Summary
Statutory Review of the Life Sciences Research Board
and Life Sciences Research Trust Fund
Statutory Authorization
- Sections 196.1100 - 196.1130, RSMo, Cumulative Supplement, 2003, authorize the Life Sciences Research Board (LSRB) and Life Sciences Research Trust Fund (LSRTF).
- The LSRB is created as Type III division in the Missouri Office of Administration. See, RSMo-2000, Volume 15, Appendix B, Reorganization Act of 1974, Section 1.7(c).
- Under a Type III designation the department (OA) has "only such supervision by the head of the department for budgeting and reporting as provided under subdivisions (4) and (5) of subsection 6 of this section and any other supervision specifically provided in this act or later acts. Such supervision shall not extend to substantive matters relating to policies, regulative functions or appeals from decisions of the ...board...unless otherwise provided by this act or later acts."
Duties and Responsibilities of the Life Sciences Research Board
- Management, governance, and control of appropriated moneys in LSRTF to the LSRB - 196.1103.
- LSRB shall monitor and adopt rules to assure quality and accountability in operation of centers for excellence. -196.1106(2).
- LSRB shall receive and review suggestions for formation and composition of the initial CE. Upon review of suggestions LSRB shall determine initial composition and shall consider and approve the organizational plan and structure of 4 CE. To be a CE, its composition and organizational structure must be approved by LSRB. -196.1106(7); 196.1106 (8).
- LSRB shall consider proposals endorsed by CE subject to a process of peer review conducted under the auspices of LSRB. - 196.1112.
- LSRB may:
- Award and enter into grants or contracts relating to increasing Missouri's research capacity at public or private not-for-profit institutions;
- Make provision for peer review panels to recommend and review research projects;
- Contract for administrative and support services;
- Lease or acquire facilities and equipment;
- Employ administrative staff; and
- Receive, retain, hold, invest, disburse or administer any moneys that it receives from appropriations or from any other source. - 196.1115 (1)-(6).
- LSRB shall utilize as much of funding as reasonably possible for building capacity to do research rather than for administrative expenses. LSRB in each fiscal year, unless General Assembly appropriates more for administrative expenses, limited to 2% of total moneys available for its own administrative expenses. - 196.1115.3.
- LSRB shall provide for annual fiscal year audit. (Either from state auditor or outside PAF.) - 195.1118. (Not part of administrative costs.)
- LSRB shall prepare comprehensive report every 3 years for governor, general assembly, and public. - 196.1118. (Not part of administrative costs.)
- LSRB may issue rules and guidelines for reimbursement of costs consistent with such four-part test and provide grant and contract recipients with a list or other explanation of regularly permitted costs. - 196.1121.1.
- LSRB shall adopt reasonable rules to ensure that any such intellectual property rights are utilized reasonably and in a manner that is in the public interest. - 196.1121.2.
- LSRB may issue conflict of interest guidelines and requirements with respect to the administration of the life sciences research program. - 196.1124.
- LSRB and research limitations the moneys appropriated to the life sciences research board pursuant to sections 196.1100 to 196.1124 shall be subject to the provisions of this section. (Abortion services, human cloning, prohibited human research, research project.) -196.1127.1.
- If the LSRB issues rules the rules shall be promulgated pursuant to Chapter 536, RSMo. - 196.1130.
- Moneys appropriated to LSRB and not distributed in a fiscal year to a CE, shall be held in reserve by LSRB or shall be awarded on the basis of peer review panel recommendations for capacity building initiatives proposed by public and private not-for-profit academic, research, or health care institutions or organizations, or individuals engaged in competitive research in targeted fields. - 196.1115.1.
Centers of Excellence (CE)
- Centers of Excellence (CE) shall be established and shall be subject to provisions of 196.1106.
- Definition for - Center of Excellence for life sciences research. 196.1106 (1). "center for excellence for life sciences research" means a system or regional consortium of public and private not-for-profit academic, research, or health care institutions or organizations engaged in competitive research in targeted fields consistent with the strategic purposes of life sciences research as provides in sections 196.1100 to 196.1130."
- CE may be established within: St. Louis area - City of St. Louis; Counties of St. Louis, St. Charles, Jefferson, Franklin. Kansas City area - Counties of Jackson, Clay, Andrew, Buchanan, Platte. Springfield - Counties of Greene, Christian, Webster. Missouri Statewide CE comprised of institutions, agricultural research centers dedicated to the development of plant-made pharmaceuticals, and campuses within the University of Missouri system and those regions of Missouri not within another center for excellence. University of Missouri-Kansas City in Kansas City area CE. University of Missouri-St. Louis in St. Louis area CE.
