Ethics

Question 1

Ethics in clinical trials

Answer 1

Minimize possibility of exploitation

Ensure rights and welfare of subjects

Question 2

Important history in terms of ethics

Answer 2

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)

Question 3

Nuremberg trials

Answer 3

Nazi experimentation

Jewish Children and prisoners in concentration camps were used for experimentation

Question 4

Thalidomide

Answer 4

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

Question 5

Nuremberg Code

Answer 5

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

Question 6

Declaration of Helinski

Answer 6

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

Question 7

Belmont report

Answer 7

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

Question 8

National research Act/Belmont report

Answer 8

1979
Three tenet of ethical research were established

1. Respect for person
2. Beneficence
3. Justice

Question 9

What is beneficence

Answer 9

Welfare of research participants as a primary goal

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

Question 10

Essential elements of ethics in research

Answer 10

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

Question 11

Essentiallity

Answer 11

Only test on human beings if Absolutely necessary

Does all current research certify the drug is safe?

Question 12

Non exploitation

Answer 12

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)

Question 13

Privacy and confidentiality

Answer 13

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

Question 14

Balancing principles

Answer 14

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

Equipoise
Randomization
Choice of control

Question 15

Choice of control

Answer 15

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

Question 16

Clinical equipoise?

Answer 16

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

Freedman 1987

Question 17

Competence

Answer 17

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

Question 18

Two pillars of ethics

Answer 18

Informed consent

Institutional Ethics Committes

Question 19

Transparency & Accountability

Answer 19

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

Question 20

Distributive justice

Answer 20

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

Question 21

Use of Placebo

Answer 21

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

Question 22

Trial:

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

Answer 22

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

Question 23

Special groups

Answer 23

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

Question 24

Ethics Committee members

Answer 24

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

Question 25

Criteria for IEC review

Answer 25

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

Question 26

Informed consent

Answer 26

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