Quiz Results - SBE Refresher 1 - Defining Research with Human Subjects

Which of the following is a measure researchers can use to protect the confidentiality of subject data?

Keep sensitive and identifiable data in encrypted files on a password protected hard drive.

If federally funded research involves collaboration with an organization that is "engaged" in research in a foreign country, the foreign organization can rely on the US researcher's institution's IRB for its review.

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According to the criteria for IRB approval, when considering equitable treatment of subjects, special care must be taken with which of the following populations?

prisoners

IMMUNIDEFICINECY DISORDERS 1. what is ID? WHAT IS IT CHARACTERISTICS? VERSE NEOPLASMS? 2. ID hallmark?

1-characterized by absences ; EXCESS oR UNCONTROLLED 2-enhanced susceptibility to infections -More frequent illness -Common illness that is more severe or lasts longer than normal o Disease due to uncommon pathogens o Disease due to commensal organisms o Disease that fails to respond to otherwise normal treatment

Which of the following proposed studies would constitute human subjects research as defined under the federal regulations?

A researcher from a school of social work obtains access to students' academic records (including identifiable information) to assess the effect of drug awareness programs on student academic achievement.

The informed consent document, regardless of the research topic, must always include the following:

A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.

Providing parents information about a study, in lieu of active parental permission, is allowed when:

An IRB has approved a waiver of the requirement for parental permission

Which of the following activities meets the federal definitions of research? Your Answer

Collection of elementary school test scores to evaluate the effectiveness of an experimental program to teach reading Comment

When the primary potential harm is the breach of individually identifiable data, to protect against such disclosure the researcher should.

Encrypt the data and store it in password protected files.

Which of the following practices is an example of how the principle of beneficence is applied to a study involving human subjects?

Ensuring that risks are reasonable in relationship to anticipated benefits.

Which statement is correct about informed consent?

It requires disclosure of any benefits to the subject or to others that may reasonably be expected Comment

A graduate student in Communications intends to write her thesis, as part of a federally-funded study, on the effect of print versus televised media on people's daily lives. The researcher wishes to conduct the study in a local prison because of limited resources for subject recruitment. The subjects will be asked for 15 minutes of their time. The questionnaire appears innocuous and the risks appear to be minimal. The IRB should:

Not approve this project because the research question could be answered without the participation of prisoners.

A researcher wishes to conduct a study on the relationship between paternal care giving (that is, the care the prisoner subjects received as children from their fathers) and incarceration, using a short 15-minute survey. Which category applies to this research?

Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects (Category i) Comment

When research is conducted in educational settings with children, when is the assent of potential student subjects required?

When the IRB has determined that students are capable of providing assent.

Which of the following research activities with children qualifies for exemption?

A researcher observing children in a playground to identify bullying behaviors.

When evaluating risks of harm IRBs must determine that:

isks are reasonable in relation to anticipated benefits.

Which of the following constitutes both a breach of a confidentiality (the research data have 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 faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

Which of the following activities constitutes engagement in research?

Obtaining informed consent and conducting research interviews.

In accordance with federal regulations, which of the following statements best describes when research with children may be exempt?

Only certain exemption categories can be used with research involving children.

Which of the following statements about individually identifiable research data is correct?

Researchers may be required to release individually identifiable information outside the research setting.

A researcher fails to inform subjects about the risks and benefits of being in a focus group. Which of the following describes the ethical principle violated by the researcher?

Respect for persons