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          Bangladesh Journal of Bioethics 2021; 12 (1):35-48 

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Ethical issues in biomedical research in Nigeria: a systematic review  

Chinaza Richard Ikeagwulonu1, Chigozie Jesse Uneke2
,
 Obeta Mark Uchejeso3 

1. Senior Medical Laboratory Scientist, Department of Medical Laboratory Science, Alex Ekwueme Federal 

University Teaching Hospital, Abakaliki, Nigeria and Member, African Institute for Health Policy and Health 

Systems, Ebonyi State University, Abakaliki, Nigeria. Email: rikeagwulonu@gmail.com, 

2. Deputy Vice Chancellor, Academics Ebonyi State University, Abakaliki and Founder/Director, African Institute 

for Health Policy and Health Systems, Ebonyi State University, Abakaliki, Nigeria. Email:unekecj@yahoo.com 

3. Head of Department / Chief Medical Laboratory Scientist, Department of Medical Laboratory Management, Federal 

School of Medical Laboratory science, Jos, Nigeria. (Corresponding author):  

Email: uchejesoobeta@gmail.com 

DOI: https://doi.org/10.3329/bioethics.v12i1.51904  

Abstract: The use of human subjects in research comes with lots of ethical challenges. The purpose of this 

review is to assess the various ethical issues that have been associated with biomedical research in Nigeria.  

This article also find out the possible ways of improvement of this scenario.  Pubmed/Medline, Google 

Scholar, JSTOR, and AJOL search were the possible search engine for literature from 2000 to 2020. Key 

words were used including ethics, ethical issues, biomedical research and Nigeria. Of the 113 publications 

were found. A total of 18(15.9%) fulfilled the study inclusion criteria and were included in this review.  

Twelve ethical issues were highlighted including Informed consent (12 studies), autonomy and 

voluntariness (8 studies), beneficence (8 studies), counseling (5 studies), compensation (4 studies), 

professional behavior and attitudes (2 studies), confidentiality (2 studies), social, cultural and religious 

practices (2 studies), scientific integrity (1 study), communitarianism (1 study), equity (1 study), and trust 

(1 study). Most of the studies were cross sectional and carried out in southern Nigeria. We found that there 

are ethical issues in biomedical research in Nigeria of which informed consent is most widely studied. Also, 

participants had varying degree of understanding of their rights as research subjects. As a result, there is 

need to enhance the capacity of investigators to better understand these issues and also increase their 

explanatory skill to help participants achieve complete understanding of their various rights and process. 

Keywords: Ethics, ethical issues, biomedical research (BR), research, systematic review 

 

Introduction: Ethical issues in biomedical 

research involving human subjects have 

received a growing concern since the 

promulgation of Nuremberg Code as far back 

as 1947 1. Ever since then, adhering to ethical 

principles has helped to protect the dignity, 

rights and welfare of research participants 

and reduce to barest minimum moral doubts 

that can arise when carrying out any 

biomedical research involving human 

subjects. “Ethics” in simple terms is defined 

as “norms for conduct” that distinguishes 

between acceptable and unacceptable 

behavior 2 and in a very common sense, 

honesty; social responsibility and integrity 

are considered the basic ethical norms. Any 

deviations from these norms result to 

research misconduct comprising of 

“fabrication, falsification, or plagiarism 

(FFP). “The ethical justification of 

biomedical research involving human 

subjects is the prospect of discovering new 

ways of benefiting people’s health” 3 and to 

achieve this, many countries and institutions 
2,3,4,5 had developed codes and regulations 

that set out guidelines. These codes must be 

followed to conduct any biomedical research 

involving human subjects. Despite these 

codes, issues of ethics have continued to pose 

a challenge to biomedical research in 

developing countries like Nigeria. 

Nonetheless, deficits in infrastructures, 



          Bangladesh Journal of Bioethics 2021; 12 (1):35-48 

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paucity of funds and poor human research 

capacities has resulted in most research in 

Nigeria. These hinder to take rigor and often 

timely research compared to developed and 

western countries. Although biomedical 

studies carried out in these developed 

countries are not totally free from misconduct 

and also battles with issues associated with 

ethics 6, The Trovan study conducted by 

Pfizer in Kano, Nigeria in 1996 8 was a 

wakeup call to Nigeria to led development of 

the Nigerian Code of Health Research Ethics 

(NCHRE) by the National Health Research 

Ethics Committee in Nigeria in 2007 9.  This 

NCHRE guide all researchers involved in 

human subjects’ researches in Nigeria. 

