To understand the complexities of using human participants in research, healthcare
professionals must apply ethical principles to the research process. The Collaborative
Institutional Training Initiative (CITI) program has developed training modules to assist
researchers in designing and conducting ethical research. Universities, local, state, and
federal governmental agencies, and other businesses that engage in human subject
research use CITI training to help ensure ethical research practices. Completion of this
training supports the professional formation of the nurse practitioner role.
Course Outcomes
This assignment enables the student to meet the following course outcomes:
CO 3: Appraise legal, regulatory, and professional standards in research and scholarship.
(POs 3, 4)
Due Date
The assignment is due by Sunday at 11:59 p.m. MT of Week 6.
The Late Assignment Policy applies to this assignment:
Students are expected to submit assignments by the time they are due. Assignments
submitted after the due date and time will receive a deduction of 10% of the total points
possible for that assignment for each day the assignment is late. Assignments will be
accepted, with a penalty as described, up to a maximum of three days late, after which
point a zero will be recorded for the assignment. Quizzes and discussions are not
considered assignments and are not part of the late assignment policy.
Total Points Possible
This assignment is worth 100 points.
Preparing the Assignment
Follow these guidelines when completing each component of the assignment. Contact
your course faculty if you have questions.
,General Instructions
This week, you will complete the CITI Program Biomedical Research Basic program. The
training program consists of 16 modules. To complete the CITI training certificate,
complete the 11 required modules and at least one of the elective modules.
Access the CITI Program homepageLinks to an external site. to register as a new user or
login as an existing user.
Follow instructions to access the training program Download instructions to access the
training programOpen this document with ReadSpeaker docReader.
Select the Biomedical Research Investigators course.
Complete the 11 required and one elective modules. You must earn a minimum of 80% on
all modules to complete the training program successfully and earn the Certificate of
Completion.
Save your transcript and Certificate of Completion.
Upload the Certificate of Completion to the Week 6 Dropbox.
Question 1
Question Informed consent is considered an application of which Belmont
principle?
Your answer Respect for Persons
Result Correct
Comment Respect for persons involves respecting individual autonomy in the
decision to participate in research. That respect is implemented through
the process of informed consent.
Question 2
, Question Which of the following is included in the The National Research Act of
1974:
Your answer Voluntary consent
Result Correct
Comment The Nuremberg Code included the requirement of the voluntary consent
of subjects. While all of the choices are valid ethical concerns, none of
the other choices were included in the Nuremberg Code.
Question 3
Question The National Research Act of 1974
Your answer Required that all federal agencies have the same regulations
governing human subjects research.
Result Incorrect
Correct Answer Established the National Commission.
Comment The National Research Act of 1974 established the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research. The identification of guidelines, ethical
principles and regulations came as a result of the deliberations of the
National Commission.
Question 4
Question The use of prisoners in research is a concern under the Belmont
principle of Justice because:
Your answer Prisoners are not free to say no
Result Incorrect
, Correct Answer Prisoners may not be used to conduct research that only benefits the
larger society
Comment The Belmont Principle of Justice requires the equitable distribution of
both the benefits and burdens of research. Prisoners should not bear
the burden of participating in research that only benefits the larger
society.
Question 5
Question Which of the following brought increased public attention to the
problems with the IRB system?
Your answer Death of Research Subject (Jesse Gelsinger)
Result Correct
Comment Although all of these are related to the problems with the IRB system, the
death of a research subject (Jesse Gelsinger) was what received public
attention.
Question 1
Question A subject in a clinical research trial experiences a serious, unanticipated
adverse drug experience. How should the investigator proceed, with
respect to the IRB, after the discovery of the adverse event occurrence?
Your answer Report 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.
Result Correct
professionals must apply ethical principles to the research process. The Collaborative
Institutional Training Initiative (CITI) program has developed training modules to assist
researchers in designing and conducting ethical research. Universities, local, state, and
federal governmental agencies, and other businesses that engage in human subject
research use CITI training to help ensure ethical research practices. Completion of this
training supports the professional formation of the nurse practitioner role.
Course Outcomes
This assignment enables the student to meet the following course outcomes:
CO 3: Appraise legal, regulatory, and professional standards in research and scholarship.
(POs 3, 4)
Due Date
The assignment is due by Sunday at 11:59 p.m. MT of Week 6.
The Late Assignment Policy applies to this assignment:
Students are expected to submit assignments by the time they are due. Assignments
submitted after the due date and time will receive a deduction of 10% of the total points
possible for that assignment for each day the assignment is late. Assignments will be
accepted, with a penalty as described, up to a maximum of three days late, after which
point a zero will be recorded for the assignment. Quizzes and discussions are not
considered assignments and are not part of the late assignment policy.
Total Points Possible
This assignment is worth 100 points.
Preparing the Assignment
Follow these guidelines when completing each component of the assignment. Contact
your course faculty if you have questions.
,General Instructions
This week, you will complete the CITI Program Biomedical Research Basic program. The
training program consists of 16 modules. To complete the CITI training certificate,
complete the 11 required modules and at least one of the elective modules.
Access the CITI Program homepageLinks to an external site. to register as a new user or
login as an existing user.
Follow instructions to access the training program Download instructions to access the
training programOpen this document with ReadSpeaker docReader.
Select the Biomedical Research Investigators course.
Complete the 11 required and one elective modules. You must earn a minimum of 80% on
all modules to complete the training program successfully and earn the Certificate of
Completion.
Save your transcript and Certificate of Completion.
Upload the Certificate of Completion to the Week 6 Dropbox.
Question 1
Question Informed consent is considered an application of which Belmont
principle?
Your answer Respect for Persons
Result Correct
Comment Respect for persons involves respecting individual autonomy in the
decision to participate in research. That respect is implemented through
the process of informed consent.
Question 2
, Question Which of the following is included in the The National Research Act of
1974:
Your answer Voluntary consent
Result Correct
Comment The Nuremberg Code included the requirement of the voluntary consent
of subjects. While all of the choices are valid ethical concerns, none of
the other choices were included in the Nuremberg Code.
Question 3
Question The National Research Act of 1974
Your answer Required that all federal agencies have the same regulations
governing human subjects research.
Result Incorrect
Correct Answer Established the National Commission.
Comment The National Research Act of 1974 established the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research. The identification of guidelines, ethical
principles and regulations came as a result of the deliberations of the
National Commission.
Question 4
Question The use of prisoners in research is a concern under the Belmont
principle of Justice because:
Your answer Prisoners are not free to say no
Result Incorrect
, Correct Answer Prisoners may not be used to conduct research that only benefits the
larger society
Comment The Belmont Principle of Justice requires the equitable distribution of
both the benefits and burdens of research. Prisoners should not bear
the burden of participating in research that only benefits the larger
society.
Question 5
Question Which of the following brought increased public attention to the
problems with the IRB system?
Your answer Death of Research Subject (Jesse Gelsinger)
Result Correct
Comment Although all of these are related to the problems with the IRB system, the
death of a research subject (Jesse Gelsinger) was what received public
attention.
Question 1
Question A subject in a clinical research trial experiences a serious, unanticipated
adverse drug experience. How should the investigator proceed, with
respect to the IRB, after the discovery of the adverse event occurrence?
Your answer Report 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.
Result Correct
