To bring you up to speed, the use of OnCore is School of Medicine policy on all studies with human subjects. It’s canon. We need to see that you’ve accounted for this in your submissions. The use of OnCore is mandated to help track human subjects populations here at Wayne State and, until recently, OnCore fees were to be budgeted into all studies with human subjects. While a good portion of budgets still need to reflect this, the mandate has been altered slightly.
Going forward, investigators applying for funding from non-corporate (i.e., federal and foundation) sources no longer need to include OnCore fees in their budget. They DO, however, need to ensure that their protocol and human subjects populations are registered in the OnCore database at time of award. Please note that proposals and contracts with corporate entities (i.e. pharmaceuticals, biomarkers, and devices) that exceed $50,000 in total direct costs WILL still need to include OnCore fees in their budgets. For all funded studies (corporate and non-corporate) that wish to use OnCore as their Clinical Research Management tool, respective OnCore fees will apply.
This should bring some relief to federal and foundational proposal budgets that are often subject to caps. To reiterate, however: your human subjects populations must still be registered with OnCore (this includes non-clinical trial populations). Please be sure to contact the Clinical Research Services Center (CRSC) for assistance in registering your population, or for questions regarding study management capabilities.
May your June submissions be fruitful!
School of Medicine-level review in the proposal queue has been around for a while now, but long cycles of funding can prevent even the most well-funded among us from subjection to our scrutiny. And, as in all protocols sponsor-related, new compliance elements are being added all the time. Here’s a quick-reference guide on what we’re looking for, and why:
- The full proposal. We have to see what is going to the agency, even if internal budgets are provided. This way, we can say “yes, we knew that this is what Dr. X communicated to the sponsor, and we can support that with necessary School of Medicine resources.” If you are using the system-to-system submission feature through Evisions, your full proposal is already included! If your proposal needs to be submitted by other means (such a sponsor website), use the “Print to PDF” or similar feature to save a copy of the proposal, and upload the PDF to the “Attachments” section of the Evisions record.
- For subcontracts: if WSU is the subcontractor, we don’t need the prime proposal, but we do need the letter of intent to subcontract, and the supporting documents that are being submitted to the prime recipient institution.
- Your internal budget. If you are doing a detailed budget on a system-to-system submission, you’re probably covered. If, however, you are submitting a budget overview or a modular proposal, we need to verify that the funds requested are commensurate with planned funding. This also helps us check for cost share.
- Cost share commitment forms. Speaking of cost share, any cost share commitment forms must be uploaded to the “Attachments” section of the Evisions record. If there is a cash match commitment in the proposal, there must be evidence of the agreement of the match source uploaded. In addition to the uploaded forms, choose “YES” on the Evisions “Proposal Budget” page as the answer to “Cost Sharing.” This will reveal the ability to enter cost share information, such as department and index, so that the cost sharing department can verify their commitment to the cost share.
- For over-the-cap: In pre-award, we do not require a fully-executed cost share commitment form for the amounts over-the-cap (no Dean signature, no Fiscal Affairs signature) but we do require a department signature for awareness documentation. Please also provide the index that will fund the cost share. Note: over-the-cap cost share is considered “Voluntary.”
- OnCore accountability, or waiver: If you have human subjects, you have to either include OnCore fees in your budget, show how you will be cost sharing the fees, or upload a waiver to “Proposal Attachments.” Waivers are obtained from the Clinical Research Service Center, whether your project is clinical or not. Unfamiliar with the policy? Check out the handbook!
- Correct coding. Evisions coding is super important! The data that is input at this phase is the basis for a whole host of reporting that affects such things as department rankings and investigator credit. To be sure that you are getting full and accurate credit for the submission, be sure the “General Information” is input correctly; take a look at our coding table for guidance, or ask us if you’re not sure.
- Investigator credit: This is done on the “Personnel Roster” page of the Evisions record. If your investigator has a retreat to more than one department, s/he will have to be listed twice (or as many times as s/he has appointments) and the credit split proportionally between departments. Confused? Give us a shout.
