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Public Policy Issues in Clinical Research Informatics

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Clinical Research Informatics

Part of the book series: Health Informatics ((HI))

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Abstract

Recently, a national imperative to “develop better cures faster” has been a rally cry for clinical research, as stakeholders work to apply advances in data storage, computation, and methodology toward the clinical research enterprise. This work is, at its core, the domain of Clinical Research Informatics (CRI), and the intersection of public policy and CRI will be the focus of this chapter. The goal of this chapter is to provide a foundation for clinical research policies impacting the domain of CRI and to describe the emerging landscape of public policies likely to impact CRI for some time to come.

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Notes

  1. 1.

    Kilpatrick, D. Definitions of Public Policy and the Law. Available at: https://mainweb-v.musc.edu/vawprevention/policy/definition.shtml.

  2. 2.

    Embi PJ, Payne PR. Clinical research informatics: challenges, opportunities and definition for an emerging domain. J Am Med Inform Assoc. 2009;16(3):316–27.

  3. 3.

    https://www.fda.gov/AboutFDA/Transparency/Basics/ucm214416.htm.

  4. 4.

    “‘Death Drug’ Hunt Covered 15 States,” New York Times, Nov. 26, 1937 https://nyti.ms/2EzSmoO.

  5. 5.

    Title 42, Chapter 6A, Subchapter III.

  6. 6.

    Title 42, Chapter 6A, Subchapter VII.

  7. 7.

    Title 42, Chapter 6A, Subchapter XXVIII.

  8. 8.

    Title 42, Chapter 6A, Subchapter III-A.

  9. 9.

    Title 42, Chapter 6A, Subchapter III, Part D, Subpart 1 § 286(a).

  10. 10.

    Ibid. § 286(b)(7).

  11. 11.

    Title 42, Chapter 6A, Subchapter XXVII, Part A §300jj–11(b). Office of the National Coordinator for Health Information Technology.

  12. 12.

    Public Law 79–404, 60 Stat. 237, enacted June 11, 1946.

  13. 13.

    https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.101.

  14. 14.

    Ibid.

  15. 15.

    Skloot, R. The Immortal Life of Henrietta Lacks. (2011). Broadway Books.

  16. 16.

    80 Fed. Reg. 173. Pages 53933-54061. September 8, 2015.

  17. 17.

    Ibid.

  18. 18.

    Ibid.

  19. 19.

    Council on Governmental Relations. Analysis of Public Comments on the Common Rule NPRM. May 2016. Available at: http://www.cogr.edu/sites/default/files/Analysis%20of%20Common%20Rule%20Comments.pdf.

  20. 20.

    82 Fed. Reg. 12, Pages 7149–7274. January 19, 2017.

  21. 21.

    §___.116(a), 0.116(b) & 0.116(c) discussion beginning 82 Fed. Reg. 12, page 7210.

  22. 22.

    §___.116(d) discussion beginning 82 Fed. Reg. 12, page 7216.

  23. 23.

    §___.104(d)(4) discussion beginning 82 Fed. Reg. 12, page 7191.

  24. 24.

    §___.102(l)(2) discussion beginning 82 Fed. Reg. 12, page 7175.

  25. 25.

    §___.109(f) discussion beginning 82 Fed. Reg. 12, page 7205.

  26. 26.

    §___.116(g) discussion beginning 82 Fed. Reg. 12, page 7227.

  27. 27.

    see Title 21 CFR Part 50 and 56.

  28. 28.

    Title 21 CFR §11.1(a).

  29. 29.

    See 45 CFR 164.501.

  30. 30.

    FDA Science Board, FDA Science and Mission at Risk, Report of the Subcommittee on Science and Technology, November 2007. https://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf.

  31. 31.

    Food and Drug Administration. “Advancing Regulatory Science for Public Health: A Framework for FDA’s Regulatory Science Initiative,” October 2010. Available at https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM228444.pdf.

  32. 32.

    Ibid.

  33. 33.

    Ibid.

  34. 34.

    Ibid.

  35. 35.

    Food and Drug Administration. “Advancing Regulatory Science at FDA: A Strategic Plan,” August 2011. Available at: https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf.

  36. 36.

    Food and Drug Administration. “Regulatory Science Priorities for Fiscal Year 2017,” September 2016. Available at: https://www.fda.gov/downloads/MedicalDevices/ScienceandResearch/UCM521503.pdf.

  37. 37.

    Ibid.

  38. 38.

    Food and Drug Administration. “Health Innovations, Safer Families: FDA’s 2018 Strategic Policy Roadmap,” January 2018. Available at: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf.

  39. 39.

    Ibid.

  40. 40.

    Food and Drug Administration. “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022,” June 2017. Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.

  41. 41.

    Food and Drug Administration. “Industry MDUFA IV Reauthorization Meeting.” May 16, 2016. Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM507305.pdf.

  42. 42.

    Food and Drug Administration. “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022,” June 2017 (page 30).

  43. 43.

    Ibid. (page 35).

  44. 44.

    Food and Drug Administration. “Use of Electronic Health Record Data in Clinical Investigations Draft Guidance for Industry.” May 2016. Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf.

  45. 45.

    American Medical Informatics Association. Letter to FDA Commissioner Dr. Robert Califf RE: “Use of Electronic Health Record Data in Clinical Investigations; Draft Guidance for Industry.” Available at: https://www.amia.org/sites/default/files/AMIA-Response-to-FDA-Draft-Guidance-on-Using-EHR-Data-in-Clinical%20Investigations.pdf.

