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Research Support

Everything you need to understand the steps

Objective

Provide a Landscape

Provide a landscape that explains the roadmap from study idea to initiating study implementation for a global health project within the Stanford system.

Highlight common pitfalls

Highlight common pitfalls and strategies to avoid them.

Connect researchers

Connect researchers to broader university resources to address their specific issues.

Landscape

Develop Study Idea

Discuss with Collaborators

Identify Candidate Funders

Develop Proposal

Submit Proposal

Formal or Informal Notification of Award

Once contract is in Place and PTA is Open

Develop Study Idea

Discuss with Collaborators

  • An early concept note and budget
  • Clarify process and timeline for proposal development, budgets and approval

Identify Candidate Funders

Aligned with study objectives?

Regarding the funder:

  • Note their timelines. Is there sufficient time to develop a competitive proposal?
  • Is this a new funder for RMG? (adds time)
  • What is their policy for covering indirect costs?
    • Do they have a written policy published on their website?
    • Link to overhead policy on DoResearch site
    • If indirect cost offered from donor is less than provided by US Federal projects, need to request a waiver
      • Develop budget with presumed indirect rate, even if not yet confirmed.

Note RMG timelines. Is there sufficient time to complete administrative processes?

Go/no go decision

Develop Proposal

  • Organize workflow, so that a scope of work for collaborators and a draft budget is developed early so that this can be worked through iteratively and ultimately become the basis for the administrative agreement
  • Complete Progress Intake Form (PIF) within SERA to engage the Research Management Group. This requires having a budget, budget justification and scope of work for collaborators.
  • Iteratively revise proposal and budget based on input from collaborators and from RM
  • Finalize budget that collaborator has the requisite support and understanding to complete the Stanford paperwork (if Stanford is the prime)
    • Documents will vary depending on the proposed donor, but commonly include
      • OSR form 33 (a Stanford form required for nearly every project when the proposal engages a subcontractor)
      • Scope of work (probably best for the person putting the whole proposal together to draft this. It is useful to share with collaborators, so that you align on purpose and can then use that to assess budget.
      • Budget
      • Budget Justification
      • For NIH grants:
        • Biosketches in the NIH format
        • Description of facility/environment
        • List of other support
        • Letters of support
    • Consider providing administrative support
    • Ensure collaborators are clear on deadlines
      • Recognize that some iterative development may be required
      • Regular follow-up can often address delays
    • Early in the process access if Stanford will require that you collaborator show proof of insurance. If Stanford is requesting it, but it is not possible, it is important that you begin negotiating with Stanford legal early enough that this does not prevent an on-time submission.
  • Follow email closely for input from RMG or collaborators to ensure that deadlines are met.

Submit Proposal

  • For NIH / NSF proposals, RMG must submit
  • For other proposals there is often a choice. If the principal investigator submits, they are typically well placed to address questions that arise and receive feedback. If the principal investigator submits, they need to carbon copy their RMG preparer.

Formal or Informal Notification of Award

Celebrate! Get to work!

Develop an eProtocol so you have human subjects approval to proceed with the work.

  • Stanford policy does not allow any spending on a project that engages human subjects until human subjects approval is obtained. Approval may well be a six-month process of developing a specific protocol and working with both local and Stanford human subjects committees. Although it is useful to jumpstart this activity, there are processes options for lite protocols that allow the administrative process to advance.
  • For NIH proposals, if the initial score looks fundable, initiate efforts to secure human subjects approval otherwise delays risk being excessive

Engage OSR.

  • Stanford global health researchers report that this process characteristically takes months. It involves contracting issues, concerns with intellectual property and innumerable details. The processes are optimized to protect Stanford’s financial and reputational interest, not to promptly implement research projects.
  • Clarify what OSR needs to advance the process so that
    • You have an agreement with your collaborators
    • You have an open PTA
  • Follow up with your OSR contact every 2 weeks for an update on the progress and what can be next steps.
  • If there are substantial disagreements between the version of the contract favored by Stanford attorneys and the version that was favored by your collaborator’s attorney, it is often useful to convene a combined meeting that includes the senior scientists on both sides with the attorneys. If the scientists are involved in the conversation, they can usually quickly agree on general principles that the attorneys can then put into a document. Without clear direction from the scientists, attorneys often default to extreme positions to maximize the protection of their respective institutions instead of working towards a common sense agreement.

Ensure that your collaborator understands how to invoice Stanford, and the schedule of those invoices to ensure funds flow as needed. Consider engaging a conversation with staff in Sponsored Receivable Management at Stanford.

Assess if your collaborator requires forward funding to initiate activities. If they do, this is outside of the usual procedures at Stanford. It is possible to negotiate this, but it requires substantive discussion and a willingness to pledge unrestricted funds to backstop commitments.

Once contract is in Place and PTA is Open

  • Ensure that the collaborator understands how the invoice Stanford
  • Begin study implementation

Develop Study Idea

Develop Study Idea

Discuss with Collaborators

Discuss with Collaborators

  • An early concept note and budget
  • Clarify process and timeline for proposal development, budgets and approval

Identify Candidate Funders

Identify Candidate Funders

Aligned with study objectives?

