Clinical Research Oriented Workshop (CROW) Meeting: Feb 5, 2010

Present: Kairn Kelley, Amanda Kennedy, Rodger Kessler, Ben Littenberg, Charlie MacLean, Connie van Eeghen
Absent: Matt Bovee, Abby Crocker, Kim Dittus, Liz Chen, Maria Ramos, Alan Rubin

1. Start up: IRB proposal review day; NOTE NEW TIME NEXT WEEK: 10 – 11 on 2/12

2. Roundtable, with update, short term goals, long term goals

a. Connie: Review of Common Protocol Cover Form and Human Subjects Research Protocol for second study. Key points:
i. Criteria for an expedited review, rather than a waived review, likely includes data collection of subject names and dates of birth. The subjects are not patients, so protections around PHI are not necessary.
ii. This study is not multi-institutional. The fact that the graduate program is at UNC is not relevant to the study.
iii. Key personnel include anyone that might be asked to help review the data. It’s polite to ask them first.
iv. Err on the high side in terms of estimating the number of subjects and the length of time of the study.
v. Answer questions literally – what they say, not what you think they say or should say. Do not provide more information than is asked; keep it on point.
vi. Write simply; this is not the research proposal nor its write up
b. Rodger: Does the card study qualify as multi-institutional? No, it’s all under one institution, with low risk to participants. FAHC site includes Aesculapius, which is not considered a separate site. Expect a response to take 4-6 weeks for an expedited review.
c. Ben: Updates/suggestions:
i. Proposed that the Workshop start a book club with “Checklist Manifesto.” Participation requires at least one comment/observation about the assigned section of the reading.
ii. Welcome new CTS student: Helen Smith (Debi to add to PRIMO list)

3. Next Fellows Meeting(s): Feb 5, 2010 from 10:00 – 11:00 a.m., at Given Courtyard Level 4
a. Feb 12: Kim update (no Matt, Rodger or Kairn)
b. Feb 19: Peter Callas on data entry of results; (no Connie, Matt)
c. Feb 26: cancel – winter holiday
d. Mar 5: Book club starts: Ben to assign first section of “the Checklist Manifesto”; Workshop self-assessment (students and faculty scholars only) (no Rodger)
e. Mar 12: Kim Luebbers; book club
f. Mar 19: Book club
g. Mar 26: Book club
h. Future agenda to consider:
i. Skype demo: Connie & Matt? Wait until Amanda K is back. Or do twice?
ii. Future: Review of different types of journal articles (lit review, case study, original article, letter to editor…), when each is appropriate, tips on planning/writing (Abby)
iii. Future: Informed consent QI: Connie to follow up with Nancy Stalnaker, Alan Rubin will follow up with Alan Wortheimer or Rob McCauly

4. Fellows document – nothing new this time
Recorder: Connie van Eeghen