Develop Proposal

Initial Steps

Carefully read the Funding Opportunity/ Program Announcement guidelines and instructions
Check the Standard Due Dates/ Deadline Schedule
Check eligibility requirements for the PI and Institution
Determine what forms are required
- NIH link to Forms H and the OGS Forms H presentation
Understand budget parameters
- What are the restrictions? What is allowable and unallowable?
Determine what platform is used for submission
- What are the steps for obtaining a log-in?
Review post award reporting requirements

And most importantly, develop a timeline including the deadlines for the department, OGS, and the sponsor.

Note: Cayuse routing must be started 8 days before the sponsor deadline!

For more examples, visit NIH’s Plan your Application and NIAAA’s Quick Guide for Grant Applications

Grant Writing

How to Write a Successful Grant: Step by Step Guide

Other resources:

Grant Advisory Service

The College is now offering a grant proposal advisory service to Einstein investigators. The purpose of this service is to aid investigators in generating high quality, polished proposals in order to increase their chances of securing funding for their research.

For more information, please contact OGS at ogs@einsteinmed.edu or 718-430-2238.

Grant mechanisms eligible for support:

All major NIH award categories, including the R, K, T & F, as well as program project and center grants.

Research grants offered by:
- Other federal agencies (e.g. NSF, CDC, DOD)
- Voluntary health organizations (e.g. ACS, AHA)
- Private foundations

(Please note that priority will be given to NIH R-series applications.)

Types of Support Offered:

Defining the scope and optimizing the wording of specific aims.
Improving content, organization and language of specific sections of the grant application.
Improving content and clarity of figures and data presentation.
Read-through with basic editing and point-by-point commentary to identify weaknesses and problems.
Detailed editing and assistance with re-writing (especially for first-time applicants or investigators whose first language is not English)
Face to face meetings to discuss applications.

(Please note that these services are not meant to turn rough drafts or fragmentary proposals into polished applications. Our goal is to work together with you to create the highest quality application possible.)

Documents and information required:

A brief summary of the type of assistance requested.
An electronic version (as a Word document) of the complete draft of the proposal (preferred), or of specific sections of the proposal for which the investigator is requesting assistance.
Supporting materials relevant to the proposal such as web links, RFAs, award guidelines, study section reviews, study section rosters, and anything else the investigator believes may enhance the editing process.

Deadlines:

Support will be offered on a first come, first serve basis but priority will be given to NIH R series applications.
It is highly recommended that investigators submit their applications at least two weeks before the submission deadline.
Applications provided less than two weeks before the grant submission deadline will be processed depending on availability. The full scope of requested aid may not be available with less than 2 weeks notice.

Feedback:

Investigators will be asked to fill out a short questionnaire to rate the level of satisfaction with the service. This will be submitted directly to the Dean’s office by e-mail.

-For more information, please contact OGS at ogs@einsteinmed.edu or 718-430-2238.

SF424 Forms H

Please refer to the SF424 Application Guide for more information

SF424 (R&R) Cover
PHS398 Cover Page Supplement
F&F Other Project Information
Project/Performance Sites
R&R Senior/Key personnel Profile (Expanded)
R&R Budget
- R&R Subaward Budget Attachment, Modular Budget, Training Budget
PHS398 Research Plan
SBIR/STTR Information
PHS Human Subjects and Clinical Trials information
PHS Assignment request (optional)

Forms H Training Presentation

Write Your Research Plan

How to Write a Successful Grant: Step by Step Guide

Workshop Schedule

Spring/Summer 2023 Workshop Schedule and Structure
(May through August, Wednesday afternoons, 3:30 - 5:30pm) via zoom.

Participants must send their assigned grant sections to the leader and fellow participants by Monday at 10:30 am, for discussion that week at the next Wednesday class. Students review each otherâ€™s grant sections according to assignments as primary or secondary reviewer at each session. The workshop leader will review all submissions each week and comment. The mock study section is an event at which scholars review assigned completed grants. Participants may schedule individual sessions with leaders if the need arises. Submission of the completed grant to NIH and the score is the key evaluation of the workshop and the scholar.

