Intellectual Property,Human Subjects in Research,

& Informed Consent

GRAD 721: Research EthicsFall 2008

Intellectual Property

• Property– Tangible: can be sensed or touched– Intangible (Intellectual): • Ideas in books• Music• Codes and software

(Ideas must be expressed or instantiated to qualify as intellectual property)

– Property makes possible rights. • What is the value of property rights?

Socrates Plato

John Locke1632-1704

• U.S. Constitution, Art. 1, sec. 8:

• Congress has the right … “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”

The Prisoner’s Dilemma

The Setup:• Two men, A and B, have been arrested and

are suspects in a burglary.• The police have evidence sufficient to convict

each of stealing the getaway car, but not sufficient to convict either of burglary.

• A confession from either would give them sufficient evidence of burglary.

The Prisoner’s Dilemma, cont.

Confess Don’t Confess

Confess

10

6

0

Don’t Confess

6

0

10

2

2

Prisoner B

Prisoner A

Tragedy of the Commons Imagine a commons in which shepherds graze their sheep.• Each shepherd wants to own as many sheep as possible.• Once the “carrying capacity” of the pasture is reached, each

additional sheep harms the pasture.• Each shepherd benefits by adding another sheep to the

pasture (regardless of what the other shepherds do).

• This problem has no technical solution.

Garrett Hardin: “Therein is the tragedy. Each man is locked

into a system that compels him to increase his herd without limit – in a world that is limited. Ruin is the destination toward which all men rush, each pursuing his own best interest in a society that believes in the freedom of the commons. Freedom in a commons brings ruin to all.”

Tragedy of the Commons, cont.

Other Examples:• Fishing• Foresting• Parking in free areas• National Parks• Population • Air and water pollution

Tragedy of the Commons, cont.

• “Invisible hand” arguments fail– Adam Smith: Each individual, who “intends only his own

gain,” is “led by an invisible hand to promote…the public interest.”

– Hardin: “The rational man finds that his share of the cost of the wastes he discharges into the commons is less than the cost of purifying his wastes before releasing them. Since this is true for everyone, we are locked into a system of ‘fouling our own nest,’ so long as we behave only as independent, rational, free-enterprisers.”

Tragedy of the Commons and Intellectual Property

• Solutions:– Trust or coercion– Private Property

• Intellectual Property?– Rights limit access (which has economic benefits)– Problems:• Fichte: Ideas contained in a work belong to society;

original expression of an idea belongs to the author. • Fichte has artworks in mind.

Intellectual Property Rights, cont.• Copyright: – Legal protection of authorship – Limited by Fair Use doctrine

• Patent– Property rights for inventions

• Trademarks– Words or symbols that indicate the provider of a

good.• Trade secrets– Information that gives the holder a competitive

advantage in the marketplace.

Conflicts of Interest

• Situations in which financial or other personal considerations have the potential to compromise or bias professional judgment.– See the 19 guiding principles in the FASEB Report

Research on Human Subjects

• Belmont Report Principles:– Respect for persons• Respect for dignity and autonomy• Importance of Informed consent

– Beneficence• Protect from harm• Analyze risks and benefits

– Justice• Benefits and burdens of research should be equitably

distributed • Justice should guide the selection of research subjects

Research on Human Subjects• Institutional Review Board Decision Criteria– Risk vs. Reward

• Are risks identified?• Are risks minimized?• Do benefits outweigh risks?

– Selection of Subjects• No discrimination• Safeguard vulnerable populations• Distribute benefits fairly• Protect Privacy

– Informed Consent– Research Design

• Are methods valid to justify risk? Is PI qualified?

The Milgram Experiment

Recall: Psychological Research on Heuristics and Biases

• Our reliance on heuristics is generally beneficial, but we can but we can make important mistakes.

• Our preferences (and values) are not pre-existing and firmly fixed. They are constructed in the process of elicitation, and they are influenced by the framing (description) of the problem, and not solely by the value of the expected outcomes.

• Experts are as prone to these influences as lay people.

• We need to be guided by knowledgeable experts who describe alternatives to us.

Informed Consent

• Four models of informed consent for medical decisions (Emanuel and Emanuel, 1992):

– Traditional (separate) models:• Paternalistic:

– The physician is the expert; the physician decides.

• Informative: – The physician gives the facts, the patient expresses

preferences.

Informed Consent• Four models of informed consent for medical

decisions (Emanuel and Emanuel, 1992):

– Interactive models:• Interpretive:

– The physician takes on the role of a counselor, helping the patient to articulate her values and make a decision that best realizes her aims.

• Deliberative: – The physician is a “teacher or friend.” – Physician and patient together judge through a dialectical

process the worthiness and importance of health-related values.

Informed Consent• Strengths and weaknesses of the models:

– Deliberative methods make demands on a physician’s time and requires skills that are beyond some physicians’ expertise.

– Deliberative methods risk lapsing back into a paternalistic method.

• E&E claim that autonomy requires “that individuals critically assess their own values and preferences; determine whether they are desirable; affirm, upon reflection, these values as ones that should justify their actions; and then be free to initiate actions to realize the values.”