Most of what we need to see is what your GCO also needs, with a few additions and for different reasons. We’re not here to duplicate SPA review; we’re here to ensure the School of Medicine can support your project in a compliant way. Remember: it’s extremely important to route your proposal before submission! This way, every source of manpower and resources on your project is aware and on board. The result? Fewer headaches at award time, and more credit where credit is due.
Check your budgets, folks! The Office of Personnel Management has released increased executive level compensations caps effective January 7, 2018.
- Your new salary cap: $189,600.
If you are awarded with a budget that did not included the new cap, you’re welcome to rebudget using the new cap within the limitations of the award, but no new funds will be given by the agency. If you’re submitting for the March 16 NIH deadline (hello out there, R03/R21 resubmissions and renewals!) now is a great time to revise those budgets and any associated cost sharing.
Happy Halloween from RAS!
- Freeman M. J Epidemiol Community Health. 2006 Jan; 60(1): 6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2465539/
As the October deadline for new R03s rapidly approaches, heed this friendly reminder to ensure that the institute/center to which you are applying does, in fact, accept the Parent R03 application. Over the nine months or so, many institutes have decided not to participate in the R03 program. Some have decided to chuck it altogether, and some have sidelined it in favor of their own, specific announcements. Here are the institutes that DO still participate in PA-16-162:
Here are the institutes that DO NOT participate in PA-16-162, but do have their own, specific FOAs:
For more information, pop on over to the NIH R03 page. If you’ve already started an application for the Parent R03 (PA-16-162) in Cayuse but your institute has its own announcement, take a moment to review the instructions on how to copy or transform a proposal to the correct announcement. If you’re stuck and you’re not sure how to proceed, give us a shout; we’re here to help.
We’re all clear that Forms-D are being retired in favor of the new, improved Forms-E, right? Right. Forms-E must be used for due dates on or after January 25, 2018. We’re all on the same page here. This is old news.
BUT WAIT, THERE’S MORE! As of December 31, 2017, downloadable Forms packages will no longer be available. You read that correctly: downloadable application packages are no longer a thing (don’t say we didn’t warn you). Your only options for submission after December 31, 2017 are: system-to-system submissions (our Evisions, for example), ASSIST (your life will be easier if you just do Evisions, but OK), or Workspace (just… don’t).
Do yourself a favor: if you haven’t transitioned Evisions yet, do it now and get used to it for your upcoming (likely October) deadlines. If you need help, we at RAS are happy to walk you through your application (and Tim Foley in SPA offers training on Evisions as well, if you don’t have a specific application yet).
If you came here looking for ways to get your hands on some delicious mini-burgers, this post is not for you.
If, however, you’re looking for a way to simplify unallowable cost determination under the Super Circular, rejoice! Cost-allocation software company CostTree is giving away handy pocket sliders to aid you in your cost determination quests (and if you’re not into print materials, they have a digital version, too).
To get yours, head on over to the CostTree request site and input your vitals. It’s helpful, it’s nice-looking, and it’s free for the low, low cost of being added to a mailing list. Happy allocating!
In a department, administrators and PIs have a lot of room to negotiate with other institutions when it comes to budgets involving awards and subcontracts. Personnel effort? That’s a classic. Materials and supplies? Probably your first stop. Indirect cost percentage? Slow your roll, holmes.
If the project is federally-sponsored, chances are slim that you’ll be successful in your quest F&A reduction below our negotiated 54%*. There are times when a lower F&A rate is acceptable without waiver/permission; for instance, the funding opportunity announcement caps the rate at lower than our negotiated rate, or the award is being transferred from another entity with direct cost equivalency. Anything else requires a waiver with approval from the Vice Dean and SPA. You cannot negotiate a reduced F&A on your own.
