P.R. Laws tit. 24, § 3073
(a) At the time the patient is diagnosed, the healthcare provider shall notify the Puerto Rico Central Cancer Registry if the case in order to keep real statistics on this population and prevent any penalties provided in §§ 390 et seq. of this title, better known as the “Puerto Rico Central Cancer Registry Act.”
(b) Healthcare providers must obtain special training to manage cancer patients and survivors. The creation of protocols and regulations specifically directed to tend to cancer patients in the early detection, diagnosis, and treatment stages, as well as during their participation in clinical trials, shall be the responsibility of the Department of Health and the University of Puerto Rico Comprehensive Cancer Center, which is the entity empowered by §§ 417 et seq. of this title, better known as the “Public Policy of the Government of Puerto Rico on Comprehensive Cancer Control in Puerto Rico”, to develop the cancer policy in the island and to implement the Comprehensive Cancer Control Plan.
(c) An interagency service plan shall be established between healthcare providers, insurers, nonprofit organizations, the UPR Comprehensive Cancer Center, the Department of Health, municipalities, and the State Government to tend to this population.
(d) The Puerto Rico Comprehensive Cancer Center, which was empowered by §§ 417 et seq. of this title, better known as the “Public Policy of the Government of Puerto Rico on Comprehensive Cancer Control in Puerto Rico”, to develop the cancer policy in Puerto Rico and implement the Comprehensive Cancer Control Plan, shall carry out feasibility studies, so that steps may be taken, if necessary, to establish exclusive treatment facilities for pediatric cancer patients in Puerto Rico, the Virgin Islands, and the Caribbean.
(e) The participation in clinical trials of people with multiple morbidities should be encouraged and must be designed so that the elderly, children, and people with disabilities, whether or not cancer-related, may easily participate.
(f) Researchers shall assess the benefits and risks of participation by children and the elderly in clinical trials, as established in the protocols approved by the IRB.
(g) Researchers, trial sponsors, and regulators, such as the IRB, shall ensure that the clinical criteria, as well as the impact thereof in the patients’ quality of life, used to carry out clinical trials are relevant for people in all age groups and for different types of cancer.
(h) When designing clinical trials and establishing criteria to assess results, trial sponsors shall involve the elderly, health professionals in the fields of oncology, geriatrics, and pediatrics, elderly and child care, and organizations that provide support and group patients, survivors, and their families.
(i) Ethics committees, sponsors, medical magazine editors, and inspectors shall critically review the procedures carried out during and after screening tests, anticancer treatments, and clinical trials, in addition to those established by the IRB to detect unjustified exclusions based on, but not limited to, age, other diseases, disability, or pharmacological treatment received. All these exclusions, if any, shall be fully justified.
(j) If public funds are involved, either in whole or in part, or if any other resource of the State is used to conduct clinical trials, sponsors and researchers shall also submit a full report about the organization, expenditures, incidences, and results of the study to the Legislative Assembly, the Office of the Healthcare Advocate or equivalent juridical entity, the Office of the Ombudsman, the Puerto Rico Comprehensive Cancer Center, and the Department of Health.
History —Sep. 27, 2012, No. 275, § 4, eff. 180 days after Sept. 27, 2012.