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Submitting Protocols with
Special Populations/Concerns
Special Population: Individuals
with Compromised Mental/Communication Capacity
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more information about:
Consent / Assent Issues
- Two crucial issues when a researcher wishes to collect data
from cognitively challenged participants are (a) legal consent and (b) communication about the research
with the participant.
- It is the researcher's responsibility to determine if the participant
themselves can legally
consent. If not, it is the researcher's responsibility to find out who
can
legally consent, and seek that person’s signed consent.
- Regardless of whether the participants may legally
consent for themselves, if it is judged that the
participant is capable of understanding what is being asked of them,
then it is the researcher's responsibility to make a
consent/assent
process that will be optimally understood by the
participant.
- As
with any consent/assent process, the protocol must detail how all
efforts will
be made to have the participant understand who the experimenter is and how they can withdraw their consent if desired.
- Also, in cases of those who are
communicatively challenged, the protocol needs to detail how
the researcher
will determine that the participan wants to stop
participating. The researcher may, for example, include consulting with the participants' regular caregivers
on how
the participant might express when they wish to withdraw from an activity.
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Safety issues
- Some special populations may
pose a risk to themselves,
those around them, or those working on the study. This is especially true of violent or self-injurious individuals.
- It is quite important
that
the protocol describe the experience and credentials of those working
with the
population, so that the IRB can judge if the study will be carried out
by those who have the skills to minimize the risk of injury, and to respond effectively to potentially harmful events.
- There are also certain
behavioral interventions with
mentally challenged violent individuals where the researchers
must first determine what is rewarding unwanted behavior (commonly called
functional analysis). If this unwanted behavior is violent to
the self or others, the protocol must include details
about how the functional analysis will be set up so to decrease risk of
injury, when functional analysis will be stopped, and when/how
intervention will take place to
stop self harm or harm of others.
- All of this information should also be included in consent documents if the participants to the legal guardian.
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