scholarly journals Reshaping the review of consent so we might improve participant choice

2021 ◽  
pp. 174701612110437 ◽  
Author(s):  
Hugh Davies
Keyword(s):  
Research Ethics ◽  
Public Involvement ◽  
Informed Choice ◽  
Information Sheet ◽  
Central Importance ◽  
Research Ethics Review ◽  
Poor Understanding ◽  
Key Issues ◽  
The Uk ◽  
Participant Information

Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC (an NHS Research Ethics Committee based in the UK) we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps: Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues. Step 2: Explaining all the details of the study using the detailed Participant Information Sheet. Step 3: After a gap, if necessary, reviewing and checking understanding. Step 4: Reaching agreement and recording consent. These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations.

scholarly journals Trust and regulatory organisations: The role of local knowledge and facework in research ethics review

2012 ◽  
Vol 42 (5) ◽  
pp. 662-683 ◽  
Author(s):  
Adam M. Hedgecoe
Keyword(s):  
Research Ethics ◽  
Social Relations ◽  
Scientific Community ◽  
Interpersonal Trust ◽  
Ethics Committees ◽  
Regulatory Decision ◽  
Research Ethics Review ◽  
The Uk ◽  
Oversight Body

While trust is seen as central to most social relations, most writers, including sociologists of science, assume that modern trust relations – especially those in regulatory relationships – tend towards the impersonal. Drawing on ethnographic material from one kind of scientific oversight body – research ethics committees based in the UK NHS – this paper argues that interpersonal trust is crucial to regulatory decision-making and intimately bound up with the way in which these oversight bodies work, and that as such they build on, rather than challenge, the trust-based nature of the scientific community.

scholarly journals An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial

2020 ◽  
Vol 3 ◽  
pp. 4 ◽  
Author(s):  
Christopher P. Dwyer ◽  
Robert A. Joyce ◽  
Eimear M. Bane ◽  
Anusha Moses ◽  
Alberto Alvarez-Iglesias ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Information Sheet ◽  
Double Blind ◽  
Link Type ◽  
Participant Information Sheet ◽  
Study Within A Trial ◽  
Trials Methodology ◽  
Participant Information

Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets.  Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.

scholarly journals How to make study documents clear and relevant: the impact of patient involvement

BJPsych Open ◽  
2021 ◽  
Vol 7 (6) ◽  
Author(s):  
Sagar Jilka ◽  
Georgie Hudson ◽  
Sonja M. Jansli ◽  
Esther Negbenose ◽  
Emma Wilson ◽  
...  
Keyword(s):  
Public Involvement ◽  
Patient And Public Involvement ◽  
Mixed Methods Design ◽  
Information Sheet ◽  
Participant Information Sheet ◽  
Before And After ◽  
Research Document ◽  
The Impact ◽  
Participant Information ◽  
Over Time

Background Patient and public involvement can improve study outcomes, but little data have been collected on why this might be. We investigated the impact of the Feasibility and Support to Timely Recruitment for Research (FAST-R) service, made up of trained patients and carers who review research documents at the beginning of the research pipeline. Aims To investigate the impact of the FAST-R service, and to provide researchers with guidelines to improve study documents. Method A mixed-methods design assessing changes and suggestions in documents submitted to the FAST-R service from 2011 to 2020. Quantitative measures were readability, word count, jargon words before and after review, the effects over time and if changes were implemented. We also asked eight reviewers to blindly select a pre- or post-review participant information sheet as their preferred version. Reviewers’ comments were analysed qualitatively via thematic analysis. Results After review, documents were longer and contained less jargon, but did not improve readability. Jargon and the number of suggested changes increased over time. Participant information sheets had the most suggested changes. Reviewers wanted clarity, better presentation and felt that documents lacked key information such as remuneration, risks involved and data management. Six out of eight reviewers preferred the post-review participant information sheet. FAST-R reviewers provided jargon words and phrases with alternatives for researchers to use. Conclusions Longer documents are acceptable if they are clear, with jargon explained or substituted. The highlighted barriers to true informed consent are not decreasing, although this study has suggestions for improving research document accessibility.

scholarly journals An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial

2020 ◽  
Vol 3 ◽  
pp. 4 ◽  
Author(s):  
Christopher P. Dwyer ◽  
Robert A. Joyce ◽  
Eimear M. Bane ◽  
Anusha Moses ◽  
Alberto Alvarez-Iglesias ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Information Sheet ◽  
Double Blind ◽  
Link Type ◽  
Participant Information Sheet ◽  
Study Within A Trial ◽  
Trials Methodology ◽  
Participant Information

Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets.  Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.

scholarly journals Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere?