Interestingly, biomedical researchers in 

Nigeria have identified some of the ethical 

issues confronting them in the course of their 

research, however; there has been no effort to 

review these ethical issues for proper 

understanding. The growing call for these 

reviews necessitated the present study to give 

a general overview of what these ethical 

challenges are at a glance.  

Method: A systematic review of literature on 

ethical issues in the context of biomedical 

research in Nigeria was conducted between 

August 2017 and May 2020 with articles 

published in the last 20 years (2000 and 2020) 

using Pubmed/Medline, Google scholar, 

JSTOR, and AJOL(African journal online). 

Key words included a combination of the 

following: ethics, ethical issues, biomedical 

research and Nigeria. We included only 

studies reported in English. full text original 

research articles of studies involving human 

subjects, addressing issue of ethics in 

biomedical research, and research done in 

Nigeria. All review articles, case reports, 

letters, brief reports, communications, 

retrospective chart reviews, news articles, 

articles published before 2000 and articles 

written in other language were excluded from 

this study. All publications were retrieved 

online, and data search ended 2nd May 2020. 

Data extraction was carried out for each 

paper highlighting the following: name of 

first author and year of publication, study 

design, study location, subject, main study 

population, journal name, and ethical issue(s) 

studied/identified. The search strategy and 

results are provided in figure 1. The authors 

are aware the elements of an informed 

consent including voluntarism, information 

disclosure (counseling), and decision-making 

capacity (autonomy) 7; however, we decided 

to present them individually for clarity and 

for better understanding of this study. 

Results: A total of 113 articles were found 

following a thorough search of databases 

listed above criteria. Out of which 18 (15.9%) 

articles (8 -23) met the inclusion criteria. Out 

of the 18 articles 10 (55.1%) were carried out 

in the southern part of Nigeria, while 

2(11.1%) where carried out in Northern part 

of the country. Two of the studies (11.1%) 

were multi-country in nature, whereas 

2(11.1%) where done both in Northern and 

southern part of the country. Among the 

studies conducted in southern Nigeria, the 

southwest leads with 10(60%) followed by 

the south east 3(30%). In terms of study 

design, 17(94.4%) of all the studies were 

cross sectional in nature with just 1(5.6%) 

cohort study design. Clinical practice 

represents the highest area of biomedical 

research identified with about 8 (44.4%) 

studies, followed by genetics/genomics 

5(27.8%).  Clinical trials and non specific 

studies were 2(1.1%). Most of the studies as 

shown in table 1 were conducted in 2014 

(22.2%) followed by 2018 (16.7%). Almost 

all the studies were adult based. A total of 

twelve (12) ethical issues associated with 

biomedical research where identified in this 

review and presented in table2; they include: 

Informed consent (11 studies), autonomy and 

voluntariness (8 studies), beneficence (8 

studies), counseling (5 studies), 



          Bangladesh Journal of Bioethics 2021; 12 (1):35-48 

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compensation (4 studies), professional 

behavior and attitudes (2 studies), 

confidentiality (2 studies), social, cultural 

and religious practices (2 studies), trust (2 

studies), scientific integrity (1 study), 

communitarianism (1 studies), and equity (1 

study). 

 

 

 

     Fig. 1. Flow diagram for the selection of studies on ethical issues in biomedical research 

in Nigeria 

Informed consent (IC) : A total of eleven 

studies (61.1% )(table 2) investigated the 

ethical issue of obtaining an informed 

consent in the research. In their reports, IC 

was not being observed before treatment 20, 

respondents were not asked if they wanted to 

join the study 10, research participants either 

did not understand that the information given 

to them were  adequate  2,4. Four studies 

(36.4%) reported poor understanding of the 

key elements of the IC process, e.g. the rights 

of the participants and invitation  to joining 

the research 9,10,14,20. Participants in four 

studies reported that they were told the 

purpose of the study during the informed 

consent discussion 8,18,21,22. One study (9.6%)  

