CITI International Research
This compilation of laws, regulations, and guidelines is helpful to CITI
Program organizations that are involved in international research.
They included laws, regulation, and guidelines have been classified
into nine categories:
● General
● Drugs and Devices
● Clinical Trial Registries
● Research Injury
● social-behavioral Research
● Privacy/Data Protection
● Human Biological Materials
● Genetic
● Embryos, Stem Cells, and Cloning
A researcher proposes a study and wants to recruit subjects from health care
clinics in Jamaica. The survey will be conducted by U.S. researchers at the clinic.
The nurses at the clinic will inform prospective subjects about the availably of the
research, but will not consent the subjects nor perform any research procedures
(even screening procedures). Are the nurses engaged in the research according
to federal regulations?
, No, they are not engaged because they are only informing the subjects and not
consenting or performing any research procedures, or receiving or sharing any
private, identifiable information.
A professor at Big State University proposes to study attitudes about obesity in
Chile by giving subjects in Chile surveys to complete. Which is a question that
the Big State University IRB should ask the researcher in order to determine if
this study should be reviewed by a local Chilean IRB or ethics committee as well
as the Big State University IRB?
Will the researcher have collaborators at the research site abroad?
Which of the following is the LEAST important activity when protecting human
subjects in international research?
Assessing transportation conditions
What procedures must be described in an agreement called an “assurance of
compliance” with OHRP?
Procedures in place that ensure that subjects will be protected in a manner
commensurate with the Common Rule, including review by an independent
committee comparable to an IRB.
This compilation of laws, regulations, and guidelines is helpful to CITI
Program organizations that are involved in international research.
They included laws, regulation, and guidelines have been classified
into nine categories:
● General
● Drugs and Devices
● Clinical Trial Registries
● Research Injury
● social-behavioral Research
● Privacy/Data Protection
● Human Biological Materials
● Genetic
● Embryos, Stem Cells, and Cloning
A researcher proposes a study and wants to recruit subjects from health care
clinics in Jamaica. The survey will be conducted by U.S. researchers at the clinic.
The nurses at the clinic will inform prospective subjects about the availably of the
research, but will not consent the subjects nor perform any research procedures
(even screening procedures). Are the nurses engaged in the research according
to federal regulations?
, No, they are not engaged because they are only informing the subjects and not
consenting or performing any research procedures, or receiving or sharing any
private, identifiable information.
A professor at Big State University proposes to study attitudes about obesity in
Chile by giving subjects in Chile surveys to complete. Which is a question that
the Big State University IRB should ask the researcher in order to determine if
this study should be reviewed by a local Chilean IRB or ethics committee as well
as the Big State University IRB?
Will the researcher have collaborators at the research site abroad?
Which of the following is the LEAST important activity when protecting human
subjects in international research?
Assessing transportation conditions
What procedures must be described in an agreement called an “assurance of
compliance” with OHRP?
Procedures in place that ensure that subjects will be protected in a manner
commensurate with the Common Rule, including review by an independent
committee comparable to an IRB.
