BIO 550 Week 8 Discussion Questions

he National Research Act of 1974¹ created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.² The act charged the commission with identifying the “basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects” and with developing associated guidelines for the ethical conduct of research.³ The resulting Belmont Report, issued in 1978, drew a sharp distinction between research, defined as “an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge,” and practice, or “interventions…designed solely to enhance the wellbeing of an individual patient or client.”⁴ In addition, and most important, the report articulated three basic principles that provide the ethical foundation for the conduct of research involving human subjects.

Respect for persons involves two ethical considerations: (1) individuals are and should be treated as autonomous agents and (2) individuals with diminished autonomy, due to youth, illness, mental disability, or restricted liberty (e.g., prisoners) should receive additional protections. The principle of respect for persons means recognizing the authority of an individual’s preferences and choices about his or her life. In the context of research, the principle of respect for persons is expressed primarily in the use of informed consent, which requires that, as a general rule, individuals be afforded the opportunity to choose whether or not to be involved in research. It is incumbent upon investigators to disclose information about a study in language that is comprehensible to potential subjects so that they can provide meaningful and voluntary informed consent. These disclosures typically include the purpose of the research, the research procedures, risks, anticipated benefits (if any) to the subject, the opportunity to ask questions and receive satisfactory responses, and a statement that participation is voluntary and that the subject has the right to withdraw from the study at any time, for any reason.

Beneficence involves two considerations: (1) the maximization of possible benefits for society and subjects; and (2) the minimization of possible harm to subjects. The principle of beneficence presents obligations that are woven throughout the research enterprise. Investigators, institutions, and sponsors must always endeavor to design and conduct research studies so that these obligations are met. Defining the optimum balance between the obligation to maximize benefit and minimize harm is often challenging. Notably, although the principle of beneficence refers to maximizing benefits for society, the Belmont Report does not expand upon this requirement.

Justice is articulated in the Belmont Report as “fairness in distribution” of research benefits and burdens.⁵ Questions of justice and equal treatment in the research context are critical in the selection of subjects. The application of justice means that investigators must not offer potentially beneficial research only to some groups, nor select only some accessible, vulnerable, or disadvantaged groups for research that involves high risk or little prospect of direct benefit.

Click here to ORDER an A++ paper from our Verified MASTERS and DOCTORATE WRITERS: BIO 550 Week 8 Discussion Questions