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Definition
When a study protocol uses deception or partial disclosure,
(Misleading or misinforming people of the nature, objectives or
consequences of research must always be explained and justified.
The use of deception or partial disclosure is unethical when:
§ it conceals information about the risks of a study that could affect
a participant's decision to become involved
§ it is not necessary because another non-deceptive methodology
could satisfy the research goal
§ it is not adequately explained or justified
,§ it is not mitigated by an explicit debriefing procedure included in
the study protocol)
participants must be debriefed once their involvement in the study
has ended. Depending upon the complexity of the study this may be
done verbally or with the provision of a written explanation. A
debriefing should include:
§ clear statement of the research question
§ disclosure of any deception involved in the study and the rationale
for its use
§ explanation of how the participants' data will be used to seek an
answer to the question
§ opportunity for participants to ask questions and/or seek
clarification
contact information for the researcher and the REB that approved
the study
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Informed (principles of consent) Scholarly review
Debriefing (when required)
Individual medical emergencies
(The Consent Process)
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Definition
,-When an emergency situation presents extraordinary risks to the
general public, an authorized public official (e.g. mayor, premier,
prime minister) may declare it a public emergency. The SARS crisis
is one example of a publicly declared emergency. Civil disorder,
environmental disasters, and releases of bio-hazards may also
trigger the declaration of a public emergency.
-An official declaration gives special responsibilities and powers
to authorities to help them deal with the emergency (e.g. the
regulation or prohibition of travel, the establishment of
emergency shelters, orders of evacuation or quarantine). The
exercise of these powers is limited in time and extent by law at the
municipal, provincial, territorial and federal level.
-It has been widely recognized in the wake of recent crises that
institutions need to plan for the review and conduct of research in
the context of a publicly declared emergency. REBs are expected
to uphold the core principles of TCPS 2 with the support of their
institution. Researchers are expected to maintain the highest ethical
standards in any research that must be reviewed and conducted
during a publicly declared emergency.
· Preparedness Plans
· REB Policies and Procedures
· Limiting Requests for Exceptions
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, Research in Publicly Declared Failure to identify data security
Emergencies measures
Deciding on inclusion & exclusion Debriefing (when required) (The
criteria Consent Process)
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Term
Who's In and Who's Out?
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In the design stages of a study, researchers have to decide who to include
and who to exclude in their recruitment of participants. They create a list of
inclusion criteria and a list of exclusion criteria. These criteria are based
upon the research question, the available participant population, and the
goals of the research.
At the review stage, it is the REB's responsibility to examine the research
proposal and determine if the inclusion and exclusion criteria are justified
by the research question in accordance with the core principles of TCPS 2.
• Work station Comparison
• Learning Disability Assessment
• Effects of Frequent Body Scans
In some studies, the quality of the data depends on the participants being
unaware of the true research goal. A consent procedure that is not fully informed
may be allowed as long as the tasks that the participants will be asked to