Who has the responsibility for verifying and ensuring “other
support disclosures” in applications to the sponsor is accurate? If you answered-the institution applying for
and receiving the funds, you are correct.
“Other support” is not to be confused with the “research
support” section within the bio-sketch. Refer
to this link https://grants.nih.gov/grants/forms/othersupport.htm
for guidance as to what info the PI is required to provide in an Other Support
as well as samples. Administrators should
work in tandem with the PI to ensure all of the active and pending funding sources
are accurately referenced as Sponsors use the “Other Support” to make sure
there is no budgetary, scientific or commitment overlap. Note there can be serious ramifications for
inaccurately reporting other support information, especially when the sponsor
is federal, since it involves the use of U.S. taxpayer funds. The severity and length of time for noncompliance
determines the type of sanctions received, such as termination of the award. The link for the NIH Extramural Nexus has
been included for further reading on the subject (https://nexus.od.nih.gov/all/2019/07/11/clarifying-long-standing-nih-policies-on-disclosing-other-support/)
Your principal investigator has answered yes on the export
control compliance section in Cayuse.
Did you remember to add Export Control to the Approving Units page? This is an important section that will
protect the university and the researcher from severe criminal and or civil
penalties, because of unintentional noncompliance to federal regulations. Export Control is not a topic that is widely
discussed or thought about when a principal investigator begins writing a
proposal and the administrator starts assembling the application package.
The word “export” will cause many to believe you’re talking
about sending items outside the United States, but this is not the case and it
may also include consulting, training, and speaking at conferences. The code of federal regulations under the
Export Administration Regulations (EAR) defines export as, “an actual shipment
or transmission of items out of the United States”, which also includes
releasing or transferring. Most don’t
consider that something can be exported via auditory, visual, verbal or
electronic means. This is the reason
that our Export Control office exists in order to prevent the innocent
violation of any federal regulations. If
you want to learn more about export compliance click on the link https://research.wayne.edu/integrity/export-control
and take note there is an CITI Export Control Module offered by WSU.
A Research Performance Project Report (RPPR) is required at least annually as part of the NIH non-competing renewal (type 5) award process and it must be submitted via the eRA Commons.
NIH has recently published a new resource “RPPRs: Who Can Do What?” which provides a quick look at the Annual, Interim and Final RPPRs. Only the PI or their delegate may initiate an RPPR in the eRA Commons. The RPPR must be received and approved by the Institute’s Program and grants management staff prior to funding for each subsequent budget period within a previously approved competing project period.
To find out which progress reports are due over the next 4 months, click on this NIH link to Pending Progress Reports to obtain a list of progress reports for a selected grantee institution. For Wayne State University, use 9110501. Note any project that shows a “Yes” to SNAP is actually due on the 15th of the month instead of the 1st as shown in the query results. This query will not include progress reports for Multi-Year Funded (MYF) awards which are always due on or before the anniversary of the budget/project period start date of the award and are uploaded as a PDF through the eRA Commons (see http://grants.nih.gov/grants/policy/myf.htm for instructions).
If you have questions or you’ve been told something different, you can reach out to RAS@med.wayne.edu.
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.
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.
“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!
Now that February 6 has come and gone, most everyone has had experience with what we’re looking for at the brand-spankin’-new School of Medicine level of approval. One of our major review points is cost share, and whether an index has been identified if it exists. Not sure how to record that on the SP side of Evisions? Don’t fret; you’re not alone. Here is a step-by-step guide to recording your index for approval (click on images to see full mark-up):
1. Go to proposal budget:
2. Find “Cost Sharing” heading; choose “Yes”
3. When the cost sharing options box appears, choose “Voluntary”
4. Choose “Salary Cap.” Enter the amount of cost share. Refer to calculations in the comments line. Don’t forget to actually upload the cost share calculations document to “Proposal Attachments.” (Note: SoM is not requiring signatures for over-the-cap cost sharing at this time.)
5. Click the “Add Unit” link to assign your department to cost share and record the index. Use the search icon to find your department. Note: you can add more than one unit of account if you are splitting the amount between departments or accounts.
6. Choose “Add Unit” once the appropriate information has been entered.
7. Congratulations! You’ve added your cost share record to your proposal.
(Don’t forget to insert the number into the budget line by scrolling all the way down to the bottom of your page, so you don’t get the nasty error message.)
Let us know if you have any problems; we can walk you through it 🙂
We all love hearing about changes to the federal register, amirite? Well celebrate, one and all: last week, a new final version of the “Common Rule” for the protection of human subjects was published by fifteen federal agencies (including DHHS and NSF) in effort to strengthen the Federal Policy for the Protection of Human Subjects. The intent is to both enhance protections and reduce administrative burden(!), and here’s what it means to you:
- Consent forms are required a better understanding to provide potential research subjects of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
- A single institutional review board (IRB) for multi-institutional research studies is required in many cases. (There is substantial flexibility in now allowing broad groups of studies, instead of just specific studies, to be removed from this requirement; this provision is delayed until 2020.)
- Studies on stored identifiable data or identifiable biospecimens allow researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens. Aside: if you’ve been following along, you’ll note that this is a change of course from earlier intent to apply the principles of informed consent to all biospecimens.
- New exempt categories of research are established based on the level of risk posed to participants. (For example, there is a new exemption for secondary research involving identifiable private information as regulated by and participants protected under HIPAA; the intent is to reduce regulatory burden to allow IRBs to focus their attention on higher risk studies.)
- Continuing review of ongoing research studies is no longer required in instances where such review does little to protect subjects.
- Consent forms for certain federally funded clinical trials are required to be posted on a public website.
The general effective/compliance date of the final rule is January 19, 2018; all studies without initial IRB review as of 1/20/18 will be subject to the new requirements. Any ongoing research at that time (i.e. studies with IRBs approved under the current version of the Common Rule) will continue to be subject to the current, pre-2018 version of the rule unless the university chooses to mandate compliance with the final version. For more on the transition provisions, check out the final rule preamble, as well as Section 101(l) of the regulatory text.
Stay tuned for further guidance; HHS intends to issue direction on specific provisions of the rule changes in the near future.