CITI Training Objectives Flashcards
What are the three principles in the Belmont report?
Respect for Persons, Beneficence, and Justice
How can we apply the principle of beneficence?
Assess the risks and benefits of the study
How can we apply the respect for persons principle?
Informed consent
How can we apply the principle of justice?
Moral requirement that there be fair outcomes in the selection of research subjects
What are the rules of the Nuremberg Code?
A requirement for voluntary consent
That the research have scientific merit
That the benefits of the research outweigh risks
That the subjects have the ability to terminate participation in the research at anytime
What occurred in the PHS Study of Untreated Syphillis?
A medical research project conducted by the PHS from 1932 to 1972 (commonly known as the “Tuskegee Syphilis Study” or the “PHS Syphilis Study”) that examined the natural course of untreated syphilis in Black American men (CDC 2013). According to the Centers for Disease Control and Prevention (CDC), the subjects, all impoverished sharecroppers from Macon County, Alabama, were unknowing subjects in the study; they were not told that they had syphilis, nor were they offered effective treatment when it became available in the late 1940s with the availability of penicillin. The study concluded in 1972 when stories about the study appeared in the public press and caused a public outcry
What is the IRB?
A review committee was established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for research involving human subjects if it is conducted, supported, or regulated by U.S. federal departments and agencies
What is informed consent’s purpose? What are the three steps?
A demonstration of how researchers and those involved in human subjects research show respect to research subjects in order to protect human subjects, ensure safety, provide the potential study subjects with information
Steps:
Providing information to the subject
Answering questions the subject may have to improve his/her comprehension
Obtaining the subject’s voluntary agreement to participate in the study
What are the vulnerable populations when obtaining informed consent?
Children
Prisoners
Pregnant women
Handicapped persons
Mentally disabled persons
Economically or educationally disadvantaged persons
What is a conflict of interest? What are the major types?
situations in which financial or non-financial considerations may compromise, or have the appearance of compromising, a researcher’s objectivity in meeting duties or responsibilities (including those associated with research activities)
Types: individual and institutional
Subcategories: financial & non-financial
