



































Title:  Ethics in Clinical Research


Bangladesh Journal of Bioethics 2012; 3(3):16-20 

 
 

16 

 

ETHICS IN CLINICAL RESEARCH 

Md. Fakruddin
1
, Abhijit Chowdhury

1
, Md. Nur Hossain

1
, Khanjada Shahnewaj Bin Mannan

2
 

1
Institute of Food Science and Technology (IFST), Bangladesh Council of Scientific and Industrial 

Research (BCSIR), Dhaka, Bangladesh 

2
Center for Food & Waterborne Diseases, ICDDRB Dhaka, Bangladesh. 

Email: fakruddinmurad@gmail.com  

 

ABSTRACT: History of unethical clinical research practice date back to a very long time, though the 
most remarkable unethical clinical research was those by the Nazis during second world war, which 
eventually shaken the scientific community and gives birth to the first guideline of ethics in clinical 
research, the Nuremberg Code. Following Nuremberg code, a number of ethical guidelines has been 
formulated most important of which are the declaration of Helsinski. To make any research involving 
human subjects or samples ethically acceptable, a number of key features have to be considered by 
the scientists. These guidelines are internationally accepted and without following these guidelines, no 
clinical research is acceptable in the world. Though, there are many countries in the world like 
Bangladesh, which don’t have any ethical guidelines of their own and thus scientists in those countries 
do not adhere the any ethical guideline while conducting their research. Each country should have 
their own ethical guidelines and each clinical research institutes should have own ethical review 
committee to ensure ethical clinical research.    
 

Key words: Ethics, Clinical, Human, Bangladesh 

 

INTRODUCTION: The ethics of contemporary research practice, especially with respect to the design 
and conduct of clinical trials, has been subjected to considerable scrutiny in recent years

1
. Issues 

related to informed consent, the use of placebo controls and the tension between the requirement for 
scientific evidence on the one hand and for patient autonomy on the other have all generated heated 
debate

2
. In this editorial I review some recent controversies that highlight the fractious nature of the 

debate and point to the watershed we are approaching in clinical research ethics. Although there are 
no obvious solutions, it is clear that there is a need for increased patient participation in any attempt to 
achieve consensus on the ethical conduct of medical research

3
. 

 

HISTORY OF UNETHICAL CLINICAL RESEARCH: History of unethical clinical research and trials 
dates back to ancient times. Many of the early advances in medicines have been developed at the 
expense of many marginal groups such as asylum inmates and prisoners. These test subjects were 
involved in these clinical trials without being informed or even asked

4
.  

The most horrifying example of unethical clinical trials and research was that done by the Nazi doctors 
in Germany. They conducted clinical research trials with prisoners of concentration camp against their 
consent and most of the prisoners died due to such trials. Not only in Germany, has unethical clinical 
trials also been performed in United State and Britain

5
. Revelation of these unethical trials have 

shaken the public and research communities and aware them of the necessity of bioethics and 
guidelines. The Nazi doctors were trialed at Nuremberg court and this trial gives birth to the world’s 
first guideline for ethical medical research, the Nuremberg code in 1948

6
. 

But ironically, unethical clinical practice does not end right then. Many unethical clinical trials have 
been revealed time to time till 1990s. The most remarkable of those were the Tuskegee Syphilis Study  

mailto:fakruddinmurad@gmail.com


Bangladesh Journal of Bioethics 2012; 3(3):16-20 

 
 

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conducted from 1932 to 1972 by the United States Public Health Service. As many as hundred men 
were died in that trial from syphilis as the doctors willingly refrained from treating them with penicillin, 
the most effective drug till then against syphilis, for the sake of research. When revealed in 1972, 
whole world was shacked with terror and US president Clinton had to formally apologize for the study

7
. 

