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多选题 What are the ethical requirements in clinical research
学科：Bioethics 《生物伦理学》全英教学专业基础课
时间：2024-11-03 08:13:24
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题目1多选题
Types of clinical research includeA. Epidemiology, which improves the understanding of a disease by studying patterns, causes, and effects of health and disease in specific groupsB. Behavioral, which improves the understanding of human behavior and how it relates to health and diseaseC. 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 careD. Clinical trials, which evaluate the effects of an intervention on health outcomes
题目2多选题
Based on the nature and purpose of the study, clinical research includes the following typesA. 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 changesB. 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 conditionC. 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 healthD. 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
题目3多选题
The 4 phases of clinical trials areA. 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 effectsB. 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 safetyC. 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 safelyD. 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
题目4多选题
A typical clinical trial protocol includeA. the goal of the study, the benefits of the study & who is eligible to take part in the trial & who is notB. protections against risks to participantsC. details about tests, procedures, and treatmentsD. how long the trial is expected to last & what information will be gathered
题目5多选题
What are the ethical requirements for informed consentA. 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 requirementsB. Respect for autonomy — an individual's capacity & right to define his/her own goals & make choices consistent with those goalsC. "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…1982D. 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
题目6多选题
What rights do human subjects have according to the National Institute of Justice in the United StatesA. voluntary, informed consent, respect for persons: treated as autonomous agentsB. right to end participation in research at any time, right to safeguard integrityC. benefits should outweigh cost, protection from physical, mental and emotional harmD. access to information regarding research, protection of privacy and well-being
题目7多选题
Which of the following statements about the goals of clinical research are correctA. The goal of clinical research is to generate useful knowledge about human health & diseaseB. Clinical research results in compelling societal health benefits – development of therapies, diagnostic & preventive strategies, improvement in quality of life, & understanding of health & diseaseC. Clinical research provides evidence which clinicians use to know how to safely & effectively treat, prevent, or diagnose diseases or promote healthD. 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
题目8多选题
What are the ethical requirements in clinical researchA. Promote the responsible conduct of useful clinical research & progress in understanding & intervening in human health & illnessB. Minimize the possibility of exploitation & harmC. Ensure that the rights & welfare of subjects are respected while they contribute to the generation of knowledgeD. Help to maintain public trust
题目9多选题
What challenges does informed consent hasA. stored data and biospecimensB. pragmatic trials, learning health care systemsC. digital dataD. What kind of consent is appropriate? – What and how should information be disclosed? – What level of understanding? – Voluntary choice
题目10多选题
What features do easy-to-read informed consent documents haveA. familiar, consistent words, Active voice and personal pronouns; short, simple, and direct sentences with limited line lengthB. short paragraphs, one idea per paragraph, clear and logically sequenced ideasC. important points highlighted, avoiding acronyms and abbreviationsD. 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
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