Subscribe to RSS
Informed ConsentDoes Anyone Really Understand What Is Contained In The Medical Record?
20 September 2015
accepted in revised form: 07 May 2015
19 December 2017 (online)
Background: Despite efforts to provide standard definitions of terms such as “medical record”, “computer-based patient record”, “electronic medical record” and “electronic health record”, the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all participants in the research process — patients, information technology and regulatory staff, and the investigative team — fully understand what data and information they are asking to obtain and agreeing to share.
Objectives: This descriptive study explored the terminology used in research informed consent documents when describing patient data and information, asking the question “Does the use of the term “medical record” in the context of a research informed consent document accurately represent the scope of the data involved?”
Methods: Informed consent document templates found on 17 Institutional Review Board (IRB) websites with Clinical and Translational Science Awards (CTSA) were searched for terms that appeared to be describing the data resources to be accessed. The National Library of Medicine’s (NLM) Terminology Services was searched for definitions provided by key standards groups that deposit terminologies with the NLM.
Discussion: The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant work to be done to assure the HIPAA Omnibus Rule is applied to contemporary activities such as biorepositories and learning health systems.
Conclusions: “Medical record”, a term used extensively in research informed consent documents, is ambiguous and does not serve us well in the context of contemporary information management and governance.
Citation: Fenton SH, Manion F, Hsieh K, Harris M. Informed Consent: Does Anyone Really Understand What Is Contained In The Medical Record? Appl Clin Inform 2015; 6: 466–477
- 1 Committee on Improving the Patient Record.. The Computer-based Patient Record: An Essential Technology for Health Care. Washington, D. C.: National Academies Press; 1997
- 2 Cohasset Associates, AHIMA.. 2014 Information Governance in Healthcare: A Call to Adopt Information Governance Practices. Minneapolis, MN: 2014. p. 38.
- 3 Eiseman E, Haga SB. Handbook of Human Tissue Sources 1999. www.rand.org/pubs/monograph_reports MR954.html
- 4 International Cancer Genome Consortium. Hudson TJ, Anderson W, Artez A. et al. International network of cancer genome projects. Nature 2010; 464 7291 993-998.
- 5 Cancer Genome Atlas Research Network. Weinstein JN, Collisson EA, Mills GB, Shaw KRM, Ozenberger BA, Ellrott K, Shmulevich I, Sander C, Stuart JM. The Cancer Genome Atlas Pan-Cancer analysis project. Nat Genet 2013; 45 (10) 1113-1120.
- 6 Scott CT, Caulfield T, Borgelt E, Illes J. Personal medicine--the new banking crisis. Nat Biotechnol 2012; 30 (02) 141-147.
- 7 Institute of Medicine (US) Roundtable on Evidence-Based Medicine.. The Learning Healthcare System: Workshop Summary. Olsen L, Aisner D, McGinnis JM. editors. Washington (DC): National Academies Press (US); 2007 www.ncbi.nlm.nih.gov/books/NBK53494
- 8 Institute of Medicine [US].. Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care: Workshop Series Summary. Grossmann C, Powers B, McGinnis JM. editors. Washington (DC): National Academies Press (US); 2011 www.ncbi.nlm.nih.govbooks/NBK83569/
- 9 President’s Council of Advisors on Science and Technology. Designing a Digital Future: Federally Funded Research and Development in Networking and Information Technology. Washington (DC): Executive Office of the President; 2013. Jan p. 60. www.whitehouse.gov/sites/default/files/microsites/ostp/pcastnitrd2013.pdf
- 10 Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep 2013; S16-S27.
- 11 Sanderson IC, Obeid JS, Madathil KC, Gerken K, Fryar K, Rugg D, Alstad CE, Alexander R, Brady KT, Gramopadhye AK, Moskowitz J. Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents. Clin Trials 2013; 10 (04) 604-611.
- 12 Chalil Madathil K, Koikkara R, Obeid J, Greenstein JS, Sanderson IC, Fryar K, Moskowitz J. An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting. Int J Med Inf 2013; 82 (09) 854-863.