Biostatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
BMJ Open. 2020 Jun 22;10(6):e036226. doi: 10.1136/bmjopen-2019-036226.
Pilot/feasibility studies assess the feasibility of conducting a larger study. Although researchers ought to communicate the feasibility objectives to their participants, many research ethics guidelines do not comment on how informed consent applies to pilot studies. It is unclear whether researchers and research ethics boards clearly communicate the purpose of pilot studies to participants consenting.The primary objective of this study is to assess whether pilot/feasibility studies submitted for ethics approval to a research ethics board transparently communicate the purpose of the study to participants through their informed consent practice. A highly transparent consent practice entails the consent documents communicate: (1) the term 'pilot' or 'feasibility' in the title; (2) the definition of a pilot/feasibility study; (3) the primary objectives of the study are to assess feasibility; (4) the specific feasibility objectives; and (5) the criteria for the study to successfully lead to the main study. The secondary objectives are to assess whether there is a difference between submitted and revised versions of the consent documents (revisions are made to obtain research ethics approval), to determine factors associated with transparent consent practices and to assess the consistency with which pilot and feasibility studies assess feasibility outcomes as their primary objectives.
This is a retrospective review of informed consent information for pilot/feasibility studies submitted to the Hamilton integrated Research Ethics Board, Canada. We will look at submitted and revised consent documents for pilot/feasibility studies submitted over a 14-year period. We will use descriptive statistics to summarise data, reporting results as percentages with 95% CIs, and conduct logistic regression to determine characteristics associated with transparent consent practices.
The study protocol was approved by the Hamilton integrated Research Ethics Board, and the results of this study will be submitted for publication in a peer-reviewed journal.
试点/可行性研究评估进行更大规模研究的可行性。尽管研究人员应该向参与者传达可行性目标，但许多研究伦理准则并未就知情同意如何适用于试点研究发表评论。目前尚不清楚研究人员和研究伦理委员会是否向同意参与研究的参与者清楚地传达了试点研究的目的。本研究的主要目的是评估提交给研究伦理委员会进行伦理审查的试点/可行性研究是否通过其知情同意实践向参与者透明地传达了研究目的。高度透明的同意实践需要在同意文件中传达：(1)研究标题中包含“试点”或“可行性”一词；(2) 试点/可行性研究的定义；(3)研究的主要目的是评估可行性；(4)具体的可行性目标；以及(5)研究成功引领主要研究的标准。次要目标是评估同意文件的提交版本和修订版本（修订版本是为了获得研究伦理批准）之间是否存在差异，确定与透明同意实践相关的因素，并评估试点和可行性研究将可行性结果作为主要目标进行评估的一致性。
这是对提交给加拿大汉密尔顿综合研究伦理委员会的试点/可行性研究的知情同意信息进行的回顾性审查。我们将查看在 14 年期间提交的试点/可行性研究的提交和修订同意文件。我们将使用描述性统计来总结数据，以百分比和 95%置信区间报告结果，并进行逻辑回归以确定与透明同意实践相关的特征。
该研究方案已获得汉密尔顿综合研究伦理委员会的批准，本研究的结果将提交给同行评议期刊发表。
