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A consolidated page of frequently asked questions for Researchers and Administrators. If you have a question that is not listed below, please visit our comprehensive pages located on the left navigation menu or contact us.

Most Commonly Asked


 

Please contact your Grant Administrator  in the Research Operations Grants and Contracts Office.They will answer any questions you may have about submitting proposals through BMC. They will also assist Investigators and Research Administrators:

  1. Obtain a Username and Password and train on the BMC electronic Proposal Development system, InfoEd.
  2. Obtain the appropriate internal forms and Institutional information required for grant application
  3. Coordinate a time line for proposal submission.  

Additional guidance outlining the requirements for Federal applications, can also be found through the BMC Grants and Contracts Office's Proposal Submission Guide and Checklist

 

 

 

Please see the Space Matrix to find out through which Institution you should submit your application

 

Please review BMC Proposal Submission Policy  For Federal applications submitted electronically through InfoEd, the following time line should be honored:

Types of Documents Submission

Initial Review of Administrative Components due

Completed Administrative Components due

Final Application Due

InfoEd PD Proposals   System to System

10 business days before the sponsor deadline

5 business days before the sponsor deadline

2 business days before the sponsor deadline

 

 

If the protocol is a corporate-sponsored clinical trial and the PI received a CDA from the corporate sponsor, The CDA should be forwarded to the Contract Attorney in the Clinical Trial Office for processing. If the protocol is PI initiated and the PI is seeking funding from an outside sponsor, the PI should contact the Contract Attorney to discuss options.

 

The first step is to complete an MCA/VelosCT Determination Checklist. The questions on the checklist will allow the Clinical Trial Office (CTO) to complete an initial assessment of what type of study or trial is being contemplated and if the participants and study activities will need to be captured in our Clinical Trial Management System – VelosCT.

The CTO will provide a response to the MCA/VelosCT Determination Checklist and request that you set up your study/trial in VelosCT for management of the contract negotiation. Once the draft, or final, protocol, draft Clinical Trial Agreement (CTA), draft budget and draft ICF are uploaded, and study summary and more study details are completed, then a Study Initiation eForm should be completed. This will trigger an email notification to the CTO Inbox, and the CTO will begin the process of reviewing the documents, beginning the coverage analysis and initiating the contract negotiation.

 

The MCA/VelosCT checklist  provides the details needed for that first assessment of what type of study/trial you are interesting in being a site for, and allows us to analyze whether our CTMS – VelosCT will be utilized.

 

The coverage analysis, or Medicare coverage analysis, is a tool created to document the protocol defined clinical services and research administrative services that will occur in the clinical trial. Using the CMS Clinical Trial Policy, and the sponsor's offer, each clinical service is defined with regard to its status regarding billing to Medicare (and third party payers). The coverage analysis is an important component in the accurate and compliant billing of research clinical services.

 

To meet the requirement to oversee and accurately bill for research clinical services BMC uses VelosCT, a clinical trial management system, that allows for participants and event management. This enhances the overall level of accuracy of billing of research services and supports billing compliance.

 What is the process of getting a clinical trial agreement executed?

The staff of the CTO will efficiently process the Medicare coverage analysis, budget negotiation and negotiation of the terms and conditions of the agreement. Once both parties agree, site and sponsor, the agreement can be signed and fully executed.

 

Typically, account setups are completed and notifications with the new activity number are sent to the PI and Administrator between five to ten business days after the award notice.

 

 

Request a Lawson LBI user account by visiting the FIS User Access Forms page and selecting the LBI Reports option for "Research" for Finance/Grants reporting.You may also select the "Hospital/Non-Grant" option if you need access to VelosCT reports for Clinical Trials.

To run VelosCT reports, please see the VelosCT-Reports User Guide 

To run Lawson reports, please see the Lawson Reports Guide 

 

 

A BU IO# is used to facilitate cross-institutional salary support on research projects.  The IO# is identified on the account setup notification sent from Research Operations to the PI and Administrator.

General


 

 

 

Proposal Summary sheet  (required for all applications)

Conflict of Interest form(s) for key personnel, non- key personnel, and unpaid consultants (required for all new applications, and non- competing applications if there is a change in the previously reported conflict)

Conflict of interest forms should be filled out prior to grant submission through the BU Compliance Office's online system found here.  For all questions regarding Conflict of Interest please contact [email protected]

Letter of Intent (if subcontracts)

 

For new proposal and contracts, for non-competing continuations/progress reports, and for yearly amendments to contracts, FCOIs must be submitted for all "investigators" and key personnel listed on the BMC proposal (including non-key and unpaid personnel if they fit the FCOI definition of "investigator"). FCOIs do not need to be submitted for personnel listed on a subcontract to an outside institution if this institution has an existing conflict of interest policy.

