Belmont Report
In reviewing a research study, the IRB reviewer assesses the proposed research according to the ethical principles of the Belmont Report as well as the applicable federal regulations. The consideration of the Belmont Report include the following principles:
Respect for Persons
This principle acknowledges the participant's autonomy and the researcher's obligation to respect that autonomy. It also protects participants with diminished autonomy (e.g., children) from possible exploitation.
From this principle of respect for persons comes the informed consent process in which researchers must provide potential participants with information about the study in a manner they can understand and then allow them to choose whether or not they wish to participate.
Beneficence
This principle obligates the researcher to protect participants from harm as well as to maximize the anticipated benefits of the research and minimize possible risks resulting from the research.
To apply the principle of beneficence, researchers and IRB reviewers analyze the risks and benefits to the participants to ensure that the anticipated risks are commensurate with the potential benefits. In every study researchers should minimize the risks as much as possible.
Justice
This principle requires the equitable distribution of both the benefits and the burdens of research.
Implementing the principle of justice requires researchers to avoid selecting participants solely because they are accessible or easy to influence. In addition, it charges researchers not to exclude participants who are likely to benefit from a study.
