Khan Mohammed I U, Mbuagbaw Lawrence, Holek Matthew, Bdair Faris, Durrani Zoha H, Mellor Katie, Eddy Saskia, Eldridge Sandra M, Chan Claire L, Campbell Michael J, Bond Christine M, Hopewell Sally, Lancaster Gillian A, Thabane Lehana
Biostatistics Unit, St. Joseph's Healthcare, Hamilton, Ontario, Canada.
University of Toronto, Toronto, Ontario, Canada.
Pilot Feasibility Stud. 2021 Apr 16;7(1):96. doi: 10.1186/s40814-021-00828-w.
Pilot and feasibility studies (PAFS) often have complex objectives aimed at assessing feasibility of conducting a larger study. These may not be clear to participants in pilot studies.
Here, we aimed to assess the transparency of informed consent in PAFS by investigating whether researchers communicate, through patient information leaflets and consent forms, key features of the studies. We collected this data from original versions of these documents submitted for ethics approval and the final approved documents for PAFS submitted to the Hamilton Integrated Research Ethics Board, Canada.
One hundred eighty-four PAFS, submitted for ethics approval from 2004 to 2020, were included, and we found that of the approved consent documents which were provided to participants, 83.2% (153) stated the terms "pilot" or "feasibility" in their title, 12% (22) stated the definition of a pilot/feasibility study, 42.4% (78) of the studies stated their intent to assess feasibility, 19.6% (36) stated the specific feasibility objectives, 1.6% (3) stated the criteria for success of the pilot study, and 0.5% (1) stated all five of these criteria. After ethics review, a small increase in transparency occurred, ranging from 1.6 to 2.8% depending on the criteria. By extracting data from the protocols of the PAFS, we found that 73.9% (136) stated intent to assess feasibility, 71.2% (131) stated specific feasibility objectives, and 33.7% (62) stated criteria for success of the study to lead to a larger study.
The transparency of informed consent in PAFS is inadequate and needs to be specifically addressed by research ethics guidelines. Research ethics boards and researchers ought to be made aware and mindful of best practices of informed consent in the context of PAFS.
试点研究和可行性研究（PAFS）通常具有复杂的目标，旨在评估开展更大规模研究的可行性。这些目标对于试点研究的参与者可能并不明确。
在此，我们旨在通过调查研究人员是否通过患者信息传单和同意书传达研究的关键特征，来评估PAFS中知情同意的透明度。我们从提交伦理审查的这些文件的原始版本以及提交给加拿大汉密尔顿综合研究伦理委员会的PAFS最终批准文件中收集了这些数据。
纳入了2004年至2020年提交伦理审查的184项PAFS，我们发现，在提供给参与者的已批准同意书中，83.2%（153份）在标题中提及了“试点”或“可行性”一词，12%（22份）阐述了试点/可行性研究的定义，42.4%（78项）研究表明了评估可行性的意图，19.6%（36份）阐述了具体的可行性目标，1.6%（3份）阐述了试点研究成功的标准，0.5%（1份）阐述了所有这五项标准。伦理审查后，透明度有小幅提高，根据标准不同，提高幅度在1.6%至2.8%之间。通过从PAFS的方案中提取数据，我们发现73.9%（136项）表明了评估可行性的心，71.2%（131份）阐述了具体的可行性目标，33.7%（62份）阐述了研究成功从而开展更大规模研究的标准。
PAFS中知情同意的透明度不足，需要研究伦理准则专门加以解决。研究伦理委员会和研究人员应该了解并铭记PAFS背景下知情同意的最佳做法。