which was based on obtaining assent in 

children, reported that the health care 

researchers fail to obtain assent from children 

during research, but reported obtaining 

consent directly from their parents 16. Poor 

communication, poverty, illiteracy, 

therapeutic misconception and confusion 

about the dual roles of the researchers and the 

health professionals were factors 

compromising understanding of IC 3,4, 



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whereas retrospectives, belief that consent 

from parents are enough and assent was 

unnecessary 16. Some researchers opined that 

medico legal reasons, hospital/unit policy, 

informing patients about benefits, risks and 

alternatives and to take decisions about the 

planned clinical procedures were reasons for 

obtaining consent before going ahead to carry 

out any clinical procedure 11. Participants 

were divided if they could change their minds 

after signing a consent form, considers the 

form a legal document and insist their 

consent should be sought before enrolling 

them in any research/trial respectively 14. As 

identified in three studies, some subjects only 

give their consent to participate in research 

depending on what they are to benefit 

directly11,16,19. Therapeutic options, special 

ways of minimizing risks of operation and 

detailed explanation about diagnoses are 

more frequently asked questions during IC 

process in clinical practice, whereas taking a 

course in bioethics and compulsory 

communication skills are ways of improving 

IC process generally 11. Satisfying consent 

from the patients’ perspective is associated 

with better recall of consent information for 

clinical procedures 22. In situations the 

participants fail to provide IC, they will not 

likely be threatened 11. Researchers and 

participant’s practice of IC is independent of 

their social demographic variables 16; 

however educational level 14 and age 9 were 

seen to play significant role in other studies. 

 

Autonomy and Voluntariness: Eight 

studies (44.4%) were identified which 

investigated autonomy and voluntariness in 

biomedical research (table 2). Respondents 

from three of the studies clearly reported 

being told the research they were invited to 

partake in research  voluntarily availed 

themselves without being pressured 8,18,21.  

Five studies reported that decision to 

participate in the research was a collectively  

on  their husbands 8,12,18,19,21.  Married women 

were most likely to discuss enrollment 

decision with someone else before making a 

decision 8,12,19. Significant association was 

seen between women having decision to 

participate in clinical procedures and 

obtaining her husband’s permission as well 

as 21. Voluntary participation in research is a 

factor of the benefits accruable from such 

research 10,12,19,23. From four studies, 

respondents acknowledge knowing their 

right to either participate or withdraw from 

the studies at any time 8,9,10,18. Two of these 

studies equally reported low understanding of 

these rights among few research participants 
9,10. One study reported consequences of 

withdrawing from research after giving 

consent to include losing all benefits, being 

seen as an ungrateful person, and seen to be 

unwise withdrawing while still ill of the same 

disease of which the research could have 

helped provide treatment 9. 

 

Counselling: Five studies (27.8%) reported 

the ethical issue of providing adequate 

information and counsel to study participants 

during biomedical research. Three of these 

studies (60.0%) reported that the study 

participants were not adequately counseled 

and are not being well armed with enough 

information concerning the research they 

were involved in 9,20,25. Two studies (40.0%)  

however, opined that respondents were 

adequately counseled for the benefits and 

risks associated with the study they were 

involved in 18,21. Significant association was 

found between having a clinical procedure 

done on client and having counseled clients 

on benefits and risks of the procedure 21. One 

study also reported that most times 

counseling was geared toward giving patients 

an exaggerated hope of success 25. 

 

Beneficence: Eight studies (44.4) 

documented the issue of beneficence in 

biomedical research. Four of these eight 

studies (50%) reported appropriate 



          Bangladesh Journal of Bioethics 2021; 12 (1):35-48 

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knowledge of benefit associated with 

participating in research among the 

respondents 9,12,18,21. There were three studies 

(37.5%) that identified poor knowledge and 

poor understanding of risks associated with 

participating in biomedical research among 

respondents 8,10,18. However, there was one 

study (12.5%) reported that the poor 

knowledge of benefits 10 and good 

knowledge of risks 22 among research 

subjects. One study reported immediate 

benefit as one major reason respondents 

considers before deciding whether or not to 

participate in the research 23. Five studies 

(62.5%)  enumerated some of the benefits in 

participating in research to include obtaining 

free medical tests, free checkup (to know 

their oral health, sugar, cholesterol and blood 

pressure level as well as their genotype), 

improved knowledge of their health 

conditions as well as improvement in health 

delivery of their communities 9,10,12,19,23. One 

study (12.5%) identified risk in biomedical 

research participation to include:  

diminishing of the immune system, general 

drug side effects, death on discontinuation 

and inefficacy of the drug and compliance 

issues 9.  

