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Bangladesh Journal of Bioethics 2015; 6(3):37-40 
 

 

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Review Article 

Ethical Issues of Fair Subject Selection in the Research 

Sifat Rahman 

B.D.S (DU), MPH (AIUB) 

Email: rahmansifat@yahoo.com 

 

Abstract: Ethics and ethical principles extend to all spheres of human activity. They apply to our 

dealings with each other, with animals and the environment. They should govern our interactions 

not only in conducting research but also in commerce, employment and politics. Ethics serve to 

identify good, desirable or acceptable conduct and provide reasons for those conclusions. Fair 

subject selection is the first and foremost concern which must be ensured before initiating a 

research project.  Which subjects may enroll in the research is determined by the study’s 

inclusion or exclusion criteria. One of the important aspects of fair subject selection is to have an 

oversight system through International Review Board (IRB) to review to conduct the research 

and to have approval whether subject selection is fair or not.  

Key Words: Fair subject selection, Research 

Introduction: To maintain ethical regulation in clinical research involving human subjects is 

very much important. Medical research is subject to ethical standards that promote respect for all 

human beings and protect their health and rights. Some research populations are vulnerable and 

need special protection. The particular needs of the economically and medically disadvantaged 

must be recognized. Special attention is also required for those who cannot give or refuse 

consent for themselves, for those who may be subject to giving consent under duress, for those 

who will not benefit personally from the research and for those for whom the research is 

combined with care. According to WHO (2008), Fair subject selection can be expressed as; 

subjects should be selected on the basis of scientific importance, not based on convenience, 

vulnerability or bias1. 

Method: This is a brief article prepared as a part of the assignment in the educational activity 

and training on research ethics titled “Ethical and Regulatory Aspects of Clinical Research” 

arranged by the Bangladesh Bioethics Society (BBS), Dhaka, Bangladesh, in collaboration with 

the Department of Bioethics of National Institutes of Health (NIH), Bethesda, Maryland, USA, 

through video conferencing between October 1, 2014 and November 12 of 2014. The 

information gathering conducted through search was confined to ‘Google’, ‘HINARI’ and ‘Pub-

Med’ search. Besides, some guidelines on roles and responsibilities of Institutional Review 

Board (IRB) were taken into consideration. 

Ethical Aspects of Fair Subject Selection: There are three aspects of subject selection2. These 

aspects are: 



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1. Selection: determining eligibility of individual group 

2. Recruitment: approaching individuals in selected group 

3. Retention: retaining enrolled subject 

 

Methods of Recruitment: Vulnerable groups should not be recruited.2 Incentives may be 

offered to physicians to refer their patient to trials. Incentives may encourage investigators to 

enroll inappropriate subjects. International Review Board should monitor advertising and 

evaluate relative size of type used and other visual effects.3 

Selection, recruitment & retention should distribute burdens and benefits properly, ensure social 

value of research, enhance scientific validity, minimize risks to subjects and protect the 

vulnerable. Though there may be conflicts between these goals in some cases. Excluding very 

sick person from the research may give rise to chance of decreasing of social value of research. 

By balancing the competing goals investigators, review committees and sponsors can minimize 

conflict. Circumstances should be judged for understanding so that importance of factors in that 

case, can be determined.2 

Criteria of Subject Selection: Subject selection should be based on two criteria2: 

1. Inclusion criteria  

2. Exclusion criteria 

Inclusion and exclusion criteria may include factors such as age, sex, race, ethnicity, type and 

stage of disease, the subject’s previous treatment history, and the presence or absence (as in the 

case of the “healthy” or “control” subject) of other medical, psychosocial, or emotional 

conditions. Inclusion criteria are used to determine whether a person can participate in a research 

study or whether an individual study can be included in a systematic review. Exclusion criteria 

are those who cannot participate in a research study or whether an individual study can be 

excluded with good reason2. 

Exclusion without a good reason may be unfair or discriminatory2. Research should be begum 

with considering that everyone is eligible to ensure fairness. In determining who can enroll, the 

scientific goals of study should be the primary consideration. Individuals with physical and 

mental disability who cannot respond to scientific questions and who cannot satisfy the protocol 

requirements or who cannot make the required visit should be eliminated. Exclusion criteria are 

important in minimizing risks of research study. Subject selection should focus on enhancing 

benefit of study2. 

