Ethics

Question 1

What was the Tuskegee Study?

Answer 1

A study on the effects of syphilis on the human body done by the US Public Health Service

Question 2

Why was the Tuskegee Study unethical?

Answer 2

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

Question 3

Who did the Tuskegee Study affect?

Answer 3

• The participants, many of whom had died from the disease or complications
• Wives/significant others/sexual partners
• Children who contracted the disease at birth

Question 4

What is the Nuremberg Code?

Answer 4

The right to say “no”

Question 5

What does the Helsinki Declaration state?

Answer 5

The health of the patient comes first

Question 6

What did the Belmont Report establish?

Answer 6

Beneficence
Respect for human dignity
Justice

Question 7

What is beneficence?

Answer 7

Freedom from harm, exploitation

Benefit from research

Question 8

What does respect for human dignity entail?

Answer 8

Self-determination
Full disclosure
Respect

Question 9

What does justice include?

Answer 9

Fair treatment

Privacy (anonymity & confidentiality)

Question 10

Consent

Answer 10

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

Question 11

Assent

Answer 11

child’s (or other that is unable to formally give consent) affirmative agreement to participate

Question 12

Permission

Answer 12

agreement of parent(s) or guardian(s) to the participation of their child/other

Question 13

What is included in informed consent?

Answer 13

Purpose, duration, & procedures of research
Risks & benefits--alternatives
Confidentiality
Compensation for injury
Emergency contact
Right to refuse or withdrawl
Selection
Sponsorship

Question 14

What are the 5 basic rights of research participants?

Answer 14

1. Right to Self-Determination
2. Right to Privacy & Dignity
3. Right to Anonymity
4. Right to Fair Treatment
5. Right to Protection from Discomfort & Harm

Question 15

What is included in the Right to Self-Determination?

Answer 15

Informed about the study
Allowed to choose to participate or not
Allowed to withdraw at any time w/o penalty

Question 16

Who requires more protection when it comes to research?

Answer 16

Vulnerable groups

Those with diminished autonomy

Question 17

How can the Right to Self-Determination be violated?

Answer 17

Coercion
Overt data collection
Deception

Question 18

What the is Right to Privacy & Dignity?

Answer 18

The freedom to determine the time, extent, and general circumstances under which private info will be shared or withheld from others

Question 19

When does complete anonymity exist?

Answer 19

When the subject’s identity cannot be linked, even by the researcher, with his or her individual responses

Question 20

What is confidentiality?

Answer 20

Researcher’s management of private information shared by a subject or participant

Question 21

What ethical principle is the Right to Fair Treatment based on?

Answer 21

Justice

Question 22

What ethical principle is the Right to Protection from Discomfort & Harm based on?

Answer 22

Beneficence

Question 23

Research involving human subjects must be reviewed by…

Answer 23

The Institutional Review Board (IRB)

Question 24

The IRB confirms that research…

Answer 24

Protected the rights and welfare of participants
Used the appropriate methods to secure informed consent
Had greater benefits than risks

Question 25

What are the 3 possible outcomes of research reviewed by the IRB?

Answer 25

1. Approved
2. Requires modifications
3. Disapproved

Question 26

Responsibilities of the IRB

Answer 26

• 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

Question 27

How can a study be exempt from review?

Answer 27

If the research poses no apparent risks for the subjects

Question 28

Which studies are qualified for an expedited review?

Answer 28

Studies that carry minimal risk