A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge constitutes research. When this research involves living individuals about whom an investigator obtains data through intervention or interaction, or identifiable private information, specific ethical and regulatory considerations come into play. For instance, a study analyzing the effectiveness of a new therapeutic drug on a group of patients, or a survey collecting sensitive personal data from individuals regarding their health habits, falls under this category.
Adherence to established ethical principles and federal regulations protects the rights, welfare, and well-being of individuals participating in these investigations. This safeguarding not only upholds the integrity of the research process but also fosters trust between researchers and the public. Historically, incidents of unethical research practices have underscored the necessity for robust oversight and the establishment of clear guidelines to prevent harm and ensure respect for autonomy.