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Definitions of Criteria and Considerations for HEI-S10 Critiques
Updated July 31, 2017
Reviewers will provide an overall benefit score to reflect their assessment of the likelihood that the requested instrument will exert a sustained, powerful influence on the conduct of research projects and their scientific outcomes, in consideration of the following 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 three 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?
If a SUI is requested, is the Plan to Protect Access of Major and Minor Users to the instrument well designed? Will a SUI put an unreasonable burden on the Major and Minor User groups? Does the commitment letter of the institution sufficiently protect the research time and efforts of the Major and Minor user grups?
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?
Protections for Human Subjects.
Inclusion of Women, Minorities, and Children.
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.
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.
Additional Review Considerations
Applications from Foreign Organizations.
Select Agent Research.
Resource Sharing Plans.
Authentication of Key Biological and/or Chemical 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. Reviewers will comment whether applicants employed the best economical approaches, including securing academic discounts, to formulate the cost-effective budget while meeting users’ scientific needs.
Additional Comments to the Applicant
Reviewers may provide guidance to the applicant or recommend against resubmission without fundamental revision.