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Establishment of a Standing Ethics/Institutional Review Board in a Nigerian University: A

Blueprint for Developing Countries

Article  in  Journal of Empirical Research on Human Research Ethics · April 2007

DOI: 10.1525/jer.2007.2.1.21 · Source: PubMed

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J R020103 3/29/07 8:29 PM Page 21
E STABLISHMENT OF A S TANDING E THICS /I NSTITUTIONAL
R EVIEW B OARD IN A N IGERIAN U NIVERSITY:
A B LUEPRINT FOR D EVELOPING C OUNTRIES
A DEYINKA G. FALUSI
Institute for Advanced Medical Research and Training,
University of Ibadan, Ibadan, Nigeria
O LUFUNMILAYO I. O LOPADE
Department of Medicine,
University of Chicago, Chicago, Illinois, USA
C HRISTOPHER O. O LOPADE
Department of Medicine,
University of Illinois at Chicago,
Chicago, Illinois, USA
ABSTRACT: AN ETHICS/INSTITUTIONAL REVIEW BOARD
(IRB) was established according to International stan-
dards at the University of Ibadan in Nigeria. To achieve
this, a private-public partnership was developed to sup-
port a review of prevailing practice and the develop-
ment of necessary infrastructure for an effective IRB.
An internationally registered and well-constituted IRB
with a federal-wide assurance (FWA) from the National
Institute of Health in the United States was established
within a year. Over a 3-year period, the number of
proposals reviewed increased by 150% while time to
approval decreased by 62%. International collaboration
and external research funding has increased substantially.
These findings support our initial supposition that the
development of a properly functioning IRB can be a cat-
alyst for increased research productivity at academic
centers in developing countries while ensuring the pro-
tection of vulnerable human research subjects. The
University of Ibadan is now assisting other academic
Institutions in Nigeria and sub-Saharan Africa with the
establishment of their own IRBs.
KEY WORDS: Developing countries, ethics boards,
IRBs, ethics education
Received December 4, 2006; Revised March 8, 2007
Journal of Empirical Research on Human Research Ethics, PP. 21-30. PRINT ISSN 1556-2646, ONLINE ISSN 1556-2654. © 2007 BY JOAN SIEBER .
ALL RIGHTS RESERVED. PLEASE DIRECT ALL REQUESTS FOR PERMISSIONS TO PHOTOCOPY OR REPRODUCE ARTICLE CONTENT THROUGH THE
UNIVERSITY OF CALIFORNIA PRESS ’ S RIGHTS AND PERMISSIONS WEBSITE , HTTP :// WWW. UCPRESSJOURNALS . COM / REPRINTINFO. ASP.
DOI: 10.1525/ JERHRE .2007.2.1.21
Ethics Boards and Developing Countries 21
N
inety three percent of the global burden of
premature mortality due to disease occurs in
developing countries. Unfortunately, less
than 10% of the estimated US $70 billion
annual global health expenditure is spent on addressing
the health problems relevant to 90% of the world’s pop-
ulation (World Health Organization, 2004). This 10/90
disequilibrium and the expansion of clinical and bio-
medical research globally has made the need for appro-
priate ethics education and training of scientists who
conduct research involving human subjects more acute.
This need is greatest in developing countries, especially
Africa, where dramatic increases have occurred in the
number of human studies being performed.
In a span of less than 10 years, the United States Food
and Drug Administration (FDA) recorded a 20-fold
increase in the number of international clinical trials
from 400 in 1991 to 7,500 in 2000. The relative increase
in the number of clinical trials in less developed coun-
tries is even greater with an increase from fewer than 10
in 1993 to over 700 in 2000 (FDA, 2003). While there is
consensus on the need to have a uniform global ethics
guideline for the conduct of human research, there are
many difficulties in the adoption of ethical principles
used in wealthy industrialized nations.
In contrast to standards in developed countries,
poor education, poverty, lack of communication,
socio-cultural influences on decision making and the
consent process, especially for women, pose unique
and more difficult challenges in developing countries.
The powerful influence of husbands, community elders
and religious leaders on decision making calls for a
more pragmatic presentation of research projects to
avoid coercion while obtaining patient consent within
the realities of the socio-cultural setting.
Historically, abuses in human research, with poor
to no patient protection, have been documented espe-
cially with the Tuskegee syphilis experiments of 1932
(Fairchild & Bayer, 1999), the Nazi experiments of
J R020103 3/29/07 8:29 PM Page 22
22 A. Falusi, O. Olopade, C. Olopade
1930-45, and the Jewish cancer research experiments of
1963 to mention a few (Stephens, 2006: Langer, 1964;
Lerner, 2004). Sadly, these abuses continue today as
exemplified by the recent trial of the drug Trovafloxacin
