Clinical Research Oriented Workshop Notes of Dec 4 09

Clinical Research Oriented Workshop (CROW) Meeting: Dec 4, 2009

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

1. Start up: Updates on where we are and what we’re doing next

2. Roundtable, with update, short term goals, long term goals
a. Connie: Spires of Excellence – Public Health Input – resulted in a wide ranging conversation about the strategic purpose of the UVM administration, past processes that were similar, the significance for the CCTS, and the impact on our role as largely independently funded researchers. The outcome is that Connie will submit her letter, primarily as a way of expressing her own interest in public health related research and to share that interest with the community of like-minded researchers and administrative leaders at UVM. (We also talked a lot about how to make the process of sharing our own work, within the CCTS and across UVM, more systematic without killing it with protocols. As with much else about CCTS, this is an unfolding set of answers about this new program.)
b. Connie: AHRQ Informed Consent Toolkit. The toolkit provides advice to:
i. Raise awareness among researchers
ii. Access resources about IC available on the web and through specific agencies
iii. Create mechanisms for change: education – especially around common concerns, advisory councils
iv. Improve the process, addressing:
1. The research culture within an organization
2. The need to train staff
3. Physical environment of consent
4. Plan to promote comprehension: translations, interpreters
5. Process of reading with potential subjects
6. Need for allowing time
7. Verifying understanding through teach-back (process example)
v. The toolkit provides a checklist, a “researcher’s certification tool,” to assist researchers in accomplishing IC. It provides sample forms which conform with regulations re: informed consent and HIPAA.
vi. Suggestions:
1. Use to update educational course materials we currently offer
2. Pass on to IRB for their consideration
3. Explore the possibility of a grant to study our use of IC and the application of ways to improve
vii. Next step: ask Alan Rubin about discussion at a Friday seminar. (He said yes; Connie will follow up with Nancy Stalnaker, Alan will follow up with Alan Wortheimer or Rob McCauly.)

3. Next Fellows Meeting(s): October 23, 2009 from 9:30 – 11:00 a.m., at Given Courtyard Level 4
a. Dec 11: blog seminar (Ben); state and national datasets for secondary data analysis – Abby (no Kim); calendar for next semester (Kairn)
b. Future agenda to consider:
i. Dec 18 (no Connie)
ii. Dec 25: no Workshop
iii. Jan 1: no Workshop
iv. Jan 8: ???
v. Skype demo: Connie & Matt? Wait until Amanda K is back. Or do twice?
vi. 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)
vii. Workshop’s WIP (the history document) – discuss goals and progress, make recommendations, review and modify document, add Fellows’ orientation

4. Fellows document – nothing new this time

Recorder: Connie van Eeghen