by a well consti-
Ghanaian public tuted Institutional Review Board in accordance with all the
None 6 75.0 guidelines for the operations of the Board and the United
1-20 2 25.0 States of America Federalwide Assurance mechanism, hence
International development partners the establishment of our REC. This was part of the conditions
None 2 25.0 on the release of funds for the project.
1-20 5 62.5
21-40 1 12.5 Six out of the eight RECs surveyed reported that they
Approved humanities protocols reviewed and approved between 1 and about 350 student
1-20 3 37.5 research protocols between January 2019 and December
21-40 3 37.5 2019 (15, 23, 27, 78, 86, 347, 640 and 1,500 protocols
41-80 1 12.5 respectively), while 25% of the RECs did not approve any
>81 1 12.5 research protocols from faculty/lecturers, health profession-
Approved medical sciences protocols als, the general public and international development part-
1-20 4 50.0 ners. Re-categorizing the approved protocols in 2019 by
41-80 0 0 subject disciplines indicated protocols in the medical scien-
81-100 1 12.5 ces dominated, while those in the natural sciences were least
>100 3 37.5 represented Table 1).
Approved natural sciences protocols
None 5 62.5 Membership and Regularity of Meeting. We asked our
1-20 3 37.5 respondents a series of questions as a proxy to determine
Approved other disciplines protocols institutional acceptability and commitment to their activi-
None 4 50.0
ties, legitimacy of operations and, perhaps, the expanse of
1-20 3 37.5
their authority to enforce research ethical breaches. With
21-40 1 12.5
regard to their appointing authorities, all the eight institu-
Source: Field survey, 2021. tions surveyed and the two key informants indicated that
118 Journal of Empirical Research on Human Research Ethics 17(1-2)
the vice-chancellors of the universities or the chief executive Table 2. Membership Composition.
officers of the hospitals, first and foremost, constitutes the
Frequency
RECs and make subsequent appointments of new Particulars (N= 8) %
members to serve on the RECs. The key informants, in par-
ticular, further explained that appointments of new members Appointing authority of
are usually by recommendations of the RECs to the appoint- Members
ing of cers for consideration and approval. This nding was Chief executive officers 4 50.0fi fi
very consistent with the appointment of administrators of Vice-chancellors 4 50.0
the RECs. Appointing authority of
Administrator
Both our survey results and key informant interviews
Chief executive officers 4 50.0
indicated that the RECs were composed of members with Vice-chancellors 4 50.0
varied backgrounds including academics, research scien- Membership Yes [F (%)] No [F (%)]
tists, health practitioners, lawyers, religious leaders, com- composition
munity members, psychologists, bioethicists and Academia/research scientist 8 (100.0) 0 (0.0)
biostatisticians. All eight RECs surveyed had academics/ Lawyers 6 (75.5) 2 (25.0)
research scientists and medicine/health practitioners cur- Religious Leaders 6 (75.5) 2 (25.0)
rently serving as board members. Other dominant member- Medicine and health 8 (100.0) 0 (0.0)
ship background included lawyers, religious leaders and practitioner
community members (75.5% each). Conspicuously under- Community member 6 (75.5) 2 (25.0)
represented were members with philosophy or ethics back- Philosophers 1 (12.5) 7 (87.5)
grounds and representatives of local Civil Society Administrator/ 1 (12.5) 7(87.5)
Organizations. Indeed, only one REC reported having a biostatistician
member with a philosophy background (Table 2). A desk Psychologist and a 1 (12.5) 7(87.5)
biostatistician
review of some SOPs of the RECs did not indicate manda-
Regularity of meetings F=8 (%)
tory inclusion of members with ethics backgrounds but we
At least five times in a year 1 12.5
presumed that since the core mandate of the RECs was to At least once a month 3 37.5
review ethical issues related to proposed research studies, Bi-monthly 2 25.0
its members would, at least, comprise experts with this spe- Every two weeks 1 12.5
cialized philosophical knowledge. The local Civic Society Once a quarter 1 12.5
Organizations usually represent members who are unaffili- Membership
ated with the institution that sets up the REC but largely rep- composition by gender
resent the interest of the communities. About 21%-40% females 6 75.0
All the RECs indicated the existence of formal meeting About 41%-60% females 2 25.0
schedules to transact their business. Between a quarter and Gender representation About About
two-thirds indicated that they conduct monthly and by type of institution 21%-40% 41%-60%
bi-monthly meetings, respectively, while the other RECs female female
meet at different scheduled intervals such as quarterly or Hospital-based 2 (100.0) 0 (0.0)
once every two weeks (Table 2). In terms of gender, more University/research institute 4 (66.7) 2 (33.3)
(75%) of the surveyed RECs reported lower female repre- Nature of membership Partially Fully
composition composed composed
sentation (just about 40% of the members) than males.
Hospital-based 1 (50.0) 1 (50.0)
Contrasting the gender membership composition by type University/research institute 1 (16.7) 5 (83.3)
of REC, our survey results indicated that both hospital-
based RECs and most of the university/research institute Source: Field survey, 2021.
RECs (66.7%) had lower female representation on their
boards. Similarly, one hospital-based REC and one univer- of males and females. For us, at least, we have an epidemiolo-
sity REC were yet to fully assemble a complete board gist, a social scientist, a clergyman and bioethicist as members
(Table 2). All the RECs reported operating within their man- of our Board.
dated tenures (data not shown).
