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dc.contributor.authorKhan, MIen_US
dc.contributor.authorHolek, Men_US
dc.contributor.authorBdair, Fen_US
dc.contributor.authorMbuagbaw, Len_US
dc.contributor.authorEldridge, SMen_US
dc.contributor.authorChan, CLen_US
dc.contributor.authorCampbell, MJen_US
dc.contributor.authorBond, CMen_US
dc.contributor.authorHopewell, Sen_US
dc.contributor.authorLancaster, GAen_US
dc.contributor.authorThabane, Len_US
dc.date.accessioned2020-06-30T14:05:41Z
dc.date.available2020-05-07en_US
dc.date.issued2020-06-22en_US
dc.identifier.urihttps://qmro.qmul.ac.uk/xmlui/handle/123456789/65338
dc.description.abstractINTRODUCTION: 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.en_US
dc.format.extente036226 - ?en_US
dc.languageengen_US
dc.relation.ispartofBMJ Openen_US
dc.rightsCreative Commons Attribution Non Commercial (CC BY-NC 4.0) license
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subjectethics (see medical ethics)en_US
dc.subjectmedical ethicsen_US
dc.subjectprotocols & guidelinesen_US
dc.subjectstatistics & research methodsen_US
dc.titleAssessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol.en_US
dc.typeArticle
dc.identifier.doi10.1136/bmjopen-2019-036226en_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/32571863en_US
pubs.issue6en_US
pubs.notesNot knownen_US
pubs.publication-statusPublished onlineen_US
pubs.volume10en_US
rioxxterms.funderDefault funderen_US
rioxxterms.identifier.projectDefault projecten_US
rioxxterms.funder.project483cf8e1-88a1-4b8b-aecb-8402672d45f8en_US


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Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license
Except where otherwise noted, this item's license is described as Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license