Scope of Key Function Committees

Mentoring, Career Development and Training Commitee (MCDTC)

The aim of this committee is to establish and operate a mentoring, career development and training platform to train and cultivate the IDCRC science workforce and leadership of the future.

The Mentoring and Career Development Section of the MCDTC fosters the development of junior investigators in clinical and translational infectious diseases research. The IDCRC believes that the success of research leading to new vaccines and therapeutics depends on a vibrant well-trained cadre of young investigators. The program includes the IDCRC Mentorship Program, which includes 16 early-career investigators (faculty and fellows) across eight VTEUs. The program is structured as a two-year program which includes mentoring advisory meetings, lectures and seminars, and other opportunities tailored to the mentee’s career goals. The Mentoring Lecture Series provides information on such key topics as Study Design, Regulatory Considerations, Statistics in Proposal Development and Laboratory Aspects of Clinical Protocol Development. Committee Co-Chairs also meet individually with mentees twice during the year to review their progress, to outline potential needs of the mentees, and to receive feedback on improvements in the program. The program also includes the New Investigator Pilot Grants Program. An RFA is developed annually to solicit applications. Using an NIH-style grant review process, two Pilot Award recipients are selected each year. 

The Training Section of the MCDTC provides overall IDCRC Leadership Group oversight of training and education activities. This oversight includes proficiency and regulatory training and training documentation.  The committee will engage infectious diseases researchers, coordinators and staff to develop the ideal training activities for all IDCRC research personnel. The MCDT KFC is overseen by the IDCRC Leadership Operations Center (LOC) Co-Chairs. 

Performance Evaluation, Ethics and Quality Assurance

The Performance Evaluation, Ethics and Quality Assurance (PEQ) KFC develops and incorporates policies, methods and approaches for monitoring implementation of clinical research conducted by the VTEUs and affiliated Clinical Research Sites (CRS) and evaluates the operational performance of the overall Leadership Group (LG), each LG element including the Clinical Operations Unit (COU), the Lab Operations Unit (LOU) and the Statistics and Data Sciences Unit (SDSU), the Key Function Committees (KFCs) and Expert Working Groups (EWGs). Additionally, this committee develops strategies for assuring quality management and ensures that the risk assessment and mitigation strategies are an integral part of all research activities within the IDCRC. These strategies complement quality management systems and processes established by NIAID. A key component of this function is ethical conduct of research and performance standards of leaders, investigators, clinical coordinators, laboratory and other staff.   

The PEQ KFC members work closely with the IDCRC COU to develop the plan for measuring performance of the IDCRC and monitoring adherence to quality assurance and ethical standards, soliciting input as needed from the LOU, SDSU and NIAID. The plan will outline the metrics, standards and data elements that will be targeted to evaluate the consortium. It will also describe the format, frequency and process for aggregating data elements and reporting on established metrics. Finally, it will outline the plan for risk identification and mitigation and corrective action.     

The PEQ evaluation plan and reporting processes provide a mechanism to ensure that a comprehensive internal review of performance and output of the various IDCRC units occurs throughout the year. The PEQ annual report provides summary evidence of effectiveness and impact in reaching the specific aims and objectives of IDCRC. The PEQ report is shared with the EMT for review. The PEQ KFC is overseen by the IDCRC Leadership Operations Center (LOC) Co-Chairs. 

Collaborations and Publications

All manuscripts covering primary research conducted by the IDCRC must be submitted to the Collaborations and Publications Committee (CPC) of the SOGC for review and clearance prior to submission to a journal.  The CPC will share the manuscript with all CPC members and send it to the Chair of the appropriate Expert Working Group for primary review.  That individual will either review the manuscript or select someone within the EWG to perform the primary review.  Reviews will then be returned to the lead author from the submitting writing group within 10 business days with any requested revisions.  If the review requires changes, the primary authors will be given 30 days to make the changes and resubmit to the CPC.   Both the CPC and the primary reviewer will evaluate the revised draft. If approved, the manuscript will be forwarded to the SOGC and NIAID for parallel review and clearance that should be completed electronically within 10 working days.  Changes requested by SOGC and/or NIAID will be sent to the lead author, who will take responsibility for subsequent revisions.  Once those changes are made, the manuscript will be forwarded to the SOGC and NIAID for final approval.  If approved, the primary author will be advised to submit the manuscript to the agreed upon journal.  If the journal requires substantial revisions prior to publication, the author may be required to resubmit to the CPC/SOGC and NIAID or clearance.  Modified SOPs will be developed for secondary and tertiary analyses and for abstracts that may require shortened timelines for submission to scientific meetings. The CPC and SOGC will have an expedited process for manuscripts of time-sensitive public health importance, for example during a pandemic when information is needed to guide decision-making.

