As previously indicated in communication from the Program for the Protection of Human Subjects (PPHS), all NIH funded protocols that were active on December 31, 2016 (or commenced after that date) and involve human subjects, activities using or generating identifiable human subject data or samples, or the generation of individual level, human genomic data was automatically granted a certificate of confidentiality (CoC) by the NIH, effective October 1, 2017 (Please see the PPHS announcement for details).
In order to assure that the affected participants in qualifying protocols have been, or will be, notified, the PPHS requires that the Principal Investigator submit a copy of the Investigator’s CoC Notification Form for each protocol that received a CoC on October 1, 2017. While it is not required that the plan be fully executed at this time, it is important that the form(s) acknowledging that the plan is being implemented are sent to IRB@mssm.edu as soon as possible, if not done so already.
The PPHS has drafted a letter describing the pertinent information for participants (Spanish translation available upon request); however, research teams that choose to mail/email the letter to participants must also draft a cover letter reminding participants of the study and providing contact information for the study team in the event the participants may have questions. Please note that the original deadline for sending the letter to all participants, or notifying the PPHS that the task has not yet been completed was October 31, 2017.
If you have chosen to contact participants directly (e.g. phone, in-person), you should still complete the Investigator’s CoC Notification Form as soon as possible, if not done so already. If you have not spoken with all participants by November 30, 2017, you will need to re-contact the PPHS with an update on your progress.
If you have not already completed the above mentioned steps, please submit the Investigator’s CoC Notification Form upon receipt of this email, and reference the Guidance and Policies section of the PPHS website for additional details.
The Grants and Contracts Office conducted a major upgrade of InfoEd on Friday, November 17, 2017, and it may have affected some users’ submissions. Researchers may need to take additional steps to ensure that their submissions are properly completed.
If you started your project in InfoEd prior to the upgrade, which began at 5 pm of 11/17, and it has not already been received by the GCO, please be aware that finalizing, routing and sign off may be impaired since the old template will not convert to the new template properly without a manual intervention. Below are the steps to fix it:
- Go into the Setup Questions > Please select a Submission Mechanism/Screen Template. In this drop down, select any choice. Then re-select yours. This refreshes the program and creates the correct InfoEd application.
- You must re-upload your Lay Summary, Research Plan, Progress Report, and/or Final Report in the appropriate tabs.
- You should now see the eForm as a stand alone tab. If it’s new, the eForm is called “New/Competitive Renewals/…”. For other projects, it is called “Non-Competi Cont/Supplement…”
- On the eForm, please answer q. 16 re: location again.
Technical support for InfoEd applications is available by opening a Ticket with Research IT.
The CoRE administration is pleased to announce the formal agreement for Stony Brook University (SBU) to provide Proteomics and Metabolomics support to the Icahn School of Medicine at Mount Sinai (ISMMS). This agreement was presented at the recent SBU / ISMMS Scientific Symposium on October 30, 2017.
At the end of November all SBU cores, including Proteomics and Metabolomics, became available to ISMMS researchers. For more information on the proteomics services provided by SBU, please visit their Proteomics Core at http://dev-office-of-scientific-affairs.pantheonsite.io/research-core-facilities/bms.
To access SBU cores, please follow these steps:
- Log into iLab using ISMMS url (https://ismms.corefacilities.org/account/login)
- Click on the “list all cores” link on the left-hand menu
- Select other institutions in the dropdown menu and search for Stony Brook
- Select the core you want to use
The Mount Sinai Scientific Computing and Data Science team has launched training resources via PEAK to take researchers step-by-step through the i2b2 (Informatics for Integrating Biology & the Bedside) program, preparing them to take advantage of this cost-effective and efficient way to identify patients for many types of clinical and translational research. The i2b2 framework was developed through NIH funding to make research cohort discovery possible through the integration, standardization, and analysis of heterogeneous data from electronic health record systems. The implementation of i2b2 at the Mount Sinai Health System is supported by ConduITS, the Institutes for Translational Sciences and Mount Sinai’s CTSA (an NIH|NCATS Clinical and Translational Science Award).
To access the training on PEAK, simply click here, or head over to peak.mountsinai.org, sign in and search for “i2b2.” It’s also available through clicking on Online Courses, navigating to Research and clicking on the i2b2 Tutorial.
With an easy to use, drag-and-drop interface, i2b2 enables researchers to query a repository of patient information gathered from multiple sources throughout the Mount Sinai Health System, including electronic medical records, lab results, and demographic data. Using de-identified data, investigators can determine potential cohorts of interest for later obtaining identified or limited data sets with Institutional Review Board (IRB) approval. For more information about the IRB approval process, contact firstname.lastname@example.org.
This web-based tool works on Windows and Mac, on multiple browsers (Firefox, Internet Explorer, Safari, and Google Chrome) within the Mount Sinai network (on campus or via VPN). Data is uploaded from the Mount Sinai Data Warehouse on a regular basis, but only de-identified data can be accessed through the web client. Mount Sinai researchers can perform queries at http://msdw.mountsinai.org/webclient.
Please email email@example.com with questions or comments.
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:
- Podcast: “Understanding the Definition of a Clinical Trial and What That Means for You”
- Overview of New NIH Policies on Human Subjects Research and Clinical Trials
- A Walk-through of the PHS Human Subjects and Clinical Trials Information Form
(view below or click on link above to watch on YouTube)
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.
The 2017 Mount Sinai Inventor of the Year Award was presented to Yiannis Ioannou, PhD at the SinaInnovations Awards Ceremony on October 16 for his groundbreaking research and entrepreneurial spirit in bringing his research “from bench to bedside.”