These findings reported above were similar to the
responses provided by the two key informants. For instance, Funding of REC Operations. Half of the surveyed RECs indi-
key informant ‘A’ indicated that their REC is composed of: cated they had a dedicated annual budget allocated for their
operations by their institutions or appointing authorities
A mixture of technical and lay members or we can also say it is (Table 3). Of the institutions that had dedicated budgets,
a mixture of people from the university and from outside the half indicated that their budgets ranged between US
university. Furthermore, we can also look at it as a mixture $3,490.001 to US$8,724.00 for the 2020 fiscal year while
Owusu et al. 119
the remaining two were allocated amounts between US Table 3. Funding of REC Operations.
$1,745.00 to US$3,490.00 and over US$8,724.00, respec-
Frequency (N
tively. Instructively, three of the four institutions with ded- Particulars = 8) %
icated budgets further indicated that their budgets for the
2020 fiscal year remained the same as the allocation they Availability of dedicated budget
received for the 2019 fiscal year. The RECs that did not No 4 50.0
receive any budgetary allocation from their institutions indi- Yes 4 50.0
cated that they relied principally on ethical clearance appli- Budget allocation for 2020 Fiscal
cation fees charged to research investigators to run their year
activities. Five of the eight surveyed RECs declined to More than US$8,724.00 1 25.0
US$1,745.00 - US$3,490.00 1 25.0
comment on the adequacy of funding for their activities;
US$3,491.00- US$8,725.00 2 50.0
nonetheless, when the remaining three were asked to indi-
Changes in budget allocation
cate the adequacy or otherwise of their funding, the Above 2019 budget allocation 1 25.0
general picture depicted a somewhat inadequate funding Same as 2019 budget allocation 3 75.0
source: two rated this at between 41%-60% adequate Sources of funding not from
while the other rated it 21%-40% adequate. It must be dedicated budget
noted that adequacy of funding for the activities of the Fees charged investigators 3 75.0
RECs may largely depend on the workload or activities of Donations from institution 1 25.0
the RECs that were assessed. Almost all the RECs reported Adequacy of funding
that they have a system of auditing their financial statements Adequate (41%-60%) of required 2 25.0
by their institutional internal auditors (50%), external audi- funding
tors (12.5%) or both (25%). We also contrasted availability Low (21%-40%) of required funding 1 12.5
of dedicated budget allocations by type of institutions. Our None response 5 62.5
results indicated that both hospital-based RECs did not have Auditing of accounts
dedicated institutional budget to support the operations of External auditors 1 12.5
the activities of the RECs while four (66.7) out of the six Institutional internal auditors 4 50.0
university/research institute RECs had dedicated funding External and internal auditors 2 25.0
to implement their activities (Table 3). No formal auditing 1 12.5
Both key informants expressed faint knowledge of the Availability of dedicated budget Yes No
by type of institution
nitty-gritties of their funding and budget allocations for Hospital-based 0 (0.0) 2 (100.0)
the institutions. This was partly due to their role as chairper- University/research institute 4 (66.7) 2 (33.3)
son whose primary responsibility includes convening board
meetings, steering the meetings and guiding the process of Source: Field survey, 2021.
communicating review feedback to research investigators.
Both indicated that these funding or budgetary issues are
generally under the purview of the administrators of the last five years. Copies of some RECs’ SOPs reviewed as
RECs. They were thus unable to explicitly confirm or well as an unpublished 2016 seminar report by
deny availability of dedicated budgets by the institutions GHAAREC indicated that the documents are to guide the
to fund the activities of the RECs. RECs to ensure quality and consistency in their review of
research protocols to be able to safeguard and protect
Availability of Office Space and Other Logistics. The RECs research participants as well as guide the operations of the
were also assessed on the availability of permanent office RECs in accordance with best international practices as
space and other administrative logistics to facilitate their enshrined in documents such as the Declaration of
operations. Some institutions may treat their RECs as any Helsinki, the Belmont Report, the Common Rule and the
other board or committee and not provide a full range of Council for International Organization of Medical
this type of support to undertake their activities. Sciences. It sets out the mandate of the RECs, membership
Significantly, all except one REC reported not having a per- composition and functions, research protocol review pro-
manent office space for its activities (Table 4) but it must be cesses, administrative procedures, record keeping proce-
noted that the availability of office space(s) for the RECs dures, archiving processes and post-protocol approval
may be dependent on the size of the RECs operations. activities including field monitoring. An approved and func-
The REC with permanent offices also reported of owning tional SOP plays a critical role in the determination of the
a variety of office equipment such as computers, printers, authority or legitimacy of RECs in Ghana, especially in
scanners and furniture in various quantities. All the RECs the absence of a national regulatory body. Besides the
reported having approved Standard Operating Procedures SOPs, most of the RECs also indicated that they had
(SOPs) with the majority (75%) being operational for the adopted and are being guided by other operational
120 Journal of Empirical Research on Human Research Ethics 17(1-2)
Table 4. Availability of Office Space and Other Logistics. dynamic and always evolving due to factors such as advances
in scientific knowledge, innovation explosion and improve-
Frequency
Responses (N= 8) % ments in technology. The dynamic and evolving nature of
research are also associated with changing ethical thinking
Availability of office space and requirements. It is therefore prudent for RECs to train
Yes 7 87.5 their members in some of the contemporary knowledge,
No 1 12.5 approaches, resources or materials that enhance the ethical
Office equipment review processes and decision-making. Indeed, few of the
Computers, furniture and internet 1 12.5 SOPs reviewed have provisions for organization of training
connectivity programs for their members and administrators through activ-
Computers, printers, furniture and 2 25.0
internet ities such as participation in international and national confer-
Computers, printers, scanners, furniture 4 50.0 ences, workshops and seminars. There are also research
internet investigators who are informed about some research ethical
None response 1 12.5 issues or how research designs should be aligned to ensure
Number of computers ethical conduct of research studies. Although this may not be
One 1 12.5 regarded as a core mandate of RECs, it may also become
Two 2 25.0 imperative to routinely orient or provide some training to
Three 3 37.5 research investigators or prospective researchers such as stu-
Five 1 12.5 dents on ethical issues like fair selection of research partici-
None 1 12.5 pants, respect for persons and assurance of beneficence.
