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DOK 3a: two case studies

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Theresa Meir

on 12 October 2015

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Transcript of DOK 3a: two case studies

Case Study #1: Cosmetic Treatment or Damaging Experiment?
More Terms to Know
• Experiment: A test, trial, or tentative procedure; an act or operation for the purpose of discovering something unknown or of testing a principle
• Standard of care: The caution that a reasonable person in similar circumstances would exercise in providing care to a patient
• Institutional Review Board (IRB): A committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.

Responsibilities of "players" in Medical Research
• It is a Medical Journal's responsibility and also the media's to make sure the research being written/spoken of includes all benefits and side effects or risks and also to make sure the research contains ALL information on the trial and what all is happening. Lastly, they need to make sure that the research does not result in more damage than benefits before publishing.
It is the responsibility of subjects or patients involved in the clinical trial to know all side effects, benefits, risks and all parts of the experiment. They also must give written consent and be eligible for the trial before completing the trial.
Procedures Preceding An Experiment
Study investigators enter recruitment information on the School of Medicine list of UCSF Clinical Trials web page, advertisements, notices, and/or media to recruit subjects. Then after all interested and eligible subjects have been found, they are given all information for the experiment and given consent forms to sign.
Terms You Need to Know
DOK 3a: two case studies
By Theresa meir, Nissa Rodriguez,
Autumn Rose, Mikah Vega, & charlee young

• Clinical trial: The scientific investigation of a new treatment that has shown some benefit in animal or laboratory studies, but that has not yet been proven effective in humans.
• Protocol: The plan for carrying out a scientific study or a patient's treatment regimen.
• Research subject (or subject volunteer): A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.
• Informed consent: Permission granted voluntarily by a person who is of sound mind and all risks involved have been explained to where the person understands.

Importance of Clinical Trials
It is very important that we have and continues clinical trials because although some trials are unsuccessful, there are many experiments that have given us cures to diseases and more knowledge of them such as Yellow Fever which was found to be transferred through mosquitoes, which was found during an experiment, and Polio, through a vaccine created by Jonas Salk in 1952 through testing.
It is also the responsibility of both reviewers of the clinical trial and the IRBS to make sure that the trial has more potential benefits to the subjects than risks, that the trial is ethical and all subjects have given consent, and lastly that all experimenters are qualified for the trial and their positions within it.
Lastly, all experimenters and doctors involved in the experiment must adhere to all FDA and IRB guidelines when completing the trial and must inform all subjects of ALL parts, procedures, benefits, and risks involved and that they have given written consent. The experimenters also must be qualified in their positions within the experiment.
Experiment-vs-Treatment
An experiment and treatment would be outlined by what a normal procedure would look like: what type of anesthesia is needed normally if any, the basic outlines of cuts or procedures used, medication used, tests used, etc. and if you are attempting to use any equipment, procedures, medications, anesthesia that is not typical for this treatment, or has never been used or just invented, then it would become an experiment. This might become blurred if you attempt to use a medication on a patient with allergies, and using a different medication to see if it will work.
Importance of "Player" Communication
It is very important that all those involved within an experiment communicate because without communication not all necessary information may be relayed to those who need it, such as between the experimenter and the subject. This could easily become an ethical or legal problem.
Patient Rights
It is a patient's right to refuse treatment, and also to receive information necessary for you to give informed consent before the experiment, including a description of the procedure or treatment, and any potential risks or benefits. This is why consent forms are used for trials, and why subjects are so vulnerable, they won't know if they are getting told all information of the trial.
IRBs and Their Importance
IRBs make sure that the rights of subjects are protected through consent forms and make sure that experimenters are qualified to do research, that they are ethical in their trials, the research site adheres to all guidelines, and that all necessary trials are completed before sending the data to the FDA for review.
Risks of Cosmetic Surgery
There are many risks in surgery, but there seem to be more risks within cosmetic surgery, not because it is particularly more dangerous but because it is a more personal procedure, and no cosmetic surgery is the same for the reason that no one persons body is the same as another, therefore every patient will have different results from the next.
Elective-vs-Necessary
Elective surgery is surgery that could benefit the patient or extend their life span such as a tummy tuck or cosmetic surgery, whereas necessary surgery is a surgery that must be performed in order for a patient to live, such as open heart surgery or removing a bullet.
Conclusion of Cosmetic Treatment or Damaging Experiment?
Overall, it is very important to know patients rights within a clinical trial and ethics of an experiment if ever you become involved, in either the receiving or .
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