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.
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).
How are those January applications coming? Fabulous? Great! Send ’em our way nice and early!
As the holiday closures approach, keep in mind that our office closes with the rest of the University, so we won’t be around to assist between December 23-January 2. We’ll be back at it on January 3, but if you are planning to work on your applications over the holidays, that only leaves one day in the new year before January 9 deadlines. (Remember: the SPA deadline is three business days before the agency deadline; you’ll need to have your application finalized by January 4.) Consider working with us (or your administrator) to get all of the administrative elements together well before the closure (ideally by Tuesday, December 20). This way, you’ll have your holiday break to work on the science if necessary, and we can pick back up where we left off in the new year. And to those of you who are planning to submit in January, will need our help, and haven’t yet reached out: what are you waiting for?!? Please contact us right away so we can accommodate you as best we can!
For departments with internal administration: we’re pretty sure your staff would also appreciate a well-formulated submission plan accounting for the the holiday closure, as well 😉 Happy writing!
The stone-written commandments of NIH proposals have long included, “thou shalt request prior approval when requesting more than $500,000 in direct costs (excluding consortium F&A costs) in any one year of an unsolicited proposal.” As an aside: did you know you’re supposed to request that approval no later than 6 weeks before submission?
Since the inception of this rule in the dark ages of 2002, these requests were required in writing or by telephone. You now have the option of making the request by webform in a new “Prior Approval Module” through eRA Commons (NOT-17-005). Of important note: you must request the form to be “opened” by your Program Officer before it will be accessible. Once it is available, you complete the form and submit. As another aside: the word “option” appears to be used loosely here; it’s along the lines of being volun-told).
The logic behind the Prior Approval Module appears to be subsequent management of such requests. The module allows PIs and GCOs to amend, modify and withdraw previously submitted requests as proposals shape up differently in the days leading to deadlines. The module will appear between the “ASSIST” and “RPPR” tabs on your login screen:
If you have not yet contacted your Program Officer for access to the module, you will receive an error message (“We are sorry, you are not authorized to access this function”). Not sure whether to request the limit stretch, or just not sure what to do next? Drop us a note and we’ll be happy to help you sort through!
Ah, the resubmission. We all want to draw attention to the fact that we understand the concerns of the reviewers and really drive home the fact that the amended application addresses initial concerns (or maybe even did the first time around). It’s hard to assert your strength in writing, but that’s why we have bold! And italics! And underlines! And colors! But not so fast: should you be using these textual tools to identify the changes you have made since a previous submission?
While there is no outright rule against this, the NIH states:
You must include an introduction for all resubmission[s] that:
- summarizes substantial additions, deletions, and changes to the application
> individual changes do not need to be identified within other application attachments (e.g., do not need to bold or italicize changes in Research Strategy)
- responds to the issues and criticism raised in the summary statement
- is one page or less in length, unless specified otherwise in the FOA or is specified differently on our table of page limits.
(Preceding emphasis added, read more at Resubmission Applications.) When you’re crafting your resubmission, keep in mind that the NIH expects corrections to be addressed in the introduction, and not anywhere else. While it is not expressly forbidden, your reviewers may be less annoyed that you not only acknowledged previous concerns, but format direction as well. Happy writing!
Save yourself – and those with whom you collaborate – some valuable time: update your personal profile in eRA Commons. When you’re submitting an application through ASSIST, your senior/key personnel fields can autopopulate from your profile, as your Commons ID is linked. Keeping your personal profile updated ensures that the contact and personal information sent with any application has already been sanctioned by you. So where do you go to ensure you are up-to-date? First, log in to eRA Commons, and find the “Personal Profile” link in the blue menu bar:
This will take you to a menu that allows you to update all of your personal information. Some of this populates to ASSIST, some of it does not:
* note: “REVIEWER INFORMATION” is one place to find your Continuous Submission status 🙂
Here are some key points to keep in mind as you consider your personal profile:
- The “EMPLOYMENT” section populates your contact address, and NIH wants three years of history for PIs, and at least one entry for trainees and admins. NIH states, “this information is vital to NIH and its SROs for determining any conflicts of interest with applications.”
- Be sure your institutional affiliation is correct! Did you bring your Commons ID with you to Wayne State from a former institution? You may have to change your affiliation. Go to the “Home” screen and check out your name and affiliation in the top right corner. If the institution listed under your ID is static (no link), call SPA to have your affiliation switched. If your institution is incorrect and it is linked (blue underline), you may be able to change it yourself by clicking on it:
As an aside, when filling out your ASSIST applications: two fields that will NOT autopopulate from your profile are “Division” and “Department.” To be sure that you get proper credit for each:
Confused by what you need to include? Never fear, RAS is here to help walk you through the steps!
Researchers here at Wayne State with H1B visa status are not precluded from submitting proposals to the NIH. Grants given are technically awarded to the university, so submission is allowed as long as the H1B holder is officially employed by Wayne State.
You will need to remain at WSU long enough to finish your proposed project, and you’ll have to state in your application that your visa will allow you to be here long enough to be productive. As you know, H1B visas are held for a maximum of six years, and it may be issued in increments of up to three years by the USCIS.
While submissions and award are both possible, there ARE special procedures for funded foreign nationals to perform select agents and toxins research. If your proposed project has an agent or toxin that is considered “select” (go here to find out: http://www.selectagents.gov/SelectAgentsandToxins.html) we’re happy to walk you through the whys/hows.
By now you are most certainly aware that Forms D will be required for all NIH applications on or after May 25. If you are using ASSIST, you will automatically be directed to the Forms D cloud set (in the past few weeks, you were given a choice on the initiation screen, but now we’re very close to the no-option date). If you are still using the SF424 (why aren’t you using ASSIST?) be sure that any work you are doing is in the correct form set. The Forms D application guides are revamped and available on NIH’s website.
We first warned you of this back in October, so now is a great time to re-familiarize yourselves with the required changes: Brace Yourselves, Forms D Are Coming. For an exhaustive list of changes, NIH has provided a high-level list of FORMS-D pre-award form changes, as well as a landing page for all things Forms D. And, as always, drop us a note if anything looks murky; we’re always happy to help find clarification!