Following acceptance by a journal or scientific meeting, the primary author will share the accepted manuscript/abstract with the members of the writing group, the IDCRCLG and NIAID, prior to publication/presentation.  The CPC, in consultation with the lead author SOGC and NIAID, will decide if there should be press releases associated with the publication or abstract presentation.  If so, LOC Communications and the CPC will work with NIAID and the lead author’s institution in developing the press releases. The publication policies and timelines will be evaluated and modified as needed annually.

With regard to collaborations, one focus will be on high level collaborations by the LG. VTEU collaborations also bring significant value.  The LG can reach out to major collaborators (PHARMA, Gates, Global groups) to increase recognition of this new resource.  The Committee will also help develop LG policies to encourage internal collaboration within the IDCRC, such as the role of concept submitters in implantation.

The CPC committee should have 2-3 VTEU members, 1 NIAID, and 2-3 LG, with rotating terms.

IDCRC Publication Review Request Form

IDCRC Publication Quick Reference


Laboratory innovations are also a key component of the IDCRCLG and will be incorporated in all aspects of trial design and prioritization. As is outlined in the LOU section, the revolution in areas of systems immunology including single-cell multi ‘omics platforms are leading to breakthroughs in how we understand the human immune response. We envision a seamless integration of the LOC Innovations Committee, with Dr. Paul Spearman as the Chair, and the LOU leadership, so that the latest in laboratory advances are included in trial planning and design, and appropriate internal or external investigators are engaged at early stages. We envision the studies designed and conducted by the IDCRC as the premier testing ground for innovative ideas and assays relevant to infectious diseases and vaccine evaluation, engaging the brightest minds in the field in collaborative science. 

These are examples of new approaches to connectivity, vaccine development and therapeutics and concepts in clinical trials design and laboratory innovations that enhance sensitivity and integrate new information for the advancement of scientific knowledge and clinical practice. The LOC Innovations Committee will identify and evaluate additional new approaches (e.g. new instrumentation, public-private models) that can shift infectious diseases clinical research paradigms. The committee will also focus on biomedical innovation in infectious diseases, entrepreneurship-utilization of NIAID’s small business program, the identification and development of areas of frontier research such as computational biology, immune-engineering and interfaces with the for-profit biomedical sector (biotechnology, pharmaceutical, information technology) and the non-profit sector both locally and nationally and will connect to innovation ecosystems developing globally. The committee will also address new approaches to intellectual property issues, data sharing and IDCRC reciprocity agreements.  Some innovation ideas already under discussion include:

  • Potential to create an umbrella screening protocol to allow expedited screening and enrollment for urgent trials in emerging infections area.
  • Adaptive or iterative study design to allow Phase I studies to shift into Phase II studies.
  • Find ways to publish more quickly – remove barriers to publication and other communications with the scientific community in general, such as: don’t limit all reports to after the final CSR, allow earlier data queries and locking of database. This is felt to be essential to achieve high impact from any innovation in our clinical trials.
  • Operational innovations are needed: protocol development can be greatly streamlined; face-to-face meetings emphasized; direct data entry should be the norm.
  • Find ways to prioritize or optimize moving the best products through to Phase I studies and potentially interfacing with other groups. The discussion centered on integrating our efforts by having VTEU representatives in other areas: emerging infections, flu centers, others.
  • Using big data to find the high-risk patients that would be best candidates for hard to enroll studies. Google, Amazon cited as examples.

Laboratory Sciences

The laboratory research activities will be overseen by the Key Function Laboratory Science Committee (KFLSC), chaired by Dr. Rafi Ahmed. Activities of the Committee will include:

  • Protocol Standardization across sites.
  • Defining pathogen and vaccine specifics.
  • Universal SOP for specimen handling, shipping.
  • Engaging working groups to define assays as a priority.  
  • SOP’s regarding biobanking.
  • Building a quantitative lab approach, bringing in innovative ‘omics.
  • Samples in international sites - standardizing issues of shipping or setting up regional labs to help standardize - identify the key areas where we will be working and want to have linkages with extended sites.
  • Quarterly IQA is important – look at how it can be made less burdensome.