








































Bangladesh Journal of Bioethics 2011; 2(2): 20-23

WHAT  MAKES  MULTINATIONAL  CLINICAL  RESEARCH  ETHICAL  &  HOW  TO  MINIMIZE  POSSIBLE 
EXPLOITATION IN HOST COUNTRY?

Dr. Md. Ashraf Ali 

Former consultant, Health & Population Sector Program of Bangladesh, DFID, British Council, Dhaka   

BACKGROUND:  In recent years there has been substantial debate about the ethics of research in developing 
countries.  The  controversies  have  been  centered  on  (i)  standard  of  care  that  should  be  used  in  research  (ii) 
reasonable availability of interventions that are proven to be useful and (iii) quality of informed consent.  Clinical 
research  is  different  from clinical  practice  in  ethically  important  ways  where  each  has  different  goals,  different 
methods and different justification for risk to individuals. The goal of clinical research is to generate useful knowledge 
about health and illness. Benefit to participants is not the purpose of research, although it does occur. Here people 
are the means to develop useful knowledge; and are thus at risk of exploitation. 

POSSIBLE EXPLOITATION  OF HOST COUNTRY:   In  developed  countries,  the  risk  of  exploitation  of  human 
research  subjects  or  host  communities  is  minimized,  because  (i)  society  funds  research  to  improve  health  (ii) 
researchers and research institutions are part of  the larger community and (iii) there is an infrastructure, even if 
imperfect,  translates  research  results  into  health-care  practices  for  the  benefit  of  the  larger  community.  But 
multinational clinical research in developing countries creates a greater risk of exploitation due to (i)  poverty,  (ii) 
illiteracy, (iii) limited health care services, (iv) Cultural and linguistic differences and (v) less understanding of the 
nature of scientific research. Moreover regulatory infrastructures that might minimize the risk of exploitation are less 
established, less supported and less effective in developing countries. As a consequence, individuals or communities 
in developing countries assume the risk of research, but most of the benefits may accrue to people in developed 
countries.

HOW TO MINIMIZE EXPLOITATION:  To minimize the possibility of exploitation, previously, there was delineation of 
a framework for ethical research that included 7 principles. Later on an 8th principle ‘collaborative partnership’ was 
added and elaborated these principles through 31 benchmarks that  systematically specify practical  measures to 
determine the extent to which the research satisfies the principles. The principles are as follows:

Collaborative partnership: A collaborative partnership between researchers & sponsors in developed countries & 
researchers, policy makers & communities in developing countries helps to minimize the possibility of exploitation by 
ensuring that a developing country determines for itself  whether  the research is acceptable & responsive to the 
community’s  health  problems.  Moreover  without  the engagement  of  the  researchers & host  communities  in  the 
developing country, a study is unlikely to have any lasting impact, and without the investment of makers of health 
policy, the research results are unlikely to influence policy making & the allocation of scarce health care resources.

Social value: It is widely recognized that ethical clinical research must have social value, through generation of 
knowledge that can lead to improvement in health; without social value, research exposes participants to risks for no 
good reason & wastes resources.  

 Scientific  validity:  Science  & ethics  do not  conflict;  valid  science  is  an ethical  requirement.  Unless  research 
generates reliable & valid data that can be interpreted & used by the specified beneficiaries of the research, it will 
have no social value & participants will be exposed to risks for no benefits.  

Fair  subject  selection: Historically,  populations  that  were  poor,  uneducated,  or  powerless  to  defend  their  own 
interest  were  targeted  for  high  risk  research,  whereas  promising  research  was  preferentially  offered  to  more 
privileged individuals. A challenge for research in developing countries is fair selection of target villages, tribes or city 
neighborhoods from which individual participants will be recruited.   

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Bangladesh Journal of Bioethics 2011; 2(2): 20-23

The delineated ethical principles are elaborated through benchmarks which are as follows:

Principles Benchmarks

Collaborative 
partnership

• Develop partnerships with researchers, makers of health policies, and the community.
• Involve partners in sharing responsibilities for determining the importance of  health 

problem,  assessing  the  value  of  research,  planning,  conducting,  and  overseeing 
research, and integrating research into the health-care system.

• Respect the community’s values, culture, traditions, and social practices.
• Develop the capacity for researchers, makers of health policies, and the community to 

become full and equal partners in the research enterprise.
• Ensure that recruited participants and communities receive benefits from the conduct 

and results of research.
• Share fairly financial and other rewards of the research.

Social value

• Specify the beneficiaries of the research—who.

• Assess the importance of the health problems being investigated and the prospective 
value of the research for each of the beneficiaries—what.