2019 ◽  
Vol 47 (2) ◽  
pp. 264-282 ◽  
Author(s):  
Edward S. Dove
Keyword(s):  
Research Ethics ◽  
Empirical Research ◽  
Regulatory Structure ◽  
Cooperative Research ◽  
Common Rule ◽  
Ethics Review ◽  
Research Ethics Review ◽  
General Support ◽  
The Us ◽  
The Uk

This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.

scholarly journals Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Zahra Jamal ◽  
◽  
Alexander Perkins ◽  
Christopher Allen ◽  
Richard Evans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Public Involvement ◽  
Ethics Committees ◽  
Patient And Public Involvement ◽  
Research Ethics Committees ◽  
The Public ◽  
Clinical Trials Unit ◽  
The Uk

Plain English summary Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research. During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public. In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future. Abstract Background: Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial. Methods: RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference. Results: Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice. Conclusions: PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.

scholarly journals P136 Vegan orthopaedics

BJS Open ◽  
2021 ◽  
Vol 5 (Supplement_1) ◽  
Author(s):  
Gwithyen Silk ◽  
Niraj Vetherajan ◽  
Alice Blohm ◽  
Katie Keen ◽  
Fiona Teeling ◽  
...  
Keyword(s):  
Ethnic Diversity ◽  
Informed Choice ◽  
Pharmaceutical Companies ◽  
Vitamin D2 ◽  
World Religions ◽  
Animal Products ◽  
Animal Source ◽  
Specific Manner ◽  
Prescribed Medicines ◽  
The Uk

Abstract Introduction Bristol is the vegan capital of the UK. The UK vegan index reveals that Bristol has 360,000 Google searches each month for Vegan content. However, do we think about the possible animal source of the medications we prescribe. Although all medications in the UK need to be tested on animals prior to being licensed and therefore cannot be truly “vegan”, there are alternatives available for some commonly used medications that do not contain animal products. Several world religions prohibit their followers from consuming certain foods, ranging from those not prepared in a specific manner to those derived from certain animals. Kosher and halal diet adherents share concerns with those on vegan diets. Vegan options are a solution when only non-conforming or uncertain products are available. Methods We conducted a review of commonly used medications in Orthopaedics and reviewed their source. The BNF, local pharmacy and online Summary of Product Characteristics (SPCs) for the medications were reviewed. Results Where possible we have compiled a list of those that contain animal derived components and suggest alternatives. Sometimes, pharmaceutical companies cannot guarantee or differentiate the specific sources of animal-derived ingredients, as various suppliers are used in the manufacturing process and the sources can change. All unfractionated or standard heparin is porcine in origin; Rivaroxaban and Fondaparinux are simple alternatives for example. Cholecalciferol (vitamin D3) – Manufacture also involves the use of lanolin from sheep’s wool. Vitamin D2 (ergocalciferol) is vegan. Conclusion Disclosure of animal content and excipients would help patients make an informed choice. With an increasingly informed population and ethnic diversity, we should all be aware of the drugs that may contain animal products so that we can offer alternatives. Patients are more likely to adhere to prescribed medicines if they have been actively involved in prescribing decisions.

A Novel Framework for Reflecting on the Functioning of Research Ethics Review Panels

2007 ◽  
Vol 14 (1) ◽  
pp. 99-116 ◽  
Author(s):  
Colin Macduff ◽  
Andrew McKie ◽  
Sheelagh Martindale ◽  
Anne Marie Rennie ◽  
Bernice West ◽  
...  
Keyword(s):  
Health Care ◽  
Nursing Education ◽  
Research Ethics ◽  
Health Care Professionals ◽  
Rapid Change ◽  
Health Care Research ◽  
Ethical Review ◽  
Review Panel ◽  
Ethics Review ◽  
Research Ethics Review

In the past decade structures and processes for the ethical review of UK health care research have undergone rapid change. Although this has focused users' attention on the functioning of review committees, it remains rare to read a substantive view from the inside. This article presents details of processes and findings resulting from a novel structured reflective exercise undertaken by a newly formed research ethics review panel in a university school of nursing and midwifery. By adopting and adapting some of the knowledge to be found in the art and science of malt whisky tasting, a framework for critical reflection is presented and applied. This enables analysis of the main contemporary issues for a review panel that is primarily concerned with research into nursing education and practice. In addition to structuring the panel's own literary narrative, the framework also generates useful visual representation for further reflection. Both the analysis of issues and the framework itself are presented as of potential value to all nurses, health care professionals and educationalists with an interest in ethical review.

Sign in / Sign up

Export Citation Format

Share Document