Assessing Risk - SBE, CITI Questions and Answers A 46-year-old man is currently enrolled in a Phase 2 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?
- Withhold this new information to avoid confusing the subject with other treatment
- Give the subject comprehensive information about the new drug, including its side
- Do not tell the subject about the new drug since physicians have the right to try out
- Tell the subject about the new drug but discourage him from switching treatments
options or alternatives
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 new drug.
new treatments with their patients
until the study is completed - ANSWER-B. 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 new drug.A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT: - ANSWER- Data that does not cross state lines when disclosed by the covered entity.A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: - ANSWER-A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: - ANSWER-A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements 1 / 3
in a consent form is an example of exculpatory language? - ANSWER-Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases 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? - ANSWER-Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.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 waive any of the subject's legal rights or releases 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?
- I waive any possibility of compensation for injuries that I may receive as a result of
- The investigator may stop you from participating in this research without your
- Your participation in this research is voluntary. If you choose not to participate, or
participation in this research.
consent if you experience side effects that make your condition worse. If you become ill during the research, you may have to drop out.
change your mind later, your decision will not affect your relationship with your doctor or your right t - ANSWER-A. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
A HIPAA authorization has which of the following characteristics: - ANSWER-Uses
"plain language" that the data subject can understand, similar to the requirement for an informed consent document.
A medical record is an example of:
- Public behavior.
- Public information.
- Private information.
- Private behavior. - ANSWER-C. Private information.
A medical record is an example of: - ANSWER-Private information
A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB.What action can he expect by the IRB? 2 / 3
- The IRB will not review this study because it does not involve an investigational new
- The IRB will not review this study because it does not include human subjects as
- The IRB will not review this study because it is not research as defined by the federal
- The IRB will review this study because it includes human subjects and is considered
- Researchers must only submit COI disclosures if they have a significant financial
- Not until a notice of award is received
- Never -- the PHS regulation does not require researchers to submit COI disclosures
- No later than the time of proposal submission - ANSWER-D. No later than the time of
- / 3
device.
defined by the federal regulations.
regulations.
research. - ANSWER-C. The IRB will not review this study because it is not research as defined by the federal regulations.A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB.What action can he expect by the IRB? - ANSWER-The IRB will not review this study because it is not research as defined by the federal regulations.A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB? - ANSWER-Will the researchers have collaborators at the research site abroad?A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission? - ANSWER-The research must pose no more than minimal risk.A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
interest related to the research
proposal submission A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB? - ANSWER-No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.