The document discusses the history and ethics of human subject research. It notes that the Nuremberg Code established informed consent as a key ethical principle. However, unethical experiments still occurred on vulnerable groups in the U.S. The document explores views on whether utilitarianism could justify coercive research that benefits many at the cost of few. It also examines the challenges of recruiting enough voluntary research subjects and potential problems with clinical trials like conflicts of interest and coercion. Finally, it outlines features of properly designed trials including informed consent, clinical equipoise, and asking questions that are useful and worth answering.

1. The Researcher-Subject
Relationship
Week 2 – The Rise of Bioethics

2. Nazis on Trial
 Nuremberg Medical Trials (1946-47)
 Nuremberg Code: Heavy emphasis on informed
voluntary consent of research subjects
 Became the basis for future ethical guidelines, including
The Belmont Report in the United States
 Meanwhile…
 1941: Experiments on orphans at the Ohio Soldiers and Sailors
Orphanage, the mentally handicapped at New Jersey State Colony
for the Feeble-Minded and at a mental institution in Illinois. Not to
mention studies involving soldiers themselves.
 The Tuskegee Study (~1930): 42 year long study of untreated
syphilis in 399 African-American males.

3. Justifying Coercive
Research
 Utilitarianism: That act is right which produces the greatest
balance of happiness to suffering for all affected.
 Impersonal, egalitarian; emphasizes BENEFICENCE and NON-
MALEFICENCE, rather than AUTONOMY or JUSTICE
 Likely justifies situations like Omelas and efficacious research
 Hellman & Hellman: Incompatible with proper relationship
between physician and patient
 But may represent the proper relationship between researcher and
research subject
 If research will (or is likely to) result in a great benefit to
many people, then maybe it is right to sacrifice the few for
the many

4. The Need for Research
Subjects
 Cannot get enough subjects voluntarily
 Only 3% of adult cancer patients volunteer for studies
 Fears of receiving inferior treatment or no treatment (a
placebo) and of added burden
 Many studies just never happen
 Only half of the studies sponsored by the National
Cancer Institute enrolled enough research subjects to
have the chance of producing a meaningful result
 Only 1 in 5 studies actually publishes its results
 Over burdensome for the physician-researchers
 Time consuming, poor compensation

5. Randomized Clinical Trials
 Is drug A more effective than drug B?
 Many complexities that can make that question hard to
answer
 Organize a group of subjects, and randomly divide
them into an ‘A’ and ‘B’ group
 Attempts to control for the many complexities by not
intentionally selecting for them
 May be ‘blinded’ where participants do not know
particular information, like who is taking which drug

6. Problems with Clinical
Trials
 Violates physician’s obligation to her patient
 Conflicts of Interest
 Financial benefits; physician and researcher at
the same time
 Valid Informed Consent
 Financial benefits for volunteers
 Coercion due to power imbalances
 Coercion to prevent early withdrawal from
studies

7. Features of a Properly
Designed Trial
 Passamani: 3 features of properly designed trials
 Informed Consent
 Follows from Respect for Persons
 Clinical Equipoise: None of the possible therapies has
been shown to be better than any of the others
 Forms the ethical boundary between moral and immoral
research studies
 Follows from Beneficence and Non-Maleficence
 Useful Research: Asks an open question worth
answering for therapeutic reasons
 Follows from Justice