mesylate in Kano, Nigeria in 1996 by a pharmaceutical
company during which 100 children were treated for
meningitis with a new antibiotic without due process
and appropriate consent (Stephens, 2006; Hensley,
2003). Over 10% of these children died and severe
debilitating complications such as brain damage and
deafness occurred in other subjects.
A recent questionnaire survey of 207 researchers in
developing countries (42% from Asia, 29% from
Africa and 23% from South America) to determine
prevailing methods used to conduct and document
consent for participation in research projects revealed
the following practice patterns: written informed con-
sent was documented in 68% of cases, approval from
village leader sought in 49% of cases, oral consent
with witnessed signatures in 33%, approval from family
members obtained in 19% and test of subject under-
standing determined in only 27% of study participants
(Hyder & Wali, 2006). In addition, the survey also
showed that written consents were more likely to be
obtained by physician researchers and in participants
with higher literacy.
Furthermore, written consent was less likely to be
obtained in observational studies, and studies concern-
ing cultural practices, health services or environmental
health. The wide variability in the administration of
informed consent suggests one vital area for evaluation
of current practices and education of researchers and
ethics committees.
The challenges faced by developing countries in the
global expansion of research are many and further
compounded by the increase in genetic research stud-
ies. Faced with (a) the lack of credible infrastructure to
conduct rigorous research, (b) strong local institutional
desire to contribute to global research, especially in
the area of human genetics, which holds great poten-
tial for new therapies, (c) coupled with personal
desires of the authors to create better protection for
vulnerable subjects, we embarked on the process of
developing a fully functional standing IRB at the
University of Ibadan.
The main objective of the initiative was to create a
viable IRB that would meet international standards
with the purpose of reinvigorating research activities
at the University of Ibadan. Our intention was to use
the knowledge gained in the process to promote
capacity building in biomedical ethics and to facilitate
the development of IRBs at other institutions in
Nigeria and other African countries. Our hope was
that the establishment of a uniform, predictable
approach to the development, review and conduct of
research consistent with international standards
would spur productive biomedical research activities
throughout Africa. It was important to us to incorpo-
rate local socio-cultural realities in the process.
Methods
PHASE I
In 2002, we reviewed the status of the University
College Hospital, University of Ibadan Ethics Board
that had been in existence since 1980. We found that
the Board had not been active and was poorly organ-
ized with no constitution or written standards or poli-
cies in place to guide the review of research proposals.
There was no established infrastructure such as a des-
ignated secretariat, staff, or records of previous IRB
reviews and approvals. Meetings were held as needed,
or as infrequently as every 6 months, as there was very
little research at the University due to pervasive aca-
demic strikes and the dire economic condition of the
country. The Director of the Institute for Medical
Research and Training (IMRAT) who ultimately
approved all institutional research studies made the
selection of suitable reviewers for each submitted pro-
tocols. On occasion, the Director gave executive
approvals after review of the protocol without the ben-
efit of a full committee.
Despite the importance of this essential review
process for promotion of research activities within the
University, there was no budget allocation to support
the activities of the ethics board. Predictably, there was
little or no awareness of the existence of an IRB by fac-
ulty and staff and not surprising; there was no interna-
tional registration or recognition of the existence of a
duly constituted IRB.
PHASE II
In 2002, we began to take steps towards the establish-
ment of the IRB at the Institute for Advanced Medical
Research and Training as detailed in Table 1.
The Institute for Advanced Medical Research and
Training (IMRAT) was designated as the center for
research activities for the College of Medicine at the
University of Ibadan, Nigeria in 1980. The mandate
was to serve as the research-coordinating center for ter-
tiary institutions and government agencies throughout
Nigeria.
J R020103 3/29/07 8:29 PM Page 23

Ethics Boards and Developing Countries 23

TABLE 1. Steps in Establishing the IRB at the Institute for Advanced Medical Research and Training (IMRAT).