  46. 46.

    Food and Drug Administration. FDA Voice Blog, “Fostering Medical Innovation: A Plan for Digital Health Devices.” June 15, 2017. Available at: https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/.

  47. 47.

    Ibid.

  48. 48.

    Food and Drug Administration. “Digital Health Innovation and Action Plan,” July 2017. Available at: https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM568735.pdf.

  49. 49.

    Food and Drug Administration. “Digital Health Software Precertification (PreCert) Program,” July 2017. Available at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/Default.htm.

  50. 50.

    Food and Drug Administration. “Software Precertification Pilot Program Participants,” Sept. 2017. Available at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm577330.htm.

  51. 51.

    National Institutes of Health. All of Us Research Program. Available at: https://allofus.nih.gov/.

  52. 52.

    National Institutes of Health. Cancer Moonshot Initiative. Available at: https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative.

  53. 53.

    White House. “Precision Medicine Initiative: Privacy and Trust Principles,” Nov. 9, 2015. Available at: https://allofus.nih.gov/sites/default/files/privacy-trust-principles.pdf.

  54. 54.

    White House. “Precision Medicine Initiative: Data Security Policy Principles and Framework,” May 25, 2016. Available at: https://allofus.nih.gov/sites/default/files/security-principles-framework.pdf.

  55. 55.

    http://syncfor.science/.

  56. 56.

    http://www.sync4genes.org/.

  57. 57.

    National Institutes of Health. All of Us Research Program Protocol Version 1. Aug. 2017. Available at: https://allofus.nih.gov/sites/default/files/allofus-initialprotocol-v1_0.pdf.

  58. 58.

    Scott, D., “Joe Biden calls for ‘moonshot’ to cure cancer,” Oct. 21, 2015. STAT. Available at: https://www.statnews.com/2015/10/21/joe-biden-calls-for-moonshot-to-cure-cancer/.

  59. 59.

    National Cancer Institute. Cancer Moonshot Blue Ribbon Panel Report, October 2016. available at https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel#ui-id-3.

  60. 60.

    National Cancer Institute. Cancer Moonshot Blue Ribbon Panel Report, Enhanced Data Sharing Working Group Recommendation: The Cancer Data Ecosystem https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel/enhanced-data-sharing-working-group-report.pdf.

  61. 61.

    PCORI Policy for Data Access and Data Sharing, Draft for Public Comment. October 2016. Available at: https://www.pcori.org/sites/default/files/PCORI-Data-Access-Data-Sharing-DRAFT-for-Public-Comment-October-2016.pdf.

  62. 62.

    NIH Request for Information (RFI): Strategies for NIH Data Management, Sharing, and Citation. Nov. 14, 2016. Available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-015.html.

  63. 63.

    Taichman D. Data sharing statements for clinical trials: a requirement of the international committee of medical journal editors. Ann Intern Med. https://doi.org/10.7326/M17-1028.

  64. 64.

    National Academies of Sciences, Engineering, and Medicine. Optimizing the Nation’s investment in academic research: a new regulatory framework for the 21st century. Washington, DC: The National Academies Press; 2016. https://doi.org/10.17226/21824.

Abbreviations

AHRQ:

Agency for Healthcare Research and Quality

All of Us:

NIH All of Us Research Program

AMIA:

American Medical Informatics Association

CDC:

Centers for Disease Control and Prevention

CDRH:

FDA Center for Devices and Radiological Health

CFR:

Code of Federal Regulations

Common Rule:

Federal Policy for the Protection of Human Subjects (45 CFR Part 46)

FD&C Act:

Food, Drug, and Cosmetic Act of 1938

FDA:

Food and Drug Administration

HeLa:

Immortalized cell line of Henrietta Lacks

HIPAA:

Health Insurance Portability and Accountability Act of 1996

IRB :

Investigational Review Board

MDUFA:

Medical Device User Fee Act

MIDD:

Model-informed drug development

NIH:

National Institutes of Health

NLM:

National Library of Medicine

NPRM:

Notice of proposed rulemaking

OIRA:

Office of Information and Regulatory Affairs

OMB:

White House Office of Management and Budget

ONC:

Office of the National Coordinator for Health Information Technology

PCORI :

Patient-Centered Outcomes Research Institute

PDUFA:

Prescription Drug User Fee Act

PHI:

Protected health information

PHSA:

Public Health Services Act of 1944

PMI:

Precision Medicine Initiative

PPACA:

Patient Protection and Affordable Care Act of 2010

PreCert:

FDA software precertification pilot program

RWD:

Real-world data

RWE:

Real-world evidence

SaMD:

Software-as-a-Medical Device

SIMD:

Software-inside-a-Medical Device

Author information

Authors and Affiliations

  1. American Medical Informatics Association, Bethesda, MD, USA

    Jeffery R. L. Smith MPP

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  1. Jeffery R. L. Smith MPP
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Correspondence to Jeffery R. L. Smith MPP .

Editor information

Editors and Affiliations

  1. Duke University School of Nursing, Durham, NC, USA

    Rachel L. Richesson

  2. School of Information, University of South Florida, Tampa, FL, USA

    James E. Andrews

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Smith, J.R.L. (2019). Public Policy Issues in Clinical Research Informatics. In: Richesson, R., Andrews, J. (eds) Clinical Research Informatics. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-319-98779-8_5

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  • DOI: https://doi.org/10.1007/978-3-319-98779-8_5

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