 

Confidentiality: Two studies (11.1%) 

reported the issue of confidentiality in 

biomedical research. In one of the studies 

respondents were satisfied on how their 

information was handled by the researchers 20 

whereas in the second study respondents are 

not aware of how their records would be kept 
10. 

 

Communitarianism: One study (5.6%) 

reported communitarianism as an issue in 

biomedical research. Proper engagement of 

the community where the research was 

carried out or where the participants were 

recruited in research. In this study individual 

autonomy becomes inappropriate in the face 

of communitarianism as participants stressed 

respect for the decision of the community 

elders, community leadership approval and 

opinions with compliance with traditional 

practices and norms, recognition of the 

influence of the existing societal authority 

structures in decision makings over research 

participation to protect the community from 

harm and exploitation 23.  

 

Scientific integrity: One study reported 

(5.6%) issue of integrity in biomedical 

research. In this study, chance of getting 

caught and penalties for scientific 

misconduct was reported to be low 13. 

Knowledge gaps in research ethics and 

pressure to publish enough papers for 

promotion are common predisposing factors 

to misconducts among biomedical 

researchers, resulting in research fabrication, 

falsification, and plagiarism 13. 

 

Professional behaviour and attitudes: Two 

studies (11.1%) reported issue of 

professional behavior and attitudes in 

biomedical research. In one of the study 

(50%) professionals observed professional 

boundaries with patients during treatment 20 

and the other explained respondents were not 

being pressured to garner consent during 

treatment 21. 

 

Compensation: Four studies (22.2%) 

reported compensation as an issue of ethics in 

biomedical research. While three studies 

(75%) highlighted need to compensate 

research participants and even pay those with 

higher value than others more money 15, 17, 25, 

one study (25%) reported not giving any 

incentives 21. In some instances, private firms 

like clinics indicated willingness to work 

with research teams if they would be allowed 

to distribute the study stipend to referred 

participants 17.  

 

Cultural, social and religious practices: In 

two studies (11.1%) the issue of culture, 



          Bangladesh Journal of Bioethics 2021; 12 (1):35-48 

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Table 1: General characteristics of the studies reviewed 
Author Year of 

publication 

Study location Study 

design 

Subject Main Study 

Populations 

Journal name 

8 

 

2006 Multicountry 

USA 

Nigeria 

Cross 

sectional 

Genetic Adult African 

enrolled in genetic 

studies of 

hypertension 

Am J Public 

Health 

 9 

 

 

2007 Nigeria Cross 

sectional 

HIV and AIDS 

(Clinical Trial) 

ADULT enrolled in 

an antiretroviral 

trial 

Indian Journal 

of Medical 

Ethics 

 

10 

 

2009 Southwestern 

and Northern 

Nigeria 

Cross 

sectional 

Clinical practice 

(Oral health) 

Adult dental 

subjects in an 

ongoing oral health 

research 

BMC Med 

Ethics 

 

11 

2010 Southwestern 

Nigeria 

Cross 

sectional 

 Clinical 

practice 

(Surgical 

intervention) 

Adult Surgeons and 

trainees  

JMed Ethics 

 

12 

 

 

2012 IBADAN, 

Nigeria 

Cross 

sectional  

Genetic Adult participants 

enrolled in a study 

examining the 

relationship of 

serum lipid to 

genetic variants 

Dev World 

Bioeth 

 

13 

2013 Southern 

Nigeria 

Cross 

sectional 

Non- specific Adults in the 

medical and dental 

schools 

J Empir Res 

Hum Res 

Ethics 

 

14 

 

2013 Jos 

Nigeria 

Cross 

sectional 

 

Clinical practice 

(Oral health) 

Adult dental 

patients and dental 

professionals 

J Educ Ethics 

Dent 

 

15 

2014  

 North-Eastern 

(Maiduguri), 

South-Western 

(Ibadan) and 

South-South 

(Calabar)) 

Nigeria 

Cross 

sectional 

 

Obtaining study 

approval 

Adult health 

research ethical 

committee 

 

 S Afr J BL 

 

