**8. Clinical trials on military**

Exclusion or under-representation of ethnic groups would be unfair approach, as thus they

An example of abuse and racial discrimination is The Tuskegee Study of Untreated Syphilis in the Negro Male (1932–1972). The purpose of this study was to observe the natural progression

Usually, clinical trials with homogeneous populations are cheaper. The more diverse the group of test patients is, the more variables occur throughout clinical study live cycle. Ultimately, all this leads to additional costs. Therefore, in cases where patients represent a homogeneous group, the study results should be applicable for the same group and not for the population

When attracting ethnic minorities, investigator and ethics committee should ensure that:

• in cases when representatives of minorities are poor or illiterate, their rights are protected and there is no coercion or undue incentives for their participation in the clinical trial;

Different racial and ethnic groups experience disease and respond to treatments differently. Therefore, it is important that various populations participate in clinical trials to ensure that

Population ageing is a long-term trend which began several decades ago in Europe [8]. The older population (aged 65 years and over) is constantly increasing. As seen on **Figure 1**, European population is projected to continue to age. And therefore, the importance of additional research on diseases typical for older people is becoming increasingly important.

In general, there is no certain age, after which the patient involvement is not recommended. Yet some researchers avoid recruitment of older patients because of certain difficulties they entail. Older people tend not to respect the regime of medications, have difficulties to the specific requirements of the study, especially when they are in conflict with their daily life

Older people often have problems seeing and hearing, which means more time and effort to explain the purpose and conditions of the study. They tend more often to interrupt their

Despite the above-mentioned complications, participation of older people in clinical trials is

But can the elderly make a conscious choice? It has been known that the elderly people usually perceive new information worse than younger ones. Older people have a bad memory,

absolutely necessary and very important given the overall ageing of the population.

participation in the trial, suggesting larger initial screening of patients.

• patients representing ethnic minorities are not exposed to additional risk;

• documentation is in a language understandable to the minority patients.

the treatments and interventions are going to be relevant to those populations.

**7. Clinical trials on older people**

(diet, daily regime, etc.).

are deprived of the equal benefits of treatment during the study.

in general.

132 Clinical Trials in Vulnerable Populations

of untreated syphilis in rural African-American men in Alabama, US.

In the past, military participation in clinical trials has been quite common for many reasons controlled diet, easy access to patient homogeneity of the population, etc. But the number of clinical trials conducted in the past in accordance with the norms and principles of Good Clinical Practice is comparatively small.

Examples of some of these studies include radiation exposure, mustard gas experiments and lysergic acid diethylamide (LSD) testing in non-volunteer human subjects [9], not to mention human experimentations before and during the World War II.

result in hospitalisation or medical interventions. This is considered as voluntary, even though the consent from the individual concerned is not present. The interventions might even be against the individual's expressed will, however in a legal sense will still be considered as voluntary. In other European countries, guardians or other legal representatives cannot make health care decisions. However, non-consensual interventions in the psychiatric field are still possible in most countries if a doctor finds them necessary and a court confirms the same.

Ethical Aspects of Vulnerable Group of Patients in Clinical Trials

http://dx.doi.org/10.5772/intechopen.70318

135

European legislation outlines additional protection requirements towards inclusion of inca-

• The informed consent of the legal representative has been obtained; consent must represent the subject's presumed will and may be revoked at any time, without detriment to the

• Information received during the informed consent process should be adequate in view of

• There are grounds for expecting that administering the medicinal product to be tested will

• The clinical trial is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical trials on persons able to give informed consent, or by

• The incapacitated patient should take part in the informed consent procedure as far as

In the past years, the so-called paradigm shift in disability policy is widely discussed. This is a shift from the deprival of legal capacity to the right to support for exercising legal capacity. Such example is a person diagnosed with Down's syndrome applying for a certain service. If he/she is provided information in easy-to-read format and adequate time and support, he/ she may be able to understand pros and cons of the service and choose whether or not to use it. In this situation, no disability arises. However, if information is provided in standard language and no additional effort taken to explain it in a manner adequate to person's condition, disability becomes a fact. The paradigm shift calls for legal, attitudinal and environmental

and Hristina Lebanova3

produce a benefit to the patient outweighing the risks or produce no risk at all.

• No incentives or financial inducements are given except compensation.

pacitated patients into clinical trials:

other research methods.

possible [4, 11].

changes [12].

**Author details**

Ekaterina Ivanova<sup>1</sup>

\*, Ilko Getov2

1 New Bulgarian University, Sofia, Bulgaria

\*Address all correspondence to: ekaterinakabanova13@gmail.com

2 Faculty of Pharmacy, Medical University, Sofia, Bulgaria 3 Faculty of Pharmacy, Medical University, Pleven, Bulgaria

the patient's capacity to understand it.

subject.

The ethical problem with clinical trials on military population is obvious—the military are in a position of subordination and dependency. There are methodological challenges associated with these clinical trials:


Thus, clinical studies on military should be initiated and conducted with the consent of the ethical committee only in cases where the data cannot be collected from the civilian population or purpose of the test is the prevention or treatment of conditions and/or diseases peculiar to military population.

An example is the study of the probiotic foods with Lactobacillus bulgaricus. Effect of the probiotic foods with Lactobacillus bulgaricus was investigated on 56 sailors from the Bulgarian Submarine fleet and 60 pilots from the Air Force of Bulgaria, who were put to extensive mental and physical pressure. There are lots of clinical studies of the use of probiotic food containing Lactobacillus bulgaricus as a nutritional support and a part of the medical treatment in 60 cases of severe intoxication accompanied by poly-organic insufficiency. As a result, these probiotic foods were included in the regular diet of the pilots from the Air Force of Bulgaria, sailors from the Submarine fleet of Bulgaria and of commandos [10].
