SOCRA 2024 Annual Conference Program Book - Flipbook - Page 64
https://www.hhs.gov/ohrp/education‐and‐outreach/human‐
research‐protection‐training/participant‐centered‐informed‐consent‐
training/index.html
Taking Respect for Persons Seriously Builds Trust, cont’d
New Informed Consent Requirements:
• Information that a reasonable
person would want to have in order
to make an informed decision
about participation
• Information presented in sufficient
detail and organized and
presented in a way that facilitates
understanding of why one might
or might not want to participate
Overview of OHRP Participant-Centered Informed Consent Training
Also accessible and available as part of CITI Training Program
Pay attention to
who needs the information,
what information, and
how they could best understand
the information to make meaningful
decisions
46.116(a)(4) & §46.116(a)(5)(ii)
Communicate effectively and with intention!
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Think: What is it that you need
to convey (and how) that would
be helpful for the person to
decide about participation?
Organize and say it concisely!
Neurological
•
Chronic nerve damage
•
Peripheral nerve damage
•
Psychological intolerance (fear of loss of LAP monitoring function)
•
Stroke/transient ischemic attack
•
Subdural, epidural hematoma
Cardiac
•
Acute coronary syndrome (sudden worsening of chest pain,
heaviness or pressure)
•
Arrhythmias (irregular heart rhythm)
•
Acceleration of arrhythmia (make irregular heart rhythm go faster)
•
Atrial septal defect (hole in the tissue between upper chambers of
the heart)
•
Cardiac arrest
•
Cardiac perforation
•
Cardiac tamponade
•
Damage to heart valves
•
Emergency heart surgery
•
Emergency vascular surgery
•
Low cardiac output state
•
Heart block
•
Hypotension
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Information Does Not All Have Equal Weight or Relevance
• Risk is an estimation based on “seriousness” and “likelihood”
More serious has more weight
More likely is more relevant
Providing a detailed list of isolated facts
Facilitating understanding
• Certain types of studies have certain characteristics of
unique interest to potential participants, for example,
Phase 1 drug study examining safety:
No health benefit to participant
What is known about its safety, especially in humans if at all
Uncertainties about risks exist
What safety measures are in place to monitor and minimize
potential risks to participants
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