Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

(2023) Amy M. Russell et al.   Trials

Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19

(2022) Gavin D. Perkins et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage: study protocol for a randomised clinical trial (the UK-REBOA trial)

(2022) Jan O. Jansen et al.   Trials

Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders’ attitudes

(2022) Aran Fitzpatrick et al.   Trials

Unpacking the ‘black box of horrendousness’: a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent

(2022) Victoria Shepherd et al.   Trials

Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within a Trial

(2022) Victoria Shepherd et al.   Trials

The reality of informed consent: empirical studies on patient comprehension—systematic review

(2021) Tomasz Pietrzykowski et al.   Trials

Development of a decision support intervention for family members of adults who lack capacity to consent to trials

(2021) Victoria Shepherd et al.   BMC Medical Informatics and Decision Making

South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study

(2021) Francis Akpa-Inyang et al.   BMC Medical Ethics

EXPRESS: Factors influencing the use of different methods of consent in a randomised acute stroke trial, the Third International Stroke Trial (IST-3)

(2021) Richard Lindley et al.   International Journal of Stroke

Striving for Diversity in Research Studies

(2021)   NEW ENGLAND JOURNAL OF MEDICINE

A systematic review and narrative synthesis of the research provisions under the Mental Capacity Act (2005) in England and Wales: Recruitment of adults with capacity and communication difficulties

(2021) Oluseyi Florence Jimoh et al.   PLoS One

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

(2021) Timia Raven-Gregg et al.   Trials

Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient–public involvement contributors

(2021) Katie Paddock et al.   BMJ Open

Letter on “Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK”

(2020) Sarah Griffiths et al.   Trials

Understanding Verbosity: Funding Source and the Length of Consent Forms for Cancer Clinical Trials

(2020) Quyen Duong et al.   JOURNAL OF CANCER EDUCATION

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

(2020) Victoria Shepherd   Trials

Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)

(2020) C. J. Evans et al.   BMC Medicine

Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review

(2020) Victoria Shepherd   Contemporary Clinical Trials

The ethics of deferred consent in times of pandemics

(2020) Rieke van der Graaf et al.   NATURE MEDICINE

Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process

(2020) Miles D. Witham et al.   Trials

Constructing authentic decisions: proxy decision making for research involving adults who lack capacity to consent

(2020) Victoria Shepherd et al.   JOURNAL OF MEDICAL ETHICS

Inclusion under the Mental Capacity Act (2005): A review of research policy guidance and governance structures in England and Wales

(2020) Hayley Ryan et al.   HEALTH EXPECTATIONS

Handling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?

(2019) Jana S Jensen et al.   Clinical Interventions in Aging

Research and reducing inequity in healthcare

(2019) Michael Vassallo   AGE AND AGEING

Inequity in rehabilitation interventions after hip fracture: a systematic review

(2019) K J Sheehan et al.   AGE AND AGEING

Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: the GenOSept experience

(2019) Ascanio Tridente et al.   BMC Medical Ethics

Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial

(2019) Mark D Lyttle et al.   LANCET

Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

(2019) Victoria Shepherd et al.   Trials

Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT

(2019) Shirley A Thomas et al.   HEALTH TECHNOLOGY ASSESSMENT

Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multicentre, single-blinded, randomised controlled trial

(2019) Rebecca Palmer et al.   LANCET NEUROLOGY

‘It’s a tough decision’: a qualitative study of proxy decision-making for research involving adults who lack capacity to consent in UK

(2019) Victoria Shepherd et al.   AGE AND AGEING

Ethical considerations in prehospital ambulance based research: qualitative interview study of expert informants

(2019) Stephanie Armstrong et al.   BMC Medical Ethics

Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK

(2019) Victoria Shepherd et al.   Trials

Tools for testing decision-making capacity in dementia

(2018) Catherine Pennington et al.   AGE AND AGEING

Improving Public Health Requires Inclusion of Underrepresented Populations in Research

(2018) Catherine Y. Spong et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey

(2018) Victoria Shepherd et al.   JOURNAL OF MEDICAL ETHICS

The Need for Pediatric Drug Development

(2018) Robert M. Ward et al.   JOURNAL OF PEDIATRICS

Children’s views on research without prior consent in emergency situations: a UK qualitative study

(2018) Louise Roper et al.   BMJ Open

Effect of informed consent on patient characteristics in a stroke thrombolysis trial

