[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fR6RnmP5synhXaFW-xKJc_eD17vxsVRf5-11jvFSpQjA":3},{"answer":4,"createTime":5,"id":6,"options":7,"origin":12,"question":19,"related":20,"source":30,"type":31},[],"2024-11-03 16:13:24",164300467,[8,9,10,11],"familiar, consistent words, Active voice and personal pronouns; short, simple, and direct sentences with limited line length","short paragraphs, one idea per paragraph, clear and logically sequenced ideas","important points highlighted, avoiding acronyms and abbreviations","good format: proper titles, subtitles, simple headers; balanced white space with words and graphics; proper font, style, & spacing; proper underline, bold, or boxes (rather than all caps or italics) give emphasis",{"count":13,"courseId":14,"courseImg":15,"courseName":16,"workId":17,"workName":18},71,"39a95ba37da4430c0f3ab7b73a42ef00","https:\u002F\u002Ftihai-oss-cloud.itihey.com\u002Fimg\u002F4f3e2df6db3b7274b1d83b01ca860cc8.jpg","Bioethics 《生物伦理学》全英教学专业基础课","8f63c7ffa478444190642538e6ad62d1","Test 11","What features do easy-to-read informed consent documents have",[21,32,41,50,59,68,77,86,95,104],{"answer":22,"createTime":5,"id":23,"options":24,"question":29,"source":30,"type":31},[],164300458,[25,26,27,28],"Epidemiology, which improves the understanding of a disease by studying patterns, causes, and effects of health and disease in specific groups","Behavioral, which improves the understanding of human behavior and how it relates to health and disease","Health services, which looks at how people access health care providers and health care services, how much care costs, and what happens to patients as a result of this care","Clinical trials, which evaluate the effects of an intervention on health outcomes","Types of clinical research include","v1",1,{"answer":33,"createTime":5,"id":34,"options":35,"question":40,"source":30,"type":31},[],164300459,[36,37,38,39],"Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Approaches may include medicines, vaccines, or lifestyle changes","Screening trials test new ways for detecting diseases or health conditions. Diagnostic trials study or compare tests or procedures for diagnosing a particular disease or condition","Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. Behavioral trials evaluate or compare ways to promote behavioral changes designed to improve health","Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with conditions or illnesses","Based on the nature and purpose of the study, clinical research includes the following types",{"answer":42,"createTime":5,"id":43,"options":44,"question":49,"source":30,"type":31},[],164300460,[45,46,47,48],"Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects","Phase II trials: The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety","Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely","Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment benefits, and optimal use","The 4 phases of clinical trials are",{"answer":51,"createTime":5,"id":52,"options":53,"question":58,"source":30,"type":31},[],164300461,[54,55,56,57],"the goal of the study, the benefits of the study & who is eligible to take part in the trial & who is not","protections against risks to participants","details about tests, procedures, and treatments","how long the trial is expected to last & what information will be gathered","A typical clinical trial protocol include",{"answer":60,"createTime":5,"id":61,"options":62,"question":67,"source":30,"type":31},[],164300462,[63,64,65,66],"Codes of research ethics, regulations, and laws (limited exceptions) require informed consent from the research participant or her legally authorized representative (and documentation): ICH-GCP, Declaration of Helsinki, US Federal Regulations (Common Rule (45CFR46) and FDA (21CFR50)), & National, state, institutional requirements","Respect for autonomy — an individual's capacity & right to define his\u002Fher own goals & make choices consistent with those goals",""Informed consent is rooted in the fundamental recognition…that adults are entitled to accept or reject health care interventions on the basis of their own personal values and in furtherance of their own personal goals" Presidents Commission for the study of ethical problems…1982","Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided…[when] informed consent are satisfied — The Belmont Report","What are the ethical requirements for informed consent",{"answer":69,"createTime":5,"id":70,"options":71,"question":76,"source":30,"type":31},[],164300463,[72,73,74,75],"voluntary, informed consent, respect for persons: treated as autonomous agents","right to end participation in research at any time, right to safeguard integrity","benefits should outweigh cost, protection from physical, mental and emotional harm","access to information regarding research, protection of privacy and well-being","What rights do human subjects have according to the National Institute of Justice in the United States",{"answer":78,"createTime":5,"id":79,"options":80,"question":85,"source":30,"type":31},[],164300464,[81,82,83,84],"The goal of clinical research is to generate useful knowledge about human health & disease","Clinical research results in compelling societal health benefits – development of therapies, diagnostic & preventive strategies, improvement in quality of life, & understanding of health & disease","Clinical research provides evidence which clinicians use to know how to safely & effectively treat, prevent, or diagnose diseases or promote health","A small number of participants are asked to participate in the research; benefit to participants is not the purpose (although it does occur); participants are the means to developing useful knowledge; & are thus at risk of exploitation","Which of the following statements about the goals of clinical research are correct",{"answer":87,"createTime":5,"id":88,"options":89,"question":94,"source":30,"type":31},[],164300465,[90,91,92,93],"Promote the responsible conduct of useful clinical research & progress in understanding & intervening in human health & illness","Minimize the possibility of exploitation & harm","Ensure that the rights & welfare of subjects are respected while they contribute to the generation of knowledge","Help to maintain public trust","What are the ethical requirements in clinical research",{"answer":96,"createTime":5,"id":97,"options":98,"question":103,"source":30,"type":31},[],164300466,[99,100,101,102],"stored data and biospecimens","pragmatic trials, learning health care systems","digital data","What kind of consent is appropriate? – What and how should information be disclosed? – What level of understanding? – Voluntary choice","What challenges does informed consent has",{"answer":105,"createTime":5,"id":6,"options":106,"question":19,"source":30,"type":31},[],[8,9,10,11]]