The Investigational Drug Service (IDS) has implemented e-prescribing for clinical trials. Investigators may electronically prescribe ambulatory medications for outpatient trials to the Investigational Drug Service at Mount Sinai Hospital. There are several advantages to this system. For example, medication orders are linked to GCO numbers in order to avoid protocol deviations. In addition, study-specific templates may be pre-built for the user’s convenience to be updated at the time the order is placed. Please note, if a researcher is e-prescribing controlled substances, they will need to go through an enrollment process to gain the appropriate level of permission to proceed, which can be arranged via their designated department’s enrollment supervisor.
When e-prescribing for research, please take note of the following:
- Enter the GCO number of the study (GCO#xx-xxxx) into the medication field.
- Indicate the date due after the directions for use.
- Refills are NOT authorized for investigational agents.
- Select Mount Sinai Hospital Pharmacy (ID#74819) by searching “IDS” or “Investigational” or “Mount Sinai” or “Mount Sinai Research.”
This new process has been put into place in anticipation of the New York State’s mandate effective March 27, 2016. Although these regulations do not apply to investigational medications, Mount Sinai Hospital wanted to offer the service to the research community.
If you have further questions about the e-prescribing mandate, please contact the NY State Bureau of Narcotic Enforcement. Contact information can be found online.
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:
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:
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:
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.
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:
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.
At the close of February 2016, Jonathan A. Cohen, DVM, MS, DACLAM, a trusted and valued member of the Icahn School of Medicine’s research community, took the reins as Interim Director of Center for Comparative Medicine and Surgery (CCMS).
“I embrace the challenges of this new role, and look forward to the hard work to propel the Center to new heights,” commented Dr. Cohen, reflecting his enterprising approach.
Dr. Cohen joined the CCMS faculty in 2010 as Assistant Professor Comparative Medicine and Surgery and Assistant Professor, Medicine (Renal). He has served as Assistant Director, CCMS and Head of Small Animal Medicine. He was promoted to Associate Director of CCMS in 2013 after leading the successful AAALAC re-accreditation effort, receiving high commendations from the site visit team. As Associate Director, he assumed major day-to-day oversight responsibilities for the CCMS operation. Specifically, he has been the veterinary point person for establishing the Gnotobiotic program (essential for Microbiome research), the rodent colony management program, introduction of genotyping services (Transnetyx), and oversight of the rodent health monitoring program. He oversees the Husbandry Operation team of approximately 50 technicians, supervisors, and managers.
Dr. Cohen graduated from the Tuskegee University School of Veterinary Medicine in 2007 and completed his laboratory animal training within a comparative medicine research postdoctoral fellowship at Wake Forest School of Medicine in 2010.
The research community is pleased to welcome Dr. Cohen in his new role.
The NIH updates for competitive research grants and most career development award applications for due dates of 1/25/16 to 5/24/16 are now in effect. Another round of changes, which will apply to deadlines on or after 5/25/2016, is expected to be released by the NIH by 3/25/2016. Highlights of the changes are summarized below.
The major changes from Phase 1, which are now in effect, are as follows:
- Change to Significance and Approach Sections in Research Strategy of Research Plan: Rigor and Reproducibility requirements
- New Authentication of Key Resources Document (for applicable projects)
- Change to Human Subjects Section in Research Plan: NIH Lowers the Age Individuals are Defined as Children from under 21 to under 18
- Change in Vertebrate Animals Section in Research Plan
The NIH is planning a Phase 2 of application changes, including the release an updated Application Guide in a new FORMS D version by 3/25/16. The major changes center around new forms and other clarification and highlights are as follows:
- New Data Safety Monitoring Plan Form
- Updated Inclusion Enrollment Forms
- New PHS Assignment Request Form
- Change to Font Guidelines to Add Flexibility
- Biosketch Clarifications
- Appendix Changes
The above is not an exhaustive list of NIH application changes. If you would like more information, please e-mail Allison.Gottlieb@mssm.edu for GCO’s “Special Series” e-mails or refer directly to NIH Notices NIH-OD-16-004, NIH-OD16-008, NIH-OD-16-009.
GCO has made available to the research community new resource documents. Entitled “Application Submission Process: Which Applications and Forms Do I Work on First?,” one is a general document that provides the order submission steps applicable to all projects, and the second is specifically for unfunded human subject studies.
“PIs and their staff often feel like pinballs in a pinball machine being bounced from one administrative office to another,” says GCO Sponsored Programs Education Director Allison Gottlieb. “We don’t want our research staff on ‘TILT’ mode. These 1 page step sheets were created to ameliorate that effect and provide clear easy guidelines for a smooth submission.”
The Program for the Protection of Human Subjects (PPHS) is releasing a new guidance document this week that clarifies their procedures regarding the change of research personnel. To better serve researchers and their staff, this guidance has been broken down into three easy-to-understand categories, contact person, personnel changes that require IRB review and approval prior to their implementation, and personnel changes that do not require IRB review and approval prior to their implementation.
Researchers and staff will be able to quickly determine what category applies to their change using clear and concise lists. From there, they can determine their next steps and obligations. Make sure to keep an eye on the PPHS’ Researcher’s Palette, Guidance and Policies to obtain the latest guidance on this and all other IRB-related requirements.
For more information, contact Liz Carroll, Assistant Director of Regulatory Affairs of the PPHS.
The Program for the Protection of Human Subjects (PPHS) cordially invites you to the latest IRB Grand Rounds, “Ring, Ring – Plan to Phone Screen?,” on April 20th at 12pm in Hatch Auditorium. This session offers insights and expertise from Glenn Martin, MD, DFAPA, CIP, who will be covering the policies and practices of screening potential human subjects in research.
Dr. Martin serves as Senior Associate Dean for Human Subjects Research and Executive Director for the PPHS. Originally appointed as an Institutional Review Board (IRB) member in 1996, Dr. Martin’s commitment to the protection of human subjects has spanned decades. Dr. Martin specializes in ethics in clinical research and lectures to ISMMS medical and graduate students, psychiatry residents at Elmhurst Hospital Center, and trainees at other institutions. He also conducts patient privacy and research presentations for the entire ISMMS research community.
Mount Sinai Innovation Partners (MSIP) now hosts a monthly seminar series, The Intellectual Property (IP) and Commercialization Speaker Series, featuring guest speakers from leading law firms, healthcare organizations, and institutions. Topics cover important concepts and developments within the emerging IP and technology development landscape and are chosen in advance by the guest speaker(s).
Lisa Wisniewski, President at S3B Consulting LLC and William Chiang, PhD of MISP will be addressing the question “So You Want to Develop a Drug?” in an upcoming discussion on March 23rd.
MSIP welcomes both the Mount Sinai research community and the ever-growing research community within New York City. For direct questions about the series and upcoming events, please contact Neil McNulty – Marketing Manager.
Hashley joins the GCO after serving in Department of Preventive Medicine as a Program Coordinator. As a Grants Coordinator, he will be responsible primarily for intake of sponsored project and research applications and review of corresponding Sinai Central forms.
Jennifer Pan comes to the GCO with approximately 25 years of experience in grants administration most notably as the Senior Grants Manager at Mount Sinai St. Luke’s and Mount Sinai West. Jen has been actively involved in the integration of these sites’ researchers into the Icahn School of Medicine at Mount Sinai community.