1

Discussion Board: The Belmont Report

Name

Institution Affiliation

Course

Date
 2

Discussion Board: The Belmont Report

The Belmont Report

The National Commission for the Protection of Human Subjects of Biomedical and

Behavioral Research released the Belmont Report in 1979. Based on three moral principles—

respect for people, beneficence, and non-maleficence—it offers ethical guidelines for the

conduct of research involving human subjects. Office for Human Research Protections (OHRP),

2022). Section A, "Respect for Persons," emphasizes the significance of obtaining informed

consent from research participants, ensuring that they comprehend the nature of the study and

voluntarily agree to participate, and protecting vulnerable populations like children, prisoners,

and people with cognitive or mental disabilities. According to Section B, "Beneficence,"

researchers should make an effort to do good and prevent harm by making sure that the study's

benefits outweigh its risks and by reducing the risks to research subjects (Office for Human

Research Protections (OHRP), 2022). Office for Human Research Protections (OHRP), 2022).

Section C, "Non-maleficence," emphasizes the significance of minimizing risks to research

participants by taking into account variables like the risks and benefits of the study, the selection

of participants, and the population being studied. To protect the rights and welfare of human

subjects and to make sure that the advantages of the research outweigh the risks, the Belmont

Report provides a framework for ethical analysis.

Part 3 – The Belmont Report: Basic Ethical Principles and their Application

The Belmont Report's practical application is emphasized in the video by giving

examples of how the report's principles have been used in actual research studies (U.S.

Department of Health and Human Services, 2021). The video demonstrates how the report's
 3

guiding principles have been applied to guarantee the moral conduct of research projects

involving human subjects. The video also gives examples of how the Belmont Report's

guidelines have been used to protect the rights and welfare of vulnerable populations, like

children and prisoners, in studies that involved them (U.S. Department of Health and Human

Services, 2021). The Belmont Report's guiding principles must be put into practice to ensure the

moral conduct of any research involving human subjects, as is emphasized in the video.

One of the fundamental tenets of the Belmont Report is discussed in the video as

informed consent. The video emphasizes the value of obtaining informed consent from research

subjects to ensure they know the study's purpose, risks, and potential benefits and voluntarily

agree to participate (U.S. Department of Health and Human Services, 2021). The video explains

that getting participants' informed consent requires using language they can understand, like

plain language and avoiding jargon. According to the video, informed consent must be obtained

voluntarily and free from coercion or undue influence.

How IRBs Protect Human Research Participants

The Common Rule is a set of rules by the U.S. government to safeguard research

subjects. By reviewing and approving research proposals to ensure they meet ethical standards,

the Institutional Review Board (IRB) ensures that research studies adhere to the Common Rule.

An IRB's role is to safeguard the rights and welfare of research participants using human subjects

(U.S. Department of Health and Human Services, 2018). They examine research proposals to

make sure they adhere to ethical standards, such as ensuring participant risks are kept to a

minimum and that consent is given voluntarily. The IRB also monitors ongoing research projects

to ensure they adhere to ethical standards. The IRB plays a crucial part in the informed consent

process by reviewing the informed consent document to make sure it is written in an

understandable style and that it contains all the information participants will need to make an

informed decision about whether or not to participate in the study (U.S. Department of Health

and Human Services, 2018).

IRB approval is optional for all research. IRB approval is not required for research that

does not use human subjects or involves only minor risks to participants. However, IRB approval

is necessary for research involving human subjects with greater than minimal risk. Not every

research project needs informed consent. Informed consent may not be necessary for research

involving low-risk participants and conducted in the public interest, such as observational studies

(U.S. Department of Health and Human Services, 2018). However, informed consent is

necessary for research that involves more than minimal risk to participants and is carried out for

other goals, such as developing novel therapies or treatments. Universities, hospitals, and other

research institutions all have IRBs. They typically consist of a wide range of people, such as

researchers, ethicists, and community members. Since the assignments in this course do not use

human subjects and present no risk to participants, IRB approval is typically unnecessary. IRB

approval is necessary, though, if a student is carrying out research that uses human subjects or

involves greater than minimal risk.

References

Office for Human Research Protections (OHRP). (2022, October 17). The Belmont Report.

HHS.gov. Retrieved January 25, 2023, from https://www.hhs.gov/ohrp/regulations-and-

policy/belmont-report/index.html

YouTube. (2018). How IRBs Protect Human Research Participants. YouTube. Retrieved January

25, 2023, from https://www.youtube.com/watch?v=U8fme1boEbE.

YouTube. (2021). Part 3 – The Belmont Report: Basic Ethical Principles and their Application.

YouTube. Retrieved January 25, 2023, from https://www.youtube.com/watch?

v=M6AKIIhoFn4.