CITI TRAINING: Social/Behavioral Human Research Course

The researcher's failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies?

"Tastes, Ties, and Time (T3)" study

Trust and transparency are critical to successful and culturally competent research. In the research setting, establishing trust in diverse communities does NOT require:

Limiting public transparency and accountability.

Which of the following are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice

Cultural competence in research is defined as the ability of researchers to provide high quality research that takes into account:

The diversity of population's values, beliefs and behaviors when developing research ideas, conducting research and exploring applicability of their findings.

Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

Respect for persons

Overcoming challenges to cultural competence in research requires that: (Check ALL that apply) Select all correct answers.

Investigators examine and understand historical contexts for study populations before initiating research study design. Early-phase study design should take into account race, ethnicity and cultural factors. IRB membership should include representatives of large communities and cultural groups as representatives.

NIH has set forth guidelines on the inclusion of women and members of minority groups and their subpopulations in biomedical and behavioral human subject research. This inclusion is to ensure that:

Valid analyses of differences in intervention effects can be accomplished.

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that:

Persons with diminished autonomy are entitled to protection.

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?

Determining that the study has a maximization of benefits and a minimization of risks.

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection?

PHS Tuskegee Study

In 1979, the National Commission for the Protection of Humans Subjects of Biomedical and Behavioral Research developed ethical principles and guidelines for the protection of human subjects for research. The purpose of these guidelines was to:

Provide a framework for use in the resolution of ethical problems arising from research involving human subjects.

A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of:

Respect for persons

The Belmont principle of beneficence requires that:

Risks to subjects are reasonable in relation to anticipated benefits.