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Block 4; Week 4 > Research Ethics > Flashcards

Research Ethics Flashcards

1
Q

What is one of the requirements for clinical research & using human subjects?

A

that it applies not to only one person but that it is generalizable scientific knowledge that could help many people.

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2
Q

What are the 3 ethical principles that guide research today?

A
  1. Nuremberg Code (applies to the world)
  2. Helsinki Delcaration of the World Medical Association
  3. Belmont Report (US Fed regulations)
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3
Q

T/F Nazi human experimentation is a good example of clinical medical research.

A

False. Under the guise of helping people & research. caused death, disfigurement, permanent disability. Experiments to support the Third reich. No informed consent.

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4
Q

What were some of the cruel experiments that were done at Auschwitz?

A

genetic experiments on twins

sterilization experiments-large # ppl @ once (looked @ radiation as option)

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5
Q

What were some of the cruel experiments that were done at Ravensbruck?

A

bone, muscle, nerve transplantation
purposefully created wounds on subjects to look @ wound healing. Looked @ how wounds healed w/o blood supply. Intentionally infected wounds to see what they could do for their soldiers.
sulfonamide experiments

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6
Q

What were some of the cruel experiments that were done at Dachau?

A

immunization & treatment of malaria.
killed like 500 ppl w/ malaria.
sea water experiments (looked @ ways that ppl could drink sea water for survivable). Starved subjects.

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7
Q

What were some of the cruel experiments that were done at Sachsenhausen & Natzweiler?

A

mustard gas

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8
Q

What were some of the cruel experiments that were done at Buchenwald?

A

poison. do an autopsy & see the effects.

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9
Q

In an effort to figure out how to treat hypothermia…many conc’n camps did experiments w/ ______?

A

freezing experiments
**made prisoners sit in ice cold bath for hours.
unfortunately, got important info from these experiments. Do we utilize this knowledge?

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10
Q

What happened in Tuskegee in 1932?

A

Infected black men w/ syphilis & left it untreated. Watched the natural hx of this disease.

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11
Q

What is bad blood used to mean?

A

syphilis
anemia
fatigue

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12
Q

Was the Tuskegee study done w/ informed consent?

A

not really. consented to join study & be examined. Didn’t know what would be involved & were given incentives of medical care, insurance & meals.

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13
Q

How long did the Tuskegee study go on?

A

was supposed to go on for 6 months but continued on for 40 years!!

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14
Q

What did the 1946 Judiciary Council of the AMA say? Did ppl follow this right away?

A
  • informed voluntary consent had to occur prior to research study
  • animal experimentation must begin first
  • experiment must be performed under proper medical protection & management.
  • *didn’t follow it!
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15
Q

When PCN became the syphilis drug of choice…what happened?

A

the subjects of the Tuskegee study weren’t given it!

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16
Q

Were there ever radiation experiments done on human subjects?

A

YES 1944-1974
studied effects of radiation on human subjects
**done on cancer its & pregnant women, children, prisoners, military. Vulnerable subjects.
although small traces, unlikely to have caused harm.

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17
Q

Non-therapeatuic research on children in the US increased lifetime risk for what?

A

thyroid cancer

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18
Q

T/F When total body irradiation w/ acute injuries & other radiation experiments were done in the US they were directly violating policies of human rights at the time & were done w/o thought of minimization of risk.

A

False. they “tried” to minimize risk & there weren’t policies in place @ the time.

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19
Q

What happened to the Uranium miners of the Marshall islands?

A

mined uranium for weapons use.
high levels of radon exposure
gov’t didn’t warn in time
miners died.

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20
Q

T/F The gov’t released small amounts of radiation into the environment to study weapons operations, equipment safety & environmental effects. Releases for experiments were secret.

A

True. Caused serious distrust of the gov’t. Even H1n1 was questioned by everyday Americans.

21
Q

What is the Nuremberg Code & when was it drafted?

A

1947 - Drafted during the Nuremberg War Crimes
Set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners.
The Doctors Trial

22
Q

What are the 10 things that are required for research according to the Nuremberg code?

A
  1. voluntary consent of human subject
  2. yield fruitful results for the good of society
  3. designed & based on animal experiments & natural hx
  4. conducted to avoid unnecessary physical/mental suffering.
  5. Not conducted if apriori reason to believe that death or disabling injury will occur.
  6. Risk should not exceed that determined by the humanitarian importance of the problem to be solved. Ex: not conjoined twin studies!
  7. Protections made to protect subject from remote possibility of injury, disability, or death
  8. conducted only by scientifically qualified persons
  9. subjects ALWAYS at liberty to exit study
  10. scientist must terminate at any stage if he has reasonable cause to believe that the experiment will cause injury, disability, or death to the subject.
23
Q

What is involved in voluntary consent?