Number Printers Lastly, the RECs exist to ensure the welfare of research partic-
One 4 50.0 ipants by reviewing proposed research protocols and granting
Three 2 25.0 ethical clearance before commencement of proposed studies.
None 2 25.0 In a country where community awareness of research ethics
Number of Scanners is relatively low, it may also be an additional duty of RECs
One 2 25.0 to train some community members in some basic ethical
Two 1 12.5 issues such as autonomy, confidentiality, minimization of
Three 1 12.5 harms and valid consent processes. Indeed, the mission of
None 4 50.0 GHAAREC includes sensitization of the general public to
Availability of Standard Operating
Procedures adhere to high ethical research standards (GHAAREC, 2015).
Yes 8 100.0 Six (75.0%) of the RECs surveyed indicated that they
Years in operation have organised training activities for their members and
Between 1 and 5 years 6 75.0 their clients (data not shown). These activities principally
More than 5 years 2 25.0 included orientation sessions, public/community sensitiza-
Other policy documents tion, workshops and conferences. Significantly, most of
Conflict of interest policy and Ethical 1 12.5 these activities targeted the committee members instead of
clearance application guidelines research investigators (Table 5). Of note, as indicated in
Ethical clearance application guidelines 7 87.5 Table 5, community or public outreach by RECs on issues
only of research ethics were rarely part of the activities of the
RECs who participated in our study. Indeed, only one
Source: Field survey, 2021.
REC reported ever organising an event of this type, at
least during the time of our data collection. Just one REC
documents such as conflict of interest policy and ethical reported having organized a national or international confer-
clearance application guidelines (Table 4). The ethical clear- ence. Specifically, the survey found that there were no
ance guidelines, according to the RECs, are documents or regular timelines for the organization of such training activ-
notes that explain or guide research investigators on their ities. For instance, none of the RECs had a regular schedule
research protocol application preparations and submission for orientation sessions for researchers (75.0%), orientations
processes. for board members (37.5%), public education through mass
media (75%) or international conferences for members and
Training Activities of RECs administrators. Only one REC indicated that it provided
annual training for its clients (researchers) and opportunities
Regular training activities for members of the RECs, research to members/administrator to participate in international
investigators and the research public could be described as an conferences.
essential feature of the administrative characteristics of the The issue of training activities also featured predomi-
RECs. Scientific approach to the conduct of research is nantly in the two interview sessions with the key informants.
Owusu et al. 121
Table 5. Capacity Building Activities of RECs. What was generally clear from their responses was that
some activities are episodically organised for REC
Yes [F No [F Total [F
Responses (%)] (%)] (%)] members and other research investigators such as students
and their faculty supervisors. We describe this as episodic
Capacity building because the sessions offered for REC members were gener-
activities organised by ally meant to orient new members appointed to the commit-
RECs tee or during protocol review meetings where ethical issues
Orientation sessions for 2 (33.3) 4 (66.7) 6 (100.0) come up for thorough discussion. For instance, key infor-
research investigators
Orientation sessions for 5 (83.3) 1 (16.7) 6 (100.0) mant B indicated that:
members
Public education (radio, TV, 1 (16.7) 5 (83.3) 6 (100.0) Apart from the initial training that was organized for members
or newspaper) before the committee was established, I also provide training
Community durbars 1 (16.7) 5 (83.3) 6 (100.0) for the members, when they come on board but this happens
Workshops/seminars for 5 (83.3) 1 (16.7) 6 (100.0) once in a while. On the other hand, at certain points in time
board members when we are doing the review and something comes up, I
Workshops/seminars for 5 (83.3) 1 (16.7) 6 (100.0) take the opportunity to address the issue and then it turns to
researchers some form of training for them.
National conferences for 0 (0.0) 6 (100.0) 6 (100.0)
researchers and members Similarly, key informant A asserted that
International conferences for 1 (16.7) 5 (83.3) 6 (100.0)
members/administrator when new members are appointed to join our committee, we
Regularity of capacity F % take them through training or an orientation on the mandate
building workshops of the REC and its core activities…. Ideally, every year, they
Orientation sessions for should have some training including international conferences
clients but we are constrained by funding to carry out these activities
Annually 1 12.5 as envisaged. We also organise orientation sessions for some
As and when need arises 1 12.5 faculty members and students especially when we observe
None 6 75.0 that the protocols that we were receiving from them are
Orientation sessions for below standard…
board members
At appointment of new 1 12.5
members
Bi-monthly 1 12.5
Annually 3 37.5 Research Protocol Approval Processes and
None 3 37.5 Post-Approval Activities
Public education (radio,
TV, or newspaper) Most of the RECs that participated in our survey (75.0%)
Yes 1 12.5 indicated that their prospective applicants for ethical clear-
None 7 87.5 ance could obtain the application forms online or from
Workshops/Seminars for their websites (Table 6). This is intended to facilitate or
board members expedite their activities by enabling the support of informa-
Once a quarter 1 12.5 tion communication and technology (ICT) and as a means of
Once every two years 1 12.5 easing the ethical clearance application process for research
Annually 2 25.0 investigators. For the institutions that were yet to host their
Bi-monthly 1 12.5 forms online, the dominant application process is the
None 3 37.5 manual system, where applicants either receive the forms
Workshops/Seminars for electronically through email or walk into the REC
clients Secretariat to pick up hard copies of the application forms.
