Belmont principle 1: Respect for Persons

There are two ethical statements related to the principle of respect for persons: 

1) Individuals are treated as autonomous agents

2) Persons with diminished autonomy are given protection.  

From these two statements four additional conditions have developed that are requirements for IRB approval of research: 

1) Voluntary consent to participate in research

2) Informed consent to participate in research

3) Protection of privacy and confidentiality

4) The right to withdraw from research participation without penalty 

Let's unpack all of these ideas, first let's consider the first statement concerning the right to individual autonomy and self-determination. This means that each person has the right to make their own choices and decisions. The second statement states that people with a diminished ability to make decisions must be protected. Whom are they referring to? Children are considered to not have full intellectual development and have a protected legal status in the US, so they must be protected. Similarly, prisoners no longer have the legal right to make many decisions, so they are protected. People who are in situations in which their ability to think clearly has been compromised, are protected. Some examples of this include people in crisis situations, patients, people with reduced mental capacity of dementia or other mental disorder. Also, people who do not have the educational background to understand the implications of being in a research study are considered protected. These protected individuals are often called vulnerable subjects. 

Next time I will continue this discussion by examining how to protect vulnerable subjects and the issue of coercion. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu