Ethics & Human Subjects

Question 1

protect subjects, and are carried out using scientific principles

Answer 1

ethical studies

Question 2

unethical research includes…

Answer 2

• scientific misconduct
• fraud, research protocol violations
• fabrication, falsification, forging of data
• plagiarism
• putting subjects at risk without consent

Question 3

elements of ethical research

Answer 3

• protecting human rights
• understanding informed consent
• understanding institutional review of research
• balancing benefits and risks in a study

Question 4

unethical studies

Answer 4

Nazi medical experiments
Tuskegee syphilis study
Willowbrook study
Jewish chronic disease hospital study

Question 5

ethical codes and regulations

Answer 5

Nuremburg Code (1949)
Declaration of Helsinki (1964)
DHEW (1973)
National Commission for the protection of human subject of biomedical and behavioral research (1978)

Question 6

the voluntary consent of the human subject is absolutely essential… experiment should be such as to yield fruitful results by other methods or means of study and not random and unnecessary in nature

Answer 6

Nuremburg Code (1949)

Question 7

results might benefit participants

Answer 7

therapeutic research

Question 8

results are not of benefit to participants, but might be in the future

Answer 8

non-therapeutic research

Question 9

principle of respect for persons, principles of beneficence, principle of justice; may be seen in the DHHS Belmont Report (1978)

Answer 9

ethical principles within the national commission for the protected of human subjects

Question 10

self-determination (participation and withdrawing)
no coercion
full disclosure, no deception
voluntary consent
persons with diminished autonomy have special protections

Answer 10

principle of respect for persons

Question 11

freedom from harm
freedom from exploitation
risk/benefit ratios

Answer 11

principle of beneficence

Question 12

fair treatment, right to privacy (anonymity, confidentiality)

Answer 12

principle of justice

Question 13

protection of human subjects in research
documentation of informed consent
implementation of IRB process

Answer 13

Protection of Human Subjects Regulations (title 45, part 46)

Question 14

Public Law 104-191;
Implemented in 2003 to protect individuals’ private health information; very strict; affects research studies by requiring patient consent so as to use private health information

Answer 14

HIPAA

Question 15

Human Rights include…

Answer 15

right to self-determination
right to privacy
right to anonymity and confidentiality
right to fair treatment
right to protection from discomfort and harm

Question 16

human are autonomous agents with freedom to conduct their lives as they choose

Answer 16

self-determination

Question 17

forcing someone to be in the study

Answer 17

coercion

Question 18

subjects are unaware study is taking place

Answer 18

covert data

Question 19

misinforming subjects about the study

Answer 19

deception

Question 20

principle of self-determination can be violated by…

Answer 20

coercion
covert data
deception

Question 21

are given extra protection of right to self-determination because of decreased ability or inability to give informed consent

Answer 21

people with diminished autonomy

Question 22

people with diminished autonomy include…

Answer 22

• legally and mentally incompetent subjects
• neonates and children
• terminally ill subjects
• people confined to an institution
• pregnant women and fetuses

Question 23

the freedom that an individual has to determine the time, extent, and general circumstances under which private information will be shared with or withheld from others

Answer 23

right to privacy

Question 24

protects individually identifiable health information; de-identifying protected health information is allowed only if the following are removed (name, SS, dates, phone #…); covered entities

Answer 24

HIPAA privacy rule

Question 25

researcher refrains from sharing information with others

Answer 25

confidentiality

Question 26

unauthorized access to raw data

Answer 26

breach of confidentiality

Question 27

no one, not even the researcher, knows the identity of the subjects

Answer 27

anonymity

Question 28

based on the principle of justice; selection of subjects and their treatment during the study are fair for all; prevents coercion of subjects (i.e. eating subjects large sums of $ to participate)

Answer 28

right to fair treatment

Question 29

``` no anticipated effects temporary discomfort; unusual levels of temporary discomfort; risk of permanent damage; certainty of permanent damage ```

Answer 29

right to protection from discomfort and harm

Question 30

essential information for consent; comprehension of consent information; competent to give consent; voluntary consent

Answer 30

informed consent

Question 31

1974 National Research Act requires research study review

Answer 31

IRB (Institutional Review Board)

Question 32

functions of IRB

Answer 32

protection of rights and welfare voluntary informed consent benefits exceed risks

Question 33

Exempt from review procedures

Answer 33

no risk

Question 34

Expedited review procedures

Answer 34

minimal risk

Question 35

complete institutional review procedures

Answer 35

- review studies using vulnerable populations | - have greater than minimal risk