Nuremberg Code: The Nuremberg Guidelines paved the way for the major initiative designed to 
promote responsible research with human subjects. The Nuremberg Code consisted of ten basic 
ethical principles that have been violated previously

8
. The 10 guidelines were as follows: 1. Research 

participants must voluntarily consent to research participation. 2. Research aims should contribute to 
the good of society. 3. Research must be based on sound theory and prior animal testing. 4. Research 
must avoid unnecessary physical and mental suffering. 5. No research projects can go forward where 
serious injury and/or death are potential outcomes. 6. The degree of risk taken with research 
participants cannot exceed anticipated benefits of results. 7. Proper environment and protection for 
participants is necessary. 8. Experiments can be conducted only by scientifically qualified persons. 9. 
Human subjects must be allowed to discontinue their participation at any time. 10. Scientists must be 
prepared to terminate the experiment if there is cause to believe that continuation will be harmful or 
result in injury or death

9, 10
. 

 
ETHICS PRINCIPLES: There are four principles of biomedical ethics: 1. Autonomy (respect for the 
person - a notion of human dignity). 2. Beneficence (benefit to the research participant). 3. Non-
maleficence (absence of harm to the research participant). 4. Justice (notably distributive justice - 
equal distribution of risks and benefits between communities)

11, 12
. 

 

ETHICAL CONSIDERATIONS IN CLINICAL RESEARCH INVOLVING HUMAN:  The following 

should apply to any research programme: 

i. The participant as a person 
Respect for the autonomy of the participant, whether patient or volunteer, demands that the participant 
must be treated as a unique human person within the context of his or her community system. 
Freedom of choice must be safeguarded. 
ii. Human rights 
Respect for the basic rights of the individual as a human being as well as the rights of groups and 
communities. 
iii. The ethic of justice, fairness and objectivity 
Research should always respect the dignity of people involved and should never expose them to 
intentions and motives not directly attached to the research project, its methodology and objectives

13
. 

iv. Competence 
Researchers must be professionally and personally qualified. In all circumstances they must be 
accountable and act in a responsible manner. Professional standards should be upheld in accordance 
with academic training. 
v. Integrity 
Integrity should be promoted by being honest and fair. Researchers must be honest about their own 
limitations, competence, belief systems, values and needs. 
vi. Sensitivity 
Sensitivity in research implies balancing scientific interest (the research) with general values and 
norms affecting the human dignity of the people involved

14
. 

vii. Confidentiality 
Confidentiality must be respected under all circumstances. Documentation should be safeguarded and 
viewed as strictly private in terms of the limits set by the research project. 
viii. Demarcation of roles 
There should be mutual understanding of the roles and interests of investigators and participants in 
research. 
ix. Communication 



Bangladesh Journal of Bioethics 2012; 3(3):16-20 

 
 

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Clear and understandable verbal communication is required, with factual data. Emotional and cultural 
values should be considered. 
x. Possible dangers to be taken into consideration 
(a) The danger of objectification and fragmentation 
Special care must be taken not to treat a participant as a mere object. Research objectives are 
subordinate to the following principle: to treat human beings with respect. 
(b) The danger of direct or indirect coercion 
Direct or indirect coercion of people in the name of research must be avoided under all circumstances. 
Coercion may include the exploitation of vulnerable people; taking undue advantage of a participant, 
volunteer or any other person; or the misuse of the authority and influence of the research

15
. 

 
 

HOW TO MAKE CLINICAL RESEARCH ETHICAL? Many believe that informed consent makes 
clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical 
clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other 
documents relevant to research with human subjects, 7 requirements can be proposed that 
systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) 
value— enhancements of health or knowledge must be derived from the research; (2) scientific 
validity—the research must be methodologically rigorous; (3) fair subject selection—scientific 
objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, 
should determine communities selected as study sites and the inclusion criteria for individual subjects; 
(4) favorable risk-benefit ratio—within the context of standard clinical practice and the research 
protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals 
and knowledge gained for society must outweigh the risks; (5) independent review - unaffiliated 
individuals must review the research and approve, amend, or terminate it; (6) informed consent—
individuals should be informed about the research and provide their voluntary consent; and (7) respect 
for enrolled subjects—subjects should have their privacy protected, the opportunity to withdraw, and 
their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical 
research ethical. These requirements are universal, although they must be adapted to the health, 
economic, cultural, and technological conditions in which clinical research is conducted

16, 17
. 

