Example

 

"Participant confidentiality is strictly held in trust by the Site Principal Investigator, participating investigators, research staff, and the Murdoch Children’s Research Institute (MCRI) and their agents. This confidentiality is extended to cover testing of biological samples in addition to the clinical information relating to participating participants.

 

To preserve confidentiality and reduce the risk of identification during collection, analysis and storage of data and information, the following will be undertaken:

 

(1) The number of private/confidential variables collected for each individual has been minimised. The data collected will be limited to that required to address the primary and secondary objectives

 

(2) Participant data and samples will be identified through use of a unique participant study number assigned to the study participant (“re-identifiable”).

 

The Site Principal Investigator is responsible for the storage of a master-file of names and other identifiable data with the participant ID; access to this document will be restricted to members of the research team and authorised persons as listed previously. The master file will be stored securely, and separately, from study data in locked/ password-protected databases with passwords kept separately.

 

(3) Separation of the roles responsible for management of identifiers and those responsible for analysing content. The data will be analysed by members of the research team, who will be provided with anonymised data identified only by the unique participant study ID

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..." [497].

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“To ensure confidentiality, any data dispersed to investigators will be blinded of any identifying participant information" [85]. 

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Explanation

 

Personal information about trial participants is acquired during the process of recruitment, eligibility screening, and data collection. Much of this information consists of private details over which many persons wish to maintain control, such as their health status, personal genotype, and social and family history.

 

Researchers need to safeguard confidential participant data from potential data breaches [498], sometimes while simultaneously implementing appropriate procedures for data sharing (Item 6) [499, 500]. 

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Reviews of two samples of 108 and 292 trial protocols approved in 2016, found that 76% and 88% addressed confidentiality of data [9, 10].  

 

The protocol should describe the means whereby personal information is collected, kept secure, and maintained. In general, this involves: 1) the creation of coded, de-identified data where the participant's identifying information is replaced by an unrelated sequence of characters; 2) secure maintenance of the data and the linking code in separate locations using encrypted digital files within password-protected folders and storage media; and 3) limiting access to the minimum number of individuals necessary for quality control, audit, and analysis. The protocol should also describe how the confidentiality of data will be preserved when the data are transmitted to sponsors, co-investigators, and external parties (Item 6).

 

Summary of key elements to address

• How confidentiality will be preserved when:

• Collecting and maintaining personal information before, during, and after the trial

• Transmitting data to sponsors, co-investigators, and external parties