Wednesday May 17: Intro Session (Dr. Basu)
Wednesday May 24: Aims
Wednesday May 31: Aims
Wednesday June 14: Significance/Innovation/prelim data
Wednesday June 28: Significance/Innovation/prelim data
Wednesday July 12: Approach
Wednesday July 26: Approach: Review Research Plans
Wednesday Aug 09: Mock Study Section

Eligibility

Must be early-stage investigator by NIH definition
Must be recommended by department chair (with particular reference to protected time to write the grant) and mentor
Must attend all workshop sessions
Must commit to the first Ro1 submission to be September or October 2023 deadlines

Timeline

April 7, 2023: First announcement and call for applications
April 30, 2023: Applications due (i.e., scholarsâ€™ full CV, draft aims, letter from chair with guarantee of protected time to write grant).
May 3, 2023: Review and select scholars.
May 3 - 29, 2023 Brief individual meetings to discuss research and draft aims with Marcel Yotebieng, MD PhD MPH and Michal L. Melamed, MD MHS.

Please contact Drs. Marcel Yotebieng (marcel.yotebieng@einsteinmed.edu) and Michal Melamed (michal.melamed@einsteinmed.edu) for additional questions.

Contact OGS if you need a grant consultant.

Elements of the Research Plan:

Project Summary/ Abstract
Research Plan - Significance, Innovation, Approach, Background, Preliminary results, specific aims
Budget and Justification
- Consortiums/ Subawards and Consultants/ Collaborators
Bibliography and References Cited
Biosketches
Data Management Sharing Plan
Assurances
Animal or Human Subjects (if applicable)
Facilities and other Resources/ Environment
- Einstein’s Description of Core Facilities

Follow FOA Instructions:

Both the instructions in the SF424 R&R Guide and the specific FOA should be followed while filling out NIH applications. If there is a discrepancy between the two, the FOA's instructions should be followed.

Please visit NIAID’s Write your Research Plan, NIAAA’s Quick Guide for Grant Applications, and NIH’s Additional Elements Required for more information on each section’s purpose, content, page limits, and suggestions.

Cayuse

Cayuse is a system-to-system web application portal created to simplify the creation, review, routing, approval, and electronic submission of grant proposals. Cayuse has access to nearly all federal funding opportunities. It is used for developing and submitting new, competing, noncompeting or renewal applications and for preparing progress reports, budget modifications, and other pre-award submissions (OPAS).

What are the Pre-requisites for Submitting an Application Using Cayuse:

Set-up Username and Password

How do I obtain a Cayuse Username and Password?

Send an email to Ray Hosein at rhosein@Montefiore.org with the New Cayuse User Request Form, which includes:
- Individual's name and title
- Role (department admin, investigator, post-doc, student…)
- Address and contact info, including profession email address- required!
Ray will create the account and the requester will receive an email
The username and password given are case-sensitive
The requester will be able to change the password once signed in

Set-up Profile

How do I Create a profile in Cayuse?

You may contact Ray or can do it yourself as follows:

Click on the “+Person” icon
Type in the person’s name and any other information you want to add (departments, etc.). In most cases, you need to click “Create Affiliation”
Select the appropriate educational institution. All internal personnel should choose Albert Einstein College of Medicine, Inc.
Fill in the eRA Role: which should be PI, for investigators, and administrative personnel should be listed as “Assistants”

How do I get Cayuse Training?

Prior to working on a grant application for the first time, contact Dr. Basu at indranil.basu@einsteinmed.edu for initial training in the Cayuse system.
Post-training, Cayuse has an online Research Suite Support Center.

Where can I go for help?

For non-technical assistance, contact Dr. Basu at indranil.basu@einsteinmed.edu.
For technical assistance, contact Ray Hosein at rhosein@Montefiore.org
For urgent help (when we are not available) you may call (503) 297-2108 Ex 201 or email at Support@cayuse.com

Cayuse Log-In

Cayuse Login

Cayuse includes 2 components:

Cayuse SP
Cayuse 424/Proposals S2S

What Can Proposals 424 Do?

