Human Research

“Of Mice but Not Men: Problems of the Randomized Clinical Trial”- Hellman

content that randomized clinical trials place physician scientists in a terrible ethical bind

before or during a trial, if a physician scientist believes that a new treatment is better or worse than the alternative treatment, they have a physicians duty to communicate this judgement to their patient subjects and ensure they get the best treatments

what is the role of a scientist according to the Hellmans?

answering questions-i.e determining the validity of formally constructed hypotheses

What do the Hellmans say are utilitarian objections?

physicians must care about the distribution of pain and pleasure of their patients

physicians must see patients in a Kantian way, as bearers of rights who cannot be used for the greater good of humanity

“A response to a purported ethical difficulty with randomized clinical trials involving cancer patients”- Benjamin Freedman

conflict between the conduct of the RTC and the rights of the patients

the right of the patient to some specific treatment must be greanted in a proffesional judgement derived from medical consensus

clinical equipoise

honest disagreement in the expert medical community regarding the comparative merits of two or more forms of treatment for some condition

“How to resolve an Ethical Dilemma Concerning Randomized Clinical Trials”- Don Marquis

Dilemma: suppose an RCT comparing two treatments is in progress and a physician has an opinion about which treatment is best. Since she has the duty to promote the patients best medical interests, she seems obliged to advise her patient to receive the treatment she prefers

“Racism and Research: The Case of the Tuskegee Syphilis Study”- Allan M. Brandt

Brandt recounts in detail the abuses of human rights and the deliberate harm perpetrated in the infamous Tuskegee syphillis study

He declares the the study revealed more about the pathology of racism than it did about the pathology of syphillis

“Famine, Affluence, and Mortality”-Peter Singer

1. intense suffering and/or death from famine, poverty is bad

2. We can prevent a lot of that intense suffering and death by donating to effective charities

3. Many of our spending on luxuries are morally insignificant. It would be possible to give them up without sacrificing anything of moral importance

4. If we are able to prevent something bad from happening without sacrificing anything that is morally significant then we are morally obliged to do it

Conclusion: We are morally obliged to donate to effective charities rather than spending on luxuries that are morally insignificant

“The Ethics of Clinical Research in the Third World”- Marcia Angell

maintains that randomized clinical trials comparing two treatments are morally permissible only when investigators are in a state of equipoise- that is, when there is no good reason for thinking that one treatment is better than another

-for placebo controlled trials, there must be no known effective treatment to compare with the new treatment

-third world countries should receive the best treatment and not just the local treatment

“Ethical Issues in Clinical Trials in Developing Countries”- Baruch Brody

Responds to major doubts raised by the ethics of some third world clinical trials conducted to evaluate a regimen ot prevent mother to infant transmission of HIV

-argues that the use of placebo control groups was ethical because no subjects were denied any treatment that should otherwise be available to him or her in light of the practical realities of health care resources available in the country in question.