



































ISSUES OF RESEARCH ETHICS AND CLINICAL ETHICS IN DEVELOPING WORLD, POSSIBLE SOLUTION: A WAY FORWARD


Bangladesh Journal of Bioethics 2012; 3(3):12-15 

 

 12 

 

ISSUES OF RESEARCH ETHICS AND CLINICAL ETHICS IN DEVELOPING WORLD, POSSIBLE 

SOLUTION: A WAY FORWARD 

 

Muhammad Waseem Khan
1
, Imrana Niaz Sultan

2
, Afrasiab Khan

3
 

Muhammad Bilal Khan
4
 

Department of Biotechnology & Informatics, Faculty of Life Sciences & Informatics, Balochistan 
University of Information Technology Engineering & Management Sciences (BUITEMS), Quetta 
Balochistan,  Pakistan. Email: mwaseem.tareen@yahoo.com   

 

ABSTRACT: Research plays a pivotal role in the progress of inventions in medicines and medical 
technology. It is noticed that researchers from developing world or multinational companies are 
interested to conduct their research studies in developing countries, in doing so sometimes it is 
noticed that rather benefiting the participants it causes significant harm to the research study 
participants of developing countries. Ethical lapses in research can significantly harm human subjects. 
In research ethics the basic aim of  ethics  is  distinguishing  between  right  and  wrong,  to recognize  
the  wrong  doings  and  try  to avoid  them  from  harming  research  subjects  in  any  research  study  
whether  that  is  done  in developing country or developed country. It must follow the principle of non 
malefiecence or do no harm.   

 

INTRODUCTION: There are many ethical issues regarding research ethics in developing countries 
that need to be addressed. The issue of study design,  independent ethical review, valid inform 
consent, respect for  individual’s  autonomy  and  dignity,  social  value  of  research,  scientific  validity  
of  research, fair subject selection, risk benefits ratio, standards of care, socioeconomic deprivation 
inequities and post trial benefits to host community are largely have been highlighted but mostly 
ignored by researchers in developing countries.

1,2
 

One  central  ethical  concern  when  conducting  research  on  human  subjects  in  developing 
countries  is  to  avoid  research  which  has  been  rejected  as  unethical  or  of  no  value  in  the 
developed country. Many research studies that are conducted in developing countries are of no value 
and sometimes they are scientifically invalid, but still they are conducted by multinational companies in 
resource poor developing countries.  These studies are largely conducted for financial gain rather than 
for the health care of human beings. It is noticed that such studies are conducted  in  areas  where  
participants  are  heavily  paid  for  their  participation;  the  participants  being  very poor and  illiterate 
tend to participate  in  large  numbers regardless of their  health  as they receive enough amount to 
serve their needs.

3
    

The issue of scientific validity and social value of any research study is important that lacks in 
developing countries research studies.  Before  conducting  any  research  study  the  scientific validity  
must  be  ensured  with  the  social  value  for  the  research  participants,  the  primary beneficiaries of 
the research. The research study and design must be feasible within the social, political, and cultural 
context of the research participant’s society. In developing countries it is noticed  that  the  research  
studies  are  not  carried  out  on  the  diseases  which  are  causing more mortality and morbidity in 
developing countries rather it is largely conducted on the issues which are  prevalent  in  the  
researcher’s  society  from  developed  countries,  which  seems  benefiting developed world and 
harming the participants from developing countries. The impact of research study  needs  to  be  
addressed  for  the  research  participants  rather  than  research  conducting countries.

4
    

mailto:mwaseem.tareen@yahoo.com


Bangladesh Journal of Bioethics 2012; 3(3):12-15 

 

 13 

A  research  study  should  advance  scientific  knowledge,  should  lead  to  improvements  in  health 
and  should  have  social,  scientific  and  clinical  value.  The research studies carried out in most 
developing countries are sometimes aimed for academic success, institutional demands, success and 
promotion and to secure research grants. The researchers tend to achieve relevant reports and results 
rather than improving the health of society. The researcher main aim should be the impact of research 
study for the improvement of health standards which must be above such kinds of selfish motives. 