Downloads funding opportunities (i.e., forms)
Stores data and files (i.e., contact information, bio-sketches, budgets – auto calculates most items)
Enables users to easily prepare applications
Checks for errors and warnings (including sponsored required validations)
Electronically submits proposals to Grants.gov
Can prepare reports about submissions

What Can Cayuse SP Do?

Creates routing chain and helps routing the application for approval
Stores data and files any information that is necessary for routing and approval, but are not going to the sponsor
Enables users to prepare application reports based on specific criteria
Can prepare reports about submissions and awards

Creating an Application

Cayuse Handbook

Download FOA application package on Cayuse server

Most FOAs are already in the Cayuse system. If a particular FOA does not appear on the pop-up list after clicking "Create Proposal," go into the Opportunities tab and add it. Click on "Retrieve Opportunity" and type in the FOA Number (e.g., RFA-AG-12-000). If it cannot be added, please contact the Office of Grant Support (X3643) for assistance.

The proposal can be started in either Proposals S2S or Cayuse SP. We recommend building your proposal in Cayuse SP, but proposals can also be paired after creation.

Click on My Dashboard, and click on Start New Proposal
Select either grants.gov for the full S2S application package or other for the abbreviated package.
Fill out Sponsor Information and General Information for your proposal. All fields marked with a red asterisk are required.
- Please review our Cayuse Field Definitions.
Complete the Short Project Name field. (This is known as the Proposal Name field in Cayuse 424.) Please follow the naming conventions below, using Einstein’s guidelines (It’s an internal title):
- Competitive grants: PI’s last name/Grant Mechanism/Deadline (e.g., Smith/R01/2-5-16)
- Non-competing RPPRs/Progress reports: NC-PIs last name/Grant Mechanism/Deadline (e.g., NC-Smith/R01/2-15-16)
Click save at the bottom of the page

It is also possible to copy an existing proposal. When copying a cayuse proposal, the following information is copied:

General tab information
Approving units information

Pairing/Linking

Upon filling out General and Sponsor Information when creating your proposal, you will see an option to pair your Cayuse SP proposal with a Cayuse 424 proposal. During proposal creation, only one of these options is active: Create a Paired Proposal. Upon saving this page, Pair with a 424 Proposal will also be active.

Adding a New PI or DA

How do I add a New PI or DA to Cayuse SP?

Send the following information to Ray Hosein (rhosein@montefiore.org):

Name of the investigator
Investigator’s title
Department/Unit
Role in a grant (student, trainee, investigator)
Single Sign on User ID
Contact information (email address)

How do I add a new PI or DA in a Cayuse application so that the individual can work on a proposal?

You can add a person by following the instructions below:

Click on the “People” tab to check if they are listed
Key persons should not, ideally, be manually entered in the actual application; they should have a professional profile in the People section that can be auto-filled in the application, as certain setting will allow for auto-calculations/proper auto-fill functions on Cayuse.
Auto-fill sections are indicated by a pencil icon on the right side of the text field

Creating a New Sponsor

How do I create a new sponsor?

Ff you can't find a sponsor and want to add a new one, please provide the following information to Rayard Hosein.

Organization/Sponsor Name:
UEI Number:
Address Line 1:
Address Line 2:
City:
State:
Zip/Postal Code (+4):
Country:
IDC Rate, %
Fringe Rate, if applicable

Creating a New Paired Proposal

Creating A New Paired Proposal

Once you have filled out all the basic information required to create your proposal, click Create a Paired Proposal.
Depending on your settings, Cayuse 424 will open in a new window or tab, and the Create Proposal dialog box will pop up.
The Cayuse SP Proposal's Short Project Name becomes the Cayuse 424 proposal's Proposal Name, and the Sponsor Deadline is the Due Date. This information is carried over from Cayuse SP for your convenience, and you can change it as you would for any Cayuse 424 proposal. This will not affect the linkage between the proposals.
Follow the steps for creating a Cayuse 424 proposal.
After completing SP, click Pair with a 424 Proposal