Choice of the IMRAT as home for Board activities

Provide educational opportunities for IMRAT Director as IRB Director designate
Identify credible leadership for the IRB
Create private/public partnership to raise capital for the project
Develop Training programs to educate the wider college leadership on Ethical principles and benefits of a well constituted
and internationally recognized IRB
Support capacity building and motivate new leadership in Biomedical-Ethics
Promote education on ethical principles and all stages of developing a research project
Proposal writing
Informed consent
Data integrity
Plagiarism
Conflict of interest in Medicine and management
Constituting an Ethics/IRB Board
Developing policies and procedures for IRB function
Effective management of IRB meetings
Securing IRB registration and Federal-wide assurance

To accomplish this mission, specific goals were (1) to
strengthen manpower development by training investi-
gators at all levels that includes students, postdoctoral
fellows and faculty, (2) to promote collaboration
among researchers at local, national and international
levels, and (3) to facilitate funding support for research
activities at the center. Additionally, IMRAT was
expected to provide assistance with the dissemination
of research findings through appropriate media to
other professional groups such as industries, private
sector, policy makers and the general public. The man-
date, which was consistent with the goals of the initia-
tive, made IMRAT the natural base for developing a
fully operational IRB.
The director at IMRAT provides leadership for all
research activities at the College of Medicine. This
positions the director to shape the direction of all
research activities towards accomplishing the
University’s stated mission of “expanding the fron-
tiers of knowledge and to transform the society
through innovation.” Unfortunately, the University’s
mission on innovation could not be accomplished
without the necessary framework for ethical oversight
and review.
The engagement of the IMRAT Director was there-
fore felt to be essential to achieving the goals of this ini-
tiative. As the oldest, most reputable, and largest
University in Nigeria with undergraduate and postgrad-
uate enrollment of 17,461, as well as having the largest
academic (1,152) and non-academic (3,563) faculty in
the country, the potential for the University to influence
the direction of research in Nigeria is great.
Private/Public Partnership in Setting
up the IRB Secretariat
Despite the declared interest in fostering research, the
University of Ibadan has never had sufficient resources
from the Federal Government to operate an IRB.
Hence, for this effort to be successful a model of private/
public partnership was developed. The University of
Chicago through a generous grant from the Ralph and
Marion Falk Medical Research Trust provided $40,000
in grant support over two years from 2002-2004. This
investment led to the development of a designated IRB
office at IMRAT with appropriate procurement of fur-
niture, needed equipment such as computers, printers,
photocopier, scanner, filing cabinets and staffing with a
secretary and clerk to execute all related activities of the
IRB. An Executive Officer from the College of
Medicine, chosen by the Provost was also assigned to
the IRB to provide administrative and logistical sup-
port for effective organization of the meetings.
Setup and Membership of the UI/UCH IRB
In 2002, the University of Ibadan (UI) and the
University College Hospital in the College of Medicine
(UCH) established a joint Institutional Review Com-
mittee (UI/UCH IRC) in accordance with regulations
J R020103 3/29/07 8:29 PM Page 24
24 A. Falusi, O. Olopade, C. Olopade
at both institutions. The Director at IMRAT also serves
as Chair of the newly constituted IRB. The choice of the
membership of the committee was carefully considered
based on some knowledge of the degree of ethics train-
ing and interest in ethics by faculty members. An out-
side legal non-institutional member and 2 laypersons
were added to the team. Membership is multidiscipli-
nary with clinicians, basic scientists, one lawyer, one
statistician, one social scientist and a pharmacist
included.
There was a strong bias in favor of physicians in dif-
ferent disciplines including pediatrics, medical micro-
biology, dentistry, radiology, and medical oncology.
Scientists such as hematologist/geneticists, social scien-
tists, public health specialists and other professionals