Dr. Ioannou’s work in lysosomal storage diseases led to the first ever treatment for Fabry disease, in collaboration with Robert Desnick, MD, PhD, and the discovery of small-molecules that may serve as the basis for novel therapies for the treatment of numerous lysosomal storage diseases, including those with severe neurodegenerative effects. Yiannis’ commitment to seeing these discoveries translated into products that benefit patients and his tireless effort as an inventor-collaborator with Mount Sinai Innovation Partners culminated in the launch of a new company in partnership with institutional investors in early 2017.
The Mount Sinai Inventor of the Year Award was created to recognize individual or collaborative investigators in the Mount Sinai Health System. The award offers $10,000 to the recipient whose research is making, or has the potential to make, significant positive and product-driven impacts on health. The 2016 recipient was Dennis Charney, MD, Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai and President for Academic Affairs for the Mount Sinai Health System.
Watch the video highlighting Dr. Ioannou’s research endeavors and his inspiration for commercializing his technology with MSIP.
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.
Postdoctoral Enrichment Program – Burroughs Wellcome Fund
Postdoctoral Enrichment Program (PDEP) provides a total of $60,000 over three years to support the career development activities for underrepresented minority postdoctoral fellows in a degree-granting institution (an institution includes its affiliated graduate and medical schools, hospitals and research institutions) in the United States or Canada whose training and professional development are guided by mentors committed to helping them advance to stellar careers in biomedical or medical research.
- Generally, up to 12 awards will be granted for enrichment activities annually. This grant is meant to supplement the training of postdocs whose research activities are already supported. It is not a research grant.
- The program provides a total of $60,000 over three years as follows:
- Year one: $20,000 will be granted to support enrichment activities of the postdoctoral fellow ($10,000 for research supplies or equipment uniquely required to enhance the postdoctoral fellow’s research and $10,000 for education and training, including for mentors in the research lab where the postdoctoral fellow is assigned.)
- Year two: $20,000 (same allocation as year one)
- Year three: $20,000 will be granted to help the postdoctoral fellow advance research efforts towards the professoriate. The funds must be used to develop independent, innovative areas of research.
- Deadline: January 16, 2018 by 4 PM EST
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: 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.
The Office of Research Services is pleased to announce that its piloted process for shipping biological substances for clinical trials via FedEx at Icahn School of Medicine at Mount Sinai has facilitated nearly 2000 shipments since its pilot in April 2016. Mailroom Assistant Manager Sybil Allen reports, “the program has been a great success, and I work very closely with the Manager at FedEx, who makes sure that the packages are picked up on time.” Due to consistently positive feedback and increasing traffic, growing to an average of 40 packages per week in recent weeks, this service is now available on an ongoing basis.
Clinical trial shipments with a FedEx pre-paid label can be dropped off at the mailroom by 4:00pm for same-day shipping. Any FedEx shipments after 4:00pm will continue to be the responsibility of the research team. The mailroom is located on the SB Level of 5 East 98th Street, and Assistant Manager Sybil Allen can be reached at (212) 241-6161 (x46161).
For all shipments, the study team must 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/). If you have any questions about shipping biological substances, please email Mark Matthews, Director of Environmental Health and Safety, at firstname.lastname@example.org.
If you have any questions regarding this process, please open a ticket with your question to the Office of Research Services via Research 411.
Some of us may strive to be like a robot achieving our goals in the most efficient and systematic way possible. Others may resemble this robot before drinking their morning coffee. Wherever we may fall in this inner and outer robotic spectrum, please be aware that with the new version of InfoEd that went live on Tuesday, November 21, adjustments need to be made in our inner auto-robotic settings as some of the InfoEd fields and tabs have changed. You may also be pleasantly surprised with InfoEd’s enhanced functionality in the budget section.
The below highlights significant changes and increased functionality. In addition, Research Information Technology posted a slide set with screenshots and a corresponding podcast. They plan on updating training material as needed, so please do check back on the Research IT InfoEd Instructions web page for the latest updates.
- Initial Set Up Tab: “Step 3 Selecting a Sponsor”
Removal of sponsor drop down menu and “Preferred” box with simple typing data entry box.
- Tabs that Remain the Same or Little Change
- Brief Lay Summary
- Research or Program Plan and Progress Report Tabs
- Classification Codes
- Tabs that Are Different
- Set Up
- Internal Documents: Location of the “eForm” Moved to a Stand Alone Tab
- Personnel Tab: When Adding Personnel, the Default is Key Personnel
Please be sure to change the default in the provided drop down menu if you are adding someone other than key personnel.
- Subawards Are Added Differently
- Budget Tabs: Option to Enter Entire Budget onto the Main Budget Tab or into Individual Tabs by Period
- Budget Tab > Personnel: Defaults to “Person Months” Rather Than “% Effort”
You can change the default to “% effort” if you wish.
- Budget Tab > Personnel > Fringe Benefits: Option to Use Sinai’s Rates or Manually Data Enter the Amount
- Budget Tab: Entry of $ Amounts in Y1 in “Personnel” and “Non-Personnel” sections -Automatically Adds the Same Costs to Future Years if Future Years are Included.
Easy to remove or change the costs if needed.
- Modular Budget Tab – Defaults to Increments of 10, that is 10 Modules x $25,000 = $250,000
If your modular budget is not a request for $250,000 in direct costs per year, please do change to the appropriate number of modules.
Please open a Ticket with Research IT if you need technical assistance with your proposal.