2 - On arrival, the patients have been greeted by the research nurse, John, who sees them one by one. Dr France has not arrived at the clinic and the nurse doesn’t want to overrun the time allotted. John has been trained by Dr France to review the trial with the patients using the approved patient information leaflet. However, Dr France has decided that he must discuss the trial with the patient before the ICF is signed. The first patient is a 22 year old woman who has a long history of migraine headaches. Can John start the consent procedure? Can John take the patient’s vital signs? Can John collect for laboratory analysis? 3 - Dr Scotland is the clinical director of a phase 1 unit in London. The unit regularly conducts clinical trials in healthy elderly volunteers. The aim of the trials is to determine drug levels post-dosing with new drug. The clinic advertises widely for new volunteers to take part in the trial. The adverts have been approved by the Ethics Committee and the clinic is licensed to carry out phase 1 work. The following three potential participants have responded should each one be permitted to take – part in the trial? An 82 year old man in good health? A 67 year old woman with mild dementia? 70 year old man with severe dementia? 4 - Dr Holland has agreed to conduct a trial on children with Type 1 Diabetes. The protocol allows for patients between the ages of 6 and 16 to enter the trial. The first patient that is scheduled to enter the trial is a 15 year old girl, the second a 6 year old girl. Can the same ICF be used for both patients? Can the parents of the 6 year old review and sign the ICF on the child’s behalf? As her representative has taken this responsibility, does the 6 year old need to be involved in the consent process? Can the 15 year old can review and sign an ICF designed for parents/guardians of younger children? If the 15 year old has signed and reviewed an adult form, do her parents/guardians still need to grant consent on her behalf? Answers…
2 - On arrival, the patients have been greeted by the research nurse, John, who sees them one by one. Dr France has not arrived at the clinic and the nurse doesn’t want to overrun the time allotted. John has been trained by Dr France to review the trial with the patients using the approved patient information leaflet. However, Dr France has decided that he must discuss the trial with the patient before the ICF is signed. The first patient is a 22 year old woman who has a long history of migraine headaches. Can John start the consent procedure? Can John take the patient’s vital signs? Can John collect for laboratory analysis? 3 - Dr Scotland is the clinical director of a phase 1 unit in London. The unit regularly conducts clinical trials in healthy elderly volunteers. The aim of the trials is to determine drug levels post-dosing with new drug. The clinic advertises widely for new volunteers to take part in the trial. The adverts have been approved by the Ethics Committee and the clinic is licensed to carry out phase 1 work. The following three potential participants have responded – should each one be permitted to take part in the trial? An 82 year old man in good health? A 67 year old woman with mild dementia? 70 year old man with severe dementia? 4 - Dr Holland has agreed to conduct a trial on children with Type 1 Diabetes. The protocol allows for patients between the ages of 6 and 16 to enter the trial. The first patient that is scheduled to enter the trial is a 15 year old girl, the second a 6 year old girl. Can the same ICF be used for both patients? Can the parents of the 6 year old review and sign the ICF on the child’s behalf? As her representative has taken this responsibility, does the 6 year old need to be involved in the consent process? Can the 15 year old can review and sign an ICF designed for parents/guardians of younger children? If the 15 year old has signed and reviewed an adult form, do her parents/guardians still need to grant consent on her behalf? Answers…
Informed%20Consent%20and%20clinical%20trials.docx