Concept Development

Proposing a Study Concept for the Network

Initial Concept Proposal Form

Proposals for IDCRC studies may be submitted through the Initial Concept proposal (ICP) available above. Key information about the process and eligibility is as follows:

  • For COVID-19 concepts involving new vaccines or therapeutics, preclinical data (in vitro, animal studies, toxicology, etc.) with SARS-CoV2 or other CoV is required for a review. The following contacts for the NIAID/DMID preclinical services for concepts that need more extensive animal and in vitro testing:
    • Contacts for COVID19 Antiviral testing:  Ann Eakin, NIH/NIAID
    • Contacts for COVID19 small animal testing: Chelsea Lane, NIH/NIAID
  • ICPs are welcome from investigators who are affiliated with the IDCRC/VTEU network as well as investigators external to this network. Investigators external to the network are advised to seek a partner within the established network or at DMID prior to concept submission. The IDCRC will facilitate finding a partner if requested.
  • ICPs may be submitted at any time throughout the calendar year.
  • The ICP form will be submitted to the IDCRC Expert Working Group (EWG) Liaisons, Executive Management Team (EMT), appropriate EWG Co-Chairs and DMID representatives, and the appropriate EWG. EWG Liaisons may request a review from the Statistics and Data Science Unit (SDSU) and may provide preliminary feedback and/or request additional information if needed to make an initial determination. The EWG Co-Chairs and DMID representatives will review the ICP using the standardized criteria listed below, solicit input from EWG members, and submit a summary/recommendations to the EMT for their further review.   
  • The EMT will review the ICP, including the EWG summary/recommendations and a final decision on whether to invite submission of an Extended Concept Proposal (ECP) will be made in consultation with NIAID/DMID. ICPs will be reviewed for suitability for IDCRC generally within four weeks of receipt of the completed ICP (after receipt of any additional information requested by the IDCRC).
  • 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 Chairs in the case of public health emergencies. This process will include expedited review by the IDLG Chairs and EMT and recommendations will be made in consultation with NIAID/DMID.
  • In general, specific pathogens will align with the identity of EWGs and the main pathogens of concern are listed by category below.
  • If a concept is approved for protocol development, then the individual or team that submitted the concept will remain involved in study planning, implementation, and publication.

Model ICP 

Shell Protocol Example

Extended Concept Proposals (ECP) for IDCRC studies may be invited after review of the ICP described above. Key information about the ECP review process and eligibility is as follows:

  • Expanded concept proposals (ECP) will be submitted using a template format that is approximately 10 pages in length (excluding references and budget estimate) and will describe the proposed study in greater detail than the ICP.
  • The EMT may assign staff from the Clinical Operations Unit (COU), SDSU and Laboratory Operations Unit (LOU) to support the development of invited ECPs. The COU may provide administrative and coordination support to the concept development group. The SDSU statistician(s) provides advice on study design and sample size calculations, and the LOU provides advice on laboratory evaluations, as needed.
  • The ECP review and scoring criteria are shown below.
  • A primary and secondary reviewer will be assigned by the Co-Chairs from within the appropriate EWG, along with a reviewer with biostatistical expertise from the SDSU. Written reviews with scores will be submitted. Discussion among the full EWG membership will be held on regularly scheduled calls with exceptions made for concepts that require urgent consideration.
  • A recommendation on the disposition of the ECP, including the scores and results of the EWG vote, will be provided to the EMT for further consideration. The EMT will then review the EWG recommendations, determine the ECP’s relative priority and the final decision on the disposition will be made in collaboration with NIAID/DMID.
  • It is anticipated that the review process for ECPs will be completed within a 2 month timeframe (from submission of a complete ECP thru decision).

Workflow Illustration

Please include the following citation in any publications resulting from direct or indirect IDCRC support:

"Supported by the Infectious Diseases Clinical Research Consortium through the National Institute for Allergy and Infectious Diseases of the National Institutes of Health, under award number UM1AI148684. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."