International Research - SBE (ID 509)
Questions and Answers
A great deal of research in the social and behavioral sciences may qualify for
exemption, depending upon institutional policy. If a proposed study qualifies for
exemption, federal regulations do not require review at the foreign site where it will be
conducted. Federal regulations do not require exempt research to be reviewed by an
institution's IRB or an institutional official - those decisions are left to institutional policy.
- ANSWER-
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? - ANSWER-Will the researchers have collaborators at the research site abroad?
A researcher proposes a study and wants to recruit subjects from health care clinics in
Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses
at the clinic will inform prospective subjects about the availability 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? -
ANSWER-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 researcher proposes to conduct a study at a foreign site. The research has been
determined to be exempt from the federal regulations by institutional policy. According
to federal regulations, is review required at the foreign site? - ANSWER-If a proposed
study qualifies for exemption, federal regulations do not require review at the foreign
site where it will be conducted.
If an institution obtains informed consent and conducts research interviews it is engaged
in research. - ANSWER-
If research involves collaboration with an institution that is "engaged" in research in the
foreign country, the collaborating institution will need to have 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. These
procedures must be described in an agreement called an "assurance of compliance"
with a U.S. federal agency. The written procedures for reporting unanticipated problems
are institutional policy, the procedures outlining randomization should be covered in the
research plan/protocol, and the procedures in place to comply with ethical principles is
the Federalwide Assurance (FWA), not "assurance of compliance." - ANSWER-
Questions and Answers
A great deal of research in the social and behavioral sciences may qualify for
exemption, depending upon institutional policy. If a proposed study qualifies for
exemption, federal regulations do not require review at the foreign site where it will be
conducted. Federal regulations do not require exempt research to be reviewed by an
institution's IRB or an institutional official - those decisions are left to institutional policy.
- ANSWER-
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? - ANSWER-Will the researchers have collaborators at the research site abroad?
A researcher proposes a study and wants to recruit subjects from health care clinics in
Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses
at the clinic will inform prospective subjects about the availability 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? -
ANSWER-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 researcher proposes to conduct a study at a foreign site. The research has been
determined to be exempt from the federal regulations by institutional policy. According
to federal regulations, is review required at the foreign site? - ANSWER-If a proposed
study qualifies for exemption, federal regulations do not require review at the foreign
site where it will be conducted.
If an institution obtains informed consent and conducts research interviews it is engaged
in research. - ANSWER-
If research involves collaboration with an institution that is "engaged" in research in the
foreign country, the collaborating institution will need to have 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. These
procedures must be described in an agreement called an "assurance of compliance"
with a U.S. federal agency. The written procedures for reporting unanticipated problems
are institutional policy, the procedures outlining randomization should be covered in the
research plan/protocol, and the procedures in place to comply with ethical principles is
the Federalwide Assurance (FWA), not "assurance of compliance." - ANSWER-
