STUDY WORKSHEET FOR HUMAN SUBJECTS PROTECTION CERTIFICATION
Find answers and take tests at http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp
History Question 1. Match the items below with their appropriate descriptions.
A.
Belmont Report
B.
Nuremberg Code
C.
Tuskegee Syphilis Study
D.
Willowbrook Study
E.
Declaration of Helsinki
F.
CIOMS Guidelines
1. Originated in 1947 and sets forth 10 conditions that must be met before research is ethically permissible.
2. A statement of ethical principles developed by the World Medical Association to provide guidance to physicians
and others in the medical community conducting medical research involving human participants.
3. Highlighted the vulnerability of institutionalized children as participants in research and concerned the issue of
children deliberately infected with the hepatitis virus.
4. Document based on three basic principles: respect for persons, beneficence, and justice; defines and describes the
nature of informed consent.
5. Concerned with international ethics for biomedical research involving human participants, and sets forth 15
principles of ethical research for the international biomedical community.
6. A study that spanned over 30 years and violated the rights of more than 400 human research participants by
failing to obtain informed consent and misinforming participants that they were being treated for their disease when,
in fact, they were not.
History Question 2. Match the items below with their appropriate descriptions.
A.
Justice
B.
Beneficence
C.
Respect for Persons
1. The Belmont Report principle that is applied when attempting to distribute research risks fairly and without bias.
2. “Individuals should be treated as autonomous agents,” describes this Belmont Report principle.
3. This principle obligates the researcher to maximize possible benefits and minimize possible harm to human
research participants.
The Basics Question 1. Which of the following constitutes research involving human participants?
A.
A study using information from death certificates
B.
A study using identifiable patient tissue samples targeted for disposal
C.
A study using observations of public behavior
D.
A study using sensitive information collected through a survey voluntarily completed by study participants,
in which the survey was coded so respondents could be matched to the mailing list for follow-up.
A.
B.
C.
D.
a, c
b, d
a, b, d
a, c, d
The Basics Question 2. Which of the following is NOT acceptable when conducting research involving human
participants?
A.
Saliva and blood samples are taken from a group of intellectually gifted volunteer individuals and used in a
study regarding DNA and giftedness. Volunteers give proper informed consent for the study. A year later, data
obtained from the saliva and blood samples are used in a study regarding diabetes and DNA.
B.
A group of high school males with advanced intelligence is identified as the population sample for a study
on giftedness in all teenagers. Participation in the study is voluntary, and the participants give proper informed
consent.
C.
An investigator makes an announcement in a psychology class that student volunteers are being sought for
a behavioral psychology study. The investigator informs the class that the first 50 participants to sign up and give
consent will receive 10 extra-credit points.
D.
None of the above is acceptable.
The Basics Question 3. Who has the primary responsibility for ensuring that the study has been approved by
an IRB?
A.
Federal agencies
B.
Funding agencies
C.
Principal Investigator
D.
Research Team
The Basics Question 4. All of the following populations have additional and specific federal regulations that
must be met for their protection except:
A.
Prisoners
B.
Children
C.
Fetuses
D.
The elderly
The Basics Question 5. A(n) ______ is a mechanism employed by investigators to protect against compelled
disclosure of a research participant’s identity or personal information in a court of law.
A.
Breach of Confidentiality
B.
Certificate of Confidentiality
C.
Certificate of Privacy
D.
Unauthorized Disclosure Form
Informed Consent Question 1. The Common Rule at 45 CFR 46.116 lists all the following requirements for an
informed consent form except:
A.
A description of foreseeable risks to the participants
B.
A disclosure of appropriate alternative courses of treatment that may be advantageous to the participants
C.
A statement describing to what extent records will be kept confidential
D.
A statement describing all the organizations or agencies funding the research study
E.
A statement that participation is voluntary and participants may refuse to participate or withdraw at any
time
Informed Consent Question 2. When determining a participant’s mental capacity to consent, if the person has
sufficient mental capacity to carry out daily activities of living and make his or her own decisions, he or she
has the capacity to consent to the research.
A.
True
B.
False
Informed Consent Question 3. If a researcher has difficulty determining whether a research participant has
sufficient mental capacity to consent, the best thing to do is to:
A.
Ask the potential participant’s family and close friends if he or she has sufficient mental capacity to
comprehend the research.
B.
Have a family member, caretaker, or guardian give permission for participation in the research and sign the
consent form for the participant.
C.
Consult a psychiatrist, neurologist, or other specialist for an independent capacity assessment.
D.
Explain to the participant that you don’t believe he or she fully understands what is involved and, therefore,
should not participate in the research.
Informed Consent Question 4. What should be done to obtain informed consent from a participant whose
native language is not English?
A.
The participant should be given a consent form written in his or her native language.
B.
A family member who speaks English should be asked to orally translate the consent form to the
participant.
C.
A family member who is fluent in English can be asked to read the consent form in place of the research
participant.
IRB Review Question 1. An institutional review board is:
A.
A group of pharmaceutical experts within the Food and Drug Administration that has been given authority
to regulate research involving human participants.
B.
A diverse panel of men and women over age 65 established to represent the health and safety issues of
elderly human research participants.
C.
A diverse group of qualified individuals, authorized by Congress to regulate federally supported research
that involves human participants.
IRB Review Question 2. All of the following are true of an IRB except:
A.
It should have at least five members
B.
At least three members should have an advanced degree in the scientific field related to the study.
C.
No members should have a vested interest in the research study under review.
D.
Members should be from diverse backgrounds regarding race, gender, and cultural heritage.
IRB Review Question 3. In order for a research protocol to be approved by an IRB, all of the following
requirements are necessary except:
A.
Informed consent will be sought from each prospective participant.
B.
The protocol makes adequate provisions for monitoring data collection.
C.
Adequate provisions exist for protecting the privacy and confidentiality of human participants.
D.
The protocol contains a complete description regarding the use of placebos in the research, and why it is
deemed necessary.
Ongoing Protections Question 1. All of the following are considered methods of providing ongoing protection
to human research participants, except:
A.
Reporting adverse events
B.
Monitoring participants’ financial condition with regard to the cost of the study
C.
Data and safety monitoring
D.
IRB review of the ongoing study
E.
Ongoing informed consent
Ongoing Protections Question 2. Which of the following is not an objective of data and safety monitoring?
A.
Ensure that risks associated with research participation are minimized
B.
Ensure that private medical information is kept confidential
C.
Assess the integrity of a study
D.
Stop or modify a study if safety concerns arise
Ongoing Protections Question 3. The researcher is a voting member of an independent data and safety
monitoring board.
A.
True
B.
False
Ongoing Protections Question 4. Who has the responsibility for initially reporting specified adverse events?
A.
The IRB
B.
The data and safety monitoring board
C.
The FDA
D.
The Investigator and research team
International Research Question 1. If research conducted in a foreign country is supported by any U.S.
Government funds, the foreign institution must comply with U.S. regulations governing the protection of
human participants.
A.
True
B.
False
International Research Question 2. Which of the following is false?
A.
Federal regulations permit approval of research in foreign countries when the procedures prescribed by the
foreign institution afford protections that are equivalent to those in the United States.
B.
U.S. policy approves supplementing the individual consent form with group consent in cultures in which
permission to conduct the research is required from senior family members.
C.
U.S. policy permits different consent procedures for men and women in countries in which the culture and
leadership dictate this necessity.