**4. Clinical trials on students and employees**

• if it cannot be conducted on other patient groups;

feeding women, or other children or embryos;

• if it holds minimal risk to the subjects [4].

**3. Clinical trials on minors**

128 Clinical Trials in Vulnerable Populations

primary consideration.

and pain during the study.

enclosed to the study documentation.

• Informed consent

• Assent

• if it contributes greatly to obtaining results which could be beneficial to pregnant or breast-

In paediatrics, it is often that methods and therapies are applied based on studies conducted on adults. But the results in children are not always the same. Therefore, the treatment for children needs to constantly improve and enhance based on clinical trials conducted on children population. However, the best interests of the child should be a

According to the Convention on the Rights of the Child adopted by the UN General Assembly in 20 November 1989, the children have the same rights as adults. Thus, clinical trials on children should meet the same requirements needed for such trials on adults. However, due to children's vulnerability, they require special care and additional protection of their interests. It is essential to obtain informed consent, assess the risks to the child and minimise the fear

For the first time, the term assent is mentioned in the Declaration of Helsinki, which states that when a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addi-

Prior including a child into a clinical trial, his assent needs to be obtained. If such is missing, this fact, along with reasonable explanations of the same, needs to be noted in the Informed Consent of child's parents or legally authorised representative. Child's assent alone is not sufficient; it should always be accompanied with the informed consent of the parents. If a child reaches age of legal competency during the trial, his informed consent should be obtained and

However, the degree of child's involvement in the decision depends on its age and maturity. Ethical committee can determine the age of the child when it can give consent to participate. This decision should comply with the local laws. Only the child's age, however, is not determinative of whether it is capable of giving consent to participate. The level of development, intellectual ability and experience may also be decisive. In all cases, trial information pro-

There are two main concepts on the child's participation in a clinical trial:

tion to the consent of the legally authorised representative [5].

vided to a child needs to be adapted to its age and mental maturity.

When attracting healthy volunteers, it is imperative that they take the decision to participate in a clinical trial on their own and without pressure. They should receive all needed information related to the trial and declare their voluntary informed consent. Volunteers are usually compensated for their time, discomfort and possible risks. Thus, ethical commission is to make sure that these cash compensations are not unreasonably high and that attracted patients are not from category that is easily persuaded and influenced (*people with low incomes or without education*).

Healthy volunteers are usually patients in Phase I clinical trials. The task of this phase is to evaluate drug's safety, determine a safe dosage range, pharmacokinetics and side effects.

The researcher should consider possible action in the event that a patient volunteer gets sick or hurt during the tests. These actions must be thoroughly listed in the informed consent form:


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 concerns.

receive any medical care than nothing. Some terminally ill patients consider their participation in the trial as an opportunity to be helpful to others. It is therefore important that they are

Ethical Aspects of Vulnerable Group of Patients in Clinical Trials

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Nowadays the topical question is around participation of terminally ill patients in Phase I clinical trials from, as medicines in this phase can be dangerous (e.g. a new kind of chemotherapy). Despite the researcher's willingness to be helpful and give positive results of the tests, the patient may not improve or even get worse. For this reason, it is very important for the patient to be thoroughly informed the potential risks and benefits of the research, without giving unnecessary hope. Study participants must be informed whether their participation or non-participation in the study is a prerequisite for treatment in a hospital, and whether the

The AIDS epidemic boosts new kind of demand—access to investigational drugs. Many terminally ill patients are willing to take investigational drugs in a clinical trial because there is

In the United States, there are several examples of treatment use of investigational drugs. In 1976, the 'Group C' treatment was established by agreement between FDA and the National Cancer Institute. The purpose of the programme is to distribute investigational drugs to oncologists to treat cancer under studies outside the controlled clinical trial. Another expanded access concept is so-called Parallel Track policy announced by FDA in April 1992, which per-

In Europe, 'Compassionate use' programmes allow a medicinal product, without marketing authorisation, to be given to patients with a life-threatening disease when no alternative authorised treatments exist. The European Regulation 726/2004/EC provides directions to 'compassionate use' programmes in the European Union. It states that patients must have a chronic or life-threatening disease, and the medicinal product must be undergoing assessment in a clinical trial or be in the marketing authorisation stage. However, details around authorisation procedures are still missing and ultimately the programmes are governed by

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 exclu-

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.

no other way to get them—they are either not available or too expensive.

mits wider access to new drugs for AIDS/HIV-related diseases [6].

properly informed and do not participate in the trial based on false assumptions.

stay in hospital is at patient's cost.

individual member states [7].

sion of specific populations.

**6. Clinical trials on ethnic minorities**

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 with the teaching staff or employer.

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 decision-making.

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 the investigational staff is the employer.