16 

2014 Abakaliki, 

Nigeria 

Cross 

sectional 

Non-specific Adult medical 

specialists and 

trainees 

Adolesc Health 

Med Ther 

 

17 

2014 Multicountry  

USA 

Ibadan Nigeria 

Cohort Genomic  Adult and Children BMC Med 

Ethics 

 

18 

2014 Ibadan 

Nigeria 

Cross 

sectional 

Genetic  Adult breast cancer 

women enrolled in 

a genetic 

epidermiological 

study 

BMC Medical 

Ethics 

 

19 

2015 Lagos, 

Nigeria 

Cross 

sectional 

Clinical Trial Adult participants 

enrolled in a study 

of an anti malarial 

drug 

Indian Journal 

of Medical 

Ethics 

 

20 

2015 Enugu, Nigeria Cross 

sectional 

Clinical practice Adult patients who 

underwent 

radiological 

examination 

BMC Med 

Ethics 



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21 

2016 Osun, Lagos 

Nigeria 

Cross 

sectional 

Clinical 

practice(tubal 

litigation) 

Adult patients who 

underwent female 

surgical 

sterilization 

Journal of 

Basic and 

Clinical 

Reproductive 

Sciences 

 

22 

2017 Enugu, 

Nigeria 

Cross 

sectional 

Clinical practice 

(surgical 

Intervention) 

Adult surgical 

patients who were 

booked for elective 

major surgical 

procedures 

BMC Med 

Ethics 

 

23 

2018 Southwestern 

Nigeria 

Cross 

sectional 

Genomic Adults  PLoS ONE 

(Public Library 

of Science) 

 

24 

2018 Gombe, Jos 

Nigeria 

Cross 

sectional 

HIV and 

Clinical 

Practice 

(Surgical 

intervention)  

Adult health 

professionals 

 

 S Afr J 

Bioethics Law 

 

25 

2018 Nigeria  Cross 

sectional 

Clinical practice 

(assisted 

reproductive 

technologies ) 

Adult conference 

attendees 

 

 Afr J Reprod 

Health  

 

 

Table 2: Identified ethical issues in biomedical research in reviewed studies 

ETHICAL ISSUES AUTHORS Number of study/frequency 

Informed consent 8,9, 10,11,14,15,16,18,19, 

20,24 

11(61.1%) 

 

 

Autonomy/voluntariness 8,9,10,  12,18,19, 21,23 8 (44.4%) 

Beneficence 8, 9, 10, 12,18,19,21,23 8(44.4%) 

Counseling 9, 18, 20,  21,25 5(27.8%) 

Professional behavior and 

attitudes 

20,21 

 

2(44.4%) 

Equity 20 1(11.1%) 

Confidentiality 10,20 2(44.4%) 

Communitarianism 23 1(11.1%) 

Cultural, religious and social 

practices 

17, 23 2(44.4%) 

Trust 17, 23 2(44.4%) 

Compensation 15, 17, 21, 25 4(22.2%) 

Scientific integrity 13 1(11.1%) 

social and religious practices among some 

ethnic groups and tribes were reported by 

biomedical researchers. Cultural beliefs in 

voodoo or juju which vary within religious 

groups among the Yorubas resulted in 

participants withdrawing from studies and 

also led to delays and difficulties in re-

contacting study participants 17,23. Two 

(11.1%) of the articles under review 

expressed fear of misuse of the research 

samples  as emphasized by Olaitan et al. who 

puts it that they feared that  their saliva and/or 

blood could be used for evil rituals 17. 

 

Equity: Equity as an ethical issue in 

biomedical research was reported by one 

study (5.6%) which observed that equity was 

practiced during a medical procedure 20. 



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Trust: Two studies (11.1%) reported that the 

trust as an issue in biomedical research. 

Regardless of age, respondents identified 

trust in the researcher and research institution 

as an important factor when deciding to 

participate in genomic research and also 

whether the community will agree to the 

research 17, 23. Trust in community leaders 

also will enable respondents commit their 

blood samples without fear it would be used 

for money making rituals or voodoo practices 

to harm individuals17,23. Trust in community 

leaders enables the respondents allow them 

make decision on behalf of their community 

concerning their participation in the study 23.  

