Relink

In Round 4, the cap is $250K.  If the budget is over this amount, the proposal will be rejected and returned to the applicant.  The expected range is $20–250K with an average grant size of $100–120K.

There is not.  The advisory board discussed this and agreed that any indirect cost would be acceptable with the understanding that the project cost per individual accounts for 60% of selection criteria.

The number of grants awarded will depend on the proposals. 

Neither. It can span over a calendar or fiscal year.

You can add indirect costs for admin.  That said, a higher the total cost could increase your Cost per Individual which accounts for a significant amount of the weighting system used to select proposals.

It is not forbidden but we do not recommend anything that will drive up your costs because your proposal will be judged relative to the other applicants. Thus, if another group can link the same number of people to care at a lower cost than your group, then their application will be selected over yours. Feel free to include these costs if you can maintain an efficient program.

No. The grant does not cover direct medical expenses related to screening or treatment. It is focused exclusively on finding already diagnosed individuals (who were lost to follow up and so remain untreated), in order to relink them to care, i.e., connecting them to a physician with whom they can review treatment options.

Yes, more than one investigator may be included. There is no limit to the number of co-PIs as long as they also have tax-exempt/??non-profit status. The budget sheet does have empty grey rows that allows applicants to add other personnel. What is listed is suggestions only.

As long as they meet the Inclusion Criteria (Eligible State, Tax Exempt, Non-Profit, Healthcare Institution etc.), yes. For Round 4, we strongly encourage you to partner with State Health Agencies.

Yes.

Yes.

Whoever we can contact to talk about the program/?progress with. They do not have to be clinical leads.

You can use any data management system you have access to. However, for aggregate analyses, we will use REDCap so we ask that you plan to send us data in a format that can be imported to REDCap (e.g., Excel)

Yes. Mt Sinai will provide the template free of charge, but you’re welcome to use your own if you prefer.

In the absence of better information, we will use the Mt Sinai protocol.

Grants can only be awarded to one organization so there needs to be a lead organization or PI, with the other agreeing to the terms agreed to by the first. We do not require separate DUAs unless your institutions require them.

Gilead is not a third-party sponsor for the grant and will not have access to any data/results that comes from this work other than what will be available in the public domain (peer review publications and/or posters and presentations). In addition, Gilead will not review any of the data.

We define linked to care as the patient seeing a physician with whom they can review treatment options. We define setting, as the different locations where HBV or HCV-infected individuals can access or be referred to care. This includes clinics, hospitals, emergency rooms, prisons, opioid substitution centers or a community setting like immigration centers or homeless shelters.

“DBU” stands for diagnosed but untreated.

You do not need IRB approval to qualify for a Relink grant. We do, however, recommend that you follow your organization’s policies about publishing data which might include getting IRB approval.

See two reference papers, Doyle and Rowan for examples on how two studies circumvented IRB approval requirements. It is also possible to start the program without an IRB and obtain one if needed during the process.

Yes. The Relink grant is for both HBV and HCV, so you can focus on either one.