Personality Profiles

  • Research type

    Research Study

  • Full title

    Understanding the personality profile of healthy volunteers who take part in early phase clinical trials in the UK: A pilot study

  • IRAS ID

    195892

  • Contact name

    Lynne Macrae

  • Contact email

    fbmhethics@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • Duration of Study in the UK

    0 years, 7 months, 28 days

  • Research summary

    The early stages of drug development focus on gaining knowledge about the suitability of a novel compound and collecting information regarding its pharmacokinetic properties. Therefore, healthy volunteers rather than patients usually receive the new drug in early phase clinical trials in order to evaluate pharmacokinetics and investigate pharmacodynamics without the interference of pre-existing pathological conditions.
    While clinical research participants with existing pathologies are often motivated to participate in research to gain therapeutic benefits and free medical treatment, the motivations of healthy research participants are likely to be quite different.
    Additionally to the motives that urge healthy individuals to participate in research there is also the view that personality characteristics can also play a significant role in their decision. Previous studies have shown that people who exhibit sensation seeking behaviour, disinhibition, impulsivity and extraversion or sociability are more likely to take part in clinical trials as part of a risky behaviour pattern.
    This proposed pilot study will aim to explore and understand how certain personality traits commonly found in healthy volunteers, may contribute to their decision to take part in research. Understanding these could have an effect on some trial designs and could in turn, affect suitability of recruiting certain groups of volunteers to trials. Furthermore, it can potentially improve participant safety through improved reporting and participation in trials.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    16/YH/0092

  • Date of REC Opinion

    2 Mar 2016

  • REC opinion

    Unfavourable Opinion