Ethics in Research Flashcards
What were the effects of the nuremberg code?
introduced the idea of voluntary consent
What is the declaration of Helsinki?
the first unified effort of the medical community
What were the 2 contributions of the declaration of Helsinki?
-informed consent
- risks should not exceed the benefits of a study
What is the Tuskegee Syphilis Study?
o Study of how people die of syphilis
o Followed 600 poor black sharecroppers in alabama
o Researchers did not give treatment when it was discovered and held back information about avaibile treatment options
o 1932-1972 until it was leaked to the press
What is the Belmont Report?
o Adopted in 1978 in response to Tuskegee study
o Identified the fundamental principles for research with human subjects
o Led to establishment of IRB in USA
What is the IRB?
o An independent entity that reviews propsed research for compliance with ethical standars
o Each institution has their own
o Made up of peers and community members who do not have an interest in the study
What are the 3 things the IRB does?
- review
- regulate
- enforce research ethics
What are the 3 principles of ethics?
- respect for persons
-beneficence - justice
What is respect for persons?
Individuals should be treated as autonomous agents
Persons with diminished autonomy are entitled to protection
What is beneficence?
Making an effort to secure the well-being of participants by:
* Not harming then
* Maximizing benefit and minizing harm
What is the principle of justice?
Fair distribuitions of benefits and burdens of research
* Ex. Not only choosing poor participants
What does autonomous agent mean?
o Capable of deliberation about personal goals
What is voluntary consent?
Not forced, coerced, or induced to participate, continue, or complete study
What is a consent form?
A written form that is
* Simple
* 6th-8th grade reading level
* Using 2nd person
* Should be translated
What are the 8 components of the consent form?
Why selected for study
Purpose & Procedure of study
Risks and benefits
Statement of confidentiality
Names to contact with questions
Voluntary participation/ withdraw without penalty
Place for signatures
Special section/signature for use of audio-/video-taping in presentations
What is the term for when there is a lack of choice in the participation of research?
Forced
What is coerced consent?
- unfairly persuaded
- usually caused by imbalance of power
What is induced consent?
- influence based on the circumstanced
- often monetary or other study benefits
