PPHS Takes Steps to a Uniform and Integrated Submission Process

The Program for the Protection of Human Subjects (PPHS) Office reports the following updates to the integration of IRB operations across the Mount Sinai Health System (MSHS), and the ongoing implementation of IDEATE, Mount Sinai’s new electronic system for research application submissions.  Together, these policy changes and the establishment of IDEATE will create a more uniform and efficient process for starting a human subject research project.

 Effective immediately:

  • The 229R Reliance form is no longer required for multisite research.  For research occurring at more than one Mount Sinai Health System site, the PPHS Office will accept the System Chair’s signature as approval for all sites. The System Chair can designate this signing authority, and only one signature will be required regardless.  This signature is currently affixed to the HRP-211 form, but this will change as the PPHS further integrates our processes into IDEATE.
  • All federally funded projects will be submitted through the PPHS Office, regardless of the project’s Health System site of origin. This change will support a more streamlined submission process and allow for better coordination of grant approvals with federal agencies.
  • All new multisite projects involving Icahn School of Medicine at Mount Sinai and/or The Mount Sinai Hospital will be submitted to the PPHS Office, either through the current process or IDEATE, when applicable.  Applications for these multisite projects should not be submitted to another Health System site for review. Initial expedited projects will be submitted through IDEATE as the new system is rolled out to each department.  The PPHS Office has already made this change with select departments, whose investigators will now submit all initial expedited projects through IDEATE, regardless of the project’s Health System site of origin.  As more departments begin using IDEATE for project submissions, they will also use the new system for research at all Health System sites.  As the IDEATE rollout schedule accelerates, the PPHS Office will work closely with each department as they adopt the IDEATE submission process for initial expedited projects.
  • All Exempt projects to be conducted at any site within the Health System will be submitted through IDEATE.
  • Full Board projects will be submitted through IDEATE on a pilot basis over the next several weeks to ensure a smooth transition process.  It is anticipated that all Full Board projects will be submitted through IDEATE beginning Q3 2016. If you are interested in using your Full Board project for the IDEATE pilot, please contact me at lori.jennex@mssm.edu or (212) 824-8203.

 Projects not impacted by the changes above at this time:

  • Multisite projects that do not involve Icahn School of Medicine at Mount Sinai and/or The Mount Sinai Hospital should be submitted to the IRB of the Health System site where the majority of human subject interventions will take place (e.g., Mount Sinai Beth Israel).
  • Single site, non-federally funded Full Board projects should continue to be submitted to that Health System site’s IRB.

E-Prescribing Study Medications to the Investigational Drug Service

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.

For more information about e-prescribing within the Mount Sinai Health System, visit the EPCS Intranet, email the project team: EPCSquestions@mountsinai.org, or contact the IDS at 212-241-2437.

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.

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:

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.

Gerber Foundation:

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.


New Interim Leadership for the CCMS

JonathanCohenAt 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.


NIH Changes to Application Forms – Phase 1 Now in Effect

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:

  1. Change to Significance and Approach Sections in Research Strategy of Research Plan: Rigor and Reproducibility requirements
  2. New Authentication of Key Resources Document (for applicable projects)
  3. Change to Human Subjects Section in Research Plan: NIH Lowers the Age Individuals are Defined as Children from under 21 to under 18
  4. Change in Vertebrate Animals Section in Research Plan

For more information, refer to NIH’s updated Application Submission Guide (FORM C 11/25/15 version), the Rigor and Reproducibility webpage, Rigor and Reproducibility FAQs,  and NIH’s Open Mike Blog.

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:

  1. New Data Safety Monitoring Plan Form
  2. Updated Inclusion Enrollment Forms
  3. New PHS Assignment Request Form
  4. Change to Font Guidelines to Add Flexibility
  5. Biosketch Clarifications
  6. 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.


The Anti-Pinball Effect Documents: New GCO Resources for Proposal Submissions

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.

Pinball-2“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.”


Making Changes to Research Personnel in IRB Submissions

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.


IRB Grand Rounds Returns in Spring

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.