Must See Videos and Podcasts for Human Subjects Researchers

The Grants and Contracts Office (GCO) strongly recommends that human subjects researchers take advantage of educational resources issued by the National Institutes of Health (NIH) to inform grants applications submitted for due dates on or after January 25, 2018.

A primary component of NIH’s initiative to enhance the stewardship of clinical trials is the creation of a new application form that consolidates all Human Subjects and Clinical Trial related information into one place, and also expands the information required for studies that meet the NIH definition of a clinical trial. This new form will be included in the new FORMS-E Application Packages and will be required for all applications with due dates on or after January 25, 2018.

To support this endeavor for Mount Sinai Health System (MSHS) researchers, the GCO would like to highlight the following NIH resources:

To learn more about the new Human Subjects and Clinical Trial Information form which will be included in grant application packages and contract for all human subjects and/or clinical trial research applications beginning for January 25, 2018 due dates, visit the NIH New Human Subjects and Clinical Trial Information Form web site.

For more information about conducting human subjects research at MSHS, please contact the Program for the Protection of Human Subjects.

For more information about NIH grant submissions at MSHS, please click here for a listing of Departmental Grants Specialists at the GCO who can assist you.

 

Less InfoEd Data Entry – Elimination of Requirement to Enter Non-Key Personnel on Select Submission Types

Effective August 18, 2017, if researchers are submitting an InfoEd proposal for which the budget tab is not required, they no longer need to data enter non-key personnel in the InfoEd Personnel tab.

Below are project types that do not require a budget tab:

  • ISMMS funded
  • Projects in which the extramural funding agency provides funding by per subject payments (e.g.,  Pharmaceutical sponsored multi center clinical trial, NIH CALGB protocol)
  • No cost extensions

Examples of typical non-key personnel positions are research coordinators, research assistants and technicians.  Please review GCO’s Glossary of Common Terms for  additional information.

Also, please be aware that this policy change is for GCO InfoEd submissions only.  This policy neither applies to documentation submitted to PPHS or IACUC nor personnel data entry on Sinai Central, Ideate, or any other software system. Please contact the GCO at grants@mssm.edu, if you have questions about this change.

Retirement of Rebecca Balentine, GCO Associate Director and Promotion of Amanda Amescua, GCO Assistant Director Announced

Rebecca Balentine and Her Team

Rebecca Balentine and Her Team
(from left to right Mary Mbabazi, Amanda Amescua, Rebecca Balentine, Olga Carr, Michelle Yoon, Edwin Berrios)

We are both saddened and delighted (for her!) to announce the retirement of Rebecca Balentine from the position of Associate Director, Grants and Contracts Office (GCO) effective Friday, April 28, 2017. She has  been an outstanding member of the GCO family, and her three year term at Mount Sinai has been a wonderful capstone to an exciting 35-year career in research administration! Her hard work, dedication, and sense of humor have been central to the success of her team, and she will be greatly missed. Please join the GCO in thanking Rebecca for her valuable years of service and wishing her well in her future travels!

While we are sad to see Rebecca go, we are also pleased to announce Amanda Amescua will be taking over her role as Assistant Director, effective May 1, 2017.  Amanda Amescua has received a well-deserved promotion from GCO Senior Grants Specialist to Assistant Director.  Amanda has approximately 10 years of experience in sponsored project administration including positions at Columbia University Medical Center, Duke University Medical Center, and the University of Texas at Austin.  We are confident that Amanda will make a fine edition to the leadership team.  Please join us in congratulating Amanda in her new role.

Updated Financial Administration of Clinical Trials Services (FACTS) Website Coming Soon and Other Announcements

Please stay tuned for a new reorganized Financial Administration of Clinical Trials Services (FACTS)  website that will provide a more comprehensive and transparent approach to navigating the contract life cycle through Meditract. Meditract, which was launched last year, offers users the ability to track the status of their agreements in real time.

Reflected in this new website is the fact that the FACTs team has grown. Their addition of new Senior Contracts Specialist allows for more efficient and expedient contract management and thus an improvement on turnaround time.

In addition, a new fee schedule for FACTS services was announced on March 3, 2017 and will be implemented starting April 1, 2017.

 

GCO Helpful Hints – Travel Haiku to Ponder

Suitcase with Map_smFrom the Desk of Allison Gottlieb, Director of Sponsored Programs Education:

Traveling by way of airplane is often a time with many hours sitting around to wax pensive on the grandeur of the universe in all its complexity or the karmic force that put you next to the hyper-active hysterical child.

