Standard Development Group: Consent and Recruitment

Ethical guidelines have recommended special protection for children in research.  All research involving human subjects requires consent, but consent and assent procedures and requirements are more complicated in children. This standard development group aims to provide guidance on how to best recruit children to clinical research and to obtain appropriate consent and assent in an efficient and ethical manner.

Patrina Caldwell


Affiliation: Associate professor, University of Sydney and Senior Staff Specialist, The Children’s Hospital at Westmead, Australia

Research interests: Recruitment, design and conduct of paediatric trials, medical education research, paediatric urinary incontinence and bladder dysfunction

Current projects: Comparison of clinical trials conducted in low and high income settings; Comparison of the barriers and enablers for paediatric trials in different countries and settings; Assessing the standards of ethics applications for paediatric trials to identify gaps and areas of needs; Conducting a randomised controlled trials of an intervention for daytime urinary incontinence; Conducting a randomised controlled trial using an  interactive eHealth app to improve clinical outcomes and reduce waiting times for specialist appointments; Conducting a number of other studies on various aspects of paediatric incontinence and to explore the use of technology (eHealth, eLearning, social media) in health and health education.

Helen Sammons

Affiliation: Helen is Associate Professor of Child Health at the University of Nottingham and a Consultant Paediatrician at the Derbyshire Children’s Hospital. She is chair of the RCPCH Medicines Committee and vice chair of the NRES Derby Research Ethics Committee.

Research Interests:  Her research interests include clinical drug trials in children and neonates, safe and effective prescribing and the ethics of paediatric clinical trials.

Current projects:  A member of the working part for the Nuffield bioethics report on Children and clinical research: ethical issues. Ethics Work package leader for two European FP7 funded projects in neonates (TINN and TINN 2) and member of the ethics boards of a further 2 FP7 projects currently (ASTROLAB and GAPP).

Bridget Young

Affiliation: Bridget is Professor of Psychology in the Institute of Psychology, Health and Society, University of Liverpool, UK and co-lead of the Patient Perspectives Theme of the Medical Research Council Hub for Trials Methodology Research.

Research Interests: Communication and decision making processes in research; methodological research to improve research for the benefit of patients, including children and their families.

Current projects:  Process and impact of patient and public involvement as partners and advisers in health research; communication about treatment preferences in clinical trials; recruitment and retention in child mental health clinical trials.

Leonila Dans

Affiliation: Professor, Clinical Epidemiologist and Pediatric Rheumatologist, University of the Philippines - Manila; Philippine General Hospital

Research interests: Pediatric rheumatic diseases, systematic reviews for child health problems, evidence-based medicine, knowledge management and health policy issues

Current projects: Systematic review of complementary medicine for Juvenile arthritis, measuring healthcare workforce distribution in the Philippines, Underuse of technology in developing countries, Incorporating Educational Modules to the school curriculum to prevent child abuse.

Kerry Woolfall

Affiliation: Research Fellow, Medical Research Council (MRC) Hubs for Trials Methodology Research (HTMR), University of Liverpool

Research Interests: involving vulnerable populations in research to inform policy and practice, recruitment and consent in challenging clinical trials, bioethics and children’s medicine

Current projects: Kerry holds a Wellcome Trust funded post-doctoral fellowship in bioethics. Her study (called CONNECT) is investigating consent in children’s emergency research. Findings will include a set of guidelines for practitioners to inform approaches to deferred consent in children’s critical care trials. She is about to begin a study exploring parent and practitioner views and experiences of recruitment and consent in a pragmatic randomised controlled trial called ‘EcLIPSE’: Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus.

William Van't Hoff

Affiliation: William is a Consultant Paediatric Nephrologist at Great Ormond Street Hospital for Children NHS Foundation Trust in London, UK. He is Head of the Clinical Research Facility at Great Ormond Street, Joint (interim) Director National Institute for Health Research Clinical Research Network: Children

Research Interests:  Basis and treatment of renal tubular and genetic disease; Medicines in Children

Current projects:  Involvement of children and young people in improving research, ethics of clinical trials in children

Merle Spriggs

Affiliation: Research Fellow, Children’s Bioethics Centre, Royal Children’s Hospital / Centre for Health Equity, Melbourne School of Population and Global Health, University of Melbourne / Honorary Research Fellow, Murdoch Children’s Research Institute.

Research interests: Bioethics, informed consent, ethics of research practice, paediatric ethics, empirical ethics, ethical issues and responsibilities in paediatric biobanking, e-health ethics, the ethics of internet-based research and the ethical issues of electronic health records.

Current projects:  Publication in progress; ‘Clarifying ethical responsibilities in paediatric biobanking’ (Merle Spriggs & Craig Fry) Publication submitted; ‘Involving children in social research:Balancing the risks and benefits’.  3 year ARC Discovery Project 2015-2017.  (M. McArthur, A. Graham, M. Spriggs, J. Chalmers, T. Moore, S. Taplin); ‘Child co-researchers: Ethical challenges for researchers and Human Research Ethics Committees’ (Merle Spriggs & Lynn Gillam); ‘Clinicians attitudes and responses to requests for Female Genital Cosmetic Surgery (FGCS) for Adolescents’. (Merle Spriggs & Lynn Gillam)

Jenny Preston

Affiliation: Jenny is currently funded by National Institute for Health Research (NIHR) Clinical Research Network (CRN): Children and NIHR Clinical Research Facility, Alder Hey NHS Children’s Foundation Trust to facilitate and coordinate the active involvement of young people and families in the design and delivery of research in children.

Research Interests: information, communication and decision making in children’s research; the impact of patient and public involvement on the design and delivery of research.

Current projects: recently just completed two patient involvement projects that explored measuring the impact of patient and public involvement in health research; working with European and International colleagues to explore the concept of a virtual young person’s network to inform all stages of research design and delivery in paediatric research; co-applicant on a Seventh Framework Programme (FP7) Collaborative Project looking at the development of a new formulation of metformin for young people with Polycystic Ovary Syndrome.

Martine de Vries

Affiliation: Paediatrician and medical ethicist at the Leiden University Medical Center. Chair of the Committee on Ethics and Health Law of the Dutch Paediatric Association.

Research interests: Communication and decision making processes in research; optimizing the informed consent and recruitment process. Fundamental research on the concepts “child”, “vulnerability”, “best interests”

Current projects: Development of the multidisciplinary guideline “Medical research with children – norms for a careful and child friendly environment” (sponsored by the Dutch Ministry of Health). Development of information material with and for children. Development of a tool to assess competence in children being asked to participate in a trial.

Martin Offringa

Affiliation: Senior Scientist and staff neonatologist, Hospital for Sick Children

Research interests: Design, conduct, and reporting of high quality trials that inform decision making.

Current projects: Developing standards, frameworks, and tools for ethics review of multicentre trials; deferring consent in trials in acute medical conditions (publication submitted); developing justifiable comparators to enhance recruitment; developing relevant, acceptable and responsive health outcomes for children.


StaR Child Health is an international collaboration that seeks to enhance the quality, ethics, and relevance of clinical research in child health by promoting the use of evidence-based standards and guidance for the design, conduct and reporting of clinical trials with children



The Hospital for Sick Children

555 University Ave

Toronto, Ontario

Canada M5G 1X8

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Last updated: January 2021

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