It is scientific research that participants agree to undergo even though it may not directly benefit their health. It often involves studies on a medication that has not yet been approved by the government. These studies check the new product’s safety, effectiveness and toxicity (danger to the health).

The law requires medical experimentation to respect certain conditions, in order to protect the participants.

Here are the main conditions set out in the law:

• The possible benefits must be proportionate to the risk for the study’s participant. For example, if a person undergoes an experiment with the goal of trying to increase the speed of cartilage regeneration by 1% (a positive benefit, but minimal), he should not be risking severe and permanent side effects on his digestive system;
  
• If participants are incapable of giving consent, there must not be any serious health risks;
  
• The researchers must obtain the clear and enlightened consent of the participants or of the person legally entitled to consent on their behalf.

The members of an ethics committee have this responsibility. An ethics committee, made up of health professionals, lawyers, philosophers and members of the public, is responsible for considering and approving research projects proposed by health establishments.

The members of the ethics committee must make sure that the research project respects certain laws and guidelines set out by the federal and provincial governments and public organisations.

Among other things, they evaluate:

• the goal and objectives of the project;
  
• the way it will be carried out;
  
• the recruitment methods;
  
• the risks and benefits;
  
• the clauses that explain confidentiality;
  
• any possible conflicts of interest;
  
• the compensation and indemnity in case of damages;
  
• the freedom to participate and the right to withdraw.

A private company can have its own committee, provided the company recruits its own volunteers and doesn’t use researchers from a Quebec health or social services establishment. The company can also go to a private research ethics committee.

No. Participation in a medical experiment is completely voluntary. Patients are completely free to decide whether or not to participate. Furthermore, their decision must not affect relations with their doctor or the care provided to them.

Also, with some exceptions, no one can force someone else to undergo treatments or experiments without their consent. The consent must be free (not obtained by coercion or threats) and enlightened (the person received all pertinent information regarding their choice).

The information and informed consent form is a document that is often given to people who wish to participate in a research project. Its goal is to provide information so that the person’s decision to participate is based on informed consent. Therefore, the form must be written in an appropriate language, so that the person can make a decision with full knowledge of the facts.

This form generally contains explanations on:

• the type, goal and objectives of the study;
  
• the way the study will be carried out and its duration;
  
• the recruitment criteria;
  
• the possible risks (including those that are rare and unlikely) and the anticipated benefits;
  
• the usage of a placebo;
  
• the clauses indicating confidentiality and possible conflicts of interest;
  
• the compensation and indemnity in case of injury;
  
• the freedom to participate and the right to withdraw;
  
• the names of the researchers and their sources of funding.

To participate in a study, you must sign this form.

Yes, but only in certain very specific circumstances.

An incapacitated person (someone who is unable to take care of themselves because of a disability, accident or illness) or a person under the age of 18 cannot undergo an experiment unless the following conditions are met:

• There is no serious risk to their health;
  
• They do not oppose it (if they understand the nature and the consequences of the study);
  
• The study has possible benefits for their health or the health of people sharing the same age, illness or disability;
  
• The ethics committee of the study have approved the research study and will ensure its follow-up;
  
• In the case of a minor, the holder of parental authority (generally the parents) or the tutor have consented to the study.

In the case of a person who is incapacitated and over the age of majority, the tutor or the curator must have consented to their participation in the study. For example, let’s say that 80-year-old René has Alzheimer’s disease. His neurologist invites his wife Rita to have him participate in research involving a new medication that may slow the development of his illness. Rita cannot consent for René unless she has been legally named his mandatary, tutor, or curator.

If a person over the age of majority suddenly becomes incapacitated, a spouse, parent or friend can give consent for them without being their mandatary, tutor or curator, if:

• the ethics committee has determined that the experiment must be carried out soon after the onset of incapacity, and
  
• there is not enough time to name a legal representative.

For example: The emergency physician confirms to Giuliana’s husband that she has just suffered a CVA (cerebrovascular accident, often called a “stroke”). After explaining the consequences of a CVA, the doctor asks the spouse if he consents to Guiliana taking a new medication for victims of CVAs. The doctor explains to him that the medication, which has not yet been approved, is most effective if administered within the first 24 hours following the CVA. Guiliana’s spouse consents to the trial. When Guiliana regains consciousness, she can decide if she wants to continue participating in the experiment.

Yes. It is possible to stop participating in a medical experiment at any time during the research project. You can withdraw from the project by simply giving verbal notice. You will still have a right to the medical follow-up that you would have received if you had stayed on.

However, in certain research projects, you may be asked to undergo medical tests to make sure that stopping the experiment will not endanger your health. You may be asked to sign another information and informed consent form regarding your withdrawal.

It is also important to know that in many projects, the data collected up until your withdrawal will be kept in order to assure that the project was carried out properly. In addition, certain samples given, like blood, cannot be destroyed after you leave the project if they were taken anonymously (they are not identifiable).

A placebo is a substance that doesn’t contain any active product. Sometimes, when the researchers are testing the effectiveness of a medication, they compare the results of taking the medication with the results of taking a placebo.

The information and consent form must expressly mention the use of a placebo. Also, the ethics committee must agree to the use of this method beforehand, especially if the volunteers are seriously ill or they are normally on medication and must stop their regular treatment.

Once a new medication is developed by a pharmaceutical company or a team of university researchers, a preclinical study (tests on animals for example) must be submitted to Health Canada. If this stage shows that the product isn’t toxic and that it gives the desired effect, an authorisation to carry out clinical trials on humans can be obtained. These trials are done in 4 phases:

• Phase 1 aims mainly to test the product’s safety on 20 to 100 people in good health;
  
• Phase 2 aims to study the toxicity (danger to health) and effectiveness of the product with approximately 100 to 300 volunteers that suffer from the illness or the condition targeted by the medication;
  
• Phase 3 is a comparative study on a larger scale with 1000 to 5000 patients (often carried out in multiple countries at the same time). If the results are conclusive, the pharmaceutical company can put their products on the market (after having obtained what is called a “Notice of Compliance” from Health Canada);
  
• Phase 4 is a study that is done after the medication has been put on the market. This study aims to gather additional information with the goal of better understanding the effectiveness and the long-term safety of the product.

Knowledge about the product increases throughout the different phases. Participating in a phase 4 study will normally involve fewer unknown risks. However, the actual degree of risk in a clinical study depends on the kind of product tested.

Yes. The research doctors are held to professional secrecy and must respect the confidentiality of your medical files and the research unless you consent in writing to sharing them. You should know that, in the research files, identification is often limited to just your initials paired up with a code number.

The following people might also have access to your files: members of organisations like Health Canada, the ethics committee of the research, or certain representatives of the pharmaceutical company funding the project.

Technically, according to the principle that humans cannot be objects of commerce in Quebec, a person cannot be paid for their participation in an experiment. The amount received is therefore compensation for the “expenses” and the “stress” that was suffered.

It is true that certain pharmaceutical companies give amounts that seem higher. However, these studies often require the volunteers (mostly people in good health) to stay on site for a few days and nights. They may also undergo unpleasant things like blood tests and inconveniences that interrupt their sleep.