Privacy of Clinical Research Subjects: An Integrative Literature Review with Best Practices

With changes in clinical research practice, the importance of a study-subject’s privacy and the confidentiality of their personal data is growing. However, the body of research is fragmented, and a synthesis of work in this area is lacking. Accordingly, an integrative review was performed, guided by Whittemore and Knafl’s work. Data from PubMed, Scopus, and CINAHL searches from January 2012 to February 2017 were analyzed via the constant comparison method. From 16 empirical and theoretical studies, six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymizing data, collaboration among stakeholders, the complexity of regulation, and ethics-related tension between social benefits and privacy. Study subjects’ privacy is an increasingly important ethics principle for clinical research, and privacy protection is rendered even more challenging by changing research practice.

The article concludes with suggested best practices based upon the findings.  

Best Practices

• Encourage collaboration - Collaboration among stakeholders is one of the prerequisites for protecting privacy in clinical research.
• Transparency - A well applied, transparent process with properly surveilled procedures ensures compliance with legal guidelines.   
• Reduce tension - The tension between study-subject privacy protection and benefits to society must be eased. This requires, public trust and more flexible privacy rules. But most important is a guarantee of adequate research-ethics training for researchers and clinical-study staff, with solid recognition of the moral rationale behind the regulations.

The full article can be downloaded below.