Keeping this in mind brings me to my next thought and that is about, yes. Haiku (plural). My first foray into the venerable language art form of haiku was in 4th grade starring my pet Gerbil Jerry, may he rest in peace.

Jerry the Gerbil
Lives in a small dirty cage
He gnaws newspaper

Post elementary school and many years of gainful employment at Mount Sinai is my next foray into haiku where a reader can plumb the depths of travel policy vis-à-vis grants.  Here are a few poetic lines to keep in mind before taking that trip by plane, boat, subway, taxi, rental car or sneakers* funded by your sponsored project.

Haiku 1. All Travel

Travel on a Grant
To get reimbursed, must have
Prior Approval


Haiku 2. International Travel on NIH Grants

Prior Approval
International Travel
GCO approves.


Haiku 3. International Travel on NIH Grants – A Point of Confusion Clarified

Part 1

Traveler on a Grant
But nowhere found on budget
GCO questions –

Part 2

The PI answers –
Traveler added in mid-year
Can we charge grant fund?

Part 3

GCO responds –
Yes, do add a comment in
Sinai Central please.


Haiku 4.  Creative Space for Reader to Add His/Her Own

[intentionally left blank]

 

 


Haiku 5, 6, 7 and 8    Reasons Travel Requests Frequently Get Rejected/Delayed

For those inspired to create travel haiku but in need of more structured topics –

  1. Not booking a Fly America Act compliant airline; more info in link in Haiku 1 above.
  1. Not an obvious or well explained relationship between the trip and the scope of work of the project; see link in Haiku 2 above.
  1. Referencing foreign collaborators in the justification for the trip, but having no foreign involvement as per the grant submission.
  1. Check Google Maps Prior to Submitting International Travel Request (and Going on Your Trip) – New Mexico, Babylon, and Toledo Might Actually Be in the USA

[intentionally left blank]

 

*list is not all inclusive

 

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.

 

FACTS Office Launches Budget Negotiation Services for Industry Sponsored Research Studies

The Financial Administration of Clinical Trials Services (FACTS) office is pleased to announce the availability of budget negotiation services for industry sponsored research studies. With the recent addition of specialized staff, FACTS can now assist with the development and negotiation of budgets by doing a complete comprehensive review of the protocol in order to identify the best estimate of costs to conduct clinical research. The staff will work with the Principal Investigator and study team to identify all internal budget needs based on fair market value.

Please call the FACTS office at 646-605-7251 or email FACTS@mssm.edu to discuss these services.

 

NIH Phase II Application Changes (Forms D) for Competitive Applications with Due Dates on or After 5/25/16

Important NIH application changes (Forms D) are in effect for competitive applications with due dates of 5/25/16 or later.  You may wish to review the “Significant Changes” section of the Forms D Version Application Guide or NIH’s reminder notice NOT-OD-16-081, which summarizes the changes.

Please be reminded that PIs submit NIH single project applications (e.g., New R03, Resubmission K08, Competitive R01) and other federal sponsored projects (e.g. new AHRQ grant) through InfoEd directly as “System to System” submissions.  Do not log onto the federal grants.gov to submit these applications.

 

Helpful Hints: What the GCO Doesn’t Need in Your InfoEd Application

MessyDesk_2Here’s a list of the Top 6 Items the GCO doesn’t need in your InfoEd application, which should reduce some cyber clutter and save you time.

 

  1. IRB Forms

Thanks but no thanks.  GCO has enough of its own forms.  If your application is a yearly continuation of an unfunded human subject project, please feel free to copy the progress report (HRP 212), which you need for the IRB submission, and submit it in the Progress Report tab in the InfoEd application.  However, please don’t send the GCO consent forms, etc. unless the funding agency is requesting you send these items to them.

  1. Biosketches

That place in the Personnel tab sure looks like a requirement. But no, only include the Biosketch if this is a System to System (S2S) application and in that case only for key personnel, Other Significant Contributors and Consultants.  Otherwise ignore.  Sorry, it is not possible to deactivate the button.

  1. Other Support

That place in the Personnel tab sure looks like a requirement too. But no.  Ignore. Only include if it is a requirement for a S2S application, which would be a rarity.  Sorry, it is not possible to deactivate the button.

