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Definitions of Criteria and Considerations for HEI S10 Critiques
Updated December 16, 2015
Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the request instrument will exert a sustained, powerful influence on the conduct of research projects and their scientific outcomes,, in consideration of the following review criteria and additional review criteria.
1. Justification of Need.
Is the need for the instrument clearly and adequately justified? Is the equipment essential and appropriate? Are all specific features and special accessories of the requested instrument well justified; in particular, by their need of Major Users? Is Accessible User Time (AUT) well defined and explained? Is AUT reasonable? Justification of selection of proposed instrument may include but is not limited to comparison with other commercially available instruments of similar function.
2. Technical Expertise.
Does the institution have the technical expertise to make effective use of the requested equipment? How well qualified are the participating investigators or other assigned personnel to operate and maintain the instrument, conduct the projects, and evaluate the research results, including analysis and interpretation of data? How will new users be trained? How will biosafety procedures be implemented?
3. Research Projects.
Will research with the requested instrument advance the knowledge and understanding of the proposed projects? How will the research projects of individual Users be enhanced? Do Users adequately justify the requested instrument for the needs of their specific projects? If accessories are requested for the instrument, do at least half of the Major Users require each of the accessories for their research projects?
Is the plan for the management and maintenance of the requested instrument appropriate? Is the membership of the Advisory Committee broadly based to oversee the use of the instrument for the appropriate range of biomedical investigators, to balance interests of different users, and to resolve disputes (if they arise)? How will research time be allocated among the projects? Are the sharing arrangements equitable? If needed, are the policies to manage projects which have human subjects, animals or biohazards adequate? Is the financial plan for the instrument for five years or the expected lifetime of the instrument reasonable and secured, balancing anticipated expenditures and anticipated income? Is the expected usable lifetime of the instrument reasonable?
5. Institutional Commitment.
Did the institution provide the required letter of commitment to back-up the submitted financial plan in the event of a shortfall of income? Is the institutional commitment to back-up the financial plan provided for a time period consistent with the expected effective lifetime of the requested instrument? Has the institution provided the required “Letter of Support” table listing previous S10 instruments awarded or installed within the past five years? Is the management of awarded S10 instruments adequate? Does the Institution provide adequate infrastructure support for the requested instrument including space to house the instrument and site for sample preparation, if needed?
Inclusion of Women, Minorities, and Children. Generally Not Applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Vertebrate Animals. Generally Not Applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
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.
Resubmissions. For Resubmissions, 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.
Renewals. Not Applicable.
Revisions. Not Applicable.
Applications from Foreign Organizations. Not Applicable.
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. Not Applicable.
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.