Ethics Flashcards
What was the Tuskegee Study?
A study on the effects of syphilis on the human body done by the US Public Health Service
Why was the Tuskegee Study unethical?
The men who signed up for the free medical care were not told they had syphilis. They were told that they had “bad blood” and were denied access to treatment, even though penicillin was available
Who did the Tuskegee Study affect?
- The participants, many of whom had died from the disease or complications
- Wives/significant others/sexual partners
- Children who contracted the disease at birth
What is the Nuremberg Code?
The right to say “no”
What does the Helsinki Declaration state?
The health of the patient comes first
What did the Belmont Report establish?
Beneficence
Respect for human dignity
Justice
What is beneficence?
Freedom from harm, exploitation
Benefit from research
What does respect for human dignity entail?
Self-determination
Full disclosure
Respect
What does justice include?
Fair treatment
Privacy (anonymity & confidentiality)
Consent
legally effective agreement of the subject(s) legally authorized representative based on information that is given to the subject or the representative in language that is understandable
Assent
child’s (or other that is unable to formally give consent) affirmative agreement to participate
Permission
agreement of parent(s) or guardian(s) to the participation of their child/other
What is included in informed consent?
Purpose, duration, & procedures of research Risks & benefits--alternatives Confidentiality Compensation for injury Emergency contact Right to refuse or withdrawl Selection Sponsorship
What are the 5 basic rights of research participants?
- Right to Self-Determination
- Right to Privacy & Dignity
- Right to Anonymity
- Right to Fair Treatment
- Right to Protection from Discomfort & Harm
What is included in the Right to Self-Determination?
Informed about the study
Allowed to choose to participate or not
Allowed to withdraw at any time w/o penalty
Who requires more protection when it comes to research?
Vulnerable groups
Those with diminished autonomy
How can the Right to Self-Determination be violated?
Coercion
Overt data collection
Deception
What the is Right to Privacy & Dignity?
The freedom to determine the time, extent, and general circumstances under which private info will be shared or withheld from others
When does complete anonymity exist?
When the subject’s identity cannot be linked, even by the researcher, with his or her individual responses
What is confidentiality?
Researcher’s management of private information shared by a subject or participant
What ethical principle is the Right to Fair Treatment based on?
Justice
What ethical principle is the Right to Protection from Discomfort & Harm based on?
Beneficence
Research involving human subjects must be reviewed by…
The Institutional Review Board (IRB)
The IRB confirms that research…
Protected the rights and welfare of participants
Used the appropriate methods to secure informed consent
Had greater benefits than risks
What are the 3 possible outcomes of research reviewed by the IRB?
- Approved
- Requires modifications
- Disapproved
Responsibilities of the IRB
- Review research
- Require that informed consent is in accordance with regulations
- Require documentation of informed consent (or may waive documentation)
- Notify investigators of decision in writing
- Conduct continuing review of research no less than once per year
How can a study be exempt from review?
If the research poses no apparent risks for the subjects
Which studies are qualified for an expedited review?
Studies that carry minimal risk
