RESEARCH PARTICIPANTS

RESEARCH PARTICIPANTS

Deciding to take part in a clinical study is an important personal decision. This section aims to help you understand more about clinical research and how you can get involved.

Clinical research is research involving humans, their bio samples (e.g. blood sample) or their data. Clinical research is carried out with the aim of improving existing healthcare for the benefit of current and future patients.

A research study/trial can involve ‘healthy participants’ (i.e. people who do not have an underlying medical condition) but more often, studies/trials involve patients with a specific health condition that we want to study. Research studies are designed to answer specific questions on how to prevent, diagnose or treat a particular disease.

There are two main types of clinical studies: Interventional trials and Observational studies.

Deciding to take part in a clinical study is an important personal decision. This section aims to help you understand more about clinical research and how you can get involved.

Clinical research is research involving humans, their bio samples (e.g.  blood sample) or their data. Clinical research is carried out with the aim of improving existing healthcare for the benefit of current and future patients.

A research study/trial can involve ‘healthy participants’ (i.e. people who do not have an underlying medical condition) but more often, studies/trials involve patients with a specific health condition that we want to study. Research studies are designed to answer specific questions on how to prevent, diagnose or treat a particular disease.

There are two main types of clinical studies: Interventional trials and Observational studies.

FAQ’S

This is where the trial participants receive a specific intervention according to the research protocol. It might be a medication (also known as a ‘drug’), a medical device or some other intervention e.g. a food supplement or exercise programme.

Interventional trials involving new medications (drugs) or new medical devices are very strictly controlled and regulated in Ireland. Before such a trial can be carried out approval has to be given by both the National Research Ethics Committee and the Regulatory Authority in Ireland. Other interventions such as food, exercise etc , because they are lower risk, are not regulated by the HPRA but must be approved by a Local Research Ethics Committee before they can go ahead.

In this type of study, you continue to get your normal standard of care as a patient with the disease being studied (e.g. you take your usual medication for your disorder) and the study team just observe and collect data– no trial intervention is given. You may be asked to give bio samples or to fill in questionnaires (e.g. about your quality of life or your symptoms). These studies help us to understand the mechanisms and time course of diseases and may show us which existing treatments work best for what groups of people. For example, doctors may carry out an observational study on a group of older adults to learn more about the effects of different lifestyles on cardiac health. 

A clinical study/trial is led by a researcher who is an expert in that disease area, known as the ‘Principal Investigator’. For studies of medications (drugs) in Ireland this person must be a medical doctor. The Principal Investigator is usually supported by a study team consisting of doctors, nurses, and other health care professionals. 

Clinical studies can be sponsored (managed and funded by) pharmaceutical or medical device companies who are developing new drugs or medical devices.  Clinical studies/trials can also be sponsored by academic institutions such as Universities, by charities (e.g. The Irish Cancer Society), patient organisations etc. 

People participate in clinical studies for several reasons. In the case of a clinical trial, participants may be able to access potentially life-saving or life changing experimental medications or treatments before they become available to the public.  Many participants take part for altruistic reasons, to help doctors gain knowledge which may help other people with this disease in the future. Participants may also feel they are playing a more active role in their own health care by taking part in medical research.

Each study has its own requirements re who can take part. These are set out in the study protocol The investigator checks if a potential participant meets all the requirements, for example Do you have the disease she is studying, are you within the right age range, do have a negative pregnancy test etc. These criteria, called “inclusion and exclusion criteria” are not used to reject or exclude people personally. They exist to help ensure that the researchers will be able to answer the study question using the data collected and to ensure the safety of participants. For example, if the treatment drug has the potential to interact with alcohol the study may require that people who drink more than 10 units of alcohol per week are excluded from the study.  

All clinical research studies undertaken in Ireland must comply with the highest national and international ethical standards and relevant legislation which include the EU Clinical Trials Regulation, EU Medical Device Regulations, and ICH Good Clinical Practice Guideline.  

Research studies must be approved by a research ethics committee and, in the case of drugs or medical devices, by the regulatory authority (HPRA). Potential participants are given information about the study/trial verbally and in written form in a Patient Information Leaflet (PIL). This includes information about re foreseeable benefits and risks, what is expected of them during the trial (e.g. how many study visits, how many blood samples etc), information about the drug or device, who to contact for more information, what happens to their samples and data, what are their rights etc. Potential participants can ask as many questions as they like. If they decide to take part, they are asked to sign an informed consent form (ICF) to record their consent. Participants can stop taking part in the study at any time they wish. Confidentiality of records and data are also assured as clinical research must comply with the data protection requirements (GDPR and the Health Research Regulations) which are in use in Ireland. 

Patient information leaflet (PIL): The purpose of the PIL is to give you all the information you need to make an informed decision about whether you wish to take part in a study. It informs you why you have been asked to take part, what the study is about, how many visits and what kind of tests are involved. It gives information on the treatment, foreseeable benefits and risks, alternative treatments (if you decide not to take part in the study). Before you can be enrolled into a research study, you should read the PIL carefully and ask for more information if you wish. You will get a copy of the PIL to keep for your own reference. 

Informed consent form (ICF): If you decide take part in a study and if the investigator has confirmed that you are suitable (‘eligible’) to take part, you are asked to give your consent by signing an ICF.  The investigator, or other member of the research team also signs the ICF.  By signing the ICF you are confirming that you have read the PIL, understand the information you have been given and voluntarily agree to take part. You will be given a copy of the ICF to take home.

Randomised trial: In a randomised trial neither the investigator or the participant choses what treatment group the participant goes into. The participant is randomly allocated into one of the groups in a process similar to tossing a coin. Randomisation is done to help prevent bias in the trial. 

Blinded trial: In a single blinded trial, you (the participant) will not be aware of which treatment group you are in, but the investigator/ research team will know. In a double-blinded trial neither you (the participant) nor the research team are aware of which treatment group you in until the end of the trial when all the data have been analysed., Blinding is used to help prevent bias. 

Placebo controlled: A study may include a ‘dummy’ treatment group which is matching in appearance to the active treatment. Participants will be randomly assigned to receive the placebo (also known as a sugar pill or dummy drug) or the active treatment.

Bias: Bias is when our preconceived ideas lead to incorrect conclusions about the effects of treatment. It is really important to avoid bias in health research, as it can distort the results and could lead to unsafe or inefficient treatments being used, or lead to useful treatments being overlooked. Researchers try to reduce bias by using techniques like randomisation and blinding.

If you are interested in becoming a participant in research, please consult with your own doctor in the first instance. You may also wish to contact your patient representative organisation or publicly available clinical research registers. We have listed some relevant websites for your information below.

  • Irish Platform for Patient Organisations, Science and Industry (IPPOSI) websites: www.ipposi.ie and www.clinicaltrials.ie . The websites and associated documents are part of an IPPOSI information campaign intended to advise the public about taking part in clinical trials, including information specifically tailored for different age groups of children.
  • Information about regulated clinical trials in EU is in a transition process at time of writing (July 2022). Up to January 2022 all EU drug trials were registered on the European Medicines Agency publicly accessible database: www.clinicaltrialsregister.eu.
  • With the introduction of the clinical trial regulation (30 Jan 2022) new trials are now registered on the new Clinical Trials Information System (CTIS) at Clinical Trials in the European Union – EMA (euclinicaltrials.eu).
  • The United States authorities have created a website where trials / studies conducted around the world can be found: www.clinicaltrials.gov.

Please note that, in accordance with ethical standards for clinical research, HRB NCTO is not able to provide advice or consult with individual patient’s regarding participation in specific clinical studies.