Ethics Flashcards

1
Q

Ethics in clinical trials

A

Minimize possibility of exploitation

Ensure rights and welfare of subjects

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2
Q

Important history in terms of ethics

A
The Nuremberg code (1947)
The declaration of Helsinki (1964)
US code of federal regulations (1974)
The national research Act and the IRB system (1979)
The Belmont report (1979)
ICMR Guidelines (2000, 2006)
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3
Q

Nuremberg trials

A

Nazi experimentation

Jewish Children and prisoners in concentration camps were used for experimentation

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4
Q

Thalidomide

A

Used by pregnant women for morning sickness.
Caused phocomelia in newborns.

Conducted without consent
Caused uneccessary pain suffering and death
Absence of benefit for the participants
Lack of adequate scientific rationale

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5
Q

Nuremberg Code

A

A set of 10 points for research ethics principles for human experimentation as a result of Nuremberg trials in second world war

The voluntary consent of human subject is absolutely essential

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6
Q

Declaration of Helinski

A

Relaxation of consent
Obtain consent if at all possible
Oversight by an independent committe (IRB/IEC)

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7
Q

Belmont report

A

Most famous biomedical research in US history

399 black men thought of have syphilis were recruited and followed to determine the course of disease (what would happen to them)

Penicillin was known to be an effective treatment of syphilis by about 1947
The subjects were NOT INFORMED of what was being studied or of the treatment alternatives available

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8
Q

National research Act/Belmont report

A

1979
Three tenet of ethical research were established

  1. Respect for person
  2. Beneficence
  3. Justice
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9
Q

What is beneficence

A

Welfare of research participants as a primary goal

Remove harm from the patient to the best of one’s ability

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10
Q

Essential elements of ethics in research

A

Minimize risks to subject
Maximize benefits
Benefits should proportionally weigh out risks
Non maleficence or Beneficence

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11
Q

Essentiallity

A

Only test on human beings if Absolutely necessary

Does all current research certify the drug is safe?

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12
Q

Non exploitation

A

Provide remuneration to test subjects
Inform subjects about all potential side effects and risks
Ensure amole compensation for accidental injury
(Insurance , rehabilitation, life long support)

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13
Q

Privacy and confidentiality

A

Inform subjects about the extend ti which personal info should be disclosed

Do not divulge identity & records of test subjects as far as possible

Do not provide information which will allow identity to be guessed

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14
Q

Balancing principles

A

Balancing need for rigorous design with obligation to maximize benefits and minimize harm

Equipoise
Randomization
Choice of control

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15
Q

Choice of control

A

The benefits risks and effectiveness of a new method should be tested against those of the best current prophylactic diagnostic and therapeutic methods

Helsinki 2000

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16
Q

Clinical equipoise?

A

Genuine uncertainty within the scientific community
about the comparative merits of intervention A & B

Freedman 1987

17
Q

Competence

A

All personnel involves in trials must be trained and qualified.
Must have a string sense of ethics.

18
Q

Two pillars of ethics

A

Informed consent

Institutional Ethics Committes

19
Q

Transparency & Accountability

A

No aspect of study to be hidden except that for privacy reasons
Prior disclosure of all conflicts of interest
Maintain permanent records of all research dara and notes
Fox responsibility fir study & its outcome
Burden of proof always with those who conduc the trial

20
Q

Distributive justice

A

Benefits of research would be equally distributed:

  1. Research on generic should not lead to racial inequalities
  2. Do not conduct research on economically weak sections to create benefits for those who are better off

Avoid implicit coercion:

  1. Do not enroll people at a disadvantage in study
  2. Ensure complete freedom of choice when they are enrolled

Affordability

21
Q

Use of Placebo

A

Unethical to use placebo to a group of patients when there is a drug available to cure

22
Q

Trial:

Single dose perinatal nevirapine + standard Zidovudine to prevent mother to child transmission of HIV-1 in Thailand

A

Study was designed to test superiority of nevirapine-zidovudine regime over placebo regimen

Critics: Use of placebo unethical

Supporter: poor countries can never anyway afford the AZT regimen

Argued for local standard of care. In this case “absence of care”was found

23
Q

Special groups

A

Pregnant nursing women
Children (only conduct trials on child after phase 3 trials on adults) (exception for children only diseases)
Consent taken from parent/ guardian

24
Q

Ethics Committee members

A
  1. Chair person preferably from outside the institution
  2. 1- 2 basic medical scientist
  3. 1-2 clinicians from various institute
  4. one legal expert or retired judge
  5. One social scientist
  6. 1 philosopher or ethicist
  7. 1 lay person from community
  8. Member secretary
25
Q

Criteria for IEC review

A

Risks are minimized
Risks are justified by anticipated benefits
Subject will be selected and treated fairly
Informed consent is adequate

26
Q

Informed consent

A

Subjects should be fully informed about objectives , risks, benefits of the study
Informed about the right to withdraw anytime
No refund will be demanded on withdrawal
Consent should not be coerced or pressured