Peoria Institutional Review Board
One Illini Drive, Box 1649
Peoria, Illinois 61656-1649
Phone: 309-680- 8630
Fax: 309-671-3406
UNIVERSITY OF ILLINOIS
COLLEGE OF MEDICINE AT PEORIA
Printed Name:
Department:
__________________________
Address:
Signature:
__________________________
Email:
_________________________
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Date:
Nurses’ Research Test
Circle the correct answer
1. The Syphilis Study is an example of research with ethical problems. An important lesson
from this study is that:
A. researcher may violate ethical norms even though they have good intentions.
B. only biomedical research has been associated with ethical problems.
C. research scandals never result in national legislation or regulations
D. mistakes of the past can never be repeated.
2. The FDA and DHHS published federal regulations for the protection of human subjects
in biomedical and behavioral research. What two protections do these “Common Rule”
regulations mandate?
A. payment to subjects and compensation for injury
B. informed consent and IRB review
C. confidentiality of research records and privacy guarantees
D. direct benefit to subjects and elimination of all risks.
3. The Belmont Report contains the ethical principles upon which the federal regulations
for the protection of human subjects are based. There are three ethical principles contained
in the Belmont Report. They are:
A. Respect for Persons, Beneficence, Therapeutic Value
B. Respect for Persons, Beneficence, Justice
C. Respect for Persons, Therapeutic Value, Justice
D. Therapeutic Value, Beneficence, Justice
4. According to the federal regulations, all of the following are criterion that must be
satisfied if an IRB is to approve the research EXCEPT:
A. The risks to subjects are minimized and risks to subjects are reasonable in relation to
anticipated benefits.
B. The selection of subjects is equitable and informed consent is adequate and
appropriately documented.
C. Where appropriate, the research plan makes adequate provision for monitoring the
data collected to ensure the safety of subjects.
D. When some or all of the subjects are likely to be vulnerable to coercion or undue
influence, an uninvolved patient advocate must be documented as soliciting consent
from the subject.
UNIVERSITY OF ILLINOIS
COLLEGE OF MEDICINE AT PEORIA
Peoria Institutional Review Board
One Illini Drive, Box 1649
Peoria, Illinois 61656-1649
Phone: 309-680- 8630
Fax: 309-671-3406
5. According to the Belmont Report, the process of informed consent requires three key
components to be adequately addressed to be considered ethically valid. These are:
A. confidentiality, compassion and comprehension
B. information, understanding and voluntary agreement
C. signatures of the subject, person obtaining consent and a witness
D. subject’s signature and date plus receipt of a copy of the form
6. The federal “Common Rule” regulations for human subject research requires that the
following basic elements of informed consent be provided to each subject EXCEPT
A. Duration of subject’s participation.
B. A statement that the study involves research.
C. Circumstances under which the subject’s participation may lead to opportunities for
commercial gain for any patents that may result from the research.
D. Whether on not there is compensation to a subject, if they are injured while enrolled
in research.
7. The Department of Health and Human Services (DHHS) regulations governing human
subjects research provide guidances for which three “vulnerable populations”:
A. 1) Pregnant women, and fetuses; 2) prisoners; and 3) children.
B. 1) Pregnant women, and fetuses; 2) healthy volunteers; and 3) prisoners.
C. 1) Trauma or comatose subjects; 2) children and 3) students.
D. 1) Trauma or comatose subjects; 2) healthy volunteers and 3) illiterate subjects.
8. The Privacy Rule:
A. Establishes criminal and civil penalties for improper use and disclosure.
B. Gives the patient the right to receive a Notice of Privacy Practice
C. Gives the patient the right to receive a list of possible disclosures;
D. All of the above
9. Individual authorization is required from the patient before any of their PHI is used or
disclosed for research unless:
A. The PHI is de-identified.
B. A waiver of authorization is obtained from the IRB.
C. A limited data set is used with a Data Use Agreement.
D. All of the above.
10. According to the federal regulations, which of the following best describes when
expedited review of a new study can be used by the IRB?
A. The study is required for a student research project
B. The study does not require informed consent or survey instruments
C. The investigator needs to meet a grant deadline
D. The study involves no more than minimal risk and meets one of the allowable
categories of expedited review specified in the regulations
UNIVERSITY OF ILLINOIS
COLLEGE OF MEDICINE AT PEORIA
Peoria Institutional Review Board
One Illini Drive, Box 1649
Peoria, Illinois 61656-1649
Phone: 309-680- 8630
Fax: 309-671-3406
11. The Declaration of Helsinki defines rules for “therapeutic” and “non-therapeutic”
research.
A. True
B. False
12. As defined in the Belmont Report, the ethical principle of respect for persons relates to
the general rule: the burdens of research should be shared equally.
A. True
B. False
13. A human subject is a living or deceased individual about whom an investigator (whether
professional or student) conducting research obtains data.
A. True
B. False
14. An IRB must be “appropriately constituted” with at least five (5) members with varying
backgrounds. At least one member must have primary concerns in scientific areas and at
least one member must have primary concerns in nonscientific areas. Each IRB shall have
one member who is affiliated with the research institution.
A. True
B. False
15. A consent for research under the Common Rule is the same as an authorization for
disclosure of Protected Health Information (PHI) under the HIPAA Privacy Rule.
A. True
B. False