Assignment 2, Belmont Report

1) What were some of the events the caused the Belmont Report to be Written?

The development of rules governing ethical human research manifested as a result of the atrocious human biomedical research committed at concentration camps during the Second World War. These ethical standards became the Nuremberg Code, which were applied to Physicians and Scientists who conducted such research on concentration camp prisoners to determine their guilt or innocence in how they followed or violated these standards.

Over the next 30 years, complex situations arose that caused different rules to conflict. Additionally General rules were often difficult to apply in several particular situations, and were left open to interpretation. To address this, the National Research Act of 1974 was signed into law, which led to the creation of the National Commission for the Protection for Human Subjects of Biomedical and Behavioral Research.

The Belmont Report is the product of this Commission's work, which provides general outlines for Basic Ethical Principals and for the means to apply them in research.


2) What are the "Basic Ethical Principles" cited in the Belmont Report?

There are three basic ethical principals cited:
1. Respect for Persons
2. Benificence
3. Justice

Respect for Persons ensures that the person is informed about the potential risks of such research and is competent to understand what those risks entail. Children or elderly people with failing mental faculties would not be ethical candidates to select. Additionally, prisoners or other people in compromised positions could also pose ethical dilemmas.

Benificence encompases two interrelated ideas:
a) do no harm
b)maximize possible benefits and minimize potential harm

One example of research which exemplifies do no harm includes when placing Flouride in drinking water for the experimential group of children while doing nothing for the control group. This research yielded far fewer cavities for the experimental group. One counterexample of research the maximized potential harm was conducted during the 1930's at Tuskegee; this entailed African-American men who were left untreated with Syphillis and died as a result. The purpose of the research was to document the different stages of the disease. Although, potential negative outcomes of research may not be forseen, in the instance they emerge, consideration for further experimentation should be considered.

Justice considers questions as to what people or groups of people may benefit from research versus which should be burdened by it. Some accepted considerations include that all be treated equally; some will benefit based on need; others benefit based on what a person can contribute to socitey.


3) How are the "Basic Ethcial Principals" assured in research practice?

The tools to ensure basic ethical principals include:
1. Informed consent
a. Information
b. Comprehension
c. Voluntariness

2. Assessment of risks and benefits
a. The nature and scope of risks and benefits
b. The systematic assessment of risks and benefits

3. Selection of Subjects.

People consenting to research should have all availbe information about the research available to them, and should clearly understand benefits and consequences. Documents signed that outline should provids such information clearly and be free of obfuscation. Potential subjects should be willing participants in conducting research and should not be intimidated or coerced by superiors or as a result of an existing medical condition. Finally, patients should have an equal opportunity to be selected for such research as parameters of the research allows. Limitationis to this may include research into conditions which may apply to a narrow group of people.