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

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

SUBMITTER: Khan MI 

PROVIDER: S-EPMC7311004 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature