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.

 

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.

GCO Helpful Hints: Submitting a Multi-Project Application

Preparing a competitive multi-project (also known as a multi-component or complex) application?  GCO would like to remind you of two important resources.

  • Review GCO’s NIH ASSIST Checklist. It will walk you through administrative logistics and ways to avoid administrative  delays for NIH competitive multi-project applications.
  • Attend an InfoEd Open Help session. The Research IT team will help you set up the project on InfoEd and will be available to answer technical questions.  Bring your questions and any file you want to work on.

Questions about Sponsored Projects?  Please click here for a listing of Departmental Grants Specialists at the GCO who can assist you.

 

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.

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.

 

Ideate Now Available for Initial Expedited Projects

In a continued effort to support the clinical research community, the Program for the Protection of Human Subjects (PPHS) is offering researchers an opportunity to use Ideate now for Initial (new) Expedited project submissions to the IRB.

Ideate is an advanced, logic-driven, user-friendly system that is specifically designed to simplify and expedite the research application submission process for investigators and research personnel.

Please contact Lori Jennex (lori.jennex@mssm.edu) directly to discuss this opportunity.