Definitions of Criteria and Considerations for Bioengineering Research Partnerships (BRP)

Updated March 21, 2016

Standard criteria and considerations are shown below. Individual Funding Opportunity Announcements (FOAs) may have additional criteria and considerations.

[Return to ‘Guidance for Reviewers’ website]

 

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

1. Significance. Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project?  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?   Will the project address a problem or critical barrier for which there is a scarcity of other solutions?  If the goals of the BRP are achieved, will they provide new capabilities that will enhance biomedical research or clinical practice?  Will the technological advances improve human health?

2. Investigator(s). Are the PD/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-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Does the leadership team have sufficient project management experience?  Does the partnership have appropriate experience with enhancing, adapting, optimizing, validating or otherwise accelerating the development and adoption of biomedical technologies?  Does the team have experience assessing and meeting stakeholder needs?  Will the PD(s)/PI(s) provide an appropriate level of effort to effectively lead the project, manage resources, and coordinate the partners?

3. 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? Will the project deliver new capabilities, taking into account end-user resources, workflow and skills?  Will the proposed approaches or concepts solve current scientific or technical problems in creative ways?

4. Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Are the BRP engineering, scientific, and clinical approaches and methods adequately developed, well-integrated, and appropriate to the aims of the project?  Is the Leadership Plan clear, sound, appropriate, and practical?  If partnership with industry or other organization is proposed, does this positively affect the research goals and technology dissemination?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of children, justified in terms of the scientific goals and research strategy proposed?

5. 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? Does the partnership create potential opportunities to foster trans-disciplinary communication and training across traditional scientific and technical boundaries?

Additional Review Criteria

Leadership Plan

Do the organizational structure and leadership plan of the project indicate an ability to meet the proposed goal(s) within 5-10 years? Does the information provided suggest an ability to effectively partner and manage multidisciplinary projects and deal with sensitive but critical go/no-go decisions in a team-based environment?

Milestones and Timeline

Are milestones associated with clear, quantitative criteria for success that allow go/no-go decisions?  Are the timeline proposed for achieving the milestones realistic and inclusive of necessary steps?  Would achieving all milestones in the application allow the project to achieve the end goals for the project?

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 additional information, see the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information, see the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmission.

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.

When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision.

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.

Additional Review Considerations

Applications from Foreign Organizations.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Additional Comments to the Applicant.

Reviewers may provide guidance to the applicant or recommend against resubmission without fundamental revision.

[Return to ‘Guidance for Reviewers’ website]