Several ethical issues arise when designing and implementing a research study in human subjects, which include (1) safety, (2) voluntary participation, (3) confidentiality, and (4) adverse events. First and foremost is the safety of the research participant. For any study, the potential benefits must outweigh the risks, and continual monitoring of the safety of the project should occur throughout the duration of the study. Willingness to participate in the study is another ethical issue. Individuals must provide written, and in some cases, oral consent after appropriate discussion of risks and benefits, and the opportunity to review questions and concerns. Confidentiality and patient privacy should always be addressed. Protection of patient information must be considered and outlined. The tracking and management of adverse events should be clearly planned, as well as compensation related to the event [7].

The ethical standards that govern research in human subjects are based on the principles of autonomy, beneficence, and justice. The concept of autonomy is based on respect for individuals. Each subject must be treated as an individual who is capable of making an informed decision. The researcher must ensure that the participant has had full disclosure of all the risks and benefits of the study, the nature of the study, the duration of the study, as well as alternatives. Researchers must be truthful. Included in this concept is that individuals with decreased autonomy are entitled to special protection. Examples include children, neonates, prisoners, and additional regulations have been implemented to offer additional protection to these individuals. The informed consent is the best application of this principle. Subjects enrolled in research studies must be informed of the risks and benefits and must consent to treatment.

Beneficence is based on the concept of not providing harm to individuals. The intent of the study should be to maximize the possible benefits for the participant, and minimize the possible harm or risk from the research. The third principle, justice, ensures that the benefits and burdens of the study are distributed evenly and fairly, so that no group of individuals is exploited [1, 2, 5, 8].

The informed consent is a vital part of any research study involving human subjects (Table 7.2). As previously mentioned, the informed consent is based on the principle of autonomy, or recognizing that each individual has the capacity to make an informed decision. The informed consent must have certain components to render it ethical and valid.