**7. Clinical trials on older people**

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.

and show lower performance in some cognitive functions—hearing, vision, and reaction time. Thus, older people need more time to absorb and understand a similar volume of mental

**Figure 1.** Population pyramids, EU-28, 2015: provisional; estimate. 2080: projections (EUROPOP2013) (% of the total

Ethical Aspects of Vulnerable Group of Patients in Clinical Trials

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

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population). Source: Eurostat (online data codes: demo\_pjangroup and proj\_13npms).

Thus, in order to ensure that old patients understand and remember information and requirements regarding the study, the researcher is advised to split the procedure of obtaining informed consent in two parts. The purpose of the second part is to verify and confirm whether the old patient understands and remembers the information obtained in the first meeting. Patients who cannot remember important facts about the study should not partici-

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

work than people in younger age.

**8. Clinical trials on military**

Clinical Practice is comparatively small.

pate in the trial.

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 (diet, daily regime, etc.).

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

Despite the above-mentioned complications, participation of older people in clinical trials is absolutely necessary and very important given the overall ageing of the population.

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,

**Figure 1.** Population pyramids, EU-28, 2015: provisional; estimate. 2080: projections (EUROPOP2013) (% of the total population). Source: Eurostat (online data codes: demo\_pjangroup and proj\_13npms).

and show lower performance in some cognitive functions—hearing, vision, and reaction time. Thus, older people need more time to absorb and understand a similar volume of mental work than people in younger age.

Thus, in order to ensure that old patients understand and remember information and requirements regarding the study, the researcher is advised to split the procedure of obtaining informed consent in two parts. The purpose of the second part is to verify and confirm whether the old patient understands and remembers the information obtained in the first meeting. Patients who cannot remember important facts about the study should not participate in the trial.