 

You will need an InfoEd account in order to submit grants through our office. Contact [email protected] to have one setup. Please include the fallowing information when contacting RBIS:

  • Full name
  • Role in InfoEd (PI/administrator/restricted administrator/development)
  • E-mail
  • Department/Section
  • Address
  • Phone & fax numbers
  • Title (optional)
  • BU ID (for BU PI's)
  • eRA Commons ID( for PI's , if available)

For a federal grant application you will need an eRA commons username affiliated with BMC. Contact your Grant Administrator to have one setup or to have BMC affiliated to an existing account. **This must be done at least 48 hours before the grant is submitted**

The Grant Administrator  assigned to assist with your application is department and section based

 

In general, a departmental account number must be provided on the proposal summary sheet for any costs required and shown on the application's budget but not requested from the sponsor. This includes "donating time/effort" and "in-kind contributions" on a project.

**Federal Funds can not be used as a cost-sharing source**

The full research cost-sharing policy can be found here:  http://10.153.11.138/grants/post_policies.htm 

 

At a minimum, we require a Letter of Intent (LOI), scope of work, detailed budget, budget justification, and BMC internal paperwork. The prime institution may also request biosketches, resources/facilities pages, letters of support, etc. You should coordinate with your collaborators at the prime institution to determine exactly what they require prior to submitting the paperwork to the BMC grants office.

 

Any budgets proposing patient care costs should be forwarded to the Clinical Trial Office (CTO). We recommend you discuss patient ancillary costs with your Clinical Trial Financial Analyst; before you develop the budget.

 

Subcontract

  • Collaborator will have programmatic decision making responsibility
  • Collaborator will manage technical and administrative aspects of a portion of the overall project statement of work
  • Collaborator will perform work as part of an institutional appointment and utilize their institutional facilities such as, students, staff, patient population...etc.
    • Subcontract costs are excluded from BMC's indirect cost calculation in the budget.

Consultant

  • An individual/firm/organization identified to provide professional advice or services for a fee
  • Operates in a competitive environment
  • Does not participate in the programmatic decision making of the project
  • Provides similar goods or services to many different purchasers
  • BMC's indirect costs are applied to all consultant costs.

**If the consultant is an individual affiliated with another academic institution, the services must be provided outside of their institutional time commitments, without use of their institutional resources, and paid directly to the consultant as an individual and is subject to income taxes**

**BMC employees can not be paid consultants on BMC grants**

 

Sponsor guidelines usually dictate what the earliest start date you can have for your budget as well as the length of the budget and project periods. You should review the sponsor guidelines carefully before developing the budget.

For NIH grants, the earliest start date is often dictated by the funding cycle in which the grant is submitted. We recommend reviewing the specific program announcement to confirm due dates and budget start dates. The standard funding cycle chart can be found below.

Cycle 1 submission: January- April

Cycle 2 submission: May- August

Cycle 3 submission: September- December

Review and Award Cycles:

 

Cycle I

Cycle II

Cycle III

Scientific Merit Review

June - July

October - November

February - March

Advisory Council Round

August or October *

January

May< /strong>

Earliest Project Start Date

September or December *

April

July


NOTES:

The actual date of the Advisory Council may occur in the month before or after the month listed.  For example, some ICs may actually hold the January Advisory Council meeting in February or the October Advisory Council meeting in September.

Awarding components may not always be able to honor the requested start date of an application.  Before incurring any pre-award obligations or expenditures applicants should be aware of NIH policy governing pre-award costs prior to receiving a Notice of Award.  See the NIH Grants Policy Statement.

* Advisory Council Round for Cycle I applications may be August or October, and their earliest project start date may be September or December respectively.

 Where can I find general research compliance information?

For HIPAA Information:

For General Research Compliance Issues for both BMC/BU Research, go to:  http://www.bu.edu/orc/

For questions about human subject research, go to:  http://www.bumc.bu.edu/irb/

For questions regarding animal research, go to: http://www.bu.edu/animalcare/ or http://www.bu.edu/orccommittees/iacuc/ (IACUC)

 When do I need to complete an InfoEd entry?

A new InfoEd entry should be completed for all grants prior to review and submission. Electronic grant applications to many federal agencies, including NIH, CDC, and AHRQ, should be developed using the SF424 (system to system) mechanism. For grant types that do not use the system to system mechanism, information should be entered through InfoEd using the "generic sponsors" option. Instructions for both can be found online or in the pre-award training manual. http://10.153.11.138/grants/nihcommons.html 

 

In the setup page:

The PI of the application must be selected here.

  1. DO NOT copy applications from an existing proposal in InfoEd. Even if you are resubmitting a grant that was previously developed in InfoEd, all applications must be created new.
  2. When initiating a system-to-system application in InfoEd to NIH, select National Institute of Health/DHHS as your sponsor. If you wish for your application to be assigned to a specific institute within NIH, you can indicate this in your cover letter
  3. You must select a valid opportunity number
  4. Make sure the primary department is selected under "PI Departments". You may need to add this manually. Do NOT change the "Associated Department". This is the PI's division. If this in incorrect, please contact todd.erceg@bmc.org to update.

