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.

 

Helpful Hints – Summer Time and NIH Other Support

...Oh summer time,

… a beautiful time of year to relax in the sun by the beach listening to the restorative sounds of the ocean waves or at least dream about it while stuck in your clammy cubicle at work. 
… Oh summer time,

… a slower time to get to know each other better or at least to daydream about that opportunity. 
… Oh summer time,

… no time like the present to talk about how the NIH wants to get to know you better, dear senior/key personnel, through a document they call the “Other Support” page.

One type of Other Support page that the NIH wants is requested before the NIH might make that exciting award for new, resubmission or renewal applications as part of the Just In Time (JIT) process. The other type of Other Support page wants is part of the annual RPPR (i.e., non-competing) application process.  You can find instructions and helpful samples of both Other Support types here.

The Other Support (OS) page is not a portion of your Biosketch repackaged.  Pay attention to the details below and may you be rewarded with a more timely award and fewer delays in the process.

Ever hear of the “Overlap” statement that goes at the bottom of each Other Support page?  Be sure to read all about it in section “1.8 Other Support” in this NIH Supplementary Instructions document.

Other Support Page: New, Resubmission and Renewal Applications
Do Include:

  • Both active and pending sponsored projects.
  • A page for each Senior/Key Personnel.
    Is there a subaward on your project? Don’t forget to get their pages too. Same rules above and below apply for the subs.
  • An OS page for each senior/key person that says “None” if he/she has no active or pending projects.
  • Calendar months effort (e.g., 6 CM) for each sponsored project, not percent effort (e.g., 50%).  Note at Mount Sinai we use “calendar month” effort.  If you’re working with subs, they may use calendar, academic, and/or summer months effort as per their institutional policy.
  • The annual direct cost amount and not the total cost amount for each project.
  • An overlap statement at the bottom even if the overlap is “None.”
  • A commitment overlap statement at the bottom if awarding this new grant will put you over 95% effort on active sponsored projects.  Add a note to the overlap section at the bottom explaining what change you plan to make.
    Read more about Faculty Effort on Sponsored Projects in Sponsored Projects Accounting’s policy.
  • Industry awards (e.g., pharma funded clinical trials) and sponsored projects in no cost extensions.

Don’t Include:

  • The new grant –  the one you have your fingers crossed for funding.  Leave that one off.
  • Expired projects.
  • Training grants where you are listed as a Mentor.  However, are you a training grant director or participating with measurable effort (i.e., check budget – are you listed with effort)? If yes, then yes, do include on the OS page.
  • Prizes or Gifts or Major/Minor User Status on Equipment Grants.
  • Other significant contributors unless their involvement has changed so that they now meet the definition of senior/key personnel.

Other Support Page: Research Performance Progress Reports (RPPRs)
Do Include:

  • A page for each Senior/Key Personnel only when
    –  there is a new active project or projects to report on
    and/or
    –  a sponsored project that was previously reported on expired or the person is no longer participating.
    Is there a subaward on your project? Don’t forget to check on their pages too. Same rules above and below apply for the subs.
  • Calendar months effort (e.g., 6 CM) for each sponsored project, not percent effort (e.g., 50%).  Note at Mount Sinai we use “calendar month” effort.  If you’re working with subs, they may use calendar, academic, and/or summer months effort as per their institutional policy.
  • The grant for which you are submitting the RPPR.  When doing so, include the effort that will be devoted in the next reporting period.
  • Active sponsored projects.
    –   Annotate what the change is; which previously active awards ended and/or which previously pending awards are now active.
  • Industry awards (e.g., pharma funded clinical trials) and sponsored projects in no cost extensions.
  • The annual direct cost amount and not the total cost amount for each project.
  • An overlap statement. See the JIT OS section above for more info.

Don’t Include:

  • Any pending sponsored projects.
  • Training grants where you are listed as a Mentor.  However, are you a training grant director or participating with measurable effort (i.e., check budget – are you listed with effort)? If yes, then yes, do include on the OS page.
  • Prizes or Gifts or Major/Minor User Status on Equipment Grants.
  • When there are only changes in levels of effort of active support.  Let’s say your co-investigator reported last year that her effort on a grant was 15% and now it’s 10%. If that’s the only change, don’t submit the Other Support page.
  • Other significant contributors unless their involvement has changed so that they now meet the definition of senior/key personnel.

Now that we’ve got the Other Support page squared away for now, here’s one final wistful note about summer…

… Oh summer time, stay with us longer.  How we enjoy you so.

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.

