CITIop 3

Download as pdf or txt
Download as pdf or txt
You are on page 1of 5

Miriam Macias

ID 7748193

International Research - SBE


Seattle University - Human Subjects Research for IRB (Faculty, Staff, and
Student)

Quiz Results
You correctly answered 5 of 5 quiz questions.

Question 1
Question Which of the following is the least important activity when protecting
human subjects in international research?

Your Assessing transportation conditions


Answer

Result Correct

Comment It is essential that researchers have sufficient knowledge of the local


research context to be able to design and carry out research in a way that
protects the rights and welfare of the subjects. This includes knowledge
about unique risks subjects might face given the local socio-economic
conditions. Community consultation is particularly important when
research has the potential to affect the community as a whole and when
there are gatekeepers for the community (for example, a tribal council).
Question 2
Question What procedures must be described in an agreement called an "assurance
of compliance" with a U.S. federal agency?

Your Procedures in place that ensure that subjects will be protected in a manner
Answer commensurate with the Common Rule, including review by an independent
committee comparable to an IRB.

Result Correct

Comment 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.”

Question 3
Question 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 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?

Your No, they are not engaged because they are only informing the subjects and
Answer not consenting or performing any research procedures, or receiving or
sharing any private, identifiable information.
Result Correct

Comment 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. An institution is not engaged if
its only involvement is to provide space for the U.S. researchers to conduct
their own research.

Question 4
Question Which of the following activities constitutes engagement in research?

Your Obtaining informed consent and conducting research interviews.


Answer

Result Correct

Comment If an institution obtains informed consent and conducts research interviews


it is engaged in research.

Question 5
Question What are some considerations for a U.S. researcher conducting a study in a
non-U.S. setting when obtaining informed consent from subjects?

Your In addition to the consent of the research subjects, are there other
Answer individuals or groups whose permission must be sought?

Result Correct

Comment The points to consider when obtaining informed consent in non-U.S.


settings include in addition to the consent of the research subjects, are
there other individuals or groups whose permission must be sought?

Sometimes, in non-U.S. communities, people other than the individual


taking part in the research may be required to give permission before the
potential subject may be asked to participate. These individuals may
include a spouse, a head of household, or a group leader. However,
another individual's permission should not substitute for a subject's
voluntary informed consent unless an IRB or equivalent local review
committee has waived that consent process. The witness signature line is
an issue in documentation of informed consent; ensuring that the consent
process does not slow down recruitment is an issue in study design and not
a non-U.S. setting specific issue; and maintaining confidentiality is a
privacy/confidentiality issue.

You scored 100% on the quiz.

Congratulations! You have completed this Course.

View Post-Course Completion Options

Leave feedback for this Module


Return to Gradebook
View Courses

SUPPORT
888.529.5929
8:30 a.m. – 7:30 p.m. ET
Monday – Friday
Contact Us

LEGAL
Accessibility
Copyright
Privacy and Cookie Policy
Terms of Service

You might also like