Psy 212

D

A 46-year old man is currently enrolled in a Phase 1 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? Select one: a. Do not tell the subject about the new drug since physicians have the right to try out new treatments with their patients. b. Withhold this new information to avoid confusing the subject with other treatment options or alternatives. c. Tell the subject about the new drug but discourage him from switching treatments until the study is completed. d. Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the

D

A general requirement for the informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? Select one: a. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with your doctor or your right to health care of other services that you may be eligible for. b. In the event of any injury you may have related to this research, you will be given medical treatment. c. The investigator may stop you from participating in this research without your consent if you experience side effects that your condition worse. If you become ill during the research, you may have to drop out. d. You must provide blood samples that will be kept in a "bank" for future research. Once you have provided these blood samples, you cannot change your mind about being in the research and have the sample removed from the "bank". Correct

B

An investigator fails to inform subjects about the foreseeable risks in a study of a new drug. Which of the following best describes the ethical principle violated? Select one: a. Access to research b. Respect for persons Correct c. Justice d. Research Integrity

A

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent for the individual's legal representative. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator. Select one: a. The investigator and another physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. Correct b. Do not use the test article until either the subject or the subject's legal representative can give consent. c. Use the test article without obtaining consent from the subject or the legal representative then notify the IRB. d. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.

A

An investigator wishes to study lifestyle and diet influences on the risk of developing a specific cancer. The investigator chooses a case control design with paired lifestyle interviews and a few blood and urine tests and assigns a study manager to identify patients with the diagnosis from the pathology logbook that lists names. The study manager would then ask each patient's primary physician for permission to contact the patient. Which of the following is required before the investigator begins the study? Select one: a. IRB review and approval Correct b. Hospital accreditation c. A Clinical Trials Office d. Permission from the Oncology Department

C

In what way did the Beecher article impact research in the United States? Select one: a. It prompted congress to create an ad hoc panel to provide oversight for human research. b. It resulted in the creation of the IRB. c. It heightened awareness of problems with unethical research. Correct d. It reinterpreted the Belmont principles with a focus on therapeutic medical research.

a

The Belmont Report describes all of the following EXCEPT: Select one: a. The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest as an example of the Principle of Justice. Correct b. The Belmont Report describes the concept of "Respect for Person". c. The Belmont Report defines and delineates the differences between "Practice" and "Research". d. The Belmont Report describes the need to carefully consider how research discoveries and risks will be fairly distributed in the society.

B

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Select one: a. Providing detailed information about the study and obtaining the subject's consent to participate. b. Determining that the study has a maximally favorable risk vs. benefit ratio. Correct c. Insuring that the selection of subjects includes people from all segments of the population. d. Insuring that confidentiality is maintained/

D

Which of the following lists the three principles discussed in the Belmont Report? Select one: a. IRB Review, federal regulations, Declaration of Helsinki b. Privacy, Confidentiality, Equitable selection of subjects. c. Informed Consent, Institutional Assurance, Researcher responsibility. d. Respect for Person, Beneficence, Justice Correct

B

Which of the following studies led to the establishment of the National Research Act and ultimately the Belmont Report and Federal and Federal regulations for human subject protection? Select one: a. Obedience to authority study (Milgram study) b. The Public Health Service (PHS) syphilis study Correct c. Nazi medical experiments d. Jewish chronic disease study