Once every two years 1 12.5 It must also be noted that the RECs that rely on hard
Annually 4 50.0 copies often demand a number of copies of the whole pro-
None 3 37.5 tocol for each member, irrespective of the number of
International conferences for
members/administrator pages. The number usually varies but largely depends on
Annually 1 12.5 the number of the REC members. Half of the institutions
None 7 87.5 reported that it takes an average of three weeks between
receipt of research protocol and communication of first
Source: Field survey, 2021. review decision to an applicant while some (38%) take
more than a month to complete the process2.
122 Journal of Empirical Research on Human Research Ethics 17(1-2)
Table 6. Protocol Approval Processes and Post-Approval informants. One crucial post-approval activity they often
Activities. cited was field monitoring of approved protocols, but this
F (N= largely has not been implemented for some time now.
Responses 8) % They lucidly provided various reasons why this activity
should be implemented. For instance, they mentioned pro-
Mode of accessing application forms tection of volunteer participants from abuse or exploitation
Website 6 75.0 by research investigators, ensuring investigators’ compli-
Through emails 1 12.5 ance with approved ethical directives or procedures, record-
Walk-in to office 1 12.5 ing of adverse findings and maintenance of ethical standards
Turn-around processing time in the conduct of research as well as enhancement of com-
More than a month 3 37.5
munity engagement. Nonetheless, the key informants indi-
One month 1 12.5
cated the unavailability of committee members to
Three weeks 4 50.0
Duration for submission revised undertake field monitoring activities as the prime reason
protocols that this all-important activity was not carried out.
No deadline 2 25.0 According to the informants, members of the RECs have
Less than one week 1 12.5 other responsibilities that often conflict with scheduled
Two-three weeks 2 25.0 field monitoring.
One month 1 12.5 In addition, the informants, like the relatively few survey
More than one month 2 25.0 participants (25%), cited lack of funding to undertake field
Implementation of post approval monitoring activities. They opined that implementation of
activities such activities requires basic logistics such as a vehicle,
No 3 37.5 fuel, accommodation and allowances for the resource
Yes 5 62.5 persons but this is hampered due to the limited budgetary
Reasons for no post-approval activities allocation or funding of RECs activities. Narratives from
None 5 62.5 the two informants are summarized below:
No funding 2 25.0
We do not know anything like that 1 12.5 Ideally, we are to monitor the study after approval so that we
No skills for such activities 1 12.5 are assured that the research investigators are implementing
Post-approval activities implemented Yes No what we have approved for them. The trouble we have had is
Field monitoring 4 (80.0) 1 (20.0) really the financial challenge of carrying out these monitoring
Reports to appointing authorities 1 (20.0) 4 (80.0) activities and also the availability or time constraints of the
Mentoring of clients (researchers) 1 (20.0) 4 (80.0) Board members who happen to be so busy it’s always a chal-
lenge getting them to commit…. The bigger bother is the finan-
Source: Field survey, 2021. cial component to go and conduct the field monitoring. But
some studies have been monitored in the past (Key informant
A).
Silverman et al., indicated that accountability, usually
measured by monitoring and research review activities, Our research investigators produce annual reports at the end
forms part of the characteristics of RECs. Indeed, the of the year but that is if the research is going to go for a
GHAAREC unpublished report on a harmonization of the long time. On paper yes, but in practice, this is very
various SOPs in Ghana indicated that almost all the RECs minimal…The members of the RECs are usually specialists
had post-protocol monitoring activities incorporated as part or experts and these are people who do not have time
because of their other important activities like teaching or
of their mandates. This monitoring could either be adminis-
doing clinical work almost for the entire day…it boils down
trative through review of progress reports received from to the investigators. We trust they will do the right thing (Key
research investigators or field monitoring of on-going imple- informant B).
mentation of approved protocols. We therefore asked our
participants to provide information on their post-protocol
approval activities. Most (62.5%) of the RECs reported Research Misconduct, Achievements and Challenges
that, beside the protocol review and approval activities,
they undertake other post-approval activities such as field Research misconduct is defined as the fabrication, falsifica-
monitoring andwriting of reports for their appointing author- tion or plagiarism in proposing, performing, or reviewing
ities. Funding and limited capacity to implement these activ- research, or in reporting research results (Office of
ities were the main reasons provided for the non-expansive Science & Technology Policy, 2000; Resnik et al., 2015).
implementation of post-approval activities (Table 6). In some countries such as the US, RECs are not charged
Implementation of post-protocol approval activities also with tracking research misconduct, especially since other
featured extensively in our interviews with both key ethical issues such as authorship disputes are included
Owusu et al. 123
Table 7. Issues on Research Misconduct. draw the blood from the veins. They both indicated that
these violations are infrequently recorded.
Response F (N= 8) %
Nature of misconduct
Plagiarism 1 12.5
Falsi cation 1 12.5 Main Achievements, Challenges and way Forwardfi
Plagiarism/Falsification 1 12.5 The RECs provided various responses in response to a ques-
None 5 62.5 tion on their achievements after becoming operational. The
Recent misconduct/violation main achievement cited by 35% of the RECs surveyed was
Plagiarism 2 25.0 their ability to ethically review and approve protocols sub-
Falsification 1 12.5 mitted by research investigators while 25% also indicated
None 5 62.5 their organisation or participation in various training activi-
Follow up actions ties (Table 8). Other achievements cited were organisation
None 5 62.5 of community sensitization events, improved administrative
No mandate to act 1 12.5
operations, enhanced protection of research participants and
Research was terminated 1 12.5
registration approval from the US Department of Health and
Approval denied 1 12.5
Research misconduct by type of REC No Yes Human Services.
