Cleared Export Control… Leaving on a Jet Plane

Your principal investigator has answered yes on the export control compliance section in Cayuse.  Did you remember to add Export Control to the Approving Units page?  This is an important section that will protect the university and the researcher from severe criminal and or civil penalties, because of unintentional noncompliance to federal regulations.  Export Control is not a topic that is widely discussed or thought about when a principal investigator begins writing a proposal and the administrator starts assembling the application package.

The word “export” will cause many to believe you’re talking about sending items outside the United States, but this is not the case and it may also include consulting, training, and speaking at conferences.  The code of federal regulations under the Export Administration Regulations (EAR) defines export as, “an actual shipment or transmission of items out of the United States”, which also includes releasing or transferring.  Most don’t consider that something can be exported via auditory, visual, verbal or electronic means.  This is the reason that our Export Control office exists in order to prevent the innocent violation of any federal regulations.  If you want to learn more about export compliance click on the link https://research.wayne.edu/integrity/export-control and take note there is an CITI Export Control Module offered by WSU.

Is this the Right FOA for Me?

NIH advertises available funding for grant support through funding opportunity announcements (FOAs). One can search for an announcement specific to their area of interest/expertise or apply to one of the generic NIH parent announcements.  FOAs can be accessed via the federal-wide portal – Grants.Gov or via the NIH Guide for Grants and Contracts.

Please be sure to read the FOA very carefully as there may be additional instructions that refer you to select a specific “companion funding opportunity” within the Parent Announcement.  For example, applications that include clinical trials must be submitted in response to an announcement that allows clinical trials; the same applies to applications that do not allow clinical trials. 

You want to avoid a situation where you’re close to completing the application only to find out the “error” that keeps arising is the result of downloading the wrong application.  If you want to know more about “Understanding the Funding Opportunities”, NIH has a website that provides you with some great tips to be aware of.

If you have any questions, don’t hesitate to contact the SOM Research Administrative Services (RAS) Office via RAS@med.wayne.edu

What Do You Want From Me? A Field Guide to SoM-Level Review

School of Medicine-level review in the proposal queue has been around for a while now, but long cycles of funding can prevent even the most well-funded among us from subjection to our scrutiny.  And, as in all protocols sponsor-related, new compliance elements are being added all the time.  Here’s a quick-reference guide on what we’re looking for, and why:

 

  1. The full proposal. We have to see what is going to the agency, even if internal budgets are provided.  This way, we can say “yes, we knew that this is what Dr. X communicated to the sponsor, and we can support that with necessary School of Medicine resources.”  If you are using the system-to-system submission feature through Evisions, your full proposal is already included!  If your proposal needs to be submitted by other means (such a sponsor website), use the “Print to PDF” or similar feature to save a copy of the proposal, and upload the PDF to the “Attachments” section of the Evisions record.
  • For subcontracts: if WSU is the subcontractor, we don’t need the prime proposal, but we do need the letter of intent to subcontract, and the supporting documents that are being submitted to the prime recipient institution.

 

  1. Your internal budget. If you are doing a detailed budget on a system-to-system submission, you’re probably covered.  If, however, you are submitting a budget overview or a modular proposal, we need to verify that the funds requested are commensurate with planned funding.  This also helps us check for cost share.

 

  1. Cost share commitment forms. Speaking of cost share, any cost share commitment forms must be uploaded to the “Attachments” section of the Evisions record.  If there is a cash match commitment in the proposal, there must be evidence of the agreement of the match source uploaded.  In addition to the uploaded forms, choose “YES” on the Evisions “Proposal Budget” page as the answer to “Cost Sharing.”  This will reveal the ability to enter cost share information, such as department and index, so that the cost sharing department can verify their commitment to the cost share.
  • For over-the-cap:  In pre-award, we do not require a fully-executed cost share commitment form for the amounts over-the-cap (no Dean signature, no Fiscal Affairs signature) but we do require a department signature for awareness documentation.  Please also provide the index that will fund the cost share.  Note: over-the-cap cost share is considered “Voluntary.”

 

  1. OnCore accountability, or waiver: If you have human subjects, you have to either include OnCore fees in your budget, show how you will be cost sharing the fees, or upload a waiver to “Proposal Attachments.” Waivers are obtained from the Clinical Research Service Center, whether your project is clinical or not.  Unfamiliar with the policy?  Check out the handbook!

 

  1. Correct coding. Evisions coding is super important!  The data that is input at this phase is the basis for a whole host of reporting that affects such things as department rankings and investigator credit.  To be sure that you are getting full and accurate credit for the submission, be sure the “General Information” is input correctly; take a look at our coding table for guidance, or ask us if you’re not sure.
  • Investigator credit: This is done on the “Personnel Roster” page of the Evisions record.  If your investigator has a retreat to more than one department, s/he will have to be listed twice (or as many times as s/he has appointments) and the credit split proportionally between departments.  Confused?  Give us a shout.

 

Most of what we need to see is what your GCO also needs, with a few additions and for different reasons.  We’re not here to duplicate SPA review; we’re here to ensure the School of Medicine can support your project in a compliant way.  Remember: it’s extremely important to route your proposal before submission!  This way, every source of manpower and resources on your project is aware and on board.  The result?  Fewer headaches at award time, and more credit where credit is due.