DACoRe Study (Protocol version 1.0 dated 22nd May 2013)
Research type
Research Study
Full title
Development and validation of a Direct observation of procedural skill DOPS tool for Assessing informed Consent to Research for Nurses and allied healthcare professionals - DACoRe - a feasability study.
IRAS ID
133164
Contact name
Carly Brown
Contact email
Sponsor organisation
South Tyneside NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Informed consent is central to ethical research and must be obtained through delivering correct information and establishing full participant understanding and consent by the lead researcher or an appropriately qualified and trained member of the research team.
Evidence suggests that deficiencies still exist in participant comprehension of the research in which they participate, which indicates that further developments need to be made to improve this process.
The experience level of the researcher has been noted as having an association with good quality informed consent and guidance indicates that the competence of the researcher is key to ensuring that potential participants understand the information delivered during consent.
Good Clinical Practice training is recommended to staff which gives an overview of the research processes including informed consent, and also separate informed consent training sessions are now offered to interested researchers.
However, there are no validated formal assessments to measure competence following attendance at these training sessions and furthermore the competence of researchers in obtaining informed consent to research is not formally assessed.
It is well known in clinical practice that attendance to training does not always marry up with evidence in practice, and many areas of clinical practice have moved towards competency assessments to bridge the theory-practice gap including the area of gastrointestinal endoscopy, where a direct observation of procedural skill DOPS method has been evidenced as being successful in assessing staff competence.
This feasibility study has been developed to explore the direct observation of procedural skill DOPS approach to supporting nursing/ allied healthcare professionals competence in obtaining informed consent to research in order to strengthen the quality of the informed consent to research process.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
14/SW/1168
Date of REC Opinion
28 Nov 2014
REC opinion
Favourable Opinion