Use of participant data and biological samples is insufficiently described in participant information leaflets

Background

With greater availability of participant data and biobank repositories following clinical trial completion, adequately describing future data and biological sample reuse plans to trial participants is increasingly important. We evaluated how trial teams currently describe current and future use of participant data and biological samples in participant information leaflets (PILs).

Methods

Retrospective qualitative analysis of 240 PILs (182 clinical trials) in Ireland and the UK. Descriptions of data and sample use/reuse were extracted and analyzed using a 4-stage pragmatic content analysis approach. A recommended list of questions to be addressed by trial teams when designing PILs was developed.

Results

Of the 240 included PILs, 85% specifically mentioned, or directly implied, how confidentiality of participant data would be maintained; 38% were considered by the authors to adequately describe how data confidentiality would be maintained (ie, the PIL specifically mentioned data deidentification and compliance with data protection regulations); 47% reported the intended duration of data storage (mean 15; SD ± 9 years); 40% specified if data would be used in future research studies and 28% stated if data would be shared with other researchers. Of the 117 PILs stating biological samples would be collected from participants, 80% provided a reason for requesting the sample, 66% stated whether stored samples would be deidentified, 21% specified if individual-level results would be made available to participants and 70% specified whether samples may be used for future studies. Of the 73 PILs specifying planned future sample storage, 18% stated the intended duration of storage and 48% specified if samples would be shared with other researchers. A list of 8 recommended questions to be addressed by trial teams when designing PILs were identified, for example, ‘What is the intended duration of data and sample storage for the current study?’.

Conclusions

PILs often provide insufficient detail regarding plans for current use and future reuse of participants’ data and their biological samples. The majority do not adequately describe plans for maintaining data confidentiality. Best practice approaches to describing data use and reuse in PILs are needed. This will require multistakeholder input, including potential trial participants to progress this.