Would your Institutional Review Board (IRB) cede authority to our IRB? Does Tufts participate in SMART IRB?
How will the publication process work?
If the state were to choose a random site-selection assignment, can sites opt-out? How would you account for the critical difference between sites or individuals who opt-in vs opt-out?
Are non-RCTs really an accepted method for these grants?
Will you also control for confounding variables for impact outcomes? I would think it’d be hard to attribute an outcome like breastfeeding rates to this intervention?
I assume you’ll need Personal Identifier Information from the administration data to link to the survey data? WIC ID is considered an identifier by our IRB.
What cost data will be collected?
Will you be providing a budget template for all costs you are asking for during proposal implementation?
In reviewing the RFP, I did not see any discussion of indirect costs, and the limitations of the indirect cost estimates.
If we go through our IRB, what do we list you as? Co-PI’s? Are you thinking you’ll put this in on your end as “exempt” in that you’ll receive data that is already existing and deidentified by us? Also, anticipating that it may be a problem to release contact information from our participants to you for you to do surveys or interviews.
What evidence is there in the existing literature that there would be significant differences in an outcome such as fruit and vegetable intake from telehealth vs. usual care?
Are you looking for, or expecting, a certain size of participants—the “n”? There are small and large interventions we can devise, but sometimes smaller is better (a pilot) to start, but we don’t want to reduce our chances of funding if our sample isn’t large enough.
If the clinic is the unit of randomization, that will be a cluster RCT, with a complex sample size calculation, analyses, etc. Is this the design you’re hoping for and what realities of most State Agencies to pull that off?
What are you anticipating for loss to follow up? Build-in 50%?
What is the total dollar amount available? How many grants will be funded?
What if I don’t make it past the brief proposal phase of the process? Who can help my state agency look further into implementing telehealth solutions?
Can budget be used for incentives to encourage participants to agree to the study?
Can you explain what you’re looking for in the brief proposal for the following question: Explain the complex problems among WIC participants that limit their access or use of WIC services and/or require qualified professionals at the SA level?