35 Pa. Stat. § 5701.905

Current through Pa Acts 2024-35, 2024-56
Section 5701.905 - Peer review procedures
(a) Peer review required.--Except for infrastructure and for projects funded under section 906(1) , research funded under this chapter shall be peer reviewed and selected in accordance with this section.
(b) Prior peer review.--Research which has received peer review by the National Institutes of Health, the Centers for Disease Control or another Federal agency may be approved and ranked for funding by the department consistent with the priorities established under section 904(2) .
(c) Department peer review.--Research which has not received peer review as provided in subsection (b) shall be subject to peer review by the department in accordance with subsection (d) prior to being considered for funding under section 906(2) and (3).
(d) Peer review panels.--The department shall establish peer review panels in various disciplines, as necessary, to review research grant proposals which are consistent with the priorities established under section 904(2). A panel shall be composed of at least three nationally recognized physicians, scientists or researchers from the same or similar discipline as the research grant proposal under review. Members of a peer review panel may be residents of other states. In no case shall a member of a peer review panel be an employee of an applicant whose grant proposal is under its review.
(e) Panel review factors.--A review panel shall determine eligibility for grant funding based on the highest-ranked peer review scores through a rating system consistent with Federal rating standards as developed by the department. A panel shall review and rank research projects eligible for funding in a manner which recognizes scientific and technical merit on the basis of scientific need, scientific method, research design, adequacy of the facility and qualifications of the research personnel.
(f) Ethical standards.-- No research funded under this chapter shall be permitted until a memorandum of understanding between the applicant and the secretary has been executed specifying that the research to be performed and all individuals performing such research shall be subject to Federal ethical and procedural standards of conduct as prescribed by the NIH on the date the memorandum of understanding is executed. Research funded under this act shall observe the Federal ethical and procedural standards regulating research and research findings, including publications and patents, which are observed under NIH extramural funding requirements and NIH grants policy statements and applicable sections of 45 CFR Pt. 74 (relating to uniform administrative requirements for awards and subawards to institutions of higher education, hospitals, other nonprofit organizations, and commercial organizations; and certain grants and agreements with States, local governments and Indian tribal governments) and Pt. 92 (relating to uniform administrative requirements for grants and cooperative agreements to State and local governments).
(g) Ethics Advisory Board.--
(1) The Ethics Advisory Board shall be composed of six individuals who are not officers or employees of the Commonwealth. The secretary shall make appointments to the board from among individuals with qualifications and experience to provide advice and recommendations regarding ethical matters in research. The members of the board shall include one attorney, one ethicist, one practicing physician, one theologian, one scientist with experience in biomedical research and one scientist with experience in behavioral research. In no case shall a member of the board be an officer, director, employee or paid consultant of an applicant whose grant proposal is under review.
(i) A majority of the board shall consist of four members.
(ii) Members of the board shall serve at the pleasure of the secretary.
(iii) The secretary shall designate an individual from among the members of the board to serve as the chair of the board.
(iv) A member of the board shall receive no payment for service but shall be reimbursed by the department for necessary and reasonable expenses incurred in the course of the member's official duties.
(v) An annual report setting forth a summation of the board activities as well as each board decision shall be submitted no later than November 30 of each year to the chair and minority chair of the Public Health and Welfare Committee of the Senate and to the chair and minority chair of the Health and Human Services Committee of the House of Representatives and shall be made available to the public.
(2) The board shall be convened by the secretary to advise and make recommendations when a research project may be denied due to ethical considerations, consistent with the standards set forth in subsection (f) that are in effect on the date the board is convened.
(i) The department shall notify the research applicant of the initiation of an ethics review. The applicant shall have the opportunity to provide comment on the ethical considerations of the project to the board. The board may receive other comments or information to assist in its review.
(ii) The board shall have access to all relevant information possessed by the department regarding the research project.
(iii) Within 60 days of initiating its review, the board shall submit to the secretary a report with its findings and recommendations regarding the ethical considerations of the research project.
(3) Funding for a research project under this chapter shall be denied by the secretary based on a finding of improper ethical considerations by a majority of the board.
(4) As used in this subsection, the following words and phrases shall have the meanings given to them in this paragraph:

"Board." The Ethics Advisory Board.

"Ethical considerations." Matters concerning whether the proposed conduct of or subject of the research is medically, sociologically, and legally moral and proper.

(h) Final selection.--Based on the procedures set forth in this section and the rankings established by the relevant peer review panel, the department shall award research grants to selected applicants. In making these awards, the department shall avoid unnecessary duplication, ensure relevance to the appropriate research priority, encourage collaboration between applicants and provide for the development of a complementary Statewide research program.

35 P.S. § 5701.905

2001, June 26, P.L. 755, No. 77, § 905, effective 7/1/2001.