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Sep 17 / RAS

No Agreement, No Rate, No Problem

When utilizing subcontracts on a proposal, occasionally we run into domestic institutions who have no negotiated federal rate agreement.  This means (among other things) that there is no F&A rate.  If the subcontracting institution doesn’t require administrative overhead in their role on the project, it’s not necessary to grant them these costs.  But what if they do require administrative costs?  Scientists gotta science, administrators gotta administer!

 

For cases like these, there is a minimal threshold set by the federal government for institutions with no negotiated rate: it has been 8%, but has been increased by the OMB Uniform Guidance to 10% for domestic institutions, effective December 26, 2014 (as stated in Section 200.110).  We have been successful here at using the 10% rate on proposals as of late.  To view the full text of the Final OMB Uniform Guidance regarding the increase of the de minimis threshold, take a look at Subpart E, 200.414 on the Federal Register site.  For a breakdown interpretation of the language (for this and other changes), check out the table produced by The Huron Consulting Group, or our post entitled “Super Circular, Super Fun“!

 

RAS is here to help if you have any questions on how to budget your subcontracts with no negotiated rate.  Feel free to reach out if you need us!

Sep 10 / RAS

Back to the Future

September has officially settled in, which means resuming our monthly Tips & Tools meeting! We hope everyone had a wonderful summer and are gearing up for a very productive fall.

 

For those of you who may be unaware, our School of Medicine Research Administrative Services (RAS) team hosts a regular meeting (Tips & Tools) on the third Wednesday of each month. At these meetings, we highlight changes and information coming down both internally at Wayne, and from external agencies.  Additionally – and perhaps most importantly – these meetings serve as a forum for research administrators to ask and answer each other’s questions, trouble-shoot, and give/request input on processes. These meetings began for the administrators of the departments at the School of Medicine, but we have many administrators attending from outside the SOM as well! If you are interested in attending, please send us a quick note expressing your interest (RAS@med.wayne.edu) and we’ll give you the details of time and place.

 

This month’s meeting will take place in one week (September 17, 2014) and will feature special guests Dr. Stephen Lanier (our new Vice President for Research at Wayne State; check out his Crain’s Q&A!) and Ms. Gail Ryan (Wayne’s Assistant Vice President for Sponsored Program Administration).  Come with your questions; they’ll both have answers!  We look forward to seeing you there.

Sep 3 / RAS

Farewell to Terri Larrew

Terri Larrew, long-time friend and administrator for Anatomy and Cell Biology, passed away this past Labor Day weekend. Terri was known not only for her keen ability to perform her job with competence and grace, but for her sense of humor and infectious laughter as well. Please keep Anatomy in your thoughts during this difficult time, and take a moment to remember Terri.

Aug 28 / RAS

25 is the Magic Number

The magic number for NIH seems to be “25%”.  Whether we’re talking about carry forward balances or effort devoted to a project, you have to be under the quarter mark or else have special permission.  Here’s how to determine whether you will need to communicate with your program officer (through your GCO, of course!):   CARRY-FORWARD If you find yourself with unspent funds at the end of a project, you can’t carry those funds forward to the next project period without permission, unless the leftover/unobligated funds equal less than 25%  current year’s total approved budget (including prior-year carryover).  If, for instance, your total approved budget for Year Two is $150,000 and you have monies left over going into Year Three, you must request permission from NIH to keep those funds to spend in addition to your Year Three budget IF you have more than $37,500 left over.  The formula to find your threshold is [Period Total Approved Budget] x [0.25].  If you find yourself with $23,000 at the end of Year Two, you’ll likely not need permission to carry it forward and spend it on top of your approved budget for Year Three.** Keep in mind, however, that if you should find yourself with a balance at the end of Year Three, you must include the Year Two carry-forward in calculating your threshold.  If your approved budget for Year Three is also $150,000, your threshold is calculated as follows:

  • [Period Total Approved Budget + Prior Period Carry-Forward] x [25%]
  • = [$150,000 + $23,000] x [0.25]
  • = [$173,000] x [0.25]
  • = $43,250

If you are carrying funds from Year Three to Year Four in this scenario, and you find yourself with a balance of $43,251, you will need to request permission from NIH to do so, or expect to have your award for Year Four reduced/offset by the unobligated amount.  Note: this means that you will still have the authority to spend at the originally-approved amount in Year Four, but the source of that funding becomes dual: part of your funds for Year Four will come from the left-over funds that remain in your account from Year Three, and NIH will send the remainder in the new period award.  In this example, if the Year Four approved budget was also $150,000, NIH would provide Year Four funds in the amount of [Year Four Approved Budget - Year Three Unobligated Balance], or [$150,000 - $43,251] = $106,749.  This does NOT reduce the Year Four budget to $106,749; rather, NIH expects you to spend at the approved $150,000 level using the unobligated funds from the year before and the new funds to make up the difference.  Had a carry-forward been both requested and approved, NIH would have sent a check for $150,000 and allowed the expenditure of the $43,251 on top of the originally-approved budget.

