【正文】 confidentiality issues 2 What can be used to show that patient consent and safety have been considered in the application? The inclusion of relevant patient information sheets, consent forms, current health status checklist and checklist for preclinical testing. All of these are listed under Patient consent and safety on the web page. 3 What can help to show the benefits of the research when making an application? These could include the clinical justification for proposed trial, the implications of the oute for the target patient group, the societal benefits, the broader economic justifications and the statement of conflict of interest. Extending skills D Study the phrases in box c. 1 What purpose would you use these phrases for in a seminar? 2 Which phrases can you use for linking your new point to a contribution by another speaker? Extending skills D Study the phrases in box c. I’d like to start by explaining … To carry on from this point, I want secondly to look at … I don’t think that is the main reason. That seems like a very good point X is making. On the other hand, you might want to say that … So to sum up, we can say that … Does anybody have any opinions or anything they would like to add? I think we need a different viewpoint. OK, to continue then, … = beginning = maintaining/continuing a point = disagreeing = confirming = summarizing/concluding = disagreeing = concluding = disagreeing = maintaining/continuing a point Extending skills D Study the phrases in box c. I’m going to expand the topic by mentioning … As well as this issue, we can also look at a very different issue. Following on from what X has said, … = adding a new point to someone else’s previous contribution Extending skills They have been asked to discuss ethical issues in relation to treatment and research. While you listen, make a note of。 patient safety。data sets target 39。patient identifiable information 39。governance 3 Adjective + noun (second word has stronger stress): biomedical research, informed consent, legal regulation, moral rights. Extending skills B Look at the topics below. ? regulatory aspects of biomedical research ? examples of the failure of biomedical research ethics 1 What would you like to know about these topics? 2 Prepare a page in your notebook to make some notes. 3 Listen to the final part of the lecture (Part 3) and make notes. If there is information which you miss, leave a space. 4 Compare your notes with someone else. Fill in any blank spaces. Openended. Extending skills C Answer the questions on the Hadford University handout, using your notes. Extending skills C Answer the questions on the Hadford University handout, using your notes. 1 What is research governance? The work of ensuring that research protocols which set out how the study is to be undertaken meet the necessary ethical standards. 2 Why is the storage of research data particularly important for patients? In order to ensure the privacy of participants is not promised. 3 What does the lecturer say is happening because of increased regulation of drug testing? Increasingly, drug panies are conducting their tests outside the developed world, for example in Africa and Asia, where research regulatory regimes are less strict. 4 What does the lecturer think the Tuskegee Study is a good example of? What can happen without a clearly defined system of regulation for biomedical research. Extending skills C Answer the questions on the Hadford University handout, using your notes. 5 Why is the study still causing debate? It is not clear whether it is having an effect on the numbers of minorities recruited for clinical trials. 6 What is your research task? To do some research to identify examples of situations where doctors make decisions with patients, in either a treatment or research context, where there is a conflict between two or more of the main ethical principles in medicine. They will need to look at specific cases to substantiate their arguments. If possible, they should consider whether it is possible to resolve the conflicting principles in the examples they identify. Extending skills D Study the stages of building an argument (a–f) in box b. 1 Put the stages in an appropriate order. 2 Match each stage (a–f) with a phrase from box c. E Look at box b again. 1 Listen to a section from the lecture. Make notes on what the lecturer says for each stage of the argument (a–f). 2 Check your answers to Exercises D and E1. Extending skills D Study the stages of building an argument (a–f) in box b. E Look at box b again. Type of statement Phrase Lecturer’s words c stating the issue a giving a counter argument e rejecting a counter argument b giving your opinion f giving a reason for your opinion g supporting the reason with evidence The question is … Some people claim … I’m afraid that just isn’t true. It’s quite clear that … The research has concluded that The evidence lies in the fact that The question is then: is this legal regulation justified? There are those who claim that imposing this regulation on research simply increases the time needed to bring drugs onto the market… I’m afraid that just isn’t true. It’s quite clear that without this protection, more people … The research has concluded that regulatory regimes do much to protect patients from unsafe and ineffective drugs … The evidence lies in the fact that in 2020 in the UK, the lives of six volunteers in a clinical trial … Extending skills F Use your notes to write 75–100 words about the main points in the final part of the lecture. G In groups, discuss the research task set by the lecturer. Talk about these questions: 1 What are the two contexts you need to consi