Risks at the Intersection of Research and Oncology Nursing

2010 National Cancer Institute. Familial cancer susceptibility syndromes. Available at: https://www.cancer.gov/about-cancer/causes-prevention/genetics/overview-pdq#_123. (Accessed August 5, 2019). Kalia, 2017, Recommendations for reporting of secondary findings in clinical exome and genome sequencing, 2016 update (ACMG SF v.2.0): a policy statement of the American College of Medical Genetics and Genomics, Genet Med, 19, 249, 10.1038/gim.2016.190 US Food and Drug Administration. 23andMe personal genome service (PGS) genetic health risk report for BRCA1/BRCA2 (selected variants) decision summary of automatic Class III designation. Available at:https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170046.pdf. (Accessed August 5, 2019). US Department of Health & Human Services. Genetic Information Nondiscrimination Act guidance. Available at:https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-genetic-information-nondiscrimination-act/index.html. (Accessed August 23, 2019). National Human Genome Research Institute. Genome statute and legislation database. Available at:https://www.genome.gov/about-genomics/policy-issues/Genome-Statute-Legislation-Database. (Accessed August 23, 2019). Federal Genetic Information NondiscriminationAct of 2008; 42 USC § 2000ff. Available at:https://www.eeoc.gov/laws/statutes/gina.cfm. (Accessed August 23, 2019). US Food and Drug Administration. Product label HERCEPTIN® (trastuzumab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf. Accessed (August 5, 2019). Schroeder, 2017, Personalized medicine Schroeder, 2016, Molecular diagnostic testing: alphabet soup with a side of codes, J Hosp Admin, 5, 88, 10.5430/jha.v5n2p88 US Food and Drug Administration. Laboratory developed tests. Available at:https://www.fda.gov/medical-devices/vitro-diagnostics/laboratory-developed-tests. (Accessed August 2, 2019). US Food and Drug Administration. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Available at:https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools. (Accessed August 2, 2019). National Cancer Institute. Targeted cancer therapies. Available at:https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet. (Accessed August 2, 2019). US Food and Drug Administration. Premarket approval (PMA) FoundationOne CDx next generation sequencing oncology panel, somatic or germline variant detection system. Available at:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p170019. (Accessed August 3, 2019). US Food and Drug Administration. Precision medicine. Available at:https://www.fda.gov/medical-devices/vitro-diagnostics/precision-medicine. (Accessed August 4, 2019). Robson, 2015, American Society of Clinical Oncology policy statement update: genetic and genomic testing for cancer susceptibility, J Clin Oncol, 33, 3660, 10.1200/JCO.2015.63.0996 Campbell, 2018, The 2018 revision of the ISBER best practices: summary of changes and the editorial team's development process, Biopreserv Biobank, 16, 3, 10.1089/bio.2018.0001 US Food and Drug Administration. Recognized consensus standards. Available at:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=37014. (Accessed August 3, 2019). Miseta, 2019, A patient's journey: human interactions matter in immunotherapy trials, Clinical Leader Wagner, 2006 National Cancer Institute. Biological therapies for cancer. Available at:https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/bio-therapies-fact-sheet. (Accessed August 10, 2019). Cancer Research Institute. What is immunotherapy? Available at:https://www.cancerresearch.org/immunotherapy/what-is-immunotherapy. (Accessed August 10, 2019). Hargadon, 2018, Immune checkpoint blockade therapy for cancer: an overview of FDA-approved immune checkpoint inhibitors, Int Immun, 62, 29 National Cancer Institute. What types of biological therapy are used to treat cancer? Available at:https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/bio-therapies-fact-sheet#what-types-of-biological-therapy-are-used-to-treat-cancer. (Accessed August 8, 2019). Kulemzin, 2017, Engineering chimeric antigen receptors, ActaNaturae, 9, 6 Dudley, 2019, Chimeric antigen receptor (CAR) T-cell therapy in B-cell malignancies, SoCRA Source, 99, 10 Code of Federal Regulations Title 21. 21 CFR 1271.10(a). Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do? Available at:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.10. Nixon, 2018, Current landscape of immunotherapy in the treatment of solid tumours, with future opportunities and challenges, Curr Oncol, 25, e373, 10.3747/co.25.3840 US Food and Drug Administration. Product Label Herceptin® (trastuzumab) (2010).https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf. Accessed August 10, 2019. US Food and Drug Administration. Product label Rituxin® (rituximab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5450lbl.pdf. (Accessed August 10, 2019). US Food and Drug Administration. Product label Arzerra® (ofatumumab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s062lbl.pdf. (Accessed August 10, 2019). US Food and Drug Administration. Product label Campath® (alemtuzumab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103948s5070lbl.pdf. (Accessed August 10, 2019). US Food and Drug Administration. Product label Kadcyla® (ado-trastuzumab emtansine). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125427s105lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Adcetris® (brentuximab vedotin). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s099lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Blincyto® (blinatumomab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Yervoy® (ipilimumab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s087lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Keytruda® (pembrolizumab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Opdivo® (nivolumab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s055lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Tecentriq® (atezolizumab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s018lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Imfinzi® (durvalumab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Bavencio® (avelumab). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761049s006lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Provenge® (sipuleucel-T). Available at:https://www.fda.gov/media/78511/download. (Accessed August 12, 2019). Bielefeldt, 2009, 4 US Food and Drug Administration. Package insert Imlygic™ (talimogene laherparepvec). Available at:https://www.fda.gov/media/94129/download. (Accessed August 12, 2019). US Food and Drug Administration. Product label Tice® BCG (live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. Available at:https://www.fda.gov/media/76396/download. (Accessed August 12, 2019). US Food and Drug Administration. Product label Intron® A (Interferon alfa-2b, recombinant). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103132Orig1s5199lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Proleukin® (aldesleukin). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Aldara® (imiquimod cream 5%). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020723s022lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Product label Ontak® (denileukin diftitox). Available at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103767s5094lbl.pdf. (Accessed August 12, 2019). US Food and Drug Administration. Package insert Kymriah™ (tisagenlecleucel). Available at:https://www.fda.gov/media/107296/download. (Accessed August 12, 2019). US Food and Drug Administration. Package insert Yescarta™ (axicabtagene ciloleucel). Available at:https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-YESCARTA.pdf. (Accessed August 12, 2019). Lee, 2014, Current concepts in the diagnosis and management of cytokine release syndrome, Blood, 124, 188, 10.1182/blood-2014-05-552729 US Food and Drug Administration. Approved risk evaluation and mitigation strategies (REMS) Kymriah (tisagenlecleucel) BLA #125646. Available at:https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=368. (Accessed August 12, 2019). Code of Federal Regulations Title 21 (21 CFR 211.22). Responsibilities of quality control unit. Available at:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.22. US Food and Drug Administration. Step 3: clinical research. Available at:https://www.fda.gov/patients/drug-development-process/step-3-clinical-research. (Accessed August 15, 2019). Centers for Medicare and Medicaid Services local coverage determination (LCD): stereotactic radiation therapy: stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) (L34151). Available at:https://med.noridianmedicare.com/documents/10546/6990983/Stereotactic+Radiation+Therapy+-+Stereotactic+Radiosurgery+%28SRS%29+and+Stereotactic+Body+Radiation+Therapy+%28SBRT%29+LCD. (Accessed October 18, 2019). GammaTile™ therapy. Available at:https://www.gtmedtech.com/. (Accessed October 18, 2019). The National Association for Proton Therapy. How does proton therapy work?. Available at:https://www.proton-therapy.org/science/. (Accessed October 18, 2019). University of Texas MD Anderson Cancer Center. What is proton therapy?. Available at:https://www.mdanderson.org/patients-family/diagnosis-treatment/care-centers-clinics/proton-therapy-center/what-is-proton-therapy.html. (Accessed October 18, 2019). Schroeder, 2018, So, I asked myself, what's a lab-developed test?, J Health Care Compliance, 20, 27 Centers for Medicare and Medicaid Services. National coverage determination (NCD) for next generation sequencing (NGS) (90.2). Available at:https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=372&ncdver=1&bc=AgAAgAAAAAAA&. (Accessed October 18, 2019). Institute for Clinical and Economic Review. 2018 Final Evidence Report: chimeric antigen receptor T-cell therapy for B-cell cancers: effectiveness and value. Available at:https://icer-review.org/wp-content/uploads/2017/07/ICER_CAR_T_Final_Evidence_Report_032318.pdf. (Accessed August 15, 2019). Centers for Medicare and Medicaid Services. Decision memo for chimeric antigen receptor (CAR) T-cell therapy for cancers (CAG-00451N). Available at:https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=291. (Accessed August 9, 2019). American Nurses Association. Scope of practice. Available at:https://www.nursingworld.org/practice-policy/scope-of-practice/. (Accessed August 15, 2019).