(2017) Götz Thomalla et al.   NEUROLOGY

Research involving adults lacking capacity to consent: the impact of research regulation on ‘evidence biased’ medicine

(2016) Victoria Shepherd   BMC Medical Ethics

The “Vulnerability” of Psychiatric Research Participants

(2016) Dearbhail Bracken-Roche et al.   CANADIAN JOURNAL OF PSYCHIATRY-REVUE CANADIENNE DE PSYCHIATRIE

Brief Report

(2016) Danny A. Young-Afat et al.   EPIDEMIOLOGY

Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials

(2015) Kerry Woolfall et al.   Archives of Disease in Childhood-Education and Practice Edition

Participant exclusion criteria in treatment research on neurological disorders: Are unrepresentative study samples problematic?

(2015) Ranak B. Trivedi et al.   Contemporary Clinical Trials

A collaborative approach to supporting communication in the assessment of decision-making capacity

(2015) Simon John Zuscak et al.   DISABILITY AND REHABILITATION

Researching Scabies Outbreaks among People in Residential Care and Lacking Capacity to Consent: A Case Study

(2015) Michael G. Head et al.   Public Health Ethics

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

(2015) Kerry Woolfall et al.   BMJ Open

Minimum Risk and HEAT-PPCI

(2014) Byron J. Berger   ANNALS OF EMERGENCY MEDICINE

Dilemmas in undertaking research in paediatric intensive care

(2014) H. K. Kanthimathinathan et al.   ARCHIVES OF DISEASE IN CHILDHOOD

Systematic review on the inclusion of patients with cognitive impairment in hip fracture trials: a missed opportunity?

(2014) Simran Mundi et al.   CANADIAN JOURNAL OF SURGERY

Medical research in emergency research in the European Union member states: tensions between theory and practice

(2014) Erwin J. O. Kompanje et al.   INTENSIVE CARE MEDICINE

Research participation by people with intellectual disability and mental health issues: An examination of the processes of consent

(2014) Chris Taua et al.   International Journal of Mental Health Nursing

Stroke Research Staff’s Experiences of Seeking Consent from People with Communication Difficulties: Results of a National Online Survey

(2014) Mark J. Jayes et al.   Topics in Stroke Rehabilitation

The trials methodological research agenda: results from a priority setting exercise

(2014) Catrin Tudur Smith et al.   Trials

Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

(2014) Kerry Woolfall et al.   BMJ Open

Patients enrolled in randomised clinical trials are not representative of critically ill patients in clinical practice: Observational study focus on tigecycline

(2013) Johannes B. Zimmermann et al.   INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Substitute consent practices in the face of uncertainty: a survey of Canadian researchers in aging

(2013) Gina Bravo et al.   INTERNATIONAL PSYCHOGERIATRICS

Initial evaluation of the Consent Support Tool: A structured procedure to facilitate the inclusion and engagement of people with aphasia in the informed consent process

(2013) Mark Jayes et al.   International Journal of Speech-Language Pathology

People with Aphasia: Capacity to Consent, Research Participation and Intervention Inequalities

(2012) Marian C. Brady et al.   International Journal of Stroke

The Disappearing Subject: Exclusion of People with Cognitive Impairment and Dementia from Geriatrics Research

(2012) Janelle S. Taylor et al.   JOURNAL OF THE AMERICAN GERIATRICS SOCIETY

Treatment consent capacity in patients with traumatic brain injury across a range of injury severity

(2012) K. L. Triebel et al.   NEUROLOGY

Effect of consent rituals on mortality in emergency care research

(2011) Ian Roberts et al.   LANCET

Use of deferred consent for severely ill children in a multi-centre phase III trial

(2011) Kathryn Maitland et al.   Trials

Informed Consent: The Rate-Limiting Step in Acute Stroke Trials

(2011) David Z. Rose et al.   Frontiers in Neurology

Challenges to Effective Research in Acute Trauma Resuscitation

(2010) John B. Holcomb et al.   SHOCK

Research involving adults who lack capacity: how have research ethics committees interpreted the requirements?

(2009) M Dixon-Woods et al.   JOURNAL OF MEDICAL ETHICS

Informed consent and aphasia: Evidence of pitfalls in the process

(2008) Claire Penn et al.   APHASIOLOGY

Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes

(2008) Piotr Iwanowski et al.   Trials