 

EFFORT REDUCTION

Bear in mind that “25%” is also the threshold for NIH permission for project effort level reductions.  This reduction threshold is seen as cumulative, i.e., the 25% threshold may be reached by the reduction of two or more efforts per individual in successive project periods that total 25% or more.  Let’s say that Dr. Alpha devotes 25% effort to a project, or 3.0 months.  His threshold for effort reduction is 25% of 3.0 months, or 0.75 months.  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%.

Note: once NIH has approved a reduction, all subsequent reductions are measured at 25% of the last approval (as opposed to consistent measurement against the originally-approved effort levels).   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, give us a shout!

** Remember, certain programs are routinely excluded from the ability to automatically carry forward, no matter the balance.  These include centers (P50, P60, P30, and others); cooperative agreements (U); Kirschstein-NRSA institutional research training grants (T); non-Fast Track Phase 1 SBIR and STTR awards (R43 and R41); clinical trials (regardless of activity code); and awards to individuals.

Aug 20 / RAS

Supplemental Form

Most NIH announcements at this point have required the use of the Forms-C package, with two notable exceptions: PA-12-149 “Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)” and PA-12-150 “Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp)”.

 

As of last week, both of these programs do, in fact, require the Forms-C set.  For more information, see NOT-OD-14-118.  If you need clarification or guidance on the Forms C set, see our prior post, “Forms “C” and Fringe Rates and Agents, Oh My!” or contact RAS with specific questions!

Aug 13 / RAS

You’re Late, You’re Late, for a Very Important Submission

It happens.  Sometimes your lab floods, or your building is on fire, or you have to flee the country, or you are inundated with paper by your study section.  And sometimes this happens very close to submission deadlines.  What to do?  Here’s what you must be aware of if you are under the gun:

 

The NIH

  • An error free application is successfully submitted to Grants.gov by 5 p.m. local time on the due date.  This means that you must allow enough time to correct any errors that may be returned by 5:00pm on the deadline date; an application that was returned with an error at 4:55p and resubmitted with corrections at 5:02p is late and will not be accepted.
  • When due dates fall on a weekend or Federal holiday, they are extended to the next business day. Free time!
  • Permission to submit late is never granted in advance.
  • On EXTREMELY RARE OCCASIONS, late applications may be accepted when accompanied by a cover letter that details compelling reasons for the delay.  The NIH will decide what is “compelling.”  Specific detail about the timing and cause of the delay should be provided so “an informed, objective decision can be made.”  Only the explanatory letter is needed; no other documentation is expected. This letter is available only to NIH staff who have a “need to know” (such as those with referral or review responsibilities); it is not available to reviewers or other staff.
  • Examples of “compelling” reasons include: death of an immediate family member of the PD/PI, sudden acute severe illness of the PD/PI or immediate family member, or large scale natural disasters. Also, recent temporary or ad hoc service by a PD/PI that required a commitment of time that could have been used to prepare an application may be an acceptable reason (i.e.: serving on an NIH extramural review group, NIH Board of Scientific Counselors or an Advisory Board/Council).

  • Examples of unacceptable reasons for late submissions: failure to complete required registrations in advance of the due date, heavy teaching or administrative responsibilities, relocation of a laboratory, ongoing or non-severe health problems, personal events, review service for participants other than a PD/PI, participation in review activities for other Federal agencies or private organizations, attendance at scientific meetings, or having a very busy schedule. For electronic submissions, correction of errors or addressing warnings after the due date is not considered a valid reason for a late submission. However, if the problem is with Grants.gov or eRA Commons, grounds will be considered on a case-by-case basis.  Be sure to follow the directions for documentation given be the NIH here.

  • Late submissions to the NIH are are governed by NOT-OD-11-035.

 

Other Agencies

  • Most agencies follow policies similar to NIH.  Check your RFP for specific details, or contact us to help you figure out specific guidelines for your agency.

 

WSU School of Medicine

  • Any proposal submitted with fewer than the required internal three days lead time is considered late, and a late submission form is required to be filed with the SOM Office of Research.
  • Proposals considered “late” by the School of Medicine that are still before the agency deadline may still be submitted; the late submission form serves as documentation of understanding of responsibility for outcomes.  Assistance with late submissions by the RAS office is entirely dependent on volume of on-time submissions.
  • The policy and late submission form for the School of Medicine can be found here.

