Current through Register Vol. 48, No. 12, March 22, 2024
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.