Vulnerable groups unless their participation is mandatory for scientific reason should be 

excluded for their protection.2 According to Belmont report, adults should be selected prior to 

children.3 Those who are less able to protect their own interest and being unable to give 



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voluntary informed consent, defined as vulnerable subjects. Those who are unable to consent 

should be excluded unless there is a compelling reason to enroll them.2 

According to Declaration of Helsinki-2008, Medical research involving a disadvantaged or 

vulnerable population or community is only justified if the research is responsive to the health 

needs and priorities of this population or community and if there is a reasonable likelihood that 

this population or community stands to benefit from the results of the research4. 

Protections for Vulnerable Populations: Current Federal regulations provide additional 

protections and special requirements for research involving children and prisoners and instruct 

IRBs to be cognizant of the special problems of research involving vulnerable populations. 

Groups considered to be vulnerable are: children, prisoners, pregnant women, mentally disabled 

persons, and economically or educationally disadvantaged persons. Studies seeking to enroll 

vulnerable subjects must provide additional safeguards to protect the rights and welfare of these 

subjects.5 

Informed Consent: When seeking informed consent for participation in a research study the 

physician should be particularly cautious if the potential subject is in a dependent relationship 

with the physician or may consent under duress. In such situations the informed consent should 

be sought by an appropriately qualified individual who is completely independent of this 

relationship2. 

For a potential research subject who is incompetent, the physician must seek informed consent 

from the legally authorized representative.2 These individuals must not be included in a research 

study that has no likelihood of benefit for them unless it is intended to promote the health of the 

population represented by the potential subject, the research cannot instead be performed with 

competent persons, and the research entails only minimal risk and minimal burden.2 

Review by an Institutional Review Board: Human subject research is reviewed and approved 

by an IRB using the following criteria: 1) risks to subjects must be minimized and reasonable in 

relation to anticipated benefits; 2) the selection of subjects must be equitable, with attention to 

the special problems of research involving vulnerable populations ; 3) additional safeguards must 

be included if the research involves vulnerable populations; 4) informed consent must be sought 

and appropriately documented if the risk is greater than minimal; 5) researchers must continually 

monitor the data collected to ensure safety of subjects ; and 6) the privacy of subjects must be 

maintained.5 

Three Fundamental Ethical Principles3 

1. Respect for Persons: protecting the autonomy of all people and treating them with courtesy 

and respect and allowing for informed consent. Researchers must be truthful and conduct no 

deception; 



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2. Beneficence: The philosophy of "Do no harm" while maximizing benefits for the research 

project and minimizing risks to the research subjects;  

3. Justice: ensuring reasonable, non-exploitative, and well-considered procedures are 

administered fairly — the fair distribution of costs and benefits to potential research participants 

and equally. 

Conclusion: Loss of enrolled subjects undermines scientific validity and wastes resources. 

Future research is needed to identify ways to encourage subjects to continue to participate, and 

retain them, without undermining their right to withdraw. Subject selection, recruitment and 

retention are central to the ethics of clinical research.2 Yet, these issues have not received the 

attention they deserve in practice, or in the literature. Subject selection should be fair for ethical 

regulation of research involving human subjects. Often, subject selection is not given much 

thought. However, one of the principles of ethical clinical research is just that subjects should be 

selected for participation principally based on the scientific question. Due consideration should 

be given to risk, benefit and vulnerability of the subjects. 

References:  

1. Jon C Tilburt, Ted J Kaptchuk, Bulletin of the World Health Organization, Volume 86, 

Number 8, August 2008, 594-599. 

2. David Wendler, Department of Bioethics, NIH Clinical Center,  Fair Subject Selection, 

http://bioethics.nih.gov/courses/pdf/2012/Wendler.pdf  

3. National Commission for the Protection of Human Subjects of Biomedical and 

Behavioral Research, Department of Health, Education and Welfare (DHEW) (30 

September 1978). The Belmont Report (DHEW pub. no.(OS) 78-0012). Washington, 

DC: United States Government Printing Office. 

4. World Medical Association Declaration Of Helsinki, Ethical Principles for Medical 

Research Involving Human Subjects 

5. U.S. Department of Health & Human Services - 200 Independence Avenue, S.W. - 

Washington, D.C. 20201 

Conflict of interest: There is no conflict of interest 

 

 

 

 


