Research Issues

Can be both sociological and ethical Excesses in the past have made rules and

standards necessary Rules are participant oriented and protective

Research

Issues vary with the patient populations and potential respondents involved

The issues often center around consent , failure of the consent process and the eligibility to consent (protected populations

Further issues are centered around what science can do and what science SHOULD do (moral issues)

Research

Clear differences in the articles between utilitarian and Kantian approaches to the problems

Utilitarian—community priority, gives science free rein

Kantian—Individual priority, limits science to what can be done with the least harm

Research

Uses scientific method Scientific method reviewed Science only peripherally values human

subjects, not their individual values and value Science to be convincing must be objective Medicine to be convincing must be subjective

—value the individual they serve

Scientist-physicians

Have a dual role Have dual and competing social contracts Physician—duty to the individual patient above all, to

save, heal and alleviate suffering Scientist—to objectively find the answers to

scientifically styled questions and to advance the communal knowledge base, to find, in medicine, better and safer treatments and causations for disease

Excesses

Nazi researchers Tuskegee and syphilis Applications of WHO protocol 076 in the

developing world Children and surrogate consent AIDS activism and available therapies

Randomized Trials

New therapy one group Old therapy/standard therapy/no therapy

other group Can’t know which person goes into which

group Thereby making INDIVIDUALS not the focus

of therapy

Randomized Trials

Advance science because we know 1] that new therapy is better/worse 2] that new therapy is safer/not safer Therapeutic/non-therapeutic Equipoise concept—scientist does not know

the outcome and cannot predict the outcome therefore the research can continue

Research

The issues really come down to practical issues of research clashing with ideals of medical care and medical ethics

Example--AZT trials

Controversy centers around drug availability, cost and the use of humans who are disadvantaged to determine standards of care

Blinded placebo studies

Issues

Physician has a duty to individual patients welfare

Researcher has a duty to find best therapy and to the community of medicine

These duties clash “Genuine uncertainty” standard for ethical

studies

Rights

Do poor uneducated [often foreign] people have the right to drugs that can cure them?

How is that right legally and ethically crafted? Do you have a right to medical care or to

research protocols?

Responsibilities and Duties

Who has the responsibility for care—doctors? Drug companies? Researchers?

What is the fiduciary duty? Does that duty increase with patients who

are unable to pay?

What is the Standard of care?

Legal context In international research, is there a

documented higher standard of care for use human subjects?

What standard? Local and global viewpoints

Local Standard

Determined by local conditions Availability of care and drugs locally Genuine uncertainty at a local level Placebo trials acceptable

Global Standard

Standard of genuine uncertainty measured globally—research crosses borders and humans are humans

In most cases if placebo done in developed world then can’t be done in developing world

Places duty on humans in developed world for determining the standards for everyone

Benefit Arguments

Looking at issue from patient viewpoint and researched person viewpoint

Why would YOU do the research trial? What would you get out of it? Communal and individual benefits

Exploitation Risks

Council for International Organizations of Medical Sciences (CIOMS) standards

Vulnerable populations No use of developing countries to do trials if

can be done in developed country by genuine uncertainty standard

Must benefit actual individuals No placebo trials, trials between drugs

Vulnerable Populations

Groups that cannot consent Groups that have coercion to consent

Ethics

Involved in every decision we make as doctors

Even research “At risk” populations

Summary

Easy to place risk somewhere else and benefit from it

Hard to be truly altruistic when so much money, prestige and medical opportunity is at stake