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Jun 25 / RAS

Status Updates: Not Just For Social Media Anymore

A couple of weeks ago, we talked about preserving your New Investigator or Early Stage Investigator (ESI) status.  But how can you be sure if you have those statuses at all?  NIH calculates your qualification for ESI based on your funding and terminal degree year, while New Investigator status is solely on past funding type.  You can be a New Investigator with qualifying to be ESI, but you can’t be ESI without qualifying to be a New Investigator.

 

To find out whether you are considered to be an ESI, you can check your status in eRA Commons.  To do it, log in and go to your “Personal Profile.”  Once you are there, either scroll down to or click on “Education:”

personal_profile

 

Once you are at your “Education” section, choose “Edit” (don’t choose “View”). This will reveal NIH’s record of your status as an Early Stage Investigator, or ESI:

ESI_status

 

To check your New Investigator status is a little more nuanced; to do so, choose “Status” from your top menu menu bar and find your most recent submission.  If that submission did not result in the funding of a “significant” award according to NIH standards and your “New Investigator Eligibility” reads “Y”, you are still considered a New Investigator.  This status is only monitored by NIH at submission:

new_investigator_status

 

Remember, to be considered a “New Investigator,” you cannot not yet have been awarded a substantial NIH research grant.  To be an “Early Stage Investigator,” you must have both “New Investigator” status and have completed your terminal research degrees or medical residencies (whichever date is later) within the past 10 years.  If you check you status and believe that NIH has misclassified your status, be sure to send an email to the Commons Help Desk for assistance.

Jun 17 / RAS

A Body to Die For

Have you ever been approached about body donation?  Did it catch you off guard?

 

It isn’t unheard of for patients and participants to contact admins and offer to donate themselves for post-mortem research on their specific condition.  Donating one’s body to science can be a great way to make direct contributions to research, other than dollars.  The bodies accepted at Wayne State University School of Medicine are in a clean, restricted area, accessible only to medical professionals and students. When the various studies have been completed the remains are cremated and buried in the University burial plot.

 

The Department of Anatomy facilitates a Body Bequest Program, and the process begins with their bequest form. Special attention should be given to section 10108; there are occasions when Wayne State University must refuse a donation (usually this concerns the condition of the body at the time of death).   If you are approached about body donation, encourage the interested party to contact the Body Bequest Office in the Department of Anatomy.

 

Jun 10 / RAS

They’re So Cute At That Stage

It is important to NIH to fund more new scientists, and have created special programs and higher paylines to do it.  To be a “New Investigator,” you must be an NIH research grant applicant who has not yet been awarded a substantial NIH research grant.  So, if you have been a PD/PI on an R01, you are no longer considered a New Investigator.  If, however, you were a PD/PI on and R21 or an R03, you ARE still New Investigator. If you’re not sure if your previous awards disqualify you from New Investigator status, take a look at the NIH list of non-disqualifying awards.

 

Keep in mind that multi-PI awards count as being a PD/PI (but Co-I designations do not!).  If you and a colleague or two have shared PD/PI status on an R01 that was awarded, you’re not a New Investigator.  If you are going to share multi-PI status on an R21, you DO retain your status. The length of your career has no bearing on your status as a New Investigator, but you may have an extra advantage if you are early enough along: there are separate paylines established for Early Stage Investigators, who are those New Investigators who have completed their terminal research degrees or medical residencies (whichever date is later) within the past 10 years.

 

For further clarification, head over to NIH’s FAQs for New and Early Stage Investigators.  If you’re not sure how to strategize when it comes to your status, we’re here to help you figure out your options.

Jun 3 / RAS

No Such Thing as a Free NCE

In case you missed it, Joe Schumaker wrote a good piece this month aligning requests for no cost extensions with the classic Dickens novel, Oliver Twist.  Here’s your bottom line: there can only be one (yes, that was a Highlander reference riffed from a Dickens reference.  All about the classics today, folks).

 

NIH provides an “expanded authorities” clause in almost all Standard Terms of Award that waives the requirement for prior approval No Cost Extension (NCE), among other actions.  If the text of the award allows, the grantee is permitted one NCE (that is, to extend the final budget period of a grant’s project period by up to 12 months, with no new funds).  This is usually done within 90 days of project end, when the Extension link appears in the “Action” column of the “Status” search results screen. Anything beyond that one request will require permission.

 

As NIH adjusts NCE guidelines to meet the requirements outlined in the Uniform Guidance, they have audibly noticed an increasing trend of people asking for NCEs in the middle of the project period. You can do this, but this is your one shot.  That is: if you get a permitted NCE in the middle of your project period, you won’t see your Extension link at the end of your project period;  you’ve already used your expanded authority, even though you had to obtain permission to do so.  Further, if you choose not to use the entire allowable 12 months (like you ask for, say, a 4 month extension), you can’t ask for the remainder of what’s allowable (8 months, in this case) without permission: it still counts as a second extension.

