When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Pamphlets* ; Informed Consent* ; Patient Education as Topic* ; Clinical Trials as Topic*/ethics ; Research Subjects*; Humans ; Risk Assessment ; Ireland ; United Kingdom ; Consent Forms/standards ; Risk Factors ; Health Knowledge, Attitudes, Practice ; Personal Autonomy ; Comprehension

Background: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs).
Methods: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third.
Results: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas.
Conclusion: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.
(© 2024. The Author(s).)

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Keywords: Benefits and harms; Informed consent; Participant information leaflets; Patient information leaflets; Risks; Trial methodology

Date Created: 20240501 Date Completed: 20240501 Latest Revision: 20240504

20240504

PMC11061982

10.1186/s13063-024-08087-9

38693579