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Patient Rights in Medical Research

Ashraf Saad Galal, M.DProfessor of Ophthalmology

Faculty of Medicine, Alexandria University


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Advances in Medical Research


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Serious and devastating consequences


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1st century B.C. Cleopatra (40 days to fashion a male fetus fully and 80 days tofashion a female fetus). Handmaids were impregnated with subsequent operationsto open their wombs at specific times of gestation.

1796 Edward Jenner injects healthy eight-year-old James Phillips first withcowpox then three months later with smallpox (discoverer of smallpox vaccine).

1845-1849: J. Marion Sims, "the father of gynecology" performed multipleexperimental surgeries on enslaved African women without anaesthesia.

1900: Walter Reed injects 22 Spanish immigrant workers in Cuba with the agentfor yellow fever.

1906: Dr. Richard Strong, experiments with cholera on prisoners in the Philippineskilling 13.

1913: 146 children had been inoculated with syphilis and that 15 children in St.

Vincent's House in Philadelphia had their eyes tested with tuberculin.

1919-1922: Testicular transplant experiments on 500 prisoners at San Quentin.

1945: Manhattan Project injection of plutonium into three patients at BillingsHospital at University of Chicago.

1945: Malaria experiment on 800 prisoners in Atlanta.


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a. MEDICO-MILITARY RESEARCH

i. Freezing Experiments

ii. High Altitude Experiments

iii. Sea Water Experiments

iv. Sulfanilamide Experiments

v. Bone grafting experiments

World War II (Nazi) Crimes


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b. MISCELLANEOUS

i. Poison Experiments

ii. Wound Experiments

iii. Hepatitis and TB Experiments

c. RACIALLY MOTIVATED EXPERIMENTS

i. Artificial Insemination Experimentsii. Sterilization Experiments

iii. Twin Experiments

iv. Jewish Skeleton Collection

World War II (Nazi) Crimes


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NUREMBERG CODE (1947)

1. Voluntary consent of the human subject

2. Fruitful results for the good of society

3. Based on the results of animal experimentation

4. Avoid all unnecessary physical and mental suffering and injury

5. No experiment should be conducted where there is an a priori reason to

believe that death or disabling injury will occur

6. The degree of risk should never exceed that determined by the

humanitarian importance of the problem

7. Proper preparations

8. Scientifically qualified persons

9. The human subject should be at liberty to bring the experiment to an end

10. The researcher can terminate the experiment at any stage


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Ethical principlesBelmont Report (The National Commission for the Protection of HumanSubjects of Biomedical and Behavioral Research 1979)

WHO Guidelines 1991

1. Autonomy

2. Non Maleficence/Beneficence

3. Justice


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Autonomy (Respect for persons)

Each individual:

* Is unique and free.

* Has the right and capacity to decide.

* Has value and dignity.

* Has the right to informed consent.

Informed

Free


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Primum non nocereNonMaleficence


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Beneficence

Research must:* Protect physical, mental and social well-being.

* Reduce risks to a minimum.

* Retain the community perspective.


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Justice Research must:* Conduct equitable recruitment of research participants.

* Ensure a fair distribution of risks and benefits.

* Provide special protection for vulnerable groups.


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???

Research


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GeneticResearch

Stem cellResearch

Controversial Frontiers


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Ethics must guide actions

Not all that is technicallyfeasible is ethically desirable


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Researcher Safety


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Institutional Reputation


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DECLARATION OF HELSINKI (1964)

1. Research must conform to generally accepted scientific principles and based

on adequately performed laboratory and animal experimentation

2. The design and performance of research should be under supervision of

appointed committee independent of the investigator and the sponsor .

3. Research should be conducted only by scientifically qualified persons.

4. the importance of the objective is in proportion to the inherent risk to the

subject.

5. Research should be preceded by careful assessment of predictable risks incomparison with foreseeable benefits

6. The research should respect the privacy of the subject and to minimize the

impact of the study on the subjects physical and mental integrity


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DECLARATION OF HELSINKI (1964)

7. Physicians should cease any investigation if the hazards are found to

outweigh the potential benefits.

8. the physician is obliged to preserve the accuracy of the results.

9. The subject must be adequately informed .The physician should then obtain

the subjects freely-given informed consent, preferably in writing.

10. the informed consent should be obtained by a physician who Is not

engaged in the investigation.

11. In case of legal incompetence, informed consent should be obtained from

the legal guardian.

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