 

So, Warriors, be careful what you wish for; beyond that, know what you’re wishing for.  If you’re unsure of your best strategy, let us know: we’ll help you talk it out and figure what’s best for you!

 

 

May 27 / RAS

Watch Your Asterisk

As the June 5 deadline approaches for NIH new R01s, take a moment to double-check your PDF file names (and make sure all of your attachments are PDFs, come to that). NIH systems can be touchy with unexpected character recognition, and no one wants an error at 4:58p next Friday. Remember: file names should be less than 50 characters, including punctuation and spaces. Names CAN contain any of the following characters:

  • A-Z
  • a-z
  • 0-9
  • underscore: _
  • hyphen: –
  • space
  • period
  • parenthesis
  • curly braces: { }
  • square brackets: [ ]
  • tilde: ~
  • exclamation point
  • comma
  • semicolon
  • at sign: @
  • number/pound sign: #
  • dollar sign
  • percent sign
  • plus sign
  • equal sign

 

Names CANNOT contain any of the following:

  • Two or more spaces in a row between words or characters
  • Ampersand: &
  • Apostrophe (note: the official NIH list of acceptable characters includes apostrophes, but we have encountered more than one error when using apostrophes so we recommend avoiding them)

 

Be safe: keep it simple!  For more tips on compliant file attachments, look over NIH’s PDF Guidelines.  Questions about what you’re reading? Drop us a note!

May 20 / RAS

O, What A Tangled Web

No one likes to admit defeat, and most are not particularly excited to shout a mistake from the rooftops.  Self-protection is human nature, but covering tracks in research can land you in some hot water.  HHS defines “research misconduct” as ” fabrication, falsification and plagiarism, and does not include honest error or differences of opinion.” NIH has procedures in place to handle research misconduct claims, but ultimately no power to investigate (except in the case of intramural research).  All research misconduct allegations involving NIH awards (or any agency under the umbrella of HHS) are forwarded to the HHS Office of Research Integrity (ORI) for their oversight.  Just to be clear:

 

  • Fabrication is making up data or results and recording or reporting them.
  • Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
  • Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

 

If a PI is found to have engaged in research misconduct, HHS can take action by means of debarment from eligibility to receive Federal funds for grants and contracts; prohibition from PHS service; certification of information sources by the respondent that is forwarded by the institution; certification of data by the institution; imposition of supervision; submission of a correction of published articles by the respondent; submission of a retraction of published articles; and more, including recalled funds and withdrawal of support for associated PIs.

 

WSU PIs are full of integrity and honor, but panic can blur a bright line. In your moments of most overwhelming, results-driven disappointment, make sure the object you cling to is a life raft and not an anchor.  ORI sanction happens (and just recently did), and it can ruin a career.

May 13 / RAS

On-Again, Off-Again Relationship

Ah, the F&A rate portion of your awards: can’t live with them, can’t – quite literally – live without them.  The F&A rates here at WSU are variable as you well know (we’re in a 52.5% period on-campus right now), and that portion generated by awards is distributed according to the policies set forth in section 03-5 of the WSU Administrative Policy Manual.  Those funds pay the salaries, leases, capital projects, etc. etc. that keep our research infrastructure viable.  Many awards allow you to calculate and request F&A (or indirect costs) on top of a direct cost cap, but many do not.  When this is the case, that 52.5% can swiftly eat into your project budget.  That’s when the 26.0% off-campus rate sure starts to look good.  But when can you use it?

 

What is “Off-Campus” Research?

The definition of “off-campus” applicable to WSU is negotiated in our DHHS agreement. In our case, “off-campus” is agreed to mean:

 

For all activities performed in facilities not owned by the institution and to which rent is directly allocated to the project(s) the off-campus rate will apply.  Grants or contracts will not be subject to more than one F&A cost rate.  If more than 50% of a project is performed off-campus, the off-campus rate will apply to the entire project.

 

This is the standard for determining which rate you can use until our current agreement is renegotiated (in 2020, barring extenuating circumstances).

 

My research is done in a non-WSU facility; is it “off-campus”?

Whether your non-WSU facility research is considered “off-campus” is entirely dependent on the terms of your lease; the terms of your lease is the first place you should check.  If WSU is the responsible party for payment on your space, chances are you should be using the on-campus rate (as that cost is factored into the on-campus F&A rate).  If WSU is not the named responsible party, there is a possibility that the off-campus rate in effect at the time of submission could apply (be sure to build those costs into your proposal!).

 

Even after reading the contract, I’m not really sure who is responsible for my lease.  Who can help?

