Why Participate in a Clinical Trial?
There are many reasons why people volunteer to participate in clinical trials, including:
- Opportunity to help people suffering from medical conditions
- Access to investigational treatments before they become widely available
- Opportunity to play a role in the discovery of treatments, cures, and preventions for certain diseases or medical conditions
- Ability to play a more active role in your own healthcare
- Access to free physical examinations and diagnostic tests related to the clinical study
Potential compensation for time and travel related to the clinical study
Who can participate in a Clinical Trial?
Every clinical trial has specific requirements for who can or cannot participate.
To participate in a clinical trial, participants must meet certain standards, called “inclusion criteria.” There are also factors that can exclude some people from participating, called “exclusion criteria.” Inclusion and exclusion criteria are often related to:
- Type and stage of a disease
- Previous or current medications
- Existing medical conditions
- Recent participation in a clinical trial
Keep in mind that some clinical trials are looking for participants who have the medical condition being studied, while other clinical trials are looking for healthy study participants.
In order to become a clinical trial participant, you must qualify by satisfying both the inclusion and exclusion criteria. Inclusion and exclusion criteria are used to protect your safety during a clinical trial.
All medical care requires the patient’s consent. In some cases, you approve a care plan by getting a prescription filled or allowing blood to be drawn. This is called simple consent.
In other instances, clinical trial participants are asked to agree to the care plan in writing. This is called informed consent.
The main purpose of the informed consent process is to communicate to you, the patient, the requirements of the study. You have the right to make decisions about your own health and medical conditions.
Informed consent for a clinical trial involves two parts: a document and a process.
Clinical Trial Informed Consent Document
The clinical trial informed consent document provides a summary of the trial, including its purpose, the treatment procedures and schedule, potential risks and benefits, and alternative treatments. It also explains your rights as a clinical trial participant. If you decide to enter the trial, you give your official consent by signing the document.
According to regulations in the Republic of South Africa, no informed consent document may say anything that asks – or seems to ask – you to give up your legal rights. It also may not include anything that releases – or appears to release – the investigator, doctor, sponsor or facility from liability if they are negligent or careless.
Clinical Trial Informed Consent Process
The clinical trial informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Before you make your decision, the research team will discuss the trial with you. If you decide to participate in a clinical trial, the researchers will continue to update you on any new information that may affect you. You will also have the opportunity to ask questions before, during and after the trial.
During the process of Informed Consent at our site:
- You will have the opportunity to discuss your concerns directly with our doctors.
- You will have sufficient time to read and understand the consent document and raise any concerns that you may have.
- You will be able to choose the language of the consent process.
- Feel free to ask any questions
- A copy of the signed consent will be provided to you
Your Safety is priority!
Clinical trial patient safety is always a priority. When you participate in a clinical trial, you can be assured that:
- The ethical and legal conditions that govern a medical practice also apply to clinical trials.
- Every clinical trial in the Republic of South Africa must be approved and monitored by an Ethics Committee to make sure the risks are as low as possible and are worth any potential benefits. The Ethics Committee is an independent committee of physicians, statisticians, community advocates and others who ensure a clinical trial is ethical and participants’ rights are protected. Many countries around the world have similar review boards and regulations.
- In addition, every clinical trial in the Republic of South Africa must be approved and monitored by the Medical Control Council (MCC). The MCC is a committee of Medical experts appointed by the Minister of Health to oversee and monitor the safety of participants in a clinical trial.
- A clinical trial follows a detailed protocol, which explains exactly how researchers must conduct the trial. As a clinical trial progresses, researchers report the results of the trial at scientific meetings and in medical journals as well as to various government agencies. Individual clinical trial volunteers’ names are never revealed.
- If you do not want to continue participation in the clinical trial for any reason, you may stop at any time.
All trials involve some form of risk. However, the risks are always evaluated closely.
What can I expect in a Clinical Trial?
The process of participating in a clinical trial depends on the type of research being conducted. A team, also known as site staff, for a given clinical trial might include doctors, nurses, social workers and other specialized health care professionals. The role of the site staff is to check your health at the beginning of the clinical trial, provide specific instructions and guidance for what to do during the trial, watch over your health throughout the trial and make sure that the study protocol is followed.
Based on your condition, some clinical trials involve more diagnostic tests and doctor visits than you might initially expect. The tests and visits help the site staff ensure that your health and safety are monitored carefully.
How to Become a Clinical Trial Participant
If you are interested in being considered for clinical trial opportunities, follow the simple steps below to register:
- Contact the site and add your name to our database of potential study participants.
- If you are registered in our database, a member of the study staff will contact you when a clinical trial matching your criteria (based on the information you provided) is enrolling participants.
- If you are interested in participating in clinical trials, you will go through a screening process to make sure you qualify for the trial. This usually involves a series of questions related to your health, the medications you take and possibly your lifestyle.
- If, after screening, you are determined to be eligible to participate in the clinical trial, the site staff conducting the trial will provide you more details about your participation and answer any questions you may have. They will also ask you to review and sign an informed consent document.
Required Physical Exams, Medical Assessments and Tests
To determine if you meet all of the requirements for a clinical trial, a physical examination is usually conducted during the screening process. This exam may include:
- Measurement of your height, weight, temperature and blood pressure
- A test that records the electrical activity of your heart, known as an electrocardiogram
- Blood and/or urine samples
- Other diagnostic tests required by the clinical trial protocol
All of the information obtained during the screening process is kept secure and confidential. If you qualify for the clinical trial, you will be contacted by the site staff to schedule any trial-related clinic visits and discuss your participation in more detail. Your participation is completely voluntary. So, even if you decide to enroll in a clinical trial, you are free to leave the trial at any time, for any reason
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