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Chiropractic Research Literacy > IRB Basics > Flashcards

IRB Basics Flashcards

Ethics and human subject protections; from week 6

1
Q

What is the purpose of an IRB?

A

Review research and ensure the rights and welfare of human subjects involved in research are adequately protected

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2
Q

Name five historical events related to the need for an IRB

A
  • Nazi War Crimes (1940s)
  • US Human Radiation experiments (1944-1974)
  • The Jewish Chronic Disease Hospital Study (1963)
  • The Willowbrook Study (1956-1971)
  • Stanford Prison Experiment ( 1971)
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3
Q

The Nazi experiments triggered which ethical milestone?

A

Nuremberg Code 1947

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4
Q

The Tuskegee Syphilis Study triggered which ethical milestone?

A

National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research 1974

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5
Q

What two works were established by the National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research?

A
  • Belmont Report (1978)
  • Common Rule (1991)
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6
Q

The following are key elements of which ethical milestone:
* Voluntary consent
* Anticipate scientific benefits
* Benefits must outweigh risks
* Perform animal experiments first
* Avoid suffering

A

The Nuremberg Code

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7
Q

The following are key elements of which ethical milestone:
* No intentional death or disability
* Do no harm
* Subjects can withdraw at any time
* Investigators must be qualified
* Research will stop if harm occurs

A

The Nuremberg Code

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8
Q

Describe the events regarding Henrietta Lacks (1951)

A

Cells were harvested without permission
Cells were cultured and created first human immortal cell line

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9
Q

Describe the events of the Jewish Chronic Disease Hospital Study (1963)

A

Patients were injected with live cancer cells
Consent did not include any discussion on the injection of cancer cells

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10
Q

Describe the events of the Willowbrook Study (1956-1971)

A

“Mentally defective” children were injected with Hepatitis
Parents were coerced into agreeing in order to have their children admitted

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11
Q

Who was responsible for the Tuskagee Syphilis Study (1932-1972)?

A

Government run project by the US Public Health Service with Tuskagee University

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12
Q

In the Tuskagee Syphilis Study (1932-1972), what was communicated to subjects?

A

Hundreds of impoverished black sharecroppers were told they were being treated for “bad blood”

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13
Q

By 1947, what was the standard treatment for syphilis?
What treatment was given to those in the Tuskegee Syphilis Study (1932-1972)?

A

Standard treatment for syphilis was penicillin
Scientists withheld and prevented access to treatment for study subjects

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14
Q

What led to the termination of the Tuskegee Syphilis Study (1932-1972)?
What was the result of this study?

A

1972 a leak results in study termination
Led to Belmont Report (1976) and development of IRBs

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15
Q

The historical disclosure of the Tuskegee study in 1972 is correlated with…

A

increases in medical mistrust

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16
Q

How did the Tuskegee study affect life expectancy for black men?

A

Life expectancy at age 45 for black men fell by up to 1.4 years
This accounts for approximately 35% of the 1980 life expectancy gap between black and white men

17
Q

The principles of the Belmont Report govern…

A

all research supported by the U.S. Government

18
Q

What are the three basic principles of the Belmont Report?

A
  • Respect for persons
  • Beneficence
  • Justice
19
Q

What are some aspects of respect for persons?

A
  • Treat individuals as autonomous agents
  • Do not use people as a means to an end
  • Allow people to choose for themselves
  • Provide extra protections to those with diminished autonomy (ie. prisoners, children, cognitively impaired, etc)
20
Q

The two general rules formulated from the principle of beneficence are:

A
  1. Do no harm
  2. Maximize possible benefits and minimize risks
21
Q

What are two aspects of justice?

A
  • Treat people fairly
  • Fair sharing of burdens and benefits of the research
22
Q

An injustice occurs when…

A
  • benefits to which a person is entitled are denied without good reason, or
  • burdens are imposed unduly
23
Q

What are two rules derived from the idea of respect?

A
  • Informed consent process
  • Respect for privacy
24
Q

What are three rules derived form the idea of beneficence?

A
  • Good research design
  • Competent investigators/researchers
  • Favorable risk-benefit analysis
25
Q

What is a rule derived from the idea of justice?

A

Equitable selections of subjects

26
Q

What is the purpose of the Common Rule (1981)?

A

Describe processes and regulations
Ethics and morality takes “back-burner” and is addressed in the Belmont Report

27
Q

Name three regulations put in place by the Common Rule (1981)

A
  • Federal Policy for the Protection of Human Subjects
  • FDA-regulated clinical investigations
  • Responsibility of IRBs that review FDA-regulated clinical investigations
28
Q

What are three risk categories?

A
  • Exempt
  • Expedited
  • Full board
29
Q

A study that is in the exempt risk category does not mean…

A

exempt from submitting/review

30
Q

A study that is in the expedited risk category is reviewed by…

A

the IRB Chair or a qualified IRB member

31
Q

Which risk category has greater than minimal risk?
What are some examples?

A

Full board
ie. illegal activities, most prisoner studies, invasive procedures

32
Q

How are studies approved or denied in the full board risk category?

A

Studies are discussed during a full board meeting
A vote is taken to approve or deny
Only a full board can deny approval (rarely happens)

33
Q

What are some examples of exempt studies?

A

Surveys/interview/focus groups with adults collecting non-sensitive data
Benign behavioral interventions with adults

34
Q

What are some examples of expedited studies?

A

Research with drug and device products that is exempt from FDA IND and IDE regulations
ie. Non-invasive collection of saliva, hair, nails, teeth, skin swab, sputum, etc.

35
Q

In an expedited study, what must be considered when involving venous or fingerstick blood collection?

A

Frequency, amount, and subject
Risks must be minimal

36
Q

What are three components of informed consent?

A
  • Information
  • Comprehension
  • Voluntariness
37
Q

With informed consent, voluntariness requires…

A

conditions free of coercion and undue influence

38
Q

When can there be a waiver of informed consent and HIPAA?

A
  • Retrospective chart review
  • Collection of leftover tissue usually discarded

Chiropractic Research Literacy (5 decks)

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