There are definitely murky circumstances, especially when it comes to leasing DMC space and our affiliation agreements. If you’re not sure,  be sure to contact SPA to find out how your space relates to certain existing blanket agreements. Once you’re sure, we can help you with any adjustments that may need to be made!

May 6 / RAS

Good Morning, How May We ASSIST You?

Last week, ASSIST became a submission option for R01s and U01s.  This means that ASSIST is now available for R01, U01, R03, all multi-project grant programs, and Individual Career Development Award (K, excluding KM1 and K12) applications.  Right now, you may choose to use ASSIST for its features (we like how you can validate for errors and warnings BEFORE submission), or you may continue to use the downloadable SF424 forms.  Keep in mind, however, that SF424 wasn’t always required either 😉  In order to use ASSIST, you must use or obtain an eRACommons ID.

 

We’ve used ASSIST a few times here at RAS and we thought we’d share a few things we’ve found:

  • Because ASSIST is cloud-based and directly populated to NIH, you can see errors and warnings before submission.
  • More than one person can be signed in and working on an ASSIST application, just not on the same component.
  • Only a person with recognized signing authority by NIH (according to their eRACommons credentials) can actually submit. You’ll need to add your GCO as a contributor.
  • All components of your application will need to be marked “Final” before you can mark your application as “Ready to Submit.” Conversely, if a component is not marked “Work in Progress,” you cannot edit.  As annoying as this will be when you are making last-minute changes, it does prevent accidental submission of unrefined applications.

 

Take a look around the system and see what you find.  ASSIST is nothing to fear: if you can do an SF424, you can use ASSIST.  In fact, we bet that you’ll like the administrative data carry-over population and pre-submission validation features.  We’ve stumbled through enough now that we’ve hit many of the hiccups; if you run into one, let us know and we’ll be happy to help you navigate.  Also check out the NIH ASSIST page,  where you can access FAQs, common errors and training resources on the left-side menu.

Apr 30 / RAS

Permission to Land Short

In the season of RPPRs and changing budgets, we thought it might be a nice time to once again mention effort reduction on NIH projects.

 

Remember, if you are reducing the effort of key personnel on a grant, you need the permission of your NIH program officer if the amount of effort reduced is 25% or more.  The amount reduced is cumulative; that is, the 25% threshold may be reached by the reduction of two or more efforts per individual in successive project periods.  To revisit an example, take Dr. Alpha: he devotes 25% effort to a project, or 3.0 person months. If he reduces his effort by more than 25% of 3.0 months (which is 0.75 months), he needs permission to reduce.

 

So, if Dr. Alpha reduces his effort in Year 2 by 20% (0.6 months) to 2.4 months, he does not need to request NIH permission. If he reduces his effort again in Year 3 by 10% (0.24 months), he DOES need special permission at that point, because his effort has been reduced from the last approved level by 28%. This is where the “cumulative” term comes into play: once NIH has approved a reduction, all subsequent reductions are measured at 25% of the MOST RECENT approval (as opposed to consistent measurement against the first-year effort levels, if subsequent changes were made). For further details on the 25% thresholds, be sure to read the Section 8 of the NIH Grants Policy Statement. If you need some guidance on calculating your own thresholds, we’re always happy to help!

Apr 22 / RAS

Built by Association

Managing your citations through MyNCBI can save you a lot of time and searching if you’re using it to build your bibliography.  You can easily associate publications in your constructed bibliography with your funded research, making progress reports and access compliance that much simpler.

 

To add a publication to your bibliography via PubMed, be sure you are signed in to MyNCBI before you begin your search.  Once you are signed in to MyNCBI and in the PubMed environment, run a search to find your article (“Author Search” is one of the quickest ways to find what you are looking for). Select the citations you want to add to My Bibliography and then click the “Send to” link to expand the drop-down menu. Select the destination “My Bibliography” (a message indicates the number of citations selected to be copied to your bibliography) and click “Add to My Bibliography:”

mybibliography-Image002a

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You will have the option to save these to your “My Bibliography” or “Other Citations” list (or another list you have created).  Most choose to save their own publications to “My Bibliography.”  You’ll see them in your “My Bibliography” when you return to your MyNCBI home page.

mybibliography-Image007

click image for full view

 

If your added citation is not already associated with your award, you can do it manually.  To do so, be sure your “Display” settings are set to view by “Award:”

click image for full view

 

Choose the publication that needs assignment and the award to which it needs to be assigned; click “Assign Awards”:

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You’ll be given the option to choose from more awards. Keep yours checked or choose more and click “Save:”

my awards_1

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And you’re done!  If you have any questions on how to build yourself a usable bibliography through MyNCBI, feel free to reach out to RAS.  Having accurate bibliographies will help you if you’re using SciENcv, too!