Privacy of Clinical Research Subjects: An Integrative Literature Review

Nurmi, Sanna-Maria; Kangasniemi, Mari; Halkoaho, Arja; Pietilä, Anna‐Maija

doi:10.1177/1556264618805643

Cited by 15 publications

(6 citation statements)

References 50 publications

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“…The participants' privacy in research studies is one of the core principles and has the highest priority. 34 Consequently, the participants' identity in the registry is replaced by a pseudonym assigned by the EDC system.…”

Section: Resultsmentioning

confidence: 99%

Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern

et al. 2021

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Background Registries are an essential research tool to investigate the long-term course of diseases and their impact on the affected. The project digiDEM Bayern will set up a prospective dementia registry to collect long-term data of people with dementia and their caregivers in Bavaria (Germany) supported by more than 300 research partners. Objective The objective of this article is to outline an information technology (IT) architecture for the integration of a registry and comprehensive participant management in a dementia study. Measures to ensure high data quality, study governance, along with data privacy, and security are to be included in the architecture. Methods The architecture was developed based on an iterative, stakeholder-oriented process. The development was inspired by the Twin Peaks Model that focuses on the codevelopment of requirements and architecture. We gradually moved from a general to a detailed understanding of both the requirements and design through a series of iterations. The experience learned from the pilot phase was integrated into a further iterative process of continuous improvement of the architecture. Results The infrastructure provides a standardized workflow to support the electronic data collection and trace each participant's study process. Therefore, the implementation consists of three systems: (1) electronic data capture system for Web-based or offline app-based data collection; (2) participant management system for the administration of the identity data of participants and research partners as well as of the overall study governance process; and (3) videoconferencing software for conducting interviews online. First experiences in the pilot phase have proven the feasibility of the framework. Conclusion This article outlines an IT architecture to integrate a registry and participant management in a dementia research project. The framework was discussed and developed with the involvement of numerous stakeholders. Due to its adaptability of used software systems, a transfer to other projects should be easily possible.

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Section: Resultsmentioning

confidence: 99%

Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern

et al. 2021

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“…Privacy is recognized as a basic human right in the United States and has been identified as a core principle of ethics in clinical research. 6 Health data privacy protections were enacted in 1996 when the Health Insurance Portability and Accountability Act (HIPAA) was passed. HIPAA amended the Internal Revenue Code of 1986 with provisions to simplify the administration of health insurance, to enable the responsible flow of medical information to advance patient care, and to promote good clinical practice.…”

Section: A Fundamental Need For Privacymentioning

confidence: 99%

Important Considerations for the Institutional Review Board When Granting Health Insurance Portability and Accountability Act Authorization Waivers

Williams

Colomb

2020

TOJ

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Background: Privacy is recognized as a basic human right in the United States and has been identified as a core principle of ethics in clinical research. However, changes in the regulations, changes in how research is conducted, and the availability of health data stored in electronic health record systems all pose risks to individuals' privacy. Methods: The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule addresses the use and disclosure of individuals' health information and sets standards for privacy rights so that individuals can understand and control how their health information is used. However, despite the significant increase in the complexity of the data privacy landscape, the HIPAA Privacy Rule has been largely unchanged since its enactment in 1996. Results: Generally, healthcare entities may not use or disclose protected health information (PHI) for research without written authorization from each subject permitting that use or disclosure. However, the HIPAA Privacy Rule allows an institutional review board (IRB) to waive the need for such authorization if documentation is provided that the use or disclosure of PHI presents "no more than a minimal risk to the privacy" of the subjects. Because IRBs were one of the only bodies allowed to waive the need for authorizations in the research context, they essentially served as the gatekeepers of privacy for human subjects. However, this situation changed with the 2018 revisions to 45 CFR §46-known as the Common Rule-that added new categories of exempt research. Under the new regulations, research administrative staff may review a submitted research study and determine that it is exempt without the IRB ever being involved and with no independent review of privacy considerations. This change lessens privacy protections for research subjects. Therefore, IRBs must be mindful of the relevant HIPAA guidance and carefully consider all facts and circumstances available when granting approvals of HIPAA authorization waiver requirements, especially in the content of exempt research, so that the IRB is confident that reasonable safeguards to protect patient privacy have been maintained. Research institutions should amend their processes to ensure that the appropriate level of privacy review is given to all studies, even those that are exempt. Conclusion: Few concrete rules are applicable in the research context that ensure compliance with the HIPAA Privacy Rule. Ultimately, more definitive regulatory guidance integrating HIPAA and the revised Common Rule should be promulgated.

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“…This plan should be exposed to external evaluation by a research ethics committee before the study begins ( WMA, 2013 ). Privacy has been seen as an increasingly important ethical principle in clinical research ( Nurmi et al, 2019 ). Along with the Declaration of Helsinki, at the European level, the General Data Protection Regulation (GDPR, European Union, 2016 ) stipulates the privacy of research data and good practice in handling sensitive information.…”

Section: Introductionmentioning

confidence: 99%

Reporting of Research Ethics in Studies Focusing on Foot Health in Patients with Rheumatoid Arthritis – A Systematic Review

Stolt

Kielo-Viljamaa

Laitinen

et al. 2021

Journal of Empirical Research on Human Research Ethics

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Research ethics is a fundamental part of the entire research. Patients with rheumatoid arthritis are sensitive group of research participants because their long-term health problems cause significant changes in their foot health. In foot health research, data are usually collected through a clinical assessment of the foot or questionnaires. However, there is limited evidence of the reported research ethics of empirical studies on foot health in patients with rheumatoid arthritis. Therefore this review aimed to analyze the reported research ethics of peer-reviewed empirical studies focusing on foot health in patients with rheumatoid arthritis as research participants. This systematic review used the Medline/PubMed, CINAHL, and Embase databases. A total of 1,653 records were identified, and 32 articles were included in the final analysis. Reporting research ethics in studies of patients with rheumatoid arthritis is fragmented, focusing predominantly on ethical approval and informed consent and lacking a broader discussion about research ethics.

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Privacy of Clinical Research Subjects: An Integrative Literature Review

Cited by 15 publications

References 50 publications

Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern

Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern

Important Considerations for the Institutional Review Board When Granting Health Insurance Portability and Accountability Act Authorization Waivers

Reporting of Research Ethics in Studies Focusing on Foot Health in Patients with Rheumatoid Arthritis – A Systematic Review

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