21 Jan Experiments on twin

Question
NUR3164 Introduction to Nursing Research and Health Informatics

Unit 7 Discussion Part 1

Ethics & Health Informatics: Part I

According to the federal regulations for human subjects research, children, prisoners, and pregnant women are considered the “vulnerable” population. However, there are actually other sub-populations that are often considered vulnerable due to the nature of terms of their participation ~ that would include students, employees, impoverished, elders, ethnic groups, disenfranchised populations and cognitively impaired individuals (with cognitively impaired, it is primarily related to the capacity to give informed consent).

So, what does this mean to the student/employee as a vulnerable population? (1) a potential subject can be influenced/induced to participate or (2) a potential subject can find themselves in a situational/positional vulnerability subjecting them to coercion. The difference between these is that with unduly influencing a potential subject, one is offering them an excessive or inappropriate reward for their participation. When I received IRB approval for my study, I had to offer support to show that the gift card I was giving was a reasonable amount that would not cloud the potential subjects’ decision-making with the offered reward. Coercion on the other hand, is when someone’s power/position is used to negatively impact the potential subjects if they don’t participate, influencing the “voluntary choice” aspect of the research. (Teacher saying you get an A if you do participate and “a poor grade” if you don’t ~ that type of thing.)

Institutional Review Boards (IRB) are designed to safeguard against these issues, and all research involving human subjects must have IRB approval.

So ~ Where did we come from and where are we going in the area of ethics?

Discussion Board Topic:

Part I: After reading the Belmont Report, Answer ONE of the following questions ~ the goal is that all of the questions get covered by the students in this class for all of you to review.

Expand on the Nuremberg Code and its role in the current ethical guidelines

Expand on the declaration of Helsinki and its role in the current ethical guidelines

Many research studies that were identified as “unethical” lead to the task force and other documents forming today’s ethical guidelines. The majority of these experiments are horrific, but deserve to be remembered, lest we forget where we came from. Choose ONE of the following studies to expand upon, including their implications to the study subjects and to the development of ethical guidelines.

Tuskegee Syphilis Study

Biomedical experiments on children: The polio vaccine trials

The 1956–1971 Willowbrook hepatitis studies (institutionalized children)

Clinical trials involving thalidomide

Experiments on twin children in German concentration camps conducted by J. Mengele from 1943 to 1944 on approximately 1,500 sets of imprisoned twins at Auschwitz

What are the three ethical principles identified by the Belmont Report? (expand on each)

Who are the vulnerable populations protected by the Belmont Report? (how is “vulnerable” defined and how are they protected?)

What happened in the U.S. AFTER the Belmont Report in the U.S. in the area of ethical research practices?

What is an IRB, who does it protect, and who offers it?

What must be included in informed consent?