A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?

A. The subjects’ privacy has been violated.

B. Confidentiality of the data has been breached.

C. There was neither a violation of privacy nor a breach of confidentiality.

D. There was both a violation of privacy and a breach of confidentiality.

Which of the following constitutes both a breach of confidentiality (the research data has been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?

A. A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

B. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.

C. A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.

D. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.

In this exercise, suggest a method that might be used to collect data for the study stated below. Tell whether your method uses a population or a sample.

Heights of children entering kindergarten

A waiver of the requirement for documentation of informed consent may be granted when?

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 statement in a consent form is an example of exculpatory language?

When can a waiver of the requirement for documentation of informed consent be granted?

What is the best definition of reciprocal determinism?

One of your subjects is halfway through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should not be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher?

A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. What should the student's IRB do?

Which subpart of DHHS regulations Does NOT provide additional protections, and for which vulnerable populations?

Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:
a. Reporting data in aggregate form in publications resulting from the research.
b. Destroying all identifiers connected to the data.
c. Keeping the key linking names to responses in a secure location.
d. Requiring all members of the research team to sign confidentiality agreements.
e. All of the above

The primary purpose of a Certificate of Confidentiality is to:

A. Allow law enforcement to investigate abuse cases.

B. Prevent subjects from knowing the purpose of a study.

C. Protect identifiable research information from compelled disclosure.

D. Protect researchers from disclosing conflicts of interest.

What is a general requirement for the informed consent form?

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: