As you may have heard, the ISMMS COREs are excited to introduce iLab’s Core Facility Management software, an online system to improve your user experience and simplify the process of ordering and billing for core service requests. The new iLab solution will replace eRAP and move the COREs into the next generation of resource management processes.
Specific benefits of implementing the iLab solution to the PI/user are:
- Researchers can find all shared resource facilities in one central location.
- iLab provides a consistent interface for searching resources, requesting services, and updating project progress.
- CORE landing pages can be viewed external to the system, allowing researchers external to the institution to view services available.
- COREs can automatically generate recharges and invoices. Charges related to core services can be posted directly to the general ledger, eliminating data re-entry, and improving data accuracy.
Additionally, ISMMS is working with iLab to integrate with:
- Our Single Sign On (SSO) system so that users can use their ISMMS login credentials to access iLab (the same credentials used to access ISMMS email).
- Our financial systems so that iLab can house active funds for all PIs and their lab members.
The roll-out, effective 2/1/2016, involves six (6) CORE facilities:
- Biorepository and Research Pathology
- Flow Cytometry
- Human Immune Monitoring
- Mouse Genetics
Please stay tuned for additional announcements as we prepare for this exciting new era in Core Resource Management.
The PPHS and the IRB offices at the Mount Sinai Health System sites have been successfully integrating policies, practices, and forms this year. Below are some key policies and processes that have been adopted by all sites:
- Consent process, policies, and template:
- In April 2015, a system-wide consent template was introduced and became mandatory throughout the system on May 1, 2015. All informed consent documents should be on the 4/1/15 template version.
- In October, 2015:
- The HIV in Research Consent must be used when HIV testing will occur within the research setting, including as part of screening for a research study.
- Consent documents for storing data/specimens will use the same future use language boilerplate.
- Consent documents when depositing data/specimens in large repositories will use the same boilerplate language. (See Guidance on Future Use and GWAS)
- In August, 2015:
- all sites adopted the ISMMS/MSH Phone consent process for minimal risk research when collecting PHI.
- Short Form Consent Policy. In August, all sites adopted the ISMMS/MSH Short Form Consent Policy. All requests must be made in advance to IRB@mssm.edu. Each request is evaluated on a case-by-case basis. (It is rare that a fully translated consent document is not required; ad hoc translation is not allowed).
- Policy on use of external IRBs. In July, all sites agreed to allow for the use of commercial IRBs. These remain limited to specific types of projects and are evaluated on a case-by-case basis. All requests to use a commercial IRB must be sent to IRB@mssm.edu using HRP-229A. There is a one-time administrative set up fee of $575 for industry sponsored research permitted to use a commercial IRB for the official IRB review of the study. For additional information, please review the Use of Commercial IRBs under Guidelines and Policies
- Guidance documents:
- Recruitment methods (revised 10/7/15)
- Screening guidance
As always, we appreciate all you do to protect the research volunteers who agree to take part in the research conducted by Investigators working within the Mount Sinai Health System.
The GCO recently released “Budgeting Students and Post Graduates on Federal Research, Fellowship, and Training Grants,” a new publication that includes administrative information, such as descriptions of students and post graduates (e.g., postdocs, residents) and the types of grants they may participate in, and helpful InfoEd application submission information. One early user commented, “This is great information! Thanks for putting it together as a single document.” With such a rave review, anyone who is budgeting for these important members of our research community should check it out now by clicking here!
If you have been reading your e-mails from the GCO, you will have seen the NIH eSubmission article entitled “New Year, New Forms, New Policies” with this pretty picture of delicate yet hardy flowers blooming in the midst of a winter frost. NIH/AHRQ changes can be broken down into the following “blossoms.” OK, that’s a stretch of poetic license. We’ll just call them “groups.”
