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Wayne State University

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Nov 19 / RAS

IRB-al Remedies

IRB Operations Manager Corey Zolondek recently released three new versions of institutional review board (IRB) forms to better reflect federal guidelines.  For exempt review, both the Medical Exempt Protocol Summary form and the Behavioral/Social/Education Exempt Protocol Summary form are new versions, with questions rewritten to better indicate whether the proposed research meets the federal requirements for an exemption. For the appendices, Appendix C: Children as Research Participants has also been updated to include a request for a risk assessment for control/placebo groups with children;  the form also more clearly presents federal requirements for research on wards.  The use of these forms will be mandatory beginning January 15, 2015.

 

Though they still have October 2013 form dates, minor changes have been made to the following forms as well and it is strongly recommended that these versions are used; many questions have been rewritten to help investigators avoid common issues:

Medical/Behavioral Protocol Summary Form (Expedited and Full Board)  | Expedited Medical/Behavioral Amendment Submission Form  |  Full Board Medical/Behavioral Amendment Submission Form  |  Appendix B: Internet Use in Research  |  Unexpected Problem Report Form

 

Nov 12 / RAS

Credit Where Credit Is Due

This is just a quick reminder to ensure that you are identifying the “Division” on your SF424 proposal packages as “Schools of Medicine”.  This is the identifier category used when crediting the School of Medicine with award dollars, and any other unrecognized term will result in uncredited monies (thus dropping our rankings). “Schools of Medicine” is the recognized NIH “acceptable major component code.”

 

Stay tuned for more information in coming weeks about officially recognized department names!

 

 

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Nov 5 / RAS

Cloudy with a Chance of Overspending

November is quite a popular month for budget forecasting and cost projection among departments.  Here are a few things to keep in mind when you’re doing your calculations:

 

  1. Remember, our fringe rates have changed!  Gone are the days of 26.6%; we now have four rates that are divided in very different ways than they have been in the past.  On sponsored projects, this is most often going to look like 21.4% for your faculty researchers and 33.0% for your non-faculty research personnel (research assistants, associates, etc.)  There are, however, many different ways the rates will be applied!  To make sure you are calculating your forecasts correctly, check the E-Class designation for each of your personnel and compare it to the current composite fringe benefit rates chart.  Remember, just because it was awarded when the previous rates were in effect does not mean that the calculations stay the same for the life of the project.
  2. You don’t have to factor in termination payouts.  If you have personnel on grants that you know will be retiring or leaving, there is a designated account for termination payouts so your project funds are not harshly impacted.  for more information on this payout structure, contact SPA.
  3. Consider asking your PIs to do an inventory of their cages if they are working with animals.  A per-cage charge may be inaccurately reflected in your projections if more or less cages are being used than originally anticipated at budget time.
  4. Tuition may not hit at the time of the grant.  Make sure you account for future costs – such as tuition that is budgeted but not yet spent – that may not be projectable based on current/past expenditures.

 

For tips on calculations quasi-forensic forecasting, contact RAS anytime… we’ve all been here too!

Oct 22 / RAS

Are Those Extensions?

As we draw nearer to the implementation of the Super Circular, our friends at NCURA continue to put out some very helpful vlogs (video logs) on some of the highlighted changes.  There is a new rule for indirect cost rate negotiations, in fact, that now allows a one-time, four-year extension on current negotiated rates.  This is governed by section 200.414 (linked, for your reading pleasure); you can check out the short NCURA video here:

 

 

The possibility of a rate extension theoretically saves universities (and other entities) time and negotiation resources by allowing for the postponement of the process.  Of course, the costs associated with the preparation of the proposal for the extension itself are other other consideration factors. What is your opinion on the effect of this change; will it save administrative burden as intended?  We’d love to hear your thoughts!

Oct 15 / RAS

You’re Certifiable

It’s that time of year again: effort reporting and certification is upon us.  Wayne State relies upon effort reporting for faculty and staff on grants to confirm that salaries and wages charged to sponsored projects are reasonable for the agreements in place and the actual work performed.  Without effort reporting and certification compliance, financial penalties and expenditure disallowances could result.

 

In order to help navigate the effort certification system, the folks at CLAS put together some very helpful materials:

 

And for further reading on the process itself, check out SPA’s effort reporting page.  If you have any difficulty with the system or figuring out who needs to certify whom, RAS has been there and can offer guidance!

Oct 1 / RAS

Lunatic Fringe

Our friends in Sponsored Program Administration recently announced adjustments to the fringe benefit rates, based on the amendment to our Federal Rate Agreement.  These changes are effective today (10/1/14); here are the highlights, in case you missed them:

 

  1. There are now only four fringe rate categories (reduced from the previous six).
  2. Employee classes are allocated by new role/function definitions.
  3. The “premium” rate that was previously applied to certain designated funds has been eliminated.

 

These changes will impact the charges to non-General Fund funds, depending on the categorical mix of employees that are charged to those funds.  A schedule showing the “old” and “new” rates by employee class was provided by the Associate Vice President for Fiscal Operations and Controller (Jim Barbret), and is accessible here.

 

Mr. Barbret has indicated that the Fiscal Operations website will be updated as soon as the updated rate agreement is in hand.  Gail Ryan, Assistant Vice President for SPA, has also offered to answer any questions that you may have.  And, as always, RAS is here to help as well!

Sep 24 / RAS

International Trial of Mystery

Is your department conducting (or planning to conduct) international, patient-oriented research?  NIAID (National Institute of Allergy and Infectious Diseases) has a database of country-specific clinical research regulatory information called ClinRegs, and it is now live (beta)!

 

ClinRegs is a public resource designed to assist in the planning and implementation of international clinical research.   The database is a tool that can be used to examine regulations within a country, and compare requirements across nations.  Search countries currently include Brazil, China, India, Kenya, Malawi, Peru, United Kingdom, Tanzania, South Africa, Thailand, Uganda, and the United States; there are plans in place to incorporate regulations from Mali, Mexico, Vietnam, and Haiti in 2014.  ClinRegs allows you to explore topic areas such as:  clinical trial lifecycle, competent authority oversight, ethical review, informed consent, investigational products, specimens, and sponsorship.

 

ClinRegs is soliciting feedback through a survey (linked in the upper-right corner of their home page) or using their “Contact Us” feedback email address.  Take it for a spin and let them – and us! – know what you think!

 

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!