§285a–11 Pediatric Cancer Research, Awareness, and Survivorship

Summary

The Secretary of Health and Human Services, through the NIH Director, can give grants, contracts, or similar awards to groups that will expand research collecting donated tissue and medical data from children, teens, and young adults who have cancer types (or recurrences) that do not respond well to current treatments. Money can be used to gather and store high-quality samples and related medical and demographic information, keep a secure searchable database, set up fair rules to review requests for access, and share samples and data with qualified researchers in ways that follow federal and state law and protect privacy. No young person must give a sample or share their data if they do not want to. Applicants must apply and show they have the systems to collect these samples quickly. The Secretary must require informed permission and privacy protections, issue guidance for running these biorepositories, coordinate with federal cancer registries and related programs, and make sure federal funds add to — not replace — other funding. Not later than 4 years after January 5, 2023, the Secretary must report to Congress on how many samples and data were collected and requested, barriers found, and recommendations. Not later than 2 years after January 5, 2023, the NIH Director must review access procedures to find ways to reduce paperwork while keeping privacy and report findings to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. The NIH Director may also keep supporting research on survivorship, such as survivor outcomes (including among minority and underserved groups), barriers to follow-up care, how family and social factors affect outcomes, ways to track late effects, risk factors and predictors (including neurocognitive and molecular causes), and targeted interventions to lessen long-term harm. Research on minority and underserved survivors must address both physical and mental health needs. Definitions in the law include: “award” (grant, contract, or cooperative agreement); “biospecimen” (examples: tumor tissue, bone marrow, normal tissue, blood/plasma, DNA/RNA, familial DNA, and other cancer-related samples); and “clinical and demographic information” (examples: diagnosis date and age, sex, race, exposures, disease extent and site, tumor details, treatment and outcomes, specimen quality, and other required data). The law authorizes $30,000,000 for each fiscal year 2024 through 2028, and those funds remain available until spent.