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Patient and Public Involvement

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Patient and public involvement is when members of the public are involved in research projects, including clinical trials. 

At the HRB Clinical Research Facility Galway (HRB CRFG) we conduct advanced research in a caring environment aimed at understanding a wide range of diseases, and use this knowledge to improve medical treatment for patients.

Our research is a multidisciplinary team effort. Doctors, nurses, technicians, and scientists, work in partnership with patients to design, carry out and report on research.

Patients play a key role, bringing their expertise and helping improve what we do, based on their experience of illness and treatment. Through their involvement in research studies, they contribute towards our understanding of how diseases work and help us to improve patient outcomes in the future.

What is clinical research? 

Clinical Research refers to all research carried out on humans. It focuses on improving knowledge of diseases, developing diagnostic methods and new treatments or medical devices to ensure better patient care.  There are many different types of clinical research but it includes studies aimed at improving the prevention, diagnosis and treatment of human illness. 

What is a clinical trial?

Clinical trials can broadly be defined as health related research studies that involve people. A Clinical Trial is a research study to answer specific questions about a new medical treatment (medicine/drug, medical device, new therapies, vaccines), or new ways of using known treatments. Clinical Trials (also called medical research and research studies) are used to determine whether such new treatments are both safe and effective. Carefully conducted Clinical Trials are the fastest and safest way to find treatments that work in people. 

Why participate in a clinical trial? 

People who participate in Clinical Trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.   

What are the different types of clinical trials? 

Interventional trials (also called treatment trials) determine whether new treatments, new combination of drugs, new ways of using known therapies or new approaches to surgery or other therapies are safe and effective. These trials might ask a participant to take an experimental new drug or undergo surgery. 

Prevention trials involve tests to find ways to prevent particular medical conditions or if people have them already, to prevent them from reoccurring. The emphasis of these studies might be on medicines, vitamins, vaccines and mineral or lifestyle changes. 

Observational trials investigate health issues in large groups of people. The participants in such trials do not receive any treatment but may be asked to provide information or blood samples.  

Screening trials test the best way to detect certain diseases or health conditions.  
 
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness. 

Who can participate in a clinical trial? 

All Clinical Trials have rules about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a Clinical Trial are called ’inclusion criteria’ and those that disallow someone from participating are called ’exclusion criteria’. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.‌ 

Some research studies seek participants with illnesses or conditions to be studied in the Clinical Trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study. 

People participate in Clinical Trials for a variety of reasons. Volunteering for research studies can give participants access to promising new drugs long before they are available to the general public. Although there is always a chance that a new treatment will prove to be disappointing, there is reason to believe that it will be as good as, or better than, current treatments. Every effort is made to ensure safety and the care from a physician during the course of the study is highly controlled and monitored. 

People who take part in Clinical Trials become part of a network of Clinical Trials carried out around the country and the world. Anyone considering participating in Clinical Research should talk about it with their doctors and medical care givers. They also should ask about the credentials and experience of the individuals and the facility involved in the study. 

How are you protected if you take part in a clinical trial? 

Every person participating in a medical research study, must sign an informed consent form that explains the research study, the foreseeable risks, benefits, other appropriate treatments, and where to find further information. It also explains one's rights as a participant in the trial. If at any time a participant is not comfortable with the trial, they have the right to withdraw. Also, confidentiality of records and data are assured.