such as nurses, pharmacists, lawyers, ethicists, clergy,
and laypersons were included to represent the cultural
and moral values of the community. Current member-
ship is 17 with four statutory members (Chair-IMRAT
Director, Co-Chair-Chairman Medical Advisory
Committee, Legal Officer and Statistician) and 9
women in an effort to maintain gender balance on the
committee. The membership term was set at 2-years
with renewable membership allowed.
Leadership Training for the Director
To improve the knowledge of ethical principles and
the operations of institutional review boards, support
was provided for the Chair of the IRB to attend a
series of training workshops in Institutions with func-
tioning IRBs in East and Central Africa as well as in
the United States of America. The Chair also had
opportunities to participate in mock IRB sessions as
well as in real IRB sessions at universities in the
United States. Several educational courses offered via
the Internet were also useful in supplementing the
Chair’s education in all relevant aspects of effective
running of an IRB office. These activities occurred
very early in the process and training locally was made
available to the initial core group of members of the
UI/UCH IRC.
Capacity Building in Biomedical Ethics
Capacity building training sessions and workshops
were then organized for the newly constituted com-
mittee members’ at quarterly intervals in the first year.
The educational programs and workshops covered
topics such as proposal writing, informed consent,
data integrity, plagiarism, conflict of interest in
research and management of patients, constituting an
IRB, developing policies and procedures for IRB func-
tion, intellectual property rights, effective management
of IRB meetings and securing IRB registration and
Federal-Wide Assurance from the National Institutes of
Health in the United States of America (USA).
These workshops and seminars were usually daylong
and included formal presentations by experts in the rel-
evant areas of interest, followed by focus group discus-
sions and breakout sessions to discuss specific and
practical ethical issues in small groups prior to recon-
vening and coming to consensus. The implications for
research, protection of patients’ rights and informed
consent were stressed during all phases of the training.
Policies and standard operating procedures (SOPs)
for the submission and review of protocols by IRB were
gradually developed, implemented and published over
a 3-year period (Falusi, Ajuwon, Babalola & Obono,
2005).
Operations and Activities of the IRB office
The duly constituted Committee holds monthly meet-
ings to review proposals. In the absence of an ethics
board at the University, the newly constituted IRB
serves in the dual role of reviewing both the scientific
and ethical aspects of all proposals. This is justifiable
since there can be no clear separation between scientific
and ethical reviews and for now, there is no separate
scientific review board for research projects at the
University of Ibadan.
With the successful establishment of the IRB secre-
tariat, several workshops were organized in the first
two years with faculty drawn from within the institu-
tion to provide additional education for all faculty, stu-
dents and staff who participate in research. One such
workshop involved faculty drawn from the local pool
of experts and the international community. Topics
such as informed consent, data integrity, plagiarism,
proposal writing, conflict of interest in research and
management of research subjects were discussed. The
intent was to conduct these seminars and workshops
on a yearly basis so that updates and policy changes
may be disseminated effectively amongst researchers.
Results and Current Status
Registration
Within the first 3 months after constituting the IRB
committee, it was registered with the Office of Human
Research Protection (OHRP No. IRB00002499–May
2002) and also had a Federal Wide Assurance
J R020103 3/29/07 8:29 PM Page 25
Certification (No.00003094-U Ibadan–Aug. 2002)
issued. Registration was later renewed in 2005 through
2008. The University of Ibadan now has a well constitut-
ed Institutional Review Board (IRB) with 17 members:
Chairperson, Co-Chair, Legal adviser, a statistician,
two faculty members each from the Clinical Sciences,
Health Sciences, one faculty member each from Law,
science and Social Science, two lay individuals, a sec-
retary and five alternates. Meetings are held monthly
with 50% attendance by the membership needed for
a quorum.
In the UI/UCH IRB system, three main types of
