**Author details**

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

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

• Age range limitation does not allow to determine a strategy for prevention and treatment

• Limited duration of the study group. Often, this is associated with the period of military service or contract, as well as frequent redeployments in other locations or divisions.

• Density of settlement contributes to high levels of disease in acute respiratory tract

• Specific conditions of life style and daily regimen during military service may be a factor

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 pecu-

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,

Clinical trials involving patients with psychosocial or cognitive disorders, as well as those suffering from drug or alcohol addiction bring up an ethical question—if these patients are able

People with intellectual or psychosocial disorders are deprived of their legal capacity and put under some form of guardianship. There are two main guardianship models: full and partial. People under partial guardianship keep their main civil rights but certain capacities are transferred to a legal representative, such as financial affairs. Those under full guardianship, on the

There are European countries where guardians besides other life spheres are also empowered to take decisions on behalf of the individual in regards to health care. Guardian's consent may

sailors from the Submarine fleet of Bulgaria and of commandos [10].

**9. Clinical trials on people affected by mental health disorder**

human experimentations before and during the World War II.

with these clinical trials:

134 Clinical Trials in Vulnerable Populations

infections.

of the general population.

that could affect the test results.

to make their own rational decisions.

other hand, lose almost all of their civil rights.

liar to military population.

Ekaterina Ivanova<sup>1</sup> \*, Ilko Getov2 and Hristina Lebanova3

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

