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Working with Vulnerable Participants

Working with Vulnerable Participants. Julia Townson – Trial Manager, SEWTU Arun Acharjya – Trial Manager, SEWTU Trial Managers Network Meeting London 10 th October 2011. Vulnerable - Definition.

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Working with Vulnerable Participants

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  1. Working with Vulnerable Participants Julia Townson – Trial Manager, SEWTU Arun Acharjya – Trial Manager, SEWTU Trial Managers Network Meeting London 10th October 2011

  2. Vulnerable - Definition Individual who may experience real or potential harm and require special safe guards to ensure that their welfare and rights are protected. They are liable or likely to be susceptible to coercive or undue influence (Liamputtong 2007) • Sensitive • hard to reach • hidden populations • bottom of social hierarchy

  3. Population Vulnerable

  4. ICH GCP – Definition of vulnerable subjects Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. http://ichgcp.net/161-vulnerable-subjects

  5. Research Implications • What makes this population different • What to consider • How to resolve issues

  6. Working with Vulnerable Adults and ChildrenThemes considered from Trial Managers perspectives: Consent Issues Completion of CRFs Regulatory Governance Training Novel environments for conducting research Data Protection

  7. Working with Vulnerable Subjects • Vignette 1 : • RCT involving children aged 1-17 years • Qualitative study, interviews conducted with subjects • Questionnaires completed by parents and children

  8. Working with Vulnerable Subjects • Vignette 2 : • RCT involving adults >50 years with reduced capacity • CTIMP – double blind placebo controlled • Some subjects live in residential centres, some in community/parents • Some subjects are unable to read & write & or with learning disability

  9. Workshop - Themes Ethical and moral issues Consent TM Perspective Training CRF Completion Novel Environments/Research naiive Regulatory Governance Data Protection

  10. Working with Vulnerables Recommended reading : • Safeguarding Children & Vulnerable Adults Policy – Cardiff University 2010 • Conducting Qualitative Research with people with learning disability, communication & other disabilities: Methodological challenges – Melanie Nind, Univ of Southampton Nov 2008 • Researching the Vulnerable – PraneeLiamputtong 2007, SAGE Publications • Making written information easier to understand for people with learning disabilities - Easy Read information – Revised Edition 2010

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