scholarly journals Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Mohammed I.U. Khan ◽  
Lawrence Mbuagbaw ◽  
Matthew Holek ◽  
Faris Bdair ◽  
Zoha H. Durrani ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Feasibility Studies ◽  
Pilot Studies ◽  
Information Leaflets ◽  
Integrated Research ◽  
Ethics Guidelines ◽  
Definition Of ◽  
Research Ethics Guidelines ◽  
Pilot Feasibility Study

Abstract Background 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. Methods 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. Results 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. Conclusion 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.

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

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036226
Author(s):  
Mohammed I Khan ◽  
Matthew Holek ◽  
Faris Bdair ◽  
Lawrence Mbuagbaw ◽  
Sandra M Eldridge ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Study Protocol ◽  
Feasibility Studies ◽  
Primary Objective ◽  
Pilot Studies ◽  
Integrated Research ◽  
Research Ethics Board ◽  
Ethics Guidelines ◽  
Definition Of

IntroductionPilot/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 analysisThis 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 disseminationThe 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.

Reflexivity in Research Practice: Informed Consent with Children at School and at Home

2008 ◽  
Vol 13 (4) ◽  
pp. 17-30 ◽  
Author(s):  
Hayley Davies
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Research Process ◽  
Research Practice ◽  
Ethical Practices ◽  
Research Participants ◽  
Ethical Approach ◽  
Ethics Guidelines ◽  
Research Ethics Guidelines

Informed consent is a key consideration in ethical research, particularly research conducted with children. Devising an approach to and obtaining informed consent is a complex task involving multiple considerations. The examples used in this paper are derived from a study investigating how children constitute family members and close relationships. The paper is divided into two sections. The first section suggests that researchers should take a reflexive approach to their professional research practice and addresses how a researcher's professional location determines their particular ethical approach. Consideration is given to how the researcher's particular ethical approach can be achieved in consultation with academic thought and research ethics guidelines, which often offer contradictory advice on important ethical issues. The second section of the paper addresses how researchers negotiate their approach to informed consent in particular research contexts which offer challenges to the researcher's thinking about research participants or chosen procedures for obtaining and maintaining that informed consent is upheld. The paper concludes by arguing that the researcher can incorporate academic thought and aspects of the research ethics guidelines in an approach to informed consent that simultaneously values the research participants and the ethical practices operating in the research setting. Such an approach involves careful negotiation and consideration of the interests of all stakeholders in the research process.

Informed consent in cluster randomised trials: new and common ethical challenges

2017 ◽  
Vol 44 (2) ◽  
pp. 114-120 ◽  
Author(s):  
Sapfo Lignou
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Population Based ◽  
Ethical Challenges ◽  
Randomised Trials ◽  
Cluster Randomised Trials ◽  
Cluster Randomised ◽  
Two Factors ◽  
Ethics Guidelines ◽  
Research Ethics Guidelines

Cluster randomised trials are an increasingly important methodological tool in health research but they present challenges to the informed consent requirement. In the relatively limited literature on the ethics of cluster research there is not much clarity about the reasons for which seeking informed consent in cluster randomised trials may be morally challenging. In this paper, I distinguish between the cases where informed consent in cluster trials may be problematic due to the distinct features of ‘population-based’ interventions, which have not been adequately discussed in the research ethics literature, and the cases where informed consent may be problematic for reasons that investigators also encounter in other research designs. I claim that informed consent requirements in cluster trials should be adjusted to the level of risk involved, arguing for a more comprehensive notion of research risk than that currently found in the research ethics guidelines, and the amount of freedom to be sacrificed in relation to a particular research aim. I conclude that these two factors are the most important to consider when assessing whether a cluster study should proceed when informed consent is infeasible or difficult to obtain.

scholarly journals Guidelines for Evaluating the Feasibility of Recruitment in Pilot Studies of Diverse Populations: An Overlooked but Important Component

2020 ◽  
Vol 30 (Suppl) ◽  
pp. 745-754
Author(s):  
Anita L. Stewart ◽  
Anna Maria Nápoles ◽  
Sorbarikor Piawah ◽  
Jasmine Santoyo-Olsson ◽  
Jeanne A. Teresi
Keyword(s):  
Health Disparities ◽  
Feasibility Study ◽  
Feasibility Studies ◽  
Recruitment Strategies ◽  
Diverse Populations ◽  
Tracking Data ◽  
Pilot Studies ◽  
Recruitment Methods ◽  
Additional Information ◽  
Pilot Feasibility Study

Background: In health disparities research, studies often fall short of their recruitment goals. Conducting a pilot feasibility study of recruitment in which data are collected systematically on recruitment processes can help investigators refine methods for the larger study. However, there are few guide­lines for conducting pilot feasibility studies, and recruitment methods are seldom the focus. Feasibility indicators differ from traditional reports of recruitment results by focusing on the extent to which recruitment goals are met.Methods: We present an organizing frame­work for assessing the feasibility of recruit­ment that includes eight steps, briefly: 1) specify recruitment goals; 2) specify recruit­ment processes; 3) establish a tracking sys­tem for each individual; 4) establish a track­ing database for monitoring processes and results; 5) implement recruitment and track each individual’s progress; 6) summarize re­cruitment results; 7) calculate and interpret feasibility measures - were goals met; and 8) if goals were not met, utilize tracking data to modify methods for the larger study. We describe methods within each step, with added details for steps 2-5 (the specific pro­cesses). The framework draws from a small literature on recruitment feasibility with a focus on health disparities populations. The guidelines blend well-known methods of recruitment with additional information on calculating feasibility indicators.Conclusion: These guidelines provide a first step in thinking systematically about recruitment feasibility, to advance the field of measuring feasibility. Feasibility indicators also can be used to track the effectiveness of innovative recruitment strategies as part of building the science of recruitment, es­pecially in disparities populations. Ethn Dis. 2020; 30(Suppl 2):745-754; doi:10.18865/ed.30.S2.745

scholarly journals Research Ethics in Correspondence Testing: An Update

2019 ◽  
Vol 15 (2) ◽  
pp. 1-21 ◽  
Author(s):  
Eva Zschirnt
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Internet Access ◽  
Voluntary Participation ◽  
National Context ◽  
Internet Applications ◽  
Potential Problems ◽  
Ethics Guidelines ◽  
Use Of Internet

Correspondence testing to research discrimination in the marketplace has become common and the use of internet applications has allowed researchers to send greater numbers of applications. While questions of research ethics always arise when planning a correspondence test, the issue receives relatively little attention in published correspondence tests. This paper addresses the question of ethics in correspondence testing in the age of ready internet access. It focusses on the ethical issues that arise in correspondence testing, looking at potential problems (regarding voluntary participation, informed consent, deception, entrapment of employers, employers’ rights) and possible solutions, and technical challenges. European country examples show that the ethical questions raised in correspondence testing have to be renegotiated depending on the national context. The paper argues that correspondence testing, if planned carefully and executed responsibly, can meet most of the ethical requirements of Social Science ethics guidelines.

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