reviews are applied. These are exempted, expedited and
full committee reviews. The exempted categories of
review are delineated based on 45 CFR 46, 101) (U. S.
Government, 2005).
An expedited review procedure applies to research
activities, which present no more than minimal risk to
human subjects. It consists of a review of research
involving human subjects by the IRB chairperson or by
one or more experienced reviewers designated by the
chairperson from among members of the IRB in accor-
dance with the requirements set forth in 45 CFR 46.110.
Full committee review of a protocol involves the
assignment of the protocol to two primary reviewers,
while copies of the proposal are also sent to the other
members of the committee. Depending on the nature
of the project, consultants in specific fields are some-
times called upon for protocol reviews. Discussion of
the protocol occurs during one of the IRB meetings
with input sought from the primary reviewers and with
contributions from the other members.
Research proposals, which meet criteria for exemp-
tion, are those in which there is virtually no risk to the
participant. The initial exempt determination is made by
the IRB Chair or designee based on risk assessment and
whether the project involves “research” and whether
“human subjects” are involved. Despite meeting criteria
for exempt status by virtue of the minimal risk, an appli-
cation to the IRB is still expected with institutional
review and approval required before project initiation.
Consistent with policy and regardless of the protocol
classification, the 45 CFR 46 requirements for
informed consent must be met before the UI/UCH IRB
gives final approval for study initiation. The committee’s
decisions are pending-conditional, pending-deferral and
approved. Outright rejections are very unusual with
only two out of 500 in the past 4 years. Instead of rejec-
tion, pending-conditional approvals are granted, thus
giving room for amendment of the protocols by the
principal investigator in compliance with the IRB
requirements.
Ethics Boards and Developing Countries 25
Training programs are conducted twice a year for
IRB members, while seminars and workshops spon-
sored by the Postgraduate School, and the Nigerian
Bioethics Initiative, among others, occur frequently
and help to promote awareness and improve the func-
tion of the IRB (Falusi, 2005; Obono, et al., 2006).
Infrastructure
The Secretariat, which is located in the IMRAT build-
ing, is adequately equipped with appropriate facilities
such as a computer, printers, scanner, photocopier,
spiral binders, stationery and cabinets. The record
keeping is excellent and well documented. Standard
operating procedures have been developed as well as
the production of a handbook titled “Guidelines for
Submission and Review of Proposals for the UI/UCH
Ethics Review Board” (Falusi, Ajuwon, Babalola &
Obono, 2005). An electronic database record is cur-
rently under development.
Center Activities
In a span of 3 years from 2002 to 2005, there has been
a significant increase in the number of proposals sub-
mitted to the IRB from 63 in 2002 to 111, 162, and 164
in years 2003, 2004 and 2005 respectively (Fig 1). The
average period between protocol submission and
approval has also decreased steadily from 7.87 months
in 2002, to 4 months in 2003, 3.6 months in 2004, 3.69
months in 2005 and 3 months in the first 8 months of
2006 (Fig 2). Identified sources of delay in protocol
review and approval include inefficient mailing of sub-
mitted proposals to the reviewers, tardy receipt of
reviewers’ comments, investigators’ slow response to
corrections or lack thereof, failure to relay reminders
and lack of documentation of reminders on time to
reviewers and investigators. The inability to review
protocols on a timely basis by faculty IRB members
also contributed to approval delays. Some of the rea-
sons for faculty delay are busy clinical schedule, teach-
ing commitments and non-availability due to travel.
We also observed that proposals in which there is
international collaboration were approved slightly
faster than other proposals. This is in part due to poorly
supervised proposal writing by the local investigators,
which occasionally necessitated the near complete
rewriting of the whole application prior to review and
approval. Additionally, slow responses to reviewers’
queries especially in relation to methodology and sam-
ple size calculations also featured prominently on the
list of delaying factors.
J R020103 3/29/07 8:29 PM Page 26

26 A. Falusi, O. Olopade, C. Olopade

FIG. 1. Protocols reviewed & approved by UI/UCH IRB, Ibadan (2002-2005).

The source of the submitted proposals classified by
cadre/year is shown in Figure 3. These cadres are the
Undergraduates (UG), Postgraduates (PG—MSc., PhD,
and Residents) projects, nationally funded (local)
projects and international funded projects. During the
3 year period from 2002-2005, over 60% of protocols
submitted for review were from postgraduate projects
(Fig 4). One of the benefits of the establishment of an
IRB with FWA assurance has been the increase in the
number of proposals with international collaborators
and sponsors, which now account for over 10% of all
approved protocols at Ibadan University.
Discussion and Strategies for the Future
The development at University of Ibadan of a fully
functional, FWA-registered IRB compliant with
international ethics standards is a major achievement.

FIG. 2. Submission to approval interval.

J R020103 3/29/07 8:29 PM Page 27

Ethics Boards and Developing Countries 27

FIG. 3. Classification of Proposals by Cadre/year.

The improvement in the education of faculty, staff and researchers and funding agencies (Sylvester & Chima,
students who participate in research on study method- 2006).
ology, provides a unique opportunity to improve data The successful implementation of an IRB by the
integrity. Better protection of research subjects will University of Ibadan, and its willingness to assist other
ensure the continued growth of a viable research infra- academic Institutions in Nigeria and Africa with the
structure within the University and foster active partic- establishment of their own IRBs augurs well for
ipation in global research activities. improved capacity building initiatives in Nigeria and
The Network for Ethics of Biomedical Research in sub-Saharan Africa. An early dividend of this initiative
Africa (NEBRA) initiated collaboration between is the recent grant award by the European and
Northern/Southern partners primarily for a needs Developing Countries Clinical Trials Partnership to the
assessment in 15 countries in the West and Central IRB Director at the University of Ibadan to be used to
African sub-region. The initial success of the IRB at the assist institutions in the other geopolitical zones of
University of Ibadan resulted in its participation in this Nigeria in the development of viable Ethics Boards.
laudable outreach project. Findings revealed a lack of The expectation is that successful implementation of
infrastructure and manpower capacity and lack of
appropriate procedures for a great majority of IRBs in
Nigeria and in some other West African states.
Ongoing discussions on the Ethics of Biomedical
Research in African countries are currently focused on
subject protection from research abuse and uniform
global implementation of international ethical codes in
biomedical research. In addition, biomedical research
in Africa would benefit greatly from regulations backed
by law that provide guidance on forming viable and
active local ethics committees, shaping informed con-
sent, regulations for distributive justice such as post
trial benefits and procedures of setting relevant stan-
dards of care for injuries incurred during sponsored FIG. 4. Classification of cadre combined for 3 years
research due to negligence or unethical conduct by (2002-2005).
J R020103 3/29/07 8:29 PM Page 28
28 A. Falusi, O. Olopade, C. Olopade
these initiatives will serve as models for the develop-
ment of other ethics boards in Africa.
In addition to development of educational and reg-
ulatory frameworks at institutional and national levels
especially in sub-Saharan Africa, the strengthening of
existing networks is of paramount importance. Once
this is accomplished, the next step will be to develop
national and regional research policy guidelines and
regulations that can be interpreted by local ethics
committees to provide oversight to research reflecting
local realities. These guidelines should stipulate stan-
dards of care in the local population and compensa-
tion for injuries arising from sponsored research. All
of these principles, once well understood and imple-
mented, will eventually form the basis for review sys-
tems in institutions especially in sub-Saharan Africa,
and will guarantee a better future for research in
Africa.
There is increasing evidence that the need for devel-
opment of a cadre of bio-ethically trained researchers
and better protection of research subjects is now bet-
ter established than it was five years ago. The estab-
lishment of the West African Bioethics initiative,
with support from the Fogarty International Center
at the NIH, will expand the pool of trained experts
with the establishment of a Masters and PhD degree
in bioethics at the University of Ibadan (http://www.
westafricanbioethics.net/postgraduate/). A series of suc-
cessful workshops in bioethics, including the recently
concluded program in Ibadan sponsored by NEBRA, is
an indication that the future is bright for ethical conduct
of research in Nigeria and other African countries.
Lastly, the newly established National Code for
Health Research Ethics by the Federal Government of
Nigeria is further evidence of the continued spread of
bioethics knowledge across Nigeria and hopefully sub-
Saharan Africa.
Conclusion
Despite the growth and success of this initiative, its
sustainability remains shaky. The University of
Ibadan has not developed a mechanism to allocate
additional institutional resources towards the opera-
tion of this vital resource. However, indirect costs and
nominal overhead fees charged to all principal inves-
tigators with an approved project continue to supple-
ment resources from the private/public partnership in
sustaining the growth and expansion of the activities.
Hopefully, recognition of the importance of the IRB
to the university’s research enterprise will encourage
the allocation of adequate resources for the growth of
the office.
This successful demonstration project has significant
implications for the rapid spread of sound ethical prin-
ciples of human research across Africa and will pro-
mote improved participation in global research to the
benefit of all.
Best Practices
1. The establishment of a functional IRB in higher
institutions in Africa and other developing coun-
tries needs to be accomplished.
2. Seeking private-public partnership is critical to the
successful implementation of such a program as
resource allocation is often responsible for the lack of,
or poorly organized IRBs across sub-Saharan Africa.
3. Getting the commitment and support of the institu-
tional leadership and other stakeholders is crucial in
establishing a functioning IRB.
4. Adequate training of future IRB members on all
phases of research methodology from concept
development, proposal writing, informed consent
and running an effective IRB meeting are necessary
for successful implementation.
Research Agenda
1. Conduct a needs assessment to identify novel meth-
ods of streamlining and improving the review
process.
2. Perform an evaluation of the effect of training pro-
grams on the knowledge of research design and eth-
ical principles among faculty and students at the
institution.
3. Investigate novel approaches for funding IRB activ-
ities in resource-constrained settings.
4. Conduct a systematic review of existing national and
regional guidelines and regulations to identify gaps
in human subjects protection policies that must be
addressed.
Educational Implications
The successful demonstration project at the University
of Ibadan has the potential to create an ever-expanding
set of educational activities. It has provided a core group
of faculty who are well educated in ethical standards of
research, and in the role of the Institutional Review
Board in the promotion of research. Additionally, they
J R020103 3/29/07 8:29 PM Page 29
have willingly shared their expertise with other institu-
tions in Nigeria and Africa on how to develop a func-
tioning IRB. Furthermore, the Director of the
initiative has secured funding from the European
Union to assist in the development of IRBs in other
academic institutions spread over 6 geopolitical
regions in Nigeria. The establishment of a Masters and
PhD degree program in bioethics at the University of
Ibadan and the development of a Nigeria National
Code for Health Research Ethics are progressive
changes towards improved research ethics in Nigeria
and across the continent.
Important Resources for IRBs and Bioethics
IRB registration and assurances (U. S. Government,
2005a)
IRB Review process (U. S. Government, 2005c)
International issues in Human research protection
(U. S. Government, 2005a)
Network for Ethics on Biomedical Research in Africa
Bioethics training in Africa: http://www.westafrican
bioethics.net/new/eng?pg=home
Funding sources:Fogarty International Center, NIH:
http://www.fic.nih.gov/
Wellcome trust: http://www. wellcome.ac.uk/doc%
5Fwtd004761.html
Acknowledgment
The authors are grateful for the financial and logistical
support from the Ralph and Marion Falk Trust, USA,
and the Center for Clinical Cancer Genetics at the
University of Chicago and Healthy life for all
Foundation, Ibadan that was critical to the successful
implementation of the program.
Author Note
Address correspondence to: Christopher O. Olopade,
Department of Medicine M/C 719, Section of
Pulmonary, Critical Care and Sleep Medicine, University
of Illinois at Chicago, 840 S Wood Street, Chicago, IL
60612, (312) 996 8039, E-MAIL: cosolopa@uic.edu.
Authors’ Biographical Sketches