Regarding the funder:

  • Note their timelines. Is there sufficient time to develop a competitive proposal?
  • Is this a new funder for RMG? (adds time)
  • What is their policy for covering indirect costs?
    • Do they have a written policy published on their website?
    • Link to overhead policy on DoResearch site
    • If indirect cost offered from donor is less than provided by US Federal projects, need to request a waiver
      • Develop budget with presumed indirect rate, even if not yet confirmed.

Note RMG timelines. Is there sufficient time to complete administrative processes?

Go/no go decision

Develop Proposal

Develop Proposal

  • Organize workflow, so that a scope of work for collaborators and a draft budget is developed early so that this can be worked through iteratively and ultimately become the basis for the administrative agreement
  • Complete Progress Intake Form (PIF) within SERA to engage the Research Management Group. This requires having a budget, budget justification and scope of work for collaborators.
  • Iteratively revise proposal and budget based on input from collaborators and from RM
  • Finalize budget that collaborator has the requisite support and understanding to complete the Stanford paperwork (if Stanford is the prime)
    • Documents will vary depending on the proposed donor, but commonly include
      • OSR form 33 (a Stanford form required for nearly every project when the proposal engages a subcontractor)
      • Scope of work (probably best for the person putting the whole proposal together to draft this. It is useful to share with collaborators, so that you align on purpose and can then use that to assess budget.
      • Budget
      • Budget Justification
      • For NIH grants:
        • Biosketches in the NIH format
        • Description of facility/environment
        • List of other support
        • Letters of support
    • Consider providing administrative support
    • Ensure collaborators are clear on deadlines
      • Recognize that some iterative development may be required
      • Regular follow-up can often address delays
    • Early in the process access if Stanford will require that you collaborator show proof of insurance. If Stanford is requesting it, but it is not possible, it is important that you begin negotiating with Stanford legal early enough that this does not prevent an on-time submission.
  • Follow email closely for input from RMG or collaborators to ensure that deadlines are met.

Submit Proposal

Submit Proposal

  • For NIH / NSF proposals, RMG must submit
  • For other proposals there is often a choice. If the principal investigator submits, they are typically well placed to address questions that arise and receive feedback. If the principal investigator submits, they need to carbon copy their RMG preparer.

Formal or Informal Notification of Award

Formal or Informal Notification of Award

Celebrate! Get to work!

Develop an eProtocol so you have human subjects approval to proceed with the work.

  • Stanford policy does not allow any spending on a project that engages human subjects until human subjects approval is obtained. Approval may well be a six-month process of developing a specific protocol and working with both local and Stanford human subjects committees. Although it is useful to jumpstart this activity, there are processes options for lite protocols that allow the administrative process to advance.
  • For NIH proposals, if the initial score looks fundable, initiate efforts to secure human subjects approval otherwise delays risk being excessive

Engage OSR.

  • Stanford global health researchers report that this process characteristically takes months. It involves contracting issues, concerns with intellectual property and innumerable details. The processes are optimized to protect Stanford’s financial and reputational interest, not to promptly implement research projects.
  • Clarify what OSR needs to advance the process so that
    • You have an agreement with your collaborators
    • You have an open PTA
  • Follow up with your OSR contact every 2 weeks for an update on the progress and what can be next steps.
  • If there are substantial disagreements between the version of the contract favored by Stanford attorneys and the version that was favored by your collaborator’s attorney, it is often useful to convene a combined meeting that includes the senior scientists on both sides with the attorneys. If the scientists are involved in the conversation, they can usually quickly agree on general principles that the attorneys can then put into a document. Without clear direction from the scientists, attorneys often default to extreme positions to maximize the protection of their respective institutions instead of working towards a common sense agreement.

Ensure that your collaborator understands how to invoice Stanford, and the schedule of those invoices to ensure funds flow as needed. Consider engaging a conversation with staff in Sponsored Receivable Management at Stanford.

Assess if your collaborator requires forward funding to initiate activities. If they do, this is outside of the usual procedures at Stanford. It is possible to negotiate this, but it requires substantive discussion and a willingness to pledge unrestricted funds to backstop commitments.

Once contract is in Place and PTA is Open

Once contract is in Place and PTA is Open

  • Ensure that the collaborator understands how the invoice Stanford
  • Begin study implementation

Common Pitfalls

Assuming Stanford will negotiate overhead on a project funded by foreign government

This is a broad and nonnegotiable Stanford policy. One option to consider is to have funds go directly to your collaborating partner with support to Stanford being a smaller piece.

Assuming that Stanford / your department will accept reduced overhead

The principal investigator can make an argument through their RMG officer for reduced overhead. Arguments framed in terms of the benefit the Stanford are often persuasive.

Allotting insufficient time for RMG to complete the submission paperwork

RMG has strict timelines. Initiate the Project Intake Form and the budget early enough so that they can work with you towards a deadline. If you fail to engage professionally well ahead of time, they often lack the bandwidth to provide sufficient support to support an on-time submission.

Assuming that OSR will promptly reach a contractual agreement with the donor

The experience of CIGH researchers as this typically takes many months. We encourage you to work proactively with OSR to understand all of the pieces that need to be advanced and to work collaboratively to advance them.

Mismatch between donor’s expectation of start date, and Stanford’s routine multi-month administrative processes

CIGH is working with Stanford administrators to streamline the process. Nevertheless it is prudent to be realistic with donors.Also consider what activities you can advance in the absence of all of the contractual pieces being in place. This includes advancing the study protocol, potentially engaging stakeholders and advancing planning.