**6. Clinical trials on ethnic minorities**

The participation of **students and employees** in clinical trials is widely discussed. There are two ethical issues: whether the decision to participate was completely voluntary and privacy

On the one hand, students' and employees' participation in clinical trials conducted on campus puts under question the free nature of this decision. The student/employee may decide to participate in the study with the idea that his/her participation will be beneficial for the learning process or work conditions (better grades, good recommendations, etc.). Conversely, there is concern that non-participation in the study may have a negative impact on relations

On the other hand, the ban on students' and employees' participation in clinical trials limits their right of choice. Therefore, the Good Clinical Practice highlights the requirement to investigator to recruit patients-volunteers exclusively through advertisement of a general nature and not through individual approach to minimise any coercion or pressure in

Another ethical concern is data privacy issue. The researched should guarantee protection and confidentiality of personal data of the participants. This may not be so easy to achieve if study involves students or employees of medical institution which conducts the trials. In this case, there is a conflict of interest as participants in the study are students or employees, and

**5. Clinical trials in emergency situation and on people suffering from** 

In general, clinical trials with patients who require emergency treatment or intensive therapy differ from studies with patients in stable condition. These differences are mostly related to the problem of obtaining informed consent—the patient has blurred consciousness, unresponsive or unconscious, lack of time and opportunity to discover his legal representatives. Ethical standards and legislation allow informed consent to be missing in cases where the patient's life is in danger, and alternative ways of treating are missing. In all cases, however, the informed consent shall be sought after the performed emergency intervention to continue

If the patient or his/her legal representative does not give consent, he/she has the right to

The situation is different in clinical trials and treatment of deadly diseases. They suggest another category of patients—terminally ill. Such trials are of a great importance, as often there are no alternative types of patients that might be involved due to this is not justified

It should be borne in mind that it is possible terminally ill patients wrongly to suggest that participation in testing is a necessary condition to receive medical care and that it is better to

concerns.

130 Clinical Trials in Vulnerable Populations

decision-making.

**incurable diseases**

from the ethical stand point.

with the teaching staff or employer.

the investigational staff is the employer.

the participation of the subject in the clinical trial.

object to the use of data collected from the clinical study.

Ethical standards suggest unbiased approach to selecting patients—inclusion or exclusion criteria should not be based on gender, race or ethnicity. Most diseases are applicable to all populations, so the researcher must include the most diverse types of patients. This way the results obtained in the course of the study may be useful for all people who are at risk for a disease being treated. The researcher should provide clear justifications on inclusion or exclusion of specific populations.

Yet there are diseases that often occur in certain ethnic groups. For example, sickle cell disorders are more common among people whose ancestors have lived in tropical and subtropical regions. In such studies, the inclusion of patients from specific ethnic minority is a must. Exclusion or under-representation of ethnic groups would be unfair approach, as thus they are deprived of the equal benefits of treatment during the study.

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

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 in general.

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


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