5  
 

The issue of involuntary participation is common in developing countries in which people from 
developing countries are forced to participate in any research study. Involuntary participation is linked  
with  the  issue  of  inform  consent  which  is  rather  forced  informed  consent  due  to  any reason.  
Inform  consent  means  that  research  participants  must  be  fully  informed  about  the procedures, 
interventions and risks involved in research participation and must give their consent to participate. By 
complete consent it is meant that the five components of valid inform consent must be fulfilled which 
includes, disclosure (participant must be informed as fully as possible of the nature and purpose of the 
research, the procedures to be used, the expected risks and benefits to  the  participant/society,  
stresses,  and  discomforts,  and  alternatives  to  participating  in  the research),  understanding  
(participant  must  understand  what  has  been  explained  and  must  be given  the  opportunity  to  
ask  questions  and  have  them  answered  by  one  of  the  investigators), voluntariness (participant’s 
consent to participate in the research must be voluntary, free of any coercion or promises of benefits 
unlikely to result from participation), competence (participant must  be  competent  to  give  consent.  If  
the  participant  is  not  competent  surrogate  may  provide consent if it is in the participant's best 
interest to participate), consent (potential human subject must  authorize  his/her  participation  in  the  
research  study).  In developing countries Informed consent is considered just as singular event and a 
mere formality to be followed by researchers. The issue of standard of care is of great debate in recent 
years. In research studies in developing countries placebo has been used in control arms instead of 
universally accepted standard of care. It is mainly used in studies which are of no value to the society 
of research participants rather it is  just  for  the  registering  of  me  too  drugs  and  achieving  
financial  gain  and  registering  their products.  

The  issue  of  exposing  vulnerable  population  is  another  issue  that  needs  to  be  addressed in 
developing  countries  research  studies.  The  study  participants  are  not  fairly  selected  and  the 
procedure of  randomization  is  not  followed.  Participants  are  recruited on subject of their  easy 
availability  which  exposes  vulnerable  population  to  great  risk  and  harm.  Research ethics 
demands that study participants should be fairly selected without any biasness. Favorable risk-benefit  
ratio  that  determines  the  risks  associated  with  conducting  the  trial  should  be  clearly mentioned 
and the study participants should be given more benefit than the associated risks.

4, 6
   

Another important issue is the post trial benefits that should be focused and given importance 
especially once the research is over, pointing out that the new intervention proves to be effective and 
functioning then it should be offered to those in the control arm of the study subjects once the 
research is over. Research sponsored in developing countries by developed countries raises ethical 
issues not only during research but also once the research study is over. Researchers and sponsors  
should  be  bound  by  ethical  committees  to  guarantee  access  to  interventions  to  the research 
participants and to the local community when an intervention is found to be efficacious. The health 
care teams involved in research studies irrespective of being in develop or developing country is 
morally and ethically bound to respect human life, dignity and autonomy. They are morally bound to 
follow the principles of autonomy, beneficence by doing good, nonmaleficence by doing no harm to 
the research participants which requires investigators to minimize the harm and enhance benefits to 
the study participants and justice which requires priority to be given to the interests of research 
participants over his own.  

 

HOW CAN CLINICAL RESEARCH BE MADE MORE ETHICAL IN DEVELOPING COUNTRIES? 
Clinical research also called clinical investigation is testing new drugs and compounds in human 
subjects for discovering potential beneficial effects. Clinical research is increasingly supported and 



Bangladesh Journal of Bioethics 2012; 3(3):12-15 

 

 14 

conducted by multinational pharmaceutical companies.  As  clinical  research  involves patients,  
researchers  are  ethically  and  legally  obligated  to  protect  them.  In clinical practice a physician 
would be expected to use interventions that have a reasonable expectation of success and are 
designed solely to enhance the well being of an individual patient.  

Government  hospitals  and  private  hospitals  in  developing countries are  aimed  for  better  quality  
and affordable care to the masses. Patients in most developing countries choose public hospitals 
because they cannot afford treatment in private hospitals but even in public hospitals they pay for 
some drugs, tests and  procedures,  and  this  constitutes  a  burden  that  many  cannot  afford.  
Public hospitals in many developing countries are considered as clinical trial sites.  

In a clinical setup of developing country the patients enters the trial because of their primary care 
physician is involved in research study. As physicians are highly respected and included by patients in 
their decisions in fact they are given the authority to make decisions for their patients. Patients are not 
able to question their doctor’s judgment. They may be easily influenced by the doctor’s advice. It is 
widely thought and believed that their refusal to follow their doctor’s advice to enter a trial would affect 
their access to care.  When  the  trial’s  principal  investigator  is  also  the  patient’s primary physician, 
there  is scope  for a direct conflict of  interest. It becomes more suitable for conflict of interest when 
physicians are paid recruitment fees to recruit their patients into trials by the pharmaceutical 
companies conducting the research study.

