How Long Should a Patient Information Sheet Be for a Clinical Research Study?

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HOW LONG SHOULD A PATIENT INFORMATION SHEET BE FOR A CLINICAL RESEARCH STUDY?

Carlito Adan1, Leela Goldstein1, Iain C Macdougall1

1Renal Unit, King’s College Hospital, London

BACKGROUND: Modern-day conduct of clinical research requires a number of important regulatory procedures including ethics committee approval, adherence to Good Clinical Practice (GCP), written informed consent, etc. Before the latter is obtained, patients are required to have read (and understood) a Patient Information Sheet (PIS) about the planned clinical research.

Over the last few years, it seems as if the PIS is getting longer and longer, and for many patients (particularly those with visual problems or slightly impaired cognitive function), this is a considerable burden.

Our unit has participated in a large number of clinical trials over the last 15 years or so, both academic (NHS or university sponsor) and commercial (commercial company sponsor) NIHR portfolio studies. We have taken this opportunity to examine the length and characteristics of the PISs from a snapshot of clinical trials performed in our unit from 2005 to 2015.

METHODS: The PISs from all clinical trials conducted in our unit from 2005 to 2015were examined, and the following data extracted: characteristics of clinical trial, length of PIS, and inclusion of a 1-page summary.

RESULTS: A total of 45 NIHR portfolio studies were assessed. 20 were non-commercial and 25 were commercial; 32 were interventional and13 were observational. The length of the PIS ranged from 2 pages to 10 pages long (mean 5.9 pages) and from 5 pages to 21 pages long (mean 14.1 pages) for non-commercial and commercial studies respectively. Only 2 of the studies (both non-commercial, interventional) had a 1-page summary patient information sheet.Over the last 5-10 years, there has been an increasing trend in the length of the PIS for clinical research studies (Figure). Commercial studies have longer PISs than non-commercial studies.

CONCLUSIONS:Patient Information Sheets in the modern era of clinical research appear to be somewhat lengthy, particularly for commercial clinical trials. We suggest that this is a significant burden for many patients wishing to help with clinical research. We further suggest that a 1-page summary patient information sheet may help to reduce this burden and facilitate the informed consent process.