 

Sponsored Program Administration (SPA)

  • Proposals must be submitted to SPA a full three business days before the agency deadline.
  • Proposals submitted less than three full University business days before the agency’s deadline will be handled on a first-come, first-served basis, following the completion of proposals submitted on time.
  • Successful submissions of proposals submitted to SPA AFTER the three day window cannot be guaranteed.
  • SPA’s policy is provided on their website, here.

 

Give yourself some space to breathe: allow yourself enough time to account for the unaccountable! If you have an emergency and you don’t know what to do, contact RAS – we’ll do our best to help you through!

Aug 6 / RAS

NIH Wants to Make Your Student Loan Payments

In order to retain health professionals as researchers, the NIH is offering Research Loan Repayment Programs (LRP) in specific fields: clinical, pediatric, health disparities, contraception/infertility, and clinical research for individuals from disadvantaged backgrounds (click on the fields for their official NIH definitions).  The basic premise is simple: you do the research, NIH repays your loans.   In order to qualify, you must be researching in one of the highlighted areas and meet the basic eligibility requirements, summarized as:

 

  • Status as a U.S. citizen, U.S. national, or permanent resident of the U.S.
  • Possession of  a health professional doctoral degree* (M.D., Ph.D., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., D.C., N.D., O.D., D.V.M., or equivalent; NOTE: the Contraception and Infertility Research LRP is also open to nurses, physician assistants, graduate students, and postgraduate research fellows training in the health professions)
  • Educational debt equal to or in excess of 20 percent of your institutional base salary at the time of award
  • Research supported by a domestic nonprofit foundation, university, professional association, or other nonprofit institution, or a U.S. government agency (federal, state, or local)
  • Engagement in qualified research that represents 50 percent of your level of effort and consumes an average of at least 20 hours per week during each quarterly service period during the contract (2 years for the initial contract)

 

If this sounds like you, check out the details on the NIH Extramural LRP program information page for more details.

 

 

Recipients of a Kirschstein (NRSA) fellowships and training grants can apply for and receive LRP awards but may have to defer their NRSA service payback until the completion of the LRP.

Jul 31 / RAS

Applied [Budget] Transfer

If you’re welcoming a new faculty member to your department, there’s a good chance that you’re welcoming a new project or two as well.  Once you have received the NIH-approved relinquishing statement from the former institution, you’ll need to put together a new budget to satisfy both SPA and the Change of Grantee Organization SF 424.  (On a related note, the NIH made some updates to the SF 424 Application Guide and released it last Friday, July 25, 2014.  Edits are noted in purple.)  When building your transfer budget, these points may be helpful:

 

  • Your first year budget should match the amount on the approved relinquishing statement.  Any following out years should match the awarded direct costs on the original Notice of Grant Award (NOGA).
  • While direct costs must match the NOGA, indirects are permitted to be generated based on Wayne State University’s applicable F&A rates.  This will change the overall dollar amounts awarded in each year; that’s OK.
  • Modular submission is not permitted for a transfer/change of grantee organization.  HOWEVER, if desired, an award that was submitted as modular during the proposal phase has the option during transfer to complete only the costs for the PD/PI (Section A), and include the remainder of the direct costs under Section F (Other Direct Costs) Item 8, and Section H (Indirect Costs).  Otherwise, a detailed budget should be utilized.

 

If you’re fortunate enough to be transferring an award to your department, we’re here to help with any questions you may have!  For further details, take a look at the text of PA-14-078.

 

 

Jul 16 / RAS

Amending Expectations

The kind folks at Wayne’s Institutional Review Board (IRB) has been holding sessions to remind, refresh and renew the understanding of our application and approval process.  One of the most common processes in IRB is amending a current approval to reflect a new or altered project.  When planning your project timeline, it’s helpful to know some of the most common issues that prevent a timely amendment approval:

  • Changes to a project that are not adequately explained
  • Reasons for the change are not adequately explained
  • Missing documents
  • Revisions are not highlighted
  • Wrong submission type

(These issues were highlighted by Wayne State University IRB in their July presentation.)

 

Remember that any time there is an increase in the population that would be exposed to the risks of a study, detailed explanation is required.  In addition to an account of changes (with references and details where necessary), you must also:

  • Use the exact, accurate project title
  • Note the expiration and continuation dates
  • Ensure the funding source is up to date
  • Revise all documents affected

 

Delays in IRB approval can materially affect data collection; make your life easier with a few precautionary steps to ensure the smoothest application possible!  If you would like some clarification on an IRB issue, send an email to RAS and we’ll arrange for an IRB representative to present at Tips & Tools.  If you have a specific IRB question on a specific study submission, Ray-Nitra Pugh, IRB Education Coordinator, is an excellent resource!