- CE shall be comprised of consortium of public and private not-for-profit academic, research, or health care institutions or organizations that have collectively at least fifteen million dollars in annual research expenditures in the life sciences, including a collective minimum of two million dollars in basic research in life sciences. - 196.1106 (9).
- CE shall appoint screening committee (SC) (qualifications and conflict of interest same as LSRB members). SC shall solicit, collect, prioritize, and forward research initiatives for funding to LSRB. CE have powers consistent with 196.110-196.1130 and rules, guidelines, decisions adopted by LSRB. - 196.1106. (10)-(11).
- At least 80% of moneys appropriated to LSRB in each FY distributed to proposals and programs recommended by a CE. - 196.1112.
- Collectively single CE cannot receive in a FY more than 50% of moneys appropriated in a FY. - 196.1112.
- Single institution or organization cannot receive in consecutive three-fiscal-year period more than 40% of moneys appropriated to LSRB in that period. - 196.1112.
Missouri Institutions and Organizations - Limitations
- LSRTF shall be used... "by building on the success of research institutions located in Missouri, creating in and attracting to Missouri new research and development institutions, commercializing the life sciences technologies developed by such institutions, and enhancing their capacity to carry out their respective missions." - 196.1100.2.
- LSRB to use fund... "to increase the capacity for quality of life sciences research at public and private not-for-profit institutions in the state of Missouri...." - 196.1109
Reimbursement of Costs
- Grants and awards shall provide for reimbursement of costs. Allowance of specific costs based on application of "four-part balancing test" which shall include; reasonableness; connection to grants/contract; consistency to grant/contract; conformance to grant/contract. LSRB may issue rules and guidelines consistent with four-part test and provide recipients with list or explanation of costs. - 196.1121.1
- LSRB may use funds for... "including but not limited to the costs of personnel, supplies, equipment, and renovation or construction of physical facilities." In any single fiscal year no more than 10% of the moneys appropriated shall be used for the construction of physical facilities; in any fiscal year 80% of the moneys shall be appropriated to build research capacity at public and private not-for-profit institutions and 20% of the moneys shall be appropriated for grants to public or private not-for-profit institutions to promote life science technology transfer and technology commercialization. 20% of the moneys in any FY shall be appropriated to promote the development of research of tobacco-related illnesses.
Types of Research
LSRB to fund research including but not limited to:
- Basic research (including the discovery of new knowledge), translational research (including translating knowledge into a usable form), and clinical research (including the literal application of a therapy or intervention to determine its efficacy), including but not limited to health research in human development and aging, cancer, endocrine, cardiovascular, neurological, pulmonary, and infectious disease, and plant sciences, including but not limited to nutrition and food safety....- 196.1109(1).
- LSRB may also use funds for... "technology transfer and technology commercialization derived from research at public and private not-for-profit institutions within the centers for excellence... Technology transfer and technology commercialization" includes stages of the regular business cycle occurring after research and development of a life science technology, including but not limited to reduction to practice, proof of concept, and achieving federal Food and Drug Administration, United States Department of Agriculture, or other regulatory requirements in addition to the definition in section 348.251, RSMo.
Life Sciences Research Trust Fund
- LSRTF separate and apart from all other state funds. Includes tobacco securitization settlement trust fund but not limited. Beginning FY 2007 until perpetuity LSRTF receives 25% of all moneys received from master settlement agreement. Not subject to appropriation for other purposes and used for purposes of act only. LSRTF shall not lapse to General Revenue. - 196.1100.
- LSRB can receive funds from other sources. - 196.1100; 196.1115 (6).
Prohibited Research and Cost Sharing
- Public funds shall not be used for an existing or proposed research project that involves abortion services, human cloning, or prohibited human research. A research project cannot share costs with another research project, person, or entity not eligible to receive public funds. However a research project may pay a pro rata share of facilities and administrative costs according to standards that ensure that public funds do not in any way subsidize facilities and administrative costs of other research projects, persons, or entities not eligible to receive public funds. Pro rata costs must comply with cost accounting principles set forth in CFR. Must use separate accounts, no pass through, maintain financial records, and audits must certify compliance with subsection. Any taxpayer has standing to sue for violations of subsection. -196.1127.1-6.