# Presentation: 724492

## Regional Centers of Excellence Peer Review

- For information contact:
- Katherine L. White, Ph.D.
- Scientific Review Program, NIAID
- 301-435-1615      kw174b@nih.gov

**Notes:**
Explain Review Officer vs. Program Officer contacts at various stages of the process

## Peer Review Committee

- Scientists/Clinicians/Administrators from industry /academia with appropriate experience/expertise in administration of large centers.
- Research scientists with appropriate expertise relevant to the research projects proposed.
- Faculty with appropriate expertise reviewing training grant applications.

## Peer Review Committee

- Subgroups may be used to ensure a thorough and equitable review.
- Subcommittees within a subgroup may be established to ensure a thorough and equitable review.

## Reviewer Expectations

- Review Committee is seeing the application for the first time.
- Organization, clarity, description, and detail.
- Address the RFA.

## Review Criteria

-  5 components:
- 1. Background, Strategic Plan , and Management of the RCE (30%);
- 2. Research Program and 3. Scientific Facilities Cores (50%);
- 4. Developmental Research Plan (10%);
- 5. Career Development and Training Program (10%)
- Review Committee will use the criteria defined within RFA when evaluating applications.

## Background, Strategic Plan and Management of the RCE criteria and attributes:

- Plans to achieve the goals of the RCE.
- Plans to develop critical, new knowledge about biodefense and emerging infectious disease and enhance regional research and development capabilities.
- Plans to span basic and clinical/translational issues and lead to vaccines, diagnostics, and therapeutics.
- Plans for synergy.
- Plans for interaction with federal, state, and local agencies or industry (communication).
- Plans for assessment of milestones/productivity.
- Plans for incorporation or elimination projects/cores.
- Plans for institutional support and additional resources.

**Notes:**
Document collaborations, partnerships and facilities availability

## Background, Strategic Plan and Management of the RCE should:

- Plans to leverage additional scientific and technical support.
- Plans to be a regional biodefense first responder.
- Plans for rapid development of the Center.
- Plans for organizational structure and management.
- Description of qualifications of the Principal Investigator and key personnel.
- Plans for administrative structure and lines of authority.
- Plans for availability of Resources to investigators.
- Plans for fiscal management, accountability, and communications within the Center.

## Research Program and Scientific Facilities Cores

- Significance, Approach, Innovation, Investigator, Environment,
- Appropriateness and scope of clinical studies.
- The projects should support the strategic plan and emphasize synergy and integration of the overall theme.
- Multi-project programs will be further evaluated for cohesiveness, collaboration, exchange of ideas, synergy and overall value added to the Center.

## Research Program and Scientific Facilities Cores

- Plans to prioritize use by RCE and non-RCE investigators.
- Documentation of qualifications, experience and commitment of key personnel
- Documentation of merit in relation to existing facilities in the Center and region.
- Plans for availability during a National biodefense emergency.
- Plans for user fees to ensure accessibility and usage especially by those with limited resources.
- BSL3/4 need and plans for linkage to BSL3/4 facilities.
- Biocontainment experience and plans for training.
- Plans for a mechanism for research until facilities are available.

## Developmental Research Plan

- Plans and criteria to select, monitor success, leverage resources and complement the Center’s strengths.
- Plans to bring in new investigators into biodefense research, and for recruitment strategies to ensure a broad applicant pool and scientific topics.
- Plans and criteria for phase-in and phase-out and advancement to full Research Project Status.
- Do not submit detailed descriptions of projects.

**Notes:**
A formal outcomes assessment process should be developed and proposed.  Don’t leave reviewers guessing.

## Career Development and Training Program

- Documentation of technical, scientific expertise, mentoring experience, and availability of faculty and staff.
- Documentation of available training infrastructure.
- Plans to increase human resources available for biodefense including students, trainees, women, and minorities.
- Contribution to the RCE.
- Plans for evaluation of training and documentation of success.

## Potential pitfalls for applicants

- Failure to adequately address within the application the objective and scope as defined by the RFA.
- Failure to adequately document value added and contribution to an existing RCE already established within the same region.
- Inclusion of weak research programs.
- Failure to adequately detail the strategic plan and administration of the Center.
- Serious inadequacies of any of the  5 required components.

## Finally

- Send original and 3 copies to CSR.
- Send 2 copies and all copies of appendices to me at the NIAID Scientific Review Program.
- Published and accepted manuscripts only.
- Color photos sent in the body of the application will be photocopied in black and white.  Send color photos as appendix items.
- Label appendix sections clearly to indicate which section of the application they support with Principal Investigator name as well as project/core Principal Investigator name.

## Finally

- Address plans for protection from biohazards.
- Carefully address human subjects and animal welfare requirements.