Important Information for Healthy Volunteers/Patients and links
If you would like to participate in a clinical trial, either as a patient with an existing condition, or a healthy volunteer, then the following information and links will be of use.
Informed Consent
The first time that you go to a research site to learn about a trial, the research team will go over an 'informed consent' form with you in detail. They will make sure that you understand everything about the trial, including any possible risks and the possible benefits. Providing you are happy with the contents and wish to participate, you will be then asked to sign your agreement to enrol.
Your informed consent document should include and cover the following:
1. About the research
A statement that the study involves research.
An explanation of the purpose of the research.
The expected length of participation in the research.
A description of the research procedures [lab tests, physical examinations, other procedures].
Identification of any procedures that are experimental.
2. The potential risks involved
A description of risks/discomforts to the participant.
3. And possibly benefits
A description of possible benefits to you or to others.
4. There may be alternatives to participating in this trial
A description of other procedures/treatments that are options for you if you decide not to participate in the trial.
5. Your research record is confidential
A description of how your confidentiality will be protected.
6. You may get paid
A description of any compensation.
An explanation of who covers expenses if you are injured in the trial.
7. If you have questions, ASK
Contact information for questions about the trial and about your rights as a trial participant.
8. The decision to participate is yours
Your participation is voluntary.
If you do not wish to participate, there is no penalty, and you will not lose benefits at the site.
You may withdraw from the study at any time.
You can leave a clinical trial at anytime
If at any stage of participating in a clinical trial you do not feel comfortable or wish to leave for whatever reason, then you may do so freely.
Clinical Trial Terms
As you review the informed consent form, you may come across some of these terms:
Inclusion and Exclusion Criteria
Inclusion and exclusion criteria are the rules that say who is allowed to join a trial. The rules are different for every trial.
Inclusion criteria are characteristics you must have to participate in the trial. Some examples of inclusion criteria are:
- Male or female specific
- Willing and able to sign informed consent form
- Above or below a certain age
- Within a healthy weight range
Exclusion criteria are characteristics that you must not have in order to participate in the trial. Some examples of exclusion criteria are:
- Women who are pregnant or breastfeeding
- Any vaccination within the past month
Inclusion and exclusion criteria are also used to protect people in trials. For example, if a medication is known to cause liver problems, people with damaged livers will not be allowed to participate in the trial.
Placebos
A placebo is a substance that looks like a trial medication but does not contain active drug. The placebo is a pill if the trial medication is a pill, and it is a shot if the trial medication is a shot.
Placebos may seem unfair or unethical. Placebos are used to help determine if an experimental medication works. Some people get the medication, other people get placebo, and the results are compared. That way, researchers can see if the medication being studied really works. Placebos are used if there is no approved drug to use for comparison.