Ill. Admin. Code tit. 77 § 995.110

Current through Register Vol. 48, No. 49, December 6, 2024

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.

Ill. Admin. Code tit. 77, § 995.110