Hospital-based 1 (50.0) 1 (50.0) The respondents also reported some challenges that have
University/research institute 4 (66.7) 2 (33.3) been hampering the smooth and effective implementation of
their activities. These challenges were usually recurring or
Source: Field survey, 2021. common for all the RECs that participated in this study.
Limited access to adequate funding for their activities
along with the conduct of human or animal research. There appeared as one of the two predominant challenges in
are also separate entities that are charged with the responsi- their responses. This challenge, according to the partici-
bility of assessing misconduct and recommending remedial pants, mostly hinders their ability to engage technical
courses of action. This is not the case for research miscon- staff, procure office equipment to support their activities
duct in Ghana although there are some state regulatory and their manifest over-reliance on manual processing of
bodies that are charged with ensuring compliance of some their ethical review processes. Along with inadequate
activities such as medicines and public administrative mis- funding, the absence of a national research ethics authority
conduct. We referred to human related research misconduct or commission was a considerable hindrance to the activities
in this study as comprising issues such as research protocol of the RECs (65%). This challenge, according to the partic-
violations, noncompliance or putting research participants at ipants, seriously affects regulation, accreditation, standard-
risk. The RECs in Ghana, as they exist currently, also have ization and supervision of the activities of the various
the mandate to undertake these activities. RECs in Ghana (Table 8). As indicated above, the
Generally, reports of research misconduct were not GHAAREC is a voluntary association of the
recorded by most of the RECs surveyed (62.5%). The few Administrators of the IRBs without a mandate to function
reports of such misconduct centered on plagiarism and fal- as a national regulatory body which requires national parlia-
si cation of research data or information. It might not be mentary approval and presidential assent.fi
surprising from our relatively small dataset that the The respondents suggested that, to improve the opera-
university-/research-based institutions recorded the higher tional activities of Ghanaian RECs, the establishment of a
rates of misconduct; nonetheless, it is important to note national ethics authority (65.0%) should be paramount to
that one out of the two hospital-based RECs recorded a mis- unlocking the full capacities of the various RECs. This
conduct. Subsequently, the identi ed proposed studies that would set the framework to regulate their operations andfi
were involved in the misconduct were either terminated or establish standards in key functional areas such as standard-
ethical clearance approval was denied (Table 7). ization or harmonization of research protocol submission,
When asked to provide examples of what their REC may review and approval processes. It would also eliminate or
consider a research protocol violation, a key informant enu- minimize the current high incidence of multiple applications
merated issues including not operating according to the and reporting to various supervisory agencies (12.5%).
tenets of the approved protocol by, for instance, not obtain- Eventually, this will assure transparency in interactions
ing informed consent from research participants before with all stakeholders in the research industry. A participant
recruiting them into a study or making amendments to an also proposed a mandatory monitoring of approved research
approved protocol without authorization from the REC, or protocols (12.5%) to ensure that research investigators
implementing a revised protocol such as proposing to take comply with approved ethical practice. Others also did not
a blood sample from the nger prick but later deciding to rule out access to sustained funding to support the activitiesfi
of RECs.
124 Journal of Empirical Research on Human Research Ethics 17(1-2)
Table 8. Main Achievements, Challenges and way Forward.
Responses Yes [F (%)] No [F (%)] Total [F (%)]
Main achievements of RECs
Review and approval of research protocols 3 (37.5) 5 (62.5) 8 (100.0)
Training and staff development 2 (25.0) 6 (75.0) 8 (100.0)
Community sensitization 1 (12.5) 7 (87.5) 8 (100.0)
Improved administrative operations 1 (12.5) 7 (87.5) 8 (100.0)
Enhanced protection of research participants 1 (12.5) 7 (87.5) 8 (100.0)
Registration with US HHS 1 (12.5) 7 (87.7) 8 (100.0)
Non-response 1 (12.5) 7 (87.5) 8 (100.0)
Main challenges
Inadequate funding/board members & no national REC 1 (12.5) 7 (87.5) 8 (100.0)
Limited logistics, inadequate funding & no national REC 1 (12.5) 7 (87.5) 8 (100.0)
Limited logistics, inadequate funding/board members/technical staff & conflicts with investigators 1 (12.5) 7 (87.5) 8 (100.0)
Limited logistics, inadequate funding/board members, manual procedures & conflicts with 1 (12.5) 7 (87.5) 8 (100.0)
investigators
Limited logistics, inadequate technical staff/funding, no national REC & manual procedures 1 (12.5) 7 (87.5) 8 (100.0)
Limited logistics, manual procedures & no national REC 1 (12.5) 7 (87.5) 8 (100.0)
No national REC 2 (25.0) 6 (75.0) 8 (100.0)
Absence of national REC a problem for Ghanaian RECs 6 (75.0) 2(25.0) 8 (100.0)
Problems with absence of national REC
No coordinated regulation of RECs, no supervision & no accreditation of RECs 1 (12.5) 7 (87.5) 8 (100.0)
No coordinated regulation of RECs, no supervision, no accreditation of RECs & no training of 3 (37.5) 5 (62.5) 8 (100.0)
RECs
No coordinated regulation of RECs 1 (12.5) 7 (87.5) 8 (100.0)
No supervision/accreditation of RECs & limited funding 1 (12.5) 7 (87.5) 8 (100.0)
None response 2 (25.0) 6 (75.0) 8 (100.0)
Recommendations
Establishment of national REC 6 (75.0) 2 (25.0) 8 (100.0)
Composition of multidisciplinary review REC members 1 (12.5) 7 (87.5) 8 (100.0)
Reduction in multiple protocol approvals 1 (12.5) 7 (87.5) 8 (100.0)
Mandatory post-approval monitoring 1 (12.5) 7 (87.5) 8 (100.0)
Regular training of members/administrators 1 (12.5) 7 (87.5) 8 (100.0)
Electronic protocol submission processes 1 (12.5) 7 (87.5) 8 (100.0)
Source: Field survey, 2021.
