CITI Training Review: Human Subjects Research

Example of how the principle of beneficence is applied to a study involving human subjects correct answerEnsuring that the risks are reasonable in relationship to anticipated benefits

Harvard "Tastes, Ties, and Time (T3)" (2006-2009) Study involves this primary ethical violation correct answerThe researcher's failure to protect research subjects from deductive disclosure (primary ethical violation)

"The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male" Study correct answerThe study most directly linked to the establishment of the "National Research Act" (1974) and ultimately the "Belmont Report and Federal Regulations for Human Subject Protection"

The Belmont principle of Beneficence correct answerRequires that: potential benefits justify the risks of harm

The Belmont principle of Justice correct answerMoral Requirement that: there be fair outcomes in the selection of research subjects

Identifiable Private Information (according to Federal regulations) correct answerData obtained by an investigator about human subjects/living human beings through interaction/intervention with an individual

Example of a study that meets the definition of research with human subjects (according to Federal regulations) correct answer1 - A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.

2 - A study of twenty 4th grade classrooms in which researchers ask the school to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

3 - An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.

4 - A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.

Example of Public Information correct answerCensus data (final report as published by the Census Bureau)

Example of Private Information correct answerA medical record

Example of a study the IRB will not review because it is not research (as defined by the Federal regulations) correct answerA 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

A subject in a clinical trial experiences a serious, unanticipated adverse drug experience. The investigator should proceed, with respect to the IRB, after the discovery of the adverse event occurrence by: correct answerReporting the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB

An investigator is required to keep consent documents, IRB correspondence, and research records for: correct answerA minimum of 3 years after completion of the study

Expedited review or a new, proposed study may be used by the IRB if: correct answer- the study involves no more than minimal risks

- AND meets one of the