What’s the JIT of Other Support?

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/)

Don’t’ Let These Characters Stop The Show

Discussing usage of the mathematical inequality symbols; <, >, ≥, ≤ , within NIH application text fields.

  •  In early 2015 NIH released a notice informing the  grant seeking community  of the support for the full  Unicode Character Set, in the free-text form fields.  http://unicode.org/charts/

According to the above notice and guidelines the mathematical inequality symbols are included within the acceptable/supported Unicode Character Set. However, it has come to our attention that usage of these particular symbols may delay if not prevent the successful submission of an NIH application.  While the use of these symbols will not result in error notices within the University’s Cayuse system, the problem is encountered when the application is routed from Grants.gov to eRA Commons.    

So, when entering text where these symbols may be used it is suggested that their meaning be written in longhand, i.e.

                              < ( Less than), (Less than or equal to), etc.

Research Performance Progress Report (RPPR)…I Don’t Need Time, I Need a Deadline

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.

Can I Get An OnCore, Do You Want More (Money In Your Budget)

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!

Where we’re going, we don’t need downloads.

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).

Live Wires: No Cost Extension and PI Changes Go Electronic

As of last Thursday, No Cost Extensions requiring a prior approval and requests to change a PD/PI are available to your GCO through the Prior Approval section in eRA Commons.  The electronic option through eRACommons is just that: optional.  You and your GCO can still make your requests the old-fashioned way if computers make you nervous (heck, even NIH says you should contact your awarding institute/center [IC] to determine the best method for making these requests).  How simple is this?  Once you sign in, here’s what you see:

And takes you here:

 

Not sure if you are eligible for a no cost extension (NCE) through prior approval?  Do a quick double-check:

  • You ARE eligible for a NCE through Prior Approval:
    • When an NCE under expanded authority has already been used and the grant is within 90 days of the project end date.
    • When the grantee is not under expanded authority and the grant is within 90 days of the project end date.
    • When the project end date has expired and has not been closed or has not entered unilateral closeout, whichever comes first.

 

  • You are NOT eligible for a NCE through Prior Approval:
    • When an NCE under expanded authority has never been requested and the grant is within 90 days of the project end date. In this case, the NCE will be processed normally through the Extension link in Status.
    • When the grant is closed.
    • When the grant is a fellowship grant.

 

  • What information will you need to provide to your GCO?
    • The NCE request form includes:
      • Request Detail – Here you will be asked such things as the number of months you wish to extend the project end date; the amount of unobligated money still available, etc.
      • Three PDF upload fields: Progress Report, Budget Document, Justification Document

 

RAS is here to help with interpretation if you have any questions!

Six Things in Common

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.

Your Amendment Rights for Right Amendments

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!

Personal profiles: not just for online dating

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:

pp1

 

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:

pp2

* 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:

pp3

 

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!

Don’t fence me in!

The NIH modular budget format is attractive to PIs for a lovely, time-saving reason: the lack of a detailed budget justification.   Modular budgeting may be used for research grant applications requesting up to $250,000 direct costs per year; funds are requested as direct costs in modules of $25,000.  The logic behind modular budgeting is efficiency: less work for the PI, less work for the reviewers.  Modular budgets give PIs a degree of flexibility during the course of the award (i.e. fewer rebudgeting requests).

 

If you are close to the $250,000 mark, however, modular budgeting may not be for you.  Consider the following:

  • Your competing renewal must be modular.  This means, then, that you will be limited to $250,000 for the life AND future of the project.  If your current submission is part of a grander plan, this could lead to some serious research growth-stunting.  Additionally, if it is an NCI application, it generally cannot exceed an increase of 10% over the direct cost budget awarded for the last year of the prior project period. [NOT-CA-08-026]
  • There will be no future year escalations. Annual modular budgets are average budgets for the entire award period; salary escalations may result in a request for more modules than needed for costs in the beginning years to cover escalations in future years.
  • Underfunding is a reality.  You may not have a firm grasp of the project costs at the time of submission, especially if you don’t do an internal detailed budget for yourself and/or SPA. Are costs of materials expected to increase in the out years?  What about salaries?  Space costs?  Supply needs as the project grows? Without a full understanding of the totality of costs, the project could be faced with deficits as salaries and other costs increase annually. Increases in modules can be requested in exceptional circumstances, but the request must be thoroughly justified and acquiescence is rare.

 

Detailed budgets are nothing to be afraid of, and should be done internally anyway to ensure research is adequately funded.  Modular budgets are a great tool for smaller projects but if you’re close to the border, check your figures again: the extra effort of a detailed budget could save you from the pain of future paucity.  If you need help in auditing future needs or budget framework, RAS is here to help!