All Human Subject Initial Expedited Projects to be Submitted in Ideate Beginning 5/31/16

The Program for the Protection of Human Subjects (PPHS) is moving forward in its roll-out of the IDEATE electronic submission process. Currently all Exempt projects are being reviewed through IDEATE, and starting Tuesday, May 31, 2016, all Initial Expedited applications from all departments must use IDEATE.

Research Administration has been working for many months on this new electronic submission process using a program called IDEATE, which will be used when applying for human research project approval.  At this time IACUC and some IRB submissions are reviewed using the software, and the plan is for the submission program to serve all research administration offices (i.e. PPHS, IDS, RSC, IBC, CRU, etc.) and allow all of the research offices to electronically review a single application! This will be a marked improvement over the current state where multiple different submissions may have to be made for a single project.

There is no required training, but the PPHS encourages you to connect with the IDEATE@mssm.edu team for assistance.  Remember that an IF submission must first be created through Sinai Central, all education requirements must be met for everyone on the team, and an InfoEd submission started by the research team before a submission will be accepted by the PPHS.  The PPHS also suggests that your researchers register with IDEATE for access to the system and ask that they update their profiles (adding their CV) before they begin their first submission. 

Please follow the helpful links below for assistance.

IMPORTANT NOTE: Currently, only Firefox browser is supported for IDEATE at this time: Download Firefox

We encourage your feedback over the next several months, as we make this system robust and fix the emerging issues.  Thank you in advance for your attention to this very important project.

 

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.

 

Epic for Research Participant Recruitment

The Office of Research Services (ORS) and the Epic Clinical Transformation Group are pleased to invite the Mount Sinai clinical research community to unlock the potential of the Epic Electronic Health Record (EHR) system for clinical research subject recruitment. Originally piloted by the Clinical Trials Office of Tisch Cancer Institute (TCI), Epic Clinical Trial Alerts (CTAs) can help make a meaningful match between clinical researchers and clinicians who have recently seen potentially eligible subjects for their studies.

Epic CTAs create alerts, visible to care providers at the point of care, in the Epic EHR for patients matching screening criteria for a clinical trial. The provider can then discuss with the patient and choose “yes, interested” in which case an inbox message is sent in Epic to the designated research personnel. The patient will then be contacted to discuss the trial further and obtain consent.

Myeloproliferative disorders (MPD) are a group of slow-growing blood cancers in which large quantities of abnormal red blood cells, white blood cells, or platelets grow and spread in the bone marrow. The MPD Program at TCI is one of few comprehensive, multidisciplinary programs in the Northeast offering extraordinary expertise and personalized treatments, backed by extensive research and clinical trials. The Cancer Clinical Trial Office’s MPD Research Program was able to identify 65 additional eligible patients, of which 13 were successfully enrolled in a clinical trial. This EHR CTA pilot accounted for 23% of the new subjects enrolled into MPD therapeutic clinical trials.

For more information, visit http://icahn.mssm.edu/research/resources/office-of-clinical-research/research-subject-recruitment-tools/epic-for-research-participant-recruitment, or Mount Sinai Health System researchers can also contact Joseph Kannry, MD, Lead Technical Informaticist, for further details or with questions about the functionality being offered via the Epic EMR.

 

Intellectual Property Resource Videos

Mount Sinai Innovation Partners (MSIP) is pleased to introduce Intellectual Property Resource Videos to the Mount Sinai research community. The Intellectual Property (IP) Series, created by our colleagues from the University of Michigan’s Center for Entrepreneurship, consists of short videos designed to guide entrepreneurs through the important concepts of IP during their startup. University of Michigan Law Professor, Bryce Pilz, covers a variety of important topics including patents, copyright, trademarks trade secrets, and more.

For any questions pertaining to your intellectual property, please contact your MSIP representative, send us an email at technology@mssm.edu, or call us at (646) 605-7301.

 

Funding Opportunities from the Department of Corporate and Foundation Relations

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 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.

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: Late spring 2016
  • Please contact us if interested.

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

Helen Hay Whitney Research Fellowships:
http://www.hhwf.org/HTMLSrc/ResearchFellowships.html

The Helen Hay Whitney Foundation supports early postdoctoral research training in all basic biomedical sciences. To attain its ultimate goal of increasing the number of imaginative, well-trained and dedicated medical scientists, the Foundation grants financial support of sufficient duration to help further the careers of young men and women engaged in biological or medical research.

  • Candidates who hold, or are in the final stages of obtaining a PhD, MD, or equivalent degree, and are seeking beginning postdoc training in basic biomedical research are eligible to apply. Candidates should have no more than one year of postdoc research experience at the time of the deadline for submission; received a PhD (or equiv) no more than two years before the deadline; or received an MD no more than three years before the deadline.
  • The current stipend/expense allowance is: $51K in year 1, $52K in year 2, and $53K in year 3, with a research allowance each year of $1500.
  • Application deadline: July 1, 2016

 

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.

New GCO Staff Member Announced

PlMichelle-Yoonease join the Grants and Contracts Office (GCO) in welcoming the newest addition to their staff, Grants Specialist Michelle Yoon.  Michelle comes to the GCO with 7 years of experience as a clinical research coordinator at Mount Sinai. She holds a BA from Columbia University and a BS from CUNY/Hunter College.  Michelle will be handling work from the Department of Psychiatry and the Division of Pulmonary, Critical Care and Sleep Medicine.   Michelle is replacing Leo Imatani who had handled this portfolio previously and has taken a position in the FACTS office.

Centralized FedEx Shipping of Biological Substances for Clinical Trials

On April 14, 2016, the Office of Research Services (ORS) announced a new pilot process for centralized FedEx shipping of biological substances for clinical trials at Icahn School of Medicine at Mount Sinai.

Effective Monday, April 18, 2016, clinical trial shipments with a FedEx pre-paid label may be dropped-off as follows:

  • Location of drop-off:  Mailroom on the SB Level of 5 East 98th Street
  • Drop-off Time:          On or before 4pm, Monday thru Friday
  • Mailroom Contact:     Assistant Manager Sybil Allen (212) 241-6161 (x46161)

Packages must be dropped off with a FedEx pre-paid label by 4:00pm to ensure same-day shipping. Any FedEx shipments after 4:00pm or on the weekends will continue to be the responsibility of the research team.  For all shipments, please ensure the shipper is IATA Certified and that the label and packaging are in compliance with current regulations for shipping biological substances (http://www.un3373.com/info/regulations/).

This initiative, which was developed in response to feedback from our research community, seeks to establish a more streamlined process for using FedEx for clinical trial shipments.  The pilot process will be reviewed after three months to ensure it has made a positive impact for our investigators and research staff.

If you have any questions about shipping biological substances, please email Mark Matthews, Director of Environmental Health and Safety, at mark.matthews@mssm.edu.

If you have any questions, concerns or feedback regarding this pilot process, please reach out to Sonia Kleiner-Arje, Director, Office of Research Services (ORS), at sonia.kleiner-arje@mssm.edu or 212-824-7640.