Happy Trials To You

Occasionally there is confusion as to whether clinical trials need to be processed through the Wayne State University SPA office.  To put some minds at ease, let’s clear that up now: the answer is nearly always “yes.”

Just as any other external funding that is not a gift (and is therefore processed through Development), clinical trial documentation must be handled through your Grant and Contract Officer.  An eProp starts your process, routing your contracts and budgets through the proper channels for approval. Because clinical trials involve contracts, yours will be seen by the Office of General Counsel to check for compliance with Wayne State regulations.  Again, your contracts will get to OGC by starting the process through eProp; your contracts aren’t submitted directly to the office.

Once the University has signed off on the contract and any necessary IRB approvals, a tentative or active index establishment will take place, depending on the level of execution of the contract.  For a very detailed account of the steps that take place once your clinical trial documentation has been submitted through eProp, see SPA’s information on Processing Pharmaceutical Clinical Trials.

Remember, a complete eProp for a clinical trial includes the following attachments:

  • Clinical trial agreement
  • Affirmation memo signed by the PI
  • Internal budget
  • Study protocol
  • Sponsor contact information

…until we meet again!

A1 is Not Just a Steak Sauce

Since 2009, the NIH has not allowed the resubmission (otherwise known as an “A1”) of a failed application without a significant change to the scope and content of the science.  Well, times they are a changin’.  Last week, NIH announced a policy change that allows for submissions of similar ideas that were unsuccessful in the past.  While the new policy still allows a single resubmission per application, ideas that were unsuccessful as a resubmission (A1) may now be presented in a new grant application (A0) without having to materially redesign the content and scope of the project.  This policy applies to all NIH announcements that allow resubmissions, including: FOAs for research grants, the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, Career Development Awards, Individual Fellowships, Institutional Training Grants, Resource Grants, Program Projects, and Center Grants.

NIH’s policy for accepting overlapping applications stays the same (see NOT-OD-09-100). The NIH will not accept duplicate or “highly overlapping” applications under review at the same time. This means that the NIH will not review:

  • a new (A0) application that is submitted before issuance of the summary statement for  a new (A0) or resubmission (A1) application that is considered “overlapping”;
  • a resubmission (A1) application that is submitted before issuance of the summary statement for the previous new (A0) application;
  • an application that has “substantial overlap” with another application that is pending appeal of initial peer review (NOT-OD-11-101).

Additionally, NIH will not accept a resubmission (A1) application that is submitted later than 37 months after the receipt date of the application that it follows (see NOT-OD-12-128 and NOT-OD-10-140).  There is, however, no time limit between an unsuccessful resubmission (A1) application and a subsequent, new (A0) application; or between an unsuccessful new (A0) application and a subsequent new (A0) application (see NOT-OD-14-082).

 

What this means: The ability to submit a previously-rejected idea as new frees it from previous negative associations; that is, you don’t have to respond to previous reviews or carry the burden of prior analysis.  This gives ideas the possibility of maturing before resubmission without the penalty of being presented before their time. In fact, reviewers will be briefed on review as new ideas, even if they have seen it in previous cycles. Another advantage is that applicants will be able to consider previous reviewers’ comments in strengthening their applications for each submission, even without having to answer for them.  In addition to future submissions, this also applies to previous “virtual A2s”, meaning that an application that was not accepted earlier for being too similar to a formerly-reviewed resubmission (A1) application can now be submitted now as a new (A0) application.

 

For further explanation as to implementation of the new policy, check out NOT-OD-14-074, its clarifications, and the Resubmission Frequently Asked Questions pages.  Dr. Sally Rockey also has an excellent explanation as to the thought behind the policy change on her blog, Rock Talk, from April 17, 2014.

Tips and Tools: Everything Old is New Again

Many of you who read these entries attend our Tips and Tools meetings each month, and for you we have a resource from last month’s meeting: the Grant Math slides.  As you may recall, these slides reviewed common calculations for salary cap calculations, indirect costs on subcontracts, and rebudgeting between categories.  Whether or not you were able to attend the meeting, please feel free to contact us if you have any questions about the calculations (or any calculations at all!).  In today’s meeting, we’re discussing PMCID compliance, so you may also wish to download our PMCID Primer.

 

For those who are not yet aware, the RAS office holds “Tips & Tools” meetings on the third Wednesday of each month, from 9:00a-10:00a.  These meetings generally take place in 1358 Scott Hall and are open to all department administrators to whom grant management information is helpful.  We discuss everything in the realms of both pre-award and post-award, highlighting recently-released information that is changing the landscape of the world of research projects.  This meeting is a great opportunity to not only learn what is new, but to hear about methods and implements that other administrators have to share that have made their jobs easier.  If you are interested in attending or having your name added to the distribution list, please send us an email at RAS@med.wayne.edu!