Department of Corporate and Foundation Relations Announces Funding Opportunities

The Department of Corporate and Foundation Relations of the Mount Sinai Development Office provides this curated list of funding opportunities to find faculty who may be interested and to provide assistance with the application process. Please see below for some of their upcoming deadlines, and check out their website for more information: http://icahn.mssm.edu/research/portal/resources/corporate-foundation-relations.

Please note – if you are interested in general funding opportunities (not a specific RFP listed here), please fill out the form linked on the site with your inquiry.

Melanoma Research Foundation: https://www.melanoma.org/research-center/research-grants
The Melanoma Research Foundation (MRF) is committed to advancing research across the spectrum of melanoma – from prevention through diagnosis, staging and treatment. The MRF proactively partners with the NCI, Congress, the Department of Defense and other foundations to develop and collaborate on a broad agenda for melanoma research that takes full advantage of all opportunities, while also sharing challenges. Since 1998, the MRF has funded over 130 innovative, high impact, basic, translational and clinical research projects. Further, in 2016, the MRF awarded over $1.2 million dollars in new melanoma research.

  • Young Investigator Research Team Award
  • The MRF, in partnership with the MRF Breakthrough Consortium (MRFBC) and Bristol-Myers Squibb (BMS), is pleased to announce a new research award for 2017 for young investigator teams designed to advance the field of translational immuno-oncology research.
  • Applications will be accepted until September 15, 2017.

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 deadline is October 1, 2017.

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.

  • 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.

Pepper Center Requests for Proposals to Support Innovative Pilot Projects and Junior Investigators

Mount Sinai’s Claude D. Pepper Older American’s Independence Center (“Pepper Center”) innovative mission is to stimulate, develop, and fund research to improve quality of life and independence of older adults with serious illness and their caregivers. This multiyear program project grant from the National Institute of Aging has helped to create a foundation of pioneering research in aging and palliative care at Mount Sinai, and has helped to improve care for our nation’s sickest patients.

The goals of Mount Sinai’s Pepper Center are to identify, recruit and train leaders in aging and palliative care research as well as provide funds to support pilot and exploratory projects related to aging and palliative care.  TWO REQUESTS FOR PROPOSALS TO DIRECTLY SUPPORT PILOT AND EXPLORATORY PROJECTS AS WELL AS SUPPORT ACADEMIC DEVELOPMENT FOR JUNIOR CLINICIANS:

  • The Pilot and Exploratory Core provides support for investigators at all levels to propose innovative projects aimed at improving the care of older adults with serious illness.
  • The Research and Education Component provides support for salary and coursework for talented junior investigators interested in pursuing a career in research (basic, translation, and health services) related to the care of older adults with serious illness.

For additional information, please review the requests for proposals (linked above), which include information about funding opportunities as well as timelines. Please contact Ashleigh Manning (Ashleigh.Manning@mssm.edu) for additional information.

The Mount Sinai OAIC (Older American’s Independence Center) is supported by a grant from the National Institute of Aging (2P30AG028741; Albert Siu, PI).

 

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.

Reminders for Upcoming May 25 Competitive NIH Grant Application Deadline and Beyond

The Grants and Contracts Office (GCO) offers the following reminders about guidelines, updates, and policies pertaining to National Institutes of Health (NIH) grants and their administration.

Option to Report Preprints and Other Interim Research Products Effective 5/25/17 (NOT-OD-17-050)
(excerpted from NIH Notice)
Interim Research Products are complete, public research products that are not final.  A common form is the preprint, which is a complete and public draft of a scientific document. Preprints are typically unreviewed manuscripts written in the style of a peer-reviewed journal article. Scientists issue preprints to speed dissemination, establish priority, obtain feedback, and offset publication bias. Another common type of interim product is a preregistered protocol, where a scientist publicly declares key elements of their research protocol in advance. Preregistration can help scientists enhance the rigor of their work.

For applications submitted for the May 25, 2017 due date and thereafter, awardees can claim these products on their progress report publication list.  They can also report them on their RPPR as of May 25, 2017, and link them to their award in their My Bibliography account.

For complete information, please read NOT-OD-17-050.

Appendix Policy Change for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After 1/25/17 (NOT-OD-17-035)

Updated Font Guidelines for Applications to Due Dates On or After 1/25/17 (NOT-OD-17-030)

Coming Down the Pike – Form Changes Affecting 1/25/18 Competitive Grant Applications and Beyond (NOT-OD-17-062)
The  NIH is announcing application form changes planned for competitive applications due 1/25/18 and beyond. The form changes center on consolidating human subject and clinical trial information.   Please read NOT-OD-17-062 for more information about the move form the current FORMS-D to a FORMS-E version.