6 
 

For any research to be ethical the ethics review committee has to play its role not to allow the research  
which  has  no  impact,  which  is  exploiting  human  population  or  causing  harm  to  the 
participants.  The  ethics  review  committee  should  be  independent  bodies  and  the  committees 
should be allowed to function in unbiased environment. The committee should focus the issues that 
are involved off the field and during the field when the study is conducted.  

The  physicians  should  be  ethically  and  morally  bound  to  protect  his  patient  from  harm  and 
should  not  participate  in  trials  which  causes  conflict  of  interest  between  his  patient  and  the 
research, his primary aim should be his patient care rather than research. 

5  
 

The  physician  participating  in  clinical  research  should  be  ethically  and  legally  bound  not  to 
accept any gift, package and any benefit from pharmaceutical companies as it causes conflict of 
interest between the research and his patient care.   

The issue of therapeutic misconception may be found in clinical research in developing countries 
where the patients  are  looking  for  cure  while  he  is  participating  in  research.  The physician 
carrying the research should inform his patient before involving him in research. Being the patient’s 
primary physician, he should protect him from risks regardless of valid inform consent which he must 
obtain from his patient. The physician should only advise his patient to enter in trial if it is in patient’s 
benefits rather than receiving money for his participation.  

The impact of research should be thoroughly analyzed and only those studies should be allowed by 
ethical reviews committees which have good impact for the society. It is noticed that many research 
studies conducted in developing countries are of no impact; they are only for financial gain, personal 
or degree and project requirements.  

Another issue is of wild lab referrals and unnecessary lab procedures. In developing countries it is 
considered due to the physician having share in such procedures which may be demanded by 
pharmaceutical companies or lab owners. There should be double check on such procedures to 
ensure that poor patients are not exposed to expensive wild procedures.   

The privacy and confidentiality is considered of no use in a clinical setup of many developing 
countries. Physicians and researchers must be sensitive to not only how information is protected from 
unauthorized observation, but also if and how participants are to be notified of any unforeseen findings 
from the research that they may or may not want to know.  The investigator must enumerate how 
privacy and confidentiality concerns will be approached. 



Bangladesh Journal of Bioethics 2012; 3(3):12-15 

 

 15 

CONCLUSION: Ethical  guidelines  and  rules  can  be  set  easily  but  it  is  difficult  to  ensure  that  
they  are  duly followed. We have to educate the inner human of individuals, the physicians and the 
researchers to act morally and ethically. We have to make it our habit and not to compromise on 
anything less than morality and virtuous values benefiting our fellow human beings. 

 

REFERENCES: 

 1.  Bhutta, Z, A. Ethics in international health research: a perspective from the developing world. 
Bulletin of the World Health Organization. 2002; 80:114-120.  

2.  Emanuel E J. et al. What Makes Clinical Research Ethical? JAMA. 2000; 283(20):2701- 

2711.  

3.  Kiatboonsri P, Richter J. ‘Unethical trials of dipyrone in Thailand’. Lancet, ii. 1988. 1491.   

4.  Emanuel EJ. et al. What Makes Clinical Research in Developing Countries Ethical?  

The Bench marks of Ethical Research. Perspective. JID 2004 March 01:189.935.  

5.  Kalantri SP. Ethics in clinical research. Indian J. Anaesth. 2003; 47 (1): 30-32.  

6.  Benatar SR. Reflections and recommendations on research ethics in developing countries. Social 
Science & Medicine. 54. 2002. 1131–1141. 

 

Competing interests: The authors declare that they have no competing interests.  

Authors’ contributions: All authors have contributed substantially to the conception and design of 
the manuscript. Muhammad Waseem Khan is the 1

st
 and corresponding author. Imrana Niaz Sultan, 

Afrasiab Khan and Muhammad Bilal Khan are 2
nd

 authors and they have contributed equally. 
Muhammad Waseem Khan has critically revised the manuscript. All authors have read and approved 
the final manuscript. 

Funding: The Authors declare that the current study was not funded. 

 