Getting Carried Away with Saving Money

You’re responsible.  You’re conservative.  You’re great with money.  You get to the end of the year on your NIH project, and you have only spent $220,000 of your $300,000 budget!  Joy!  Rapture! New cell lines for all in Year 2!  You have a carryover!  But not so fast… sometimes being frugal doesn’t pay; in fact, if not done right, it could lead to penalty.

Carryover (or carry forward) is the transfer, at the end of a budget period to the next budget period, of any unobligated balance or over expenditure of funds which remains (except in the final year of a grant; and NIH allows carryover between competing awards: see NIH Grants Policy section 8.1.1.1.). Overexpenditures carried forward are a debit (including the prior year’s indirect cost rate) from the total funds available for the current year.  Keep in mind when calculating: there is a difference between unliquidated obligations and unobligated balances. Unliquidated obligations are commitments of the recipient and are considered to be obligations and, therefore, should not be reported as unobligated balances.  This affects your carryover percentage.

Wayne State University is a Federal Demonstration Partnership (FDP) university.  As such, automatic cumulative carryover is allowed up to 25% of the current year’s total budget. Any estimated unobligated balance (including prior year carryover) that is greater than 25% of the current year’s total budget on more than $250,000 must be explained in the non-competing continuation applications. To ensure carryover, the Financial Status Report (FSR) must be received by the agency no later than 90 days after the close of the budget period. This means that the Principal Investigator must work with SPA to ensure that the FSR is received by the agency within the 90-day period.

So back to our original hypothetical: what happens if you really DO only spend $220,000 of the $300,000 budget? The $80,000 in unspent/unobligated funds amounts to 26.7%, which means an explanation is required (unless specifically stated otherwise in your Notice of Award).  If you find yourself in need of approval for a carry forward, here is the information you will need to provide:

  • A detailed budget by direct cost category with the F&A cost information (base and rate) for the proposed use of the carryover funds. In general, carryovers to the following year will be approved using the F&A rate that was in effect at the time of initial award.  However, actual expenditures will still be based on the rate applicable when the cost is incurred.  Note: if personnel costs are requested, include a detailed breakdown of personnel costs, including base salary, salary requested and effort to be spent on the project during the extension.  
  • A scientific justification for the use of funds.
  • The reason for the unobligated balance.

For more information on carryover procedures and requirements, see NIH Grants Policy sections 8.1.2.4 (Carryover of Unobligated Balances) and 8.4.1.2.1 (Modified Annual Progress Reports), and let us know if you need assistance!

 

So You Have A Consultant

Before you read on to determine the best way to handle your consultant during the pre-award period, be sure you really DO have a consultant: check out “Show Us What You’re Working With: Consultants, Collaborators and Co-Is” to be sure your classification is correct!

Consultants are entities (individuals or companies) that recieve a portion of the funds from your grant as an expert advisor or provider of goods and services.  They are paid by the hour or day for the work they do on the project, unless they are not paid at all. Consultants do not maintain rights to intellectual property or authorship for published work from the sponsored project. While a consultant may contribute their expertise on a project, they cannot be named as a Co-PI or Co-Director, nor can they be considered as “key personnel.” Consultants should only be external to Wayne State; in rare instances a consultant may be employed by the University, but the chances are very high that if you are listing Wayne State University faculty, they should not be classified as “consultant.”  Don’t forget, there are parameters for any WSU employees to receive compensation for consulting services on sponsored projects.  The Office of Technology Commercialization provides a seven-point list on staying within bounds.

If required, all Conflict of Interest disclosures and any training from consultants must be submitted prior to the proposal deadline. See the WSU Division of Research Conflict of Interest page for details.

What to Include in the Proposal for Consultants
When listing a consultant in the proposal budget, include all their travel expenses and supplies as line items under the “consultant” subheading if these elements are part of their agreement. Since they are not employed by Wayne State, their travel and supplies cannot be listed under the normal “travel” and “material and supplies.” Consultants fees are generally listed as a daily/weekly rate or a flat fee for services.

Unless the sponsoring agency guidelines require any forms or letters related to consultants be included with a proposal, proposals are typically not required to include any additional forms related to consultants listed on those proposals. Once a grant is awarded, consultant expenses are treated as any other expense on the award.

If you have questions about how to properly classify personnel on your grant, don’t hesitate to contact us!  To learn more about the parameters for defining roles, check out Part II of the NIH Grants Policy Statement. “Consultant Services” are well defined in the table at 7.9.1, about half-way down the page.