• Enhance the value of the research for each of the beneficiaries through dissemination 
of knowledge, product development, long-term research collaboration, and/or health 
system improvements.

• Prevent supplanting the extant health system infrastructure and services.

Scientific validity

• Ensure that the scientific design of the research realizes social value for the primary 
beneficiaries of the research.

• Ensure that the scientific design realizes the scientific objectives while guaranteeing 
research participants the health-care interventions to which they are entitled.

• Ensure  that  the  research  study  is  feasible  within  the  social,  political,  and  cultural 
context  or  with  sustainable  improvements  in  the  local  health-care  and  physical 
infrastructure.

Fair  selection  of 
study population

• Select the study population to ensure scientific validity of the research.
• Select the study population to minimize the risks of the research and enhance other 

principles, especially collaborative partnership and social value.
• Identify and protect vulnerable populations.

Favorable risk-benefit 
ratio

• Assess the potential risks and benefits of the research to the study population in the 
context of its health risks.

• Assess the risk-benefit ratio by comparing the net risks of the research project with the 
potential benefits derived from collaborative partnership, social value, and respect for 
study populations.

Independent review

• Ensure public accountability through reviews mandated by laws and regulations.
• Ensure public accountability through transparency and reviews by other international 

and nongovernmental bodies, as appropriate.
• Ensure independence and competence of the reviews.

Informed consent

• Involve the community in establishing recruitment procedures and incentives.
• Disclose information in culturally and linguistically appropriate formats.
• Implement supplementary community and familial consent procedures where culturally 

appropriate.
• Obtain consent in culturally and linguistically appropriate formats.
• Ensure the freedom to refuse or withdraw.

Respect for recruited 
participants  and 
study communities

• Develop  and  implement  procedures  to  protect  the  confidentiality  of  recruited  and 
enrolled participants.

• Ensure that participants know they can withdraw without penalty.
• Provide enrolled participants with information that arises in the course of the research 

study.
• Monitor and develop interventions for medical conditions, including research-related 

injuries, for enrolled participants at least as good as existing local norms.
• Inform participants and the study community of the results of the research.

Favorable risk-benefit ratio: A clinical research should offer participants a favorable risk-benefit ratio, or, if potential 
risks  outweigh  benefits  to  participants,  the  social  value  must  justify  these  risks.  Only  benefits  that  accrue  to 

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Bangladesh Journal of Bioethics 2011; 2(2): 20-23

participants from the interventions necessary to achieve the research objectives or those deriving from the knowledge 
to be gained by the research should be used to justify risks to participants.

Independent  review:  To minimize  concerns  with  regard to  researchers’  conflicts  of  interest  & to  ensure public 
accountability, independent ethical review of all clinical research protocols is necessary. In multinational research, 
there is  a special  need for transparency.  Transparency enhances accountability  by assuring the public  that  the 
research is not exploitative. 

Informed consent: Individual informed consent has been recognized as a principle of ethical clinical research for 
more than a century. The concept of formally taking consent with emphasis on patient’s rights & his/her autonomy 
emerged in early twentieth century when some law suits were filed in courts, particularly in USA. Later the well known 
infamous  atrocities  carried  by  Nazi  doctors  on  prisoners  during  Second  World  War  &  consequent  verdict  by 
Nuremberg tribunal & milestone declaration of Nuremberg made a landmark in the history of medical ethics & provide 
a ground on which the doctrine of informed consent is built.     

Respect for recruited participants & study communities: The ethical conduct of clinical research does not end 
when informed consent is obtained. Researchers have ongoing obligations to participants, former participants & the 
host community.

DISCUSSION & CONCLUSION:  Together, these principles & benchmarks constitute a systematic framework that 
specifies core practical considerations necessary to ethically justify research in developing countries. This framework 
functions within general ethical values, such as honesty,  that are relevant to scientific integrity and avoidance of 
fraud. Application to actual research studies may suggest refinement or the need for additional benchmarks. For a 
developing  country  to  minimize  the  risk  of  exploitation  it  is  necessary  to  apply  a  previously  proposed  ethical 
framework for clinical research within developed countries to developing countries, explicating a previously implicit 
requirement  for  collaboration.  Application  of  ethical  framework  of  principles  and  benchmarks  in  designing  and 
conducting clinical research is essential to minimize the risk of exploitation. To apply these ethical principles and 
benchmarks in clinical research the host country has to build capacity of its researchers and research institutions for 
(i)  establishment  of  a  system  for  independent  ethical  review  of  research  proposals  and  (ii)  development  and 
implementation of standard operating procedures for both clinical research and ethics review. 

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