STAT 110 1nd Edition Lecture 5 Outline of Previous Lecture I. Experiments In the Real World a. GoalsII. 3 Experiments to Meet Our Goalsa. Completely Randomized Experimental Designb. Block Designc. Matched Pairs Design Outline of Current LectureI. Ethicsa. Federal Guidelines to Protect Human Subjects b. Research Involving Human Subjectsc. Violations of Ethical Guidelines II. Clinical Trialsa. Phases Current LectureI. Ethicsa. Federal laws require that research involving human subjects must have an Institutional Review Board: an IRB reviews the plans of a study in order to protect the participants from harm. An IRB must:i. Have at least 5 members: one scientist, one non-scientist, and at least one person who is unaffiliated with the organization proposing the research b. In the research study involves human subjects:i. Written informed consent must be obtained ii. Subjects’ data must be kept confidential and anonymous c. Violations of Ethical Guidelinesi. The Tuskegee Syphilis Study is an infamous study involving the mistreatment of human participants. The blatant disregard for the subjects’ wellbeing led to many of the ethical guidelines we have today.II. Clinical Trials a. A clinical trial is an experiment that studies the effectiveness of medical treatments on patients. Medical treatments can be tested in clinical trials only if These notes represent a detailed interpretation of the professor’s lecture. GradeBuddy is best used as a supplement to your own notes, not as a substitute.there is reason to believe that they will be helping the patients receiving the treatment. i. The phases of a clinical trial are as follows:1. Phase I: researchers test the treatments on a small group of people to evaluate its safety, determine a safe dosage range, and identify side effects2. Phase II: researchers test the treatments on a larger group of people to confirm its effectiveness and continue to evaluate its safety3. Phase III: the treatment is given to large groups of people to confirm its effectiveness, look for side effects, and compare it to commonly used treatments. In Phase III, the treatment becomes available on the market 4. Phase IV: researchers study the drug after it goes on the market tofurther identify risks and