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OTD 8161: Week 6 - Ethics in Research (Winter 2016)
Transcript of OTD 8161: Week 6 - Ethics in Research (Winter 2016)
What is ethics?
Let us take a look at the details back through time.....
1963 Milgram Study
Yale University social psychology researcher (Stanley Milgram) performed obedience to authority experiment; deception; resulting concerns for psychological stress, social, legal, and economic harm to participants (Hurley, Denegar, & Hertel, 2011, p.59).
Nazi experiments - Healthy prisoners were researched:
1946 The Nuremberg Doctors' Trial
In this section of the Prezi please be sure to review the:
1. Belmont Report
2. The 3 Key principles of the Belmont Report
What do researchers need to consider?
time to consider
free to withdraw
An area worth researching?
1950s-1962 - Pregnancy Thalidomide
Used to treat discomforts in pregnancy
Not standard to inform women that drugs were investigative
In 1962 it was found that thalidomide caused birth deformities
Public outrage resulted in amendments to the food, drug and cosmetic acts
Student Videos on Ethics in Research
OTD 8161: Evidence and OT Practice
Winter - 2016
a set of principles of right conduct
A theory or a system of moral values
The rules or standards governing the conduct of a person or the members of a profession
The study of the general nature of morals and of the specific moral choices to be made by a person; moral philosophy
Let's think together....
Examining Ethics in Research
3 Key Ethical Principles
"For a clinical trial to be in equipoise, investigators must not know that one arm of a clinical trial provides greater efficacy over another, or there must be genuine uncertainty among professionals about whether one treatment is superior than another." (NIH Office of Extramural Research)
1932 Tuskegee Syphilis Study
Researchers failed to treat patients appropriately after the 1940s validation of penicillin
participants were lulled with free medical care, meals and burials
Never told they had syphilis - just 'bad blood'
Please watch this short video: it does a good job reviewing the history of The Belmont Report and Ethics in Research in the U.S.
Now for a more global perspective: Watch this video about running clinical trials in developing countries around the world (specifically Sub-Saharan Africa)
how does this video relate to Polit & Beck's section on determining if appropriate informed consent procedures were used?
Does this video change the way you view clinical trials?
Please review this short video to get a clearer picture on the Tuskegee Syphilis Study
Please watch this video and ask yourself -if someone told you to do something you would say no....but if you had a choice would you do it to please them?
Can not attest to the veracity of the next video however it gives you pause to consider the frequency of ethical violations that have and potentially will occur in the future.
Please watch this video as it discusses the founders of the Belmont report to help reinforce your understanding of this report.
Please watch this video as it gives good examples to solidify the concepts of informed consent:
1st scene is of a researcher meeting with a more seasoned researcher (Dr. Mitchel) to go over some research protocol questions/issues she has for obtaining legally effective informed consent from potential subjects with schizophrenia before she submits her documentation to the IRB office.
What does the term 'exculpatory language' mean? as it relates to informed consent process?
2nd scene Dr. Presley obtains appropriate informed consent from a potential subject, Mr. Smith, who has the capacity to consent.
the video goes step by step through key items needed in the informed consent document.
key terms such as, but not limited to: break the blind, purpose of the study, statement that the study involves research, duration of the subject's participation, and foreseeable risks or discomforts.