Chapter 18: Research Governance in Clinical Research: Addressing Ethical Issues
Quizzes give you the chance to test your knowledge through multiple choice questions, short answers, matching activities and other revision tools.
Consider the following scenarios, if possible discuss them with colleagues or fellow students and consider the associated question;
1. Mia, a registered nurse is conducting interviews with teenagers about their experiences of having insulin dependent diabetes. Where appropriate the parents have given consent and the teenagers their assent. It has been agreed that the parents will not be present during the interviews. During an interview with Amy, who is 15, Amy discloses to Mia that she thinks she is pregnant. Amy asks Mia not to tell anyone. What should Mia do?
2. A large-scale national longitudinal survey is being undertaken involving adult males about work-life balance. Data are collected every six months by postal questionnaire. The research team have assured participants that their data will be anonymized and confidentiality will be maintained. One section of the questionnaires involves questions that measure psychological wellbeing. It is noted that the responses of one participant have changed dramatically in comparison to 6 months ago. The most recent responses indicate that he is now feeling suicidal. What should the research team do?
3. Claude is 5 days old and is being cared for in a neonatal intensive care unit. Claude’s mother has severe pre-eclampsia and is being cared for in the high dependency unit of another hospital. The neonatal team would like to enrol Claude in a randomised controlled trial. Claude’s father is visiting the neonatal unit this afternoon. Can Claude’s father consent to his son’s participation in the trial?
4. Mary has Alzheimer’s disease and is attending an out-patient’s appointment with her daughter Eve. The consultant tells Eve about a new drug trial and Eve would like her mother to take part in the study. Can Eve consent to Mary’s participation in the study?
5. Zak is eight years old and has cystic fibrosis. Zak’s parents have been approached about a research study. Zak’s father feels he has already been bombarded with treatments and that they should decline. Zak’s mother however, is very keen that he be enrolled in the study, she is desperate to try any treatment. How should the clinicians proceed?
6. Marim has been involved in a road traffic accident and is being cared for in the emergency department. He is conscious, but is distressed and agitated. The health care team are struggling to manage Marim’s level of pain. He requires urgent surgery and will then be cared for in the intensive care unit. Before being transferred to the operating theatre, it is noted that Marim meets the criteria for a randomised controlled trial. The clinician’s would like to enrol Marim in a study which will determine the type of surgery undertaken. Participation in the study has the potential to dramatically improve Marim’s survival and recovery. How should the clinicians proceed?
7. Eliana is thirteen years old and has leukaemia. Her parents have consented to Eliana’s involvement in a study. However, Eliana has made it very clear that she does not want to take part in the study and has said she will refuse to take the required medication. How should the clinicians proceed?
8. Wendy is fifteen years old and her son is three days old. The clinician’s would like to enrol Wendy’s son in a research study. How should the clinicians proceed with regard to obtaining consent for the study?