  1. Select "Budget by Total Project" as the budgeting model. It is easier to develop the budget using this scheme.

In the SF424 (R&R) page:

  1. Todd Erceg should be selected as the Administrative Official and Authorized Representative. Click on the blank boxes and a drop down menu will appear. By selecting Todd, his information will automatically populate the boxes.

In the personnel page:

  1. All key personnel/significant contributors must have their entire personal profiles filled out (including zip code).
  2. Biosketches should be in the new NIH format with a personal statement.
    1. 15 publications MAX.
    2. No $ amounts or % effort should be listed on research support section.
    3. Biosketches are typically limited to 4 pages, but special funding opportunities may limit it to 2 pages. Review the sponsor guidelines to confirm.
    4. Certain fellowship/training applications require a different biosketch template for fellows/trainees. Review the guidelines for the specific fellowship to see if this applies to your application.
  3. If you want to include a biosketch for a consultant, add them as a significant contributor in the personnel section. Their consultant fee (if applicable) should still be listed under non-personnel costs in the budget page.
  4. Make sure Pubmed Central IDs are included in the PI biosketch and references section for any publications that are NIH-funded and authored/co- authored by the PI.
  5. Make sure that eRA Commons username is listed in the Credential box for the PI. The application will not be accepted by NIH/AHRQ/CDC if this is omitted or incorrect.

In the budget page:

  1. Modular grants should have a budget justification for personnel only.
  2. In applications using non-modular budgets, the subcontract justification should be added to the BMC justification and uploaded as one document. In applications using modular budgets, the subcontract justification should be uploaded as a separate document in the Consortium Justification.

**Specific instructions and more detailed information for system to system applications can be found in Appendix B of the PreAward training manual as well as the BMC internal grants website:  http://10.153.11.138/grants/nihcommons.html

  1. Generic sponsor applications in InfoEd are a way to submit all other application types to the BMC grants office for review and approval. This includes, but is not limited to, foundation grants, federal electronic applications that can not be submitted system to system, paper applications, subcontract applications, etc.

If you have any questions whether an application should be developed using the system to system mechanism or generic sponsors, please contract your PDS .

  1. Components of the application must be uploaded in the Internal Documents tab for us to retrieve and review.
  1. The budget tab of the generic sponsor template must be completed even if a separate budget page is uploaded in the Internal Documents tab.
  1. When completing an Adobe package for federal applications that cannot be submitted system to system thru InfoEd, do not include spaces, numbers, or special characters in attachment filenames. Using underscores is OK. Also, all attachments in Adobe grants package must be converted to PDFs.
  1. If BMC is a subcontract, the proposal sponsor should be set as the prime institution (eg. Children's Hospital) in InfoEd. The originating sponsor (e.g. NIH) can be set on the setup questions page, once the question "Is this a flow through Project?" is marked "yes".
  • **Specific instructions and more detailed information for generic sponsor applications can be found in Appendix C of the Pre Award training manual

 Who can be a Principal Investigator on a research proposal?

Boston Medical Center does not currently have a policy limiting who can be PI or apply for a grant, however approval and support is required from the applicable department/division.

 How do I sign up to be on the Research Operations e-mail distribution list?

Grant Related


 

A grant is an offer of assistance where the government is a partner/patron and the purpose is to provide support and stimulation. It benefits a public purpose and is investigator initiated. A contract is an acquisition where the government is a purchaser of goods and services. Contracts are initiated by the government and directly benefit them.

 

A sponsored project typically has two or more of the following characteristics: defined work statement; competitive proposal/award process; a line item budget identifying expenditures by activity, function and project period; specific commitment of deliverables and level of personal effort; a formal report that summarizes results. A gift would have only one or none of above characteristics.

 

BMC: $5,000

 

EIN: 04-3314093 DUNS: 00-549-2160

 

http://www.irs.gov/ - Click on Forms and Publications Finder; Type in W-9; Click Go; Click on Form W-9. You must have Adobe to Read/Print.

 

No - This person should be charged to the FMLA Detail Account. Contact your Grant Accountant if an adjustment has to be made.

 

Per NIH Grants Policy Statement dated March 2001 the definition of Expanded Authorities is as follows: The operating authorities provided to grantees under certain research grant mechanisms that waive the requirement for NIH prior approval for specified actions.

 

The program has 90 days after the grant end date to post expenses that occurred within the grant budget period.

 

Income account balances are shown at the bottom of the Budget Status Report. Income accounts will not have budgets entered and the administrator should rely on the balance available data when reviewing these accounts. Income account balances are posted twice monthly so it is possible for a deposit to take several weeks before appearing in the balance on the BSR.