 

Discussion: The present study tried to 

identify all the various ethical issues in 

biomedical researchers. Informed consent 

(IC) was most studied {11/18, 61.1%} among 

biomedical researchers (BR) in Nigeria and 

in most studies subjects reported the purpose 

of the study during the informed consent 

discussion. The importance of IC in research 

involving human subjects has become so 

important that it’s now the basis upon which 

researchers or even physicians are allowed to 

carry out any treatment or procedures or even 

trials on the subjects. This also may explain 

why IC was described as the foundation of 

the subject-researcher relationship26. 

Interestingly, all researchers have to follow 

the regulations of obtaining IC which has 

been made mandatory by all regulations and 

guidelines governing the conduct of clinical 

research7. Poor understanding of the IC 

process and poor knowledge of the right of 

the subjects could be attributed to the way the 

information was presented to them 27. The 

low level of literacy, religious and cultural 

hindrances, pressure of work as well as 

uneducated and unsophisticated patient 

population has been attributed to pose serious 

challenges to conveying adequate 

information to subjects in developing 

countries like Nigeria 26. Problem of 

obtaining assent in children as reported by 

one study is similar to a work done by 28 who 

at the end reported that examination of 

guidelines in obtaining assent in children 

shows there is still confusion regarding the 

concept of assent. Interestingly, this does not 

replace the fact that ethics of human research 

as stressed by most international guidelines 

requires that the principle of assent must also 

be applied in pediatric research 4,5. The 

findings in this review about IC are similar to 

that reported in a WHO sponsored review 31. 

  

The concept of voluntarism is one of the core 

elements of informed consent and has being 

elaborated in various codes of biomedical 

ethics and regulations 4,5 hence the fact that it 

is reported as one of the ethical issues of BR 

in Nigeria is not a surprise. Subject 

participation in research is voluntary and 

devoid of any form of pressure. This is 

evidence that the researchers in sub-Saharan 

Africa especially in Nigeria are not left out on 

issue of allowing individuals to judge freely, 

independently, without coercion when 

making decision about joining any research. 

This can equally be due to ability of research 

staffs to explain in detail study objectives 

during consent discussion and could also 

reflect the educational level of the subjects 18. 

The report of right to either participate or 

withdraw from the studies at any time as 

reported in this review could mean that they 

were giving information about withdrawal 

from the studies during consent and can still 

recall the information. Failure to make such 

explanations and ensure understanding by 

subjects could be responsible for those 

studies whose subjects had low 

understanding of their right to withdrawal. 

The findings from this review is similar to 

two studies conducted in Thailand 29and 

Uganda 30 respectively where they also 

reported subjects making enrollment decision 

themselves and having good knowledge on 



          Bangladesh Journal of Bioethics 2021; 12 (1):35-48 

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their right to withdrawal at any time. 

Dissimilarly, one of the studies reported 

various forms of pressure on the study 

participants 29. The report of subjects seeking 

external permission from spouses before 

making decisions is a typical culture and 

family setting in Nigeria. It is also worthy to 

note that voluntary participation in research 

cannot be diminished by the need for spousal 

permission 8,12,18. The concept of voluntarism 

reported in this review is similar to a WHO 

sponsored systematic review on informed 

consent 31. 

 

The process of decision making is one of the 

essential elements of a valid informed 

consent that requires adequate information 

detailing the research goal, its benefits, risk 

among other information about any research 

is disclosed to the subject. Counseling to 

inpatients clinical research offers patients 

alternatives to clinical procedures thus 

offering a wide range of choice to them. In 

most of the time this information is brought 

to the subjects by the research team during 

the consent process. Failure on either the part 

of the research team or the subjects (probably 

as a result of differences in educational 

background, social economic status, age and 

health status) in passing and /or 

comprehending this information could be the 

reason for the findings in this review where 

some study subjects reported having poor 

information and counseling while others have 

enough information on the benefits and risks 

associated with the research, they were 

invited to be a part. On the other hand, it is 

not clear to what extent the information 

should be provided on various aspects of 

research such as benefits and risks and it’s 

mostly dependent on the investigator 7. The 

importance of given early attention to 

providing adequate information and 

counseling in clinical practice or research 

was noted in a study 25.  

