Big Data, Ethics, and Regulations: Implications for Consent in the Learning Health System

Overview

Journal Med Phys

Specialty Biophysics

Date 2018 Aug 26

PMID 30144096

Citations 3

Authors

Kayte Spector-Bagdady

Reshma Jagsi

Affiliations

Soon will be listed here.

Citing Articles

Learning health systems: A review of key topic areas and bibliometric trends.

Pomare C, Mahmoud Z, Vedovi A, Ellis L, Knaggs G, Smith C Learn Health Syst. 2022; 6(1):e10265.

PMID: 35036549 PMC: 8753300. DOI: 10.1002/lrh2.10265.

Patient and Provider Perspectives Regarding Enrollment in Head and Neck Cancer Research.

Shuman A, Gornick M, Brummel C, Kent M, Spector-Bagdady K, Biddle E Otolaryngol Head Neck Surg. 2019; 162(1):73-78.

PMID: 31818193 PMC: 6946860. DOI: 10.1177/0194599819889976.

Analysis of state laws on informed consent for clinical genetic testing in the era of genomic sequencing.

Spector-Bagdady K, Prince A, Yu J, Appelbaum P Am J Med Genet C Semin Med Genet. 2018; 178(1):81-88.

PMID: 29566453 PMC: 5994926. DOI: 10.1002/ajmg.c.31608.

References

Abernethy A, Etheredge L, Ganz P, Wallace P, German R, Neti C . Rapid-learning system for cancer care. J Clin Oncol. 2010; 28(27):4268-74. PMC: 2953977. DOI: 10.1200/JCO.2010.28.5478. View

Faden R, Kass N, Goodman S, Pronovost P, Tunis S, Beauchamp T . An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep. 2013; Spec No:S16-27. DOI: 10.1002/hast.134. View

Grady C, Wendler D . Making the transition to a learning health care system. Commentary. Hastings Cent Rep. 2013; Spec No:S32-3. DOI: 10.1002/hast.137. View

Spector-Bagdady K, Lombardo P . "Something of an adventure": postwar NIH research ethos and the Guatemala STD experiments. J Law Med Ethics. 2013; 41(3):697-710. DOI: 10.1111/jlme.12080. View

Brody H, Miller F . The research-clinical practice distinction, learning health systems, and relationships. Hastings Cent Rep. 2013; 43(5):41-7. DOI: 10.1002/hast.199. View

Grande D, Asch D, Wan F, Bradbury A, Jagsi R, Mitra N . Are Patients With Cancer Less Willing to Share Their Health Information? Privacy, Sensitivity, and Social Purpose. J Oncol Pract. 2015; 11(5):378-83. PMC: 4575401. DOI: 10.1200/JOP.2015.004820. View

Kelley M, James C, Kraft S, Korngiebel D, Wijangco I, Rosenthal E . Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making. Am J Bioeth. 2015; 15(9):4-17. PMC: 4821628. DOI: 10.1080/15265161.2015.1062163. View

McNolty L, Payne R . Relying on Trust for Research on Medical Practice in Learning Health Systems. Am J Bioeth. 2015; 15(9):30-2. DOI: 10.1080/15265161.2015.1062172. View

Morain S, Kass N . Ethics Issues Arising in the Transition to Learning Health Care Systems: Results from Interviews with Leaders from 25 Health Systems. EGEMS (Wash DC). 2016; 4(2):1212. PMC: 4827789. DOI: 10.13063/2327-9214.1212. View

10.

Lee S, Kelley M, Cho M, Kraft S, James C, Constantine M . Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System. AJOB Empir Bioeth. 2016; 7(2):125-134. PMC: 5130156. DOI: 10.1080/23294515.2016.1155674. View

11.

. Federal Policy for the Protection of Human Subjects. Final rule. Fed Regist. 2017; 82(12):7149-274. View

12.

Mayo R, Summey J, Williams J, Spence R, Kim S, Jagsi R . Qualitative Study of Oncologists' Views on the CancerLinQ Rapid Learning System. J Oncol Pract. 2017; 13(3):e176-e184. DOI: 10.1200/JOP.2016.016816. View

13.

Jones R, Sabolch A, Aakhus E, Spence R, Bradbury A, Jagsi R . Patient Perspectives on the Ethical Implementation of a Rapid Learning System for Oncology Care. J Oncol Pract. 2017; 13(3):e163-e175. DOI: 10.1200/JOP.2016.016782. View

14.

Smith J, Birkeland A, Goldman E, Brenner J, Carey T, Spector-Bagdady K . Immortal Life of the Common Rule: Ethics, Consent, and the Future of Cancer Research. J Clin Oncol. 2017; 35(17):1879-1883. PMC: 5791844. DOI: 10.1200/JCO.2016.68.4522. View

15.

Jagsi R, Griffith K, Sabolch A, Jones R, Spence R, De Vries R . Perspectives of Patients With Cancer on the Ethics of Rapid-Learning Health Systems. J Clin Oncol. 2017; 35(20):2315-2323. PMC: 5501364. DOI: 10.1200/JCO.2016.72.0284. View

16.

Spector-Bagdady K, Shuman A . Reg-ent within the Learning Health System. Otolaryngol Head Neck Surg. 2018; 158(3):405-406. DOI: 10.1177/0194599817740522. View

17.

Tait A, Voepel-Lewis T, Siewert M, Malviya S . Factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research. Anesth Analg. 1998; 86(1):50-3. DOI: 10.1097/00000539-199801000-00010. View