1. What you know… You work at the East Texas Cancer Center in Tyler, Texas as a physicist who “maintains and checks the machine regularly.” (Huff 2005) Patient complains of “a bright flash of light, heard a frying, buzzing sound, and felt a thump and heat like an electric shock.” (Huff 2005) This indicates radiation overdose but AECL engineers say, “the Therac-25 was unable to overdose a patient and also… that AECL had no knowledge of any overexposure accidents by [other] Therac-25 machines [in use].” A few days after the unit was put back into operation, another patient complained that his face felt like it was on fire (Huff 2005)

2. Something is clearly wrong. But you have no idea what it is. You would like to investigate further to see whether… – the patients’ complaints indicate radiation overdoses – the overdoses were caused by a defect in the Therac- 25 machine – the overdoses were caused by operator error Constraints – AECL engineers state that there is no problem with the machine, and they have received no complaints about the other machines that are in operation – ETCC administrators have told you that you cannot interview the two patients making the complaints – Your job is on the line

3. Decision Point You supervise the radiation unit at your hospital. A patient has complained that he has received a radiation overdose during a treatment session caused by the malfunctioning of the Therac-25 unit. Construct an argument for or against the continued operation of the therac-25 units while investigating complaints. Integrate ethical, social and financial considerations into your argument. How does the informed consent of the patients enter into this situation? What role do safety and risk play?

4. Informed Consent  Consent of risk taker to understand the nature and breadth of the risk he or she is being asked to take. 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.” Free and informed consent is essential to autonomy The standard threat occurs when crucial risk information is not uncovered in risk assessment or is covered up by those who stand to lose due to its publication Informed Consent does suffer limits in terms of its feasibility. Do private indivuals have the right to veto large scale government projects? (This is not just a utilitarian vs. deontological issue: it could also be framed as a conflict within deontology between different, conflicting rights and duties) Belmont Report: Conditions for Informed Consent 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. Institutional Research Boards IRBs) now require documentation of informed consent on research projects carried out under that university’s auspices. This is in response to requirements by federal granting agencies such as the NIH and the NSF. http://www.hhs.gov/ohrp/humansubjects/guidance/ belmont.htmhttp://www.hhs.gov/ohrp/humansubjects/guidance/ belmont.htm (Accessed December 13, 2007) Consenting to the transfer of PII (personal identifying information) online Opt-in: information transferred only with express consent. Default is not transferring information Opt-out: information transfer is halted when person to whom PII refers does something positive. Default is on transferring information Liability Rules and Property Rules: 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. Therac-25 Case  Patients receiving radiation therapy should be made aware of the risks of this treatment including the possible malfunction of the machine or its software