Understanding research in
the Intensive Care Unit (ICU)

We hope the information on this page will help you to

1 understand how research works;

2 ask important questions to researchers; and

3 make the best possible decisions about participating in studies.

Many different types of research are done in the ICU, including:

  • Studies comparing different treatments
  • Studies of new medicines or treatments
  • Studies to understand how the body reacts to illness
  • Studies to improve the safety and efficiency of the ICU
  • Studies to understand the experiences and opinions of
    ICU patients and families
  • Studies examining the body’s response to illness at the
    cellular and genetic level
  • Studies to improve the implemention and uptake of
    new knowledge in the ICU

All of these types of studies are important to advancing the science of critical care;
however they may have different risks of harm or benefit for you or your family member.


Why participate in research?


Participating in research is always voluntary. Patients and families do not have to participate in research if they do not want to. Deciding not to participate in research will not adversely impact the care you receive in the ICU. In addition, there is no guarantee that participating in research will help you or your loved ones.

However, there are many reasons people choose to participate in research in the ICU, including:

desire to improve the understanding of medicine and disease

access to tests or treatments which may not otherwise be available outside of research

an opportunity to give an opinion or view on the ICU

helping future patients who may suffer from the same problems

Consent for research

Before agreeing to participate in a study, it is important that you have a clear understanding of the purpose of the study, the nature of any study interventions, and the risks and benefits of participation.

You may be asked to participate in a study or to give permission for your loved one to be in a study, if your loved one is too sick or unable to make decisions. Participation in research is voluntary. For most types of studies, researchers must ask your permission before the study starts. Some exceptions to this are described below. The process of obtaining your permission is referred to as “informed consent.”

Before agreeing to participate in a study, it is important that you have a clear understanding of the purpose of the study, the nature of any study interventions, and the risks and benefits of participation.

Making a decision about research can be easy or it can be difficult. If possible, talk about research opportunities with other family members or friends. Sometimes research decisions are time-sensitive and you may only have a few hours to make a decision. Remember that the research team and the ICU team are there to support you to make the decision that is right for you at the time.

If you do decide to provide consent, you will usually be required to sign a consent form to demonstrate your agreement with participation and show that you have understood what the research study entails. You will be provided with a copy of the form for your records. The form will also provide you with contact information for the research team so you know who to contact if you have questions or concerns.

For studies involving participants who may not be able to understand all the study information (such as children, or cognitively-impaired adults) an assent form may be used to make sure they are
comfortable with participating.

For some types of research, such as studies conducted in emergency situations
or studies that are of very low risk to patients,
consent may not be required.

In Canada, the TriCouncil Policy Statement on the Ethical Conduct of Research Involving Humans provides guidance to researchers related to informed consent approaches.

Before any patient or family member can be approached to participate in research, studies must be reviewed and approved by a Research Ethics Board (REB).

The role of the REB is to ensure the protection of participants’ rights, privacy, and safety related to research and to decide whether or not informed consent is required. The box below describes circumstances in which consent may not be required.

Some studies may not require consent before the study starts, but you may be contacted afterwards for consent. This only occurs if:

  • the study involves minimal risks to patients in the study
  • getting consent before the study starts would make the study impossible or very impractical

Example 1: A study comparing two emergency treatments, both of which are commonly used, but it is unclear which is best.

Example 2: A study looking at patterns of drug prescriptions in the ICU which doesn’t collect personal information from patients.