77 Ill. Adm. Code 995.110
Application Review Process
Section 995.110 Application Review Process
a) At
the end of an application period, the Department will conduct a screening
review to confirm that each application is complete. The screening review will
confirm that:
1) All
required questions in the application have been answered;
2) All
required forms and materials have been submitted;
3) All
ethical and legal guidelines applicable to the research project have received
appropriate approvals, including any required approvals by the institution's
IRB, ESCRO committee or IACUC, or that the appropriate approvals have been
applied for and are pending. No monies shall be spent on an activity without
appropriate approvals;
4) The
description of the research project and its objectives, protocols and ethical
and legal guidelines is clear and concise. Applications that exceed the
maximum length permitted in the written instructions for applicants shall be
returned without consideration; and
5) All of
the necessary parties have signed the application.
b) The
Scientific Review Panel will have 10 to 20 members appointed by the Director to
serve a term of two years. If a vacancy occurs, the Director will appoint a
replacement to serve the remainder of the term. Panel members will:
1) Not be
residents of Illinois;
2) Not
be employed by a medical research institution with its principal place of
business in Illinois;
3) Not be
members of the Committee; and
4) Have
demonstrated at least one of the following:
A) Scientific
research and experience in the derivation and use of human embryonic stem
cells, human embryonic germ cells or human adult stem cells;
B) Knowledge
and understanding of the ethical and medical implications of the derivation and
use of human embryonic stem cells, human embryonic germ cells and human adult
stem cells.
c) The Panel will:
1) Establish
guidelines for scoring applications, which shall adhere to the National
Academies of Science Guidelines for Human Embryonic Stem Cell Research, 2007
Amendments to the National Academies of Science Guidelines for Human Embryonic
Stem Cell Research, and 2008 Amendments to the National Academies of Science
Guidelines for Human Embryonic Stem Cell Research.
2) Review
complete applications submitted by eligible institutions and make
recommendations to the Committee with respect to the scientific and ethical
merit of the applications reviewed.
3) Review
progress and final reports prepared by awardees as required in grant agreements
with the Department.
d) Two
members of the Panel will review and evaluate each complete application and
present their evaluations to the entire Panel. The Panel will review and study
the application, rate the scientific and technical merit of the application,
and propose terms for the grant agreement. The Panel will review and rank the
quality of the research project under the following criteria:
1) The
activities identified by the applicant will lead to achievement of the research
objectives;
2) The
project objectives are achievable in the stated time frame;
3) The
evaluation methods measure progress toward the identified objectives;
4) The
budget provides sufficient resources that include, but are not limited to,
staff, equipment and supplies, and justifies the need for funds to carry out
the project;
5) The
investigators, especially the principal investigator, have a history of
conducting and completing scientific research on time, on budget and as
planned;
6) The
investigators, especially the principal investigator, have significant
expertise in biotechnology and have a reputation for innovation and for
developing practical applications for biotechnology;
7) The
applicant has the facilities and resources to complete the research project as
described;
8) The
research leads to or involves clinical trials;
9) The
stem cell research project has the greatest potential, based on the information
presented in the application and the Panel's knowledge and experience, for
therapies and cures and cannot receive or is unlikely to receive sufficient
federal funding;
10) The
research is likely to lead to new therapies, treatment or cures for
debilitating diseases and injuries, based on the information presented in the
application and the Panel's knowledge and experience;
11) The
research will lead to patents, articles in peer-reviewed journals or additional
grant funding;
12) The
research proposes projects of established researchers to undertake stem cell
research, of junior investigators to develop stem cell research projects, or of
researchers in human embryonic stem cells;
13) The
research project will develop or refine the understanding of the ethical, legal
and social issues raised by stem cell research;
14) The
project proposes novel ideas and approaches to develop the ideas;
15) The
project proposes human embryonic stem cell research that may attract venture
capital for biotechnology start-up companies in Illinois;
16) The
research that is likely to accelerate the pace at which basic and preclinical
findings are translated into clinical benefits;
17) The
project proposes collaborative and interdisciplinary research among
investigators, whether at the same or different institutions; and
18) Funding
the project will increase awareness and understanding of stem cell research.
e) The
Panel will prepare a report for the Committee, setting forth its analyses,
impressions and recommendations on the application, the rank order of the
projects and the amount of the grant recommended, if any. The Panel may
approve part of an application and recommend partial funding (see Section
995.130).
f) After
the Panel ranks the approved applications in order and submits the list to the
Committee, the Committee will decide which applications to fund based on the
reviewers' recommendations and the criteria listed in this Section. If the
amount of recommended funding exceeds the total amount for awards, the
Committee may approve reduced funding for one or more applicants. Those
applicants offered reduced funding may decline; if they accept, they shall
submit a revised budget for the reduced amount within 10 days after acceptance.