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Infectious Diseases Research Clinic

URMC / Infectious Diseases Research Clinic / UR Vaccine and Treatment Evaluation Unit (VTEU) / Study Proposal

Study Proposal

Proposing a Study Concept in the VTEU Network

Proposals for Infectious Diseases Clinical Research Consortium (IDCRC) studies may be submitted through the Initial Concept proposal (ICP) available on this site. Key information about the process and eligibility is as follows:

  • ICPs are welcome from investigators who are affiliated with the IDCRC and VTEU network as well as investigators external to this network.
  • ICPs may be submitted at any time throughout the calendar year.

Submission Process

  • The ICP form will be submitted to the IDCRC Executive Management Team (EMT). EMT and Expert Working Group (EWG) Liaisons will review the concept for suitability for VTEU. EWG Liaisons may provide initial feedback and request additional information. If and when the ICF is deemed suitable to advance, submission of the extended concept form (ECF) will be requested and assigned to the appropriate EWG for review. EWG Co-Chairs will be informed of anticipated extended concept proposals under development. 
  • The EMT will review the EWG advice and make a recommendation and include an indication of priority to NIAID, where the final decision will be made.
  • Concept proposals of high general priority for multi-site implementation may be solicited from IDCRC/VTEU collaborative teams or developed by NIAID or the EMT for review by the appropriate EWGs.
  • An expedited concept review process will be utilized at the discretion of NIH and the IDLG Directors in the case of public health emergencies. This process will include expedited review by the IDLG Chairs and EMT and recommendations will be made to DMID for their final decision.
  • In general, specific pathogens will align with the identity of EWGs and the main pathogens of concern are noted below by category.
  • If a concept is approved for protocol development, the individual or team that submitted the concept will remain involved in study planning and implementation. 

Evaluation Criteria

The criteria below (if relevant to individual proposals) will be used to assess the quality of concepts during both initial and expanded phases.

Scientific Merit

  • Are the hypotheses scientifically sound and answerable by the proposed design?
  • Is the study appropriately designed to address the hypothesis?
  • Is the proposed population appropriate for the research? Do the eligibility criteria specify an appropriate population?
  • Does the concept proposal include proper randomization and stratification procedures, as relevant?
  • Are safety parameters specified?

Public Health Impact

  • What is the relevance of the concept to the prevention, diagnosis or treatment of infectious diseases, e.g. will it prevent spread, save lives and/or decrease morbidity and if so, how much?
  • What is the value added to the field, e.g. existing interventions and unmet need?
  • Does it contribute to a critical pathway that will advance science and impact public health, and if so, how?
  • If shown to be effective, will the procedures or outcome described in the concept be acceptable to key affected stakeholders (communities, clinicians, policy makers, as applicable)?

Feasibility

  • Is the concept proposal feasible for implementation?
  • Is study product produced and available?
  • Is an appropriate study population available for recruitment? What is the level of difficulty for study implementation and meeting target accrual?
  • Is the study schedule appropriate?
  • Are there barriers to IRB and/or regulatory approval?

Fit with the IDCRC Mission

  • Is the concept aligned with the scientific priorities of the IDCRC?
  • Does the proposal benefit from a multi-site, multi-disciplinary collaboration involving different populations?
  • How is the proposed intervention well-suited for evaluation through the VTEU mechanism? Is this a concept that would otherwise not be evaluated through other mechanisms such as alternative/industry development pathways?

Innovation

  • Is the concept, approach, population or intervention novel?
  • Will the proposed trial involve innovative methodologies or assays?
  • Is this an incremental approach or one that has the potential to significantly advance the field?

Concept Proposal Form

Download the IDCRC Study Concept Proposal Form

Submit proposal form via email to goonwattie_surajpal@urmc.rochester.edu