b) What monitoring should be undertaken to ensure that participants are complying with the study protocol? c) What should be done if participants withdraw from the study? The company should ensur

To ensure that all participants provide valid consent, the company must follow a set of ethical guidelines and legal requirements, taking into account the age of the intended participants (14-20 years old). Here is a detailed strategy to address this: 1. Parental or Guardian Consent: Since the intended participants include individuals aged 14-17, who are considered minors, obtaining informed consent from a parent or legal guardian is necessary. Provide detailed information of the study, benefits, risks, and the rights of the participants, as well as alternative treatments if available. This information should be presented in a comprehensive and comprehensible manner and documented using a consent form signed by the parent/guardian. 2. Assent from Minors: Obtain assent from minor-aged participants (14-17 years old) in addition to parental or guardian consent. Assent means the process of involving minors in the decision-making process by ensuring that they understand the information shared and agree to participate in the study. Assent should be documented through age-appropriate forms. 3. Informed Consent from Participants Aged 18-20: For participants who are at least 18 years old, obtain informed consent directly from them. Provide complete information about the study, risks, benefits, and participant rights, using language that is easily understood. Give enough time for them to read and ask questions before signing a consent form. a) To ensure compliance with the Declaration of Helsinki, the company should use an appropriate control in the study: Placebo-Controlled: Use a placebo group, wherein the control group would receive a placebo that resembles the new drug but does not contain the active ingredients. This choice is suitable when no standard treatment already exists for the targeted asthma sufferers. Ensure all participants are fully informed about the possibility of receiving a placebo and there is no risk of them being denied essential treatment. Active-Controlled: If an established standard therapy for asthma sufferers exists, the company should use active control, administering the standard treatment to the control group. The study would then compare the efficacy and safety of the new product with the existing standard treatment. Regardless of the control being used, the study should be designed with safeguards ensuring that all participants in the trial receive proper care, and their rights and well-being are a priority. To minimize any susceptibility to bias, the study should also consider employing methods like randomization and blinding (keeping participants and researchers unaware of who is receiving the experimental treatment or control). Lastly, ensure that an independent ethics committee or institutional review board has reviewed and approved the study design and recruitment process, confirming that they meet ethical guidelines and protect the rights, well-being, and privacy of the participants.