- Changes to Competitive Applications for due dates on/after 1/25/16 through 5/24/16
- Changes to Training Grants beginning with RPPRs 12/1/15
- Changes to Competitive Applications for Due Dates on/after 5/25/16
The NIH and AHRQ have been announcing many new forms and policies and a good way to find out about the details is to read those GCO communications. If you’ve missed GCO’s trilogy, back copies are available upon request by e-mailing firstname.lastname@example.org. If you prefer reading direct from the source over GCO’s Reader’s Digest version, please click on these NIH notices: NOT-16-004; NOT-OD-16-006; NIH-OD-16-007; NIH-OD16-008; NIH-OD-16-009; NIH-OD-16-010; NIH-OD-16-011; NIH-OD-16-012.
In July, the Office of Research Services launched a new tool called the “Agreement Navigator.” If you ever have had an agreement and you weren’t sure where it was supposed to go for processing and signature, (was it GCO or maybe MSIP or was it the FACTS office?), this new resource will help you. Confidentiality Agreements, Data Use Agreements, Subaward Agreements, and Grant Agreements are some of the categories you will find. Click here to open the Navigator. The Grants and Contracts Office posted a link in the Getting Started section of the GCO Application Info webpage and the Policies and Procedures section as well.
In July, the Program for the Protection of Human Subjects (PPHS) announced that all sites within the Mount Sinai Health System can use commercial IRBs in accordance with the Icahn School of Medicine at Mount Sinai’s policy.
All requests to use a commercial IRB must be sent to IRB@mssm.edu using HRP-229A. The PPHS office must approve any request to submit an application to the commercial IRB. While the official IRB review will then be conducted by the external IRB, all other institutional requirements must be met. These are including but not limited to Investigational Drug Service review, Radiation Safety Committee review, submission to the Grants and Contracts Office, Conflict of Interest disclosure and management, and fulfillment of education requirements. Requests will be evaluated to ensure these institutional requirements have been met before a study team will be granted permission to move forward with their application.
There is a one-time administrative set up fee of $575 for industry sponsored research permitted to use a commercial IRB for the official IRB review of the study.
The 229A form is available on the Forms and Documents Kiosk on the PPHS website.
For additional information, please review the Use of Commercial IRBs under Guidance and Policies.
After reviewing the 229A form and Commercial IRB guidance and policies, if you have questions about the policy and if your study might qualify, please contact Liz Carroll at email@example.com or 212-824-8225.
Back in July, the GCO released Sinai Central Investigator Form (IF) Instructions, which are a comprehensive set of policies and procedures that apply to the Icahn School of Medicine at Mount Sinai and all the member hospitals. “Designing and implementing the best conflict of interest management policy is complicated,” says Jessica Moise, Grants and Contracts Officer and Senior Associate Dean for Sponsored Programs. “Filling out the disclosure forms shouldn’t be.” The IF instructions include technical instructions on completing the form, common problems and solutions, status tables, a contact section, and other helpful information.
This Fall, effective with competitive grant applications submitted on or after January 25, 2016, the National Institutes of Health (NIH) plans to release updated SF424 application instructions and funding opportunity announcements that will include additional requirements in the Research Strategy section. The Research Strategy section must address three more points of consideration as follows:
- Scientific Premise
- Rigorous Experimental Design
- Consideration of Sex and Other Relevant Biological Variables
Although the NIH requires more information in this section, the page limit does not increase.
Principal Investigators will also need to include a new attachment entitled “Authentication of Key Resources” into their application. In this attachment, researchers disclose what they have done to authenticate key biological and/or chemical resources.
The NIH has posted more information in two policy notices, NOT-OD-15-102 and NOT-OD-15-103, and the research community can also refer to NIH’s FAQs , which contain helpful definitions and other practical information on this topic.
The use of the new National Institutes of Health (NIH) biographical sketch format is required for all applications due on or after May 25, 2015 per NOT-OD-15-024. A Biographical Sketch, or Biosketch, is required for all key personnel included in NIH grant applications. Applications may be rejected by the NIH if the old biosketch format is used. Creating the new biosketch takes time, so it is important that key personnel start early!