 

The Space Survey is the process of assigning institutional space into OMB Circular A-21 functional categories based on space use. The results are used to calculate the percentage of space that is used to support the subsequent allocation of space related costs to organized research. The survey is conducted biannually.

 Who is responsible for proposal and pre-award post submissions material? E.g. Just-In-Time, NIH post submission material?

All requests for pre-award post submission material must be reviewed by the Grants and Contracts Office prior to submission to the sponsor. At times the sponsor may directly contact the PI and Research Administrator. In order to better serve the research community we request that this information be forwarded to our office. We will be able to provide support and guidance on post-submission documentation prior to submission to the sponsor.

Rate Related


 

Click here for most up-to-date rates:
Rate Summary Sheet

 

Subcontracts, Equipment above $5K, Other Patient Care, and Stipends are all common indirect exclusions.

 

Click here for most up-to-date rates: Federal Government Mileage Rates

 

MTDC are only those direct costs upon which the indirect rate can be charged (all direct costs after exclusions are taken out).

 When do I need to use the Facilities and Administrative (F&A) request reduction form?

The full F&A DHHS negotiated rates must be used on all applications, unless the sponsor has a posted a reduced rate.   The exception is Industrial Clinical Trial budgets , which are usually 30%.

If the Investigator want to reduce the OH rate from the published rates, a F&A reduction form must be submitted to the Grants and Contracts Office at the start of the budget development process. 

If the reduction request’s OH loss is ≥ $25k over the life of the project, this form must be signed by the Department Chair, as well as the following individuals.

Reduction Amount Final Approval
Up to $25K Director, Grants and Contracts or Director, Clinical Trial Office
$25K-100K Executive Director, Research
>$100K Chief Financial Officer

The full Facilities and Administrative Rate Policy can be found here.

Procedural


 

BMC:Manager/Program Admin -Up to $49,999
PI - $50,000 and over

 

Senior Director of Research Operations (Grace Cashman) and Director, Grants and Contracts (Todd Erceg) can sign all documents.

 

 

 

Budget revision procedures are dependent on funder regulations. Most funders require revision requests in writing that often need the current budget, proposed changes, and revised budget as well as a written justification to support necessity. Programs can work with their Research Finance Analyst to outline funder requirements and develop the budget revision. If the funder does not require formal documentation in order to revise budgets, a copy of the revised budget can be forwarded to Research Finance to input changes.

 

The Principal Investigator writes a letter requesting a no-cost extension to Alexandria Hui, Associate Director of Research Finance. The letter should contain the Federal Grant Number, time of requested no-cost extension (usually is one year), and explanation as to why the extension is needed. Reference to dollars should not be listed. The no-cost extension is approved here at the institutional level and faxed to NIH, where approval is automatic and a revised NOGA is generated.

 

Employee reimbursements should contain all receipts that total the amount being requested for reimbursement. Receipts should be itemized and not contain any unallowable expenses such as alcohol and entertainment costs.

Compliance Related


 

 

 Office of Human Research Affairs: FAQ's - Quality Assurance Reviews

 Office of Human Research Affairs: FAQ's - Research Participants

Employee Service Form (ESF)


 

No - One ESF must be used per person. Include ALL of the activity numbers on this one form. The basic rule to remember is that the ESF must equal the 3454-8 code on the BU turnaround form.

 

Yes - you must fill out the Employee Services Form, write the termination date in the appropriate box and forward onto your Research Finance Analyst.

 

If a person is shared amongst several administrators, the person who handles the turnaround should handle the ESF as well. If you have a grant that the individual will be working on, forward that information to the person who handles the turnaround so that they can update the ESF and forward to Research Finance for signature.

Accounts Payable/Material Management


 

MM - for Research: 638-6051
A/P - for BMC vendors A to I: 414-1163, and for BMC vendors J to Z: 414- 1167

 

If the order is related to an independent contractor/consultant/subcontract, a fully executed contract is needed. If the order is with a vendor who will be performing a service (maintenance, electrical work, extermination,etc), documentation is required for backup. When the order is for a vendor that will provide a varied amount of supplies, a contract or other backup is NOT required. For products/services of less that $1000, no quotes are required. For $1001 to $4999, 2 quotes are required. For $5000 and above, 3 quotes are required.

 

Tips: Make sure Activity Number matches Accounting Unit and Account Category matches Detail Account. Make sure you have the correct Company box checked off ( BMC-100). The Requester cannot be the authorizing signature. Make sure appropriate Level Authority has signed for the amount being requested (see FAQ #4). Original invoices only for attached documentation. Past Due charges may not be applied to current invoices.

 

Run the Grant Expense report in Crystal. If an invoice has been paid, it will show up here with corresponding check number and check date. If it has not been paid, it will still show up on this report but without a check number/date next to it.