Research Participants

Human research is a systematic, rigorous investigation designed to gather valuable information with the intention to increase our current understanding of mankind and the world around us.

You may be solicited to become a research participant in all phases of your life, whether you are healthy or have a speciﬁc health condition, or because you belong to a particular group of individuals. The level of your participation in a research study may vary between research studies; some research procedures may be invasive (i.e. requires a puncture, an incision or administration of a product in the body), while others may only require the completion of a questionnaire or access to your medical records.

Various types of information are gathered from research studies such as information related to the functioning of the human body, the eﬀects of a new medication on individuals, individuals’ behaviours, opinions, preferences, life styles and conditions. Researchers must ensure that human research meets high scientiﬁc and ethical standards. And because research entails risks, researchers must ensure that these risks are minimized and your rights as a research participant are protected and respected.

As a research participant, you are directly involved in the research process. You are as important to the research process as the researcher, the sponsor of the research, and the research ethics board.

The research ethics board, also known as the REB or IRB, is an independent, multidisciplinary group of men and women with various levels of expertise depending on the type of research being studied. For example, the research ethics board may have individuals who have extensive knowledge of clinical research, medicine, pharmacology, biomedical sciences, psychology, anthropology, sociology, ethics, law, as well as those who represent your community.

The primary mandate of the research ethics board is the protection, safety and well-being of the individuals who participate in research studies under its supervision. It ensures the protection of research participants like you by reviewing and evaluating research studies prior to their initiation and throughout their process in order to ensure that the projects are ethically acceptable.

The research ethics board has the regulatory authority to approve, disapprove, require modiﬁcations to, as well as terminate or suspend approval of any proposed or ongoing research study under its jurisdiction if it considers that the research study would jeopardize the welfare and rights of its participants.

Before you decide to participate in a research study you should be aware of your rights.

You have the right to know the purpose of the research study
You have the right to know what will be done to you during the research study
You have the right to know the potential risks and discomforts resulting from participating in a research study, if any
You have the right to know the potential benefits resulting from participating in a research study, if any
You have the right to ask as many questions as you deem necessary in order to make an informed decision and you have the right to ask questions throughout your participation in the research study
You have the right to take the time necessary in order for you to decide whether or not to take part in a research study and to make that decision without feeling forced or required to participate
You have the right to show the informed consent form to your spouse, relatives, friends or anyone you consider important prior to deciding whether or not to take part in a research study
You have the right to receive the signed informed consent form from the researchers
You have the right to know the name of the physician or researcher that will conduct the study and you have the right to know his/her telephone number in case you have any questions about the research study
You have the right to know the telephone number of the research ethics board that reviewed and approved the study in case you have any questions about your rights as a research participant or the responsibilities of your study physician or researcher
You have the right to refuse to participate in a research study
You have the right to stop your participation in a research study at any time with the knowledge that this decision will in no way jeopardize your medical care or prejudice you in any way