Review Criteria

Purpose

To provide peer reviewers standard review criteria, and possibly, initiative-specific review criteria, for judging an application's scientific and technical merit.

Procedure

Investigator-initiated R01 funding opportunities typically use the standard NIH review criteria only.

Other types of investigator-initiated applications (e.g., P01, R21, R34, and U01) and initiatives (e.g., requests for applications, program announcements) may list additional review criteria in the funding opportunity announcement.

Investigator-Initiated Review Criteria

• Significance. Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
• Investigators. Are the PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
• Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
• Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities, members of both genders, and children justified in terms of the scientific goals and research strategy proposed?

• Environment. Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Reviewers will also assess the following items in determining scientific merit and priority score:

• Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

For more information, see the Grant Application Guide (for an electronic application) or PHS 398, Research Plan, Human Subjects Research (for a paper application).

• Inclusion of Women, Minorities, and Children. Adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children, as appropriate, for the scientific goals of the research. Reviewers will also evaluate plans for recruiting and retaining subjects.

For more information, see the Grant Application Guide (for an electronic application) or PHS 398, Research Plan, Human Subjects Research (for a paper application).

• Vertebrate Animals. If vertebrate animals are to be used in the project, see the five items described under the Grant Application Guide (for an electronic application) or PHS 398, Content of Research Plan, Vertebrate Animals (for a paper application).
• Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
• Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
• Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
• Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Unless the funding opportunity announcement states otherwise, the sharing plans for data from genome-wide association studies and other research data, resources, and model organisms would not affect the score.

Applicants

• Learn more about review in Part 8. Assignment and Review of the NIH Grant Cycle: Application to Renewal, including How NIH Review Criteria Affect Your Score. Also read the review-related Questions and Answers for general information.
• If you're applying for a grant other than an R01, read the NIH Guide notice referenced in the funding opportunity announcement to see if there are additional review criteria.
• For SBIR/STTR applications, also read the SBIR/STTR Grant Application Guide for additional review criteria for Fast Track and Phase II Applications.

Program Officers

• When writing an RFA, use the investigator-initiated review criteria as the basis for writing, and if necessary add wording to expand these criteria.
• If more criteria are necessary to evaluate applications, work with the scientific review officer to develop additional review criteria. Add no more than five additional criteria specific to the RFA.
• For contracts, read the following SOPs: Peer Review of R&D Contract Technical Proposals, Contracts Involving Animals, and Contracts Involving Human Subjects.

Scientific Review Officers

• If additional criteria are required, develop them with the program officer.
• Prepare reviewers to evaluate any opportunity-specific review criteria.
• For contracts, read the following SOPs: Peer Review of R&D Contract Technical Proposals, Contracts Involving Animals, and Contracts Involving Human Subjects.

Contacts

Applicants with review questions should contact the scientific review officer. For NIAID, see the Scientific Review Program contacts.

For general information, contact Contact for NIAID Staff

For initiative development, contact Contact for NIAID Staff

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Animals in Research for Grants SOP

NIAID's Grant Application portal

Grant Application, Electronic SOP

Grant Application, Paper SOP

Human Subjects Research Requirements SOP

NIH Grants Administration Manual - 4204-204B - Peer Review Process

NIH Grants Policy Statement section on peer review

Scientific Review Meeting Rosters and Schedules, CSR