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Why Clinical Research Trial Participation is Important

Dedicated to you, the research participant

ethica’s mission centers on the protection of research participants and advocating for their rights and welfare. This section provides information to help you make an informed decision about your participation in a research study.

ethica does not directly recruit research participants for the studies it manages but has a hotline available 24/7 to answer any questions you may have.

This section is for you. We welcome your feedback and suggestions.

What you need to know before consenting to participate in studies.

Access resources that provide valuable information on study participation.

Understand your rights and responsibilities as a research participant.

Know your rights. Get informed.

What is clinical research?

Early phase clinical research is used to evaluate the safety and efficacy of new medications, devices, diagnostic products and treatment regimens that are intended for human use.

Before a therapeutic product can be commercialized, it must first be approved by regulatory agencies such as Health Canada or the U.S. Food and Drug Administration. Data from completed clinical trials demonstrates to regulatory agencies that a therapeutic product is safe and effective.

Why should I participate in clinical research?

Many treatments available today are thanks to the people who volunteered for clinical research. Their participation contributed to understanding diseases and risk factors, learning the benefits of different treatment options, and improving the practice of delivering care. The ultimate goal of health research studies is to improve the health and wellbeing of individuals.

According to participants surveyed, the main reasons why people volunteer for clinical research is:

1. Altruism
2. Potential for personal therapeutic benefit
3. Helping others with similar condition
4. Financial gain (not all research have a potential of financial compensation)
5. Advancing science.

Positive outcomes of your participation in research:

The positive feeling from helping others and sharing information about your condition with others.

The gain of knowledge, awareness and/or information about your condition and your general health.

The pride of having contributed to the advancement of science.

Difference between clinical research and clinical practice

Clinical research serves to collect evidence to support regulatory approval for treatments. It is not yet known whether the investigational therapy constitutes optimal care. Clinical practice obliges the physician to provide optimal clinical care using approved therapeutic products.

What are the criteria for participation in clinical trials?

The criteria for research participation differ from one study to another depending on the research question, approaches, and purpose. Research studies provide various types of information such as insights into the functioning of the human body, the effects of new medication on individuals, and their specific behaviours, opinions, preferences, lifestyle, and conditions.

Research participants can be solicited based on various life phases, whether healthy or experiencing a specific health condition, or if they belong to a particular group of individuals.

The required level of participation is specific to each research study as are research procedures. Some procedures may be invasive, requiring a puncture, an incision, or administration of a product in your body. Others may only require the completion of a questionnaire or access to medical records.

Prior to the start of a study, investigators must inform potential research participants on the nature of the study, its purpose, duration, experimental procedures, alternative treatments, risks, and benefits. Informed consent is not just a form to be signed. It is an important educational process between the investigator and the prospective research participant. The participant is also given the opportunity to get all their questions answered before knowingly and voluntarily deciding whether or not to participate in the study. It is important to note that participants retain their right to leave a study at any time after giving consent, without having to justify their decision.