Adeyinka G. Falusi, PhD, is Professor of Hematology
and Human Genetics at the University of Ibadan,
Nigeria and Protem Chair, Nigerian Bioethics Initiative.
Ethics Boards and Developing Countries 29
She served as the Director of the Institute of Medical
Research and Training, College of Medicine,
University of Ibadan during the conduct of this proj-
ect and was intimately involved with all phases of the
establishment of the Ethics/Institutional Review
Board and its successful operation thereafter. She
actively participated in all stages of preparing this
manuscript. She has become an authority on the
Ethical principles of research, leading workshops and
seminars across the African continent on research
Ethics and how to establish functioning IRBs. She has
recently secured funding from the European Union to
assist 6 other higher institutions in Nigeria to develop
their Ethics/IRB.
Olufunmilayo I Olopade, MD, is the Walter L Palmer
Distinguished Service Professor of Medicine and
Director, Center for Clinical Cancer Genetics at the
University of Chicago, Chicago, Illinois. She is a 2005
MacArthur Fellow and Internationally recognized
expert in Breast Cancer. She was instrumental in nur-
turing the Private-Public partnership, which provided
the critical funding necessary for the successful imple-
mentation of this project. Her commitment to the
development of an active Bioethics program and capac-
ity building at the University of Ibadan is evident
through her collaborative work that has promoted the
academic careers of many faculty members at the
College of Medicine, University of Ibadan. She partici-
pated actively in the development and implementation
of the strategy to revamp and establish the Ethics/IRB
program at Ibadan and contributed to the writing of
this manuscript.
Christopher O Olopade, MD, MPH, is Associate
Professor of Medicine and Director of Clinical
Research in the Section of Pulmonary, Critical Care
and Sleep at the University of Illinois at Chicago,
Chicago, Illinois. He is the American College of Chest
Physicians Governor for the State of Illinois and
President of the New York based Nigeria Higher
Education Foundation charged with providing support
for the growth and development of 6 designated higher
institutions in Nigeria. He has expertise in Health
Policy and has committed time and resources towards
capacity building initiatives at Academic centers in
Nigeria. He was an active participant in the training
seminars and workshops organized for the Ethics/IRB
members and other researchers at the University of
Ibadan, Nigeria. He also actively participated in all
stages of the development of this manuscript and will
serve as the corresponding author.
J R020103 3/29/07 8:29 PM Page 30
30 A. Falusi, O. Olopade, C. Olopade
References
FAIRCHILD, A. & BAYER , R. (1999). Uses and abuses of
Tuskeg ee, Science, 284(5416), 919-921.
FALUSI , A. (2005). The role of ethical reviews and approvals in
human participant research. Ibadan, Nigeria: Corporate Graphics.
FALUSI , A., A JUWON , A., BABALOLO, C. & O BONO, O.
(2005). University of Ibadan and University College Hospital
Guidelines for Ethical Review. Ibadan: Corporate Graphics.
Food and Drug Administration (2003). International Clinical
Trials, FDA Biomonitoring Research Database.
H YDER , A. & WALI , S. (2006). Informed consent and collabo-
rative research perspectives from the developing world.
Developing World Bioethics, 6, 33-40.
L ANGER , E. (1964). Human experimentation: Cancer studies
at Sloan-Kettering stir public debate on medical ethics.
Science, 14 3, 551-553.
L ERNER , B. (2004). Sins of omission: Cancer research without
informed consent. New England Journal of Medicine, 351(7),
628-630.
O BONO, O., A JUWON , A., A ROWOJOLU, A., O GUNDIPE , G.,
YAKUBU, J., & FALUSI , A. (2006). Ethics in Research (2nd Ed.)
Ibadan, Nigeria: Corporate Graphics.
View publication stats
H ENSLEY, S. (2003). Court revives suit against Pfizer on Nigeria
study. Retrieved September 15, 2006 from www.ahrp. org/
infomail/03/10/14a.php.
S TEPHENS , J. (May 7, 2006). Panel faults Pfizer in ‘96 clinical
trial in Nigeria: “Unapproved drug tested on children,”
Washin gton Post, A-9.
S YLVESTER , C. & C HIMA , A. (2006). Global medicine:
Regulation of biomedical research in Africa, British Medical
Journal, 7545, 848-851.
U.S. Government (2005a). International Issues, July 19.
Retrieved March 4, 2007 from http://www.hhs.gov/ohrp/
international/.
U.S. Government (2005b). Policy Guidelines. Retrieved
March 4, 2007 from http://www.hhs.gov/ohrp/policy/
index.html/.
World Health Organization (2004). Revised global burden of
disease (GBD) 2002 estimates incidence, prevalence, mortality,
YLL, YLD and DALYs by sex, cause and region, estimates
for 2002 as reported in the World Health Report 2004:
World Health organization.