Who can participate in a Σellas clinical trial?
To participate in a Σellas clinical trial, both patients and healthy volunteers must meet certain prerequisites that may differ
from study to study. Participants may belong to one of the following groups:
· children and adults wishing to improve their own health. They may be patients with either a newly diagnosed medical problem, a medical problem experienced over a period of time, or having a family history on a certain disease
· healthy volunteers. All healthy persons seeking to advance knowledge on causes and treatment of a disease can also participate in clinical research. They provide important medical information to researchers by helping them compare how healthy people differ medically from those who have a specific disease
Before participating in a Σellas clinical trial…
… you should be well informed and feel totally confident about your decision: talk with your own doctors, family members and the Σellas Clinicals team, and make sure you know the answers to the following questions:
- what is the purpose of the study?
- what is required from me?
- what is my role in the study?
- will the study directly benefit me?
- will the study benefit others?
- are there any risks? If so, what are they and what are the chances that they will occur?
- what discomforts are involved?
- what is the total time involved?
- do I really wish to participate in this study?
Clinical trial risks and benefits
It is important to understand that some risks are involved in clinical research, just as in routine medical care and daily activities. When thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only for a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research.
In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer all your questions. Before deciding whether to participate or not, you should carefully weigh these risks against possible benefits. You may, or may not, receive direct benefit for yourself and your condition as a result of participating in research, but in either case, you will know that the knowledge acquired may help others.
Signing the Informed Consent Form
To fully describe participation to a candidate subject, Σellas doctors and nurses involved in the trial explain the details of the study using terms that the person understands. After this procedure is concluded, Σellas research team will provide an informed consent document that includes trial details, such as its purpose, duration, required procedures, risks, potential benefits and key contacts. Each and every patient or volunteer should sign this informed consent form before participating in a clinical trial.
The informed consent is a legally-defined process of a person being informed about key facts involved in a clinical trial before deciding whether or not to participate. The participant then decides whether or not to sign the document in agreement. Informed consent is not an immutable contract, as the participant can withdraw from the procedure at any time.