Would your Institutional Review Board (IRB) cede authority to our IRB? Does Tufts participate in SMART IRB?
THIS-WIC will lead the IRB approval process, and will submit protocols to the Tufts Institutional IRB, which will oversee all research and evaluation involving human subjects. Should grantees have their own IRBs/research review processes, THIS-WIC will work collaboratively with them to complete the review and approval process. Tufts University does participate in SMART IRB.
How will the publication process work?
THIS-WIC will prepare abstracts for scientific and practitioner-oriented meetings and publish peer-reviewed manuscripts related to findings. SAs can collaborate with THIS-WIC to develop these abstracts and manuscripts if desired. THIS-WIC will work with each grantee to establish guidelines for authorship.
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?
THIS-WIC team will work with funded SAs to finalize the evaluation design. If a SA selected an evaluation design including a random site-selection assignment, the goal would be to have local agencies/clinics commit to participating and the agreed-upon design before randomization assignments are made.
Are non-RCTs really an accepted method for these grants?
While THIS-WIC encourages applications to strongly consider RCT designs, non-RCTs are an accepted method. The goal is to balance rigor with feasibility. An applicant’s evaluation strategy will inform THIS-WIC about evaluation designs applicants would be willing to implement as well as potential challenges applicants might encounter in implementing the proposed evaluation. Applicants will be asked to consider and explain whether they can:
- implement the proposed intervention in a randomized (i.e., coin toss) fashion, by randomly assigning WIC participants or sites (i.e., local agencies or clinics) to receive either the telehealth intervention or usual care OR
- implement the proposed intervention using treatment and comparison groups (i.e., not randomized)
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?
When creating their evaluation strategy, applicants should have in mind outcomes of interest for the proposed telehealth intervention. The outcomes shown on the Evaluation Outcomes page are required outcomes for each category (process, intermediate, impact and cost) that we anticipate all projects to examine in collaboration with THIS-WIC.
The controlling for confounding variables will depend on the evaluation design. THIS-WIC will lead the process to control for these variables for either design.
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.
THIS-WIC may not need the personally identifiable ID for the survey process (e.g., WIC card number, WIC ID assigned). THIS-WIC will work with funded SAs to establish a system that works for both parties.
What cost data will be collected?
THIS-WIC will finalize the evaluation design with the funded WIC SAs. In general, cost data will be organized by task (i.e., developing the telehealth program) and by time period (i.e., monthly, quarterly) depending on the source; these data will be provided by different stakeholders engaged in the intervention (i.e., SA, local agencies, telehealth intervention contractor). Data may be needed from key stakeholders (e.g. WIC SA, telehealth vendor, etc) to support cost estimates as appropriate per participant, per participant month, or per contact occasion.
For each stakeholder organization, cost documents will be expected to estimate staff time (coded in full-time- equivalent units) and personnel (i.e., managerial, non-managerial personnel) expenditures.
Will you be providing a budget template for all costs you are asking for during proposal implementation?
Yes, funded applicants will be provided with templates to collect cost data.
In reviewing the RFP, I did not see any discussion of indirect costs, and the limitations of the indirect cost estimates.
Information around indirect costs can found in the full proposal template example starting on p. 9. All applicant organizations, including any sub-grantees as part of a consortium application, should request indirect costs in accordance with a current approved federally negotiated indirect cost rate agreement (NICRA). Applicant organizations, including sub-grantees as part of a consortium application, that do not have an approved NICRA are limited to a 10% de minimus indirect cost rate. In the case of consortium applications with sub-grantees, a detailed budget should be submitted for each proposed sub-grantee in addition to the overall application budget.
Please reach out to the THIS-WIC Financial Coordinator, Jessica Coté, CRA, for any financial related questions: Jessica.Cote@tufts.edu
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.
We will work with each WIC SA to determine which personnel should be listed on each IRB protocol application and their role in the project. The type of IRB protocol application to be submitted will be determined once the evaluation design has been finalized between THIS-WIC and the grantee. THIS-WIC will work with funded SAs to establish a system that works for both parties.
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?
Existing literature on telehealth and the WIC program can be found on the THIS-WIC website under the Resources tab. The purpose of this funding opportunity is to help establish a more robust evidence base.
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.
THIS-WIC wants potential applicants to identify study designs that are important and feasible for their local agencies, staff, and participants. The sample size will depend on factors such as if you’re submitting a proposal to priority area 1 or priority area 2.
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?
We have purposefully designed a collaborative evaluation process to support WIC SAs. THIS-WIC is open to any study design that is feasible, realistic, and rigorous for applicants to implement. For cluster-randomized designs, THIS-WIC recognizes that cluster-randomized designs may have smaller effective sample sizes (lower statistical power) compared to individual-level-randomized designs. Yet, for practical implementation reasons, such as difficulty or cost in having people within the same clinic get different delivery methods, some applicants may nonetheless choose cluster-randomized designs.
What are you anticipating for loss to follow up? Build-in 50%?
THIS-WIC will work with funded applicants to anticipate loss to follow up in the final evaluation design phase. Meanwhile, applicants should use their best judgment based on the knowledge of their participant base to make these estimates.
What is the total dollar amount available? How many grants will be funded?
THIS-WIC’s goal is to fund between 5-8 grants. Grants can request up to $1 million in funding for their projects.
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?
The Telehealth Resource Centers is a consortium established to provide assistance, education, and information to organizations and individuals who are actively providing or are interested in providing care at a distance. Because they are federally funded, the assistance they provide is generally free of charge. Any WIC SA may reach out to their regional TRC regardless of whether your proposal advances to the full proposal phase or not. You can be connected to your regional TRC by filling out this form.
Can budget be used for incentives to encourage participants to agree to the study?
Yes, it is possible to budget for incentives to encourage participation. However, the extent to which the incentive could be considered coercive or unduly induce individuals to participate must be considered, and ultimately addressed in the IRB protocol application as various laws, regulations, and ethical guidelines that govern the conduct of human subjects research may apply.
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?
SAs need to identify the complex nutrition and/or breastfeeding problems/access issues within their WIC participants.
