Tuesday, September 17, 2013

Clinical Research Oriented Workshop (CROW) Meeting: September 12, 2013

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

2.                  Next Workshop Meeting(s): Thursdays, 11:45 a.m. – 1:15 p.m., at Given Courtyard South Level 4.   
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

Recorder: Connie van Eeghen

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