The Belmont Report is a document created by the National Commission for the Protection of

Human Subjects of Biomedical and Behavioral Research in 1979. It provides an overview of the
ethical principles that should be followed in research involving human subjects. The report is
divided into three sections: A, B, and C. A speaks about boundaries between practice and
research and provides regulations for determining when an activity is considered research and
when it is considered practice. B is on basic ethical principles. This section outlines three basic
principles, which are respect for persons, beneficence, and justice. Lastly, C is on applications
and outlines the various ways through which sections A and B can be applied in practice. The
Belmont Report sets out ethical guidelines for research involving human subjects to safeguard
the rights and well-being of those participating in research (Office for Human Research
Protections (OHRP), 2022).

The report states that informed consent is a process that involves three elements: information,
comprehension, and voluntariness. It is meant to protect research participants by giving them the
opportunity to choose what happens to them during the research. Vulnerable populations in
research include those who may not be able to fully understand or provide informed consent,
such as children or individuals with cognitive impairments or even the incarcerated and those in
institutions. The report also states that risks and benefits should be carefully looked at and that
the benefits of the research should be more than any risks the participants shall face. Factors
involved in the selection of participants include ensuring that the research will not
disproportionately affect certain groups and that the participants are able to give informed
consent (Office for Human Research Protections (OHRP), 2022).

The video emphasizes the application of the Belmont Report by starting off with the history that
led to its formation. It also mirrors the report by providing the key principles mentioned in part
B, which are respect, beneficence, and justice. The video further helps me understand the
Belmont report by expounding on the ethical considerations of research using human subjects by
using the three principles as a foundation from which everything stems. For example, when
discussing justice, the video shows how the poor can be vulnerable to unjust research, as was
seen in the 19th and early 20th century when poor patients often served as research subjects in
comparison to the richer ones (U.S. Department of Health and Human Services, 2021).

The Common Rule is a set of federal regulations that safeguard individuals participating in
research that is funded by the government. These regulations issue that a committee, known as
an institutional review board (IRB), evaluate and approve a study prior to allowing individuals to
take part in the research. The IRB's purpose is to review research studies and ensure they comply
with ethical standards and regulations for research involving human subjects. In the informed
consent process, the IRB verifies that potential participants have the necessary information to
make a decision about volunteering for the study, that they can comprehend the study, and that
they have the freedom to choose whether or not to participate. Not all research necessitates IRB
approval, only research that involves human subjects. Not all research studies necessitate
informed consent; low-risk studies do not require it. IRBs can be found at institutions that
conduct research, and they are made up of at least five members with diverse backgrounds who
can provide different perspectives on the research. In this class, we will not need IRB approval as
we are not using human subjects, and the work our assignments are not under FDA regulations
(U.S. Department of Health and Human Services, 2018).