Final answer:
FDA approval, informed consent, and IRB determination of minimal risk are required for Dr. Young's investigation of drug X's effectiveness for ADHD. Funding from a pharmaceutical is not a regulatory requirement, but often necessary.
Step-by-step explanation:
When Dr. Young proposes to investigate the effectiveness of drug X for ADHD, several requirements must be met before the clinical trials can begin. Firstly, FDA approval is essential before conducting the trial. An Investigational New Drug (IND) application must be submitted to the FDA's Center for Drug Evaluation and Research (CDER), and a 30-day waiting period is observed for their review. During clinical trials, the collection and analysis of data on the drug's effectiveness and safety are critical. Secondly, informed consent from all patients is required. Participants must read and sign an informed consent form, which explains the research procedures, risks, and their rights as research subjects, including their right to withdraw at any time without penalty. Thirdly, an Institutional Review Board's (IRB) determination of minimal risk is needed, where the IRB evaluates the potential risks to participants and ensures that they are minimized. Funding from a pharmaceutical company, while often necessary for practical reasons, is not a regulatory requirement for conducting clinical trials.