IPF Sections

Section	Details
Early Approval/ Submission Request	If you need to request early approval, click yes and add the date approval is needed by. If not, click no.
General Information	This section holds information about the proposal opportunity, sponsor, deadline, project dates, etc.
Investigator/Research Team	The Principal Investigator (or "Lead Principal Investigator"), Co-Investigators and Key Personnel are identified in this section
Budget	Either summary or detailed budget information. You can autofill the budget from 424 proposal.
Conflict of Interest	OGS has worked with Einstein's Conflict of Interest (COI) dept. to make the questions self-explanatory
Regulatory Compliance	Questions related to human subject, animal subject or research materials.
Subcontractors	Details for the outgoing subcontractor if applicable.
Export Control	Einstein is required to comply with Federal regulations governing the distribution of controlled information and technology to foreign nationals and foreign countries for reasons of foreign policy and national security.
Intellectual Property	Terms and conditions in sponsored reserach agreements and licensing or material transfer agreement can sometimes conflict with one another, affecting the management of intellectual property.
Location of Sponsored Activities	There on-campus locations, in-state location, out of state locations and out of the country locations. You may list multiple sites under each location but the sum of all percentages in all locations must equal 100%
Proposal Attachments	This section is a key resource for investigators departmental administrators, and approvers in Cayuse SP. The uploaded documents are a permanent record of the proposal, including the opportunity announcement, proposal, excel budget, cost share documentation, letters of support, subcontract/subrecipients commitment forms etc.
Approving Units	Cayuse SP automatically includes the Lead Principal Investigator, Principal Investigators, Award Department (managing department), Pl department(s), and affiliated centers and institutes in the list of Approving Departments. Regulatory Compliance approvers must be manually added.
Submission Notes	Provide any additional information, comments, or instructions regarding the proposal in this section. There is no limit on the number of notes. Notes are visible to all members listed on the Research Team, proposal approvers, and OGS, and may not be changed or deleted after creation.

SF424 Sections

For a system to system (S2S) proposal to be submitted directly through Cayuse to Grants.gov, the following package of SF424 forms are required:

SF424 RR

Note for #5: Applicant Information- This is up to the dept’s discretion. The PI or DA or Dr. Basu can be added here. However, for all DOD applications, Indranil Basu’s name must be listed in #5 so that it is routed to the correct BO in eBRAP.
Note for #19: Authorized Representative- Dr. Basu’s name must be listed.

RR Performance Sites
RR Other Project Information
RR Key Persons
RR Bugdet
PHS Human Subjects and Clinical
PHS 398 Modular Budget
RR Subaward Budget Attachment
PHS 398 Cover Page Supplement
PHS 398 Research Plan
PHS Assignment Request

Attaching Documents

The following attachments are required for ALL proposals:

New cayuse supplemental form 5.0 May 2024 (this dictates the routing chain)
PI Certification Form (if not completed online)

Adding a Note to an Application

Final Steps Before Moving On

Before moving on:

Please submit early!
As per the Einstein policy# GRT-POL-2018-001 Section III.B.3 (Cayuse Policies and Procedures) effective February 12, 2019, please route your grant application eight days prior to the deadline.
If it is a clinical trial, or involves patients’ charges, OCT needs to review the budget. They require at least 2 weeks.
On major grant deadlines it takes up to two hours before the application is validated and moved to eRA Commons.
Please submit your application at least before noon
In cayuse, in the left panel, mark each section as Complete. All sections must have a green check. This is required prior to routing the proposal.
The tab at the bottom of the left panel “Submit for Routing” will be active once every section is completed.
It will remain greyed out until every section is completed.
If you get an error when you click this button, the proposal cannot be routed yet. Check the Item List and complete the necessary sections.

