EXPERIMENTATION



EXPERIMENTATION and ETHICS

Purpose:

To gain information and hopefully to use that information to assist people, to cure illnesses, to alleviate pain.

CASES:

1. Africa and HIV Drugs- 

          Issues: Standard of Care  , Placebo,  Informed Consent

2. Cold War Radiation Experiments

3. Willowbrook hepatitis Experiments

4. New York State Psychiatric Institute- 1993-1996 violent males and fenfluramine

5. Baby Fae 1984

6. The Pernkopf anatomy - Use of Morally tainted Information, Data (Nazi)

Two types of Experiments

Therapeutic

Non therapeutic

Codes Governing Research and Experimentation

Nuremberg Codes

Helsinki Code

World Assembly

AMA

PHS 1966

 

5 Points

1. Subjects must volunteer

2. Freedom to withdraw

3. Unnecessary risks are eliminated - prior animal experiments

4. Benefits to subjects / society must outweigh the risks and harms

5. Only qualified individuals and researchers

 

CONDITIONS

1. Science has progressed to the point where the experiment is justified

2. prior non human experiments

3. chance of benefit for the subject

4. subject is informed of diagnosis, prognosis, alternatives

5. subject consents

6. No better alternative available

7. Continuation of the experiment is not assumed

8. Repair of any damage or side effects is responsibility of researchers

 

INFORMED CONSENT

a. Competent individuals-??? Mentally retarded, incurably ill and life threatened, children

b. Informed

c. voluntary

 

VULNERABLE SUBJECTS

• Children

         how old? what conditions?

         Parental Consent???

• Retarded

• Mentally ill

• Those in PAIN

• Those in TOTAL Institutions

o Prisoners-  rewards verus duress

o Ward Patients

o Military Service

• Students in Colleges/Universities

• Fetuses

• Non-Human Animals

 

EXPERIMENTAL DESIGN

valid

reliable

minimize risk

DOUBLE BLIND METHODOLOGY

Medical Research versus Therapy

Who Controls the Experiment??

Peer Review to legitimize research and protect subjects

such peer review groups are often "rubber stamps"

 

KEY QUESTIONS FOR REVIEW OF EXPERIMENT for APPROVAL

1. Is it worth the risk?

2. Is the information otherwise obtainable?

3. have non human animal experiments been done?

4. Is the experiment meeting scientific standards?

5. Do the experimenters have the proper background?  Are they qualified?

6. Are the risks minimal? Have they been minimized?

7. Has the appropriate, competent, and independent peer review group approved?

 

Ethical Theories:

Utilitarianism:  in general would approve as long as the benefits to society are clear, subjects are protected and compensated.

Kantian: subjects must be fully competent, rational and autonomous.

Ross: similar to Kant

Natural Law Theory: applies the principle of the Double Effect and Totality

Rawls: permissive but would protect the vulnerable subjects, preserve liberty and provide advantage for the least well off.

 

 

 

 

 

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