Publications which include the PI or any co-investigator must include a PMCID, PMID, or doi depending on which is applicable.  These must be included on the Bibliography and the Biosketch.

• PMCID (PubMed Central Identification):  all publications after April 7, 2008 whose research has been supported by federal funding is required to obtain a PMCID.
• PMID (Pub Med Identification):  abstracts located in Pub Med. The PubMed Central reference number (PMCID) is different from the PubMed reference number (PMID). PubMed Central is an index of full-text papers, while PubMed is an index of abstracts. The PMCID links to full-text papers in PubMed Central, while the PMID links to abstracts in PubMed. PMIDs have nothing to do with the NIH Public Access Policy.
• DOI (digital object identifier):  The American Psychological Association describes a DOI as “a unique alphanumeric string assigned by a registration agency (the International DOI Foundation) to identify content and provide a persistent link to its location on the Internet. The publisher assigns a DOI when your article is published and made available electronically.”

Budget Rules

• Only people within your affiliate can be listed as personnel in the budget
• Individuals from other affiliates must be a subcontract or a professional service agreement (depending on what they are providing).  This may change with Research Integration, depending on how it is structured.
• Consultants: 
  • Employees at Sutter Health may not be paid consultants on a grant at any Sutter Affiliate.  They may serve as co-investigators or unpaid consultants.
  • Must submit a letter of support which includes:  the rate of pay and the number of hours to be paid each year (even if the rate of pay = $0.
• We use current negotiated F&A Rates in the budgets
• Agencies that do not allow full negotiated rates require special permission to be submitted
• Use current salary rates and budget for increases at appropriate intervals
• Benefit rates:  we use the negotiated benefit rate or the actual rate depending on the institution.

Budget Parameters

• Personnel:
  • Name of Staff and/or position to be included
  • Estimated percent of effort per year
• Subcontractor names and contacts
• Consultant Names and contact information (estimated hours and pay rate)
• Other expenses and supplies
  • Individual items priced at $5,000 or more should have a written quote
  • Services should have a written quote outlining work to be performed and cost
  • Supplies
    • Line items at $1000 or more should be costed out in the budget justification (include tax and shipping)
• Travel
  • Where are you going
  • How many people will travel
  • How many days will you stay
  • How many trips per year
  • Registration fee involved?

• Generally only key personnel are required to submit biosketches
• Biosketches are to be prepared by each individual person according to the parameters required by the funding agency
• All Biosketches are reviewed for compliance by the Grants Team.  We have frequently had to send them back for revision due to personnel not following the agency formatting requirements.  This is a time consuming endeavor and it is crucial to receive biosketches  early on in the process.
• Biosketches may be formatted by the Grants Administrator for a uniform format to enhance the professional look of the application.   This is only done if time allows.
• Biosketches can cause an entire grant application to be rejected if the following conditions are not met (as cited in the NIH FAQ’s):
  • Completing each section (A - Personal Statement; B – Positions and Honors; C – Contributions to Science; D – Research Support or Scholastic Performance)
  • Including no more than 5 contributions to science with no more than 4 citations per contribution
  • Ensuring that if you include the optional link to a full list of your published work in a site like My Bibliography that the URL is .gov
  • Refraining from including information, such as preliminary data, that belongs elsewhere in the application
  • Following NIH guidance on font type, font size, paper size, and margins (See Format Attachment instructions)
  • Using PDF format for your biosketch attachment
  • Limiting the length of your biosketch to 5 pages or less

Useful Links:

• NIH Biosketch – instructions and word document
• DOD/CDMRP biosketch forms

These documents should be specific to the grant application: one size does not fit all.  Each PI/Laboratory/Research Group may have a standard resource page which may or may not require edits depending on the project submitted.

Examples: 

• if you are doing a clinical trial that does not involve any bench research, then you should not include information about bench laboratories or equipment that is used in basic science.  You would, however, want to include information about how many patients for the disease you are studying that are seen in your clinics or at your institution that you would have access to.  If this study would involve patients throughout the Sutter system, then you would want to include information about all of Sutter.  You also would want to include information about the Research Institute teams throughout the Sutter system that specialize in clinical research.
• If your research involves information about non-human subjects, you would then want to include the information about the facility that exists.  If your research does not include that group, then you would list that as N/A.
• If you are proposing a project that involves bench research coupled with clinical research, then you want to include information about the laboratory facilities available as well as the clinical research team structure.

All MPI plans (regardless of who generates them) must be reviewed and signed off by the Director of Grants and Contracts to ensure that the duties are well delineated and that the conflict resolution plan is acceptable.

Collect from whom (“Anyone contributing in a substantive, measurable way to the scientific development or execution of the project.”):

• Consortium PI’s*
• Senior/Key Personnel
• Other Significant Contributors

Content:

• Co-authorship expected*
• Whether resources such as cell lines, samples, or data will be provided for this project only to which investigators or if they are freely available to scientific community*
• Consultants are to include rate/charge for consulting services and the number of hours per year anticipated.
• If access to core facilities or resources are being provided by another institution, letter should indicate if it will be provided as a fee-for-service.

*For Consortia, the Statement of Work will be included in the grant application and it should outline expectations and resources to be made available.

The Scope of Work is a collaborative document between the Prime and the Subrecipient.  Some investigators prefer to complete it on behalf of their subrecipients; some prefer the subrecipient completes it.  Either method is fine, but in all cases, both institutions should review it to ensure that they agree with what is written.

Whether we are the subcontractor or we have subcontracts on our proposal(s), the Scope of Work is a crucial document and should be given very careful attention.  If there is a contract dispute, what is written in the Scope of Work governs the outcome of that dispute.  While we don’t like to think collaborators will ever be our adversaries, it can and does happen.  

The Scope of Work is included in the Consortium section of an NIH grant application or elsewhere for other agencies and it is always included in the SubAward agreement if the project is funded, thus it is a legal document describing the expectations of the subrecipient.

It should define the expectations of the work to be performed and delivered.  CPMC uses a 5 question format:  1)  Statement of Purpose (why and who); 2) Scope of Services;  3) Project Milestones (when); 4) Deliverables and Acceptance Criteria (what tangible goods) and 5) Place of Performance.

Samples of SOW from other proposals can be provided upon request.

Statement of Purpose:  in this section, you should describe the overall project and where and how the subrecipient fits into the project – describe their overall objectives.

Scope of Services:  elaborate on the specific duties to be performed by the Subrecipient.  If you expect them to participate on conference calls, attend meetings, to follow a set protocol, to be in charge of certain sections of the proposal, you should list it explicitly.  Your science should be your guide to what their role will be.

Deliverables and acceptance criteria:  describe what products, reports, and/or plans are supposed to be delivered.  If they are supposed to participate on manuscripts, state so.  If they are supposed to provide advice, state how they are supposed to deliver it (in a report, on a telephone call, in an email, all of the above)?  If they are supposed to deliver data, state so.  Describe the format the data is supposed to be delivered – it is considered final upon delivery, or is it considered final upon receipt of  cleaned and verified data.

Place of Performance:  This is the easiest question. The Subrecipient should list the full address of all the places where their scope of services will be performed.  If more than one site, list each site.