Once this is completed, you can Route, Submit, and Track the proposal

Resources

Budget Preparation

OGS guidelines for Cayuse Budget Preparation
Uniform Guidance Cost Principles - Costs must be allowable, reasonable, and allocable!
Develop your Budget
- Allowable Direct vs Allowable F&A costs
- Modular vs Detailed
- Detailed Budget: Personnel (Sec A & B)
- Detailed Budget: Equipment, Travel, and Trainee Costs (Sec C, D, and E)
- Detailed Budget: Other Direct Costs (Sec F)
- Consortiums/Subawards, Subrecipient vs Contractor Guide and Checklist
  - Note: Subrecipients are processed through Research Finance, but Contractors are processed through the Purchasing Department.
Plan your Budget and Personnel
- NIH Salary cap and Salary Cap template
- NCI Effort Requirements
Create a Budget
Single IRB and Budget
Budget Justification

For more information on Budget Development, please see Einstein’s Human Subjects Research Project Setup or Initiation site.

Note: Effort must be reported in person months. Click here for help converting percent effort to person months.

Please ensure before routing:

Key personnel must be budgeted at their base salary with their percentage of effort = percentage of salary
The NIH salary cap ($221,900) applies to certain Federal agencies including NIH and other grantors may have different cap
If a Montefiore employee is named on the budget, please note this including their name and add MMC ORSP to the routing chain
Always include a detailed budget for all subcontracts
If the indirect cost rate is less than Einstein’s Federal negotiated rate, provide documentation from the sponsor and attach a note
If you change the budget while the application is routing, notify Gerard and he will Re-autofill the budget in Cayuse SP.
Indicate any salary variations due to promotion, change of status, etc.. that are not reflected in Banner as a note in Cayuse SP.

Single IRB and Budget

Note: At this moment, IRB is not in the routing chain in Cayuse SP. Please contact OHRA in advance while creating a proposal involving human subjects (including human-derived data or specimens) at irb@einsteinmed.edu.

IRB protocol numbers must be approved within 3 years.

Guidance on the NIH Single IRB Policy and Letters of Support

If this is a multi-site study, it is important to determine if each site is using a different IRB (multiple IRB’s being used) or are all sites using a single IRB.

If multiple sites are using a Single IRB, is Einstein serving as the single IRB for all sites? Yes / No
- If Yes, an IRB Reliance Request form is needed at least 10 business days prior to the grant deadline.
- Following review of the request form the Einstein IRB will provide:
  1. Single IRB fees that must be included in the budget as a direct cost item
  2. A Single IRB Letter of Support (LOS) that must be attached in CayuseSP
- Please contact the Einstein IRB with any single IRB related questions at singleirb@einsteinmed.edu.
If multiple sites are using a Single IRB that is NOT the Einstein IRB, which IRB is being used?
- An IRB Reliance Request form is needed at least 10 business days prior to the grant deadline. The IRB will provide a Single IRB Letter of Support (LOS) agreeing to cede to the designated IRB upon Notice of Award(NOA). The LOS must be attached in Cayuse SP.
- Have you included the external IRB’s fees in the budget as a direct cost item? These fees must be provided by the designated lead IRB. How much will they bill us?
- Please contact the Einstein IRB with any single IRB-related questions at singleirb@einsteinmed.edu.

If a grant or contract requires the use of a Single IRB, then the department administrator needs to contact Office of Human Research Affairs at SingleIRB@einsteinmed.edu to obtain a Letter of Support (LOS.)

The LOS must be uploaded in Cayuse as part of the grant submission.
If Einstein will serve as the Lead IRB, the LOS will specify the exact amount to budget for IRB expenses. If an external IRB will serve as the Lead IRB, the OHRA will provide guidance on what IRB expenses to include in the budget and can assist in facilitating discussions with the external IRB.

Consortiums/Subawards

In this section, explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s).

Subaward Budgets

Subaward Statement of Intent Forms:

Subaward Statement of Intent: Einstein LEAD Institution

Subaward Statement of Intent: Einstein NON-Lead Institution

Note: If you have a foreign subcontractor, the PI must have an eRA Commons ID. This process could take over 2 weeks so plan accordingly.

Adding a new subcontract institution in Cayuse:

Please send an email to Ray Hosein at rhosein@Montefiore.org, including all of the following:

Institution Name
Address
UEI/DUNS number
Congressional District
Fringe Rate
IDC rate

An institutional profile will be created. It is not necessary to create a new institutional profile for a consultant from another institution

Clinical Research

Clinical research is medical research involving people, or human subjects.

