Week 7: Research with Human Subjects

Medical Research

Goals

Determine causes of diseases.

Determine effective treatments for diseases.

Effective clinical trials: Evidence-based medicine

Randomized: Divide people randomly into conditions.

Double blind: Neither the participants (subjects) nor the researchers know what condition each participant is in.

Placebo controlled: Include a condition in which people are given a non-treatment.

Canadian Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans

Principles

1. Respect for persons: autonomy, protect those with diminished autonomy
2. Concern for welfare: quality of life, avoidance of harm
3. Justice: fairness and equality

Questions

1. Does the proposed research jeopardize the safety of participants and/or researchers?
2. Are the risks to the participants justified by the potential benefits of the research?
3. Is there a process that ensures that participants give consent?
4. Do the researchers have any conflicts of interest?
5. Do incentives of the study make participants vulnerable to harm?
6. Are there threats to privacy and confidentiality?
7. Does dissemination of results put participants at risk?
8. Are vulnerable individuals included in the study?  If so, how are they protected?
9. Are relevant individuals or groups being excluded from the study?

Competence vs Incompetence

A person is competent to make medical decisions if he or she:

• Understands different options available.
• Understands the consequences of different options.
• Can compare the consequences in order to choose the best option.

Examples of incompetent people:

• Very young.
• Seriously cognitively disabled
• Seriously mentally ill
• Unconscious.
• Demented.

Research Involving Competent Persons

Some Notorious Cases

Tuskegee Experiment, 1932-1972

Nazi Medical Experiments

Some Canadian Cases

Brainwashing at McGill

The Olivieri controversy

David Healy

Ethical Issues

1. Should research be approved by Research Ethics Boards (REB)?

2. Does research require informed consent by the subjects? What degree of information is necessary?

3. How can the risks to subjects be balanced against the potential benefits for later patients?

4. Is it ethical to use placebos, especially when standard therapies are available?

5. Should medical research be funded by industry?

6. Should industry employ medical ghostwriters?

Placebo Trials

Placebos are used to determine whether a treatment is biologically effective.

Problem 1: Deception vs. informed consent.

Problem 2: Availability of standard therapies.

University-Industry Relationships

Problems

1. Researchers may have conflicts of interest, becoming motivated to get results that support those who fund them.
2. Universities may have conflicts of interest, not supporting ethical researchers.

Possible Solutions

1. Have researchers disclose all sources of funding.
2. Schafer: Ban all industry funding of university research.
3. Moderate: ensure more oversight.

Research Involving Incompetent Persons

Neonatal Research

Problems with informed consent:

• Efficacy of new treatments needs to be evaluated.
• Newborns cannot give consent.
• Time is very limited with neonatal problems.
• Parents are distressed and have difficulty giving informed consent.
• Specific antenatal consent is unattainable.

Manning's solution:

• Parent's consent would be presumed.
• Parents could opt out.
• Benefits: Increased recruitment and less parental distress.

Dementia

Kinds of dementia: senile, Huntington's.

Dementia involves loss of insight, intellect, and judgement.

Should patient's be informed that they have Huntington's?

How directive should physicians be?

Review Questions for Week 7

1. For experiments with human subjects, what is informed consent and why is it necessary?
2. State 5 proposed rules for governing university-industrial relationships.
3. Essay question: Discuss whether using placebos in research with human subjects is right or wrong, taking into account consequences and rights and duties. For each option, discuss: consequences pro, con, and overall; rights pro, con, and overall; your overall conclusion concerning the options based on consequences and rights.
4. Why is it difficult to acquire informed consent in neonatal research?
5. How does dementia render people incompetent to provide informed consent?
   

Phil 226

Computational Epistemology Laboratory.

Paul Thagard

This page updated Oct. 29, 2012