Present: Marianne Burke, Kat Cheung, Ahmed Hamed, Kairn
Kelley, Amanda Kennedy, Ben Littenberg, Connie van Eeghen
Start Up: Ben’s experience in setting
up an internal medicine service resulted in desegregating part of St. Louis in
the 1990s – one for the history books.
See the social history: “American Nations” to explain the diversity of
cultures in this country.
1.
Discussion: Kairn
- IRB application
a. Much
of the IRB narrative related to design may (and should) be pulled from the
methods section of the proposal. Detail
is important and should reflect the work as planned, but should be focused on
the questions asked and only at the level of detail that is necessary.
b. In
objectives: brief explanation of the problem
c. Study
design: extract from methods section
d. Procedures:
Use research protocol, if it already exists.
Review with the CVMC Privacy Officer to ensure that the requirements of
the clinical setting will be met.
i.
Consider completing the research protocol, to reduce
the volume of later amendments.
ii.
Steps in the process MUST include consent, and the
education process underlying consent (and the consent form).
iii.
Incentives can be referenced, e.g. “consistent with standard clinical practice, such as a pencil,
an eraser, or a lollipop.”
iv.
Include a plan for dissemination of results to
subjects. For example, share the results
of the hearing sensititivity test with the parents, with appropriate references
for follow up care if needed. Also
include a plan for sharing results with pediatrician (include in the consent
form).
v.
Including a plan for a registry must appear in one of
the objectives of the study and in the consent form. Or, collect the students’ contact information
and address the development of a registry later.
e. Risks
and benefits: there are benefits: each student gets a free hearing sensitivity
test
f. Data
Safety and Monitoring has 2 objectives:
i.
Does there need to be an outside reviewer that will
stop the study in case harm is being done?
No.
ii.
Is there the possibility of unexpected events that
would need to be reported? Yes. “The PI will assess all adverse events and
report them to the IRB”
iii.
Plan for review of adverse events with committee
a. September
19: CANCELLED
b. September
26: Abby (and Sharon Henry?) – practice presentation about VHCURES data base
c. October
3: Abby - Update on Natural History of Opioids projects
d. October
10:
e. October
17: SPECIAL GUEST: Jay Piccirillo is an ENT from Wash U in St Louis who is
expert in prediction models in cancer. He and Ben did a lot of work together
many years ago about how to incorporate functional status measures into cancer
staging to improve prognosis. Now he is working on how to develop personalized
prognosis estimates and share them with patients. A top-notch researcher and collaborator to
meet and talk with. 10:30 – 12:00
f. October
24:
g.
Future agenda to consider:
i.
Peter Callas or other faculty on multi-level modeling
ii.
Charlie MacLean: demonstration of Tableau; or Rodger’s
examples of Prezi
iii.
Journal article: Gomes, 2013, Opioid Dose and MVA in Canada
(Charlie)
iv.
Ben: Tukey chapter reading assignments, or other book
of general interest
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