85R23634 JG-F     By: Parker H.B. No. 3721     Substitute the following for H.B. No. 3721:     By:  Price C.S.H.B. No. 3721       A BILL TO BE ENTITLED   AN ACT   relating to access to and participation in cancer clinical trials.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  (a) This Act shall be known as the "Improving   Patient Access to Cancer Clinical Trials Act."          (b)  The legislature finds that:                (1)  the ability to translate medical findings from   research to practice relies largely on robust patient participation   and a diverse participation pool in cancer clinical trials;                (2)  diverse patient participation in cancer clinical   trials depends partly on whether a participant is able to afford   ancillary costs, including transportation and lodging, during the   course of the patient's participation;                (3)  significant health disparities exist among   socioeconomic, racial, ethnic, and regional groups in this state;   and                (4)  the health disparities threaten one of the most   basic ethical underpinnings of clinical research: the benefits of   research must be made available equitably among all eligible   individuals.          (c)  It is the intent of the legislature to:                (1)  provide for a program in this state that   encourages greater patient access to cancer clinical trials;                (2)  assist patients who are facing financial barriers   that limit their ability to participate in cancer clinical trials   and patients who have been identified as a priority for health   services in participating in cancer clinical trials by reimbursing   the patients for directly incurred expenses;                (3)  ensure that cancer clinical trials are widely   accessible, improve the development of cancer therapy, and enhance   innovation in cancer research and treatment; and                (4)  clearly provide that the reimbursement of direct   costs incurred by a cancer clinical trial participant or ancillary   medical costs incurred by a third party does not constitute   coercion or undue influence and instead improves access to cancer   clinical trials as supported by the United States Food and Drug   Administration's draft guidance "Informed Consent Information   Sheet:  Guidance for IRBs, Clinical Investigators, and Sponsors,"   which provides that the payments made to cancer clinical trial   participants are considered reimbursement for expenses and   inconveniences and not a benefit of participation.          SECTION 2.  Section 102.051(a), Health and Safety Code, is   amended to read as follows:          (a)  The institute:                (1)  may make grants to provide funds to public or   private persons to implement the Texas Cancer Plan, and may make   grants to institutions of learning and to advanced medical research   facilities and collaborations in this state for:                      (A)  research into the causes of and cures for all   types of cancer in humans;                      (B)  facilities for use in research into the   causes of and cures for cancer;                      (C)  research, including translational research,   to develop therapies, protocols, medical pharmaceuticals, or   procedures for the cure or substantial mitigation of all types of   cancer in humans; [and]                      (D)  cancer prevention and control programs in   this state to mitigate the incidence of all types of cancer in   humans; and                      (E)  programs designed to encourage access to and   participation in cancer clinical trials and associated research and   community outreach;                (2)  may support institutions of learning and advanced   medical research facilities and collaborations in this state in all   stages in the process of finding the causes of all types of cancer   in humans and developing cures, from laboratory research to   clinical trials and including programs to address the problem of   access to advanced cancer treatment;                (3)  may establish the appropriate standards and   oversight bodies to ensure the proper use of funds authorized under   this chapter for cancer research and facilities development;                (4)  may  employ necessary staff to provide   administrative support;                (5)  shall continuously monitor contracts and   agreements authorized by this chapter and ensure that each grant   recipient complies with the terms and conditions of the grant   contract;                (6)  shall ensure that all grant proposals comply with   this chapter and rules adopted under this chapter before the   proposals are submitted to the oversight committee for approval;   and                (7)  shall establish procedures to document that the   institute, its employees, and its committee members appointed under   this chapter comply with all laws and rules governing the peer   review process and conflicts of interest.          SECTION 3.  The heading to Section 102.155, Health and   Safety Code, is amended to read as follows:          Sec. 102.155.  AD HOC ADVISORY COMMITTEES [COMMITTEE].          SECTION 4.  Section 102.155(a), Health and Safety Code, is   amended to read as follows:          (a)  The oversight committee shall create [an] ad hoc   committees [committee] of experts to address childhood cancers and   access to and participation in cancer clinical trials.  The   oversight committee, as necessary, may create additional ad hoc   committees of experts to advise the oversight committee on issues   relating to cancer.          SECTION 5.  Section 102.203(b), Health and Safety Code, is   amended to read as follows:          (b)  Except as otherwise provided by this section, money   awarded under this subchapter may be used for authorized expenses,   including honoraria, salaries and benefits, travel, conference   fees and expenses, consumable supplies, other operating expenses,   contracted research and development, capital equipment, [and]   construction or renovation of state or private facilities, and   reimbursement for costs incurred by cancer clinical trial   participants that are related to the participation, including   transportation and lodging.          SECTION 6.  This Act takes effect September 1, 2017.