Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol

Mohammed I Khan, Matthew Holek, Faris Bdair, Lawrence Mbuagbaw, Sandra M. Eldridge, Claire L. Chan, Michael J. Campbell, Christine M. Bond, Sally Hopewell, Gillian A. Lancaster, Lehana Thabane* (Corresponding Author)

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

Introduction: 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.
Methods and analysis: 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.
Ethics and dissemination: 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.
Original languageEnglish
Article numbere036226
Pages (from-to)e036226
Number of pages5
JournalBMJ Open
Volume10
Issue number6
Early online date22 Jun 2020
DOIs
Publication statusPublished - 2020

Keywords

  • ethics (see medical ethics)
  • medical ethics
  • protocols & guidelines
  • statistics & research methods

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