What the GCO Actually Does Need From You in Your InfoEd Application

Last month GCO issued a Helpful Hints e-column on “What the GCO Doesn’t Need From You in Your InfoEd Application,” which generated some enthusiastic feedback.  So the GCO decided to let the pendulum swing the other way by offering you the Helpful Hints companion column, “What the GCO Actually Does Need From You in Your InfoEd Application.”

Here’s a list of the Top 9 Items the GCO needs to keep your project on track, in shape, and administratively healthy.

  1. Your Research or Sponsored Project Application

This one might be obvious since the GCO is the centralized office for research and sponsored project applications, but it must be not so obvious since it’s making its way to the #1 slot on this list. The list below highlights some of the more obtuse GCO submissions.  Needless to say, it is not exhaustive.

  • New Sponsored Project Application – The actual entire application.
  • Industry Sponsored Clinical Trial  – The company written protocol; GCO doesn’t need the Investigator Brochure.
  • New Project Where You (i.e., Mount Sinai) are the Sub-Award on Someone Else’s Project – Statement of Work (SOW) and relevant parts of the application if the SOW does not provide adequate information.  Refer to GCO’s Policy/Procedure Memo When Mount Sinai is the Subawardee for more information.
  • New internally funded / unfunded study – The protocol that you or a colleague wrote.  You may also use the HRP-503 Protocol Template if the project is going to the IRB.  But please, don’t give the GCO all the IRB forms.

Rule:  Whatever documentation the funding agency is asking from you, please submit that to the GCO.

  1. Your Progress Report

What is the use of a Progress Report application without a progress report?  This one is actually equally tied for the #1 slot but let’s make it # 2 to make this communication more art than science. More obtuse examples are outlined below.

  • Projects where the external funding agency requires a progress report every year- the actual entire external progress report.
  • NIH 1st No Cost Extension – Make it easy and complete this NIH 1st Time No Cost Extension and Progress Report Form.
  • Non-Competitive Continuation Where You (i.e., Mount Sinai) are the Sub-Award on Someone Else’s Project – SOW or confirmation of No Change in the SOW; and a Progress Report.  Refer to GCO’s Policy/Procedure Memo When Mount Sinai is the Subawardee for more information.
  • Internally funded study continuation or externally funded without a requirement for a progress report from the funding agency –  A progress report that you write yourself.

You may also use the HRP-212 Continuing/Final Review Progress Report if the project is going to the IRB. But please, don’t include all the other IRB forms.

Rule: When reading this column, apply the rule in #1 to # 2 too.

  1. E-Form

Forgot to click on the link at the bottom of the Internal Documents tab, choose the appropriate 1 of 2 e-forms, and complete it?  Not a problem.. The GCO will just submit your multi-million dollar InfoEd application back to after you moved major mountains to get 5 departments to sign off in 10 minutes flat and burned all your political capital to go through this routing process once again.  There’s no other workaround.  The GCO has in earnest tried.  Please remember the form and the right one at that too.  GCO takes no pride in the power of the reject button.

  1. Investigator Form (IF)  #

Think bold.  When you insert that # in your E-form, it’s like you’ve built a bridge between two cyberspace universes – InfoEd and Sinai Central, enabling your designated GCO Grants Coordinator to  transverse these parallel systems as he/she goes along methodically checking that the appropriate personnel signed off on the Sinai Central forms for your project.

Added the IF # to the box in the E-form?   Take a deep breath, internalize your achievement, and move on to the next item on the list.

Did you, by chance, insert last year’s IF #, an IF # from another project, or some other alien UFN (unidentifiable form number)?  It’s like you’ve created a volcano of confusion which can cause a meltdown of both staff as well as the actual cyberspace universes you truly seek to bridge.  New Info Ed submission = New IF #.  We’re moving on.

  1. Signed Conflict of Interest (COI) Forms and Suspension and Debarment (S&D) Form, if applicable

Now that you’ve got the IF # squared away, don’t forget the GCO can’t review your InfoEd application until all the appropriate personnel have electronically signed off on the Sinai Central COI and S&D forms (when S&D is applicable).  You don’t need to add any extra documentation in the InfoEd application.

Allison Gottlieb of the GCO reports, “If I had a nickel for every time a GCO Grants Coordinator issued an ‘Incomplete COI’ email to a PI, I’d be able to pay for private school college tuition for all my kids and that’s a lot of kids. Donations, anyone?”

Seriously, you are empowered in your spare work time to check Sinai Central to see if the investigators have signed the forms and follow up with them if you see “Status: Not started” or some other equivalent, worrisome term.   What do the statuses mean? How do you go about checking?  Go to the IF Instructions for more information and helpful tips.

  1. Up to Date Certification of COI Education Module for all Investigators

The GCO is the institutional gatekeeper for research and sponsored projects and reviews compliance with both external and internal regulations for each project under review, and that includes whether investigators are COI certified.   You don’t need to include anything extra in the InfoEd application for this requirement.

But what you can do is be proactive and check that the investigators’ education certification on your project has not expired.  It is good for four years.  How to check and what to do if it is expired?  Refer to the Sinai Central COI Education Module section of the Application Submission Checklist Instructions.  GCO must notify the COI Office of investigators who are not certified and must also remove them from NIH projects.

  1. Project with Subawards? Don’t Forget all the Subaward Documentation

This would make for a good class but until then, please do refer to GCO’s subaward policy/procedure memo.  There’s a list of what’s required. Take heed of all of the “show stopper” information in there.  Failure to include required items can result in removal of the subaward from your project.

  1. Less is Not Always More.  Include the Triple Signed Cost Sharing Memo if You Need

“Don’t worry,” your co-investigator reassures you.  “I’ve got this one covered. I’m working for free on your project.”  That might sound simple and save you the money that you need to use for something else on the project BUT you now need to jump through three administrative hurdles worth of signatures and include the signed cost sharing form in your InfoEd Application.  If you’ve put an investigator on with effort and no salary and cannot procure a triple signed cost sharing form documenting that some internal fund (i.e., not another grant fund) somewhere in the school/hospital is actually covering the cost, the GCO has no choice but to remove the investigator from your project.  Please review the cost sharing policy for more examples of cost sharing and general policy/process information.

  1. New Competitive Application to Say … the Chamber Music Society of America testing whether chamber music orchestra members are more calm and composed than heavy metal artists? Due tomorrow, but not getting funded for a year?  Wait before you submit that IRB application! GCO’s got an easier initial step.

Include a compliance waiver form signed by the PI with your InfoEd application, which explains that if the project will be funded, the PI will submit to the PPHS Office at a later time, and of course not rush the PPHS Office for immediate review if the PI forgets.  If this project were, say, with chimpanzee and zebrafish musicians, you can use the waiver form for the down the road IACUC submission too.

For additional criteria for the use of the waiver form refer to the Compliance (PPHS/IACUC) section of the Application Submission Checklist Instructions.

Got any other useful advice for your fellow investigators?  Feel free to send to allison.gottlieb@mssm.edu to include in a future GCO Helpful Hints column.

 

Are You Recruiting Healthy Subjects for Clinical Research?

The Office of Research Services periodically receives inquiries from members of the general public seeking opportunities to participate in clinical research projects. In order to serve our research community and the community at large, we are establishing an informal list of studies that are currently seeking participants. If you would like to add your study to this list, please submit a Research Subject Recruitment Request with a copy of the current IRB-approved consent and preferred contact information.