What were your reactions to reading about some of the past violations of human r
ID: 124257 • Letter: W
Question
What were your reactions to reading about some of the past violations of human rights in the quest for knowledge about disease and treatment? Please be specific.
Please comment on the adequacy of the protections and regulations that are now built into the system to protect human subjects, especially for vulnerable populations.
Randomized clinical trials (RCTs) are the gold standard for research as you know. What are some of the ethical issues to consider when recruiting for RCTs? How can these issues be addressed? Do you agree that RCTs are necessary given the difficulties in recruiting participants?
Do you think informed consent is always necessary for any kind of research? What is your rationale?
What is your role as an FNP in the protection of human rights in the research process? Please be specific.
Explanation / Answer
In some area of china the goverment has restricted the protest regarding lead pollution from factories and even restriction was made on parents opting to take medical treatment as lead is more harmful for children and can affect their developing nerves and brains. Here people should be given priority befor setting up factories which release harmful chemicals, as due to carelessnesss and for the benefit of few a large population was getting affected.
Adequacy of the protection and regulation in the system in order to protect human rights are as follows:
1) The voluntary consent of individual or human subject has been made compulsory.
2) Subjects have given rights to step back any time during the trials.
3) Subjects should not be expose to any kind of suffering, risk factors and its scientific significance should be discussed.
Ethical issues to consider for RCTs are as follows:
1. No clinical trials can be conducted on individual without their consent, a consent form is a must.
2. A subject should be clearly informed about the risk and benefits of the trial.
3. He or she has rights to withdraw from the trial any time.
The above issue can be addressed by providing detail education about the trial and ultimately full freedom should be given to subject about taking their decision.
RCT recruit their subjects based on specific criteria and full consent of the subject. Convincing of the subject maybe difficult sometimes.
Informed consent is neccessary whenever any kind of research or trials are conductted on human. It is human rights to know about the research and how his /her sample are processed. What are parameters are being tested and risk factors associated with the trial.
Role of FNP in the protection of human rights in the research process is:
1. Clearly explain subject about the consent form.
2) Make them fully aware about the risk factors and benefits associated with the rsearch.
3) Listen to patient concern about their confusion and try to help resolve their issue before opting for trials.
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