 

Biomedical researchers have a moral duty in 

promoting the course of action believed to be 

in the interest of the patient. Most research 

subjects in sub-Saharan Africa and Nigeria 

places immediate individual gain and 

sometimes community benefit first before 

making decision to participate as evident in 

one of the findings in this study 23,32. In the 

present review, there were almost equal 

number of studies that reported subjects 

having adequate knowledge of the risks and 

benefits that go with the studies and those 

who do not have this knowledge. Moreover, 

among the participants that were aware of 

potential risks and side-effects, some were 

not able to name at least one risk and, 

although they understood the benefits of 

participating in a study, they were less aware 

of the uncertainty of these benefits. This is 

corroborated in a similar systematic review 

study 31. The findings could be attributable to 

the ethical principle of counseling the 

subjects during the consent process, thus, 

there is need to give priority to it since 

literacy level of participants, duration of 

explanation of IC and the research team 

explanatory skills have a triple effect on 

participants understanding 31,32. Some 

benefits and risks in participating in research 

have been listed in previous section. Benefit 

could either be financial or medical benefit 

(see ethical issue of compensation). 

According to Article 8, Declaration of 

Helsinki, 2001, interests in science and 

society should not take precedence to 

considerations related to the well-being of the 

human subject 33.  

 

Researchers have almost absolute 

responsibility to protect subject’s 

confidentiality by managing private 

information in such a way as to protect the 

subject’s identity. This issue of 

confidentiality should be addressed before 

any research with human subject begins. 

Hence, the discordant report from the two 



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studies in this review that reported on the 

issue of confidentiality clearly shows the 

need to openly address research participants 

on how their personal responses and 

information would be handled so as to build 

trust among them and enable them be blunt to 

truth in their participation. Confidentiality is 

closely related to right to privacy and a 

patient’s Bill of rights document published in 

1975 by the American Hospital Association 

(AHA) clearly affirm the patient’s right to 

privacy 34. A similar systematic review on 

ethics in medical research equally 

highlighted the importance of Confidentiality 
35. 

 

When research is focused on ethnically or 

culturally distinct population, community 

engagement is one surest way to drive 

research in such population. ‘Community 

engagement (CE) has been broadly defined 

as a process of working collaboratively with 

a group or groups of people on a shared goal 

or common interest’ 36. During CE 

communities are educated about the research 

and information is exchanged between the 

research team and potential research 

participants about the research process over a 

period of time. Most times outcome of 

research is equally communicated through 

same means, thus CE can occur before, 

during and after a research project 37. The 

attendant effect of CE is increase in 

awareness and decrease in clashes between 

the community and the research team leading 

to greater research outcomes. Thus, the report 

of communitarianism seen in one study in 

this review as one of the ethical issues in 

biomedical research shows Nigerian 

communities are increasingly becoming 

aware the role communities and its leaders 

play in research. Community engagement in 

BR can better be understood in similar work 
38. 

 

A study in this review reported the issue of 

misconduct among biomedical researchers in 

Nigeria. In a recent similar systematic review 

work in China on issue of research integrity, 

high level of misconduct was equally 

reported among their medical researchers 39. 

A national survey of scientific misconduct in 

United States reported low level of 

misconduct among her professionals 40. 

Falsification, fabrication, and plagiarism as 

well as improper authorship and duplicate 

submission are some highlighted research 

misbehaviors common among biomedical 

researchers 13,39. This is largely as a result of 

inadequate knowledge and mentorship for 

ethical conduct of research as well as the 

culture of mounting pressure on researchers 

to publish more papers as a means of securing 

promotion. The way out is to strengthen 

research integrity training, increase the 

severity of penalties for scientific 

misconduct, improve the scientific evaluation 

system, develop the governance system and 

increase institutional effectiveness as regards 

to rules and procedures for reducing 

scientific misconduct 13,39,40. 

 

Professionals in the health care industry are 

bound to some form of code of conduct 

peculiar to each profession. Since these 

ethical procedures are linked to improving 

patient satisfaction, they should not be 

ignored by health care professionals in 

service delivery. Through good 

communication, patient care skills and 

professional conduct must remain sensitive to 

the needs of the patients even when recruiting 

them as research subjects in clinical research 

or trial 41. The report of two studies in this 

review of professionals observing 

professional boundaries with their patients 

during treatment and also not pressurizing 

their patients show these professionals still 

work within the tenets of their code of 

conduct and this is similar to another study 

report 41.  Nonetheless, there is still need for 



          Bangladesh Journal of Bioethics 2021; 12 (1):35-48 

45 

 

training in ethical conduct and 

professionalism for health professionals in 

Nigeria and increasing institutional 

effectiveness in monitoring the enforcement 

of these conducts.  

 

Though issue of compensation is related to 

the principle of beneficence and has been 

widely accepted as a common practice in BR, 

it was still usually not made compulsory for 

researchers 15. Compensation in research 

needs to be regulated since it can also act as 

a barrier to voluntary participation in 

research 42. According to Grady 43 

‘Compensation may be handed out as refunds 

for expenses incurred by participants; for 

time, effort and inconvenience; injury or 

harm associated with research participation 

or as incentives to stimulate participants to 

follow the study protocol to completion’. The 

need to regulate this practice has been 

reported as a result of its associated ethical 

concerns of exploitation, coercion, and undue 

influence 44. Compensation can be financial 

or medical benefit. Financial incentives such 

as transport and refreshment allowances were 

advised when there was no direct benefit to 

the research participant 15. In this review, four 

studies reported the issue of compensation to 

research participants. It is becoming 

increasingly clear that most times research 

participants tie their level of involvement to 

the amount of compensation they will receive 

at the end of the process. Not compensating 

your subjects especially when there is need 

for such may dampen their spirit which 

inadvertently will affect the overall outcome 

of the study as seen in this report where some 

private firms tied their willingness to 

participate to the study stipend that would be 

given. However, the report of incentives not 

offered to the participants in one of the 

studies could be due to the nature of the 

research and the statutory, policy, and 

legislative requirements guiding the practice 

as the study claimed 21. Compensation as an 

ethical issue is contained in similar studies 
45,46. 

 

Two studies from this review identified 

ethical issue of culture, social and religious 

practices in BR. This probably may be due to 

the fact Nigerians value their cultural and 

religious practices that even in most places 

where the people are known Christians or 

Muslims17. The leaders or custodians of these 

cultures commonly referred to Oba among 

the Yorubas, Igwe among the Ibos or Emir 

among the Hausas have overwhelming 

influence on people’s decision. The practice 

of voodoo among the Yoruba’s has caused 

lots of apprehension and fear which has 

affected research uptake among the populace 

and could account for the fear reported 

among the subjects in the two studies 

mentioned. The influence of socio-cultural 

variables in BR is explained in a study 47.  

 

Equity is an expression of social justice and 

it has to do with fair distribution of benefits 

from health. Observing equity in BR as 

reported in one study in this review 20 is one 

sure way of improving research outcomes.  

 

Limitations: This study was done in Nigeria 

alone.  This is the first limitation of this study. 

It does not represent the Africa. Hence 

similar studies should be carried out covering 

sub-Saharan Africa and the global 

community of Africa. .It should be noted that 

only English articles have been searched in 

this study.  Also, only four search platform 

has been searched in this study e.g. 

Pubmed/Medline, Google Scholar, JSTOR, 

and AJOL.  Only eighteen articles have been 

discussed in this study and twelve ethical 

issues were discussed. Therefore, further 

study is needed with large number of 

populations with more search engines and 

large number of articles.   

 



          Bangladesh Journal of Bioethics 2021; 12 (1):35-48 

46 

 

Conclusion: We found that there are ethical 

issues in biomedical research in Nigeria of 

which informed consent is most widely 

studied. However, participants had varying 

degree of understanding of their rights as 

research subjects. As a result, there is need to 

enhance the capacity of investigators to better 

understand these issues and also increase 

their explanatory skill to help participants 

achieve complete understanding of their 

various rights and process. This shall assist 

both the investigators and participants 

towards a better research approach.  

 
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Authors Declaration: 1st author Ikeagwulonu Richard 

Chinaza conceptualized the project, designed the study 

and carried out the database search and screening, and 

wrote the initial draft of the manuscript. 2nd author 

Chigozie Jesse Uneke reviewed and provided 

substantial modification to the intellectual content of 

the draft manuscript. 3rd author Obeta, Mark Uchejeso 

contributed in data search and extraction, reviewed the 

initial manuscript draft. All authors reviewed and 

approved the final manuscript for publication. 

 

Conflict of Interest: There is no Competing interests 

between the authors.  

 