These issues were also explored during our interviews harmonize the process so that some shed off their approval
with the key informants which they expressed as follows: rights to another sister REC which they think can handle it
for them, then maybe it will be less of a strain on the investiga-
The bigger challenge is the availability of the people and that I tors… It will also speed up the process (Key informant A).
think is the same across the two boards that I have served on…
The availability of time of the committee members to be Funding is a huge problem… We need equipment in the office:
involved in field monitoring activities is also one of our chal- laptops, computers, shredders, cabinets. If you are not very
lenges… The RECs in Ghana should talk to each other or col- careful, you will charge the research investigators very
laborate in their activities…We have GHAAREC and we should high… There should be money somewhere. How they are
have a similar one of the chairpersons of the various RECs. able to get the money, I cannot tell…The other challenge is
There should be also joint meetings of these two which will also expertise because these things are so dynamic…We need
serve as a forum for sharing experiences, learning from each to build capacity with our members but in our SOPs, it says
other and moving ahead with the process…The other issue is that, after 3 years, your time is up but renewable for another
the multiplicity of the ethics committee and the requirements term of 3 years so by 6 years the person is so good with the
for approval before conducting the work. We may have a pro- review but…And then also, pressure from the investigators.
tocol which has to go to a number of ethics committees for They will say we have the money for research and you are
approval from all of them before the researchers can go and wasting our time, you do not want to review this little thing.
do their work. If there was a way by which they could After all who are you? I want to know the members of the
Owusu et al. 125
committee… My recommendation is one, we should be able to institutions. However, this issue of control and regulation
build the capacity of members. Two, we should also focus on has the potential of leading to multiple approvals for one
finding a mechanism of trying to get new members from time proposed research study by different RECs, which would
to time…The other thing is that we should all put our heads delay the implementation of the proposed research as indi-
together to ensure that we have a National Ethics Committee cated by key informant B as well as duplicate payment of
so that we can have the National Ethical Guidelines. We do
application fees by researchers.
not have it now but we are working. And then dedicated
of ces or rooms for meetings (Key informant B) We earlier reported that one of the eight surveyed RECsfi
reviewed and approved some 1,500 research protocols in
2019, which is highly commendable. Nonetheless, if we
consider the high number of students in addition to studies
Discussion conducted by health practitioners, faculty members and
other scientists, it appears that there other several other
In line with some existing measurable international indica- research studies that are implemented in Ghana without ade-
tors or frameworks to assess the operational characteristics quate RECs ethical scrutiny. Certainly, we are not oblivious
of RECs in low and middle income countries such as the to desktop or systematic review studies conducted by
Development of an Accessible Self-Assessment Tool for researchers as well as our considerable limitation of not pre-
Research Ethics Committees in Developing Countries by senting a generalized result of the approval rates of all
Sleem et al. (2010), our results have provided some opera- Ghanaian RECs. But comparing our aggregated approved
tional characteristics of the RECs in Ghana that participated numbers based on our findings with the perceived high
in our study. For instance, they are recognized independent number of students and other research studies conducted
entities by their institutions and are duly appointed by autho- on an annual basis in Ghana, we are of the belief that a
rized high-ranking institutional authorities such as vice- greater proportion of these studies are conducted in the
chancellors or chief executive officers. Moreover, the sur- country without proper ethical scrutiny. The relative low
veyed RECs were composed of members with diverse exper- humanities and natural science approved studies could
tise and operated within their mandated tenure in office. We also serve as reference point to buttress our claim.
consider these as very significant in our assessment of the Clearly, the RECs that participated in our study were
legitimacy, competency and capacity of the RECs to fulfil composed of members with varied technical and profes-
their mandates. For instance, being appointed by high- sional backgrounds that could significantly position them
ranking institutional officials provides some guarantees to to discharge their mandate. Nonetheless, the irregular train-
the RECs that they will be able to implement their mandates ing activities offered to the members is a phenomenon that
without much interferences from external parties while being may negatively affect their judgment and functionality.
