Ethics Flashcards

1
Q

IACUC

A

Institutional Animal Care and Use Committee

standards for animal research, have very different rules/restrictions vs human research

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2
Q

Adverse Events

A

untoward or unfavorable occurrence in a human subject. Can be anticipated, related to study participation, considered moderate to severe

must be reported to IRB within 30 days

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3
Q

Unanticipated Problems

A

any incident or experience that is unexpected, related to participation in study, suggests that research increases risk of harm to subjects

must be reported to IRB within 3 days

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4
Q

Informed assent

A

for minors under age 18 need parental permission

lack of capacity or unconsciousness, need surrogate to make the decision

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5
Q

Informed consent includes

A
  1. study purpose and brief intro/background
  2. explanation of all study procedures
  3. all risks and benefits of participation
  4. must state that participants are free to withdraw at any time
  5. participation is voluntary
  6. details compensation for participation
  7. how confidentiality will be protected
  8. contact info for study staff
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6
Q

Minimal Risk

A

probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams/tests

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7
Q

Full Board Review

A

more than minimal amount of risk to potential subjects

do not fit the exempt or expedited categories
ex: invasive studies, vulnerable populations, rigorous ex, drug testing

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8
Q

Expedited Review

A

minimal amount of risk to potential subjects

data collected through non-invasive procedures

ex: non-invasive methods, analyses of voice recordings, studies involving collection of hair/saliva/plaque

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9
Q

Exempt Review

A

lowest amount of risk to potential subjects

often involves anonymous or publicly available data

ex: retrospective chart reviews, research on educational practices, outcomes of standard clinical practice

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10
Q

Types of IRB Reviews

A

exempt, expedited, full review

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11
Q

Study Approval Factors

A
  1. scientific merit
  2. perceived competence of investigators
  3. participant characteristics and vulnerability
  4. safety of the procedures
  5. risk/benefit ratio
  6. informed consent process
  7. data security and confidentiality
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12
Q

Who sits on the IRB?

A

faculty, clinicians, community members

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13
Q

Role of IRB

A

meet and review all research proposals

make decisions regarding study

follow up on studies

implement policies, procedures, and documentation for review and follow-up

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14
Q

Justice

A

ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly and equally

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15
Q

Beneficence

A

philosophy of do no harm while maximizing benefits for the research project and minimizing risks to the research subjects

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16
Q

Autonomy

A

Respect for persons

protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception.

17
Q

Belmont Report

A

1979

summarizes ethical principles and guidelines for research involving human subjects

three guiding principles = autonomy, beneficence, justice

18
Q

National Research Act

A

1974

response to syphilis study

created to protect human subjects when doing medical experimentation

19
Q

Declaration of Helsinki

A

1964

specifically addressed clinical research and addressed changes w/medicine

notable change was relaxed conditions of consent

20
Q

Nuremberg Code

A

1947

response to Nazi experimentation

set of research principles for human experimentation

consent, avoid harm, qualified experimenters, subject can quit, experimenter can cease study

21
Q

Possible problems with studies

A

no informed consent
cruel and inhuman treatment
risks far outweighed benefits
actual treatment withheld
participants did not have option to say no

22
Q

Tuskegee Syphilis Study

A

prime example of human research abuses

withheld penicillin from individuals with syphilis to test effects of untreated disease

23
Q

Scientific Method Steps

A

Observation, Question, Hypothesis, Experiment, Analyze the Data, Conclusion, Report the results