 

RESEARCH ETHICS COMMITTEES: The role of Research Ethics Committees, the history of their 
origin and details of their composition and organization, has been provided by the Royal College of 
Physicians of London. Research Ethics Committees are of crucial importance in the proper regulation 
of research involving humans and animals, since investigators should not be the sole judges of 
whether their research conforms to generally acknowledge ethical codes

18
. 

 
All research involving humans, whether patients or healthy volunteers, must be referred to a Research 
Ethics Committee. Sometimes class approval may be given in advance to applications for minor 
research, or a series of studies of a particular type carried out as a regular feature of a research or 
training programme. Even in these circumstances, the Committee will wish to be informed of each 
individual study by title at least

19
. 

 
The objectives of Research Ethics Committees are the following: 
i. to maintain ethical standards of practice in research; 
ii. to protect research participants and investigators from harm or exploitation; 
iii. to preserve the research participant's rights, which take preference over society's rights; 
iv. to provide reassurance to society that this is being done

20
. 

 
The Research Ethics Committee should see to it that the responsible investigator is appropriately 
qualified and experienced. The Research Ethics Committee should also ensure that: 
i. Adequate preliminary literature has been consulted and experimental studies have been undertaken. 
ii. Every reasonable effort has been made to inform prospective participants of the objectives and 
consequences of their involvement and particularly of identifiable risks and inconvenience. Informed 
consent should be obtained,  



Bangladesh Journal of Bioethics 2012; 3(3):16-20 

 
 

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iii. Any arrangement to delegate consent has adequate justification, and that appropriate safeguards 
have been instituted to ensure that the rights of participants will not be abused. 
iv. Appropriate measures have been adopted to ensure the confidentiality of data generated in the 
course of research, through the use of coding or anonymity of participants, for example. 
v. Every effort has been made to ensure that participants have an opportunity to comment on and, if 
they wish, to decline to participate, or to withdraw from a research project easily - without having to 
give a reason, and without any adverse consequence

21, 22
. 

 

BANGLADESH PERSPECTIVE: Though ethical considerations in clinical research are a big issue in 
developed world, it is not the same in Bangladesh. Even, neighboring country, India is also far ahead 
in this regard. In 2006, Indian Council of Medical Research has published Ethical Guidelines for 
Biomedical Research On Human Participants as guideline for indian researchers, where no such 
guideline is still formulated in Bangladesh. Every research organization should have an ethical review 
committee comprised of qualified ethical reviewer, but unfortunately except icddr,b, no organization 
have ethical review committee. Bangladesh Medical Research Council is mandated by Govt. to 
monitor and maintain the quality and ethical status of clinical research, its activity is not satisfactory till 
now. Again, most of the clinical researcher and other researchers are not aware of the importance of 
ethical clearance of their research. As a result, they face difficulty in publishing scientific article is 
reputed and international journals. Again, due to lack of ethical guidelines, participants or volunteers 
do not get back the feedback of the research. It is high time that the country formulate a national 
guideline on ethics for Biomedical and Clinical Research involving human participants or involving 
samples from human such as blood. Involved scientists and workers as well as common peoples 
should be aware of the applicability of the guideline. 

 
CONCLUSION: Contemporary research ethics are intricate enough to defy consensus even on long-
established features of randomized trials. Clearly, ethical research practice extends far beyond 
obtaining institutional review board approval and informed consent. These maneuvers, while designed 
to protect patients’ rights, can only serve as components of a more comprehensive system of 
safeguards

23
. These safeguards include the investigators’ commitment to maintaining the highest 

ethical standards and the inclination of other researchers to criticize unethical studies. Recent 
discussions on the ethics of clinical research have benefited from increased input from patients. 
Although such input may tend to make an already complex situation more contentious, the added 
perspective is clearly necessary. Closer scrutiny of established practices, with input from increasingly 
concerned and informed patients, should serve to further what has been described as the search for 
absolutes in a secular and ambiguous age. 

 
 

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