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CVB by Minnie (Madeleine) > CVB Professional Development > Flashcards

CVB Professional Development Flashcards

1
Q

Describe the Jewish Chronic Disease Hospital Study (1963)

A

At the Jewish Chronic Disease Hospital in New York, live cancer cells were injected into chronically ill and debilitated patients who were told they were recieving a skin test.

The purpose of the study was to learn more about the human immune system’s response to cancer

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2
Q

Describe the “Expedited” IRB review category

A
  • Minimal risk, identifiable, more personal information than exempt category
  • Reviewed in the office except for vulnerable populations
  • If the expeditied reviewer does not approve, the study must go to the full board
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3
Q

What are the basic ethical principles and applications of the Belmont Report?

A

Ethical principles

  • Respect for persons/patient autonomy
  • Beneficience
  • Justice

Applications

  • Informed consent
  • Assessment of Risks and Benefits
  • Selection of Subject
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4
Q

Which “Regulatory Unit” would be involved in grant submission?

A

The OSR - Office of Sponsored Rsearch

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5
Q

Describe the “exempt” IRB review category

A
  • Minimal Risk
  • Belmont Principles still apply
  • Does not apply to FDA regulated research unless it falls under emergency use
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6
Q

What are the 5 roles of the investigator/study team member in obtaining informed consent?

A
  • Ensure that the participant understands all the information
  • Facilitate participant’s decision without coercion or undue influence
  • Use the most current version of the ICF document
  • Answer all the participant’s questions
  • Give the participant a copy of the signed ICF document (ensure that it is signed by both parties)
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7
Q

The National Research Act of 1974 was enacted in response to which unethical research study?

A

The Syphilis Study at Tuskegee (among others)

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8
Q

The Belmont Report was drafted in reaction to which unethical research study?

A

The Syphilis Study at Tuskegee (among others)

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9
Q

What study prompted the protection of pregnant women and fetuses under the common law?

A

The study of thalidomide and DES (Diethylsetilbestrol)

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10
Q

Which groups constitute “vulnerable populations” under the…

Belmont Report?

Common Rule?

A

Belmont Report

  • Racial minorities
  • The economically disadvantaged
  • The very sick
  • The institutionalized

Common Rule

  • Pregnant women
  • Fetuses
  • Neonates
  • Children
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11
Q

What is an IRB?

A

An Institutional Review Board is a committe established to review research involving human subjects

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12
Q

What are the 3 basic principles stated in the Belmont Report?

A
  • Respect for Persons
    • Recognizing the autonomy and dignity of individuals
    • Recognizing the need to protect those with diminished autonomy
    • Voluntariness is important
  • Beneficence
    • Obligation to protect persons from harm by maximizing benefits and minimizing risks
    • Especially vulnerable populations
  • Justice
    • Fair distribution of the benefits and burdens of research
    • No populations of convenience
    • Equal accessiblity to research
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13
Q

What does the Nuremberg Code state?

A

The voluntary consent of the human subjects is absolutely essential

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14
Q

What are the general steps for IRB submission at Northwestern?

A
  • PI submits new application
  • IRB analyst pre-review
    • Modifications may be required for formal review
  • Assigned to reviewer or panel
    • ​Changes may be requested
  • If approval criteria are met…
    • ​Goes on to post-approval
      • Modifications
      • Continuing Review
      • Reportable new information
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15
Q

What is the significance of the Tuskegee study?

A

Black male prisoners were subjected to untreated Syphilis for 40 years as part of a research study

This eventually led to the Belmont report, which gives extra protections from research studies to racial minorities, prisoners, the very sick, and the intitutionalized

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16
Q

Describe the “full board” IRB review category

A
  • Minimal risk research that is NOT in the exempt or expedited category
  • Research that is more than minimal risk
  • Certain research with vulnerable populations
    • Children
    • Pregnant women
    • Prisoners
17
Q

List the 3 IRB review categories

A

Exempt

Expedited

Full Board

18
Q

Informed consent and the ability to consent fall under which principle of the Belmont Report?

A

Respect for Persons

19
Q

If a request for an expedited IRB review is not approved by the expedited reviewer, what happens to the study?

A

It goes to the full board

20
Q

What kind of FDA regulated research would fall under the “exempt” IRB review category?

A

Emergency Use

21
Q

Describe the Willowbrook Study (1963-1966)

A

At the Willowbrook State School for “mentally defective persons,” studies were conducted to learn more about the transmission and treamtent of hepatitis

  • All subjects were children
    • Only children whose parents gave consent for participation were admitted to Willowbrook: coercion
  • They were deliberately infected with hepatitis by…
    • Ingesting stools of infected persons
    • Recieving injections of purified virus preparations
22
Q

What does the Nuremburg Code (1947) establish?

A

10 directives for human experimentation

It was the first international code of research ethics

23
Q

The Nuremburg Code was written in response to what?

A

Nazi Medical War Crimes

24
Q

Which populations are considered “vulnerable to coercion or undue” influence, according to the IRB lecture?

A
  • Children
  • Prisoners
  • Individuals with impaired decision-making capacity
  • Economically or educationally disadvantaged persons

Note:

  • Under the Belmont Report
    • Racial minorities
    • The conomically disadvantaged
    • The very sick
    • The institutionalized
  • Under the Common Rule
    • Pregnant women
    • Fetuses
    • Neonates
25
Q

Which “Regulatory Unit” woudl be important in animal studies?

A

The IACUC - Institutional Animal Care and Use Committee

26
Q

“Selecting subjects equally” and “sharing benefits and burdens of research between subjects equally” fall under which principles of the Belmont Report?

A

Justice

27
Q

What are the 4 major roles of the IRB (Institutional Review Board)

A
  • Reviews and approves research projects involving human subjects or identifiable private information obtained from human subjects
  • Assists investigators in planning and conducting experiments in accord with the highest scientific, humane, and ethical principles and in conformity with relevant laws, regulations, and policies
  • Liaison between investigators and the federal government
  • Safeguards rights and welfare of human subjects
28
Q

Which “Regualtory Unit” would be relevant to studying recombinant DNA or stem cells?

A

The IBC - Institutional Biosafety Committee

29
Q

For IRB approval, what must be done in a study that uses deception?

A

Participants are fully debriefed if deception is used

30
Q

“Do not harm” and “Maximize benefit” fall under which principle of the Belmont Report?

A

Beneficence

31
Q

Which groups constitute “vulnerable populations” under the…

Belmont Report?

Common Rule?

A

Belmont Report

  • Racial minorities
  • The economically disadvantaged
  • The very sick
  • The institutionalized

Common Rule

  • Pregnant women
  • Fetuses
  • Neonates
  • Children
32
Q

Describe the Syphilis Study at Tuskegee

A

~600 African-American men were the subjects of a study of the natural history of untreated syphilis

  • They were recruited without informed consent
  • They were told they were recieving “special treatments”
  • They were not treated with the known treatment for syphilis
33
Q

What “regulatory unit” is relevant to human research?

A

The IRB - institutional review board

34
Q

What is the purpose of an IRB?

A

To ensure that all human subject research is conducted in accordance wiht federal, institutional, and ethical guidelines

CVB by Minnie (Madeleine) (43 decks)

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