Please contact Allison Gottlieb, Director, Sponsored Programs Education, GCO, if you have any questions or need additional information.

Department of Corporate and Foundation Relations Announces Funding Opportunities

The Department of Corporate and Foundation Relations of the Mount Sinai Development Office provides this curated list of funding opportunities to find faculty who may be interested and to provide assistance with the application process. Please see below for some of their upcoming deadlines, and contact them at CorpFoundHelp@mountsinai.org, if you would like to find out more.

Melanoma Research Foundation: https://www.melanoma.org/sites/default/files/2017MRFRequestForProposals.pdf
The Melanoma Research Foundation (MRF) is committed to advancing research across the spectrum of melanoma – from prevention through diagnosis, staging and treatment. The MRF proactively partners with the NCI, Congress, the Department of Defense and other foundations to develop and collaborate on a broad agenda for melanoma research that takes full advantage of all opportunities, while also sharing challenges. Since 1998, the MRF has funded over 130 innovative, high impact, basic, translational and clinical research projects. Further, in 2016, the MRF awarded over $1.2 million dollars in new melanoma research.

  • Established Investigator Awards: up to $100K/year for two years
  • Career Development Awards: up to $50K/year for two years
  • The deadline for applications is March 1, 2017 at 5 pm ET.
  • Please see website for additional details and eligibility information.

American Society for Reproductive Medicine: https://www.asrm.org/uploadedFiles/ASRM_Content/Resources/Research_Grants/ASRM_Research_Grants.pdf
The primary purpose of the ASRM and SREI Research Grant Programs is to provide funds for new investigators to establish independent research programs. New investigators are those who have completed their training within the past three years and have independent faculty appointments at the commencement of the research. In special cases applications for bridge funding (i.e., between grant funding periods) for projects that are of benefit to other members of the Society, or for funding of new, highly innovative research projects by established investigators will be considered.

  • Grants in amounts of $10K to $50K will be considered on an annual basis; a total of $200K is available for 2017. The SREI Board will fund one grant of up to $40K.
  • Funds are available for project expenses, technical assistance, patient expenses, research supplies and durable laboratory equipment.
  • Up to ten percent (10%) of funds may be used for indirect costs or institutional overhead in circumstances deemed to be rare and extraordinary that are explained to the Research Committee.
  • Research grant funds may be expended over a 2-year time interval.
  • Please see website for eligibility information.

Harold Amos Medical Faculty Development Program: http://www.amfdp.org/for-applicants
The Harold Amos Medical Faculty Development Program of The Robert Wood Johnson Foundation, formerly known as the Minority Medical Faculty Development Program, was created to increase the number of faculty from historically disadvantaged backgrounds who can achieve senior rank in academic medicine, dentistry, or nursing and who will encourage and foster the development of succeeding classes of such physicians, dentists, and nurse-scientists.

  • The Harold Amos Medical Faculty Development Program supports basic/biomedical, clinical, dental, nursing, and health services/epidemiology research.  The purpose of the AMFDP award is to facilitate the transition of the newly-trained clinician who wishes to develop into an independent investigator.
  • The Award includes an annual $75K stipend + $30K for research support/year, for four years (up to $420K total).
  • The deadline for submission is March 15, 2017, 3pm EST for the online portion and March 16, 2017 for the postmark of the hard copy.

 

The STTEP-UP Initiative in Science and Medicine – Apply by March 31

The STTEP-UP Initiative in Science and Medicine, an NCATS funded training program, is delighted to announce the solicitation of applications from highly motivated URM trainees in residency, subspecialty fellowship training or postdoctoral laboratory positions within our health care system, for the academic year starting July 1, 2017 – June 30, 2018. This award provides salary support and tuition dollars for four postdoctoral trainees.

Application deadline: March 31, 2017.

Please visit our article in the previous issue of Research Digest for application details or contact Christine Acevedo (christine.acevedo@mssm.edu) at 212-824-7014.

 

GCO Helpful Hints – A Heartfelt Reminder

From the Desk of Allison Gottlieb, Director of Sponsored Programs Education:

This edition of the Grants and Contracts Office (GCO) Helpful Hints will be short and sweet, just like some of the people we know and love, who perhaps additionally (but no pressure), might have been the recipients of flowers, chocolates, and other heart felt gifts from you this past Valentine’s Day. image001

Please let this article serve as a reminder that if any related persons, regardless of height or temperament, are participating on your sponsored project, certain rules and regulations must be followed.  You’ll find them here in GCO’s policy entitled, “Supervision of a Related Party on a Sponsored Program.”

The document includes a definition of related parties and what exactly you need to do.