Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release trial [ISRCTN13204258]

Service users within the NHS are increasingly being asked to participate in clinical research. In Liverpool Women's NHS Foundation Trust, approximately 35% of women take part in research during their pregnancy. For many studies the consent process is simple; information is provided and signed consent is given. There is a difficulty, however, with obtaining informed consent from women in pregnancy who become eligible only when they develop unforeseen complications, especially when they occur acutely. The problem is compounded with women in labour who may be frightened, vulnerable, in pain, under the effect of opiate analgesia, or all of the above. If research to improve the care of these women is to continue, then special consent procedures are needed. These procedures must ensure that the woman's autonomy is protected whilst recognising that women under these circumstances vary enormously, both in their desire for information and their ability to comprehend it. This paper will discuss the obtaining of consent in this situation, and describe an information and consent pathway for intrapartum research which has been developed in collaboration with consumer groups as a way in which these issues can be tackled

How to involve cancer patients at the end of life as co-researchers

The importance of user involvement in the organisation and delivery of health services and the conduct of research has increased over recent decades. Involving people at the end of life in research remains an under-developed area of research activity. The Macmillan Listening Study, a UK-wide study exploring research views and priorities of people affected by cancer, adopted a participatory research approach. Patients and carers, including two participants receiving palliative care services, collaborated in all aspects of the study as co-researchers. In this paper, we discuss the experience of working with co-researchers to collect data from two hospices. We will discuss practical, ethical and methodological challenges, including specific training needs and the emotional demands of conducting the research. Recommendations are made to facilitate successful collaboration with palliative care service users in end of life research

Nurses' knowledge of pharmacology behind drugs they commonly administer

Aim. To determine if nurses had adequate pharmacology knowledge of the drugs they commonly administer. Background. Literature suggests that nurses have insufficient pharmacology knowledge. We also know that nurses and teachers of pharmacology are not satisfied with the amount of pharmacology taught in preregistration programmes in the UK. There is a lack of primary research on nurses' knowledge of pharmacology for the purpose of drug administration. Design. We used a non-experimental causal comparative and correlational design. Methods. We recruited a convenience sample of 42 nurses working in surgical wards of a foundation hospital in the North of England. Data were collected by structured interview and questionnaire methods. During the interview, the participants made a blinded selection of one out of four drugs they commonly administer and answered standard questions which focused on specific pharmacology knowledge. Their answers were given a score out of 10 (100%) to determine their actual pharmacology knowledge. Results. The sample comprised of 18 (42.9%) junior nurses and 24 (57.1%) senior nurses. They had a median experience of 10.87 years postregistration. Their mean knowledge score was six ranging between two and nine (SD 1.9). Only 11 (26.1%) nurses scored eight or above and the majority 24 (57.2%) scored below seven, indicating inadequate knowledge. Knowledge of the mechanism of action and drug interactions was poor. There was a correlation between knowledge and experience. Conclusions. The results of this study suggest that nurses have inadequate knowledge of pharmacology. The results will contribute to the evidence of nurses' knowledge of pharmacology in the UK. Relevance to clinical practice. This study supports the need for supplementary pharmacology education for nurses in clinical settings, focusing on common drugs they administer. This will increase nurses' knowledge and confidence in drug administration and safer medicines management. © 2008 The Authors

Ethical issues in social research involving people with dementia

Involving people with dementia in research raises many ethical and practical issues for people with dementia, carers and family members, researchers and care professionals. Internationally, the legal, governance and ethical framework for such research is rapidly changing, and there is considerable debate about how these changes will affect social research that needs to involve people with advancing dementia. This article is based on challenges that the authors faced when trying to develop a follow-up research proposal that would have involved people with advancing dementia, and consequential loss of capacity, in social research. It explores a range of issues and concerns, including accessing data to identify potential participants, assessing mental capacity, obtaining consent and the role of gatekeepers. These issues are discussed in the context of emerging governance in social care research and current and new legislation in the UK, the rest of Europe and beyond. The existing processes of ethical review are outlined and the implications for research of the new Mental Capacity Act, recently implemented in England and Wales, are considered. The difficult balance between protecting vulnerable individuals, recognizing the importance and benefits to society of research and maintaining an individual's right to take part in research is discussed. The article concludes with recommendations for researchers planning to undertake projects that may include people with reduced capacity as participants. © 2007 Sage Publications