5.3 Toysmart case exercises - student module  (Page 5/19)

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Supporting documents and tables

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Intermediate moral concept: informed consent

Concept and definition

• Informed Consent : The risk bearer consents to taking on the risk on the basis of a complete understanding of its nature and breadth.
• Belmont Report : "subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them."
• "This opportunity is provided when adequate standards for informed consent are satisfied."
• Quotes take from Belmont Report

Arguments for free and informed consent as a moral right

• Free and informed consent is essential for the exercise of moral autonomy. Absence implies force, fraud, or manipulation all of which block the exercise of moral autonomy.
• The standard threat occurs when crucial risk information is not communicated to risk taker. This could be because the risk taker cannot appreciate the risk, because the mode of communication is inadequate, or because the information has been covered up. Given this standard threat, free and informed consent is vulnerable ; it must be protected.
• Informed consent must be shaped around its feasibility, that is, the ability of the duty holder to recognize and respect this right in others. If private individuals exercise their right as a veto, then they can block socially beneficial projects. There are also serious problems concerning children, mentally challenged adults, and future generations. Finally, it may not be possible or feasible to know all risks in advance.

Conditions for recognizing and respecting right

• From Belmont Report
• Information : research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research.
• Comprehension : manner and context in which information is conveyed is as important as the information itself.
• Voluntariness : an agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence.

Other legal and moral frameworks

• Institutional Research Boards or IRBs now require documentation of informed consent on research projects carried out under the university's auspicies. This is in response to requirements by granting agencies such as the National Institute for Health and the National Science Foundation.
• Consenting to the transfer of PII (personal identifying information) online :opt-in and opt-out.
• Opt-in : Information is transferred only upon obtaining express consent. Default is not transferring information.
• Opt-in : Information transfer is halted only when person to whom information applies does something positive, i.e., refuses to consent to transfer. Default is on transferring the information.
• Liability Rules and Property Rules : These also have to do with consent. Sagoff makes this distinction with reference to activities that have an impact on the environment. an injunction referring to liability rules stops the activity to protect the individual who proves impact. Property rules require only that the producer of the environmental impact compensate the one who suffers the impact.