composed of diversified members who are operating within Ethical judgments are very dynamic and evolving. For
their legitimate tenure gives some assurances that compre- instance, the evolution and involvement of information
hensive and independent review of submitted research proto- communication technology in the conduct of research
cols will be performed. There were also reported accounts of raises several ethical issues involving privacy, virtual or
the RECs receiving, reviewing and approving proposed online recruitment, consenting, data collection, processing
research studies in addition to having access to some and analysis. Similarly, human advancement in science
limited funding for their activities or operations. In addition, and specific disciplines such as neuroscience, organ trans-
these members were reported to be undergoing periodic plant and artificial intelligence, as well as involvement of
training, although these were largely unstructured, but some vulnerable populations like pregnant women, prison-
there was no reported national ethics authority or commis- ers, children and adolescents in research, ought to constantly
sion to regulate the activities of RECs in Ghana; each oper- invoke training and re-training of REC practitioners to
ated independently and in a silo. Relatedly, this means enable them function optimally. We are of the view that
limited collaboration among the RECs as evidenced in the the training that is offered to new members and the episodic
multiple application processes of research protocols. training offered in focused areas when issues arise seem an
Our key informants cited institutional control or regula- appropriate approach to training the members especially
tion of the activities of research investigators as one of the within the context of their limited resources. We are also
motivating factors for establishing RECs. We are of the of the view that other formalized training programmes that
view that this reason raises an ethical issue for reflection. have been proposed by Laar and his collaborators (Laar
If the RECs were established by institutions such as hospi- et al., 2020) would complement the training requirements
tals to monitor the activities of research investigators on of the RECs in Ghana
patients or research participants involved in studies con- Central to the episodic training activities implemented by
ducted by university or other research institutions, then our assessed RECs for their members and the general public
this is a motivation worth applauding since it stands to max- is the issue of limited funding for the operations of RECs,
imally protect the welfare of research participants in the although this may not be the case for all the RECs. It was
126 Journal of Empirical Research on Human Research Ethics 17(1-2)
evident from our data that the various RECs were constituted were unable to verify, query or probe responses for clarifica-
by high powered appointing authorities, but the RECs were tion. The 50% response rate as well as the diversity of the
nonetheless poorly funded for their activities. Even if the RECs surveyed also makes it impossible for us to generalize
establishing institutions, in practice, are committed to the the findings to cover the activities of all RECs in Ghana.
activities of the RECs, adequate funding for research activi-
ties remains a major determinant of conducting ethical Best Practices
research. “Adequate” as used here means RECs having the
minimum sufficient funding to implement all their intended Our study provides an empirical national overview of the
activities. Inadequate funding could also potentially compro- operational characteristics of RECs in Ghana. Firstly, we
mise the implementation of some key ethical requirements will strongly encourage institutions that have set up RECs
espoused by Emanuel and his colleagues such as indepen- in the country to sustain efforts aimed at making the
dent review, scientific validity and social value of research RECs operate independently. This will be achieved
(Emanuel et al., 2000, 2004). Resorting to fees from research through ongoing appointment of diverse and competent
investigators may also occasion payment of high or arbitrary members as well as inclusion of more members with
fees to sustain the activities of RECs. While this is not well ethics or philosophy backgrounds. This will also require tar-
documented in Ghana, examples in other African countries geted and sustained funding for the activities of RECs
such as Tanzania and Kenya may serve as pointers including well-structured capacity building activities and
(Puppalwar et al., 2015). Relatedly, resorting to fees implementation of post-approval activities such as field
charged to researchers may also affect the judgment of monitoring.
REC members. This inadequacy, in addition to other Secondly, and more crucially, is the establishment of a
factors such as limited availability of time and personnel, national policy on human subject protections and the estab-
no doubt accounted for limited or no implementation of lishment of a National Ethics Authority or Commission to
vital post-approval activities such as field monitoring, data oversee RECs in the country so that all the RECs operating
management, verification of accuracy of reported findings, in Ghana will follow similar guidelines, principles and pro-
and surveys such as research participants’ satisfaction cedures. This is imperative to prevent/ensure that almost
survey. Furthermore, the inadequacy of funding for the every research study conducted in Ghana is implemented
RECs might be the prime or contributory reason for their with proper ethical scrutiny. This should not be a peripheral
inability to engage technical staff to assist in the implemen- matter but something that ought to actively engage the atten-
tation of these post-approval activities. The often-cited tion of all stakeholders. This will be in line with interna-
reason was the unavailability of board members to embark tional best practices, which will also position the RECs to
on these activities, though these may be delegated to act proactively on issues that relate to advancing the
trained staff to be implemented. Alternatively, the establish- conduct of ethical research in Ghana.
ing institutions might consider their RECs activities as full- Protocol post-approval monitoring is important in
time engagement, not a side job for overburdened profes- advancing the conduct of ethical research. However,
sionals as is currently the case in Ghana. making REC members who are already burdened with pro-
On the other hand, all the RECs surveyed reported tocol reviews in addition to their engagements in other pro-
having operational SOPs that guide the conduct of their fessional activities, lack expertise and limited number,
activities. They serve as a quality assurance mechanism to undertake this activity as indicated by one of the key infor-
authenticate the activities of the RECs. At a minimum, an mants, may explain the near non-existence of post-protocol
SOP sets, in clear terms, the authority of the appointing monitoring activities. Lastly, we suggest that all RECs oper-
officer, the membership composition, function, procedures ating in Ghana should hire at least a research compliance
and tenure of the REC. Nonetheless, there are other officer, who will undertake regular protocol post-approval
guiding documents or policies such as having a research monitoring and report the results to the RECs for consider-
misconduct policy, conflict of interest and ethical clearance ation and remedial actions. In addition to this routine proto-
application manuals or guidelines that support the activities col post-approval monitoring, this officer can also be tasked
of RECs in Ghana. Apart from the manuals, most of the to undertake protocol audits when there are reports or alle-
other documents were not available, at least during the gations of serious protocol violations or noncompliance.
period of our data collection. Perhaps these issues have
already been incorporated into their SOPs so separate Research Agenda
policy documents for these are unnecessary.
