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Ethics
Protocol
Developing an ethical framework-guided instrument for assessing bias in EHR-based Big Data studies: a research protocol
  1. Shan Qiao1,
  2. George Khushf2,
  3. Xiaoming Li3,
  4. Jiajia Zhang4,
  5. Bankole Olatosi5
  1. 1Health Promotion Education and Behavior, University of South Carolina, Columbia, South Carolina, USA
  2. 2Department of Philosophy, University of South Carolina, Columbia, South Carolina, USA
  3. 3Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA
  4. 4Department of Epidemiology and Biostatistics, Arnold School of Public Health, South Carolina College of Pharmacy - University of South Carolina Campus, Columbia, South Carolina, USA
  5. 5Health Services, Policy and Management, University of South Carolina Arnold School of Public Health, Columbia, South Carolina, USA
  1. Correspondence to Dr Bankole Olatosi; olatosi{at}mailbox.sc.edu

Abstract

Introduction The emergence of Big Data health research has exponentially advanced the fields of medicine and public health but has also faced many ethical challenges. One of most worrying but still under-researched aspects of the ethical issues is the risk of potential biases in data sets (eg, electronic health records (EHR) data) as well as in the data curation and acquisition cycles. This study aims to develop, refine and pilot test an ethical framework-guided instrument for assessing bias in Big Data research using EHR data sets.

Methods and analysis Ethical analysis and instrument development (ie, the EHR bias assessment guideline) will be implemented through an iterative process composed of literature/policy review, content analysis and interdisciplinary dialogues and discussion. The ethical framework and EHR bias assessment guideline will be iteratively refined and integrated with preliminary summaries of results in a way that informs subsequent research. We will engage data curators, end-user researchers, healthcare workers and patient representatives throughout all iterative cycles using various formats including in-depth interviews of key stakeholders, panel discussions and charrette workshops. The developed EHR bias assessment guideline will be pilot tested in an existing National Institutes of Health (NIH) funded Big Data HIV project (R01AI164947).

Ethics and dissemination The study was approved by Institutional Review Boards at the University of South Carolina (Pro00122501). Informed consent will be provided by the participants in the in-depth interviews. Study findings will be disseminated with key stakeholders, presented at relevant workshops and academic conferences, and published in peer-reviewed journals.

  • MEDICAL ETHICS
  • HIV & AIDS
  • PUBLIC HEALTH
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2022-070870

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    Footnotes

    • Contributors SQ, XL, BO and GK conceptualised the study and SQ wrote the first draft. XL, JZ and GK participated in writing sections of the original proposal. All authors critically reviewed and edited the manuscript. BO completed the Institutional Review Board approvals. BO and JZ secured the funding.

    • Funding Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases (NIH/NIAD) under award number R01AI164947.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.