A

Legal capacity
Able to exercise free power of choice
Without force, fraud, deceit, duress, constraint or coercion
Sufficient knowledge and understanding
Prior to consenting should be made aware of the nature, duration, and purpose of the experiment, the methods and means, all inconveniences and hazards to be expected, and effects upon health that may come from participation

24
Q

What happened at Willowbrook State school in Staten Island, NY? 1956

A
  • school for MR children
  • children given hepatitis to track the development of the viral infection
  • said they would likely get it @ this school b/c of the outbreak & then they could study cures.
  • lasted for 14 years.
  • tried to give gamma globulin injections
25
Q

What did the international Declaration of Helsinki of 1964 say?

A

*duty of physician to promote & safeguard the health of people & protection life, privacy & dignity
*well being of human subject > science
*vulnerable pop must be especially protected (economically & medically disadvantaged, those who can’t consent, duress, not benefit personally from research)
*investigators will be held accountable by these codes
can’t declare standards less than this!

26
Q

T/F Unethical to combine research w/ care.

A

TRUE!!!!

27
Q

T/F Scientists should exercise caution when research may affect the environment. According to Nuremberg.

A

False. Yes, but according to Helsinki.

28
Q

T/F Research protocols must be review by Ethical Review COmmittee.

A

True.

29
Q

T/F If the research subject is incapable of giving consent, consent must be obtained from a legally authorized representative.
According to Helsinki.

A

True.

30
Q

T/F Minors do not have to assent to research as long as the parent agrees.

A

False. THe minor must agree too. You have to talk to them in age appropriate language.

31
Q

What were the results of the Tuskegee experiment?

A

28 men died of syphilis
100 others died of syphilis
at least 40 wives had been infected
19 children contracted the disease @ birth
no longer any study participants that are alive.

32
Q

When did the Tuskegee study end?

A

1972!

33
Q

US had Congressional hearings following Tuskegee. What were the outcomes of these hearings?

A

National Research Act of 1974
National Commission for Protection of Human Subjects of Biomedical & Behavioral Research–>gave Belmont Report in 1979. Key guideline in the US now.

34
Q

What did the Belmont Report outline?

A

review of proposed research via IRB
informed consent required
fair selection of subjects required

35
Q

What are the 3 basic ethical principles of the Belmont Report?

A

Respect for Persons
Beneficence
Justice

36
Q

Explain more about respect for persons.

A

Individuals’ autonomy should be respected
Persons with diminished autonomy are entitled to protection.
In research involving human subjects
Subjects enter into research voluntarily and with adequate information.

37
Q

Explain more about beneficence.

A

Physicians have an obligation to secure their subjects well-being
“Do no harm”
Maximize possible benefits and minimize possible harms
Investigators are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from research investigation.

38
Q

Explain more about justice.

A

consider who receives benefits of research & who bears the burdens of research.
protect vulnerable grps
avoid providing advantages only to the wealthy
avoid subjects that won’t benefit from applications of research.

39
Q

What are the application of these 3 principles?

A

informed consent–[voluntary, info given (including research procedure) & purpose of the study & alternative procedures, risk & benefits & opportunity to withdraw & ask Qs]
Risk/Benefit Assessment
Fair Selection of Subjects

40
Q

How much info is needed for informed consent?

A

based off of the reasonable volunteer. What would they need to know?

41
Q

What’s the deal w/ the IRB?

A

any research that is federally funded must be submitted to the FDA. purpose; protect research participants.

42
Q

What reparations were made for bad US hx of tortuous clinical research?

A

1994 – President Clinton appoints the Advisory Committee on Human Radiation Experiments.
Declassifies info and issues an apology
1997 - The government formally apologized for the unethical study of Tuskegee.

43
Q

Difference b/w social & individual justice in selection of participants.

A 
Individual justice: Not offer potentially beneficial research to only patients who are in their favor
Not select only “undesireable” persons for risky research
Social Justice: Distinction be drawn between classes of subjects that ought and ought not participate in any particular kind of research, based on “the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons.”
44
Q

Who really discovered DNA structure?

A

Rosalind Franklin. Not Watson & Crick! They stole it! And yet they got the Nobel Prize

45
Q

What did William Summerlin claim?

A

1974 – William Summerlin at Sloan Kettering Cancer Institution, reported that he could transplant tissue from genetically unrelated animals without rejection.
He fabricated his data!! Unethical.

46
Q

What did Andrew Wakefield do?

A

came out w/ paper that claimed the MMR vaccine led to problems w/ autism.
published in Lancet in 1998.
claimed IBD & regressive autism.
paper DID say that there was no causal connection.
but he DID call for the suspension of the MMR vacc
This is why we don’t like him.

47
Q

What is the problem with what Wakefield did?

A

there was a measles outbreak & a number of children died from this.
he then claimed that all vaccines are suspect.

48
Q

Was Wakefield scolded?

A

YES 2004. Big article against him.
Wakefield said his study was approved by England’s version of IRB. It didn’t.
children underwent extensive procedures for minimal benefit.
he was hired to find a link for a legal case.
he patented his own measles vaccine.
his results were fabricated.

49
Q

T/F Wakefield was brought to justice & the Lancet paper was retracted.

A

true.

Block 4; Week 4 (8 decks)

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