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Standard Operating Procedure Table of Contents
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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
Program Officers
Scientific Review Officers
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 |