Assessment of the operational characteristics of a REC
Limitations could be approached from two perspectives: from that of
the RECs and that of their users or clients. We focused on
Our main limitation is the challenge usually associated with the former. It is imperative and, perhaps urgent, to also
self-accounts/self-administered surveys. The researchers assess the latter. This will provide a holistic picture of the
Owusu et al. 127
operational characteristics of RECs in Ghana. We have also Funding
indicated that half of the eighteen RECs in Ghana did not The author(s) disclosed receipt of the following financial support
participate in this study. It will be worthwhile to reach out for the research, authorship, and/or publication of this article:
to all of them as a means of gathering a comprehensive This work was supported by the Fogarty International Center –
national database on RECs operating in Ghana. The eigh- U.S. National Institutes of Health (grant number
teen identified RECs operating in the country also raise R25-TW-010886).
questions for consideration by researchers to inform a
research agenda on this topic. For instance, how are ORCID iD
Ghanaian research institutions, both private and public,
Samuel Asiedu Owusu https://orcid.org/0000-0002-9249-6036
without RECs advancing the conduct of ethical research
in their institutions? Furthermore, what challenges have
been stifling their abilities to do this, if any, and what
could be implemented to facilitate their efforts aimed at Notes
advancing the conduct of ethical research in Ghana? 1. US$1.00=GH¢5.73141
2. Our application for ethical clearance for this study lasted for
an average of four months after submission to two RECs.
Educational Implications Perhaps the experiences of other research investigators will
illuminate the operational timelines of RECs.
Our results suggests that key indicators for measuring the
operational characteristics of RECs including transparency, References
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The datasets used and/or analysed during the current study are doi.org/10.1111/dewb.12146
available from the corresponding author on reasonable request. Office of Science and Technology Policy (2000). Federal
Research Misconduct Policy. Federal Register, 65, 76260–
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Declaration of Conflicting Interests Puppalwar, G., Mourya, M., Kadhe, G., & Mane, A. (2015).
The author(s) declared no potential conflicts of interest with respect Conducting clinical trials in emerging markets of sub-saharan
to the research, authorship, and/or publication of this article. Africa: Review of guidelines and resources for foreign
128 Journal of Empirical Research on Human Research Ethics 17(1-2)
sponsors. Open Access Journal of Clinical Trials, 7, 23–34. ethical intuitions. She co-led in writing the introduction and meth-
https://doi.org/10.2147/OAJCT.S77316 odology sections, led in the development of qualitative research
Resnik, D. B., Neal, T., Raymond, A., & Kissling, G. E. (2015). instruments and collection of the qualitative data as well as contrib-
Research misconduct definitions adopted by US research insti- uted in the write up of the manuscript.
tutions. Accountability in Research, 22(1), 14–21. https://doi.
Barbara Redman is an international researcher and author in the
org/10.1080/08989621.2014.891943
field of bioethics. She is currently an Associate of the Division of
Silverman, H., Sleem, H., Moodley, K., Kumar, N., Naidoo, S.,
Medical Ethics, Department of Population Health, New York
Subramanian, T., Jaafar, R., & Moni, M. (2015). Results of a
University Grossman School of Medicine, United States of
self-assessment tool to assess the operational characteristics of
America. Her areas of expertise include research ethics (especially
research ethics committees in low-and middle-income coun-
– research misconduct), and ethics of chronic illness. She partici-tries. Journal of Medical Ethics, 41(4), 332 337. http://dx.
pated in the conception of the paper, provided inputs into the devel-
doi.org/10.1136/medethics-2013-101587
opment of the research instruments and contributed to the write up
Sleem, H., Abdelhai, R. A. A., Al-Abdallat, I., Al-Naif, M., Gabr,
of the manuscript.
H. M., Kehil, E., Sadiq, B. B., Yousri, R., Elsayed, D., &
Sulaiman, S. (2010). Development of an accessible self- Lisa Kearns is a Senior Research Associate at the Division of
assessment tool for research ethics committees in developing Medical Ethics, Department of Population Health, New York
countries. Journal of Empirical Research on Human Research University Grossman School of Medicine, United States of
Ethics, 5(3), 85–98. https://doi.org/10.1525/jer.2010.5.3.85 America. Her research interest is in bioethics. She participated in
Strauss, A. L. (1987). Qualitative analysis for social scientists. the conception of the paper, provided inputs into the development
Cambridge university press. of the research instruments and contributed to the write up of the
Terrell, S. R. (2012). Mixed-methods research methodologies. The manuscript.
Qualitative Report, 17(1), 254–280. Paul Amuna is a Professor at the School of Public Health,
University of Health and Allied Sciences, Ho-Ghana. His research
Author Biographies interests include links between maternal health and wellbeing and
inter-generational risks of chronic disease and nutrition transition.
Samuel Asiedu Owusu is a Senior Research Fellow and He provided inputs into the development of the research instru-
Bioethicists at the Directorate of Research, Innovation and ments and contributed to the write up of the manuscript.
Consultancy, University of Cape Coast, Ghana. His research inter-
est is in the areas of research ethics, mHealth, child health and Amos Laar is an Associate Professor at the Department of
mobilities. He led in writing the introduction and methodology sec- Population, Family and Reproductive Health, University of
tions, development of research instruments, data collection, analy- Ghana, Legon-Accra. He draws on theoretical and methodological
sis and write up of the manuscript. perspectives from the social sciences, bioethics, and public health
to understand how physical environment, social environment, and
Grace Addison is an Assistant Lecturer and a researcher in philos- the macro-environment affect health. He participated in the con-
ophy and research ethics at the Department of Philosophy and ception of the paper, provided inputs into the development of the
Classics, University of Ghana, Legon-Accra. Her research interest research instruments, participated in the data collection and con-
is in the areas of bioethics, epistemic and moral challenges of tributed to the write up of the manuscript.