b) What should the company do if it becomes aware of a participant who is not eligible to participate in the study? c) What should the company do if it becomes aware of serious adverse events in p

To ensure that all participants provide valid consent in the phase II clinical trial, the company should follow these steps: 1. Develop a comprehensive consent form: Create an informed consent form that outlines the purpose, risks, benefits, and procedures of the study. It should include information about the trial design, the experimental drug and nebulizer, potential side effects, and the rights and responsibilities of the participants. 2. Ensure comprehension: The consent form should be written in a language and style that is easily understandable to the target population, i.e., 14-to-20-year-olds with asthma. Use simple language and avoid technical jargon. 3. Obtain consent from legal guardians: As some of the participants will be minors, the company must also obtain consent from their legal guardians, in addition to the consent forms signed by the participants themselves. 4. Hold an informational session: Organize an informational session to discuss the trial with potential participants and their legal guardians. This will enable them to ask questions or raise concerns and help them make an informed decision about participating in the trial. 5. Verify voluntary participation: Ensure that the consent given by participants and their legal guardians is voluntary and free from coercion, manipulation, or undue influence. 6. Document consent: Document the process of obtaining informed consent for each participant, including the signed consent forms, copies of the information provided, and notes from the informational session. a) To comply with the Declaration of Helsinki, the company should use a proper control in the study. For a phase II clinical trial of a novel asthma inhaler, the company should preferably use a standard-of-care control. This means that the participants in the control group will receive the current standard treatment for asthma rather than a placebo. Using a standard-of-care control ensures that all participants receive effective treatment for their asthma, as required by the ethical principles of the Declaration of Helsinki. It also allows the researchers to compare the efficacy and safety of the new intervention with existing treatments in a scientifically valid manner. Make sure to randomly assign participants to the experimental and control groups to avoid selection bias and maintain the integrity of the study.