The revised format increases the page limit for the biosketch from four to five pages and includes a new section for researchers to describe up to five of their most important contributions to science. The new biosketch gives the researcher the ability to describe in their own words what makes them a qualified individual for the proposed project. One of the main goals is to focus on actual individual accomplishments and not publication metrics. Reviewers will be able to see and understand immediately the quality of the applicant, instead of inferring capabilities based on a list of citations. That is not to say publications are not important, and they are still included in the new biosketch format. A researcher may include up to four publications for each of the contributions to science.
While creating the new biosketch may be somewhat time consuming, it is important that it be crafted well. Researchers should not worry so much about the number of contributions listed, but should focus on communicating the quality of the work accomplished. Do not be afraid to sell yourself! This is a chance to let reviewers know that you are a qualified, dedicated researcher with all of the skills necessary to carry out the proposed project.
To help researchers make the transition to the new biosketch format, the NIH National Center for Biotechnology Information (NCBI) designed a system – the Science Experts Network or SciENcv – that allows researchers to easily maintain and create biosketches in multiple formats. SciENcv interacts with other electronic systems, eRA Commons and ORCID, to pull information already existing in those databases into a central location. NCBI also already houses a list of publication citations for each investigator via the Bibliography in the MyNCBI portal. This allows the SciENcv system to automatically pull in information and publication citations without the researcher having to type in everything or worry about formatting! The system does it for you!
If you need hands-on assistance with using the SciENcv system or have questions about the biosketch and publications, contact Amanda Norton, Senior Grants Specialist, Grants and Contracts Office at firstname.lastname@example.org.
A blank biosketch template and SF424 instructions can be found on the NIH Grants & Funding website. For more information on the new format and requirements, see Updates in NIH Biosketch and the NIH Biosketch FAQs.
The GCO is building its training and education programs by offering GCO 101 classes aimed at newcomers to the submission process and revamping its training and education webpage. “I am pleased to announce the launch of the GCO 101 classes and the new and improved training and education webpage,” says Jessica Moise, Senior Associate Dean for Sponsored Programs. “We are always striving to provide better service and an easy to understand process in a complex regulatory world. These two initiatives should go a long way in helping to achieve that goal.”
GCO 101 participants learn the basics of the sponsored project and research application submission process at Mount Sinai, including key terms and definitions used in sponsored project administration and best practices for a successful submission. These 1 ¼ hour sessions are generally held the 1st Monday at 3:00 pm and the 3rd Thursday at 9:15 am of each month. The Monday classes are held at the uptown east side Mount Sinai campus, which is a convenient location for many faculty and staff. The Thursday sessions held at the Mount Sinai 150 East 42nd Street campus, GCO headquarters, gives attendees the opportunity to meet GCO staff after the class. “(It’s a) relaxed setting away from campus,” commented one of the participants. Please see the “Upcoming Events” section for session dates and registration information.
GCO’s Training and Education Webpage
The GCO has overhauled its training and education webpage so that it truly reflects the opportunities provided by Mount Sinai, the NIH and other professional organizations dedicated to sponsored projects administration. One highlight is that the site includes the latest training resources that the NIH provides on grants, funding and the peer review process. “NIH’s training material on the grants and funding process is scattered among many different websites across the NIH, CSR, and YouTube and it’s hard to tease out which are the most important or fundamental classes, especially for new applicants to the process,” says Allison Gottlieb, Director of Sponsored Programs Education at the GCO. “Grant Application Basics, for example, is a must for the newcomer. The introductory series includes two NIH videos running only about 20 minutes and much important supplemental information.”
“We would like to say goodbye to applications with errors and delays that can be avoided and make the application submission process as turbulance free as possible,” continues Allison Gottlieb. “And of course we are aiming for more successful and awarded applications. The new, basic GCO 101 submission class coupled with a more robust training and education webpage on the submission process will help us reach these goals.”