There are two types:

Observational Studies

Monitor people in normal settings, compare changes over time
Do not test a medical intervention (drug or device) but may help identify new treatments or prevention strategies to test in clinical trials
Often observes the different ways people behave and how it affects their health.
Patient Registries - organized collection of data that patients agree to provide

Interventional Studies (Clinical Trials)

Research studies that test a medical, surgical or behavioral intervention in people
Primary way to determine if new treatment/prevention such as drug, diet or medical device is safe and effective in people
Compare 2 drugs
Compare a drug to placebo
Compare treatment vs. no treatment

Observational Studies:

Human Subjects Research definition
Decision Tool: Does my project include Human Subjects?

Clinical Trials:
- NIH definition of a Clinical Trial
- Decision Tool: Is my project a Clinical Trial?
- 4 Phases of Clinical Trials
- Registration of Clinical Trials

In your Research Design include:

Inclusion/exclusion criteria
Informed consent
Control vs test group, when possible
Biological variables
Protection of Human Subjects attachment

For more information, please refer to the Office of Human Research Affairs, Office of Clinical Trials, and Human Subjects Research Navigator.

To obtain the cost of clinical test/procedure based on the institutional charge master, contact Vivian in OCT. The charge master has NIH rates which Vivian can provide.
Note: if there is anything you plan to charge to insurance, you need to have a Coverage Analysis completed.

Vivian Nwaogbe, Senior Financial Analyst
Budgets
vnwaogbe@montefiore.org
718-920-8411

NIH Resources

NIH Home Page

NIH Institutes

Office of the NIH Director

NIH Office of Science Policy

Standard Due Dates/ Deadline Schedule

Data Management and Sharing (DMS) policy

NIH Grants Process Overview
How to Apply - Application Guide
More NIH Resources:
NIH eRA Commons
NIH eRA Training Page
eRA System Resources
- ASSIST login.
- eRA Commons login.
- NIH exchanges information with applicants and recipients through a variety of eRA systems.
- ASSIST - NIH-managed submission option institutions can use to prepare and submit grant applications.
- eRA Commons - used throughout the grant lifecycle from application intake through to closeout to exchange electronic information between agency staff and applicants/recipients.
- xTrain - accessed via eRA Commons; used to administer research training, career development, fellowships and research education awards.
- xTRACT - accessed via eRA Commons; allows applicants/recipients to create research training tables for NIH progress reports and institutional training grant applications.

Source: https://researchtraining.nih.gov/resources#system-resources

CDC grants solution

Einstein Resources

Institutional Information
Bank/Audit/Tax Information (AD Authentication required!)
F&A Rate Agreement
Forms

Einstein Administrative Departments:

Core Facilities
Environmental Health and Safety
- EHS evaluation form
Financial Conflict of Interest Office (FCOI)
Institutional Animal Care and Use Committee (IACUC) - Animal research. MOU for animal interchange
Non-Oncology services: Clemencia Solorzano (csolorza@montefiore.org) and Mark Sinnet (mmcids@montefiore.org)
Office of Biotechnology and Business Development - (OBBD)- SBIR/ STTR, inventions, industry sponsors, foreign collaborators, material transfer agreements, data transfer agreements, data use agreements, non-disclosure agreements, export controls
Office of Clinical Trials (OCT)
Office of General Counsel (OGC)
Office of Human Research Affairs (OHRA) - includes IRB (for human subjects) and Compliance Dept
- IRB Reliance Request form
- RedCAP
Oncology services: Roy Browne (rbrowne@montefiore.org) and Pragna Patel (ppatel@montefiore.org)
Pharmacy

Montefiore

Office of Research Administration

Note: It is Einstein’s policy that prior to submission, ALL grant proposals must be created, routed, and approved in Cayuse, regardless of sponsor.

Please visit NIH’s Write Application site and Einstein’s Human Subject Research Planning and Development site

When the proposal is complete, the next steps are to route, submit, and track the proposal.