  1. Extra InfoEd Budget Data Entry

Submitting a multi-million dollar NIH ASSIST project? Tons of work! Awesome and good luck! GCO only needs Y1 data entered in the InfoEd budget tab.  More budgeting shortcuts can be found in the Budgeting section of GCO’s Application Submission Checklist Instructions.

  1. InfoEd Projects Where the GCO Doesn’t Need a Budget Tab – GCO Also Doesn’t Need to Know About TBN Positions or Consultants

That’s right, less data entry on the Personnel tab. For applications that don’t need an InfoEd budget tab (e.g., any unfunded project, no cost extensions, pharma sponsored studies where the pharma company pays per subject), don’t spend time adding TBN positions or Consultants.

GCO will add this shortcut to the Application Submission Checklist Instructions.  In the meantime, take note of this shortcut.

  1. InfoEd Projects That are Non System to System – GCO Doesn’t Need to Know about Other Significant Contributors (OSC)

Got an OSC on a NIH non-competitive application?   OK, leave him or her off the Personnel tab in the InfoEd application.

GCO will add this shortcut to the Application Submission Checklist Instructions. In the meantime, take note of this short cut.

Department of Corporate and Foundation Relations Announces Funding Opportunities

The Department of Corporate and Foundation Relations of the Mount Sinai Development Office offers this curated list of funding opportunities to faculty who may be interested, and it also provides assistance with the application process for these programs. Interested investigators can contact them by emailing CorpFoundHelp@mountsinai.org to find out more.

The Sontag Foundation Distinguished Scientist Award:
https://www.sontagfoundation.org/Display.aspx?id=44

The Sontag Foundation is looking for early career scientists with the potential to create new waves across the brain cancer field. They are looking for increased survival rates and improved recovery for patients.

  • Projects are funded for four years, for a maximum of $600,000.
  • Application deadline: March 16, 2016

Whitehall Foundation Research Grants:
http://www.whitehall.org/grants/

The Whitehall Foundation, through its program of grants and grants-in-aid, assists scholarly research in the life sciences. It is the Foundation’s policy to assist those dynamic areas of basic biological research that are not heavily supported by Federal Agencies or other foundations with specialized missions. In order to respond to the changing environment, the Whitehall Foundation periodically reassesses the need for financial support by the various fields of biological research.

  • Typical grants are for up to $225,000
  • Letter of Inquiry deadlines: April 15 and October 1

Arnold and Mabel Beckman Foundation Young Investigators Program:
http://www.beckman-foundation.org/byi-program-guidelines

The BYI program funds promising young scientists early in their careers who have not yet received a major award from another organization. Projects proposed should be truly innovative, high-risk, and show promise for contributing to significant advances in chemistry and the life sciences.

  • Projects are normally funded for a period of four years, in the range of $750,000 over the term of the project.
  • Letter of Inquiry deadline: Spring 2016
  • Please contact us if interested.

Gerber Foundation:
http://www.gerberfoundation.org/pd-research/research-awards/application-process

The Gerber Foundation’s mission focuses on the nutrition, care and development of infants and young children. Therefore, grant-making interests are focused on nutrition and/or health-related research having a significant impact on issues facing infants and young children from the first year before birth to age 3. The Foundation is particularly interested in fresh approaches to solving newborn or pediatric problems or emerging issues with a predictable time frame to clinical application. Projects should be focused on issues faced by care providers that, when implemented, will improve the health, nutrition and/or developmental outcomes for infants and young children.

  • Letter of Inquiry deadline: June 1, 2016

Damon Runyon Rachleff Innovation Award:
https://www.damonrunyon.org/for-scientists/application-guidelines/innovation

The Damon Runyon-Rachleff Award is designed to provide support for the next generation of exceptionally creative thinkers with “high-risk/high-reward” ideas that have the potential to significantly impact our understanding of and/or approaches to the prevention, diagnosis, or treatment of cancer.

  • The initial award will be for two years, at $150,000/yr, with the opportunity for up to two additional years of funding, for a potential total of $600,000.
  • Application deadline: July 1, 2016

 

Rolling Deadline Opportunity: Please email CorpFoundHelp@mountsinai.org if you are interested in this rolling deadline program, and the Department of Corporate and Foundation Relations will facilitate approaching the foundation.

Broad Medical Research Program @ Crohn’s and Colitis Foundation of America

Research grants are available for innovative proposals that will lead to improvements in the prevention, diagnosis, or therapy of Crohn’s disease or ulcerative colitis. BMRP-CCFA especially supports research that can be readily translated to improve the care of human IBD in the near future.