Protecting participants
Research Ethics Boards
The safety of participants is paramount and constitutes the most important aspect of clinical trials. Every clinical trial must be conducted in accordance with ethical principles as defined by international standards. For instance, the Helsinki Declaration states ethical principles used by physicians and other participants in medical research involving human beings. Before running a research protocol, the latter must be evaluated and approved by the competent regulatory authorities in each country (Health Canada, US Food & Drug Administration, etc.) and by the Research Ethics Board of each healthcare establishment.
The Ethics Board ensures the safety of participants and protects their rights, while ensuring that the clinical trials do not include any undue risk. The Ethics Board is composed of impartial persons who have no personal interests involved in the clinical study.
Protocols
Any drug or treatment can have advantages and disadvantages. That's why every clinical study is meticulously governed by a protocol, or action plan, that each member of the research team must scrupulously respect.
A protocol specifies the scope and manner in which the study should be conducted. Then it is submitted to an ethics board which assesses the benefits and potential risks for participants.
Protocols include the following information:
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the purpose, duration, and center(s) in which the study is hosted;
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the pathology(ies), as well as the number of participants involved;
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the inclusion and exclusion criteria, which determine whether a participant can or cannot participate in the study;
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the treatment(s) prescribed and the contraindications;
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the surveillance procedures: date and frequency of examinations, consultations, etc.;
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Information on randomization and results;
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to ensure close monitoring, clinical studies are usually conducted in a hospital or through outpatient treatment.
Informed consent
Ethical standards apply to clinical trials. People who are considering taking part in a clinical trial should know everything regarding the study before deciding to participate. This is called informed consent.
Those interested in a clinical trial receive a printed consent form that provides the following information:
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the person responsible for the conduct of the study;
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the start date;
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the goals;
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the conduct of the study;
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the description of the experimental treatment;
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the possible side effects, if applicable;
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the total number of participants;
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the description of processes and tissue samples;
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the duration;
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the benefits of participating, if applicable;
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the rights of participants;
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the coordinates of the contact person, who can be reached at any time if the patient has questions.
If a person agrees to participate in a trial, he is then asked to sign the form and will be given a copy. If there are changes in the clinical trial in which you are participating, your clinical research team will provide you with a revised informed consent which has to be signed to make sure you understand these changes and that you agree with them. Remember that you can withdraw from a clinical trial at any time, even after signing the informed consent form.
Confidentiality
In clinical research, each participant is designated by his initials. Any information which can be used to identify the participant (first and last name, personal details) remains confidential at all times.
Representatives of a study sponsor, an independent Research Ethics Board, or a local or foreign regulatory agency (Health Canada, Food and Drug Administration or the European Medicines Agency) may request to review records for audit and inspection purposes. Employees of these institutions are requested to scrupulously observe privacy laws.
In cases where study results are published, the identity of participants remains strictly confidential.
In Canada, the law also requires that all documents and records related to a clinical study be kept for at least 25 years.
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