Post on 03-Jan-2016
description
Funding was provided through a Community Engagement Supplement to the Oregon Clinical and Translational Research Institute at Oregon Health & Science University (National Institute of Health/NCRR/NCATS grants UL1TR000128 and
ACTRI0601).
What did you say you would do?◦ Research Proposal◦ Target participants◦ Budget◦ Data analysis
Do you have an appropriate team?
Prepare the IRB application (and get approval)
Do the work…◦ Data collection◦ Data analysis◦ Dissemination and next steps
Review the “BIG picture”◦ Research question◦ Study aims and hypotheses◦ Method/approach (including timeline and team)
Refine the details (5Ws/1H)◦ Who◦ What? ◦ When?◦ Where? ◦ Why?◦ How?
The budget always informs what you can ACTUALLY do
Create a roadmap for the study◦ Method/approach◦ Participants◦ Data collection◦ Data analysis◦ Timeline
Ask what, who, where, when, how, and why for every procedure listed in the protocol.
Do you have contingency plans if things don’t go as planned? Do you have a timeline buffer – just in case?
Do you have access to the right participants?◦ How many participants? ◦ Is the participant pool representative of your population?◦ How will they be recruited?◦ What happens if participants drop out? Will you replace
them?◦ Is the proposed enrollment timeframe realistic?◦ Will you need an interpreter?◦ Are vulnerable populations involved?
Will participants receive payment? ◦ If yes, when and how?
Name Date of birth Date of clinic admission Address Social Security number Medical record number Telephone number Email address Full face photographs Health insurance beneficiary numbers Vehicle identifiers Device identifiers and serial numbers IP addresses
Paper questionnaires/surveys Computer monitors Filing cabinets Documents on a desk Phone screens Data storage devices
Staffing is essential to project success (and your sanity)
Now that you have a plan, do you have an adequate team?
Study staff roles:◦ Principal Investigator◦ Co-Investigator◦ Project Manager◦ Research Assistants◦ Statistician◦ Students? Volunteers?
Make sure the study team reads and understands the research proposal.
Provide and document training required by your IRB.
Protocol
Lay Language Summary
All forms are ready for review◦ Data collection forms, surveys, interview guides◦ Recruitment methods (ads, flyers, verbal) etc.◦ Consent Forms or information sheets
Study team is trained in procedures and have completed any IRB required training
“Academic” “Community/Popular”
Manuscripts in peer reviewed journals
Regional and national conferences
Newspapers Blogs Presentations to
community groups (rotary, school board)
Policy Groups (i.e., community report cards, briefings)
This is often a collaborative process in CBPR!