Assent Form: A written document
that describes all aspects of the research study that would be relevant to a
child’s decision to participate in a research study, written in language that
is appropriate for the intended age of the children being asked to participate.
Clinical Research Trial/Study: Research study that
uses human participants to increase our knowledge in a carefully planned and controlled
way. Clinical trials use humans as participants either directly (survey
questions, blood tests, physical examinations, etc.) or indirectly (a review of
medical records). The term clinical trial and clinical study are
Informed Consent: Voluntary agreement
by a parent or guardian for their child to participate in a research study
after having been informed of all aspects of the research study.
Informed Consent form: A written document
that describes all aspects of the research study that are relevant to their
decision to participate. This includes the reason for the study, how many
people will participate, what is involved (tests, treatment, questionnaires,
etc.) and the timing, the risks and benefits of participating, the alternatives
to participating, the confidentiality, privacy and rights of the participants,
whom to contact for questions, as well as a section for participant signature.
Control Group: A group of
participants in a research study who do not receive the experimental
intervention being studied. Results are determined by comparing the control
group to a group who received the experimental intervention.
Efficacy: How well a treatment or intervention
works in a clinical research study.
Eligibility: The determination of
who can participate in a particular research study based on criteria specific
to each study. Criteria include factors such as age, gender, medical history,
Intervention: The entity or thing
(drug, vaccine, psychological care, diet, device, etc) that is being
Investigator: The person
responsible for the conduct of the clinical research study. If the study is being run by a team of
individuals, then the team leader is referred to as the Principal Investigator.
Participant: Individual who
participates in the research study.
Phase (of a Clinical Trial): Clinical trials
involving new medications are commonly classified into four phases:
- Phase I studies determines whether the medication is
safe in humans. These studies can involve healthy volunteers, as well as
ailing participants. The number of participants is usually very small.
They typically determine the dose or range of doses to use in the phase II
- Phase II studies determine whether the medication
may have any biological activity or efficacy in order to determine if the
medication should continue to be researched. Safety will also continue to
- Phase III studies determine the drug’s efficacy in a
large number of participants. These studies are typically randomized.
- Phase IV studies determine and monitor any of the
medication’s long term effects.
Placebo: An inactive pill, substance, or other
intervention that does not affect the disease or condition being studied. Some
research studies involve a group of participants who receive the experimental
intervention and a group who receive a placebo intervention. Results are
determined by comparing the data from the two groups. Placebos help
investigators determine if the experimental intervention is the cause of
responses exhibited by the participants.
Protocol: A written detailed document that
describes in detail the research study. It includes the scientific basis for
the study, the question being asked in the study, a description of who is
allowed to take part, information about study treatments, the procedures
associated with the study, the possible benefits or risks, and other important
Randomization: Some research studies
randomize participants. This means that the participants are put into a
treatment/intervention group by chance, like flipping a coin or pulling a
number out of a hat. This is used in order to make sure study results are fair.
Research: This is the gathering of data,
information and facts for the advancement of knowledge.
Research Ethics Board (REB): A committee
dedicated to ensuring the rights, safety and well-being of the participants of
a clinical research study. For more information, see (link to REB page).
Side Effect: Any action or effect
of an intervention that is not the intended effect or action of the
intervention. For example, many people take medications to help with allergies,
with the intention of decreasing their stuffy nose, and itchy eyes. However, a
common side effect of allergy medications is drowsiness, as this is not the
intended action/effect of the medication. Typically side effects are negative
effects such as headaches or nausea, but could also be positive.
Study Sponsor: Study
sponsor means an individual, company, institution or organization which takes
responsibility for the initiation, management and/or financing of a clinical
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