Here at Wayne State, the waiver request process begins with an IDC Waiver form. The Research Administrator and the PI should initiate the request, and it must be approved by the PI, the department chair, and the Vice Dean for Research before being sent for approval to SPA. The Vice Dean for Research will consider requests for Indirect (F&A) cost waivers in very limited circumstances, so be sure your justification is sound. Here are some examples that may be considered on a case-by-case basis:
- Capped awards
- Seed grants which may attract larger awards
- Only available source of funds in an area
- Strategic partnerships
- Awards which include equipment or building funds
If you’re just trying to make a proposal look more competitive, or the PI/department failed to submit the proposal via approved institutional channels (e.g., through the Vice Dean or SPA) prior to submission to the sponsor, you’re out of luck. Wayne State’s acceptance of an award with an unapproved F&A reduction does not constitute acceptance of the rate. If you are awarded with a reduced F&A that was not properly approved, you must renegotiate at the time of award, otherwise the department will be responsible for cost-sharing the portion of the F&A not paid by the sponsor.
Questions? You know where to find us!
* 54% is our federally-negotiated rate at the time of this post.
Cost sharing is the art of dedicating effort to a project and getting someone else to pay for it (usually the University). It’s nuanced. It’s subtle. It can drive you crazy.
A true cost share is one in which the effort dedicated is not entirely paid for by the project, usually to alleviate a budget. In order to save you some time, please know that it is very, very rare that these types of cost shares are getting approved nowadays if general funds is involved, here at the med school. Over-the-cap cost share, of course, is picked up as a matter of policy; these are those situations in which grant personnel make a higher salary than the agency cap ($187,000 as of this post, for most federal agencies) and Wayne State needs to pick up the difference. If you’re looking for how to do those calculations, check out our post from February 26, 2014 (note that the salary cap has been raised since then).
In order to help your cost share experience go as smoothly as possible, here are some general questions and answers to help you figure out your next move:
- Is this cost share request solely for over-the-cap charges?
- If your answer is yes, you do not need chair and dean signatures in the pre-award phase, only just-in-time. You do, however, need to make the calculations and note the amount and index in Evisions/SP. We have a brief tutorial on that, too.
- If your answer is no, you need a fully-executed cost share form.
- Who needs to sign the cost share form in order to be considered “fully executed?” The cost share for must be signed by the chair of the department of the cost share request, School of Medicine Fiscal Affairs, and the School of Medicine Vice Dean for Research, in that order.
- There are instances where a business official may sign in the place of the department chair. In order for a business official to proxy for a chair, the Office of the Vice Dean for Research must have a memo on file granting this proxy. This memo must have an end date (so it remains reviewable and renewable in turnover phases), and must specifically mention cost share signatory authority. These memos can be filed with our office.
- What percentage goes in the “Effort %” box on the form? The title of this box is misleading; this is actually a space for the percentage of the investigator’s salary that will be cost shared. You can clarify the percent effort dedicated to the grant in the comments box. For instance: if an investigator has a salary of $250,000 per year and will dedicated 10% effort to a project, the percentage of her salary to be cost shared is: [($250,000-$187,000)/$250,000]*10%, or about 2.5%. That is the number that will go in the box on the form.
To help illustrate these principles, we’ve provided a few examples of redacted, approved cost share forms from our friends in Fiscal Affairs. We also have our handy over-the-cap calculator to help save you same time. As always, please feel free to contact us for guidance. Happy calculating!
“We’ve always done it that way.”
“That’s just the way we do it.”
“I don’t know what they want to see.”
“I don’t know who to ask.”
In an effort to have a jumping-off point for policy compliance, we at RAS have compiled a digital, (hopefully) handy School of Medicine Policy Handbook. Some policies originate in the SoM, some are University-wide, all affect award submission and management. The Policy Handbook is not exhaustive (we’ll keep adding and updating), but it’s a great place to start when crafting your award strategies (and figuring why, in fact, “that’s just the way we do it”). Let us know if you have questions!