Page 29 - Terminology-Clinical-Research

participant’s questions about the research. All the important Institution (research): An institution dedicated to
information about the study must also be given to the conducting research.
potential participant in a written document that is clear
and easy to understand. The informed consent document Institution (secondary): An Institution to which funds are
is reviewed and approved by the human subjects review transferred from a Primary Institution. It may be an Eligible
board before the document is given to potential participants. Institution or Non-eligible Institution.
Generally, a person must sign an informed consent Institutions: The universities, hospitals, colleges, research
document to enroll in a clinical study.
institutes, centres and other organizations eligible to receive
Inspection: The act by a regulatory authority(ies) of and manage grant funds on behalf of CIHR and Nominated
conducting an official review of documents, facilities, Principal Applicants.
records, and any other resources that are deemed by the Institutional Review Board (IRB): A committee of
authority(ies) to be related to the clinical trial and that may physicians, statisticians, researchers, community advocates,
be located at the site of the trial, at the sponsor’s and/or
contract research organization’s (CRO’s) facilities, or at and others that ensures that a clinical trial is ethical
other establishments deemed appropriate by the regulatory and that the rights of study participants are protected.
Every institution that conducts or supports biomedical or
authority(ies).
behavioral research involving human participants must,
Institution (academic): An institution: 1. Dedicated to by federal regulation, have an IRB that approves and
education and research; and 2. which grants academic periodically reviews the research in order to protect the
degrees. rights of human participants.

Institution (CIHR eligible): An institution which: 1. meets Instrument: A means to capture data (e.g., questionnaire,
the requirements for eligibility to receive funding set out in diary) plus all the information and documentation that
guidelines issued by CIHR; 2. has signed a Memorandum supports its use. Note: Generally, instruments include
of Understanding on Roles and Responsibilities in the clearly defined methods and instructions for administration
Management of Federal Grants and Awards; 3. has a CIHR or responding, a standard format for data collection, and
Common Grant and Award Account; 4. continues to comply well-documented methods for scoring, analysis, and
with the requirements of holding a CIHR Common Grant interpretation of results.
and Award Account; 5. has a process in place to conform to Intellectual property: All materials, concepts, know-how,
applicable regulatory requirements, legislation as well as
national and international ethics guidelines. formulae, inventions, improvements, industrial designs,
processes, patterns, machines, manufactures, compositions
Institution (medical): Any public or private entity or of matter, compilations of information, patents and patent
agency or medical or dental facility where clinical trials are applications, copyrights, trade secrets, technology, technical
conducted. information, software, prototypes and specifications,
including any rights to apply for protections under statutory
Institution (non-eligible): An Institution other than a proceedings available for those purposes, provided they are
CIHR Eligible Institution. capable of protection at law.

Institution (paid): Is a CIHR eligible institution that will Intent-to-treat: The principle that asserts that the effect
administer the project funds. In the case of an institution of a treatment policy can be best assessed by evaluating
or organization that is not a CIHR eligible institution, the basis of the intention to treat a subject (i.e., the planned
the institution or organization that the Nominated treatment regimen) rather than the actual treatment given.
Principal Applicant proposes will administer the project Note: This has the consequence that subjects allocated to
funds, should he/she be successful. This institution or a treatment group should be followed up, assessed, and
organization will have a maximum of one year, from the analyzed as members of that group irrespective of their
date of notification of decision to the Nominated Principal compliance with the planned course of treatment. The
Applicant, to become a CIHR eligible institution; otherwise principle is intended to prevent bias caused by loss of
the pending grant may be cancelled. participants that may reflect non-adherence to the protocol
and disrupt baseline equivalence established by random
Institution (primary): An Eligible Institution in direct assignment.
receipt of Grant funds which it transfers to a Secondary
Institution in order to facilitate research collaboration. Interaction (qualitative and quantitative): The situation

TERMINOLOGY CLINICAL RESEARCH 29